Update on Litigation Concerning Research Samples

Dr. Catalona’s patients and research participants continue to ask about the status of the litigation in the dispute between Washington University (WU) and Dr. Catalona over the samples that he collected for his research program during his tenure at WU.

The background of this dispute is set out in past issues [Fall 2004, Spring 2004, Fall 2003] of QUEST and can be accessed by visiting drcatalona.com.

Briefly in summary, Dr. Catalona let his patients and research participants know that he was moving his clinical practice and research program from Washington University to Northwestern University, and that they were free to request that their tissue samples be transferred to him if they wished.

After Dr. Catalona notified WU about the first 3,000 requests to transfer samples to him, WU sent hundreds of samples to another institution without telling the other institution about the dispute.

When Dr. Catalona informed officials at the other institution of the dispute and the requests to transfer samples to him, the other institution returned the samples to WU without using them. Dr. Catalona’s attorney then made further written requests for the release of the samples.

To date, Dr. Catalona has received approximately 6,000 signed requests to transfer tissue samples to him at Northwestern University. Counsel for Dr. Catalona has provided WU access to copies of them.

On August 4, 2003, without prior notice, WU filed a declaratory judgment action against Dr. Catalona in the federal district court in St. Louis, requesting a finding that WU owns the samples. Dr. Catalona then filed his answer and a countersuit, stating that, according to federal regulations, the patients and participants have the right to make decisions about the use of their samples in research.

To date, WU has not honored the requests to transfer the samples to Dr. Catalona.

Because of the length of time necessary to frame all the issues for presentation to the Court, Dr. Catalona’s lawyers requested that WU be prevented from using any of these samples while the attorneys prepared the case for the Court’s determination.

The judge has requested the attorney for WU provide assurance that WU would not use the samples in this interim period. WU, through its attorney, has assured the Court that the samples will not be used.

As QUEST goes to press, the trial date has not been set; however, the attorneys for Dr. Catalona will request that the Court set the matter for a date as early as reasonably possible.

Dr. Catalona continues to believe that the Court will honor the rights of the research participants concerning the use of their personal health information and blood and tissue samples in this matter.

Many individuals who signed the authorizations have expressed an interest and desire to help Dr. Catalona, and their names have been forwarded to Dr. Catalona’s attorneys.

QUEST will continue to provide status reports on this issue.

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