Facts of the Case

Diana Levine filed this personal injury action against Wyeth, the drug manufacturer, in state court in Vermont. Ms. Levine had intravenously injected Phenergan, a drug made by Wyeth and used to prevent allergies and motion sickness, into her arm, and complications arising from the injection eventually led to the amputation of her arm. Ms. Levine brought this claim asserting that Wyeth had failed to include a warning label describing the possible arterial injuries that could occur from negligent injection of the drug. Wyeth argued that because their warning label had been deemed acceptable by the FDA, a federal agency, any Vermont state regulations making the label insufficient were preempted by the federal approval. The Superior Court of Vermont found in favor of Ms. Levine and denied Wyeth's motion for a new trial.

The Supreme Court of Vermont affirmed this ruling on appeal, holding that the FDA requirements merely provide a floor, not a ceiling, for state regulation. Therefore, states are free to create more stringent labeling requirements than federal law provides.

Question

Does federal law preempt state law in a personal injury action against a drug manufacturer for failing to include an appropriate warning label where the drug in question met the labeling requirements of the Food and Drug Administration?

Conclusion

None