Litigation Update (as of July 2006)
From the Fall Issue of Quest 2006

Dr. Catalona’s patients and research participants from his time at Washington University (WU) in St. Louis continue to inquire about the status of the litigation in the dispute between Washington University and Dr. Catalona regarding the samples that Dr. Catalona’s patients and participants entrusted to him for his research program.* In March 2006, the District Court Rendered an opinion and Dr. Catalona provides a summary of the case and his views on the opinion below.

From 1976 to 2003, I was a member of the academic faculty at Washington University where I specialized in nerve-sparing prostate cancer surgery, performing thousands of surgeries. I also directed a leading prostate cancer research program.

Beginning in 1983, I began collecting blood and tumor tissue samples for prostate cancer research, establishing one of the first large collections for prostate cancer research. I was able to obtain funding from the National Institutes of Health, CaPCURE (now called The Prostate Cancer Foundation), the Urologic Research Foundation, and industry; specifically for the development and maintenance of the biorepository. Most of my colleagues in the research community came to refer to the samples as “the Catalona Collection.”

The collection began to increase dramatically in 1989, with the initiation of my PSA Study. Ultimately, I collected samples from thousands of patients and research participants and their relatives. The collection includes thousands of tumor tissue and blood DNA samples and hundreds of thousands of serum samples. These samples were stored in large freezers in my laboratory – the largest collection of tissues for prostate cancer in the world.

The samples of patients’ relatives are useful because the causes of cancer are genetic. Where prostate cancer is passing down through families, it’s likely the cause of their prostate cancer is from the same genetic defect, and if one could identify that cause, then there would be possibilities of earlier detection.

All of the samples I collected are “linked” samples – that is, the samples are matched via a computer database to the identity of the research participant. The database contains demographic information, as well as detailed medical information for each patient and very long follow-up information on many patients.

Linking the samples to the identity of their owner is important because of the genetic component to cancer. If it were determined, for example, that a certain set of genes predisposed an individual to cancer, it would be important to inform the person from which the tissue came that he was predisposed to cancer. But it would also be important to inform the blood relatives of that individual, because they too would be likely to have the same genetic predisposition.

Because Washington University receives federal funds, it must comply with regulations issued by the Department of Health and Human Services that govern the manner in which human-subjects research is conducted. Among other things, the federal regulations place strict requirements as to what constitutes informed consent by a research participant to participate in a study. In order to constitute informed consent under the regulations, the consent must contain various provisions. One such provision is a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. Where appropriate, the consent form must also state the consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.

Consistent with these governing federal regulations, the patients and research participants were presented with consent forms and a brochure drafted by Washington University. The forms provided that the patients’ tissue samples would be used for prostate cancer research and that the participants had a right to withdraw from the research later on if they changed their mind. The forms did not state that WU would own the tissue samples.

In February 2003, I left WU to continue my surgical practice and research at Northwestern University in Chicago. Before I left, I sent a form letter to my patients, the families of my patients, and many others who participated in my research protocols under my direction while I was at WU. The form letter asked if the recipient would agree to have his tissue transferred from WU to Northwestern University. The letter was also published in QUEST. Approximately 6000 patients and research participants gave their consent to transfer their samples.

When notified of these requests to transfer the samples, WU refused to honor them and filed a lawsuit against me in Federal Court in August 2003, seeking a declaratory judgment that it is the rightful owner of the collection and is entitled to use and transfer them as it wishes.

I (Dr. Catalona) answered the suit and filed a counterclaim. The court allowed a limited number of patients to be included as defendants. In April 2005, a hearing took place where Court heard testimony from me (Dr. Catalona), three patients, and several experts. Nearly one year later, the Court entered a judgment, finding that the patients had made a gift of the samples to WU and, therefore, WU owns the samples outright. The Court concluded that the patients’ right to withdraw from the research protocol meant, “nothing more than the right not to give any more samples to WU.” The Court further stated that WU could, at its sole discretion, decide to destroy the samples, store them indefinitely, or strip them from identifying information and use them in any research that WU deemed appropriate. Indeed, by declaring WU to be the tissues’ “true and rightful owner,” the Court’s decision apparently enables WU to do whatever it likes with the tissues.

I (Dr. Catalona) and the patients filed notices of appeal on May 11, 2006.

Briefs filed in support of Dr. Catalona and the patients’ physician will be posted at the close of the briefing cycle on the URF website: www.drcatalona.com

In addition, two Friend of the Court (Amicus Curiae) briefs were filed in support of the patients’ rights by The People’s Medical Society and Us Too International. Their briefs will also be posted on www.drcatalona.com

I believe that the right of patients to withdraw their samples from research without penalty (which was a part of their “consent form to participate in research”) also includes the right to transfer their samples to another research institution for continued research that may benefit them, their families, and society. Such transfers occur every day in practice. Denying patients the ability to transfer prevents them from exercising their right to effectively withdraw from research, without penalty.

I believe it is wrong for the patients to be denied control over the use of their samples. Patients do not want their samples destroyed, stored indefinitely, or anonymized. Rather, they want them to be used by me for prostate cancer research as they originally intended. In addition, the research results could be important to them and their families for personalized health care, an exciting new area of medicine.   I am convinced that when patients and potential research participants realize that if it were to become the law that when a person provides samples for research, he or she would lose all control and have no right to withdraw at all, it will undermine patients’ trust in the biomedical research establishment and many will choose not to participate in research. The opinion of the District Court, if upheld, will allow WU to use samples provided for prostate cancer research to be used for other research or to be sold for financial gain. Thus, honoring the patient’s right to withdraw is essential to the integrity and continued success of the biomedical research enterprise.

The case remains before the Court for evaluation and decision.

Quest will continue to provide status reports on this issue.

*The background of this dispute is set out in past issues [Spring 2006, Spring, Fall and
Winter 2005, Spring, Fall, and Winter 2004, and Fall 2003,] of Quest and can be
accessed on this website.