Indiana Law Review Moore v. Regents of the University of California: More for Biotechnology, Less for Patients I. Introduction Human biological materials' are frequently used in biotechnological research. These materials are useful in the development or production of novel hybridomas, cell lines, therapeutically active proteins, and anti- bodies for diagnostic or therapeutic purposes. Several interesting legal questions arise when these materials are obtained during a necessary therapeutic procedure. These issues include the respective rights of the parties to the products of the research and the consent that must be obtained for the use of the biological materials. In Moore v. Regents of the University of California,''- a patient, whose excised spleen was used to develop a cell line, asserted a right to share in the profits that were the result of research on his biological materials. The California Supreme Court decided that a physician must disclose his research interests and that the patient has no ownership interest in his biological materials which are used in the research."" This Note discusses whether the common-law obligation of disclosure by the physician to the patient is applicable when human biological material is obtained during a necessary therapeutic procedure. Second, this Note considers whether the common-law doctrine of informed consent protects the patient's right to consent to the disposition of or use of the biological materials removed from his body. This Note explores whether the recognition of conversion as a cause of action expands the common-law doctrine. Finally, the most important issue, which arises out of the Moore case, is whether existing legal doctrines can effectively resolve the issues posed by the rapidly developing field of biotechnology, or alternatively, whether the advance of science, in particular biotech- nology, has outpaced the development of the law.^ A. Biotechnology Biotechnology is currently one of the most rapidly developing areas of science. The rapid growth and development are primarily attributable 1. The term '"human biological materials" will be used to dt-i:'.:^ all materials obtained from huma- -5 can be used in research including, but not limited to, blood, serum, saliva, urine, -^i'\ and tissues. 2. 51 Cal. 31 ;: ->3 P.2d 479, 271 Cal. Rptr. 146 (1990). 3. Id. at 146, 793 P. 2d at 497, 271 Cal. Rptr. at 164. 4. See Wagner, The Legal Impact of Patient Materials used for Product Devel- opment in the Biomedical Industry, 33 Clinical Reseajich 444 (i9S5j fWagner suggested that the rapid development of biomedical science has outstripped the law's ability to keep up). 560 INDIANA LAW REVIEW [Vol. 25:559 to two important discoveries. In 1953, Watson and Crick discovered the structure of DNA,^ which is the discrete unit responsible for the char- acterization of all Hving organisms.^ In 1973, Cohen and Boyer disclosed a method for transferring genetic information from one organism to another.^ Scientists have expanded the frontiers of science beyond these initial discoveries to create a field of science that was virtually nonexistent less than forty years ago. Biotechnology comprises three main areas of technology: tissue and cell culture technology, hybridoma technology, and recombinant DNA technology.^ Tissue and cell culture technology generally include research directed toward the development of a cell line which can grow and reproduce in a continuous culture. EstabUshing a human cell Hne^ is particularly difficult; however, the probability of success is substantially increased when tumor cells are used.^^ A second area of biotechnology, which is commercially important in the production of antibodies,'^ is hybridoma technology. A hybridoma is a cell that results from the fusion of an antibody-producing cell with a tumor cell.'^ The hybridoma retains the beneficial characteristics of 5. Prior to 1953, deoxyribonucleic acid (DNA) was believed to be the carrier of a part of the genetic specificity of the chromosomes. However, until the publication by Watson and Crick, the mechanism of exact self-duplication of the genetic material was unknown. The discovery by these scientists of the structure of DNA led to a proposed mechanism of self-replication. The proposed structure was a double helix comprising two complimentary chains. The mechanism of self-replication was postulated to proceed by separation of the two chains and enzymatic synthesis of new comphmentary chains. Watson & Crick, Genetical Implications of the Structure of Deoxyribonucleic Acid, 171 Nature 964 (1953). 6. U.S. Congress, Office of Technology Assessment, New Developments in Biotechnology: Ownership of Human Tissues and Cells 41 (1987) [hereinafter OTA Report! • 7. Cohen and Boyer discovered a process for conferring antibiotic resistance in Escherichia coli cells. Their method used restriction endonucleases, enzymes which are capable of cleaving double-stranded DNA to produce cohesive ends, to form plasmid DNA segments. The plasmids were then inserted into an E. coli by transformation. The procedure was suggested to be useful for the insertion of segments of prokaryotic or eukaryotic chromosomes into independent replicating bacterial plasmids. Cohen, Chang, Boyer, & Helling, Construction of Biologically Functional Bacterial Plasmids In Vitro, 70 Proc. Nat'l Acad. Sci. 3240 (1973). 8. OTA Report, supra note 6, at 5. 9. A human cell line is defined as cells derived from humans which are capable of continuous and indefinite growth in culture. Id. at 33. 10. Id. at 5. 11. An antibody is a protein which binds to a specific foreign substance. Id. at 37. 12. Kohler and Milstein were the first to report the fusion of a B-lymphocyte with a myeloma cell. The fusion product, a hybridoma, produced homogeneous compositions of antibodies. Kohler & Milstein, Continuous Cultures of Fused Cells Secreting Antibody of Predefined Specificity, 256 Nature 495 (1975). 1991] MOORE V. REGENTS 561 each of the fusion partners, such as immortality and the ability to produce antibodies. Hybridoma technology has been essential in the development of monoclonal antibodies which are used as diagnostic and therapeutic agents.'^ Recombinant DNA technology involves the manipulation of the DNA within a cell.'* For example, a gene which codes for a particular protein is inserted into the genetic material within a cell. The recombinant cell, which contains the foreign DNA, frequently is capable of expressing this genetic information to produce the foreign protein. This technology has been commercially utilized to produce recombinant organisms which are able to metabolically synthesize therapeutically important human proteins.'^ The rapid increase in the development of biotechnology has resulted in an increase in the use of human biological materials in research. Human biological materials are indispensable as a source of important genetic information, such as a source of DNA that codes for a particular protein or antibody.'^ Also, these materials, in particular human tissues and cells, are useful in the development of human cell lines or in the production of hybridomas. Researchers obtain human biological materials by a variety of meth- ods.'^ One method of obtaining these materials is from volunteers, who frequently are compensated. A second common method is to request a sample from an organized repository.'^ Also, these materials are fre- quently obtained directly from the patient, possibly without his knowledge or consent, following a surgical procedure or diagnostic test.'^ B. Biotechnology and Law The use of human biological materials in biotechnological research has raised several important legal questions.^° These issues may be divided 13. See D. Katz, Monoclonal Antibodies and T Cell Products (1982). 14. OTA Report, supra note 6, at 5. 15. See A. Bolton, Recombinant DNA Products: Insulin, Interferon and Growth Hormone (1984). 16. Human proteins and antibodies are favored for therapy because they are allogenic (derived from a member of the same species) and therefore, less likely to initiate an immunogenic response in the patient. 17. OTA Report, supra note 6, at 52. 18. Organized repositories include American Type Culture Collection (ATCC); Human Genetic Mutant Cell Repository, Coriell Institute; National Cancer Institute, Bi- ological Carcinogens Branch; and Cell Culture Center, Massachusetts Institute of Tech- nology. Id. 19. The Use of Human Biological Material in the Development of Biomedical Products: Hearings Before the Subcomm. on Investigations and Oversight of the House Comm. on Science and Technology, 99th Cong., 1st Sess. 83 (1985) [hereinafter Subcomm. Report] (statement of David A. Blake, Ph.D.). 20. The Office of Technology Assessment identified the following issues: 562 INDIANA LAW REVIEW [Vol. 25:559 into the following categories: (1) the rights of the physician in the products of his research that are derived from the use of another's biological material; (2) the rights of the patient in the products, profits, or knowledge that is a direct result of research on his biological material; and (3) information that must be disclosed to the patient by the physician regarding the use of the patient's biological materials and potential benefits arising from the research. The resolution of these issues will affect biotechnology research, the biotechnology industry, and the phy- sician-patient relationship. A recent development in patent law resolved one of these important issues. In 1980, the Supreme Court in Diamond v. Chakrabarty^^ de- termined that a living, human-made microorganism is patentable subject matter under 35 U.S.C. § 101.