Supreme Court rules FEDERAL drug regulation does not preempt common law claims for injuries under STATE law.

In a sweeping victory for consumers, the United States Supreme Court this morning held that FDA drug regulation does not preempt common law claims for damages under state law.  Diana Levine, the courageous plaintiff in this lawsuit, lost her arm after being injected with the drug Phenergan, brought suit against the drug maker, Wyeth. The drug manufacturer argued that if it complies with the requirements of the Federal agencies in charge of drugs (the FDA), then it should be protected from lawsuits.

The Supreme Court, in a 6-3 decision in the case of Wyeth v. Levine, flatly rejected Wyeth’s argument that a drug company cannot comply with both state law duties and federal labeling requirements. It also flatly rejected Wyeth’s argument that requiring a drug company to comply with a state-law duty to provide a stronger warning label interferes with Congress’ purpose in establishing the FDA’s authority.

In fact, the Court stated forcefully 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.”

Justice Thomas, in a concurring opinion, also dismissed the Wyeth preemption argument, calling it 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.”