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High Court Examines Drug Warning Labels

by Glenn Hess
November 10, 2008 | A version of this story appeared in Volume 86, Issue 45

The Supreme Court is weighing whether federal drug-labeling regulations shield pharmaceutical companies from liability claims in state courts when one of their medicines causes harm. In Wyeth v. Levine, a Vermont woman, Diana Levine, lost an arm to gangrene after Phenergan, an antinausea drug, was improperly administered by her doctor. She sued Wyeth Pharmaceuticals, arguing that the drug's manufacturer violated a state product liability law by failing to adequately warn of the dangers of intravenous injection. Vermont courts agreed and awarded her $6.7 million in damages. But in its appeal to the Supreme Court, Wyeth maintains the lawsuit should be thrown out because Phenergan is approved by FDA, and the agency authorized the content of the company's warning label about the possible adverse effects of the drug. The case is the most recent to ask the high court to examine the scope of federal preemption of state laws. In February, the Supreme Court ruled that individuals injured by a defective medical device could not sue the manufacturer if the device received premarket approval by FDA. A decision in the Wyeth case is expected by the end of June 2009.


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