In recent years, the Ninth Circuit has broadly construed the Supreme Court’s opinion in Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), which preempts certain state-law claims pertaining to food, drugs, and medical devices regulated under the federal Food, Drug, and Cosmetic Act (FDCA). Of particular note, the court held in PhotoMedex that Buckman “limits the ability of a private plaintiff to pursue claims under state law theories where such claims collide with the exclusive enforcement power of the federal government.” PhotoMedex, Inc. v. Irwin, 601 F.3d 919, 924 (9th Cir. 2010). In Pom Wonderful, the Ninth Circuit put an expansive gloss on that holding: “PhotoMedex teaches that courts must generally prevent parties from undermining, through private litigation, the FDA’s [Food and Drug Administration’s] considered judgments.” Pom Wonderful LLC v. Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012). In short, the Ninth Circuit’s deference to the FDA’s jurisdiction is increasing and is grounded in the preemption language of Buckman. Two recent opinions from the Northern District of California, however, illustrate the malleability of those conclusions.
Khasin v. The Hershey Co.
Nowhere has the Ninth Circuit stated that Buckman preemption is limited to federal statutory claims. That, however, was the implication of a recent opinion by the Northern District of California interpreting Pom Wonderful. In Khasin, the plaintiff filed a putative class action against Hershey under several California laws including the Unfair Competition Law, Business & Professions Code § 17200 et seq.; the Consumers Legal Remedies Act; and the Beverly Song Act. Khasin v. The Hershey Co., 2012 WL 5471153, at * 1 (N.D. Cal. Nov. 9, 2012). The plaintiff alleged that Hershey “engaged in misleading conduct by advertising and labeling several of its products in violation of the aforementioned laws and labeling requirements.” Hershey moved to dismiss the amended complaint, inter alia, because each of the plaintiff’s claims was preempted by the FDCA.
In support of its position, Hershey argued that the plaintiff’s claims were preempted under the Ninth Circuit’s ruling in Pom Wonderful. The Khasin court rejected this argument, noting that Pom Wonderful only recognized preemption of federal Lanham Act claims that require litigation of whether the alleged conduct violated the FDCA. Indeed, the Khasin court noted, Pom Wonderful remanded the California state-law claims for determination of a standing issue. Thus, the district court held, Pom Wonderful did not preempt Khasin’s claims because they were based on state law.
The Khasin court’s refusal to apply Pom Wonderful to state-law claims suggests that the Ninth Circuit preempted Lanham Act claims simply because they were federal in nature, but a close reading of Pom Wonderful indicates otherwise. In fact, the district court in Pom Wonderful actually preempted only a subset of Lanham Act claims regarding the names and labels of the juice drink at issue, because only those claims intruded upon the FDA’s comprehensive regulation of food and beverage naming and labeling. Pom Wonderful, 679 F.3d at 1174. The Ninth Circuit’s decision to uphold the district court’s preemption ruling was “primarily guided . . . by Congress’s decision to entrust matters of juice beverage labeling to the FDA and by the FDA’s comprehensive regulation of that labeling.” Id. at 1178. “[U]nder our precedent, for a court to act when the FDA has not—despite regulating extensively in the area— would risk undercutting the FDA’s expert judgments and authority.” Id. at 1177. Importantly, though the court acknowledged that “a Lanham Act claim is barred when it would require a court to interpret ambiguous FDA regulations, that is not the only circumstance in which such a claim is barred. PhotoMedex teaches that courts must generally prevent private parties from undermining, through private litigation, the FDA’s considered judgments.” Id. at 1178.
There is nothing in these broad statements to indicate that PhotoMedex’s articulation of Buckman preemption is limited only to federal statutory claims. The phrase “private litigation” surely encompasses state tort claims. Indeed, PhotoMedex specifically acknowledged preemption of “claims under state law theories where such claims collide with the exclusive enforcement power of the federal government.” PhotoMedex, 601 F.3d at 924. And, while the Ninth Circuit remanded the state-law claims in Pom Wonderful, it made clear it was doing so solely on the preliminary question of standing, leaving issues such as express (and, presumably, implied) preemption to be addressed by the district court on remand “as needed.” Pom Wonderful, 679 F.3d at 1179.
