The Ninth Circuit recently answered a preemption question that we had seen arise intermittently, mostly in food litigation, over the past couple of years. Because the relevant preemption clause closely resembles the language of the Medical Device Amendments, we thought it was worth a look.
In Webb v. Trader Joe’s Co., ___ F.3d ___, 2021 WL 2275265 (9th Cir. June 4, 2021), the plaintiff attempted to maintain a class action (what else) based on the claim that the defendant sold meat with “misleading” labeling concerning that amount of “retained water” in the product. Id. at *1. Plaintiff based that claim on her counsel’s own testing of these products. “[Plaintiff] took the Products to a [local] food testing laboratory to determine whether the Products’ labels correctly reflected the retained water content.” Id. at *2.
However, after filing suit, plaintiff was unable to plead (or otherwise allege that the tests that had been run were identical to those required by the federal government to determine water content. Not only did “she fail to specify whether the . . . process utilized in her independent examination of the Products was identical to the protocol utilized by [defendant] pursuant to [federal]regulation,” but when given a second chance at oral argument, plaintiff’s “counsel was unable to confirm that [plaintiff] used [defendant’s] protocol to arrive at her retained water numbers.” Id. at *2, 6.
Failure to establish utilization of testing standards identical to what the federal government required was fatal to all plaintiff’s state claims (involving various consumer protection statutes, express warranty, implied warranty, theft by false pretenses, and unjust enrichment). The relevant federal statute, the Poultry Products Inspection Act, included a preemption clause very similar to the MDA’s, with only the order of the clauses reversed, and subject to the same general preemption standards
[Plaintiff’s] claims are preempted under 21 U.S.C. §467e, which establishes that states may not impose requirements “in addition to, or different than those” described in the PPIA. Where the intent of a statutory provision that speaks expressly to the question of preemption is at issue, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause.
Id. at *4 (citations and quotation marks omitted) (emphasis added).
First, under this preemption clause, state-law plaintiffs could not force the defendant to use a “data collection process” that varied from the tests required by the federal government. “[A]llowing [plaintiff] to impose her [testing] protocol on [defendant] via state law would require [it] to conform to a different data collection process than the protocol that was properly developed . . . as required by federal law.” Id. The defendant’s protocol was made available to the relevant federal agency, and not objected to, so that “constitutes federal approval of [the defendant’s] protocol.” Id. Thus, “[b]ecause the retained water data supporting the claims made on the Products’ labels were validated by federal regulators according to the federally proscribed [sic] method, [plaintiff’s] claims that [the] labels are in fact invalid and misbranded are federally preempted.” Id. at *5 (citation omitted).
Second, the “permissive” nature of the federal scheme did not impede preemption. The “in addition to”/”different than” preemptive language “sweeps widely,” leaving “simply no way to rule in [a plaintiff’s] favor without contradicting the certification decision, and, through it, the certification scheme that Congress enacted.” Id. (citations and quotation marks omitted).
The federal regulatory scheme is permissive and allows a broad method of compliance, in that it allows the company to craft its own data collection process and make it available for [federal agency] review. Requiring [defendant] to follow [plaintiff’s] process, or be penalized unless it follows a process different from the one it developed pursuant to regulation, would be more restrictive than the federal scheme.
Third, and finally, the labels themselves “were reviewed [by the agency] for approval in their entirety.” Id. Therefore, the language plaintiff challenged was “approved,” and “[a]ny additional label requirements [plaintiff] seeks to place on” the label “would necessarily be ‘different than’ those required by the PPIA” – and therefore preempted. Id.
In food litigation, Webb answered “yes” to the recurrent question whether plaintiffs are required, upon pain of dismissal, to plead that their testing methods are identical to what the federal government requires. Webb was decided on a motion for judgment on the pleadings.
Webb has broader implications for preemption of FDCA-based claims as well. Like the PPIA, many of the FDA’s regulations are similarly “permissive” − particularly with regards to the details of how manufacturers conduct testing, collect data, and report it to the FDA. The preemption clauses are likewise almost identical, with no substantive difference in terminology. Thus Webb is favorable precedent for the proposition that plaintiffs cannot dictate the details of such processes in purportedly “parallel” claims where the FDA had provided manufacturers with discretion as to how to conduct what Webb referred to as “data collection protocols. Biocompatibility and life cycle testing are two examples that come immediately to mind.