531 U.S. 341 (2001)
Respondent represents plaintiffs who claim injuries resulting from the use of orthopedic bone screws in the pedicles of their spines.1 Petitioner is a consulting company that assisted the screws’ manufacturer, AcroMed Corporation, in navigating the federal regulatory process for these devices.2 Plaintiffs say petitioner made fraudulent representations to the Food and Drug Administration in the course of obtaining approval to market the screws.3 Plaintiffs further claim that such representations were at least a “but for” cause of injuries that plaintiffs sustained from the implantation of these devices.4
In 1984, AcroMed sought §510(k) approval for its bone screw device, indicating it for use in spinal surgery.5 The FDA denied approval on the grounds that the Class III device lacked substantial equivalence to a predicate device.6 In September 1985, with the assistance of petitioner, AcroMed filed another §510(k) application.7 The FDA again rejected the application.8 In December 1985, AcroMed and petitioner filed a third §510(k) application by splitting the device into its component parts, renaming them nested bone plates and cancellous bone screws, and seeking clearance for use in long bone surgery.9 The FDA approved the devices for this purpose in February 1986.10
Pursuant to its designation by the Judicial Panel on Multi-district Litigation as the transferee court for In re: Orthopedic Bone Screw Liability Litigation, MDL No. 1014, the District Court for the Eastern District of Pennsylvania has been the recipient of some 2,300 civil actions related to these medical devices.11 Many of these actions include state-law causes of action claiming that petitioner and AcroMed made fraudulent representations to the FDA as to the intended use of the bone screws.12 The District Court dismissed these fraud-on-the-FDA claims.13 A divided panel of the United States Court of Appeals for the Third Circuit reversed.14 The Supreme Court granted certiorari to resolve a split among the Courts of Appeals on this question.15
Whether plaintiffs' state-law tort claims alleging that a consulting company made fraudulent representations to the FDA in the course of obtaining §510(k) clearance for orthopedic bone screws are preempted by the Federal Food, Drug, and Cosmetic Act?16
State-law fraud-on-the-FDA claims are impliedly preempted by the FDCA.17 The federal statutory scheme empowers the FDA to punish and deter fraud while balancing competing objectives such as timely device approval and off-label use.18 State claims would skew that balance by imposing additional burdens not contemplated by Congress.19
Yes. The claims conflict with federal law because they exist solely by virtue of FDCA disclosure requirements rather than traditional state tort duties.20 In the established facts the claims rest on Buckman's alleged fraudulent representations during the three §510(k) applications for the AcroMed bone screws that ultimately received clearance for long-bone use.
The FDA alone holds exclusive enforcement authority under 21 U.S.C. §337(a) and maintains flexibility to achieve statutory goals without the overlay of fifty state tort regimes.21
The state-law claims are impliedly preempted by federal law.22
Related opinions on this issue
Justice Stevens concurs in the disposition but does not join the opinion.23 He concludes that the but-for causation element cannot be proved because the FDA has taken no steps to remove the devices from the market despite awareness of the fraud allegations.24 He states that the result would differ if the FDA had first determined fraud occurred and initiated removal, allowing the state claim to rest on the agency's explicit actions rather than speculation about counterfactual FDA behavior.25
His view is that the failure of the claim arises from the details of the federal regulatory system for medical devices.26