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The Supreme Court’s March 4th decision in Wyeth v. Levine could mean increased responsibility for drug companies to adequately warn clinicians and consumers of a drug’s risks. Affirming a jury verdict in favor of a plaintiff injured as a result of inadequate drug label warnings, the Supreme Court held that the drug label’s warnings were inadequate, rejecting the argument that FDA approval of a label is sufficient to shield a drug manufacturer from state law liability.

The plaintiff, Diana Levine, received the drug Phenergan, an antinausea drug manufactured by Wyeth, by the "IV-push" method (as opposed to the safer "IV-drip" method). The drug was injected directly into her vein, after which it escaped into her artery, caused irreversable gangrene, and resulted in the amputation of her forearm.

Levine brought suit alleging that Wyeth had failed to provide adequate warnings on its label of the risks associated with administering Phenergan by the IV-push method. The jury found in favor of Levine, determining that Levine would not have suffered her injury had Wyeth provided an appropriate warning. Wyeth argued in return that Levine’s state law claims were preempted by federal law because Phenergan’s labeling had been approved by the FDA. The Supreme Court granted certiorari to determine whether the FDA’s approval of drug labels "preempt[s] state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use."

Wyeth argued that it was impossible to comply with the state-law duties underlying Levine’s claims and federal labeling requirements at the same time. The Court rejected the argument pointing out that under the FDA’s "changes being effected" (CBE) regulation, a drug company may make certain changes to a label upon filing a supplemental application with the FDA but need not wait for FDA approval. "The CBE regulation permitted Wyeth to unilaterally strengthen its warning, and the mere fact that the FDA approved Phenergan’s label does not establish that it would have prohibited such a change."

Wyeth also argued that Levine’s tort claims were preempted because they interfered with "Congress’s purpose to entrust an expert agency to make drug labeling decisions that strike a balance between competing objectives." The Court also rejected this argument, finding that Congress, being well aware of state-law suits, would have enacted a preemption provision if it determined that state law claims were an obstacle to its objectives. to see full opinion, click here

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