Supreme Court Holds That FDA Premarket Approval Preempts Common-Law Claims Challenging Safety and Efficacy of Medical Devices

The Supreme Court ruled this week that a plaintiff may not sue under state law to challenge the safety or effectiveness of a medical device to which the FDA has given “premarket approval.”  Riegel v. Medtronic, Inc., 2008 WL 440744 (Feb. 20, 2008).  This type of FDA approval—which reflects the agency’s determination that the product is reasonably safe and effective for human use—establishes certain federal requirements that preempt state law remedies, including common-law claims for strict products liability, breach of warranty, and negligent design.  This decision represents a significant victory for medical device manufacturers, protecting them from the risk of state court damage awards for devices that have been duly approved by the FDA.

Charles Riegel was injured when a catheter manufactured by Medtronic burst during a coronary angioplasty procedure.  Riegel and his wife sued Medtronic, alleging state-law claims for negligence in the design, testing, inspection, manufacture, and distribution of the catheter; strict liability; breach of express warranty; breach of implied warranty; and loss of consortium. 

Medtronic moved for summary judgment, arguing that federal law expressly preempted the plaintiffs’ state-law claims.  Specifically, the Medical Device Amendments to the Food, Drug, and Cosmetics Act (“MDA”) contain an express preemption provision stating that “[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 Act 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 Act.”  21 U.S.C. § 360k(a).  Medtronic argued that because its catheter had received premarket approval from the FDA, it could not be held liable for any alleged defect in the design of the product.  The district court granted summary judgment on all but two of the plaintiffs’ claims based on federal preemption.  (The court later granted summary judgment on the remaining claims for other reasons.)  On appeal, the Second Circuit affirmed.

The Supreme Court agreed that federal law preempted state law in this context.  In an opinion written by Justice Scalia, the Court held that premarket approval by the FDA establishes federal “requirements” that are specific to the approved device.  Indeed, premarket approval is a “rigorous process” that is “focused on safety.”  And when the FDA grants premarket approval, it effectively determines that the device “provides a reasonable assurance of safety and effectiveness.”  Next, the Court held that the plaintiffs’ common-law claims relied on “requirements” of state law.  Five Justices in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), agreed that common-law claims could amount to “requirements” for purposes of the MDA preemption provision, and the Court here followed the same approach.  “Absent other indication,” the Court wrote, “reference to a State’s ‘requirements’ includes its common-law duties.”  Because the Medtronic catheter had been granted premarket approval by the FDA, it was subject to federal requirements that could not be altered or supplemented by state-law requirements, including common-law requirements.

The Court was careful to note, however, that “State requirements are preempted under the MDA only to the extent that they are ‘different from, or in addition to’ the requirements imposed by federal law.  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.”  The plaintiffs in this case did not preserve any argument that their claims were “parallel” to federal requirements—in other words, that Medtronic somehow departed from the requirements created by FDA approval.  Undoubtedly, plaintiffs in other lawsuits will try to preserve and make such arguments.

Justice Ginsburg dissented on the ground that the history and purpose of the MDA demonstrate that “Congress did not regard FDA regulation and state tort claims as mutually exclusive.”  Justice Stevens agreed with that point, but nevertheless concurred in part and in the judgment because the text of the preemption provision reaches to any “requirement” of state law, including common-law claims.

Because this case turns on the specific language of an express preemption provision and the specific characteristics of the premarket approval process, it will likely have limited application beyond the context of medical devices. Nevertheless, the Court’s analysis here may be useful in other cases in that it expresses the Court’s willingness to understand state common law as imposing “requirements” that may conflict with federal regulations. The decision also demonstrates the rigor with which the Court is prepared to apply express preemption provisions according to their terms, notwithstanding any legislative purposes suggested by other sources.