Stengel v. Medtronic, Inc.

A federal-law duty imposed by the Medical Device Amendments to the Food, Drug, and Cosmetic Act does not preempt a parallel state-law duty of care.

A Medtronic made medical device that had risks known to Medtronic but unreported to the Food and Drug Administration (FDA) rendered Richard Stengel paraplegic. Plaintiffs Richard and Mary Lou Stengel appealed the district court’s denial of their motion to add a new state-law negligence claim to their complaint; plaintiffs also appealed an evidentiary ruling. A panel of the Ninth Circuit Court of Appeals affirmed the district court’s holding, but the Court of Appeals granted rehearing en banc. The issue was “whether the [Medical Devise Amendments (MDA)] preempts a state-law claim in which the state-law duty of care ‘parallels’ a federal-law duty imposed by the MDA.” The en banc Court relied on several U.S. Supreme Court cases interpreting preemption under the MDA, and found Medtronic v. Lohr 518 U.S. 470 (1996) to be the most comparable. Lohr involved a state-law claim for negligence that was not preempted because Medtronic failed to overcome the presumption that Congress did not intend to supersede state law when it passed the MDA. Further, the en banc Court noted that the Supreme Court did not find express, field or conflict preemption in the Supreme Court’s analysis of the MDA in Lohr. After comparing Lohr to other similar MDA preemption cases, the Court of Appeals identified the rule that “the MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA.” Thus, the Court of Appeals determined that the plaintiffs’ new state-law claim of negligence parallels a duty under federal law for Medtronic to warn the FDA when it became aware of defects. Arizona law similarly requires a general duty of reasonable care to be exercised by product manufacturers, and failure to follow this allows a cause of action for failure to warn. REVERSED and REMANDED.