^^ Chakrabarty filed a patent application which claimed, in part, a genetically engineered bacterium. The patent examiner rejected the applicant's claims on the ground that micro- organisms are "products of nature, "^^ and living things are not patentable Are bodily substances "property to be disposed of by any means one chooses, including donation or sale? Do property rights to their genetic identity adhere to individuals or to the species? Who should make the basic decisions affecting the acquisition of tissues and cells, and under what circumstances should acquisition be permitted or denied? What are patients and research subjects entitled to know about the potential commercial exploitation of an invention that uses their biological materials? And what is the probability that an individual's tissue and cells will end up in a commercial product? How is it that inventions incorporating human cells are patentable in the first place? How similar is the invention to the original biological material? What is the nature of the researcher's contribution versus the source's contribution to the invention? Who should profit from federally funded research using human tissue? To what extent are the issues raised by ownership of human biological materials related to commercial relationships between universities and companies? What are the implications of these issues for scientists, physicians, patients, volunteer research subjects, universities, and the biomedical product industry? OTA Report, supra note 6, at 1. 21. 447 U.S. 303 (1980). 22. Id. at 309. Section 101 provides: '*[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and re- quirements of this title." 35 U.S.C. § 101 (1988). 23. The term "product of nature" generally refers to a substance which is naturally produced or naturally occurring and which is not made by man. The Patent Act of 1952 authorizes the grant of a patent when three statutory requirements are met: novelty, utility, and nonobviousness. The "utility" requirement is set forth in 35 U.S.C. § 101 (1988), 1991] MOORE V. REGENTS 563 under section 101. The Supreme Court held that the genetically engineered organism was patentable subject matter under the statute.^"* To support its conclusion, the Court noted that the Committee Reports for the 1952 Patent Act expressed an intent to ''include anything under the sun that is made by man" within the meaning of patentable subject matter under section 101.^^ Since the Court's decision in Chakrabarty, researchers routinely pat- ent hybridomas, proteins, genes, and human cell lines produced through biotechnological research.^^ Upon the issuance of a patent, the researcher (patentee) may prevent others from making, using, or selling the patented invention. ^^ When the patent claims subject matter of commercial value, the patentee can license to others the right to practice the invention or the right to sell the claimed subject matter. Therefore, the grant of a patent provides the researchers with certain rights and, in part, answers the question regarding the rights of the researcher in the products of his research. However, the grant or denial of a patent does not address the question regarding the rights of the patient in the products of the research. The issue regarding the patient's rights in the products of research which directly result from the use of his biological materials has been raised in two recent disputes. The facts are clearly distinguishable on the following grounds: differences in the awareness of the patient in the research, the consent given prior to the use of the patient's biological materials, and the relationship between the patient and the researchers. The first dispute involved the use of human lymph node cells to produce a hybridoma cell Hne. In 1981, Drs. Royston and Glassy were investigating the production of monoclonal antibodies with specificity and the "novelty" requirement is contained in 35 U.S.C. §§ 101-02 (1988). The final requirement, "nonobviousness," is set forth in 35 U.S.C. § 103 (1988). In Merck & Co., Inc. V. Olin Mathieson Chemical Corp., 253 F.2d 156, 161 (4th Cir. 1958), the United States Court of Appeals noted that "products of nature" may be patented when the three statutory conditions for patentability are satisfied. See Slutsker, Patenting Mother Nature, Forbes, Jan. 7, 1991, at 290 (several biotechnology companies have patented purified human proteins). 24. Chakrabarty, AAl U.S. at 318. 25. Id. at 309. 26. Because of the newness, complexity, and rapid development of biotechnology, the pendency period for biotechnology patent applications is longer than for others. In 1989, the pendency period ranged from two and one half to four years. This delay in issuance of patents may have an adverse effect on the United States biotechnology industry. Yoo, Biotech Patents Become Snarled in Bureaucracy, Wall St. J., July 6, 1989, at Bl, col. 6. 27. Section 271 provides: "whoever without authority, makes, uses or sells any patented invention, within the United States during the term of the patent therefor, infringes the patent." 35 U.S.C. § 271(a) (1988). 564 INDIANA LAW REVIEW [Vol. 25:559 for human cancer cells. ^^ In particular, their research involved the fusion of lymphatic cells which were obtained from cancer patients^^ to an immortal cell line.^^ Dr. Hagiwara, a biology post-doctoral student from Japan, suggested that Drs. Royston and Glassy use lymph node cells from his mother, who was diagnosed as having cervical cancer. ^^ Dr. Glassy successfully developed a novel hybridoma cell line which produces antibodies to cervical cancer.^^ The Hagiwaras asserted the rights to the cell line and the antibodies on the ground that the genes were responsible for the production of the antibodies and were derived from Hagiwara' s cells." It is important to note that, prior to the commencement of the research, the parties did not enter into an agreement with respect to the rights of the parties.^"* Unfortunately, the rights of the parties in the products of the research were not addressed by a court. The parties voluntarily settled their dispute, agreeing that the university would retain all patent rights and that the Hagiwaras would receive an exclusive license to practice the invention in Asia.^^ The second case involved the use of a patient's diseased spleen to develop a commercially valuable cell line. In September 1976, John Moore was diagnosed as having hairy-cell leukemia. Because he requested a second opinion, Moore was referred to David W. Golde, M.D., head of the Oncology-Hematology Department at the University of California at Los Angeles (U.C.L.A.) Medical Center. In early October, Dr. Golde confirmed the diagnosis and recommended a splenectomy. On the day before the surgery, Moore signed a general consent form which specifically authorized the splenectomy and provided for the disposal of any severed tissue by cremation.^^ 28. Royston, Cell Lines from Human Patients: Who Owns Them? A Case Report, 33 Clinical Res. 442 (1985). 29. Specimens were obtained from the pathology department at the university. Id. 30. OTA Report, supra note 6, at 38. The particular cell line was a patented human lymphoblastoid B-cell line. This cellline is particularly efficient as a fusion partner with human lymphatic tissue. The parent cell line was derived from the culture of a spleen from a boy with hereditary spherocytosis. U.S. Patent No. 4,451,570, at col. 1, 2 (May 29, 1984). 31. Royston, supra note 28, at 442. 32. The novel hybridoma has been designated CLNH5 and is the claimed subject matter of a U.S. Patent. This hybridoma produces monoclonal antibodies which are reactive with cervical cancer cells. These antibodies are potentially suitable for use in the therapy of or diagnosis of cervical cancer. U.S. Patent No. 4,618,577, at col. 2 (Oct. 21, 1986). 33. Royston, supra note 28, at 442. 34. Id. 35. OTA Report, supra note 6, at 26. 36. The surgery consent form contained a provision for informing the patient of 1991] MOORE V. REGENTS 565 Dr. Golde and Shirley Quan, a researcher at the U.C.L.A. Medical Center, obtained a saniple of Moore's spleen from the pathologist. Using cell culture technology, Dr. Golde and Quan used Moore's spleen and established a cell line, the Mo cell line, which is capable of growing in a continuous culture for an indefinite period.-' The Mo cell line produces a number of proteins of commercial interest.^ Dr. Golde and Quan filed a patent apphcation in 1981 and received a patent in 1984 claiming the Mo cell line, methods for producing proteins by culturing the Mo cell line, and methods for cloning DNA which comprises isolating mRN.A'' from Mo cells. -^'^ The Regents of the University of California, as assignee of the patent. Dr. Golde, and Shirley Quan entered into agreements with Ge- netics Institute, Inc. and Sandoz Pharmaceuticals Corporation fSandoz) for the commercial development of the Mo cell line and the proteins produced by the Mo cells.-- These agreements allow Ge-netics Institute and Sandoz to use the Mo cells to develop commercial products in exchange for pavmenis to Dr Golde, Quan, and the Regents of the University.*^ Mr. Moore returned to the U.C.L.A. Medical Center several times between November 1976 and September 1983. Upon each visit, additional samples of his biological materials were removed. '- During one of his visits in April 1983, Mr. Moore was presented with a consent fonn which specifically authorized the use of his blood and bone marrow in research. This consent form contained a clause which granted to the the di5?05i:ion of his ic-tztc ::ss-e zy rr.t^r.-. z.:r.tr :-i' zrc—a:-- rizi-t'-tz., was lef: blank on Mc'-c . ::--e-- •':-'- 37. U.S. Pa'er: '•: --:-;:: -:: 2-3 v^.-;^ :; ,,\- 38. The M: it.'.i :-::,:t i - -— : i ,-i ....- '\ :-::eiiM, erythroid-potemiaTing i : : . ' : " , i - 1 : i : : - - " i - - ~ , - e - - ziercfiL, and ncutropbil migrati: ' : ' i: : ~ tr z-.t'.: r;,ct ^ - , :: em and have a hi^ cohl" t - : ^^ i .t i ti:-. : i^r- ~ -- ': :- i it i.r. "txwemdjf valoiMe as a scyu::r :f -.e s"'"- - -.i:t-.i. ':- :-t:t ;-::-. -i. 39. ^!r--'i- -::',:, t: -: "'.^. : - --'-.' i "t"- tz it - z-.^ - synthesis. T't gt'. t^: .:.:'.:" i'.^'.' iz'.'.c.'.tz .:. L.'^-. '.'.t' -, '.'.".z^" "- ; ;;t: process i^ * e ; _ . * e i : : ' : '. v \'i''.:\'"i.\\' : ' t L " -. : '-.'-' '-.' '. '::'". i :: ' ' : : : :. t s>r.:'c;.: :' :-:;r-: ".--z.!:. i z-..' - : - - i: ;-;-:::;:::' ;- ~?'-A ~:.ecakis iy'.:-:::.ze: :-;; : :;": t'-t'/i-. ;: ;: l'-^ :t~piate. Tne mK>«A ; -:t: ' -^-t'itioo i; i \z".z.