Last week, the Supreme Court upheld a Second Circuit decision finding that the Food and Drug Administration’s extensive pre-market approval process for Class III medical devices preempts state law causes of action for injuries allegedly caused by those devices. Riegel v. Medtronic, Inc., No. 06-179 (U.S. February 20, 2008). The decision involved a catheter manufactured by Medtronic that, according to the Supreme Court, ruptured in the plaintiff’s coronary artery during heart surgery. The Supreme Court’s ruling in Riegel was an 8-1 decision, with Justice Scalia writing the majority opinion, Justice Steven filing a separate opinion concurring in part and concurring in the judgment, and Justice Ginsberg filing the lone dissent.

The issues in the case stem from the 1976 “Medical Device Amendments” (MDA) (21 U.S.C. s. 360k) to the Federal Food, Drug and Cosmetic Act. The MDA expressly preempts state safety requirements for medical equipment that differ from or add to any requirement under the MDA for the device in question. The MDA establishes classifications for different types of medical devices. Class III devices, the devices at issue in the Riegel decision and other federal court decisions involving pre-emption under the MDA, are those that pose a potential unreasonable risk of illness or injury or that are purported to sustain life or prevent impairment of human health (such as the catheter involved in the heart surgery at issue in Riegel). Class III devices are approved under the MDA in two different ways. If they are substantially similar to previously-approved devices, they may be approved under the relatively fast “510k” process. Otherwise, the manufacturer of the Class III device must submit the device to an exhaustive pre-market approval (PMA) that takes the FDA an average of 1,200 hours to complete. The Medtronic catheter in Riegel had been approved by the FDA under the PMA process.

In 1996, the Supreme Court, in a decision entitled Medtronic v. Lohr, ruled that the faster 510k approval process does not pre-empt state law causes of action. In the Supreme Court’s opinion, the faster approval process does not establish specific regulations with respect to a particular device. However, the 1996 ruling left open the question of whether the more extensive PMA process would pre-empt state law safety requirements. Subsequent to the Supreme Court’s 1996 decision, several of the circuit courts ruled on the question, with the majority (the Second, Third, Fifth, Sixth, and Seventh) holding that the PMA process pre-empts state law causes of action. Only the Eleventh Circuit ruled the other way, although a pre-1996 decision in the Ninth Circuit suggests that that Circuit would have joined the Eleventh Circuit’s position, given the opportunity to rule on the question.

The Supreme Court’s decision last week resolves the split among the circuit courts, establishing that the PMA process pre-empts state law causes of action for injuries from the approved devices based on design defects. In so ruling, the Supreme Court found that the PMA process establishes federal regulations specific to the particular device in question.

For a full copy of Riegel decision, click here. For earlier discussions of FDA pre-emption, click here, here, here, and here.