The Ninth Circuit Court of Appeals recently shrank universe of state law claims pertaining to Class III medical devices that remain untouched by Riegel express preemption or Buckman implied preemption. In Stengel v. Medtronic, Inc., the Court ruled that a state law failure-to-warn claim premised on FDA regulations was impliedly preempted by the Supreme Court’s decision in Buckman, because it was analytically indistinct from the “fraud-on-the-FDA” claim with which Buckman dealt. To wit, both claims revolved around allegations that the defendant misled the FDA, whether by commission (Buckman) or omission (Stengel). When considered in conjunction with Riegel’s express preemption of state law claims that add to or change the duties of Class III medical device manufacturers under the Medical Device Amendments to the Food, Drug, and Cosmetic Act (“FDCA”), the Ninth Circuit’s robust view of Buckman implied preemption leaves very little room for a plaintiff to state a cognizable state-law cause of action against the manufacturer of a medical device cleared through the FDA’s premarket approval (“PMA”) process. The Court recognized the sharpened dilemma it left potential plaintiffs, but identified state-law manufacturing defect actions as a category of claims that had passed through the Reigel/Buckman gauntlet unscathed, at least in the Seventh Circuit, because they paralleled federal duties (and thus skirted Riegel) without resting solely on the breach of duties created by federal regulation (which would run afoul of Buckman).

Stengel follows the Ninth Circuit’s opinion in PhotoMedex, in which the Court interpreted Buckman to preempt, not only claims in which the plaintiff attempts to enforce the FDCA (because that is the exclusive jurisdiction of the FDA), but any attempt by a plaintiff to prove that a medical device manufacturer violated the FDCA – in the absence of a determination of such a violation by the FDA itself. PhotoMedex, Inc. v. Irwin, 601 F.3d 919, 928 (9th Cir. 2010). Perhaps with PhotoMedex in mind, the Stengel plaintiffs attempted to distinguish Buckman by arguing that the FDA had already determined that Medtronic had violated FDA regulations, and thus they could prove their failure-to-warn claim without second-guessing the FDA’s decision-making. The Ninth Circuit demurred, noting that Buckman was concerned not only with preserving the FDA’s exclusive jurisdiction, but also with avoiding the “extraneous pull” that state-law claims would exert on the Congressionally-mandated FDCA scheme.

The Stengel opinion explicitly acknowledged that federal appellate courts were divided on the issue of whether state law failure-to-warn claims were preempted by Buckman. Interestingly, it aligned itself with the Eighth Circuit’s view, while spending a good amount of space explaining why the Fifth Circuit’s countervailing view was unpersuasive. Whether the Supreme Court takes note of the brewing circuit split, or the Ninth Circuit’s justification of its decision, remains to be seen.