CEO SUMMARY: Recently, a federal appeals court affirmed a district court ruling concerning who owns human tissue specimens that are stored for research and other uses. While most clinical laboratories routinely discard many types of human specimens after use, any research facility or IVD manufacturer that retains specimens should review the new legal issues raised by this court decision. The case of Washington University versus Catalona demonstrates how legal battles over ownership and control of human specimens may lead to significant new legal precedents.
LABORATORIANS OFTEN ASSUME that their labs own and control any human specimens that the lab has analyzed. However, a recent court decision last year signals that legal rights governing who owns human specimens may soon undergo important changes.
For any laboratory or research organization seeking to collect and store specimens for ongoing research, the implications of the federal court decision in Washington University v. Catalona need to be studied and understood. Attorneys Anne Marie Murphy and Jeffrey N. Gibbs of Hyman, Phelps & McNamara, a law firm in Washington, DC, are closely tracking these developments.
Is Patient Consent Adequate?
In an interview with THE DARK REPORT, Murphy explained that, for pathologists and clinical labs, legal issues of specimen ownership may be limited because these labs generally discard on a regular basis the specimens collected for clinical testing. But the court case raises important questions about whether labs and research facilities that collect samples have adequate consent agreements in place with each patient.
“For normal chemistry and other clinical laboratory testing, everything is typically discarded at the end of each shift or within a specified number of days,” said Murphy, who had worked in a hospital-based clinical laboratory before going into law. “That’s typically the standard procedure in clinical labs. So, unless a clinical laboratory is collecting specimens or holding specimens in a repository of some kind for research purposes, this ruling may not be applicable.
“But for any laboratory doing research, this ruling could be applicable,” she continued. “That holds true for a clinical lab using human specimens to con- duct research or gathering human specimens to establish some kind of repository of tissue or body fluids.”
In the case in question (Washington University v. Catalona), an appeals court affirmed a district court’s decision that study subjects do not retain ownership rights of their biological tissue samples that are provided for research. “At first blush, the case appears to support a broad right for research institutions to use banked tissues,” wrote Murphy and Gibbs in an article recently published in IVD Technology. “But the court was careful to limit its conclusions to the specific facts of the case.”
Because of this court decision, Murphy & Gibbs say that the diagnostics research industry should not assume that researchers and institutions can use collected human tissue specimens under all circumstances. “Rather, this case underscores the importance of having clear documentation that study subjects intend to voluntarily contribute their tissue for research purposes,” explained the two attorneys.
Facts Of The Catalona Case
Here are the facts of the case. William Catalona, M.D., a prostate cancer researcher formerly at the Washington University in St. Louis, along with other researchers at the university, had collected prostate tissue samples for cancer research. When Catalona moved to Northwestern University, in Chicago, he wrote to his patients and research subjects to say that he would transfer their specimens and continue his research.
Seeking to retain the specimens, Washington University claimed that those patients had voluntarily donated their biological specimens to the university for research. But Catalona and his patients argued that the patients retained ownership rights of the specimens and could allow them to be transferred or used by others.
Seeking a declaratory judgment, Washington University sued, saying it owned the specimens. The federal district court ruled for the university, and Catalona and his patients appealed. After hearing oral arguments in 2006, the U.S. Court of Appeals for the Eighth Circuit upheld the lower court’s decision in June, 2007. In so doing, the appeals court limited its ruling to the facts in the Washington University case.
Consistent Legal Findings
In response to this federal district court decision, Murphy and Gibbs recommend that the diagnostics research industry should not assume that researchers and institutions can use human tissue specimens after collection under all circumstances. “The result of the case—that research participants retained no ownership in the biological specimens they contributed—is consistent with legal precedent,” observed Murphy and Gibbs. “But this case appears to be the first to address the ownership of the biological specimens themselves.”
THE DARK REPORT observes that any lab collecting and storing human specimens should be aware that ambiguous consent agreements can create legal uncertainties. Murphy and Gibbs suggest that, “Given the narrow and fact-specific holding of the appeals court, before embarking on projects involving tissue repositories, IVD companies should review documentation of the study subjects’ intent to ensure that it is consistent with the company’s goals with respect to the use of specimens.”
The decision in this federal case shows that it could be important to have a lawyer review the patients’ consent form. Legal review is often warranted, and generally any company that collects and stores human specimens would have legal affairs staff who could provide the legal consult. Other companies have outside counsel do such review and could prepare a consent form that could be used to protect the lab or research facility’s interests.
As genetic research intensifies the need for access to human tissue and other types of specimens, laboratories should expect more legal challenges to longstanding specimen retention practices.