Arizona Supreme Court holds that federal law impliedly preempts a state law failure-to-warn claim predicated on alleged noncompliance with federal reporting requirements.

Medtronic, Inc. manufactures “pain pumps,” implantable drug-infusion devices for pain management.  A patient implanted with one of Medtronic’s pumps suffered injuries when it malfunctioned.  The patient sued Medtronic in Maricopa County Superior Court, asserting various state law tort claims, including one for failure to provide adequate warnings.  

Medtronic successfully moved to dismiss all of the patient’s claims as expressly and impliedly preempted by federal law.  The court of appeals affirmed in part, but vacated the dismissal of the failure-to-warn claim.  Relying on Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013), which held that federal law did not preempt a similar claim against Medtronic for failure to warn under Arizona law, the court of appeals found that the patient’s failure-to-warn claim was not preempted. 

The Arizona Supreme Court affirmed in part and vacated in part.  The patient’s failure-to-warn claim relied solely on Medtronic’s failure to report adverse incidents involving its pain pumps to federal regulators as required by 21 U.S.C. § 337(a).  Because reporting adverse incidents to federal regulators would not satisfy a manufacturer’s duty to warn under Arizona law, the Court concluded that federal law impliedly preempted the patient’s claim for failure to warn.  In so holding, the Court explicitly rejected the reasoning and holding of Stengel as inconsistent with Arizona law.

Justice Pelander authored the unanimous opinion.