On February 20, 2008, the United States Supreme Court issued an important decision on when federal law bars state tort claims that allege defects in products regulated by federal law. In Riegel v. Medtronic, Inc., the Court held that state tort claims alleging defects in medical devices are pre-empted by federal law if the medical device received premarket approval from the Food and Drug Administration. The case involved a coronary catheter that was implanted in a patient’s artery and ruptured. The patient sued the manufacturer of the catheter, alleging that the catheter was defectively designed and labeled. The FDA, however, had approved the catheter for sale after determining that it was safe and effective.
The Supreme Court held that federal law pre-empted the patient’s product liability claims because the patient was essentially claiming that the design and labeling approved by the FDA were defective. The Court relied on a pre-emption clause in the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act that provides “no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement — (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device...” The Court concluded that a state tort claim imposes requirements different from, or in addition to, federal requirements if the claim alleges defects in a medical device’s design or labeling that was approved by the FDA.
The importance of this decision is not limited to medical devices. The decision may have applicability to any product subject to federal regulation. The Court made clear that federal approval may trump state tort claims just as it does conflicting state statutes or regulations. Accordingly, any product regulated by federal law may be shielded to some degree from product liability claims depending on the legislative scheme applicable to the product. As additional examples, the Supreme Court previously has held that some product liability claims against cigarettes and pesticides are pre-empted by federal law.