United States: FDCA-Based California Case Preempted As Private Enforcement

Last Updated: August 1 2019
Article by James Beck

In a significant preemption decision clipping the wings of California consumer protection plaintiffs, two identical decisions: Borchenko v. L'Oreal USA, Inc., ___ F. Supp.3d ___, 2019 WL 3315288 (C.D. Cal. July 18, 2019), and Borchenko v. L'Oreal USA, Inc., 2019 WL 3315289 (C.D. Cal. July 18, 2019) (differing only by docket number, as far as we can tell), have held that preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), precludes all of the plaintiff's UCL claims. For simplicity, henceforth we'll only refer to the first, to-be-published, decision.

The claim in Borchenko richly deserved preemption, as it attempted to second-guess the classification of several FDA-regulated products. These products were all being marketed as "cosmetics" under the FDCA, but plaintiff claimed that they were really "skin structure altering drugs" that could not be sold unless the FDA approved new drug applications for them. 2019 WL 3315288, at *1. This was a classic " money for nothing" California-style strike suit, as "Plaintiff [took] no position on whether the skin structural representations are true or false." Id. Plaintiff was simply trying to second guess the FDA's classification of these products.

Under federal law, private plaintiffs cannot do this. "21 U.S.C. § 337(a) implicitly preempts any private right of action to enforce the FDCA, providing in relevant part, 'proceedings for the enforcement, or to restrain violations, of this Act shall be by and in the name of the United States.'" 2019 WL 3315288, at *2.

In order to escape preemption by the FDCA, "[t]he plaintiff must be suing for conduct that violates the FDCA . . ., but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman)."

Id. (quoting Perez v. Nidek Co., 711 F.3d 1109, 1120 (9th Cir. 2013)). Thus, Buckman prohibits state-law plaintiffs from seeking to relitigate the proper classification of products under the FDCA.

Plaintiff also claimed that, because "California's Sherman Law parallels the FDCA in material part and adopts all nonprescription drug regulations," she could evade Buckman's prohibition, because she was only bringing a state-law action. Borchenko, 2019 WL 3315288, at *2. The court blew away this largely transparent smokescreen. First:

The provisions of the Sherman Law cited by Plaintiff each rely on and essentially mirror parallel provisions of the FDCA.

Id. Second:

In addition to referencing the Sherman Law, Plaintiff relies heavily on FDA warning letters and informal guidance to argue that Defendant's products make "drug claims" and, therefore, must receive federal premarket approval.

Id. at *3. Third:

The fact that Plaintiff's claim is technically brought under the UCL and the Sherman Law does not override the fact that Plaintiff explicitly requests relief which lies squarely within the province of the FDA. There can be no state law cause of action if a plaintiff's true goal is to privately enforce alleged violations of the FDCA.

Id. (citations and quotation marks omitted). Indeed, since plaintiff sought to enjoin the defendant from selling its cosmetics until it received NDAs from the FDA, the suit's "true goal" was unmistakable. Id.

Further, by demanding withdrawal from the market, plaintiff was also trenching upon the FDA's discretionary enforcement authority:

Plaintiff's UCL claim interferes with the FDA's enforcement and regulatory authority as set out in §336 of the FDCA, which provides as follows: "Nothing in this Act shall be construed as requiring the [FDA] to report for prosecution . . ., minor violations of this Act whenever [it] believes that the public interest will be adequately served by a suitable written notice or warning." Plaintiff's claim, like any private cause of action to enforce the FDCA, conflicts with this explicit grant of discretionary authority.

2019 WL 3315288, at *3 (emphasis added). We used §336 as a one-two punch in combination with §337(a) back in the Bone Screw litigation before Buckman was decided. Borchenko demonstrates that it still has considerable appeal in the right case. We recommend that other defendants add it to their preemption armamentarium in appropriate cases.

Finally, California has become a food litigation hotbed because Farm Raised Salmon Cases, 175 P.3d 1170 (Cal. 2008), allowed the UCL-Sherman Act dodge of FDA enforcement exclusivity in food cases – but only because of a food-specific exception to the FDCA's prohibition on private enforcement – something we discussed here. Borchenko recognized that Farm Raised Salmon had no application to drugs (or alleged drugs). "[T]his Court is bound by Ninth Circuit precedent, including Perez, and not by Farm Raised Salmon or other California case law concerning preemption." 2019 WL 3315288, at *3. That's another nice holding, since other California courts occasionally need reminding.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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