^:t \z: .-.- .,.-;--:.: :' i ::-:.;:: ::::em- L. St»thi, i.^'^Hi-^:? : :-'-618 (2d ed. 19S1). 40. U.5 ?i:-- ^: --3-:": ;- ::' l--!^ ^'.-z' V. :;-- 41. Mgc:= .. Acge-:: - .-,. :: li... :. Ci,. ii .:_., .1' , "^2 ?.:^ 4-9, 45:, 271 Cal. Rptr. 146, 149 f : » 42. Genetics Instit^^'t -;; :;.: -- Vc:: 5330,000 and Sandoz added an additions! 5110,000. 43. These 566 INDIANA LAW REVIEW [Vol. 25:559 University "any and all rights [Moore], or [Moore's] heirs, may have in any cell line or any other potential product."'^ Mr. Moore voluntarily signed this consent form after he was told that the form was a standard form and was necessary for continued medical treatment. In September 1983, Moore returned to the Medical Center and was presented with an identical consent form. Mr. Moore inquired whether there was a commercial or financial interest involved in the research on his blood. He was not informed of the commercial value of his biological materials, but was told that the consent form was merely a formality. However, on this visit, Moore did not sign the consent form and therefore, did not grant to the University of California the rights in any cell line or products derived from his biological materials. Because of the unusual circumstances surrounding Moore's failure to sign the consent form, Moore sought legal counsel. In 1984, Moore filed a lawsuit claiming that he was entitled to share in the profits resulting from the use of his biological materials in research. Moore asserted that Dr. Golde had an intent to do research on Moore's biological material prior to the surgery. Moore also asserted that Dr. Golde never informed him of any plans to conduct research on his spleen or other biological materials. The third amended complaint, which named Dr. Golde, Quan, the Regents of the University of California, Genetics Institute, and Sandoz as defendants, alleged thirteen causes of action, including conversion, lack of informed consent, and breach of a fiduciary duty.'*^ The superior court sustained a general demurrer to the entire complaint on the grounds that the allegations regarding con- version were defective and that the remaining causes of action incor- porated these defective allegations. The California Court of Appeal reversed the superior court's decision and held that the complaint did state a cause of action for conversion. The court of appeal concluded that a person has a property right in his own biological materials and, absent his consent or lawful justifi- cation, the unauthorized use of his tissue constitutes conversion. Also, the court of appeal directed the superior court to address the remaining causes of action that had not been addressed in the court below. The Cahfornia Supreme Court held that Moore's third amended complaint 44. Subcomm. Report, supra note 19, at 268. 45. Moore stated the following causes of action: (1) conversion; (2) lack of informed consent; (3) breach of fiduciary duty; (4) fraud and deceit; (5) unjust enrichment; (6) quasi-contract; (7) bad faith breach of the implied covenant of good faith and fair dealing; (8) intentional infliction of emotional distress; (9) negligent misrepresentation; (10) inten- tional interference with prospective advantageous economic relationships; (11) slander of title; (12) accounting; (13) declaratory relief. Moore, 51 Cal. 3d at 128 n.4, 793 P.2d at 482 n.4, 271 Cal. Rptr. at 149 n.4. 1991] MOORE V. REGENTS 567 did state a cause of action for breach of the physician's fiduciary duty to the patient or lack of informed consent, but the complaint did not state a cause of action for conversion/^ The bases of the court's decision will be discussed and analyzed in detail below. II. Physician's Disclosure Obligation Before considering the extent to which the physician's disclosure obligation is applicable to protect the patient from commercial exploi- tation, it is necessary to consider the basis of this disclosure obligation and the common-law doctrines of informed consent and physician's fiduciary duty. A. Common Law Disclosure Obligations The physician's disclosure obhgation arises from the right of a patient to personal autonomy. This autonomy includes the ability **to determine what shall be done with [one's] own body.'"*^ This right protects the patient's interest in the exclusive ability to decide to reject or consent to treatment of his own body.**^ Because of the importance of personal autonomy, both the common law^^ and statutory law^^ impose an ob- ligation of disclosure upon physicians. The courts consider the relationship between a patient and his phy- sician to be a fiduciary relationship.^* As a fiduciary, the physician has a duty to fully disclose any facts which materially affect the patient's rights and interests." The purpose of the full disclosure requirement is to provide the patient with an adequate basis to form an intelligent 46. Id. at 147, 793 P.2d at 497, 271 Cal. Rptr. at 164. 47. Schloendorff v. Society of N.Y. Hosps., 211 N.Y. 125, 129-30, 105 N.E. 92, 93 (1914) ("Every human being of adult years and sound mind has a right to determine what all be done with his own body.")- 48. Cobbs V. Grant, 8 Cal. 3d 229, 243, 502 P.2d 1, 10, 104 Cal. Rptr. 505, 514 (1972). 49. R. Faden & T. Beauchamp, A History and Theory of Informed Consent (1986); F. RozovsKY, Consent to Treatment — A Practical Guide (1984). 50. Cal. Health & Safety Code § 24171 (West 1984). Title 22 of the California Administrative Code requires hospitals to adopt a written policy on patient's rights. These rights include the right to receive sufficient information in order to give informed consent and the right to participate actively in decisions regarding medical care. Cal. Admin. Code tit. 22, § 70707 (1990). See also 45 C.F.R. §§ 46.101 to -.409 (1990). 51. Bowman v. McPheeters, 77 Cal. App. 2d 795, 176 P.2d 745 (1947) (the relationship between the physician and patient is a fiduciary one). See also Nelson v. Gaunt, 125 Cal. App. 3d 623, 178 Cal. Rptr. 167 (1981) (duty of disclosure is a fiduciary one); Berkey v. Anderson; 1 Cal. App. 3d 790, 82 Cal. Rptr. 67 (1969); Stafford v. Shultz, 42 Cal. 2d 767, 270 P.2d 1 (1954). 52. Bowman, 77 Cal. App. 2d at 800, 176 P.2d at 748. 568 INDIANA LAW REVIEW [Vol. 25:559 decision regarding consent to the proposed treatment." A breach of this duty subjects the physician to HabiHty,^'* especially when there is material concealment or misrepresentation." Physicians have been held liable under an intentional tort theory when they do not make full disclosure prior to treatment. In Schloendorff V. Society of New York Hospitals,^^ a patient who consented only to an examination had a tumor removed while unconscious.^^ The New York Court of Appeals noted that a physician who performs an operation without the patient's consent commits an assault.^* More recently, in Barber v. Superior Court,^^ the California Court of Appeal noted that a physician who performs treatment in the absence of informed consent commits an actionable battery.^ Today, courts treat the failure of a physician to make a full disclosure as negligence, frequently referred to as lack of informed consent.^' Informed consent occurs when the physician discloses to the patient all material risks and alternatives to therapy in such a manner that the patient fully understands and may intelligently consent to treatment.^^ The physician has a duty to inform the patient of all information that is material to his decision.^^ When the physician fails to obtain informed consent, he is liable for negligently failing his duty of reasonable dis- closure. The doctrines of informed consent and duty to disclose are not equivalent, but both are applicable in all cases. The former focuses on the patient's understanding of the risks or alternatives or whether the 53. See Berkey, 1 Cal. App. 3d at 790, 82 Cal. Rptr. at 67. 54. Id. at 803, 82 Cal. Rptr. at 77. 55. Pashley v. Pacific Elec. Ry. Co., 25 Cal. 2d 226, 153 P.2d 325 (1944) (when there is a duty to disclose, the disclosure must be full and complete, any material concealment or misrepresentation will amount to a fraud sufficient to entitle the party injured to an action). 56. 211 N.Y. 125, 105 N.E. 92 (1914). 57. Id. at 128, 105 N.E. at 93. 58. Id. (except in an emergency situation when it is necessary to operate before consent can be obtained). 59. 147 Cal. App. 3d 1006, 195 Cal. Rptr. 484 (1983). 60. Id. at 1015, 195 Cal. Rptr. at 489. 61. D. DoBBS, Torts and Compensation — Personal Accountability and Soclal Responsibility for Injury 83 (1985). 62. Canterbury v. Spence, 464 F.2d 772, 780 n.l5 (D.C. Cir. 1972) (effective consent, "informed consent," arises when the patient understands the alternatives to and the risks of the proposed therapy). 63. Id. at 786; Cobbs v. Grant, 8 Cal. 3d 229, 243, 502 P.2d 1, 11, 104 Cal. Rptr. 505, 515 (1972) (a physician has a duty of reasonable disclosure of the alternatives and of the inherent and potential risks of the proposed therapy, including all material information as determined by the patient's need). 1991] MOORE V. REGENTS , 569 consent was based upon sufficient information, while the latter focuses on the physician's disclosure.*^ For example, a physician may fully discharge his duty to disclose, but the patient may not comprehend or understand what the physician has told him. In this case, the physician has satisfied his disclosure obligation; however, the consent is not con- sidered **informed consent.'* The doctrine of informed consent is generally applied in instances in which the physician unreasonably withholds information that is ma- terial to the patient's decision to consent to therapy. In one case, the physician may be negligent for failing to disclose the inherent risk of therapy .^^ In another case, the physician may be negligent for failing to disclose the extent of the patient's injuries.^ Both cases focus on the patient's condition and the available choices and risks of the proposed therapy. B, Statutory Disclosure Obligations Statutes establish the standard of disclosure that is applicable when patients are used in medical experimentation. Federal regulations, which were promulgated by the Department of Health and Human Services (DHHS),^^ specifically enumerate the basic elements that are required for informed consent.