Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), stands for the proposition that only the federal government may enforce the Food, Drug, and Cosmetic Act and that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § 337(a), which proclaims that all actions to enforce the FDCA “shall be by and in the name of the United States.”
Plaintiffs constantly try to evade Buckman. One tack they take is to argue that Buckman is limited to its facts and thus applies only to state-law fraud-on-the-FDA claims. But, as various courts have held, “Buckman cannot be read that narrowly.” Martin v. Medtronic, Inc., 32 F. Supp. 3d 1026, 1034 n.22 (D. Ariz. 2014). Another tack plaintiffs take is to assert negligence-per-se claims based on alleged FDCA violations, arguing that Buckman does not preempt such claims because the negligence-per-se doctrine is a component of “traditional state tort law” that “predate[s]” the FDCA. Buckman, 531 U.S. at 353. That evasive maneuver fails because such a claim “would not exist if the FDCA did not exist” and “is in substance (even if not in form) a claim for violating the FDCA.” Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777, 790 (D. Minn. 2009).
In states that have adopted the FDCA as their own, yet another tack taken by plaintiffs asserting claims based on alleged FDCA violations is to argue that their claims avoid preemption under Buckman because they are, supposedly, enforcing not the FDCA but state law, which just happens to be identical to the FDCA. The case we report on today, Chong v. Kind LLC, — F. Supp. 3d —-, 2022 WL 464149 (N.D. Cal. 2022), rejected that sophistry.
Chong is a food rather than drug or device case, but its succinct implied preemption analysis applies equally to drugs and device cases—because 21 U.S.C. § 337(a) applies to all aspects of the FDCA.
The Chong plaintiffs asserted various state-law causes of action based on allegations that the defendant food manufacturer violated California’s Sherman Act because it used one method rather than another to calculate the protein content reported on the front of its packaging and because its packaging failed to report protein content as a “% Daily Value.”
Implicitly relying on 21 U.S.C. § 343-1(a), which expressly preempts any state nutrition-labeling requirement that “is not identical” to the relevant federal requirement, the court dismissed the plaintiffs’ claims insofar as they rested on the use of one protein-calculation method rather than another because the FDCA allows use of the method used by the manufacturer. Because § 343-1(a) applies only to foods, the court’s detailed analysis of the relevant labeling regulations is not directly applicable to drug and device cases. Still, the Chong court should be commended for taking “a fresh look at the governing FDA regulations” and acknowledging that it had previously “incorrectly decided” a “nearly identical” case. 2022 WL 464149, at *1. One does not often see such judicial humility.
The Chong court should also be commended for its short but spot-on implied preemption analysis, which is the reason for today’s post.
The plaintiffs argued that their claims based on the defendant’s alleged failure to report protein content as a “% Daily Value” escaped preemption because the relevant state-law labeling requirements “parallel the FDA regulations.” 2022 WL 464149, at *4. But, as the Supreme Court has held and readers of this blog know, state-law requirements that parallel federal requirements can be impliedly preempted even if they are not expressly preempted. See Buckman, 531 U.S. at 352 (citing Geier v. American Honda Motor Co., 529 U.S. 861 (2000)).
Thus, even in food cases that escape express preemption by virtue of § 343-1(a), a claim that is in substance nothing more than a recycled FDCA violation claim is still subject to implied preemption under Buckman.
The Chong court rightly concluded that the plaintiffs’ “daily value” claims were impliedly preempted under Buckman because they “ultimately are dependent on the existence of violations of federal law.” 2022 WL 464149, at *4. The court explained that to avoid implied preemption under 21 U.S.C. § 337(a), “plaintiffs must ‘rely on traditional state tort law’” that “‘predated’” the FDCA. Id. (quoting Buckman, 531 U.S. at 353). The court found the plaintiffs’ reliance on California’s Sherman Act unavailing because the statute “post-dates and is entirely dependent upon the FDCA, in that it expressly adopts the FDCA and [its implementing] regulations as state law.” Id.
Precisely so. As other courts have explained, invoking a state-law duty is not by itself sufficient to escape preemption under Buckman. Rather,
the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law—and that would give rise to liability under state law even if the FDCA had never been enacted. If the defendant’s conduct is not of this type, then the plaintiff is effectively suing for a violation of the FDCA (no matter how the plaintiff labels the claim), and the plaintiff’s claim is thus impliedly preempted under Buckman.
Riley, 625 F. Supp. 2d at 777; accord, e.g., Blankenship v. Medtronic, Inc., 6 F. Supp. 3d 979, 986 (E.D. Mo. 2014); Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206, 1214 (W.D. Okla. 2013), aff’d, 784 F.3d 1335 (10th Cir. 2015) (Gorsuch, J.).
So, the two takeaways from Chong are: (1) consider asking a court to revisit a prior holding when there is a strong basis for doing so; and (2) consider asserting an implied-preemption defense whenever a plaintiff’s claims are based on the alleged violation of a state FDCA.