Statement on U.S. Supreme Court's Denial of Certiorari in case involving ownership of tissues donated for research
January 22, 2008 -- Washington University School of Medicine in St. Louis is pleased by the U.S. Supreme Court's decision released today. The Court let stand a unanimous 2007 ruling by the 8th U.S. Circuit Court of Appeals that stated prostate tissue and serum samples donated to Washington University can continue to be used by the institution for cancer research. The appellate court had affirmed the lower federal district court ruling that donors who gave tissue or serum samples to the University for research can't later compel the school to transfer ownership of the samples to another research institution.
Today's decision affirms the critical role of research institutions to develop and maintain stable repositories of biologic material for medical research. The Supreme Court's decision also maintains the integrity of the prostate cancer repository at Washington University and provides the best opportunity for this extensive collection of tissues to be used to advance scientists' understanding of prostate cancer.
In addition, the decision will protect donors from unregulated and potentially conflicting solicitations for their donated tissues. The case involves a former Washington University surgeon, William Catalona, M.D., who was engaged in research using the prostate cancer repository. Dr. Catalona had argued unsuccessfully in the lower courts that research participants who donated tissue and blood samples to the University for prostate cancer research could require the University to transfer their tissues to him at his new place of employment.
"Washington University takes its obligation to research participants very seriously," says Larry Shapiro, M.D., executive vice chancellor for medical affairs and dean of the School of Medicine. "We will continue to use the tissues and serum samples for the purpose they were originally intended, which is prostate cancer research. It is our hope that use of the repository will lead to important advances. As we have said throughout the case, we encourage scientists both within the University community and those affiliated with other institutions to request access to the repository for their own prostate cancer studies."
Washington University was supported by numerous research institutions that filed a friend of the court brief, including Johns Hopkins University, the Mayo Clinic, Cornell University, Duke University and Stanford University among others.
Washington University will continue to share the tissues in the repository on a peer-review basis with scientists at other institutions who propose promising research using the samples. We are grateful to the many thousands of volunteers who donated their tissue for prostate cancer research. Their samples are a generous gift and a vital resource for understanding the causes of the disease and developing new cures.
Supreme Court judge says Washington University can use biological samples donated for research
August 20, 2007 -- A U.S. Supreme Court justice has denied a request by a former Washington University physician that would have prevented the institution from using thousands of tissue and blood samples donated to it for research. The denial is the latest in a string of legal rulings related to ownership of the samples.
William Catalona, M.D., who is now on the faculty at Northwestern University, filed papers with Justice Samuel Alito in August requesting that Washington University not be allowed to use the biological samples while he asks the full Supreme Court to review the case. Catalona had used some of the biological samples for his research projects while he was at Washington University.
A lower district court and the Eighth Circuit Court of Appeals in St. Louis both have ruled that the biological samples belong to Washington University. In a unanimous ruling in June, the appellate court said that research participants made informed and voluntary decisions to participate in prostate cancer research and donate their biological samples to Washington University as gifts.
Catalona, who is trying to establish a repository of tissue and blood samples at Northwestern, initially claimed that all the biological samples donated to the University for prostate cancer research belonged to him. He later changed his legal strategy, asserting that donors are the sole owners and should be able to redirect the samples to him at Northwestern.
The legal proceedings had halted researchers' use of the tissues, but the latest ruling means that scientists at Washington University and elsewhere will again have access to the samples for their studies. The samples are important for understanding the biological basis of prostate cancer and searching for more effective cures for the disease. Requests by scientists to use the samples for prostate cancer research will be evaluated on a peer-review basis by a panel of Washington University researchers.
Letter from the Supreme Court
U.S. 8th Circuit Court of Appeals rules in favor of Washington University in case involving ownership of tissues donated for research
June 20, 2007 -- In a unanimous decision, the 8th U.S. Circuit Court of Appeals upheld a lower court ruling that tissue and blood samples donated to Washington University School of Medicine in St. Louis for prostate cancer research belong to the institution. The three-judge panel said the donors voluntarily made a gift to Washington University when they donated their biological samples and, therefore, the specimens belong to the school.
"We are extremely pleased by today's decision," says Larry Shapiro, M.D., executive vice chancellor for medical affairs and dean of the School of Medicine. "The ruling will allow important research into the causes of prostate cancer to continue, with the goal of developing new cures."
The decision protects the rights of research participants by ensuring they are not exposed to misleading and potentially competing solicitations for their previously donated tissues from scientists, physicians or commercial research companies who want control over the samples. The ruling also maintains the integrity of the biorepository, one of the world's largest collected for prostate cancer research. The ruling "creates the best opportunity for this extensive collection of tissues to be used to advance understanding of the disease," Shapiro adds.
The legal proceedings had halted researchers' use of the repository, but the new ruling means that scientists at Washington University and elsewhere will again have access to the samples for research.
The case centers on whether tissue donors can reclaim their donated samples and give them to a researcher or an institution other than Washington University. William Catalona, M.D., a doctor involved in research using the biorepository, and some research participants said tissue donors had a right to require that the samples be forwarded to Catalona at Northwestern University, where he had assumed a faculty position after resigning from Washington University.