^* However, the application of these regulations is 64. Canterbury, 464 F.2d at 780 n.l5 (the duty of disclosure is described as the sine qua non of informed consent). 65. See R. Keeton, Prosser & Keeton on Torts § 32, at 190-191 (5th ed. 1984). 66. Courts have held that failing to disclose the extent of a patient's injuries constitutes fraudulent concealment. Bowman v. McPheeters, 77 Cal. App. 2d 795, 800, 176 P.2d 745. 747 (1947). 67. 45 C.F.R. §§ 46.101 to -.409 (1990). 68. The basic elements of informed consent are: (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others which may reasonably be expected from the research; (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; 570 INDIANA LAW REVIEW [Vol. 25:559 limited to research involving human subjects conducted by DHHS or funded by DHHS.^^ Also, the regulations exempt research involving the collection or study of pathological specimens or diagnostic specimens.^® Therefore, the federal regulations are not controlling when human bi- ological materials are obtained during or after a necessary therapeutic procedure. A number of states have enacted legislation to protect the rights of individuals who participate in medical experimentation.^' California has attempted to provide minimum statutory protection for individuals under the Protection of Human Subjects in Medical Experimentation Act.''^ The Act sets forth the experimental subject's bill of rights,^^ which are (7) An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. Id. § 46.116. 69. Id. § 46.101. 70. Id. § 46.101(b)(5). 71. California, New York, and Virginia have enacted such legislation. OTA Report, supra note 6, at 95. 72. Cal. Health & Safety Code §§ 24170-24179.5 (West 1984). 73. Section 24172 provides: As used in this chapter, "experimental subject's bill of rights," means a list of the rights of a subject in a medical experiment, in a language in which the subject is fluent. Except as otherwise provided in Section 24175, this list shall include, but not be limited to the subject's right to: (a) Be informed of the nature and purpose of the experiment. (b) Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized. (c) Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment. (d) Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable. (e) Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits. (f) Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise. (g) Be given an opportunity to ask any questions concerning the experiment or the procedures involved. (h) Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation in the medical experiment without prejudice. (i) Be given a copy of the signed and dated written consent form as provided 1991] MOORE V. REGENTS 571 similar to the DHHS regulations.^"* However, the Act's definition of **medical experiment" does not include research using severed human tissue.^^ As in the case of the federal regulations, the state regulations generally apply to research on the human body as a whole and are not applicable when the biological materials are obtained during a necessary procedure and subsequently used in research. C Moore v. Regents: Disclosure Obligation The California Supreme Court, in Moore v. Regents of the University of California,'^^ articulated a new standard for a physician's disclosure obligation. The Moore court held that a physician must disclose his personal interests, which potentially affect his medical judgement, to satisfy his fiduciary duty of disclosure and to obtain informed consent. ^^ These personal interests include the physician's research or economic interests."^* It is important at this point to note that only the physician's research or economic interests, which are **unrelated to the patient's health" and **that may affect [the physician's] medical judgment," must be disclosed.^^ This new standard requires a determination of the research or economic interests that affect a physician's medical judgment. The Moore court's decision was based on three general principles. The first principle is the right of the patient to personal autonomy.^° by Section 24173 or 24178. 0) Be given an opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject's decision. Id. § 24172. 74. 45 C.F.R. §§ 46.101 to -.409 (1990). 75. Section 24174 provides: As used in this chapter, ''medical experiment" means: (a) The severance or penetration of tissues of a human subject or the use of a drug or device, as defined in Section 26009 or 26010, electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of such subject or otherwise directly benefiting such subject. (b) The investigational use of a drug or device as provided in Sections 26678 or 26679. (c) Withholding medical treatment from a human subject for any purpose other than the maintenance or improvement of the health of such subject. Cal. Health & Safety Code § 24174 (West 1984). 76. 51 Cal. 3d 120, 793 P.2d 479, 271 Cal. Rptr. 146 (1990). 77. Id. at 132, 793 P.2d at 485, 271 Cal. Rptr. at 152. 78. Id. 79. Id. 80. Id. 572 INDIANA LAW REVIEW [Vol. 25:559 The second principle is the requirement that, to be effective, the patient's consent to treatment must be informed consent.*' Thirdly, the physician has an obligation to disclose all information which is material to the patient's decision.*^ Based upon these three principles, the court concluded that a physician must disclose personal interests that may affect his professional judgment.*^ Prior to the Moore decision, the scope of the physician's disclosure obligation was measured by the information material to the patient's decision.*"* Information is considered material if **a reasonable person, in what the physician knows or should know to be the patient's position, would Hkely attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy."*^ This standard considers only the inherent dangers and alternatives to proposed therapy.*^ This standard does not require disclosure of the physician's personal interests. The Moore Court, in noting that informed consent requires disclosure of a physician's personal interests,*'' cited Magan Medical Center v. California State Board of Medical Examiners.^^ The California Court of Appeal in Magan held that a statute which prohibited medical part- nerships from owning pharmacies was constitutional.*^ The Magan court, however, noted that a physician **who has a financial interest in where his prescriptions are filled" may be influenced by a profit motive in prescribing a drug for his patient.^ The Magan court stated, **Certainly a sick patient deserves to be free of any reasonable suspicion that his doctor's judgment is influenced by a profit motive. "'' An earlier case in California required disclosure of more than the physician's economic interests. In Bowman v. McPheeters,^ the California Court of Appeal noted that the physician's fiduciary duty requires disclosure of all facts which materially affect the patient's rights and 81. Id. 82. Id. 83. Id. 84. Cobbs V. Grant, 8 Cal. 3d 229, 245, 502 P.2d 1, 11, 103 Cal. Rptr. 505, 515 (1972). 85. Canterbury v. Spence, 464 F.2d 772, 787 (D.C. Cir. 1972). 86. See Morgenroth v. Pacific Medical Center, Inc., 54 Cal. App. 3d 521, 126 Cal. Rptr. 681 (1976) (physician's disclosure that the proposed procedure carried risk of death or serious disease met the materiality requirement). 87. Moore v. Regents of Univ. of Cal., 51 Cal. 3d 120, 129, 793 P.2d 479, 483, 271 Cal. Rptr. 146, 150 (1990). 88. 249 Cal. App. 2d 124, 57 Cal. Rptr. 256 (1967). 89. Id. at 128, 57 Cal. Rptr. at 259. 90. Id. at 132, 57 Cal. Rptr. at 262. 91. Id. 92. 77 Cal. App. 2d 795, 176 P.2d 745 (1947). 1991] MOORE V. REGENTS 573 interests.^3 This standard, as applied to the duty to disclose, appears to be broader than the disclosure requirement under the doctrine of informed consent. The Bowman standard requires disclosure of information that affects the patient's rights and interests, and not disclosure only of the physician's interests. However, the Moore Court failed to cite Bowman in support of its conclusion. The Moore court noted that a physician who has a research interest in his patient has potentially conflicting loyalties. ^"^ The court suggested that a physician may perform tests which are of no benefit to his patient. ^^ However, the performance of an unnecessary test will require consent by the patient.^ The court suggested that the decision to undergo tests is made exclusively by the physician.^^ However, under California law, the decision to consent to tests or therapy is vested exclusively in the patient .^^ The Moore Court held that Moore's third amended complaint stated a cause of action for breach of the physician's disclosure obligation;^ however, the court did not decide whether Moore could prevail on this issue. Two important elements of breach of the physician's disclosure obligation are materiality'^ and causation. *°' In order for Moore to succeed on remand, he must prove these two problematic elements. The question is whether a physician's personal interests in using his patient's biological materials is **material," especially when the proposed procedure is necessary. Information is material if a reasonable person would be likely to attach significance to the information in deciding whether to undergo the proposed therapy. '^^ The use of a patient's tissue after it is removed, especially if the tissue is diseased and is the cause of the patient's illness, is not likely to be considered significant in making a decision to consent to treatment. '°^ As the courts generally recognize, 93. Id. at 800, 176 P.2d at 748. 94. Moore v. Regents of Univ. of Cal., 51 Cal. 3d 120, 130, 793 P.2d 479, 484, 271 Cal. Rptr. 146, 151 (1990). 95. Id. 96. Id. 97. Id. 98. Cobbs V. Grant, 8 Cal. 3d 229, 244, 502 P.2d 1, 10, 104 Cal. Rptr. 505, 514 (1972). 99. Moore v. Regents of Univ. of Cal., 51 Cal. 3d 120, 125, 793 P.2d 479, 480, 271 Cal. Rptr. 146, 147 (1990). 