INDIANA HEALTH LAW REVIEW VOLUME 1 IssUE 1 DEDICATION Eleanor D. Kinney and David Orentlicher, Co-Directors, William S. and Christine S. Hall Center for Law and Health MCDONALD-MERRILL-KETCHAM MEMORIAL AWARD FOR EXCELLENCE IN LAW AND MEDICINE Legal and Ethical Considerations in Government Compensation Plans: A Case Study of Smallpox Immunization Naomi Seiler, Holly Taylor and Ruth Faden Giving, Selling, and Having Taken: Conflicting VIews of Organ Transfer ARTICLES Recent Modifications to the Preemption Doctrine & Their Impact on State HMO Liability Laws The Vagaries of Informed Consent Prolific Plaintiffs or Rabid Relators? Recent Developments in False Claims Act Litigation Governance Issues for Nonprofit Healthcare Organizations and the Implications of the Sarbanes-Oxley Act Legitimate Expectations, Unreasonable Beliefs, and Legally Mandated Coverage of Experimental Therapy NOTE Hospital Liability: Drawing a Fine Line with Informed Consent in Today's Evolving Health Care Arena 1004 H. Tristram Engelhardt, Jr. Karen A. Jordan George P. Smith, II Keith D. Barber, David B. Honig and Neal A. Cooper Glenn T. Troyer, David E. Jose and Andrea D. Brashear Leslie Pickering Francis Shelley S. Fraser Indiana Health Law Review Volume 1 2004 Editor-in-Chief Julie D. Reed Executive Managing Editor Kelly J. Green Executive Production Editor Leeanne R. Coons Executive Development Editor Gina M. Brown Elizabeth A. Ackmann Calvin R. Chambers Kendra L. Conover Erin M. Drummy David J. Duncan Adriane E. Giltner Jennifer M. Hamilton Theodore G. Hammond J. Brad Kallmyer Members Executive Notes Editor Shelley S. Fraser Executive Articles· Editors Heidi K. Hughes Brian C. Betner David J. Lichtenberger Shannon L. Logsdon Bryon W. Miller Lawren K. Mills Julia E. Ohl Natalie J. Tanner Cynthia M. VanVooren David L. Whitsett Jason L. Williams Faculty Advisors Lawrence P. Wilkins (Chair) Eleanor D. Kinney David Orentlicher Robert A. Katz INDIANA HEALTII LAW REVIEW (ISSN 1549-3199) Content. The Indiana Health Law Review publishes articles submitted by academics, practitioners, and students on the topics of health law and policy. The scope includes bioethics, malpractice liability, managed care, anti-trust, health care organizations, medical-legal research, legal medicine, and food and drug law. The Indiana Health Law Review is currently published one time per year. Disclaimer. The ideas, views, opinions, and conclusions expressed in articles appearing in this publication are those of the authors and not those of the Indiana Health Law Review or Indiana University School of law- Indianapolis. 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In 1994, in conjunction with the Italian Academy for Advanced Studies in America at Columbia University, the Review published a special issue on the political and social aspects ofitalian law. In 1996, the Review published an issue addressing various aspects of Chinese law. Name School/Firm/Business Address City, State, Zip Code Subscriptions within the U.S. are $18.00 per year and outside the U.S. are $21.00 per year. I enclose $ for subscription(s) to the Indiana International & Comparative Law Review. Please make your check payable to Indiana International & Comparative Law Review. Mail to: Executive Production Editor Indiana International & Comparative Law Review Lawrence W. Inlow Hall 530 West New York Street Indianapolis, Indiana 46202 NAME ADDRESS: Please enter my subscription to the INDIANA