Supreme Court Bars State Common Law Claims Challenging Medical Devices with FDA Pre-Market Approval
On February 20, 2008, the Supreme Court affirmed 8 - 1 the Second Circuit’s decision in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008). The Court held that when a medical device is given pre-market approval from the Food and Drug Administration, the preemption clause of the Medical Device Amendments of 1976 bars several state common law claims challenging the device’s safety or effectiveness.
To view the Supreme Court's decision in Riegel v. Medtronic , Inc. No. 06-179 (2008), please click here.