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Arizona Limits Failure to Warn Claims Against Medical Device Manufacturers

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On December 18, 2018, the Arizona Supreme Court issued an opinion clarifying manufacturers’ duty to warn consumers under Arizona common law. The Court held that the federal Medical Device Amendments (“MDA”) impliedly preempted Arizona common law claims in a medical device context. The opinion also disavowed the Ninth Circuit’s preemption ruling in Stengel v. Medtronic, Inc.

In Conklin v. Medtronic, Inc., Raymond R. Conklin sued Medtronic for failing to report adverse events regarding a pain pump to the United States Food and Drug Administration (“FDA”) after the FDA approved the pump. Under the MDA, manufacturers of medical devices are required to report adverse incidents in which the device may have caused or contributed to death or serious injury. Because only the federal government can seek redress for a violation of the FDA reporting requirements under the MDA, Conklin brought suit under the Arizona common law, which states that “manufacturers generally have a duty to warn consumers of foreseeable risks of harm from using their products.”

The Court found that the failure to warn claims were impliedly preempted because only federal law, and not state law, imposes a duty to submit adverse event reports to the FDA. A state law claim that exists “solely from the violation of federal requirements” is impliedly preempted because it would attempt to “enforce a federal law requirement” by using state law claims.

The Court rejected the Ninth Circuit’s opinion in Stengel, which found that the MDA did not preempt the plaintiffs’ Arizona failure to warn claim based on Medtronic’s failure to report adverse events to the FDA. The Court held that Arizona law recognizes claims for failing to provide an adequate warning to the patient directly or to certain third parties such as health care providers but does not recognize a claim for failing to report to a government agency that has no obligation to relay the information to the patient.

The Court clarified limits on Arizona failure to warn claims. It held that a medical device manufacturer may satisfy its duty to warn consumers by properly warning a third party such as a “learned intermediary.” However, the Court noted that the FDA is not a learned intermediary and is instead a “governmental regulatory body.”

The 7-0 decision provided clarity on Arizona failure to warn claims brought against medical device manufacturers.