Patients, research volunteers, professional colleagues, and the news media frequently ask Dr. Catalona about the current status of the litigation of Washington University (WU) vs. his patients and him, concerning the blood and tissue samples he collected during his tenure at WU.
Recent Decision of the 8th Circuit Court of Appeals
Dr. Catalona and patients appealed the past decision of the Federal District Court that limited the issue of who should have his patients’ blood and tissue samples to one of “ownership.”
That Court’s finding was: informed consents signed by the patients when they agreed to participate in research were “inconsequential,” and WU owned the samples.
The recent ruling of the U.S. Court of Appeals for the Eighth Circuit said that WU owns the samples; however, patients could ask that their samples be destroyed or not used for research.
Dr. Catalona and the patients then filed, and the Eighth Circuit granted (for 60 days), a motion to prevent WU from using the samples until the Supreme Court decides whether or not to hear the request for review from Dr. Catalona and his patients.
Why an Appeal to the Supreme Court
We feel strongly that the subject in question (i.e., control of blood and tissue samples taken from human beings, containing their genetic blueprint and protected by federal regulations and the *Common Rule) has far-reaching national implications for the rights of all present and future patients and research volunteers.
Patient autonomy is especially important in the emerging era of “personalized health care,” where patient management is influenced by the patient’s specific genetic makeup.
The District Court framed the case in the narrow terms of state property law. The Eighth Circuit agreed, and interpreted Missouri property law in a way that conflicts with federal regulations.
This decision creates a dilemma, not only for the 6,000 patients whose samples are directly at issue, but also for all future research participants who, in the aftermath of the court’s decision, can never be assured that their research samples, provided for a given purpose, will be used for that purpose and nothing else.
If this unfortunate ruling stands, every present and potential future research participant would be confronted with a "Catch 22” about participating in research: If someone wanted to provide a sample to be used for a specific purpose and no other purpose, once a university took possession of his sample, it would own the sample outright and could do as it wished with it, including selling it or using it for other types of research that the patient might find objectionable.
Furthermore, the person’s genetic information could be published on the Internet, exposing him and his family members to genetic-based discrimination in obtaining employment, insurance, or adversely affecting them in other aspects of their lives.
The patient’s only recourse would be to request the sample be destroyed or removed from research. Thus, the man’s informed consent would be meaningless, and the only way he could be assured that the sample was used solely for the desired purpose would be not to provide the sample in the first place, thus defeating the purposes of biomedical research.
To prevent patients from facing this "Catch 22," Dr. Catalona and his patients will ask the Supreme Court to hear this case and hold that federal regulations trump the Missouri law as interpreted by the Eighth Circuit. Their petition is due in September.
A Patient’s Perspective
From Richard Ward, a prostate cancer survivor and litigant, with Dr. Catalona, in this case
“Thousands of men afflicted with prostate cancer are not able to have their cancerous tissues directed to the specific research projects for which they were donated.
Because we have established the right to compel the University to stop using our tissues, we can only hope they will honor our wishes and transfer the tissues to Dr. Catalona to continue his research.
Otherwise, our only recourse is the unfathomable and repugnant choice of ordering the University to destroy our samples or put them permanently on the shelf. Either choice imperils vital past, current and future research.”
*The Department of Health and Human Services has established federal regulations to protect human research subjects. The "Common Rule" is the term used by 18 federal agencies that have adopted the same regulations.