LAW REVIEW Enclosed is $_for __ subscription(s) Mail to: AttN: Law Review SpeelaUst at INDIANA LAW REVIEW INDIANA UNIVERSITY SCHOOL OF LAW-INDIANAPOLIS Lawrence W. Inlow Hall 530 West New York Street Indianapolis. Indiana 46202-3225 For an academic year, the subscription rate for four issues is: *Domestic, $30; Foreign, $35; Student, $20* *Single Issue, $10;. Survey Issue, $20* *Symposium Issue, $15* DDDDDDDDOODDODDDDDDDDDODODOODO DDDOOODODOODOD THE IU SCHOOL OF LAW-INDIANAPOLIS IS OFFERING AN ll.M. IN HEALTH LAW, POLICY AND BIOETHICS Earn an LL.M. in health law, policy and bioethics at one of the country's top schools for the study of health law: The William S. and Christine S. Hall Center for Law and Health at the IU School of Law-Indianapolis is ranked in the top ten among health programs nationwide by U.S. News & World Report. • Gain Practical and Theoretical Knowledge in the Areas of Health Law, Policy and Bioethics • Learn About the Institutions and Structures of Healthcare and How They Affect the Ethical Issues that Arise in Medical and Legal Practices • Enhance Your Opportunities for Law-Related Employment • Program Consists of 2 4 Credit Hours • Courses offered in the areas of: Biotechnology Antitrust and Healthcare Bioethics Medical Malpractice For more information, or to apply, contact: Director of the LL.M. Program at (317) 278-4783 or e-mail at llmprgms@i.upui.edu. Or visit our website: www.indylaw.indiana.edu Indiana University School of Law-Indianapolis 2003-2004 ADMINISTRATIVE OFFICERS AND FACULTY Admiulstrative <>meers ADAM W. HBRBBRT, President, Indiana University. B.A., M.A., University of Southern California; Ph.D., University of Pittsburgh. CHARLEs R. BANTZ, Chancellor, Indiana University-Purdue University-Indianapolis. B.A., M.A., University of Minnesota; Ph.D., The Ohio State University. ANTHONY A. TARR, Dean and Professor of Law. B.A., LL.B., University of Natal; LL.M., Cambridge University; Ph.D., University of Canterbury; Ph.D., Cambridge University. 'IHOMAS B. AU.INGTON, Associate Dean for Teclmology and Professor of Law. B.S., J.D., University of Nebraska; LL.M., New York University. JEFFREY W. GROVE, Associate Dean for Grtllbulte Studies, Professor of Law, and Director, China Summer Program. A.B., Juniata College; J.D., George Washington University Law School SUSANAH M. MEAD, Associate Dean for Academic A/fain and Professor of Law. B.A., Smith College; J.D., Indiana University School of Law-Indianapolis. CYNTHIA BAKER. Director, Program on Law and State Government. B.A., J.D., Valparaiso University. ElJZABETHL DECoux,Assistant Dean for Student A/fain. J.D., Mississippi College School of Law. ANGELA M. EsPADA, Assistant Dean for Admissions. J.D., Indiana University School of Law-Bloomington. JONNA KANB MAcDouGAlL, Aufstant Dean for Extenuil A/fain. J.D., Indiana University School ofJ:.aw..;Jndianapolis. CAROL B. NEARY, Director ofDevel!JptMIIt. B.A., Indiana University. SHANNON L Wttl..IAMs, Director of Professional Development. B.S., Indiana University. Faeulty CYNTHIA M. ADAMS, Clinical Ass(]Ciate Professor of Law. B.A., Kentucky Wesleyan College; J.D., Indiana University School of Law-Indianapolis. THOMAS B. AWNGroN, Associate Dean for Technology and Professor of Law. B.S., J.D., University of Nebraska; Il...M., New York University School of Law. JUDliH FORD ANsPACH. Professor of Law and Director, Ruth lilly Law Librar;y. B.S., M.L.S., Kent State University; J.D., Mississippi