Riegel V. Medtronic: A Win For Medical Technology

Medical device manufacturers scored a major victory against product liability lawsuits as a result of the U.S. Supreme Court's recent decision in Riegel v. Medtronic. The court held that manufacturers of medical devices approved under the Food and Drug Administration's pre-market approval (PMA) process cannot be sued under state law theories of product liability. At the heart of this ruling was a federal statutory provision prohibiting states from imposing requirements "different from, or in addition to" existing federal requirements applicable to medical devices. The court's decision resolved a split among the lower courts, and clarified that PMA approval qualifies as a "requirement" within the meaning of the provision. Thus, products which receive federal PMA approval may not be subjected to state tort claims.

Medical Device Regulation

The Supreme Court's decision rests primarily on the fact that medical devices are heavily regulated by the FDA. But that was not always the case. Before 1976, there were no federal standards governing medical devices. By the mid-1970s, several states, spurred by scandals involving the Copper-7 and Dalkon Shield intrauterine devices, had implemented their own regulations?each one a little different from the other. Without a uniform set of federal regulations, medical device manufacturers faced the prospect of having to comply with fifty different sets of state-law requirements. Then, in 1976, Congress enacted the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act (FDCA), which established a comprehensive federal regulatory scheme?administered by the FDA?to govern medical devices. The statute specifically bars state-law requirements that are "different from, or in addition to" the requirements set by the FDA.

The MDA regulate medical devices at levels commensurate with the risks they impose. Devices that pose only moderate risks are subject to only moderate regulations. However, devices that pose great risks?known as Class III devices?are heavily regulated by the FDA. Class III devices must undergo the FDA's rigorous PMA process. To apply for pre-market approval, a device sponsor must submit copious information, typically several volumes of documents consisting of, among other things, descriptions of the device and its component parts, clinical trial information, and adverse event reports. The FDA spends an average of 1,200 hours reviewing this information, and the agency cannot approve the...