100. Canterbury v. Spence, 464 F.2d 772, 786 (D.C. Cir. 1972). 101. Cobbs, 8 Cal. 3d at 245, 502 P.2d at 11, 104 Cal. Rptr. at 515. 102. See supra note 85. 103. Certain religious groups have beliefs or traditions which do not allow the use of human biological materials in research or transplantation. See Cal. Health & Safety Code § 7152 (West Supp. 1991); Subcomm. Report, supra note 19, at 122 (statement of Thomas Murray). 574 INDIANA LAW REVIEW [Vol. 25:559 the patient is usually more concerned with the risks or alternatives to the proposed therapy. Therefore, a physician's personal interests in the use of his patient's biological materials is not likely to be considered material, especially when the proposed therapy is necessary or highly recommended. The problem of proving a causal relationship was noted by the California Supreme Court in Cobbs.^^ The standard for showing a causal relationship requires the patient to show that if the material information had been disclosed, the patient would not have consented to the therapy. ^°^ If the physician would have disclosed the information and the patient would have consented, then no causal relationship exists, and the phy- sician is not liable for his failure to disclose the information. In Moore, Golde informed Moore that a splenectomy was necessary to treat his disease. Based upon Golde's recommendation, Moore con- sented to treatment without knowledge of Golde's research interests. For Moore to show that Golde breached his duty of disclosure under the doctrine of informed consent, Moore must show that he would not have consented, or more properly, a reasonable person would not have con- sented,'^ to the proposed splenectomy. Because the splenectomy was necessary to treat Moore's illness, the disclosure of Golde' s research interests prior to surgery arguably would not have affected Moore's decision to consent to the procedure. In his dissenting opinion in Moore, Justice Mosk suggested that the cause of action for breach of the disclosure obligation is not sufficient to protect patients from commercial exploitation. '°^ First, Justice Mosk noted that under a reasonably prudent person standard causation will be difficult to show.'^^ Secondly, the nondisclosure cause of action does not give the patient affirmative rights; the action only allows the patient to withhold consent.*^ Justice Mosk further noted that the cause of action does not give the patient the right to share in the profits from commercialization, ''° which is the primary purpose of Moore's suit. Also, 104. Cobbs V. Grant, 8 Cal. 3d 299, 245, 502 P.2d 1, 11, 104 Cal. Rptr. 505, 515 (1972) (between the physician's failure to inform and the injury to the plaintiff there must be a causal relationship which arises only if the patient shows that he would not have consented if he was given the information). 105. Id. See also Canterbury v. Spence, 464 F.2d 772, 790 (D.C. Cir. 1972). 106. Cobbs, 8 Cal. 3d at 245, 502 P.2d at 11, 104 Cal. Rptr. at 515 (the court adopted an objective test, whether a prudent person in the patient's position would have consented if adequately informed). 107. Moore v. Regents of Univ. of Cal., 51 Cal. 3d 120, 182, 793 P.2d 479, 521, 271 Cal. Rptr. 146, 188 (Mosk, J., dissenting). 108. Id. at 179, 793 P.2d at 519, 271 Cal. Rptr. at 186 (Mosk, J., dissenting). 109. Id. at 180, 793 P.2d at 520, 271 Cal. Rptr. at 187 (Mosk, J., dissenting). 110. Id. 1991] MOORE V. REGENTS 575 a nondisclosure cause of action potentially affects only those in a phy- sician-patient relationship.*'* The parties who profit from the commer- cialization of the patient's biological materials may escape liability if they are not in a physician-patient (fiduciary) relationship. In Moore, the court stated that Quan, the Regents, Genetics Institute, and Sandoz were not in a fiduciary relationship with Moore. '*^ The Moore court concluded that these defendants are liable for Golde's acts only on the basis of secondary liability, for example, respondeat su- perior.'*^ Such a relationship will be extremely difficult to prove, especially with respect to Genetics Institute and Sandoz. These defendants did not direct or participate in Golde's wrongful acts, but became involved long after the splenectomy. Therefore, these parties will most likely avoid liabihty. The new standard of disclosure, as articulated by the Moore court, will not be an effective means for protecting the patient from commercial exploitation. The California Supreme Court requires disclosure of the physician's personal interests that are unrelated to the patient's health and that may affect the physician's medical judgment. ""^ However, this high disclosure standard may be rendered ineffective by the remaining elements of the cause of action, materiality and causation. If the failure of the physician to disclose his personal research interests is not a cause of the patient's injury, then the physician may not be held liable. The Moore court noted that a physician's research interests *'may affect his judgment." "^ However, a physician's research interest, in reality, is secondary to his interest in treating the patient. Also, research on human biological material is unpredictable. The probability of dis- covering a commercially valuable product is extremely low."^ The court's assertion that the physician's judgment may be affected by a desire to advance his research objectives without considering the potential benefits to the patient is unlikely. A more appropriate standard would require disclosure of all infor- mation that is related to the patient's interests. This standard was articulated by the California Court of Appeal in Bowman v. Mc- Pheeters.^^'' In Bowman, the court stated that as a part of the physician's fiduciary duty, the physician has a duty to disclose all facts which ill. /d/. at 181, 793 P.2d at 521, 271 Cal. Rptr. at 188 (Mosk, J., dissenting). 112. Id. at 133, 793 P.2d at 486, 271 Cal. Rptr. at 153. 113. Id. 114. Id. at 131-32, 793 P.2d at 485, 271 Cal. Rptr. at 152. 115. Id. at 130, 793P.2d at 484, 271 Cal. Rptr. at 151. 116. OTA Report, supra note 6, at 55. 117. 77 Cal. App. 2d 795, 176 P.2d 745 (1947). 576 INDIANA LAW REVIEW [Vol. 25:559 materially affect the patient's rights and interests.''^ A patient certainly has an interest in knowing whether his physician plans to use his biological materials in research. A patient may obtain great personal satisfaction in knowing that his biological materials are being used in medical research. The Bowman standard properly views the requirement of disclosure from the patient's perspective and not from the physician's perspective.'^^ Recognition of this standard does not create new rights for the patient; it only requires disclosure of all information that affects the patient's rights and interests. III. Conversion A. Common-Law Doctrine Conversion is based on the common-law action of trover. '^^ Trover was originally defined as an action on the case for the recovery of damages against a finder of another's goods who wrongfully converted the goods to his own use.'^' This tort became an action for **any wrongful interference with or the detention of the goods of another. '"^^ The plaintiff, if successful in his pleading, was generally awarded damages in the value of the chattel at the time of dispossession.'^^ The modern doctrine of conversion protects the owner or person entitled to possession of property from another exercising unjustified and unwarranted control over it.'^'^ Conversion has been defined as **any act of dominion wrongfully exerted over another's personal property in denial of or inconsistent with his rights therein. "'^^ An action for con- version of personal property requires the plaintiff to show the following elements: **(1) plaintiff's ownership or right to possession of the property at the time of conversion; (2) defendant's conversion by a wrongful act 118. Id. at 800, 176 P.2d at 748. 119. In Cobbs, the court rejected as a standard for disclosure the practice of a reasonable medical practitioner and adopted a reasonable prudent person in the patient's position as the appropriate standard. Cobbs v. Grant, 8 Cal. 3d 229, 243, 502 P.2d 1, 10, 104 Cal. Rptr. 505, 514 (1972). 120. Restatement (Second) of Torts § 222A comment a (1965). 121. Black's Law Dictionary 1351 (5th ed. 1979). 122. Id. 123. Id. Trover can be contrasted with replevin, which is an action by the owner or the person entitled to possession of goods to recover the goods from another. Id. at 1168. 124. Poggi V. Scott, 167 Cal. 372, 139 P. 815 (1914) (the foundation for the action of conversion rests upon the unwarranted interference by a defendant with the dominion over the plaintiff's property from which injury results), 125. Igauye v. Howard, 114 Cal. App. 2d 122, 126, 249 P.2d 558, 561 (1952). 1991] MOORE V. REGENTS 577 or disposition of plaintiff's property rights; and (3) damages. '''^^ The first element requires the plaintiff to assert ownership or a right to possession of the property at the time of conversion. This element has three aspects which require consideration: ownership or right to possession, property, and time. The settled rule is that absolute ownership of the property is not a prerequisite to maintaining a cause of action. '^^ The plaintiff need only have an immediate right to possession at the time of conversion.'^* When the plaintiff has a special interest or qualified right in the property and possession or right of possession at the time of conversion, the combination is sufficient to maintain an action for conversion. '^^ Examples of special interests or qualified rights include liens, *^° an interest as a bailee or bailor,'^' equitable title, '^^ an interest arising from services rendered,'" and secured interests.'^ The second aspect for consideration is the kinds of property that may be converted. Originally, conversion was applicable only to tangible personal property.'" The basis of this limitation was that intangible property could not be lost and subsequently found, which was the original 126. Baldwin v. Marina City Properties, Inc., 79 Cal. App. 3d 393, 410, 145 Cal. Rptr. 406, 416 (1978). 