Towards a public human tissue trust.

• Author: Harvey, Martin

Currently, major research institutions, graduate medical education programs, and the federal government store over two hundred million human tissue samples available for use in biomedical research. (1) This human tissue archive continues to increase at a rate of approximately twenty million samples per year. (2) But who "owns" this tissue: the institutions that store it, the researchers who use it, or the research participants who voluntarily provide it? Any adequate response to this question requires striking the best balance between two pressing policy goals: (1) the need to ensure biomedical progress; and (2) the need to protect the right to informed consent. Recent court decisions all vest ownership in research institutions, while legal academics tend to favor vesting ownership in research participants. The door remains open to vest ownership in researchers via the proper contractual arrangements. For reasons stated extensively below, each of these options proves lacking. Instead, this Note aims to show that the creation of a public human tissue trust affords the best option to policymakers.

In Part I, this Note provides an in-depth survey of the relevant case law. Part II discusses the equal importance of the above policy goals and why vesting exclusive ownership in either research institutions, researchers, or research participants fails on policy grounds. Part III explores the nature, mechanics, and scope of the proposed public revocable charitable human tissue trust. Part IV proffers a public tissue trust as the best policy solution to protect the right to informed consent. (3) In Part V, this Note concludes by briefly addressing the commercialization issues raised in Moore v, Regents of the University of California (4) and Greenberg v. Miami Children's Hospital Research Institute, Inc. (5)

1. CASE LAW

   The case law here is quite sparse. Very few courts have addressed the issue of human tissue ownership. Four cases stand out: Moore, Greenberg, and the district court and appellate court decisions in Washington University v. Catalona. (6) This section presents a brief overview of each case. Moore deserves particular attention, as it serves as the source of almost every major policy position in the debate.

   1. Moore

      In Moore, the Supreme Court of California notably refused to find that a conversion action lay with a patient whose tissue was the source of a valuable cell line. John Moore argued that "defendants' unauthorized use of his cells constitute[d] a conversion." (7) While the court recognized a cause of action concerning an alleged violation of Moore's right to informed consent, the court reversed the court of appeal's judgment recognizing the validity of Moore's conversion claim. The majority concluded that Moore simply did not "retain[] an ownership interest" in tissue excised from his body. (8)

      In 1976, Moore had developed hairy-cell leukemia and sought treatment at the UCLA Medical Center under Dr. David Golde. Golde advised Moore to undergo a splenectomy to slow down the progress of the disease. Unbeknownst to Moore and prior to his surgery, Golde contacted researcher Shirley Quan about using portions of Moore's spleen for possibly lucrative medical research. (9) Both Golde and Quan "were aware that certain blood products and blood components were of great value in a number of commercial and scientific efforts." (10) The proposed research activities involving Moore's tissue were of no therapeutic benefit to Moore, but "neither Golde nor Quan informed Moore of their plans to conduct this

      research or requested his permission." (11)

      Moore proved to be an "overproducer" of T-lymphokines, (12) a chemical released by white blood cells that aids in the fighting of bacterial infections. (13) Isolating the genetic material that formed the basis for the production of T-lymphokines was heretofore "akin to a search for the proverbial needle in a haystack." (14) Due to Moore's overproducer status, however, Golde and Quan were able to create a T-lymphokine producing cell line from Moore's excised spleen tissue. (15)

      Until 1983, Moore made several visits to the UCLA Medical Center from his home in Seattle. During these visits, Golde took additional tissue from Moore, primarily in the form of blood and bone marrow aspirate. Moore consented to these procedures under the assumption that the visits were necessary for his medical well-being. (16) In fact, Golde and Quan, with full knowledge of the Regents, were actively engaged in commercial biomedical research using Moore's tissue. In 1981, the Regents initiated a patent application for Moore's cell line and listed Golde and Quan as the inventors. (17) In 1984, the Patent Office granted the application. (18) The Regents then entered into a series of lucrative licensing agreements with various pharmaceutical companies. (19) As of 1990, market analysts calculated the potential value of products developed from the Moore cell line at approximately three billion dollars. (20)

