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Case Law Update: Pre-emption in Pharmaceuticals

In Wyeth v. Levine, the Supreme Court of the United States voted 6-3 that federal approval of labels giving warnings about the effects of drugs does not bar lawsuits under state law claiming inadequate warnings of the health risk. The defendant argued that state court should be preempted by federal law. Wyeth claimed that a 2006 regulations of the Food and Drug Administration expressing concern about the impact of state failure-to-warn lawsuits on federal regulation should mean that such cases are barred. The Court said that since Congress has not authorized a federal agency directly to preempt state lawsuits, the Court was going to give less weight to FDA’s views on that issue. The patient had been given an intramuscular injection of the drug Phenargen and developed complications resulting in gangrene. She ultimately had to have her forearm amputated, ending her career as a musician. On appeal, the Vermont Supreme Court ruled that Wyeth was obliged to comply with a Vermont common law duty not to use a particular form of risky drug administration. This case will have a great impact on pharmaceutical liability.