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Whose waste is it anyway? The case of John Moore.

Whose Waste Is It Anyway? The Case of John Moore

The watchword of the grasping eighties has been profit, and medicine has not been exempt. Three happenings in the summer of 1988 are emblematic, and how we deal with them will help set the tone for the 1990s: the appearance of large amounts of medical wastes on our nation's beaches; the indictment of a Queens, NY physician for Medicaid fraud; and an opinion of a California Appeals Court involving the alleged wrongful taking of tissue by a physician from his patient.

The first two occurrences are relatively straightforward. Widescale pollution and the despoilment of the environment are the inevitable results of failure to plan properly for and manage waste disposal. Profits are large in selling nonreusable medical products, and undoubtedly can also be made by cutting corners in waste disposal. We will all now bear the cost of the cleanup. Medicaid fraud is no longer uncommon, but the New York scheme has a wonderfully macabre quality about it. Since 1986, a physician and his codefendants allegedly drew blood from poor people (whom they paid as little as fifty cents a vial), processed the blood in their medical laboratories, falsely claimed it was from Medicaid patients, and billed the government (at up to $2,000 a sample tested) for more than $3.6 million. [1]

The final example, which is much more ambiguous, involves elements of each of the first two: unusual disposals of medical waste and making large amounts of money by using human tissue in novel ways. The lawsuit has not yet been tried, and court opinions to date have only dealt with the question of whether an individual can sue for the unauthorized use of surgically removed tissue. Even so, the decision has already been called "one of the most important cases of the decade," [2] and although this is hyperbole, the case does crystallize some of the most troublesome issues in medicine in the 1980s, including the monetarization of medicine, truth and trust in the doctor-patient relationship, and the effects of commercializing both human cells and academic research laboratories.

The Case of John Moore

In 1976 john Moore, then a surveyor on the Alaskan pipeline, sought medical treatment for hairy-cell leukemia from hematologist-oncologist David W. Golde at UCLA. As is standard procedure in this disease, Dr. Golde removed Moore's spleen, which had enlarged from about a half pound to more than fourteen pounds.

Moore quickly improved. Golde took a sample from the spleen and isolated and cultured an immortal cell line capable of producing a variety of products including the lymphokine GM-CSF (granulocyte-macrophage colony stimulating factor) currently being tested as an AIDS treatment. In 1979 Golde filed a report of possible patentability with the University of California. In 1983 the university applied for a patent on the cell line naming Golde and his research assistant, Shirley Quan, as inventors. The patent was granted in 1984.

Moore, who had since moved to Seattle, had been coming back to see Golde about every six months. He has told an interviewer that he never would have known about the existence of the cell line had Golde not called him in September 1983 and told him he had "missigned the consent form" (circling I "do not" instead of I "do" grant the University all rights in "any cell line...."). Moore then decided to consult attorney Sanford Gage. [3]

In September 1984 Moore filed suit against the University of California, Golde, Quan, Genetics Institute, Inc., and Sandoz, alleging eleven types of wrongdoing (including conversion, lack of informed consent, and breach of fiduciary duty) and seeking an accounting and other relief. The trial court essentially decided that Moore had no right to bring suit. Moore appealed, and in July 1988 a California Court of Appeals, in a two-to-one decision, determined that Moore had stated a proper cause of action for conversion. [4]

The Appeals Court Decision

Judge David Rothman, writing for the majority, concentrated on just one issue: Did Moore state a cause of action for conversion? Conversion is a strict liability tort that under California law is committed against a person if the person can prove: (1) ownership or right to possession of property at the time of the conversion; (2) the wrongful conversion or disposal of the property; and (3) damages. Conversion requires neither knowledge or intent of the defendant, but instead "rests upon the unwarranted interference by the defendant with the dominion over the property of the plaintiff from which injury to the latter results." For example, in one case the defendant bought a building in which the plaintiff was a subtenant who had used the basement to store numerous barrels of wine. The defendant, thinking the barrels were junk, sold them. He was liable for conversion in spite of his lack of knowledge or intent.

Thus the Moore case raises three questions regarding conversion: Were the spleen cells Moore's property? Did Golde wrongfully take them? Did Moore suffer damages as a result?

Are Cells Property?

According to a California statute: "The ownership of a thing is the right of one or more persons to possess and use it to the exclusion of others...the thing of which there may be ownership is called property." We are unaccustomed to think of the human body as property, and have put many controls over the disposition of organs and deceased bodies, including a prohibition on the sale of organs and tissue for transplantation. Nonetheless, we do have the exclusive right to our organs and tissues, at least while they are in our bodies, and the court seems correct in concluding that "The essence of property interest--the ultimate right of control...exists with regard to one's own body."

