In the case of Buckman Company v. Plaintiffs' Legal Committee, 2000, the U.S Supreme Court ruled in favor of Buckman Company. The plaintiffs alleged that Buckman made fraudulent representations to the Food and Drug Administration (FDA) during its approval process for orthopedic bone screws which were later used off-label by surgeons leading to injuries. However, the court held that federal law barred state-law fraud-on-the-FDA claims because such claims conflicted with federal statutes empowering FDA to punish and deter fraud against it. It was argued that allowing such suits would interfere with Congress's intent to entrust matters of scientific judgment about drug regulation to expert administrative agencies rather than lay juries.

In the dissenting opinion for Buckman Company v. Plaintiffs' Legal Committee, Justice Stevens argued that state law should not be preempted by federal law in this case. He contended that the majority's decision was based on an incorrect interpretation of congressional intent and a misunderstanding of the relationship between state tort laws and federal regulatory schemes. According to him, Congress did not intend to shield medical device manufacturers from liability under state law when it enacted amendments to regulate these devices more closely. Furthermore, he believed that allowing states to impose additional penalties through their own tort systems would complement rather than hinder FDA regulation efforts by providing another layer of deterrence against misconduct by manufacturers.