In Wyeth v. Levine, the Supreme Court ruled that state-law failure-to-warn claims against name-brand drug manufacturers are not preempted by federal labeling requirements under the Food, Drug, and Cosmetic Act. This case involved whether similar claims are preempted when generic drug manufacturers are sued. These manufacturers must undergo an approval process that requires them to use labels that are identical to those used by the name-brand manufacturers.
Three cases were consolidated, involving rulings from different federal appeals courts. The Eighth Circuit held that a manufacturer should propose a labeling change to the FDA or propose that a warning letter be sent to doctors. The Fifth Circuit went one step further and held that a manufacturer may also unilaterally alter its labeling after receiving federal approval. Since either of these procedures are available, according to the courts, federal law does not preempt state claims that would have been satisfied if the manufacturer had taken action.
The Supreme Court reversed. The majority found that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus preempt, state tort claims. It is impossible for a manufacturer to comply with both the federal regulations and additional state labeling requirements, and the law does not require a manufacturer to try to obtain federal labeling changes to avoid potential liability under state law. It could not independently publish different labels without violating federal law.