The court saw this as debatable, but had no sympathy at all with the defendants' position that researchers, doctors, universities, and private companies can own human cells, but individuals cannot. Similarly, the defendant's contention that a diseased spleen is a thing of no value was negated by the fact that the cells from the spleen were the foundation of a multimillion-dollar industry.

The court was equally unimpressed with the argument that permitting the plaintiff to participate in economic gain from his cells would inhibit scientific progress:

....biotechnology is no longer a purely research oriented field in which the primary incentives are academic or for the betterment of humanity. Biological materials no longer pass freely to all scientists. As here, the rush to patent for exclusive use is rampant. The links being established between academics and industry to profitize biological specimens are a subject of great concern. If this science has become science for profit, then we fail to see any justification for excluding the patient from participation in those profits.

Abandonment and Consent

But wasn't Moore's spleen just "medical waste" that he abandoned for the physicians to dispose of as they saw fit? This has certainly been the traditional view. For example, when another patient sued a physician and hospital for cremating his amputated leg, the knowledge of which he said caused him to have nightmares, the Kentucky Supreme Court was unsympathetic. It ruled that, at least in the absence of "any specific reservation, demand or objection to some normal procedure" the patient accepts the standard method the hospital uses to dispose of amputated body parts when he consents to surgery. [5] And the American Medical Association's legal office has recommended use of the following clause in standard surgical consent forms: "I consent to the disposal by hospital authorities of any tissues or body parts that may be removed." [6] But such disposal has always meant incineration or burial, and did not envision, for example, burial at sea.

Although not relying on the Kentucky case, Judge Rothman reached a similar conclusion. He asserted that "internment or incineration" would have been proper disposal methods about which Moore could not have complained. But "[a]ny use...which is not within the accepted understanding of the patient is a conversion. It cannot be seriously asserted that a patient abandons a severed organ to the first person who takes it, nor can it be presumed that the patient is indifferent to whatever use might be made of it." The conclusion follows naturally: "commercial exploitation" of human tissue is improper "without the consent of the living patient." As to damages, the court concluded that this was an issue properly for the jury.

Dissenting, Judge Ronald George would have thrown the case out because he thought Moore's claim trivial. He said, for example, that he was "not prepared to extend the constitutionally sanctified right of property...to the refuse found on the floor of the barbershop or nail salon, in the hospital bedpan, or in the operating room receptacle." Moore's contribution to the value of the cell line was minimal, "like unformed clay or stone transformed by the hands of a master sculptor into a valuable work of art." Finally, as a matter of public policy, Judge George thought that permitting patients to sell or profit from their organs and tissues would impede medical progress because patients might refuse to cooperate or try to sell to the highest bidder. Therefore, he thought it proper for the legislature, not the courts, to decide what should be done in a case like this.

The case now moves on to another court, and it could ultimately be settled. No matter how another court decides, however, the legislature can pass a statute to determine the rights and responsibilities of all parties, and physicians and hospitals can adopt research policies. What should the statute or policy be? Is there a fair and reasonable solution? Or, as Judge George suggests, will recognizing an individual's property right in his tissues simply aggravate the problems we now face with profit-seeking researchers and corporations by adding the problem of the profit-seeking patient?

The Right Analogy

Is the fact that Moore's spleen was involved in his disease and removed for therapeutic reasons sufficient to conclude that it was of no value to him? Judge Rothman says no, and suggests the following analogy. Suppose crude oil is ruining a farmer's corn crop, and that the farmer may even be willing to pay an oil refinery to take it off his land. Even though the farmer cannot make any use of the oil without the aid of the refinery, he is still entitled to a share in the refinery's profits from the product of his land. [7]

Other agricultural analogies have been suggested. For example, under Roman law, as long as crops remain in the ground, they are generally owned by the person who owns the ground. If they are removed, ownership depends upon whether they are fructus naturales (perennials such as trees and grasses) or fructus industriales (annuals such as corn). Severed fruits belonged to the gardener, whereas severed trees belonged to the landowner. The distinction was based on the amount of human input: the more effort was expended, the more likely ownership was to reside in the gardener. This analogy favors the physician. So does a similar Roman law doctrine, "specification," that holds that when an entirely new product is fashioned out of products belonging to another, the person who does the transformation owns the final product. [8]

Neither of these doctrines, however, settles the question of damages. Even if the physician-researcher now owns the cell line, he may still owe the patient something. Judge George thought that something would be the value of the portion of the spleen that was taken at the time--that is, nothing or almost nothing. But, since the cells are living and reproduce, a more apt agriculture analogy may be one stemming from farm animals. The progeny of animals are the property of the mother's owner under the maxim partus sequitur ventrem ("the birth comes from the womb"). In addition, an owner wrongfully deprived of livestock can get the value of the eggs from converted chickens, and milk from converted milk cows. These cases support a claim that the patient would have for the value of the output of the cell line resulting from wrongly taken tissues or cells. [9]

This suggests what may be the proper analogy. Suppose a farmer's cow is dying, and threatens to infect the rest of his herd. His neighbor agrees to care for the cow on the neighbor's farm, both of them believing the cow's illness is fatal. Under the neighbor's care, the cow recovers. Instead of returning the cow, he keeps it. Over the years, it has a dozen calves before the farmer discovers what the neighbor has done. Under the animal progeny cases the farmer should be able to recover not only the value of the cow, but also the value of the calves as well (perhaps deducting the cost of flood and medicine).

