The U.S. Supreme Court Immunizes Class III Medical Device Manufacturers
posted on February 29th, 2008 in Medical Devices by clintIn Reigel v. Medtronic, 2008 WL 440744 (U.S.), Charles Riegel and his wife, petitioner Donna Riegel, brought suit against respondent Medtronic after a Medtronic catheter ruptured in Charles Riegel’s coronary artery during heart surgery. The catheter is a Class III device that received FDA premarket approval. The Riegels alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law. The District Court held that the Medical Device Amendments of 1996 pre-empted the Riegels’ claims of strict liability; breach of implied warranty; and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter, and their claim of negligent manufacturing insofar as the claim was not premised on the theory that Medtronic had violated federal law. The Second Circuit affirmed.
The Supreme Court held that the MDA’s pre-emption clause bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA. The Federal Government has established “requirement[s] applicable … to” Medtronic’s catheter within § 360k(a)(1)’s meaning. In Medtronic, Inc. v. Lohr, 518 U.S. 470, 495, 500-501 (1996), the Court interpreted the MDA’s pre-emption provision in a manner “substantially informed” by an FDA regulation, 21 CFR § 808.1(d), which says that state requirements are pre-empted only when the FDA “has established specific counterpart regulations or there are other specific requirements applicable to a particular device” under federal law. Premarket approval imposes “specific requirements applicable to a particular device.” The FDA requires that a device that has received premarket approval be marketed without significant deviations from the specifications in the device’s approval application, for the reason that the FDA has determined that those specifications provide a reasonable assurance of safety and effectiveness.
The Medical Device Amendments of 1976 (MDA) created a scheme of federal safety oversight for medical devices while sweeping back state oversight schemes. The statute provides that a State shall not “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 [federal law] to the device, and … (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under” relevant federal law. 21 U.S.C. § 360k(a). The MDA calls for federal oversight of medical devices that varies with the type of device at issue. The most extensive oversight is reserved for Class III devices that undergo the premarket approval process. These devices may enter the market only if the FDA reviews their design, labeling, and manufacturing specifications and determines that those specifications provide a reasonable assurance of safety and effectiveness. Manufacturers may not make changes to such devices that would affect safety or effectiveness unless they first seek and obtain permission from the FDA.
The Supreme Court held that the plaintiffs’ common-law claims were pre-empted because they were based upon New York “requirement[s]” with respect to Medtronic’s catheter that are “different from, or in addition to” the federal ones, and that relate to safety and effectiveness, § 360k(a). The common-law negligence and strict-liability claims imposed “requirement[s]” under the ordinary meaning of that term, see, e.g., Lohr, supra, at 503-505, 512, Cipollone v. Liggett Group, Inc., 505 U.S. 504, 521-523, 548-549 (1992). There was nothing in the MDA that contradicted this normal meaning. The Court rejected plaintiffs’ contention that the duties underlying her state-law tort claims were not pre-empted because general common-law duties were not requirements maintained “with respect to devices.” The plaintiffs’ suit depended upon New York’s “continu[ing] in effect” general tort duties “with respect to” Medtronic’s catheter. Title 21 CFR § 808.1(d)(1)–which states that MDA pre-emption does not extend to “[s]tate or local requirements of general applicability [whose] purpose … relates either to other products in addition to devices … or to unfair trade practices in which the requirements are not limited to devices”–does not alter the Court’s interpretation.
This decision was expected by those who have seen a rapid expansion of federal preemption in medical device litigation. It only applies to Class III medical devices, but it is dangerous precedent. Pharmaceutical liability litgation is the next target. It is hard to believe that a Democratic Congress in 1976 intended to immunize an entire industry from liability for defective products just because the medical device received Class III premarket approval. It seems that a Democratic Congress will have to fix this harsh result.