Fourth Circuit Rules That Federal Law Preempts State-Law Claims Arising From Alleged Malfunction Of Medical Device That Complied With FDA Requirements

Originally published February 1, 2012

Keywords: Fourth Circuit, Medical Advice Amendments, premarket approval,

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...