      In 1983, Golde requested that Moore sign a consent form granting the University of California "any and all rights [Moore or his heirs] may have in any cell line or any other potential product which might be developed from the blood and/or bone marrow obtained from [him]." (21) Moore refused. Upon Golde's repeated requests that he sign the consent form, Moore contacted an attorney who subsequently discovered the existence of the cell line and patent application. On September 11, 1984, Moore filed suit alleging numerous causes of action. The trial court sustained defendants' demurrers across the board, with special emphasis on the purportedly defective conversion allegations. (22) On the matter of conversion, the court of appeal reversed. (23) On defendants' appeal, the California Supreme Court addressed two issues: (1) Golde's alleged violation of Moore's right to informed consent, and (2) the defendants' alleged conversion of Moore's excised tissue.

      In its discussion, the court found for Moore on the first issue. Specifically, the court held that the doctrine of informed consent for medical procedures required Golde to disclose his ongoing research and financial interests to Moore. Such disclosure should have occurred both prior to Moore's splenectomy and during his subsequent visits to the UCLA Medical Center. The court reasoned that "a physician who does have a preexisting research interest [in a patient] might, consciously or unconsciously, take that into consideration in recommending [a] procedure." (24) As such, "the physician's extraneous motivation may affect his judgment and is, thus, material to the patient's consent." (25) Importantly, however, the court found that only Golde, as Moore's treating physician, could engage in the alleged violation of Moore's right to informed consent. The Court thus sustained the trial court's demurrers for the other defendants in this regard. (26)

      Moore, famously, did not prevail on the second issue. In denying Moore any ongoing "proprietary interest" in his excised cells, the Court explicitly refused to extend conversion theory into the realm of human tissue ownership. (27) Justice Panelli, writing for the majority, provided three ostensible reasons under existing law for why this was the case: (1) no precedent supported Moore either directly or by analogy; (28) (2) California public health statutes severely constrained the possession of bio-hazardous materials; (29) and (3) Moore could assert no proprietary interest in the Regents' patent and the products thereby derived because Moore contributed nothing more than "naturally occurring raw materials." (30)

      Ultimately, however, the majority opinion turned on policy concerns. While stopping short of a direct prohibition on excised tissue ever counting as property, Justice Panelli argued at length that extending conversion theory in Moore's favor would undermine "socially important medical research." (31) The majority feared that granting research participants/patients ongoing proprietary interests in their excised tissue could cripple the biomedical industry: "the theory of liability that Moore urges us to endorse threatens to destroy the economic incentive to conduct important medical research. If the use of cells in research is a conversion, then with every cell sample a researcher purchases a ticket in a litigation lottery." (32) The majority further noted that rigorous enforcement of the right to informed consent offered the best protection for Moore's interests. This option avoided interfering with biomedical progress because it assigned no ongoing proprietary interests to Moore. (33) Hence, to safeguard "the socially useful activities of innocent researchers," the court denied Moore's attempt to state a cause of action for conversion. (34)

      In his concurrence, Justice Arabian eschewed much of the majority's instrumentalism and relied upon a much more deontological vein of reasoning. He found Moore's attempt to secure the validity of a conversion action was an affront to the inherent worth and dignity of every human being. To wit, "Plaintiff has asked us to recognize and enforce a right to sell one's own body tissue for profit. He entreats us to regard the human vessel--the single most venerated and protected subject in any civilized society--as equal with the basest commercial commodity." (35) On these grounds alone, Justice Arabian argued, the court must deny the validity of Moore's conversion claim. Justice Arabian, however, was not unmindful of the apparent inequity of allowing the Regents et al. to retain all of the profits ultimately derived from Moore's excised tissue. Nevertheless, the legislature, and not the courts, is the "proper deliberative forum" to address such inequity. (36) Justice Arabian concluded by suggesting the need for a legislatively created licensing scheme to compensate all contributors to biomedical progress. (37)

      In his concurrence and dissent, Justice...