Moore v. Regents of the University of California

John Moore underwent treatment for hairy-cell leukemia at UCLA Medical Center, owned and operated by the regents of the university. During the course of his treatment, Moore’s spleen was removed and various tissue samples were taken by his doctor. Moore’s doctor engaged with a researcher at the medical center to study these samples (which were to have no relation to Moore’s medical care) and to benefit financially and competitively from exclusive access to Moore’s cells. These samples were developed into a cell line of T-lymphocytes, which the regents patented and licensed out for a potential value of billions of dollars.

Moore had given his consent for the removal of his spleen and tissue samples, but had not been informed of the plan to conduct the research or been asked permission for such. Moore sued on thirteen different causes of action.

The Superior Court only considered the first cause of action, conversion. It held the conversion complaint insufficient and found that the rest of the causes of action were based on the conversion action and so failed as well. The Court of Appeals reversed, finding the complaint did state a cause of action, and directed the Superior Court to consider the rest. The Supreme Court affirmed in part and reversed in part, finding for Moore on the actions of breach of fiduciary duty and lack of informed consent, but reversing on conversion.

The court first examined whether Moore’s doctor had a duty to inform Moore of his financial and research interests in obtaining Moore’s cells, and was this required in order to obtain Moore’s informed consent to the medical procedure. The court held that “a physician who is seeking a patient's consent for a medical procedure must, in order to satisfy his fiduciary duty and to obtain the patient's informed consent, disclose personal interests unrelated to the patient's health, whether research or economic, that may affect his medical judgment.”

Previous case law in California gave rise to a physician’s fiduciary duty “to disclose all information material to the patient's decision.” The court noted that California law recognized that “a reasonable patient would want to know whether a physician has an economic interest that might affect the physician's professional judgment.” In the present case, the court was concerned with the potential for conflicting interests in physicians who treat patients in whom they also have a research interest. The court held that the concept of informed consent was broad enough to require disclosure of a physician’s personal interests in the patient and treatment under consideration. Conflicts of interest can interfere in the cost-benefit calculus of a physician’s medical recommendations, and it is a basic right of a patient to be able to take such considerations into account. The court noted that the “possibility that an interest extraneous to the patient's health has affected the physician's judgment is something that a reasonable patient would want to know in deciding whether to consent to a proposed course of treatment.” The duty to disclose therefore becomes fused in such a way that without the disclosure of potential conflicts of interest consent is not fully informed.

The court then examined whether there was there a cause of action for conversion over excised cells. Conversion is a tort that protects against interference with possessory and ownership interests in personal property. The court held that there was no direct authority in California for importing the law of conversion to the context of a possessory interest to cells. Specialized statutes in the California Government and Health and Safety Codes generally regulate biological materials to achieve public policy goals rather than leaving them to the general law of personal property. Additionally, the effect of California Health and Safety Code section 705.4 was to limit patients’ control over excised cells. The court was additionally skeptical of Moore’s attempt to link the conversion claim to decisions on privacy rights; it was unwilling to recognize that any interference with privacy amounts to conversion of property.

The Court next sought to determine whether conversion liability could be extended to Moore’s situation. The court, however, did not hold that excised cells could never be property under any circumstances. Rather, it gave three reasons for declining to extend such rights to Moore. The first involved a balance of policy considerations. The court held that while it is important for patients to have autonomy and the right to consent in their medical choices, it is also important for people to engage in socially useful activities such as medical research. The lack of clarity in the origin of cell lines could lead to ownership disputes and potentially disable innocent parties from conducting research. A lack of clear title would also discourage companies from investing in product development upon such research. The court feared that extending conversion liability would therefore cripple advances in medicine, an unnecessary consequence given that privacy concerns were legally protected through existing laws. This second factor, the existing duty of disclosure to patients, gave patients the desired privacy protections while not creating the impediments to medical research that conversion would. This was particularly relevant since conversion is a strict liability tort which would impose liability on all actors into whose hands the cells came, regardless of whether they participated in or were aware of the violation of the patient’s right to informed consent. Finally, the court declared that any expansion of tort liability under conversion would best be handled by the legislature; both for the complex policy decisions involved and due to the past involvement of the legislature in drafting laws regarding biological extracts.

The court then examined whether the subject matter of the Regents’ patent—the patented cell line and the products derived from it—was Moore’s property. The court held that “the patented cell line [was] both factually and legally distinct from the cells taken from Moore's body.” The court noted that federal law only permitted “the patenting of organisms that represent the product of human ingenuity, but not naturally occurring organisms.” Cell lines are the product of “human ingenuity” because “long-term adaptation and growth of human tissues and cells in culture is difficult . . . and the probability of success is low.” The court thus held that Moore's allegations that he owned the cell line and the products derived from it were “inconsistent with the patent, which constitute[d] an authoritative determination that the cell line [was] the product of invention.”

“These principles lead to the following conclusions: (1) a physician must disclose personal interests unrelated to the patient's health, whether research or economic, that may affect the physician's professional judgment; and (2) a physician's failure to disclose such interests may give rise to a cause of action for performing medical procedures without informed consent or breach of fiduciary duty.” 51 Cal.3d, p 129.

