Analysis of State Laws
Summary of State Laws
Ms. Smith entered the Garden City Medical Center for surgery to remove a lung tumor. Dr. Jones, the treating physician, noted Ms. Smith’s unique response to therapy and embarked on a research project to study Ms. Smith’s blood and cells without informing her. Ms. Smith was asked to come to the medical center for regular blood draws and medical procedures, and, additionally, Dr. Jones used her excised cells to create a cell line for research purposes, all unknown to Ms. Smith.
Dr. Jones and Garden City Medical Center developed a unique diagnostic test used to detect the presence of lung tumors using a simple blood test. They obtained a patent on this test and have sold the test to other health care providers.
Can Ms. Smith obtain a portion of the revenues from the patented blood test developed using her blood and tissue?
In the 1990 case of Moore v. Regents of the University of California,65 the California Supreme Court found that individuals did not retain rights of ownership in excised tissue when tissue was used for research purposes. The court also held that even if human cells initially belonged to an individual, these excised cells were legally and factually distinct from the resulting research product.
George Moore signed a consent form agreeing to the removal of his spleen for the treatment for hairy cell leukemia. Moore was asked to come to the medical center for regular blood draws and medical procedures, and, additionally, the treating physician used Moore’s excised cells to create a cell line for research purposes, all unknown to Moore. Moore sued the physician, claiming “conversion” (or deprivation of a property interest), breach of the duty to obtain informed consent, and breach of fiduciary duty for using the excised cells without the patient’s consent to the research use.
On the matter of ownership of the removed cells, the court found that individuals did not retain rights of ownership in excised tissue. However, the Court did find that the physician had breached his duty to obtain informed consent for the research conducted on George Moore, ruling that in the context of a therapeutic relationship, a physician has a duty to disclose and to obtain informed consent from a patient who is the subject of research. The court also found a breach of a fiduciary relationship and violation of informed consent since, under California law, physicians must disclose all personal interests that may affect medical judgment.
Since this case is only binding in the state of California, the question of individual ownership of excised tissue is still uncertain in most states. Nevertheless, this decision has been influential, and there is a presumption that researchers are entitled to use tissue specimens for further study as long as such use complied with existing regulations and laws.
In a more recent case decided in May 2003, in Greenberg et al. v. Miami Children’s Hospital,66 a group of families of children with Canavan’s disease, along with several not-for-profit institutions, sued the Miami Children’s Hospital and Dr. Reuben Matalon, the researcher who had developed the prenatal genetic test for Canavan’s disease, after a patent for the test was obtained. Canavan’s disease is a rare, autosomal neurodegenerative disorder characterized by degeneration of CNS white matter and specific CNS pathological findings. Canavan’s disease always results in early death in children and infants, depending on the type inherited, and no treatment is available. Diagnostic tests were not available to detect the disorder in utero until Dr. Matalon successfully isolated the gene responsible for Canavan’s disease in 1993.
The individual plaintiffs sued on behalf of their children who had donated blood and tissue samples to Dr. Matalon while he was working to isolate the gene.67 Other plaintiffs joined the suit to pursue a public policy claim protesting the enforcement of the patent, including collection of royalties and licensing fees for restrictive licensing arrangements. When the plaintiffs learned that a patent had been obtained and was being enforced to restrict the availability of the prenatal test, they sued.
According to the plaintiffs, their collaboration in the process was based on the “understanding and expectations that such samples and information would be used for the specific purpose of researching Canavan’s disease and identifying mutations in the Canavan’s disease gene which could lead to carrier detection within their families and benefit the population at large.” Plaintiffs further alleged that it was their “understanding that any carrier and prenatal testing developed in connection with the research for which they were providing essential support would be provided on an affordable and accessible basis, and that Matalon’s research would remain in the public domain to promote the discovery of more effective prevention techniques and treatments and, eventually, to effectuate a cure for Canavan’s disease.”
The judge dismissed all claims against the defendants except the claim of unjust enrichment (Ballentine’s Legal Dictionary defines unjust enrichment as the circumstances which give rise to the obligation of restitution, or the receiving and retention of property, money, or benefits which in justice and equity belong to another), for failing to share the financial benefit that accrued from licensing fees and royalties for the prenatal test.69 While the case eventually settled, the judge held that an individual does not retain a continuing interest in tissue and blood “donated” for research purposes.
While this case is helpful in understanding some rights that researchers may have to use tissue specimens, it is uncertain whether this ruling will apply to all circumstances since the case involved specific facts where the individuals were fully informed of the research purpose and gave their explicit prior consent.
