Stengel v. Medtronic Inc.

A claim under state law challenging the safety of medical equipment given premarket approval by the Food and Drug Administration (FDA) is preempted by the Food, Drug and Cosmetic Act (FDCA) if the state law provides a requirement “different from” FDCA requirements. Further, a plaintiff’s claim of injury based on a medical equipment manufacturer’s failure to report information to the FDA is invalid, because the FDCA does not provide a private right of action.

In 2000, Richard Stengel had a medicine pump surgically implanted. In 2005, Stengel suffered from ascending paralysis due to an inflammation in his spine at the end of the pump catheter, which rendered Stengel permanently paraplegic. The pump, manufactured by Medtronic Incorporated (“Medtronic”), received Class III premarket approval from the FDA in 1988, and supplemental approval in 1999. Stengel brought state law claims for negligence, breaches of express and implied warranties, and strict liability against Medtronic in Arizona state court. Medtronic removed to federal district court. The district court granted Medtronic’s motion to dismiss on the grounds that Stengel’s claim was preempted by federal law. Stengel filed a motion for leave to amend the complaint, alleging that Medtronic failed to provide required information to the FDA. The district court denied the motion to amend, finding that the revised claim was also preempted. In affirming the district court’s decision, the Ninth Circuit cited the FDCA, which preempts any claims brought under state laws that are “different from, or in addition to,” FDCA requirements. The Court relied on the Supreme Court’s decision in Riegel v. Medtronic, Inc., which held that the Class III approval process was a federal requirement under the FDCA preemption clause, and preempted “common law tort duties.” The Court also cited Buckman Co. v. Plaintiff’s Legal Committee for the principle that a claim alleging failure to report to the FDA is invalid because it interferes with the congressional scheme empowering the FDA to enforce its own rules. Thus, the Court held that Stengel’s claims were expressly or impliedly preempted. AFFIRMED.