Wednesday, March 04, 2009

Memo to drug companies: safety is YOUR responsibility

An important Supreme Court ruling today:

In one of the most important business cases in years, the Supreme Court on Wednesday ruled that a drug company is not protected from injury claims in state court merely because the federal government had approved the productand its labeling.

The 6-to-3 ruling went in favor of a Vermont musician, Diana Levine, who was awarded more than $6 million after losing much of her arm following a botched injection of an anti-nausea drug. It was a defeat for the Wyeth pharmaceutical company, which had asked the justices to throw out the award, and by extension other companies that might have pursued Wyeth’s line of argument in similar cases....

“It is a central premise of the Food, Drug and Cosmetic Act and the F.D.A.’s regulations that the manufacturer bears responsibility for the content of its label at all times,” the majority concluded in Wyeth v. Levine, No. 06-1249.

The majority upheld the Vermont Supreme Court, which in 2006 rejected Wyeth’s argument that it had been put in an untenable position: having to comply with federal law, given its requirement that the F.D.A. approve drug labels, and yet being punished by the state jury’s verdict for not using a different, more inclusive label. Federal law “provides a floor, not a ceiling, for state regulation,” the Vermont Supreme Court declared in the ruling that the United States Supreme Court affirmed on Wednesday.

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