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Drugs and Devices
The Supremacy Clause of the U.S. Constitution provides that the 'Laws of the United States … shall be the supreme Law of the Land.' U.S. Const. Art. VI, cl. 2. Therefore, 'any state law that conflicts with federal law is 'without effect.” Cipollone v. Ligget Group Inc., 505 U.S. 504 (1992) (citation omitted). The Medical Device Amendments (MDA) to the Food Drug and Cosmetics Act contain an express preemption provision, namely 21 U.S.C. ' 360k(a), which prohibits states from imposing requirements different from, or in addition to, the specific federal requirements imposed on medical devices by FDA regulations. However, the U.S. Supreme Court has held, in a case involving ' 360k(a), that traditional state law claims are permissible and are not preempted if the common law duties involved parallel the duties statutorily imposed in the federal law and do not impose higher standards. Medtronic v. Lohr, 518 U.S. 470 (1996).
Statprobe argued that plaintiffs' fraud allegation amounted to a claim of fraud-on-the-FDA, cast as a state law claim, and that any such claim was impliedly preempted by federal law in accordance with the U.S. Supreme Court's holding in Buckman Company v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001). In Buckman, plaintiff users of a medical device sued a consulting company whose role in the device's regulatory progress to market was much like Statprobe's in the present case. Plaintiffs there alleged that the consulting company made fraudulent representations to the FDA in the course of obtaining approval of the device and that but for those misrepresentations the injuries they suffered would not have occurred. The Supreme Court held that the Buckman plaintiffs' claims conflicted with, and were therefore impliedly preempted by, federal law because the subject matter of the alleged fraudulent statements made by the consulting company to the FDA were dictated by federal law provisions. In this context, the Buckman Court found that 'the relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.'
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