Chapter 6.B.2 (or 4.B.2) -- Ownership of Human Tissue
Greenberg v. Miami Children's Hospital. In a decision that was even less sympathetic to patients' interests, a federal district court followed Moore on the ownership issue, but cabined the Moore court's holding on informed consent. In Greenberg v. Miami Children's Hospital Research Institute, Inc., 264 F. Supp. 2d 1064 (S.D. Fla. 2003), individuals with a family history of Canavan disease (a rare, inherited, fatal, metabolic disorder) provided blood and tissue samples to researchers to develop a genetic test and further understand the nature of the disease. Researchers developed a test to identify the Canavan gene and then charged royalty fees to those using the tests. The court followed Moore in denying any ownership interest in the genetic test to the blood and tissue donors. It further held that the researchers had no duty to disclose their financial interests to the donors, that the Moore case's imposition of such a duty was tied to the fact that the physician in Moore was also Mr. Moore's treating physician. In Greenberg, there was no treatment relationship between the donors and the researchers.
As in Moore, the Greenberg case was settled, with Miami Childrenís Hospital permitted to license and collect royalty fees for the laboratory test for the Canavan gene but obligated to allow license-free use of the Canavan gene in research.to cure Canavan disease. Kevin L. J. Oberdorfer, Note, The Lessons of Greenberg: Informed Consent and the Protection of Tissue Sources' Research Interests, 93 Geo. L.J. 365, 376 (2004).
Click here for an excerpted version of Greenberg.
Wash. Univ. v. Catalona. While Moore and Greenberg involved disputes between patients and researchers, disputes also may arise between researchers and their institutions. When a highly-respected researcher of prostate cancer, Dr. William Catalona, moved from Washington University, St. Louis, to Northwestern University, he wanted to take a repository of prostate tissue, blood and DNA samples that he had collected from patients and that he used in his research. On summary judgment, a federal trial court concluded that the patients had donated their tissue samples to Washington University, which enjoyed ownership rights over those samples. The court therefore held that neither the patients nor Dr. Catalona could insist that Washington University transfer the samples to Northwestern University. Wash. Univ. v. Catalona, 437 F. Supp. 2d 985 (E.D. Mo. 2006). For further discussion of this case, see Lori Andrews, Who Owns Your Body? A Patient's Perspective on Washington University v. Catalona. 34 J. L. Med. Ethics 398 (2006).
Tissue Processing for Profit. Just as researchers can earn substantial sums by manipulating a personís cells in research, so can companies realize large profits by processing a cadaverís tissues for transplantation. Although, federal law prohibits payments to the decedentís family for skin, tendons, bone, heart valves and other tissues, 42 U.S.C. ß 274e, tissue banks can receive reasonable payments for their retrieval and storage costs, and tissue processors can charge what the market will bear for tissues used in transplants. In contrast to the substantial regulation of the organ transplant system, the law provides considerably less oversight of the tissue processing and transplant industry. For more discussion, see Robert A. Katz, The Re-Gift of Life: Can Charity Law Prevent For-Profit Firms From Exploiting Donated Tissue and Nonprofit Tissue Banks?, 55 DePaul L. Rev. 943 (2006); Michelle Oberman, When the Truth Is Not Enough: Tissue Donation, Altruism, and the Market, 55 DePaul L. Rev. 903 (2006).