Plaintiffs (or extra correctly, their legal professionals) throughout the nation have been submitting no-injury class actions towards over-the-counter (“OTC”) drug producers on a wide range of cooked-up theories which have little or nothing to do with the security or efficacy of those medicine. One such concept, that we’ve got mentioned a number of instances, is that medicine that the FDA permits to be labeled as “fast launch” needs to be penalized, beneath state regulation, for utilizing that purportedly “deceptive” description. This litigation is predicated on one research, carried out years in the past, that discovered that some “fast launch” merchandise didn’t dissolve any extra shortly (or much less so) than different merchandise not bearing that designation.
As our prior posts defined, most of those claims have been dismissed as expressly preempted by the relevant categorical preemption provision, 21 U.S.C. §379r(a), which offers that:
[N]o State or political subdivision of a State could set up or proceed in impact any requirement − (1) that pertains to the regulation of a drug that’s not topic to the necessities of [prescription drugs] of this title; and (2) that’s totally different from or along with, or that’s in any other case not equivalent with, a requirement beneath this chapter [of the FDCA]. . . .
21 U.S.C. §379r(a)(1). Additional, the preemption clause defines “requirement” as together with “any requirement regarding public data or another type of public communication regarding a warning of any type for a drug.” 21 U.S.C. § 379r(c)(2).
One other such preemption resolution that we didn’t weblog about, as a result of it appeared repetitive, was Collaza v. Johnson & Johnson Client, Inc., 2024 WL 3965933 (S.D.N.Y. Aug. 27, 2024). Nonetheless, Collaza was just lately affirmed, and that’s blogworthy, since Collaza v. Johnson & Johnson Client Inc., 2025 WL 2233746 (2nd Cir. Aug. 6, 2025), is the primary appellate resolution within the nation to handle preemption of this specific sort of allegations.
Sadly, it’s unpublished, however Collaza totally sticks a fork in the sort of class motion. As a consequence of preemption, it’s carried out – properly carried out.
After quoting the related statutory language, 2025 WL 2233746, at *2, the Second Circuit reviewed the 1988 FDA monograph overlaying acetaminophen ache relievers. Id. Though “tentative,” for over thirty years, it “grew to become a closing administrative order in 2020, upon the enactment of the Coronavirus Support, Reduction, and Financial Safety (“CARES”) Act.” Id. In a case of what goes round comes round, Congress took that step largely due to a bottom-ten resolution in an earlier acetaminophen mass tort that disregarded the identical monograph and let plaintiffs run wild with conflicting claims.
With Congress having cleaned up that mess, this purported class didn’t stand a lot of an opportunity as a result of these plaintiffs had been (likewise) suing over language that the FDA had particularly allowed. That’s about as removed from the FDCA’s preemptive “equivalent” requirement as you will get. Thus, the interesting plaintiff (belatedly) “concede[d] that her labeling declare is preempted . . ., and thus, she has deserted it.” Id. at *2. On enchantment, the plaintiff pursued solely what the courtroom referred to as “advertising and marketing and pricing claims.” Id.
Plaintiff additional “concede[d] that the [products] are correctly labeled as ‘Fast Launch’ pursuant to the FDA’s . . . dissolution requirements for acetaminophen OTC tablets.” Id. at *3. That concession had huge implications. It put the misinform the plaintiff’s twisted legal responsibility concept – that “fast launch” merchandise are price extra and command a premium worth. Taking the check plaintiff relied on at face worth, the defendant didn’t overprice something – however moderately underpriced “fast launch” merchandise that it may have, however didn’t, label as such. See Id. at *1 (describing research). Speak about a unfavourable worth lawsuit! Given all these concessions, plaintiff might need been higher off not interesting in any respect and saving the charge.
The Second Circuit unanimously “disagree[d]” with plaintiff’s declare that “advertising and marketing and pricing” claims had been someway distinct from, and “didn’t implicate . . . labeling.” Id. at *4. The defendant was undisputedly entitled beneath the “standards established by the FDA” to label all the pieces it did as “fast launch” merchandise. Id. Thus, if plaintiff’s declare that the FDA-approved terminology was “deceptive” beneath state regulation “had been to prevail,” the defendant “could be unable to market its product utilizing its federally-approved labeling and would successfully be required to position a disclaimer on the label.” Id. The identical could be true if plaintiff’s advertising and marketing allegations had been allowed. Id. Thus, preemption:
[I]f [plaintiff] had been to prevail on such claims, it might impose further labeling necessities past these required by the FDA. . . . To carry that the FDA’s regulation of acetaminophen dissolution charges ought not management just because a drug producer markets or costs a number of of its qualifying ‘speedy launch’ merchandise in various manners could be to create an end-run across the FDCA’s categorical preemption clause.
Id. (quotation and citation marks omitted).
Ultimately, due to this fact, it didn’t matter one iota in Collaza how the defendant selected to label and market acetaminophen merchandise that certified as “fast launch” beneath relevant FDA requirements. It was not required to make use of that labeling, nor may plaintiff declare some form of sinister scheme as a result of the defendant occurred to promote some fast release-qualifying merchandise with out that designation. Beneath plaintiffs’ personal concept she didn’t pay extra for the merchandise she purchased. As a substitute, different shoppers received discount costs for merchandise that had been really “fast launch” however didn’t bear that label.
And now we’ve got appellate precedent rejecting this form of “by no means let deed go unpunished” lawsuit and affirming preemption.