US Supreme Court Rejects Federal Preemption of Failure-to-Warn Claims in Absence of “Clear Evidence” that FDA Would Not Have Approved Stronger Warnings

March 06, 2009
The U.S. Supreme Court issued its much-anticipated decision on federal preemption of failure-to-warn claims against pharmaceutical manufacturers in Wyeth v. Levine. While it rejected the preemption defense on the specific facts of the case, the Court left open its application in future cases where the record reflects “clear evidence” the FDA actively oversaw the labeling with regard to the specific risk at issue. This update examines the decision and the outlook for subsequent challenges based on preemption.