In Walker v. Medtronic, Inc., No. 10-2219, ___F.3d___ (January 25, 2012), the US Court of Appeals for the Fourth Circuit held that the Medical Device Amendments to the Food, Drug, and Cosmetic Act preempt state-law claims arising from the alleged malfunction of a Class-III medical device that had received premarket approval from the Food and Drug Administration and had complied with all requirements imposed by the agency. 

The Medical Device Amendments contain a preemption provision that expressly prohibits any state from imposing on a medical device any safety or effectiveness requirement “which is different from, or in addition to, any requirement” imposed under the federal statute. In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the Supreme Court held that the FDA’s approval of a Class-III medical device through the agency’s “premarket approval” process imposes federal requirements that preempt any different or additional state requirements. Although Riegel recognized the broad preemptive force of premarket approval, the Court stated, in dictum, that state-law claims based on duties that “parallel” federal requirements might nevertheless survive. The Court, however, did not define what could constitute a “parallel” claim that might survive preemption.

Since Riegel, plaintiffs seeking to avoid preemption have argued that a device’s failure to operate as intended is ipso facto proof that the device had violated the federal requirements imposed through the premarket approval process, and that the purported violation gives rise to a “parallel” state-law claim that survives preemption. The Fourth Circuit’s recent decision in Walker squarely rejects that contention.

The device at issue in Walker is a pump that dispenses medication directly into the space surrounding the spinal cord. The pump, a Class-III device that was approved through the premarket approval process, is designed and manufactured to deliver a programmed dose within a tolerance range of plus-or-minus 15 percent. There was no dispute that the particular device at issue in the case was both designed and manufactured in accordance with the performance specification. 

The plaintiff alleged that the device delivered a lethal overdose well outside the 15 percent performance specification several years after it had been implanted. The plaintiff argued that the 15 percent performance specification, which had been identified in the application materials submitted by the device’s manufacturer during the premarket approval process, constituted a federal “requirement” within the meaning of the Medical Device Amendments, and that the device’s alleged failure to perform within the 15 percent tolerance range was, therefore, a violation of a federal requirement that could support a “parallel” claim within the meaning of Riegel.

The Fourth Circuit disagreed. The court concluded that the performance specification, although set forth in the manufacturer’s premarket approval application materials, did not establish a federal requirement under the Medical Device Amendments. Observing that the application materials expressly foresaw the possibility of a device failing to perform as intended and the associated risk of a drug overdose, the Fourth Circuit recognized that the 15 percent performance specification was a description of how the device was designed and manufactured to operate, not an enforceable guarantee that a particular device would always operate without malfunction.

According to the court, the plaintiff was “attempt[ing] to transform a design specification, which the FDA recognizes the device will not always function in accordance with, into an actionable guarantee,” and was thus “seek[ing] to impose an additional requirement as precluded under Riegel.”

For more information about the Walker decision, or any other matter raised in this Legal Update, please contact Andrew Tauber at +1 202 263 3324 or Daniel Ring at +1 312 701 8520.1

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1. Mayer Brown represented the defendant in Walker and in Riegel.