PATIENTS DO NOT HAVE PROPERTY RIGHTS TO BODILY SUBSTANCES
PATIENTS DO NOT HAVE PROPERTY RIGHTS TO BODILY SUBSTANCES that are removed during the course of treatment and subsequently used for research or commercial purposes, the California Supreme Court ruled July 9. In a six-to-one decision in the case Moore v. The Regents of the University of California, the court rejected the argument that a patient may bring suit under the legal theory of conversion, i.e. the assumption of property rights without the authorization of the true owner. However, the court concluded that a physician does have a fiduciary obligation to reveal to a patient any research or economic interest that might create a conflict of interest, and that a patient must be aware of these in order to give informed consent. The complaint originally was filed by plaintiff John Moore in 1984 after his spleen was removed by David Golde, MD, UCLA Medical Center, in treating Moore's hairy-cell leukemia. Golde and UCLA researcher Shirley Quan subsequently isolated and patented a cell line that was taken from Moore's spleen and used to develop products for improving the human immune system. Genetics Institute gave 75,000 shares of stock to Golde and$330,000 to the Regents for rights to products developed from the cell line, while Sandoz Pharmaceuticals paid the Regents$110,000. Moore named Golde, Quan, the UCLA Regents, Genetics Institute and Sandoz as defendants. The market for products developed under the agreements has been estimated at $3 bil. One product developed by Genetics Institute and Sandoz from the cell line, granulocyte macrophage colony stimulating factor (GM-CSF), is now being reviewed by FDA for marketing approval. The court also held that "the subject matter of the Regents' patent -- the patented cell line and the products derived from it -- cannot be Moore's property. This is because the patented cell line is both factually and legally distinct from the cells taken from Moore's body." In rejecting Moore's argument to extend the theory of conversion to bodily substances, the court reasoned that assuming patients retain property rights to tissue removed for health reasons from their bodies would "hinder research by restricting access to the necessary raw materials." Noting that thousands of human cell lines are now routinely distributed to researchers by tissue repositories, the court concluded that "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." Addressing the issue of informed consent, the court noted that "no law prohibits a physician from conducting research in the same area in which he practices." However, the ruling states: "A physician who treats a patient in whom he also has a research interest has potentially conflicting loyalties." The court reasoned that "a physician who adds his own research interests to" the benefit-risk decisions involved in treating a patient "may be tempted to order a scientifically useful procedure or test that offers marginal, or no, benefits to the patient." Consequently, the court ruled 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." While establishing Golde's responsibility to Moore under the theory of informed consent, the decision limits the liability of the other defendants -- including Genetics Institute and Sandoz -- to "secondary liability." Acknowledging that "none of these defendants stood in a fiduciary relationship with Moore or had the duty to obtain Moore's informed consent to medical procedures," the ruling states that "if any of these defendants is to be liable for breach of fiduciary duty or performing medical procedures without informed consent, it can only be on account of Golde's acts and on the basis of a recognized theory of secondary liability, such as respondeat superior." The California Supreme Court's decision in part affirms and in part reverses an earlier decision by the state Court of Appeals, which had held that plaintiff Moore could bring suit on the theories of informed consent, fiduciary duty and conversion. The case will be now be returned to California state court to determine the extent of the fiduciary relationship between Moore and the defendants and whether that relationship was breached. The American Medical Association, in a response to the ruling, acknowledged that physicians must inform patients of the economic interests in research involving their bodily substances. A recent AMA report on the issue concludes that it is "inappropriate for a physician to permit economic concerns to influence the diagnostic or therapeutic alternatives that are offered to a patient." The report was presented by AMA's Council on Ethical and Judicial Affairs at its recently concluded House of Delegates meeting in Chicago. In other responses to the decision, Association of Biotechnology Companies Executive Director Pamela Bridgen on July 10 called the decision "beneficial to the health of this nascent industry, while preserving patient rights." She maintained that if the court had upheld a patient's property rights, "major complications in research and delays in getting important products to market would have resulted." The Industrial Biotechnology Association echoed ABC's statement, saying July 11 that it "applauds" the high court's decision in that it "has removed the threat of liability which had been hovering over biomedical research." IBA President Richard Godown commented that "had the decision gone the other way, undoubtedly legal proceedings would have been mounted against innocent third-party researchers."
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth