Moore v. Regents of the University of Southern California: Do We Own Our Cells, and Can We Sell Them?

lymphokines

Alexandria, VA – October 18, 2016

Moore v. Regents of the University of Southern California (51 Cal.3d 120 (July 9, 1990)) was one of the most interesting cases I read in law school. The main issue it raises is whether individuals have property rights over their own cells.

First, Moore is a 1990 California case, not a Supreme Court case; in fact, the Supreme Court denied review. Ergo, this issue may be reopened at some point. All citations (as you see, I’m super lax about citation format) are taken directly from the decision, unless noted otherwise.

Background

Plaintiff John Moore sued his treating physician, Dr. David Golde; the Regents of the University of California; Shirley Quan, a researcher who worked for the Regents; Genetics Institute, Inc.; and Sandoz Pharmaceuticals Corporation.

Mr. Moore began treatment for hairy cell leukemia at University of California at Los Angeles
Medical Center (UCLA) in 1976. Dr. David Golde was the physician who treated Moore at
UCLA. After confirming the diagnosis, Dr. Golde and other researchers realized that “certain blood products and blood components were of great value in a number of commercial and scientific efforts” (126), and that having access to a patient whose blood had these substances would provide “competitive, commercial, and scientific advantages” (126).

Later in 1976, Dr. Golde had Moore’s spleen removed. Before the surgery, Dr. Golde and Ms.
Quan “formed the intent and made arrangements to obtain portions of [Moore’s] spleen following its removal” (126) and to take them to another research unit. Moore and Quan did not tell Moore of these plans or their intent to use portions of his spleen for research purposes (i.e., purposes other than treatment of his leukemia).

Moore returned to UCLA (from his home in Seattle) several times from 1976 through 1983, at
Golde’s direction and based on Golde’s representations “that such visits were necessary and required for his health and well-being, and based upon the trust inherent in and by virtue of the physician-patient relationship” (126). At each of these medical visits, Golde withdrew further samples of “blood, blood serum, skin, bone marrow aspirate, and sperm” (126). The bottom line is that Moore was told to go to UCLA several times for medical visits that had nothing to do with his treatment for leukemia (some of these visits did have to do with his treatment, but some did not). Further, throughout Moore’s treatment, Defendants “were actively involved in a number of activities which they intended to conceal from [Moore]” (126). Defendants were performing research on Moore’s cells and intended to “benefit financially and competitively” by taking advantage of Moore’s cells, as well as of their exclusive access to Moore through Golde’s treatment relationship with him (126).

Prior to August 1979, Golde established a cell line from Moore’s T-lymphocytes (a T-lymphocyte is a type of white blood cell). On January 30, 1981, Regents applied for a patent on the cell line, listing Golde and Quan as inventors. The Regents, Golde, and Quan would share in the profits arising out of this patent. The patent was issued on March 20, 1984, and named Golde and Quan as the inventors of the cell line and Regents as the assignee of the patent.

The Regents’ patent covers several methods for using the cell line to produce lymphokines
(lymphokines are produced by T-lymphocytes, and are proteins that regulate the immune system). Moore argued that competing commercial firms in these fields had published reports in biotechnology industry publications, which foresaw a potential market of around $3 billion by 1990 for such lymphokines (127). Well, damn.

Suffice it to say that Golde negotiated agreements to commercially develop the cell line, became a paid consultant for Genetics Institute, and made a ton of money for himself and for the Regents. Moore sued, arguing that he had been left in the dark; no one had told him that his cells were being used to create these products that were profitable. Shouldn’t he share in the profit?

Moore’s causes of action

Breach of duty to disclose

Moore sued under two causes of action. First, Moore argued that the physicians and researchers failed to disclose that they had a financial/research interest in his cells; and that they failed to obtain Moore’s consent to the medical procedures (via which his cells were extracted). That is, physicians breached their duty to disclose, and failed to obtain Moore’s informed consent to the medical procedures. Without disclosing their interests, Moore could not give his informed consent to the procedures.

In California (at the time), physicians’ duty to disclose arose from case law:

(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.

The Court found that there was enough evidence to state a claim that Defendants had breached their duty to disclose to Moore, and that Moore’s informed consent had not been obtained. Here, the Court found that the fact that Dr. Golde had a financial interest in Moore’s cells was material because it may have affected how Golde treated Moore. A reasonable patient would want to know whether a doctor has an economic interest that might affect the doctor’s professional judgment. The Court thus remanded to the lower court for decision.