College School ofLaw. BoRIS AUERBACH. Visiting Professor of Law. A.B., J.D., University of Chicago. GERALD L. BBPKO, Indiana Univer.rity-Purt:lue lhdversity-lndiantlpolis Chancellor Emeritw, Indiana University Tnlstu Professor and Projeuor of Law. B.S., Northern Dlinois University; J.D., l1T/Chicago-Kent College of Law; LL.M., Yale Law School. FRANK BOWMAN, M. Dale Pabn.el' Professor of Law. B.A., Colorado College; J.D., Harvard Law School. WlU.IAM C. BRADFORD, Assistant Professor of Law. B.A., M.A., University of Miami; Ph.D., Northwestern University; J.D., University of Miami School of Law; LL.M., Harvard Law School ROBERT BROOKINS, Professor of Law. B.S., University of South Florida; J.D., Ph.D., Cornell University. KENNETH D. Cm!sTEK, Clinical Associate Professor of Law. B.A., Pennsylvania State University; J.D., University of Pittsburgh School of Law. DANIEL H. CoLB, R. Bruce Townsend Professor of Law. A.B., Occidental College; A.M., University of Chicago; J.D., Lewis and Clark Law School; J.S.M., J.S.D., Stanford Law School. JEFFREY 0. COOPER, Associate Professor of Law. A.B., Harvard University; J.D., University of Pennsylvania Law School. PAUL N. Cox, Centennial Professor of Law. B.S., Utah State University; J.D., University of Utah College of Law; LL.M., University of Virginia School of Law. ROBIN KUNDJS CRAIG, Associate Professor of Law. B.A., Pomona College; M.A., The Johns Hopkins University; Ph.D., University of California; J.D., Lewis and Clark Law School K:ENNBTH D. CREWs, Associate Dean of the Faculties for Copyright Management cmd Scunuel R. Rosen ·II Professor of Law and Professor of Library and Information Science. B.A., Northwestern University; J.D., Washington University School of Law; M.L.S., University of California, Los Angeles; Ph.D., University of California. Los Angeles. JAMES D. DIMmu. Clinical Associate Professor of Law. B.S., Indiana University; J.D., Valparaiso University School of Law. lENN'lF1'Dl ANN DROBAC. Associate Professor of Law .. B.A., M.A., Stanford University; lD., J.S.D., Stanford Law School. GEoRGE E. EDWARDS, Professor of Law and Director; Program in Intematiqnal Hwncm Rights Law. B.A., North Carolina State University; J.D., Harvard Law School FRANK EMMERT, Professor of Law and Eucutive Direclor, Center for International and Comparative Law. Brstes 1urist:isches Staarsexamen (J.D.), University of Munich Law School; ll..M., 'lbe University of Michigan Law School; Ph.D., University . of Maastricht; Diploma, European University Institute. NICHOLAS GBoRGAKOPOUU>S, Professor of Law. Ptyhion Nomikis, Athens University School of Law; U..M., S.J.D., Harvard Law School. , Hllu5N GRANT, Vuiting Professor of Law. B.A., U..M.~ QueeDsland University of Technology; Ph.D., University of Queensland. JEfFREY W .. GROVE, Associate Dean, Professor of Law, and Direclor, China Summer Program. A.B., Juniata College; J.D., George Wasbington University Law School. FRANCEs WATSON HARDY, Clinical Associate Professor of Law. B.S., Ball State University; J.D., Indiana University School of Law-Indianapolis. JOHN LAWRENCE HlU., Professor of Law. B.A., Notthom Dlinois University; J.D., Ph.D., Georgetown University. LAWRENCE A.l'EGEN, m, Thomas.F. Sheelum Professor ofT ax. Law and Policy. A.B., Beloit College; J.D., M.B.A., The University ofMicb:igan; U..M., New York University School of Law. HENRY C. KARLsoN, Professor of Law. A.B., J.D., u..M., University of Dlinois College of Law. · ROBERT