Federal Court Holds Medical Device Claims Preempted By FDCA

A federal court in Missouri has dismissed with prejudice a suit against Cochlear Americas, a global manufacturer of hearing-loss assistance devices, for false advertising, consumer fraud and breach of implied warranty, ruling that the claims are preempted under the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act. Shook Partner Devin Ross and Associate Elizabeth Fessler represent Cochlear Americas. 

The plaintiff alleged that he suffered numbness of his ear rim and sound wave distortion after a surgical cochlear implant, and that he intended to have the device removed and replaced, which could expose him to additional pain and suffering. 

The Medical Device Amendments (MDA) include an express preemption clause that restricts states from establishing requirements that relate to a device’s safety or effectiveness that differs from or adds to any MDA requirement already applicable to the device. To determine whether the plaintiff’s claims were preempted, the Court applied the two-factor test set out by the U.S. Supreme Court in Riegel v. Medtronic, 552 U.S. 312: has the FDA established requirements to the device, and would the claims impose requirements different from or in addition to the federal requirements?

First, the Court noted that the U.S. Food and Drug Administration (FDA) separates medical devices into three categories, based on the risks of injury or illness the device presents. The Court found that as a Class III device, cochlear implants are already subject to the highest level of scrutiny under the MDA, satisfying the first step of the preemption analysis. Second, the Court said, if it found that statements made in a device’s labeling were misleading after the FDA had approved the statements, that finding would establish requirements different from those in the MDA. Accordingly, the Court held the plaintiff’s product liability claims were preempted. 

In addition, although the MDA does not prevent a state from providing a damages remedy for parallel claims premised on a violation of FDA regulations, the Court found that the complaint “expressly states” that it made no “factual allegations whatsoever” concerning FDA specifications, regulations or oversight. “Without such a comparison there can be no intelligible assertion of parallel claims by plaintiff,” the court said. “Thus, an undeveloped contention cannot save this case from preemption.” 

The case is Alexander v. Cochlear Americas, No. 18-498 (W.D. Mo., October 11, 2018).