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Publication Date

2014

Abstract

Medical device jurisprudence has taken a turn for the worse recently, turning a deaf ear to patients who have been injured or killed by devices and covertly expanding the boundaries of federal preemption in ways that threaten fundamental contractual principles. Ever since the Court's holding in Riegel v. Medtronic, district and appellate courts have effectively immunized the manufacturers of certain devices from contract, as well as tort, liabilities. The lower courts' rulings are not only

problematic as a matter of law, but raise novel concerns about federal regulatory preemption undermining individuals' contract rights. A comprehensive analysis of the Court's medical device jurisprudence and the relevant statutes and regulations establishes that consumers' contractual claims should not be preempted. Further, because preemption of these claims shifts the costs of device-related injuries away from the entities that are in the best position to manage losses, doing so is economically inefficient. Finally, federal preemption of contract claims poses unique threats to contractual liberty and state autonomy. Whereas statutory preemption of tort liabilities consists of the state limiting the applicability of state-imposed duties, preemption of contractual liabilities constitutes government interference in obligations that private parties have voluntarily imposed on themselves. Not only is contract law an area of state sovereignty, but the federal government lacks an interest sufficient to justify denying the parties involved in medical device sales the right to address liability concerns contractually

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