 “Yet a physician who treats a patient in whom he also has a research interest has potentially conflicting loyalties. This is because medical treatment decisions are made on the basis of proportionality — weighing the benefits to the patient against the risks to the patient. As another court has said, ‘the determination as to whether the burdens of treatment are worth enduring for any individual patient depends upon the facts unique in each case,’ and ‘the patient's interests and desires are the key ingredients of the decision-making process.’ (Barber v. Superior Court (1983) 147 Cal. App.3d 1006, 1018-1019 [195 Cal. Rptr. 484, 47 A.L.R.4th 1].) A physician who adds his own research interests to this balance may be tempted to order a scientifically useful procedure or test that offers marginal, or no, benefits to the patient. The possibility that an interest extraneous to the patient's health has affected the physician's judgment is something that a reasonable patient would want to know in deciding whether to consent to a proposed course of treatment. It is material to the patient's decision and, thus, a prerequisite to informed consent. (See Cobbs v. Grant, supra, 8 Cal.3d at p. 245.)” 51 Cal.3d, p 130.

“Moore alleges that, prior to the surgical removal of his spleen, Golde ‘formed the intent and made arrangements to obtain portions of his spleen following its removal from [Moore] in connection with [his] desire to have regular and continuous access to, and possession of, [Moore's] unique and rare Blood and Bodily Substances.’ Moore was never informed prior to the splenectomy of Golde's ‘prior formed intent’ to obtain a portion of his spleen. In our view, these allegations adequately show that Golde had an undisclosed research interest in Moore's cells at the time he sought Moore's consent to the splenectomy. Accordingly, Moore has stated a cause of action for breach of fiduciary duty, or lack of informed consent, based upon the disclosures accompanying that medical procedure.” 51 Cal.3d, p 132.

“No court, however, has ever in a reported decision imposed conversion liability for the use of human cells in medical research. While that fact does not end our inquiry, it raises a flag of caution. (5) (See fn. 16.) In effect, what Moore is asking us to do is to impose a tort duty on scientists to investigate the consensual pedigree of each human cell sample used in research. To impose such a duty, which would affect medical research of importance to all of society, implicates policy concerns far removed from the traditional, two-party ownership disputes in which the law of conversion arose. Invoking a tort theory originally used to determine whether the loser or the finder of a horse had the better title, Moore claims ownership of the results of socially important medical research, including the genetic code for chemicals that regulate the functions of every human being's immune system.” 51 Cal.3d, p 135.

“Not only are the wrongful-publicity cases irrelevant to the issue of conversion, but the analogy to them seriously misconceives the nature of the genetic materials and research involved in this case. Moore, adopting the analogy originally advanced by the Court of Appeal, argues that ‘[i]f the courts have found a sufficient proprietary interest in one's persona, how could one not have a right in one's own genetic material, something far more profoundly the essence of one's human uniqueness than a name or a face?’ However, as the defendants' patent makes clear — and the complaint, too, if read with an understanding of the scientific terms which it has borrowed from the patent — the goal and result of defendants' efforts has been to manufacture lymphokines. Lymphokines, unlike a name or a face, have the same molecular structure in every human being and the same, important functions in every human being's immune system. Moreover, the particular genetic material which is responsible for the natural production of lymphokines, and which defendants use to manufacture lymphokines in the laboratory, is also the same in every person; it is no more unique to Moore than the number of vertebrae in the spine or the chemical formula of hemoglobin.” 51 Cal.3d, pp. 138 - 139.

“There are three reasons why it is inappropriate to impose liability for conversion based upon the allegations of Moore's complaint. First, a fair balancing of the relevant policy considerations counsels against extending the tort. Second, problems in this area are better suited to legislative resolution. Third, the tort of conversion is not necessary to protect patients' rights. For these reasons, we conclude that the use of excised human cells in medical research does not amount to a conversion.” 51 Cal.3d, pp. 142 - 143.

“To be sure, the threat of liability for conversion might help to enforce patients' rights indirectly. This is because physicians might be able to avoid liability by obtaining patients' consent, in the broadest possible terms, to any conceivable subsequent research use of excised cells. Unfortunately, to extend the conversion theory would utterly sacrifice the other goal of protecting innocent parties. (8) (See fn. 38.), (4d) Since conversion is a strict liability tort, it would impose liability on all those into whose hands the cells come, whether or not the particular defendant participated in, or knew of, the inadequate disclosures that violated the patient's right to make an informed decision. In contrast to the conversion theory, the fiduciary-duty and informed-consent theories protect the patient directly, without punishing innocent parties or creating disincentives to the conduct of socially beneficial research.” 51 Cal.3d, p 144.

“The extension of conversion law into this area will hinder research by restricting access to the necessary raw materials. Thousands of human cell lines already exist in tissue repositories, such as the American Type Culture Collection and those operated by the National Institutes of Health and the American Cancer Society. These repositories respond to tens of thousands of requests for samples annually. Since the patent office requires the holders of patents on cell lines to make samples available to anyone, many patent holders place their cell lines in repositories to avoid the administrative burden of responding to requests. (OTA Rep., supra, at p. 53.) At present, human cell lines are routinely copied and distributed to other researchers for experimental purposes, usually free of charge. This exchange of scientific materials, which still is relatively free and efficient, will surely be compromised if each cell sample becomes the potential subject matter of a lawsuit. (OTA Rep., supra, at p. 52.).” 51 Cal.3d, pp. 144 - 145.

“As in Brown, 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. Because liability for conversion is predicated on a continuing ownership interest, ‘companies are unlikely to invest heavily in developing, manufacturing, or marketing a product when uncertainty about clear title exists.’ (OTA Rep., supra, at p. 27.) In our view, borrowing again from Brown, ‘[i]t is not unreasonable to conclude in these circumstances that the imposition of a harsher test for liability would not further the public interest in the development and availability of these important products.’ (Brown v. Superior Court, supra, 44 Cal.3d at p. 1065.).” 51 Cal.3d, p 146.