Opinion: Supreme Court Botches Preemption Case

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.

On appeal, Wyeth argued that the FDA's extensive regulation of drug labeling should preclude claims of negligent failure-to-warn, but the Supreme Court rejected that argument by a 6-3 majority. According to Justice John Paul Stevens's majority opinion, “The history of the [Food Drug and Cosmetics Act] shows that Congress did not intend to pre-empt state-law failure-to-warn actions.” Although true in a general sense, the Court failed to recognize that this is not a typical failure-to-warn case, and that permitting the suit here would interfere with the FDA's authority to regulate drug labels.