(I’ll use this format in lieu of a footnote here. Contrast the Moore case regarding informed consent with Greenberg v. Miami Children’s Hospital (264 F.Supp.2d 1064 (2003)), where the Court found there was no duty for a medical researcher to disclose economic interests when no therapeutic relationship existed. In the Moore case, the medical researchers, at least Dr. Golde, were also the physicians treating Moore for hairy cell leukemia. Also, in Moore, his physicians had him travel to UCLA Medical Center for further testing that was not necessary for his treatment, but was only for research purposes, without so disclosing to him. Further, in Greenberg, Plaintiffs knew their genetic material was being used for research; however, in the Moore case, Mr. Moore did not know that his cells were being used for purposes other than his medical treatment.)

Conversion

The most interesting aspect of this case, and the reason why it is in law school textbooks on torts, is that Moore also filed a claim of conversion. Conversion is a tort (read: civil wrong) that protects against interference with possessory and ownership interests in personal property.

The Restatement (Second) of Torts 222A explains: “conversion is an intentional exercise of dominion or control over a chattel which so seriously interferes with the right of another to control it that the actor may justly be required to pay the other the full value of the chattel.” Note that “chattel” here means property. Also note that conversion is a strict liability tort. That is, the Plaintiff only has to prove that the tort occurred for liability to be found; the Plaintiff does not have to prove negligence or intent or fault.

Here, Moore argues that he owns his biological materials, that he continued to own his cells after they were removed from his body, “at least for the purpose of directing their use, and that he never consented to their use in potentially lucrative medical research” (134-35). In this manner, Moore argues, Defendant’s unauthorized use of his cells constituted a conversion. As a result of the alleged conversion, Moore argues that he claims a proprietary interest in each of the products that any of the Defendants might ever create from his cells or the patented cell line, and that he should share in the profits.

Before we get into the Court’s rationale, let’s note that, although selling organs is currently illegal under U.S. law, individuals are able to legally sell the following:

-hair
-sperm
-plasma
-feces (bet you didn’t expect to see this here, did ya?)
-eggs
-breast milk (while technically legal, this appears to be subject to a gray area; not to mention it is difficult to maintain sterile)

Remember that state laws may differ, and some states may prohibit the sale of the above-listed items; however, they are legal in at least some states. For example, see the Virginia Code:

§ 32.1-291.16. Sale or purchase of parts prohibited; penalty.

A. With the exception of hair, ova, blood, and other self-replicating body fluids, it shall be unlawful for any person to sell, to offer to sell, to buy, to offer to buy, or to procure through purchase any natural body part for any reason including, but not limited to, medical and scientific uses such as transplantation, implantation, infusion, or injection.

In Virginia, at least under state law, it is legal to sell one’s eggs, hair, and blood (I have not fully researched under federal law, as that is too complicated and cumbersome to include in this blog post).

The Court ultimately finds that Moore has no ownership interest in his cells once they left his body; thus, he cannot state a cause of action for conversion. In my opinion, the Court’s rationale (largely for public health reasons, i.e., the greater good) is lacking and not entirely on point.

First, the Court finds that the patented cell line and products derived from it cannot be Moore’s property because the patented cell line is both factually and legally distinct from the cells taken from Moore’s body. As support for this finding, the Court indicates that the genetic code for lymphokines does not vary from individual to individual (FN 18). Even if the latter is true, obviously, Moore’s genetic makeup was different somehow; after all, physicians were interested in only his cells; the cells of other people were not useful in creating the cell line. Obviously, Moore’s cells were singular in some way.

Further, the Court argues that opening the tort of conversion up to include ownership of one’s own cells would lead to increased litigation: “If the use of cells in research is a conversion, then with every cell sample a researcher purchases a ticket in a litigation lottery” (182). Judges don’t like courts to be clogged with cases. However, this would not necessarily be the case. Physicians can avoid liability by disclosing their interests, and obtaining informed consent, which is already required under the law. If necessary, physicians could then reach written agreements with patients.

The Court does not want to “threaten with disabling civil liability innocent parties who are engaged in socially useful activities, such as researchers who have no reason to believe that their use of a particular cell sample is, or may be, against a donor’s wishes.” First, the remedy for this problem is simple. Physicians should obtain patients’ written consent for research use and, if need be, negotiate a contract via which a patient receives, for example, a percentage of the profits should doctors make money from patients’ cells.

