1. The United States Supreme Court’s mid-February 2008 decision in Riegel v. Medtronic, impacts efforts by lawyers to find relief for injured clients suffering from the adverse consequences of defective, or misdesigned, medical devices. Riegel v. Medtronic, number 06-179, decided February 20, 2008, decided a case brought by Mr. and Mrs. Riegel against Medtronic after one of its catheters ruptured in Mr. Riegel’s coronary artery during heart surgery. They alleged the device was not properly labeled under New York law.
2. The Supreme Court concluded that the Medical Device Amendments of 1976, 21 USC § 360, preempts common law claims challenging the safety or effectiveness of medical devices marketed in a form that received pre-market approval from the FDA. The court concluded that the federal government established requirements applicable to Medtronic’s catheter within § 360k(a)(1)’s meaning. Pre-market approval, according to the court imposes “specific requirements applicable to a particular device”. This pervasive federal scheme of regulation and approval preempts state law claims.
3. 21 CFR § 808(1)(d)(1) contains a provision noting that the Medical Devices Act’s preemption does not extend to “[s]tate or local requirements of general applicability [whose] purpose … relates either to other products in addition to devices … or to unfair trade practices in which the requirements are not limited to devices”. But this regulatory provision did not impact the court’s decision.
4. Preemption Doctrine cases recognizing the supercession of a federal law, and its preemption of state law claims, expands federal government regulation and control.
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