127. Everfresh, Inc. v. Goodman, 131 Cal. App. 2d 818, 820, 281 P.2d 560, 561 (1955). 128. Hartford Fin. Corp. v. Burns, 96 Cal. App. 3d 591, 598, 158 Cal. Rptr. 169, 172 (1979). 129. Pope V. National Aero Fin. Co., 236 Cal. App. 2d 722, 46 Cal. Rptr. 233 (1965); In re Dino, 17 Bankr. 316 (Bankr. Fla. 1982); Ax v. Schloot, 118 Ind. App. 458, 81 N.E.2d 379 (1948). 130. Bastanchury v. Times-Mirror Co., 68 Cal. App. 2d 217, 156 P.2d 488 (1945) (a lienholder may maintain an action for conversion); In re Dino, 17 Bankr. 316 (Bankr. Fla. 1982) (lienholder with possession or a right of possession may bring an action for conversion). 131. Hollywood Motion Picture Equip. Co. v. Purer, 16 Cal. 2d 184, 105 P.2d 299 (1940) (when bailee uses property to detriment of bailor, such use is conversion); Treasure Cay, Ltd. v. Investors Int'l Constr. Corp., 259 So. 2d 169 (Fla. Dist. Ct. App. 1972) (bailee may maintain an action for conversion if he has a present or immediate right of possession). 132. Hart v. Meadows, 302 S.W.2d 448 (Tex. Civ. App. 1957) (equitable title is sufficient to support an action for conversion). 133. Arques v. National Superior, 67 Cal. App. 2d. 763, 155 P.2d 643 (1945) (a person with an interest in property arising from services rendered may maintain an action in trover). 134. Hartford Fin. Corp. v. Burns, 96 Cal. App. 3d 591, 158 Cal. Rptr. 169 (1979) (secured party with right to immediate possession is entitled to maintain a conversion action). 135. R. Keeton, supra note 65, § 15, at 91. See Stern v. Kaufman's Bakery, Inc., 191 N.Y.S.2d 734 (N.Y. Sup. Ct. 1959) (court held that a door to door bakery route consists solely of the goodwill of the customers, which is intangible and not a proper subject of conversion). 578 INDIANA LAW REVIEW [Vol. 25:559 basis for trover and conversion. '^^ Real property was also excluded for the same reasons. '^^ The modern doctrine expanded the scope of the term **property'' to include intangible personal property.'^* The third aspect of this first element is the temporal aspect. The plaintiff is required to have an interest in the property, either ownership and the right of possession or actual possession, at the time of the wrongful act of the defendant. '^^ The importance of this temporal aspect in Moore will be discussed below. The second element is defendant's conversion by a wrongful act or disposition of the plaintiffs property rights.'"^ Conversion does not require that there be an actual taking of the property.'"^' If the defendant wrongfully exerts control or ownership of the property or applied the property to his own use, the defendant's act constitutes conversion. '"^^ B. Moore v. Regents: Conversion In Moore, the California Supreme Court held that the plaintiff's third amended complaint did not state a cause of action for conversion. '"^^ The court qualified its holding by stating that it did not hold "that excised cells can never be property for any purpose whatsoever.""^ However, the California Supreme Court concluded that "the use of excised cells in medical research does not amount to a conversion."'*^ In support of its holding and conclusion, the Moore Court suggested that finding for the patient, who is the source of the cells, will impose 136. R. Keeton, supra note 65, § 15, at 91. 137. See California Mut. Ins. Co. v. Robertson, 213 Cal. App. 3d 1172, 262 Cal. Rptr. 173 (1989). 138. 5ee A & M Records, Inc. v. Heilman, 75 Cal. App. 3d 554, 142 Cal. Rptr. 390 (1977) (recorded musical performances are subject to conversion); Fabricon Prods, v. United Cal. Bank, 264 Cal. App. 2d 13, 70 Cal. Rptr. 50 (1968) (a check is a subject of conversion); Shahood v. Cavin, 154 Cal. App. 2d 745, 316 P.2d 700 (1957) (money can be the subject of conversion when a specific sum capable of identification is involved); Mears v. Crocker First Nat'l Bank, 84 Cal. App. 2d 637, 191 P.2d 501 (1948) (shares of corporate stock and stock certificates are subjects of conversion); In re Estate of Corbin, 391 So. 2d 731 (Fla. Dist. Ct. App. 1980) (conversion may be brought for the wrongful taking of an intangible interest in a business, including goodwill). 139. General Motors Acceptance Corp. v. Dallas, 198 Cal. 365, 370, 245 P. 184, 186 (1926). 140. Baldwin v. Marina City Properties, Inc., 79 Cal. App. 3d 393, 410, 145 Cal. Rptr. 406, 416 (1978). 141. Igauye v. Howard, 114 Cal. App. 2d 122, 126, 249 P.2d 558, 561 (1952). 142. Id. 143. Moore v. Regents of Univ. of Cal., 51 Cal. 3d 120, 147, 793 P.2d 479, 497, 271 Cal. Rptr. 146, 164 (1990). 144. Id. at 142, 793 P.2d at 493, 271 Cal. Rptr. at 160. 145. Id. 1991] MOORE V. REGENTS 579 upon scientists a new tort duty that will have a chilling effect upon medical research. '"^^ The California Supreme Court noted that Moore's attempt to bring an action under a theory of conversion is "recognized as a request to extend that theory. "^"^^ The Moore Court cited three reasons for not imposing liability for conversion: (1) poHcy considerations; (2) resolution is better left for the legislature; and (3) an alternate cause of action is available. '"^^ The Moore Court's analysis regarding conversion initially focused on whether Moore's claim of conversion fits within the existing law.^"^^ Moore asserts that he continued to own his cells following their removal, he never consented to the use of his cells in medical research, and the unauthorized use of his cells constitutes conversion. ^^^ The Moore Court concluded that the application of conversion to the present case "would frankly have to be recognized as an extension of the theory. "^^' As discussed above, an action for conversion requires ownership or a right to possession of the subject converted. The Moore Court concluded that Moore did not retain a right to possession of his cells after removal and considered whether he retained an ownership interest in his excised cells. '^^ The Cahfornia Supreme Court decided that Moore did not retain an ownership interest in his cells following removal.^" The first reason for concluding that Moore did not retain an own- ership interest in his excised cells was the lack of judicial precedent supporting such a claim. '^'^ Because this is a case of first impression, the parties' and the court's research did not disclose a case on point which held that a person retains an interest in his excised cells. ^^^ The Moore Court dismissed the unwanted publicity cases'^^ as not analogous 146. Id. at 134, 793 P.2d at 487, 271 Cal. Rptr. at 154. 147. Id. at 142, 793 P.2d at 493, 271 Cal. Rptr. at 160. 148. Id. 149. Id. at 136, 793 P.2d at 488, 271 Cal. Rptr. at 155. 150. Id. at 134, 793 P.2d at 487, 271 Cal. Rptr. at 154. 151. Id. at 136, 793 P. 2d at 488, 271 Cal. Rptr. at 155. 152. Id. 153. Id. 154. Id. 155. Id. The Moore court found that this was not surprising because statutory law, both federal and state, dealing with human biologiceil materials does not address property rights of a person in his severed biological material. These statutes are directed to the proper disposal of the materials in accordance with pubhc policy. See Cal. Gov't Code §§ 27491.44-27491.47 (West 1988) (provisions governing the conduct of coroners with respect to human biological materials); Cal. Health & Safety Code § 7054.4 (West 1970 & Supp. 1991) (human tissues are disposed of in a method to protect the public health and safety); Cal. Health & Safety Code §§ 7150-7156.5 (West 1970 & Supp. 1991) (provisions governing anatomical gifts), 156. Motschenbacher v. R. J. Reynolds Tobacco Co., 498 F.2d 821 (9th Cir. 1974); 580 INDIANA LAW REVIEW [Vol. 25:559 to the present case.'" Finally, the Moore Court concluded that recognition of a property interest in excised biological materials is not necessary to protect human privacy and dignity; fiduciary duty and informed consent more properly protect these interests. '^^ The Moore Court's analysis regarding the ownership or right to possession of Moore's human biological materials raises several interesting legal questions. The first question requires a consideration of the temporal aspect of the first element of conversion. To sustain a conversion cause of action it is not necessary that Moore have an ownership interest in his biological materials if he had actual possession at the time of the alleged wrongful act.'^^ If conversion occurred at the time of the taking, '^^ then Moore had the requisite possession to maintain a conversion action. Moore should have asserted and the court should have recognized that the conversion of his biological materials occurred when these materials were removed, not after Moore lost possession. If conversion is properly viewed as occurring at the time of Moore's splenectomy or at each subsequent visit for the withdrawal of additional biological materials, then a cause of action for conversion clearly exists under common-law principles. Under the Uniform Anatomical Gift Act,'^' California law recognizes a qualified property right in one's body. This quahfied right is the ability to make anatomical gifts, which effectively is the ability to direct the disposition of one's body or parts thereof at death. '^^ Under the Act, the donor may also designate a specific donee, '^^ which implies a Lugosi V. Universal Pictures, 25 Cal. 3d 813, 603 P.2d 425, 160 Cal. Rptr. 323 (1979) (every person has a proprietary interest in his own Ukeness and unauthorized use is actionable as a tort). 157. Moore v. Regents of Univ. of Cal., 51 Cal. 3d 120, 138, 793 P.2d 479, 490, 271 Cal. Rptr. 146, 157 (1990). The Moore court reasoned that Moore's cells were not unique because every human has the ability to manufacture lymphokines. However, the court failed to recognize the fact that Moore's cells were unique because they were infected with HTLV-11. This novel retrovirus was first identified in the Mo cell line. Chen, Human T-cell Leukemia Virus Type II Transforms Normal Human Lymphocytes, 80 Proc. Nat'l Acad. Sci. 7006 (Nov. 1983); Chen, Molecular Characterization of Genome of a Novel Human T-cell Leukemia Virus, 305 Nature 502 (Oct. 6, 1983). 