FDA Must Produce Vioxx DocumentsOct 17, 2007 | Parker Waichman LLP
Vioxx documents requested by an attorney must be turned over by the Food & Drug Administration (FDA), a US District Court Judge has ruled. The decision came after the attorney had taken the FDA to court claiming that the agency had ignored repeated Freedom of Information Act (FOIA) requests for the documents.
Merck, the maker of Vioxx, removed the medication from the market in 2004 after an FDA study estimated that Vioxx could have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003. Shortly after it was revealed that the FDA had tried to silence the drug expert who headed that study. Dr. David Graham, associate director for science in the FDA Drug Center's Office of Drug Safety, told Senate investigators that he had been subjected to veiled threats and intimidation when he informed the FDA of his findings.
According to the complaint filed in US District Court for the District of New Jersey, the attorney made 10 separate FOIA requests to the FDA for various documents regarding Vioxx. The documents included clinical trail data, adverse event reports, Vioxx advertisements and correspondence between the FDA and Merck regarding the drug. Agencies have 20 days to respond to such requests. The complaint alleges that the FDA did not produce all of the requested documents in a timely manner, did not produce documents in two requests and did not even respond to five of the FOIA requests. Furthermore, the complaint says that many of the documents the FDA did produce were incomplete.
The FDA claimed that the delays were due to a backlog of similar Vioxx FOIA requests as a result of the large amount of ongoing litigation surrounding the drug. However, the federal judge ruled that the number of requests was insufficient to warrant the delay. The judge ruled against the FDA’s request that the agency be allowed to delay turning over the documents. The judge also said that a mediator would be appointed to create a process for determining what Vioxx documents the FDA must produce.
Merck now faces more than 27,000 lawsuits over the defective drug. The company has already spent $1.04 billion on its defense against Vioxx lawsuits. Merck is named in 266 potential class-action lawsuits, one class-action certified in Canada and lawsuits from seven states to recoup what they paid for Vioxx through Medicaid. Starting next year, Merck will face the first Vioxx trials that involve patients who had strokes.