Thus, the broad language and procedural posture of Pom Wonderful strongly suggest that the preemption principle it articulated properly applies with equal force to any state-law claim alleging naming or labeling deficiencies, because the FDA alone is entitled to determine those deficiencies in the first instance. Yet the court in Khasin refused to apply Pom Wonderful at all, despite the fact that at least three of the seven claims it allowed to proceed specifically alleged labeling defects. The Khasin court’s refusal to preempt those claims, solely because they sounded in state tort law, indicates an unduly narrow view of the true scope of Buckman preemption as set forth in Pom Wonderful.
Astiana v. Hain Celestial Group, Inc.
A more expansive reading of Pom Wonderful was proffered 10 days after Khasin, also by the Northern District of California, in Astiana v. Hain Celestial Group, Inc., ___ F. Supp. 2d ___, 2012 WL 5873585 (N.D. Cal. Nov. 19, 2012). There, the plaintiffs brought six California state-law claims based on the premise that the defendants’ use of the terms “natural,” “pure,” and “organic” on the labels of their cosmetic products was false and misleading. The defendants moved to dismiss the complaint on the grounds that only the FDA could decide whether a label was false and misleading, that it had not done so with any of their labels, and thus the plaintiffs were preempted—under Pom Wonderful—from asking the court to make a determination that the FDA had declined to make.
The court began by analyzing the plaintiffs’ argument that it need not await guidance from the FDA in adjudicating the plaintiffs’ claims because “courts routinely decide whether conduct is misleading.” The court conceded the truth of the general assertion, but cited Pom Wonderful for the counter-proposition that “courts do not decide such issues when such a decision would undermine, through private litigation, the FDA’s considered judgments.” The opinion went on, however, not only to apply the Pom Wonderful opinion, but to recast it entirely.
According to the Astiana court, the defendants misconstrued Pom Wonderful “as a case about preemption,” when “a closer reading of the case shows that [it] is actually based on the idea of deference to the FDA.” The court took Pom Wonderful’s focus on deference as an indication “that the Pom court was implicitly relying on the primary jurisdiction doctrine, which allows the court, under appropriate circumstances, to determine that the initial decisionmaking responsibility should be performed by the relevant agency rather than the courts.” The court then cited the Ninth Circuit’s opinion in Syntek Semiconductor Co., Ltd. v. Microchip Technology, Inc., 307 F.3d 775, 780 (9th Cir. 2002), for the factual predicates to application of the primary-jurisdiction doctrine: There must be “(1) the need to resolve an issue that (2) has been placed by Congress within the jurisdiction of an administrative body having regulatory authority (3) pursuant to a statute that subjects an industry or activity to a comprehensive regulatory authority that (4) requires expertise or uniformity in administration.”
The court found each Syntek factor present. First, there was an issue for resolution because it was called upon to determine whether a cosmetic label was false and misleading. Second, the issue was within the jurisdiction of a federal regulatory agency because cosmetic labeling was entrusted by Congress to the FDA. Third, the issue was comprehensively regulated because cosmetic labeling was governed by the FDCA and extensively regulated by the FDA. Finally, the issue required expertise or uniformity in administration because the FDA was silent as to whether the use of the word “natural” on cosmetic labels was false or misleading, and the court’s independent resolution of the issue “would risk undercutting the FDA’s expert judgments and authority.” The court therefore dismissed the plaintiffs’ claims without prejudice as barred by the primary-jurisdiction doctrine.