In 2003, the University filed suit against Catalona to ask the federal court to determine who should control the donated samples stored in Washington University's biorepository.
"Dr. Catalona initially claimed that all the prostate tumor samples in the University's repository belonged to him because his name appeared on many of the consent forms as principal investigator," says Michael Cannon, executive vice chancellor and Washington University general counsel. "Dr. Catalona then changed his legal strategy, asserting that donors are the sole owners and should be able to redirect the tissues to him. He sent unauthorized new consent forms to some 30,000 research participants asking them to have their samples transferred to him. For this reason, Washington University asked the federal district court to make a determination of who controlled the biorepository."
In the appellate court ruling, the judges said the district court properly ruled that the research participants made informed and voluntary decisions to participate in prostate cancer research and donate their biological samples to Washington University as gifts. "This voluntary transfer of tissue and blood samples to Washington University - without any consideration or compensation as an incentive for doing so - demonstrates Washington University owns the biological samples currently housed in the biorepository," the appellate panel wrote.
The court also pointed out that Catalona himself while at Washington University had signed numerous agreements acknowledging the University's ownership of the biological samples and that he routinely ordered the destruction of samples to make room for new donations and did so without the research participants' knowledge or consent.
"Dr. Catalona's habitual destruction of samples, in a manner consistent with apparent indifference to any proprietary interest of the donors, is at odds with his later assertion the research participants own the biological materials," the opinion states.
Based on this decision, Washington University will resume sharing the tissues in the repository with its own scientists and those at other institutions who want to conduct promising research using the samples, including Catalona. Proposals will be evaluated on a peer-review basis by a panel of Washington University researchers.
"We are grateful to the many thousands of volunteers who donated their tissue for prostate cancer research," Shapiro says. "Their samples are a generous gift and a vital resource. With this case behind us, we will return to using the tissue to better understand this devastating disease and to search for cures."
The consulting attorneys who worked with Cannon and others from Washington University's in-house legal team are Thomas Wack at Bryan Cave LLP and Robert Long at Covington & Burling LLP.
Excerpts from the opinion of the 8th U.S. Circuit Court of Appeals
"We now turn our attention to the pivotal inquiry in this dispute: whether
individuals who make an informed decision to contribute their biological materials
voluntarily to a particular research institution for the purpose of medical research
retain an ownership interest allowing the individuals to direct or authorize the transfer
of such materials to a third party. Under the facts of this case, the answer is no."
"Thus, the district court properly concluded the research participants made informed and
voluntary decisions to participate in genetic cancer research, and thereby donated their
biological materials to WU as valid inter vivos gifts. This voluntary transfer of tissue
and blood samples to WU – without any consideration or compensation as an incentive
for doing so – demonstrates WU owns the biological samples currently housed in the
Biorepository. Whatever rights or interests the research participants retained following their donation
of biological materials, the right to direct or authorize the transfer of their biological
materials from WU to another entity was not one of them. Thus, the release forms
authored by Dr. Catalona and signed by approximately 6,000 research participants are ineffective to
transfer possession of biological samples housed in the Biorepository to another
entity. Given WU's ownership of the biological materials, the district court neither
abused its discretion in denying Dr. Catalona's motion for injunctive relief, nor erred
in granting summary judgment in WU's favor."
"Dr. Catalona's past conduct, as well as the practical consequences of the
research process itself, also refutes the defendants' position. While at WU, Dr.
Catalona signed numerous ... agreements acknowledging WU's
ownership of the biological materials. Moreover, during Dr. Catalona's tenure, he
routinely ordered the destruction or "purging" of Biorepository samples in order to
create more storage space, and did so without obtaining any additional consent from
RPs. Dr. Catalona's habitual destruction of samples, in a manner consistent with
apparent indifference to any proprietary interest of the donors, is at odds with his later assertion the research participants own the biological materials."
3-21-06
Judge Limbaugh rules in favor of Washington University in Washington University v. William J. Catalona
Case No. 4:03 cv 01065 SNL
Important information regarding the appeal
Washington University School of Medicine in St. Louis is pleased with Judge Limbaugh's comprehensive ruling that tissue and serum samples donated to the University's repository do indeed belong to the University. The powerful language in his ruling leaves little need for further comment. Most importantly, we are pleased to be able to resume using the tissue samples for important research on prostate cancer, inasmuch as this is what the donors indicated they wanted when they provided their tissue. The judge granted authority for the University to continue to use the tissue and share it with other researchers in pursuit of a cancer cure. The peer-review mechanism for providing these samples to researchers here and elsewhere, including Dr. Catalona, will be re-established as soon as possible. Washington University is grateful to volunteers who provided their tissue for cancer research. These tissue samples are a generous gift and a vital resource.
For more information regarding this case heard by the United States District Court Eastern District of Missouri Eastern Division, please choose among the available PDF files listed below.
Washington University's Court Filings:
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