Federal Pre-Emption in Medical Device and Pharmaceutical Litigation


Over the past two years, the United States Supreme Court has had two opportunities to address and add to the jurisprudence in the area of federal pre-emption of state law claims regarding allegedly defective medical devices and prescription drugs, which are both regulated by the US Food and Drug Administration (FDA). In Riegel v. Medtronic, Inc., 128 S.Ct. 999 (U.S. 2008), the United States Supreme Court held that the Medical Device Act's pre-emption clause expressly pre-empts state law claims challenging the safety and effectiveness of a medical device marketed in a form that received premarket approval from the FDA. The Court made it explicitly clear, however, that such claims are only pre-empted insofar as they seek to impose state requirements that are "different from, or in addition to" the requirements imposed by federal law. Id. at 1011.

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