California’s Parallel State Law Duty to Report Adverse Events to U.S. Food and Drug Administration Cannot Be Reconciled with Legal Precedent

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 consumer of a risk because the “reliability of a third party, e.g., a business intermediary to convey the warning to the ultimate user” (i.e., a ski technician advising a skier), absolved the manufacturer from a duty to provide a warning directly to the consumer. 217 Cal.App.3 at 175. The court concluded that Salomon had no duty to directly warn because “Salomon had no feasible means of providing a warning directly to one who rents Salomon bindings from a ski shop” and that “the ordinary user of rental skis and bindings lacks the expertise necessary to understand and apply the requisite warning…” 217 Cal.App.3d at 172-73.

Mize’s reliance on Coleman’s analysis, erroneously applying the sophisticated intermediary doctrine to a governmental agency, goes too far and fails to consider that juries are not tasked with deciding what FDA would or would not have done with information that was allegedly not reported to the Agency. In cases involving prescription products, like medical devices, it is universally accepted that the learned intermediary, or sophisticated intermediary as explained in Persons, is the physician who interacts with and makes decisions about patient health care. The FDA is not a traditional learned intermediary as that term is used in judicial decisions. Rather, the FDA is a federal regulatory body authorized by Congress to make policy judgments based on extensive regulations adopted by the Agency, with input from scientists, medical professionals and others.

FDA’s policies and decision-making processes balance providing sufficient information to physicians for patient care and avoiding over-warning about risks that may discourage use of important medical devices. The fact that a manufacturer may have been required to submit information to FDA does not mean that FDA would have changed the warning or that FDA would have required that more information be given to the physician or that additional information would have changed the physician’s decision to use a medical device.

What is ultimately at stake from Mize’s recognition of a state law duty to warn FDA was observed in Stengel’s concurring opinion. “To prevail [based on a duty to provide adverse events to FDA], the [plaintiff] will ultimately have to prove that if Medtronic had properly reported the adverse events to the FDA as required under federal law, that information would have reached [the plaintiff’s] doctors in time to prevent his injuries.” Stengel, 704 F.3d at 1234 (conc. opn. of Watford, J.). But this inquiry requires proof of what the FDA would have done. Juries are not traditionally charged with making these types of decisions as recently articulated by the Supreme Court in Merck Sharp & Dohme v. Albrecht, 139 S.Ct. 1668 (2019), and the Mize court’s attempt to judicially impose an alleged “parallel” state law duty may very well result in a jury speculating that FDA would have acted differently than it did when the device and its labeling were approved, and make a guess that FDA would have required the manufacturer to give additional information to physicians. Those decisions about what FDA would have done lead us back to Riegel because these additional requirements may be “different from or in addition to” the federal requirements that the device be sold as approved by FDA based on its policy judgment – claims that are preempted.