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Opinion: Supreme Court Botches Preemption Case

By Gregory Conko
March 31, 2009

The Supreme Court handed down its decision last month in the case of Wyeth v. Levine, ruling that federal law did not bar plaintiff Diana Levine from suing pharmaceutical maker Wyeth over allegedly insufficient drug safety warnings, even though the warnings had been approved by the Food and Drug Administration (FDA). This decision establishes the troubling precedent that a sympathetic jury can now supersede the expert opinions of the FDA on what qualifies as adequate safety labeling.

Ms. Levine lost an arm to gangrene after a physician's assistant injected the Wyeth drug Phenergan in such a way that it came into contact with oxygen-rich arterial blood. Although the drug's label explicitly warned that doing so poses a high risk of tissue damage, Levine claimed that the label should have instructed physicians not to use this intravenous “IV-push” method at all. A Vermont jury agreed, and awarded Levine $7.4 million, which the court reduced to $6.7 million to account for an earlier settlement with the physician's assistant and supervising doctor.

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