The Supreme Court’s opinion in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349-50 (2001), recognizes that any attempt by a plaintiff to enforce the FDCA is preempted by federal law, because Congress entrusted all such enforcement efforts to the sole discretion of the FDA. In 2010, the Ninth Circuit’s PhotoMedex opinion held that Buckman not only private attempts to enforce the FDCA, but also any attempt by a plaintiff to prove that a medical device manufacturer violated the FDCA because such an attempt would require the court to usurp or second-guess the FDA’s enforcement decisions – 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). Thus, PhotoMedex clearly suggested that Buckman would not prevent a plaintiff from proving an FDCA violation where the FDA had already determined that such a violation had occurred.
But the Ninth Circuit’s Stengel opinion, issued earlier this year, muddied the waters. In Stengel v. Medtronic, Inc., 676 F.3d 1159 (9th Cir. 2012), plaintiffs sought to avoid Buckman preemption of their state law failure-to-warn claim premised on FDA regulations because there the FDA had already determined that the defendant had violated the FDCA. Thus, the plaintiffs argued, the Court could safely find an FDCA violation without preempting or undermining the FDA’s enforcement authority. The Ninth Circuit, however, rejected this argument, noting that Buckman was concerned not only with judicial second-guessing of the FDA’s determinations, but also with avoiding the “extraneous pull” that state-law claims would exert on the FDA’s Congressionally-mandated exclusive jurisdiction. In short, the Stengel Court seemed to withdraw the “prior FDA decision” exception to Buckman preemption it had recognized in PhotoMedex only two years earlier.
The Ninth Circuit had a chance to revisit the scope of Buckman preemption in its recent Pom Wonderful opinion. Pom Wonderful LLC v. Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012). Therein, the Court held that Pom Wonderful’s Lanham Act challenges to the naming and labeling of Coca-Cola’s “Pomegranate Blueberry Flavored Blend of 5 Juices” were preempted under PhotoMedex. Interestingly, the Court’s characterization of PhotoMedex appeared to broaden its focus to accommodate the Stengel result by emphasizing PhotoMedex’s concern for “the authority Congress entrusted to the FDA” and “ the regulatory regime put in place by the FDA.”
This gloss on PhotoMedex allowed the Pom Wonderful Court to find preemption regardless of the presence or absence of FDA enforcement efforts (though it was careful to retain discretion to amend its view in future opinions depending on “the particular circumstances of the case”). Thus, though Coca-Cola appeared to have complied with FDA regulations, it was not “mere compliance with the FDCA or with FDA regulations” that preempted Pom Wonderful’s claim. Nor did it matter that the FDA had not undertaken any enforcement action against Coca-Cola. What really mattered was that it was the FDA – not the civil courts – that was entitled to act or refrain in these areas, as it saw fit. In other words, the Court rested preemption primarily on deference to the FDA’s exclusive authority, and resulting expertise, to regulate the matters entrusted to its oversight. Indeed, the Court denied there was any room for civil litigation of the matters at all: “In the circumstances here, the appropriate forum for Pom’s complaints is the FDA.”
The reliance on PhotoMedex for complete abstention from litigation touching FDA-regulated matters is emblematic of the Court’s subtle expansion of that case’s import. It is not a case about waiting for the FDA to make a determination before allowing the matters under its regulatory purview to be introduced into a civil claim. Rather, “PhotoMedex teaches that [civil litigation] may not be used as a vehicle to usurp, preempt, or undermine FDA authority” and therefore “courts must generally prevent private parties from undermining, though private litigation, the FDA’s considered judgments.” Thus is Stengel reconciled, not to the fact-specific inquiry in PhotoMedex, but rather to its overarching deference to the Congressionally-mandated exclusivity of the FDA’s purview.