A. KATZ. Associate Professor of Law. A.B., Harvard College; J.D., University of Chicago Law School. LINDAKEU.Y-Hnl., Professor of Law. B.A., J.D., UniversityofVirginia. Bl.BANoR D. Kl:NNBY, Hall Render Professor of Law and Co-Director of the WiUiam S. and Christine S. Hall Center for Law and Health. B.A., Duke University; M.A., University of Chicago; J.D., Duke University School of Law; M.P.H., University of North Carolina. ANDREW R. Kl.mN, Paul E. Beam Professor of Law. B.A., University of Wisconsin; J.D., Emory University School of Law. ROBERT E. LANCASTBR. Clinical A.rsociau Professor of Law. B.A., Millsaps College; J.D., Tulane Law School. NoRMAN I...EFs'rmN, Professor of Law and Dean Emeritus. U..B., University of Dlinois College of Law; LL.M., Georgetown University Law School. MARfA PABON L6PEz, Assistant Professor of Law and Co-Director, Latin American Law Program. B.A., Princeton University; J.D., University of Pennsylvania Law School. GERARD N. MAOUOCCA, Assistant Professor of Law. B.A., Stanford University; J.D., Yale Law School. AwsoNMARTIN, Clinical Associate Professor Law. B.S., J.D., University of Dlinois. DEBORAH McGREGOR, Qinical Associate Professor of Law and Assistant Director of Legal Anal:jsis, Research and CommuniCtltion. B.A.. University of Evansville; J.D., Georgetown University Law School. SUSANAB M. MEAD, Associate Dean and Professor of Law. B.A., Smith College; J.D., Indiana University School ofLaw-Indianapoli MARY H. Mrramu., Professor of lAw. A.B .• Butler University; J.D., Cornell Law School. NOVELLAN!DBFF, QinicalAssociate Professor of Law. B.A •• J.D., Indiana University. JAMES P. NEHF, Cleon H. Foust Fellow, Professor of Law, and Director, European Law Program. B.A., Knox College; J.D., University of North Carolina Law School. DAVID OR:mm.ICBEP., Samuel R. Rosen I Professor of Law and Co-Director of the William S. and Christine S. HaU Center for Law and Health. A.B., Brandeis University; J.D., M.D., Harvard College. JOANNE ORR, Clinical Associo.te Profusor of Law. B.S., Indiana State University; J.D., . California Western School of Law. ANToNY PAGE. Assistant Profeuor of Law. B. Comm., McGill Univetsity; M.B.A., Simon Fraser Univetsity; J.D., Stanford Law School. H. KATin.'EEN PATamL, Associo.te Professor of Law. A.B., HuntingtOn College; J.D .• University of North Carolina Law School; LL.M., Yale Law School. FLoRENCE WAGMAN RoJSMAN, M~l D. McCormiclc I Professor of Law. B.A •• University of Connecticut; ll..B., Harvard Law School. JOAN M. RUHr.BNBER.G, Clinical Profeuor of Law tDUl Director of Legal Analysis, Research and Communication. B.A., Mississippi University for Women; J.D., Indiana University School of Law-Indianapolis. JOEL M. SCHUMM, Clinical As.ristant Professor of Law. B.A., Obio Wesleyan University; M.A., University of CinclDDati; J.D., Indiana University School of Law-Indianapolis. . ANTHONY A. TARR, Dean and Professor of Law. B.A., U..B., University of Natal; ILM., Cambridge University; Ph.D.. University of Canteibury; Ph.D., Cambridge University. JtJL1E-ANNE TAR.R, Visiting Profeuor of Law and Associate Dean oflntenuJtional Programs (New Initiatives), buliana University. B.A., University of W'J.SCOnsin-Madison; J.D., Cornell University; LL.M., Monash University; Ph.D., University of Queensland. JAMES W; TOBKB, Carl M. Gray Profusor of Law. B.S., J.D;, Univetsity ofW'lSCODSin. l.AWRBNCB P. WD.laNs, WiUiam R. Neak Professor of Law. B.A., 1he Ohio State