Earlier this year, the California Court of Appeals in Mize v. Mentor Worldwide LLC, 51 Cal.App.5th 850 (2020), reversed a trial court’s dismissal of failure to warn and other claims against a medical device manufacturer, holding that “California law recognizes a manufacturer’s duty to warn the [U.S. Food and Drug Administration] of adverse events.” Mize concluded that California’s duty to warn FDA was “parallel” to the requirements of federal law, and therefore not expressly preempted.
Cases like Mize involving medical devices approved for sale through the FDA’s Premarket Approval (PMA) process are generally subject to the U.S. Supreme Court’s decision in Riegel v. Medtronic, 552 U.S. 312 (2008). Riegel held that the federal Medical Device Amendments preempt state tort laws if they are “different from, or in addition to” the requirements imposed by federal law. Riegel bars state tort law claims because PMA devices are subject to specific requirements adopted by FDA through the rigorous PMA approval process. However, Riegel left open the possibility, based on an articulated judicially imposed policy, that a state might “[provide] a damages remedy for claims premised on a violation of FDA regulations” because “the state duties in such a case ‘parallel’ federal law.” 552 U.S. at 329.
But Mize’s purported parallel state tort law duty is neither well-grounded in California law nor a viable state law “damage remedy” postulated by Riegel. The Mize court cited as its source for this alleged duty Coleman v. Medtronic, 223 Cal.App.4th 413, 436 (2014). But Coleman was not based on relevant California authority. The source of Coleman’s duty was derived primarily from two cases. The first case was the Ninth Circuit’s earlier decision in Stengel v. Medtronic, 704 F.3d 1224, 1233 (9th Cir. 2013). Stengel did not involve California law but was governed by Arizona state law. Stengel’s conclusion that Arizona recognized a state law tort duty to report information to FDA has since been overturned by the Arizona Supreme Court in Conklin v. Medtronic, Inc., 431 P.3d 571, 579 (Ariz. 2018) because Arizona does not recognize this alleged state law duty.
The second case relied upon by Coleman was Persons v. Salomon North America, Inc., 217 Cal.App.3d 168 (1990), a case that had nothing to do with reporting information to FDA or any other government agency. The Coleman court cited Persons for the proposition that “[s]uch a duty to convey warnings to a third party that can reasonably be expected to warn the consumer is recognized in other contexts.” 223 Cal.App.4th at 429. But Persons was a straightforward, sophisticated intermediary decision, and the court there found that the distributor of ski bindings had no duty to directly warn the...