Second, the activity of harvesting cells for medications is “socially useful,” but big pharma is ultimately not encouraged to develop these medications because it is “useful.” Pharma is encouraged to do so to make money. Now, I’m fine with that. I have nothing against profit (see https://lawschoolheretic.com/2016/06/09/corporations-exist-to-make-money-who-knew/); profit drives medical research. Here, it appears that the physicians and medical manufacturers kept Moore out of the loop because they were afraid he would deny them access to his cells.

The Court states that “the theory of liability that Moore urges us to endorse threatens to destroy the economic incentive to conduct important medical research” (172). Wrong. It would mean that physicians and researchers would possibly have to share the profits with patients. And since courts impose a fiduciary duty to disclose a research and/or financial interest in a patient, physicians and researchers already run the risk that a patient will deny them access to/use of their own cells. Thus, this risk already exists without holding that conversion liability applies to Moore’s situation. In fact, the Court points this out: “A fully informed patient may always withhold consent to treatment by a physician whose research plans the patient does not approve.” (141).

In his dissent, Justice Broussard (note: Justice Allen Broussard was one of the first African-Americans to become a judge in California, and was one of the more liberal justices at the time) argued that Moore did indeed have an ownership interest in his cells, and that, therefore, the situation gave rise to a conversion claim. Justice Broussard further notes that physicians should get consent and, if need be, negotiate a contract with the patient as to the use of his cells: “Although such economic value may constitute a fortuitous ‘windfall’ to the patient, the fortuitous nature of the economic value does not justify the creation of a novel exception from conversion liability which sanctions the intentional misappropriation of that value from the patient” (my emphasis) (Broussard, dissent).

The Court also states that no court has ever imposed conversion liability for the use of human cells in medical research. The Court notes that conversion arose out of the common law action of trover; and early examples likely had to do with finders of lost goods failing to return the goods. So? Science and technology progress each day, and the courts need to address the changes. The argument that “well, no one’s ever done it before” is weak.

My biggest problem with this decision is well-articulated by Justice Broussard in his dissent: “far from elevating these biological materials above the marketplace, the majority’s holding simply bars plaintiff, the source of the cells, from obtaining the benefit of the cells’ value, but permits defendants, who allegedly obtained the cells from plaintiff by improper means, to retain and exploit the full economic value of their ill-gotten gains free of their ordinary common law liability for conversion” (my emphasis). How is it fair that Dr. Golde and the researchers got to keep the profits from using Moore’s cells even though they breached their fiduciary duty to disclose economic and research interests to Moore? That teaches other physicians that they can do so as well.

Lastly, and maddeningly, the Court concedes that it “do[es] not purport to hold that excised cells can never be property for any purpose whatsoever….” (142), but does not indicate any parameters as to when that finding may be the case. Thanks. That’s helpful.

After the Court’s decision, Moore subsequently negotiated what he called a “token” settlement with UCLA that covered his legal fees based on the fact that he wasn’t informed and hadn’t agreed to the research (see http://articles.latimes.com/2001/oct/13/local/me-56770 ). He died when he was 56 years old.

If the Plaintiff’s conversion argument in Moore is correct, how would this play out in real life?

The Greenberg case cited above raises an interesting point. If ownership interests are found here, would the patient then have ownership of the cell line, and subsequent medications or treatments? The courts would have to cut off the patient’s ownership interest at some point; a patient would basically sell his/her ownership rights.

As to how this would play out, it is difficult to predict whether biological materials will be profitable. If physicians suspected they would be, they should disclose their interest and, if necessary, negotiate a written agreement with the patient. Perhaps the patient would allow physicians to use his/her cells for free; perhaps the patient would share in any profits that would subsequently be obtained.

One attorney posits that patients could sign a contract akin to a preinvention contract used in the patent realm (See Christopher Scott Pennisi, More on Moore: A Novel Strategy for Compensating the Human Sources of Patentable Cell-Line Inventions Based on Existing Law, 11 Fordham Intell. Prop. Media & Ent. L.J. 747 (2001)).

Now, patients are still perfectly able to donate their cells, etc. for medical research and agree to do so without receiving a penny. That is the patient’s choice. My point is, it should be THE PATIENT’S CHOICE whether to negotiate such an agreement or not. Let me also make one thing clear. Even though, under current law, a patient may not have ownership rights over his/her biological materials in this situation, the patient can still negotiate a contract with physicians and researchers, quid pro quo.

As the Moore case suggests, conversion liability regarding biological materials is not a completely settled issue, and we may see similar cases and situations arise in the near future.

I should also state here that nothing I say in this article, or on this blog, constitutes legal advice.

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