The case concerned whether the FDCA (Food, Drug and Cosmetic Act), a federal statute, pre-empted a state-law fraud-on-the-FDA claim.

[2] A divided panel of the United States Court of Appeals for the Third Circuit reversed, arguing that there was no express pre-emption.

Chief Justice William Rehnquist wrote the decision of the Supreme Court, reversing the Third Circuit.

He concluded that there was express pre-emption because holding these claims under state law would "inevitably conflict" with the FDA's duty to police fraud.

Stevens said the lawsuit could not proceed because the plaintiffs could not rebut the fact that the FDA did not remove the allegedly defective products from the market.