44 Fed. Reg. 37437 (1979) states that it is not the intent of the Food and Drug Administration (FDA) to influence the civil tort liability of the manufacturer. 59 Fed. Reg. 3948 (1994) states that product liability plays an important role in consumer protection. The FDA regards state law as complementing the agency's mission of consumer protection.
Plaintiff was injected with Defendant's medicine, and ended up losing her hand because of gangrene. Plaintiff sued defendant for mislabeling the product. Defendant argued that the FDA labeling requirements preempted the state law tort liability claims. The Vermont State courts agreed with plaintiff, and defendant appealed to the Supreme Court.
Whether the Food and Drug Administration's (FDA's) drug labeling judgments preempt state law product liability claims.
No, the FDA's drug labeling judgments did not preempt state law product liability claims.
In finding for the plaintiff, the Court held that the defendant failed to demonstrate that it was impossible for it to comply with both federal and state requirements. Further, the Court found that the CBE regulation permitted it to unilaterally strengthen its warning, and the mere fact that the FDA approved the drug's label did not establish that it would have prohibited such a change. Additionally, there was powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.