Buckman v. Plaintiffs' Legal Committee

In Buckman v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), the plaintiffs contended that the defendant made misrepresentations to the FDA to secure PMA approval for the product at issue, and that, but for those misrepresentations, FDA would not have approved the product and the plaintiffs would not have been injured. 531 U.S. at 343. The Supreme Court concluded that "policing fraud against federal agencies is hardly 'a field which the States have traditionally occupied,'" and held that the plaintiffs' claims arising out of misrepresentations made to the FDA were "impliedly preempted." 531 U.S. at 347, 348. Such claims, the court held, "inevitably conflict with the FDA's responsibility to police fraud consistently with the Administrations judgment and objectives." 531 U.S. at 350. The Supreme Court noted that "although Medtronic, Inc. v. Lohr can be read to allow certain state-law causes of action that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state law claim." 531 U.S. at 353. The Court also note that the FDA has the tools necessary to police and punish those who conceal or fail to report information. As the Court detailed in Buckman: "The FDA is empowered to investigate suspected fraud, see 21 U.S.C. 372; 21 CFR 5.35 (2000), and citizens may report wrongdoing and petition the agency to take action, 10.30. In addition to the general criminal proscription on making false statements to the Federal Government, 18 U.S.C. 1001 (1994 ed., Supp. V), the FDA may respond to fraud by seeking injunctive relief, 21 U.S.C. 332, and civil penalties, 21 U.S.C. 333(f)(1)(A); seizing the device, 334(a)(2)(D); and pursuing criminal prosecutions, 333(a). The FDA thus has at its disposal a variety of enforcement options that allow it to make a measured response to suspected fraud upon the Administration." (531 U.S. at 349.)