The Catalona Case
James Ellis, patient protesting how his tissue is being used


PATIENTS LOSE LAWSUIT TO RECLAIM THEIR TISSUES

Patients who donate tissues to a researcher or university may lose all rights to those tissues, even if signed documents exist saying the patients retain rights. That is the meaning of a recent court ruling in St. Louis, involving internationally famous prostate surgeon William Catalona.

In the early 1980's, Dr. Catalona began asking his patients if they were willing to let him use the tissue he removed during their surgery for research. Over the years he amassed tens of thousands of tissue samples. His research led to the development of the PSA (prostate-specific antigen) test which is used to detect prostate cancer.

When Dr. Catalona began asking his patients if he could use their tissue, it was common for university researchers to use the samples and take them along if they changed job locations. But as time passed, Dr. Catalona's employer, Washington University in St. Louis, began to realize that the tissue samples could earn money for the university. In 2001, Dr. Catalona requested that a limited number of samples be sent to a biotech company to evaluate the effectiveness of a new test to identify prostate cancer. He intended to use the results of the research at an upcoming academic meeting and additionally to publish the results in a medical journal. The results would also be beneficial to men at risk of developing the disease. The university balked.

An e-mail from a business manager at Washington University's office of technology management neatly summed up the university's position:

"Bill Catalona wants to send nearly 2,000 documented samples to [Hybritech] for free. Just from a cost recovery scenario, this should be worth nearly $100,000 to the university. The only consideration [Hybritech] is offering is the potential for Catalona to get a publication. It is my opinion this is an unacceptable proposal."

A research publication however, would have enriched the medical community and benefited cancer survivors and their families. Selling the samples had none of these benefits.

Fed up with Washington University's interference with his research, Dr. Catalona decided to move his practice to Northwestern University's medical school in Chicago. He began to write to his patients, telling them that he was moving to a new institution and that they were welcome to continue to get their health care at Washington University, or he could see them at Northwestern. He also asked them to indicate whether they were willing to transfer their samples to Northwestern. Six thousand of his patients wrote that they wanted their samples to move with him for his future research.

In an unprecedented move, Washington University filed a lawsuit against Dr. Catalona, asking the court to declare it to be the owner of the research participants' samples, which it claimed were worth over one million dollars. It also asked for an order preventing him from "interfering" with the patients and with the samples they had provided.

The research participants objected. The men argued that the informed consent documents they had signed agreeing to participate in research demonstrated that they retained ownership rights over their literal flesh and blood. The forms promised the men the right to withdraw from research at any time, and some even promised the right to have the sample destroyed upon request. If they had the right to destroy their tissue, clearly someone else didn't own it. They asked to have the samples moved to Northwestern University so Dr. Catalona could continue the agreed-upon research.

But Washington University asserted that it had the right to use the men's samples as it wished "in its sole discretion." In spite of the language in the informed consent documents allowing the participants to withdraw at any time and for any reason, the university argued that the patients had given a gift - a donation - to the university, and they could not take it back.

After a three day hearing in which only three patients were allowed to testify, a trial judge ruled that the informed consent documents were "inconsequential" and decreed that Washington University is the owner of the tissue - a decision that allows the university to perform stigmatizing or ethically objectionable research on the participants' tissue, or sell it to a biotech company for profit.

The research participants filed an appeal. On appeal Washington University's attorney argued that research participants should have fewer rights than regular patients and that participants had no right to stop research on their bodies that they find objectionable. If the decision is allowed to stand, it will seriously jeopardize the future of biomedical research in this country.

Medical research depends on the altruistic actions of people - people like you and me - who generously provide the use of their time and even bodily tissues to advance medicine. Research is not a matter of conscription. People cannot be forced to participate in research without their consent.

People have strong feelings about what research they will participate in and what can be done with their body parts and tissue. For example, some people are against stem cell research and would not provide their tissues to be used in this kind of research. Other people oppose the patenting of human genes, and would not participate in research that will end with this result. If people cannot stop research on themselves and their body parts, they will simply stop joining research studies.

Washington University promised research participants that they could withdraw from the research at any time, and even that if a participant ordered, the university would destroy his sample. Yet the trial judge found that the university did not have to abide by the promises it made. If this decision stands, it means that no participant in research, and even no patient, can trust what researchers and hospitals put in writing about any procedure they are about to undergo. Clearly, this is not a precedent that we want in this country.

Yet the Eighth Circuit Court of Appeals largely missed its opportunity to correct this error, affirming the decision of the trial court in favor of Washington University. It held that under the specific facts of the case, the men who participated had given their tissue to the university as a gift and they could not get it back or have it sent to another researcher. However, the Eighth Circuit indicated that the men retained the right to stop participating in the research 1) by declining to answer any additional questions; 2) by not donating more tissue; or 3) by disallowing the use of their tissue in future research. This means that the men have the right to order the university to stop using their tissue, and the university cannot merely strip their names off it and continue to use it.


Related Articles

Federal Policy for Protection of Human Research Subjects, 45 C.F.R. § 46.101 et seq.

Rebecca Skloot, "Taking the Least of You," New York Times, (April 16, 2006)

Brief of Amicus Curiae People’s Medical Society Filed in Support of Patients, Washington University v. Catalona and Ward, Nos. 06-2286 & 06-2301 (8th Cir. July 21, 2006).

Order in Washington University v. Catalona, No. 4:03CV1065 (E. Dist. Mo. April 14, 2006), on appeal Nos. 06-2286 & 06-2301 (8th Cir.).


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