Daily front-page stories recounting the failure of defibrillators, pacemakers, heart stents and infusion pumps have raised questions about the adequacy of FDA regulation of medical devices. At the same time, lower courts are struggling to apply the Supreme Court's ruling in Medtronic, Inc. v. Lohr to determine the preemptive reach of the Medical Device Amendments ("MDA"). This article explores the repercussions of Medtronic and argues that Congress' use of words like "requirements" in regulatory statutes should be seen as references to positive state law only, and should not be read, absent an explicit command by Congress, to subsume state law damage actions. The lower courts' confusion over Medtronic's preemption rule may have been sown by the complexity of the opinion itself. Fairly read, Medtronic's preemption rule is narrow, requiring specific and conflicting requirements for a device imposed by both state and federal law. General tort duties do not trigger preemption because they do not impose requirements specific to a given device. The article also explores the Executive Branch's current efforts to push its tort reform agenda by pressing broad preemption arguments in private tort litigation. The article argues that courts should be wary of such efforts and suggests that, by working to shield industry from tort liability, the Administration has given the public reason to question whether the FDA is serving the interests of the public or the industry it regulates. Finally, the article argues that preemption claims are an effort to shed an important source of market discipline - the threat of liability for visiting unjustifiable harm on others - a discipline that regulation cannot itself provide. Judges reviewing preemption claims should evaluate industry's preemption claims in light of the overall regulatory and liability context. Medical devices are an illustration of the inadequacy of relying on regulation alone. The MDA was passed in response to several notorious medical device failures, failures which were brought to light through product liability litigation. Since the MDA became law, the medical device industry has been extensively regulated by the FDA. But the FDA alone cannot exert sufficient discipline on the marketplace to ensure an adequate margin of safety for medical devices, a fact that the agency, at least until recently, itself acknowledged.
David C. Vladeck
Preemption and Regulatory Failure,
33 Pepp. L. Rev.
Available at: http://digitalcommons.pepperdine.edu/plr/vol33/iss1/8