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Supreme Court Rejects Federal Preemption - Wyeth v. Levine

The U.S. Supreme Court on March 4, 2009 issued what will be one of the most important decisions of this term. In Wyeth v. Levine, the court wrote in a 6 to 3 opinion a sweeping and powerful rejection of Wyeth’s argument, that plaintiff’s right to sue was barred by the concept of federal preemption.

Plaintiff’s arm had to be amputated when the drug Phenergan was injected into her vein by the IV-Push method. A jury found in her favor, finding that Wyeth failed to adequately warn of the risks of this method. Wyeth argued that it was immune from suit and the jury’s finding must be overturned.

The Court wrote: “…the purpose of Congress is the ultimate touchstone in every pre-emption case” and that “in all pre-emption cases, …we start with the assumption that the historic police powers of the States were not to be superceded unless that was the clear and manifest purpose of Congress.” The Food, Drug and Cosmetic Act (FDCA) does not contain a provision expressly preempting a consumer’s right to sue in this setting; even implied preemption does not exist here. The manufacturer, not the FDA, “bears primary responsibility for drug labeling”. The Court wrote: “Indeed, prior to 2007, the FDA lacked the authority to order manufacturers to revise their labels.” This is a fact that many consumers – and jurors – do not know. The Court continued: “The FDA has limited resources to monitor 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge. State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information.”

Armed with this important decision, Locks Law Firm will continue to press claims on behalf of injured consumers against drug companies which market defective drugs.