The problem with treating Moore's spleen like garbage is that Moore did not abandon it (his physician removed it to do to it whatever is customarily done) nor had he known his spleen was valuable would he have done so. Indeed, it is primarily because of what researchers fear patients will do (that is, not voluntarily relinquish their rights in commercial products resulting from manipulation of their cells) that researchers oppose even discussing the potential value of cells with patients. Perhaps a more apt analogy involving garbage is that a person is usually happy to have their garbage removed; but if there are two competing garbage companies, and one will pay to take the garbage away (or will do it cheaper than the other) people will certainly let the company that will pay have the garbage. And if yet a third company discovers a way to turn garbage into gold, most people would want to charge that company even more, and (if their garbage is unique) might well hold out for a share of the profits.

Mining for Biological Gold

Garbage companies have no obligation to tell their clients what is being done with their garbage--but physicians do. The doctor-patient relationship is often described as a fiduciary relationship, and part of that trust is the assumption that anything not disclosed to the patient is withheld because the information could not affect the patient's decision, and that in any event the withheld information concerns something done for the patient's benefit. This is hardly the case when a patient's organ is mined for biological gold. Here, information is withheld for the benefit of the physician or researcher, and the justification offered is that the patient might not agree to "give" the tissue, but might instead expect some compensation in the event it is transformed into a commercial product.

Judge Rothman seems correct. If human cells are to be sources of profit, patented, or both, the person from whom these cells derive should have at least as much standing to own and profit from their commercial exploitation as the physician and the biotechnology company. This leaves essentially two choices. My preference is to discourage increasing commercialization of the body and its tissues by amending the Patent Act explicitly to prohibit the patenting of human cells, and the Organ Transplant Act to include a prohibition on the sale of human tissue and cells for any purpose (not just when they are intended for transplantation).

Until we can overcome our appetite for profit, however, we will need to deal with the world as we find it. Fairness and respect for persons require that we explicitly inform patients that their organs, tissues, and cells may be used for commercial purposes when this is intended. Patients should have a right to accept or reject this use, and should be offered reasonable compensation if they agree to it. This compensation could be in the form of a small payment for exclusive rights; or an agreement that a small percentage of profits (or gross sales) would accrue to the patient in the unlikely event that a commercially successful product were developed. A clause in a standard consent form requiring the patient to simply waive all property rights in tissues and cells would be legally ineffective as a coercive "adhesion" contract.

Unless this or some similar plan is followed, physicians and researchers who mine patients' bodies without their knowledge or consent will be acting much more like the doctor accused of Medicaid fraud by using the blood of unsuspecting "donors" for profit than a physician in a classic fiduciary doctor-patient relationship. We all pay the price for excessive profit -seeking activity. But if we are open and honest about it, we can at least control some of the damage.

References

[1] "Fraud, Fraud, Fraud," Time, August 15, 1988, 28.

[2] Arthur Caplan, quoted by Malcolm Gladwell and Michael Specter, "Calif. Court Rules Human Tissues and Cells are Personal Property," Boston Globe, July 23, 1988, 3.

[3] Judity Stone, "Cells for Sale," Discover (August 1988) 34-35.

[4] Moore v. Regents of the U. of California et al., 88 Dailey Journal D.A.R. 9520 (Cal. Ct. App., 2d Dist., Div. 4, 1988).

[5] Browing v. Norton Children's Hospital, 54 S.W.2d 713 (Ky. 1974).

[6] American Medical Association, Office of General Counsel, Medicolegal Forms, 1973, 58.

[7] Judge Rothman attributes the analogy to Sherman, "The Selling of Body Parts," National Law Journal, December 7, 1987, 1. And see generally, Note, "Toward the Right of Commericiality: Recognizing Property Rights in the Commercial Value of Human Tissue," UCLA Law Review 34 (1986), 207-264.

[8] Congress of the United States, Office of Technology Assessment, New Developments in Biotechnology: Ownership of Human Tissues and Cells (Washington, DC: Government Printing Office,1987), 83-85.

[9] Office of Technology Assessment, New Developments in Biogechnology.

George J. Annas is Utley Professor of Health Law and Chief, Health Law Section, Boston University Schools of Medicine and Public Health.
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Title Annotation:medical waste disposal; use of discarded tissues
Author:Annas, George J.
Publication:The Hastings Center Report
Date:Oct 1, 1988
Words:2965
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