Astiana is certainly correct that there are substantial areas of overlap between Buckman preemption and the primary-jurisdiction doctrine. Each is driven by solicitude for the exclusive jurisdiction of governmental agencies over their congressionally allocated subject matter, as well as the regulatory expertise and uniformity of regulation that often result. Cf. PhotoMedex, 601 F.3d at 930 (finding an FDCA violation where the FDA had not so found “would require us to usurp the FDA’s responsibility for interpreting and enforcing potentially ambiguous regulations,” contra Buckman) with Syntek, 307 F.3d at 781 (sanctioning application of the primary-jurisdiction doctrine when the issue for resolution had previously been placed under the comprehensive regulatory purview of a governmental agency, and required expertise or uniformity in its determination). Moreover, the ongoing nationwide battle over the proper scope of Buckman preemption rationalizes the district court’s apparent desire to avoid it entirely. See, e.g., Desiano v. Warner-Lambert & Co., 467 F.3d 85, 94 (2d Cir. 2007) (Buckman preempts only the “fraud-on-the-FDA” claims with which it dealt); Bausch v. Stryker Corp., 630 F.3d 546, 557 (7th Cir. 2010) (same); Hughes v. Boston Scientific Corp., 631 F.3d 762, 775 (5th Cir. 2011) (same); but see, e.g., Nathan Kimmel, Inc. v. DowElanco, 275 F.3d 1199, 1207 (9th Cir. 2002) (Buckman preempts any state-law claim that would raise the prospect of a defendant’s disclosures to a federal agency, though not challenged by that agency, judged illegal under state law); Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 966 (6th Cir. 2004) (Buckman preempts state-court determination of a federal regulatory violation because it “would raise the same inter-branch-meddling concerns that animated Buckman”).
Nevertheless, Pom Wonderful’s analysis was driven by Buckman preemption, not the primary-jurisdiction doctrine. Indeed, Pom Wonderful never even mentioned primary jurisdiction. On the other hand, the opinion is replete with citations to PhotoMedex, and the Ninth Circuit specifically stated that it was “[a]pplying the teaching of PhotoMedex to the circumstances of this case.” Pom Wonderful, 679 F.3d at 1176. PhotoMedex, in turn, is predicated upon Buckman’s teaching that the FDCA “limits the ability of a private plaintiff to pursue claims under state law theories where such claims collide with the exclusive enforcement power of the federal government.” PhotoMedex, 601 F.3d at 924. The Astiana court’s replacement of Pom Wonderful’s preemption rationale with the primary-jurisdiction doctrine therefore amounts to an ill-advised “rationale transplant.”
Moreover, Astiana ignores the fact that primary jurisdiction is a “prudential doctrine,” the application of which is driven by considerations of administrative efficiency and convenience. As such, the primary-jurisdiction doctrine is discretionary, and thus an inadequate substitute for Buckman preemption, which is mandatory. Cf. Syntek, 307 F.3d at 780 (“[T]he doctrine of primary jurisdiction is committed to the sound discretion of the court. . . .”) with Pom Wonderful, 679 F.3d at 1178 (“[C]ourts must generally prevent private parties from undermining, through private litigation, the FDA’s considered judgments.”). Just as importantly, preemption seeks not only administrative efficiency, but also the protection of defendants from potential conflicts between court determinations of federal regulatory violations and those of the agencies themselves. Buckman, 531 U.S. at 351 (“[F]raud-on-the-FDA claims would also cause [defendants] to fear that their disclosures to the FDA, although deemed appropriate by the Administration, will later be judged insufficient in state court.”). In other words, the incidental protection afforded to defendants through the discretionary application of the primary-jurisdiction doctrine is decidedly weaker, and less certain, than that afforded by preemption. Defendants thus accept the primary-jurisdiction doctrine as a substitute for Buckman preemption at their peril.
The proper scope of Buckman preemption remains a contentious issue nearly 12 years after the Supreme Court’s opinion was handed down. Perhaps that is why the Ninth Circuit in Pom Wonderful seemed to avoid direct citation to Buckman, preferring instead to rely on PhotoMedex. In any event, the Northern District of California’s reticence to wrestle with the ambiguities of Buckman as the animating force of Pom Wonderful is understandable. Nevertheless, Buckman is at the core of the Ninth Circuit’s preemption jurisprudence. Without it, preemption is susceptible to undue narrowing, as in Khasin, or to wholesale substitution, as in Astiana.
Keywords: litigation, mass torts, Khasin, Astiana, Northern District of California, preemption, FDA, FDCA
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