Riegel v. Medtronic..Summary of Feb. 20, 2008 Decision

This case centers on the meaning of the words "state requirements" in a federal law from 1976. The majority of the Court (8-1, Scalia writing for the Court; Ginsburg dissenting) concluded that "requirements" either referred to or could be interpreted as including common law tort suits brought under state law, while Justice Ginsburg vainly contended that to read the statute thus meant that claims against medical device manufacturers by who are victims of potentially faulty medical devices will largely disappear.

Here is the factual summary of the case, taken from the syllabus of the case:

"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."

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 MDA 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 Statute At Issue

The federal statute at issue, cited above, has the following language:

"[N]o 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 or to any other matter included in a requirement applicable to the device under this chapter.” 21 U.S.C. § 360k(a).

The issue should be coming into full focus now. Is the continuing existence of state causes of action for various kinds of negligence, strict liability and breach of warranty a kind of "state" "requirement" that is pre-empted by the federal law? Defining a lawsuit or cause of action as a "requirement" might seem to be a long-shot, but that is what the majority did. Justice Stevens, who concurred in the judgment of the Court, didn't think that the Congress originally would have included tort suits as "requirements" in the language of the law but as time evolved one could see how these suits would be so considered. Justice Scalia's final paragraph sums up the approach of the Court:

"State requirements are pre-empted under the MDA only to the extent that they are “different from, or in addition to” the requirements imposed by federal law. § 360k(a)(1). Thus, § 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case “parallel,” rather than add to, federal requirements. Lohr, 518 U.S., at 495, 116 S.Ct. 2240; see also id., at 513, 116 S.Ct. 2240 (O'Connor, J., concurring in part and dissenting in part). The District Court in this case recognized that parallel claims would not be pre-empted, see App. to Pet. for Cert. 70a-71a, but it interpreted the claims here to assert that Medtronic's device violated state tort law notwithstanding compliance with the relevant federal requirements, see id., at 68a. Although the Riegels now argue that their lawsuit raises parallel claims, they made no such contention in their briefs before the Second Circuit, nor did they raise this argument in their petition for certiorari. We decline to address that argument in the first instance here."

Thus, "parallel" claims could be entertained, while the Riegel's claims could not. Thus, I see a case coming down the pike in the future where someone tries to get the Court to define what a "parallel claim" actually is. In the meantime, however, the federal law largely pre-empts the common law causes of tort action against equipment manufacturers--as long as they followed federal procedures correctly. A big win for the medical equipment manufacturers...

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