Case Detail

Wyeth v. Levine
On March 4, 2009, the U.S. Supreme Court ruled that federal law generally does not preempt state-law tort suits challenging the adequacy of safety warnings provided by drug makers, even where FDA has determined the drug to be safe and has prescribed the warnings that appear on product labeling. The ruling was a setback for WLF, which filed a brief urging preemption. WLF argued that court judgments against a drug maker that are based on a determination that the drug's label did not provide adequate safety warnings would undermine the new-drug approval process by calling into question FDA's decisions mandating specific product labels. WLF's brief provided several examples of instances in which "overwarning" regarding potential health risks has been bad for public health. Without responding directly to the "overwarning" argument, the Court simply held that if FDA is concerned about tort suits leading to overwarning, it should take more formal regulatory action to express its concerns.
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6/3/2008: Download the Brief

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