Wednesday, March 4, 2009

Supreme Court Rejects Preemption in Wyeth

Late-breaking news from the AAJ: In a major victory for consumer rights, the U.S. Supreme Court today held that FDA drug regulation does not preempt common law claims for damages under state law.

In a 6-3 decision in the case of Wyeth v. Levine, the Court rejected Wyeth’s arguments that a drug company cannot comply with both state law duties and federal labeling requirements, and that requiring a drug maker to comply with a state-law duty to provide a stronger warning label interferes with Congress’ purpose in establishing the FDA’s authority. The Court stated that Congress never intended for FDA labeling regulation to preempt state tort law. Writing for the Court, Justice Stevens said:

“If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express preemption provision at some point during the Food, Drug and Cosmetic Act’s 70 year history . . . its silence on the issue, coupled with its certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.”

In a concurring opinion, Justice Thomas called Wyeth's preemption argument unconstitutional:

“Because such a sweeping approach to pre-emption leads to the illegitimate – and thus, unconstitutional – invalidation of state laws, I can no longer assent to a doctrine that preempts state laws merely because they ‘stand as an obstacle to the accomplishment and execution of the full purposes and objectives’ of federal law.”

Score one for the good guys. This decision will go a long way towards protecting those injured by dangerous drugs.

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