U.S. Supreme Court Ruling in Wyeth v. Levine Rejects Preemption of Failure-to-Warn Claim

In a highly anticipated decision, the U.S. Supreme Court has rejected a pharmaceutical manufacturer's argument that federal approval preempts state law failure-to-warn claims relating to FDA-approved prescription drugs.

By a vote of 6-3, on March 4, 2009 the Court affirmed the Vermont Supreme Court's decision that the plaintiff could pursue claims that Wyeth failed to provide adequate warnings, even though the FDA deemed those same warnings sufficient when the FDA approved the drug and its labeling. The decision marks a notable contrast with the Court's holding last year in Riegel v. Medtronic, Inc., in which the Court held that federal law expressly preempts state tort claims that challenge the labeling, design, or manufacturing processes of a medical device that received premarket approval by the FDA.

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