Product Liability and Preemption Under the Medical Device Amendments: The Business Implications of Medtronic, Inc. v. Lohr

In a decision that will have a substantial impact on common law-based state product liability cases involving medical devices, and potentially other types of products as well, the U.S. Supreme Court, in Medtronic v. Lohr, (Medtronic) significantly narrowed the applicability of a commonly used defense by medical device manufacturers, and thereby increased their product liability exposure and risk. See Medtronic, 116 S.Ct. 2240, (1996). Prior to this decision, courts had been divided as to whether and what extent the "preemption provision" in the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (the "Act") could be asserted as a defense in product liability cases. The preemption provision declares, in effect, that states may not impose any requirements with regard to medical devices that are different from requirements under the Act and imposed by the Food and Drug Administration ("FDA"). The decision in Medtronic may have implications for manufactures of other types of health care and consumer products subject to federal standards, because it rests on the principle that courts, when interpreting and applying those standards, should not readily interfere with state-based tort remedies in cases concerning safety and health.

For the full story, please view the PDF.

In a decision that will have a substantial impact on common law-based state product liability cases involving medical devices, and potentially other types of products as well, the U.S. Supreme Court, in Medtronic v. Lohr, (Medtronic) significantly narrowed the applicability of a commonly used defense by medical device manufacturers, and thereby increased their product liability exposure and risk. See Medtronic, 116 S.Ct. 2240, (1996). Prior to this decision, courts had been divided as to whether and what extent the "preemption provision" in the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (the "Act") could be asserted as a defense in product liability cases. The preemption provision declares, in effect, that states may not impose any requirements with regard to medical devices that are different from requirements under the Act and imposed by the Food and Drug Administration ("FDA"). The decision in Medtronic may have implications for manufactures of other types of health care and consumer products subject to federal standards, because it rests on the principle that courts, when interpreting and applying those standards, should not readily interfere with state-based tort remedies in cases concerning safety and health.

For the full story, please view the PDF.