Friday, July 6, 2007

Vioxx MDL Judge Rejects FDA Preemption of Warnings-Based Claims

Article in the New York Times -- Judge Rejects Merck’s View on F.D.A. Issue, by the Associated Press.  Here's an excerpt:

Food and Drug Administration approval of a drug label does not clear the manufacturer of claims that its warnings were inadequate, a judge ruled in a decision that could potentially affect thousands of federal suits against Merck over the painkiller Vioxx.

“The F.D.A.’s current view on the question of immunity for prescription drug manufacturers is entirely unpersuasive,” Judge Eldon E. Fallon of Federal District Court wrote in the opinion, handed down Tuesday.

Had Judge Fallon sided with Merck, the drug company could have challenged claims brought by thousands of other plaintiffs who say it is to blame for heart attacks and other cardiovascular problems.


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