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October 17, 2007: Judge Sides With Eric H. Weinberg on FDA Documents Related to Vioxx

Federal Judge Faith S. Hochberg ruled that the U.S. Food & Drug Administration (FDA) must turn over documents requested by attorney Eric H. Weinberg and related to the pharmaceutical drug Vioxx, manufactured by Merck.

Weinberg currently represents several hundred clients suing Merck over health problems allegedly caused by Vioxx. The drug was taken off the market in 2004, when a clinical trial demonstrated  an increased risk of heart attack associated with it.

From October 2004 through August 2006, Weinberg requested, under the Freedom of Information Act (FOIA), FDA documents pertaining to the drug. Weinberg sought data from FDA clinical trials, adverse event reports, and correspondence between the FDA and Merck.

In addition, Weinberg sought documents relating to a number of individuals employed by the FDA, including Dr. Peter Honig, a former senior FDA employee who has worked for Merck since 2002 as vice president of risk management; Dr. Eve Slater, a former Merck Vice President whose role at the U.S. Department of Health and Human Services included FDA oversight; Lisa Rarick, a former FDA executive who has become a consultant and expert witness for Merck at Vioxx Trials; and Dan Troy, the former FDA chief counsel who wrote agency guidelines on drug warning labels.

“I am hopeful that after years of stonewalling, we will receive documents that will shed light on the true nature of the relationship between FDA and Merck,” Weinberg said. “FDA’s job was to protect consumers, not cozy up to Merck. It will be interesting to see what these documents expose.”

Weinberg filed a total of 11 FOIA requests; he received no FDA response in five. Weinberg said that over 100 FDA documents that he received were missing pages.

According to the FDA, fulfillment of Weinberg’s requests was delayed as a result of a backlog of FOIA requests at the agency. Under FOIA guidelines, federal agencies have 20 days to decide whether or not to comply with a request.

Judge Hochberg denied the FDA’s request to further delay turnover of the documents, stating that “defendant FDA has produced no evidence of a deluge” of requests that would justify the delay. She referred the matter to mediation. A court-appointed mediator will meet with the parties to determine which documents the agency must turn over to Weinberg.

“Individuals were seriously harmed by this drug, and it is unacceptable for the FDA to deny them, through their attorney, access to relevant information,” Weinberg said. “I look forward to working with the mediator to obtain documents I formally requested years ago.”

For more information about Weinberg’s FOIA requests, please see: April 26, 2007: Eric H. Weinberg Demands Vioxx Documents. To learn more about Vioxx, please see About Vioxx on this website.

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