158. Moore, 51 Cal. 3d at 140, 793 P.2d at 491, 271 Cal. Rptr. at 158. 159. See Igauye v. Howard, 114 Cal. App. 2d 122, 127, 249 P.2d 558, 561 (1952) (plaintiff need not be the owner of the property because actual possession at the time of conversion is sufficient). 160. Justice Broussard suggested that under the traditional common-law principles of conversion, Moore could maintain an action to recover damages. Moore, 51 Cal. 3d at 151, 793 P.2d at 499, 271 Cal. Rptr. at 166 (Broussard, J., concurring and dissenting). 161. Cal. Health & Safety Code §§ 7150-7156.5 (West 1970 & Supp. 1991). 162. Id. § 7150.5. 163. Id. § 7153(b). 1991] MOORE V. REGENTS 581 right to designate the use of an anatomical gift for research purposes.'^"* Because a person has the right to direct the use of his biological material at his death, a person should legally have the same rights with respect to his biological materials prior to death. '^^ This qualified property right should be recognized as a sufficient interest in biological materials to entitle the patient to a conversion action for the wrongful or unauthorized use of those materials. Whether the plaintiff had an unlimited or limited right in his biological materials is not an appropriate consideration in deciding a motion for summary judgment. So long as a right existed, summary judgment is not appropriate. A second question is whether human biological materials, in particular tissues and organs, are tangible or intangible property that is subject to conversion. The Moore Court expressly refused to hold that "excised cells can never be property for any purpose whatsoever. "'^^ However, the question remains whether excised cells can ever be considered property for purposes of conversion. Two cases, in dicta, suggested that human biological materials are tangible property. In United States v. Garber,^^'^ Ms. Garber was indicted for failing to report as income money that she received in exchange for her plasma. '^^ The United States Court of Appeals noted that "blood plasma, like a chicken's eggs, a sheep's wool, or like any salable part of the human body, is tangible property. "'^^ Based upon this statement, human biological material is arguably the proper subject of conversion. The second case, Venner v. State, ^'^^ was cited by the California Court of Appeal in its decision. The issue in Venner was whether balloons, which were filled with narcotics, found in Venner 's feces were illegally seized. ^^' In dictum, the Venner court noted that "[i]t could not be said that a person has no property right in wastes or other materials which were once a part of or contained within his body, but which normally are discarded after their separation from the body."'^^ As in Garber, the Venner court's language suggests that human biological materials 164. Id. § 7153(a)(1). 165. Justice Broussard stated that, under California law, the patient has the right to determine the use of a body part after its removal. Moore v. Regents of Univ. of Cal., 51 Cal. 3d 120, 151, 793 P.2d 479, 499, 271 Cal. Rptr. 146, 166 (1990) (Broussard, J., concurring and dissenting). 166. Id. at 142, 793 P.2d at 493, 271 Cal. Rptr. at 160. 167. 607 F.2d 92 (5th Cir. 1979). 168. Id. at 93. Her blood contained a rare antibody useful in the production of blood typing serum. 169. Id. at 97. 170. 30 Md. App. 599, 354 A.2d 483 (1976). 171. Id. at 600, 354 A.2d at 485. 172. Id. at 626, 354 A.2d at 498. 582 INDIANA LAW REVIEW [Vol. 25:559 may be considered one's tangible property. These two cases support the existence of a property right in one's biological materials. This property right should be sufficient to maintain an action for conversion. The California Supreme Court placed undue reliance in the avail- ability of an alternate theory for imposing liability. The Moore Court suggested that the patient's interests are properly protected under the doctrine of informed consent or by the physician's fiduciary duty.'^^ As discussed previously, Moore would have to prove both the materiality of the information that was withheld and a causal relationship to impose liability and to be entitled to a recovery. The Moore Court also relied on California statutory law in support of its conclusion. The court cited CaHfornia Health and Safety Code section 7054.4, noting that a patient has limited control over his excised biological materials. ^^"^ Section 7054.4 requires the safe disposal of human biological materials following the conclusion of their scientific use.'"^^ The court concluded that this statute drastically limits a patient's control to the extent that the remaining rights in the excised material are not sufficient for purposes of common-law conversion. '"^^ However, absolute ownership is not necessary to maintain an action for conversion. '^^ The California courts previously recognized a qualified interest in property as sufficient for purposes of conversion law.'^^ To further support its rejection of Moore's conversion theory, the Moore Court asserted that the subject matter of a U.S. Patent*"^^ "cannot 173. Moore v. Regents of Univ. of Cal., 51 Cal. 3d 120, 140, 793 P.2d 479, 491, 271 Cal. Rptr. 146, 158 (1990). 174. Id. at 136, 793 P.2d at 488, 271 Cal. Rptr. at 155. 175. Section 7054.4 provides: Notwithstanding any other provision of law, recognizable anatomical parts, human tissues, anatomical human remains, or infectious waste following con- clusion of scientific use shall be disposed of by interment, incineration, or any other method determined by the state department to protect the public health and safety. As used in this section, "infectious waste" means any material or article which has been, or may have been, exposed to contagious or infectious disease. Cal. Health & Safety Code § 7054.4 (West Supp. 1991). 176. Moore, 51 Cal. 3d at 140, 793 P.2d at 492, 271 Cal. Rptr. at 159. 177. Everfresh, Inc. v. Goodman, 131 Cal. App. 2d 818, 820, 281 P.2d 560, 561 (1955) (established rule is ownership, either general or special, or right to immediate possession, is all that is required to maintain an action for conversion, and it is not a requirement that the plaintiff be the absolute owner). 178. See Ruiz v. Bank of Am. Nat'l Trust & Sav. Ass'n, 135 Cal. App. 2d 860, 287 P.2d 409 (1955) (a qualified interest in an automobile is sufficient); Bastanchury v. Times-Mirror Co., 68 Cal. App. 2d 217, 156 P.2d 488 (1945) (a lien is a sufficient interest for conversion). 179. U.S. Patent, No. 4,438,032 (March 20, 1984). 1991] MOORE V. REGENTS 583 be Moore's property. "^^^ The court noted that the Mo cell line is factually and legally distinct from Moore's cells. '^' Under United States Patent Law,'^^ the Mo cell line may be considered distinct from Moore's spleen cells. ^^^ However, in the present case, Moore's spleen was the subject of the conversion which produced the Mo cell line. The Mo cell Hne is properly viewed as a modified version of Moore's cells. Although the Mo cell line is distinct, the discovery of this cell line would have been impossible without Moore's biological materials. Therefore, the Mo cell line is properly viewed as the "product" of the conversion and not as the property ''converted" or the "subject" of the conversion. Prior to the splenectomy, Moore signed a consent form which au- thorized the disposal of his severed tissue by cremation. However, Golde and Quan used the tissue to develop the Mo cell line. In Hollywood Motion Picture Equipment Co. v. Purer, ^^^ the defendant used the plain- tiff's property to the detriment of the plaintiff. '^^ The court noted that "[i]f a bailee, having no authority to use the thing bailed, uses it, or having authority to use it in a particular way, uses it in a different way, unauthorized by the terms of the bailment . . . such unauthorized use constitutes a conversion. "^^^ Because Golde and others were au- thorized to dispose of Moore's biological material by cremation and applied Moore's biological materials to an unauthorized use for their own benefit, a cause of action for conversion exists. After determining that the recognition of a conversion cause of action required an extension of the common-law theory, the Moore court concluded that an extension of the common-law doctrine would not be appropriate.'^'' The primary reason for the Moore court's refusal to extend liability was the fair balance between competing policies. The first policy consideration was the protection of an individual's right to 180. Moore v. Regents of Univ. of Cal., 51 Cal. 3d 120, 141, 793 P.2d 479, 492, 271 Cal. Rptr. 146, 159 (1990). 181. Id. 182. 35 U.S.C. §§ 1-376 (1988). 183. The Mo cell line was established from Moore's spleen cells by Golde and Quan. The Mo cell line, which is capable of continuous culture for an indefinite period of time, is not naturally occurring, but is a product of human ingenuity. Even though these cells retain some of the characteristics of Moore's spleen cells, such as the ability to produce proteins, the cell line is factually distinguishable from Moore's cells. Because the Mo cell line was "made by man" and Moore's spleen cells are "naturally occurring," only the former are patentable subject matter under 35 U.S.C. § 101. See Diamond v. Chakrabarty, 447 U.S. 303 (1980). 184. 16 Cal. 2d 184, 105 P.2d 299 (1940). 185. Id. at 189, 105 P.2d at 302. 186. Id. 187. Moore v. Regents of Univ. of Cal., 51 Cal. 3d 120, 143, 793 P.2d 479, 493, 271 Cal. Rptr. 146, 160 (1990). 584 INDIANA LAW REVIEW [Vol. 25:559 personal autonomyJ^^ The second policy consideration was the desire to protect persons engaged in socially useful activities from civil hability.'