University; J.D., Capital University Law School; ILM., University of Texas School of Law. LLoYD T. Wtt.sON, JR., Associate Professor of Law. B.A., Wabash College; M.A., Duke University; J.D., Indiana University School ofLaw-Bloomiiigton. MARY T. Wou, Clinical Professor of Law and Director of Clinical Programs. B.A., Saint Xavier College; J.D., University oflowa College of Law. R. GBoRGE Wtuam, Michasl D. McCormid H Projtwor of Law. A.B., Univetsity of VJtginia; Ph.D., Indiana University; J.D., Inc1iana University School of Law-Indianapolis. Emeriti EDWARD P. ARCBEP., Professor of Law Emeritus. B.M.E., Renesselaer Polytechnic IDstitute; J.D.,IL.M., Georgetown University Law School JAMES F. BAJLEY, m. Profossor of Law Enwrilus. A.B., J.D., M.A.LS., 1he Univetsity of Michigan. AGNES P. BARRB'tr, A.r.sociate Professor of Law Emerita. B.S., J.D., Indiana University. CLYDE HARRisON CROCKB'IT, Professor of Law Em«rltus. A.B., J.D., UniversitY of Texas; IL.M., University of London (Tbe Lcmdon Scboo1 of Economics and Political Science). DEBRA A. FAIBNDBR. Profeuor of Law Emmta. A.B., Mount Holyoke College; J.D., Indiana University School of Law-Indianapolis. DAVID A. FuNK, Professor of Law Emeritus. A.B., College of Wooster; J.D., Case Western Reserve University School of Law; M.A., 1he Obio State University; ILM., Case Western Reserve Univetsity; ILM., Columbia Law School. PAUL J. GALANTI, Profe88or of Law Emeritus. A.B., Bowdoin College; J.D., University of Chicago Law School. HE.l.EN P. GARFIELD, Professor of Law Emerita. B.S.J., Northwestern University; J.D., University of Colorado School of Law. HAROlD GREENBERG, Professor of Law Emeritus. A.B., Temple University; J.D., University of Pennsylvania Law School. Wll.llAM F. HARVEY, Carl M. Gray Professor of Law & Advocacy Emeritus. A.B., University of Missouri; J.D., LL.M., Georgetown University Law School. W. Wll.lJAM HoDES, Professor of Law Emeritus, A.B., Harvard College; J.D., Rutgers University School of Law-Newark. WIU..IAM ANDREW KERR, Professor of Law Emeritus. A.B., West University; B.S., Duke University; J.D., LL.M., Harvard Law School. WllllAME. MARSH. Professor of Law Emeritus. B.S., J.D., University of Nebraska. RONAlD W. POLSTON, Professor of Law Emeritus. B.S., Eastern Dlinois University; LL.B., University ofDlinois College ofLaw. KBNNETH M. STROUD, Professor of Law Emeritus. A.B., J.D., Indiana University­ Bloomington. JAMES PATRICK WHITE, Professor of Law Emeritus. A.B., University of Iowa; J.D., LL.M., George Washington University Law SchooL Law Library Faculty JUDrrH FORD ANsPACI, Professor of Law and Director, Ruth Lilly Law Library. B.S., M.LS., Kent State University; J.D., Mississippi College School of Law. DRAOOMIR COSANICI, Head of Reference. B.A., Michigan State University; M.I.LS., University of Michigan; J.D., University of Kansas. DEBRA DENsu.w, Reference Librarian. B.A., Fnnk1in College; M.S., University of Dlinois Urbana-champaign; J.D., Valparaiso Univenity. MARY HuDSON, Refereru:tt/Circulation Librarian. B.A., Ball State; M.L.S;, Indiana University. Riawm HUMPHREY, Reference Ubrarilm. A.A., Brewton-Parker Junior College; B.A., Georgia Southwestern College; M.LS.; University ofKentnclcy. WENDElL E. JOHNTING, Assistant Director for Tedmical Services. A.B., Taylor University; M.LS., Indiana University. CHlus E. LONG, Catalog Ubraritm. B.A., Indiana University; M.A., Indiana University; M.L.S., Indiana University. MAHNAZ K. MOSHFEGH, Acquisiti