The NY Times and The Boston Globe today published editorials against Wyeth Pharmaceuticals (and the federal government which has sided with the company), and in support of Diana Levine, in her claim against Wyeth for failure to properly warn of the risks of injecting the drug Phenergan. In her case, it was incorrectly administered by injection that caused gangrene and ultimately the amputation of her arm at the elbow.
At issue is whether FDA approval of a warning for a prescription drug preempts any state law tort claim. The Globe states:
Suits in state courts force drug companies to do better monitoring of drugs after approval, and the discovery process in such suits often reveals to the public and the FDA much of the internal data companies have on problems with a drug, both before and after its approval.
According to Levine’s lawyer, there have been more than 20 cases of amputations involving Wyeth’s drug in the years since the FDA approved its label. That should have caused the company either to forbid the risky method of administration altogether or include a much stronger warning against it on the label. The court should not let the FDA be Wyeth’s scapegoat.
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