^^ The court sought to protect the patient's interests without imposing an undue burden on socially beneficial biotechnological or medical re- search. '^° The court concluded that liability based upon the existing disclosure obligations provides sufficient protection of the patient's rights without having a chilling effect on research. ^^^ The Moore court concluded that the extension of the common-law doctrine to recognize a cause of action for conversion would have an adverse effect on research. '^^ The court suggested that the free flow of medically useful human biological materials would be compromised if conversion law was extended. ^^^ The court asserted that biotechnological and pharmaceutical companies would not be willing to invest in research if such research would subject the company to potential liability. ^^"^ The exchange of scientific materials is not as free and efficient as the California Supreme Court suggested. Many universities and corpo- rations have entered into collaborative research agreements that usually define the rights of the parties in any discoveries or products of the collaborative efforts. ^^^ These agreements typically prohibit the transfer of research materials to persons who are not a party to the agreement. ^^^ The effect of these agreements has been a decrease in the flow of information and scientific samples. ^^^ Secondly, because of the importance of human biological materials in the development of commercial products, 188. Id. 189. Id. 190. In the OTA Report, the uncertainty surrounding the resolution of disputes between physicians and patients, with respect to their respective rights, was suggested to have an impact on both academic research and the biotechnology industry. The Report further suggested that biotechnology companies are unUkely to invest in developing, manufacturing, or marketing a product when uncertainty exists. OTA Report, supra note 6, at 27. 191. Moore, 51 Cal. 3d at 146, 793 P.2d at 495, 271 Cal. Rptr. at 162. 192. Id. 193. Id. 194. The court characterized the use of biological materials in research as purchasing a ticket in a Htigation lottery. Id. 195. One example of such an agreement is the standard Cooperative Research and Development Agreement currently in use by the National Institutes of Health and the Alcohol, Drug Abuse and Mental Health Administration (NIH/ADAMHA). See D. Murray & P. O'Connor, A Guide to Corporate Sponsored University Research in Biotech- nology — Issues, Contracts, Models, and Personnel (1983). 196. Also, materials may be transferred between the parties with certain restrictions that limit the use of the materials, for example limiting the use to only research purposes. The NIH/ADAMHA material transfer agreement contains such a provision. 197. Moore v. Regents of Univ. of Cal., 51 Cal. 3d 120, 170, 793 P.2d 479, 513, 271 Cal. Rptr. 146, 180 (1990) (Mosk, J., dissenting). 1991] MOORE V. REGENTS 585 companies are more restrictive in the exchange of samples in order to retain their competitive edgeJ^^ The Moore court also suggested that the availability of patent pro- tection increases the availability of research materials. '^^ The court failed to recognize two important considerations. First, patented materials must be available to the public,^^^ but the use of patented materials is hmited. The patent grants an affirmative right to the patentee to prevent others from making, using, or selling the patented invention. ^°^ Although the grant of a patent, in theory, places the patented subject matter in the public domain, making the patented materials freely available to the public, the use of such materials cannot be adverse to the patentee's rights. The Moore court seemed to overlook this important limitation. Secondly, the court failed to clearly distinguish between patented materials and human biological materials. Products of nature, such as human biological materials, are not patentable subject matter under the United States Patent Law.^^^ As discussed previously, a patented material and the human biological material from which the patented material was derived are legally and factually distinct. Also, patented material is only a part of the material necessary for important medical research. ^^^ Therefore, the Moore court's suggestion that the availability of patent protection increases the availability of research materials is erroneous. The Moore court articulated a second reason to support its decision to refuse to extend HabiHty. The court stated that the decision whether to extend the common-law doctrine of conversion is better left to the legislature. ^^"^ The court noted that such a decision requires the gathering 198. Biotechnology companies can protect the products of their research efforts by two methods: patents and trade secrets. Where trade secret protection is chosen, the material must be kept secret to preserve protection. U.S. Congress, Office of Technology Assessment, New Developments in Biotechnology: U.S. Investment in Biotechnology 103 (1988). 199. Moore, 51 Cal. 3d at 145 n.40, 793 P.2d at 495 n.40, 271 Cal. Rptr. at 162 n.40. 200. Section 112 of the United States Patent Law imposes a requirement that the specification of the patent contain a written description of the invention to enable any person skilled in the art to make and use the invention. 35 U.S.C. § 112 (1988). If the preparation of the patented subject matter can not be sufficiently described in writing, the material must be deposited in an acceptable depository. 37 C.F.R. §§ 1.801 to -.803 (1990). The fiction underlying the enablement requirement is that an inventor is granted an exclusive right of limited duration (17 years) in exchange for the disclosure of his invention to the public. 201. 35 U.S.C. § 271 (1988). 202. Merck & Co. v. Olin Mathison Chem. Corp., 253 F.2d 156 (4th Cir. 1958). 203. See supra notes 17-19. 204. Moore v. Regents of Univ. of Cal., 51 Cal. 3d 120, 147, 793 P.2d 479, 496, 271 Cal. Rptr. 146, 163 (1990). 586 INDIANA LAW REVIEW [Vol. 25:559 of empirical information, the solicitation of expert advice, the holding of hearings, and the choice between complex policies. ^^^ The court also noted that the existence of statutes which govern the disposition and use of human biological materials suggests that the legislature is competent to act in this area.^°^ The court cited an Office of Technology Assessment (OTA) Report as evidence that the United States Congress is interested in resolving the problems with respect to the use of human biological materials in research. ^^"^ However, the Moore court did not hesitate to extend the doctrine of informed consent. Finally, the Moore court relied upon the existence of an alternate theory of Hability to support its conclusion. The court stressed the importance of the physician's disclosure obligation as protection for the patient, "without hindering socially useful activities. "^^^ However, as discussed above, the physician's disclosure obligation does not give the patient affirmative rights, and may be no more than a "paper tiger. "^^^ IV. Conclusion The California Supreme Court in Moore articulated a new standard of disclosure for informed consent. This new standard requires the physician to disclose his personal interests that are unrelated to the patient's health and that may affect his medical judgment. ^'° The court implied that this disclosure obligation is sufficient to protect the patient's interest. However, the burden on the patient in proving materiality and causation renders this obligation illusory. Furthermore, it fails to rec- ognize affirmative rights in the patient regarding a right to direct the disposition of his biological materials and a right to share in the profits gained from the use of his biological materials. Therefore, the physician's disclosure obUgation is not an effective means of protecting patients from commercial exploitation. Secondly, the Moore court concluded that a patient does not retain an interest in his biological materials once the materials are removed from his body.^" Based upon this conclusion, the court held that Moore could not maintain a cause of action for conversion. ^'^ The most im- portant aspect of this holding is the implication that the patient, whose 205. Id. 206. Id. 101 . Id. See OTA Report, supra note 6. Congress may have decided not to act in this area and to allow the common law and the courts to resolve the disputes. 208. Moore, 51 Cal. 3d at 147, 793 P.2d at 497, 271 Cal. Rptr. at 164. 209. Id. at 180, 793 P.2d at 520, 271 Cal. Rptr. at 187 (Mosk, J., dissenting). 210. Id. at 131-32, 793 P.2d at 485, 271 Cal. Rptr. at 152. 211. Id. at 137, 793 P.2d at 489, 271 Cal. Rptr. at 156. 212. Id. at 147, 793 P.2d at 497, 271 Cal. Rptr. at 164. 1991] MOORE V. REGENTS 587 biological materials are the basis of the discovery, has no rights with respect to the products of the research. The patient also does not have a right to share in the profits. The court^s decision is a victory for the biotechnology industry. The Moore court effectively limits liability to only those persons in a fiduciary relationship with the patient. Biotechnology companies are free to use human biological materials without the threat of litigation should the patient discover that his biological materials were the basis for the development of commercial products. However, it is not clear whether a state that is more interested in protecting the patient's rights than in protecting biotechnology researchers and industry will reach the same result. The primary lesson of Moore is to recognize the importance of full disclosure to the patient. Proper disclosure should include: (1) a brief discussion informing the patient of the physician's plans to use the patient's biological materials in research; (2) whether such use will benefit the patient, physician, or anyone in the future; (3) the purpose for using the materials in research; and (4) the likelihood that such research use will lead to a commercial product. By disclosing this information, the physician will satisfy his fiduciary duty of disclosure and the new standard of disclosure for informed consent. In addition, when the physician properly obtains the patient's consent for the use of his biological materials, the physician will preclude a conversion action. With proper planning and consideration of the patient's rights and interests, the Moore case will never be repeated. James P. Leeds* * B.S., 1981, Indiana University; M.S., 1984, The Florida State University; J.D. Candidate, 1992, Indiana University School of Law-Indianapolis.