Plaintiffs (or more properly, their lawyers) across the country have been filing no-injury class actions against over-the-counter (“OTC”) drug manufacturers on a variety of cooked-up theories that have little or nothing to do with the safety or efficacy of these drugs.  One such theory, that we have discussed several times, is that drugs that the FDA allows to be labeled as “rapid release” should be penalized, under state law, for using that purportedly “misleading” description.  This litigation is based on one study, done years ago, that found that some “rapid release” products did not dissolve any more quickly (or less so) than other products not bearing that designation. 

As our prior posts explained, most of these claims have been dismissed as expressly preempted by the applicable express preemption provision, 21 U.S.C. §379r(a), which provides that:

[N]o State or political subdivision of a State may establish or continue in effect any requirement  − (1) that relates to the regulation of a drug that is not subject to the requirements of [prescription drugs] of this title; and (2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter [of the FDCA]. . . .

21 U.S.C. §379r(a)(1).  Further, the preemption clause defines “requirement” as including “any requirement relating to public information or any other form of public communication relating to a warning of any kind for a drug.”  21 U.S.C. § 379r(c)(2).

Another such preemption decision that we didn’t blog about, because it seemed repetitive, was Collaza v. Johnson & Johnson Consumer, Inc., 2024 WL 3965933 (S.D.N.Y. Aug. 27, 2024).  However, Collaza was recently affirmed, and that’s blogworthy, since Collaza v. Johnson & Johnson Consumer Inc., 2025 WL 2233746 (2d Cir. Aug. 6, 2025), is the first appellate decision in the country to address preemption of this particular type of allegations.

Unfortunately, it is unpublished, but Collaza thoroughly sticks a fork in this type of class action.  Due to preemption, it’s done – well done.

After quoting the relevant statutory language, 2025 WL 2233746, at *2, the Second Circuit reviewed the 1988 FDA monograph covering acetaminophen pain relievers.  Id.  Although “tentative,” for over thirty years, it “became a final administrative order in 2020, upon the enactment of the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act.”  Id.  In a case of what goes around comes around, Congress took that step largely because of a bottom-ten decision in an earlier acetaminophen mass tort that disregarded the same monograph and let plaintiffs run wild with conflicting claims.

With Congress having cleaned up that mess, this purported class didn’t stand much of a chance because these plaintiffs were (likewise) suing over language that the FDA had specifically allowed.  That’s about as far from the FDCA’s preemptive “identical” requirement as you can get.  Thus, the appealing plaintiff (belatedly) “concede[d] that her labeling claim is preempted . . ., and thus, she has abandoned it.”  Id. at *2.  On appeal, the plaintiff pursued only what the court called “marketing and pricing claims.”  Id.

Plaintiff further “concede[d] that the [products] are properly labeled as ‘Rapid Release’ pursuant to the FDA’s . . . dissolution standards for acetaminophen OTC tablets.”  Id. at *3.  That concession had massive implications.  It put the lie to the plaintiff’s twisted liability theory – that “rapid release” products are worth more and command a premium price.  Taking the test plaintiff relied on at face value, the defendant didn’t overprice anything – but rather underpriced “rapid release” products that it could have, but didn’t, label as such.  See Id. at *1 (describing study).  Talk about a negative value lawsuit!  Given all these concessions, plaintiff might have been better off not appealing at all and saving the fee.

The Second Circuit unanimously “disagree[d]” with plaintiff’s claim that “marketing and pricing” claims were somehow distinct from, and “did not implicate . . . labeling.” Id. at *4.  The defendant was undisputedly entitled under the “criteria established by the FDA” to label everything it did as “rapid release” products.  Id.  Thus, if plaintiff’s claim that the FDA-approved terminology was “misleading” under state law “were to prevail,” the defendant “would be unable to market its product using its federally-approved labeling and would effectively be required to place a disclaimer on the label.”  Id.  The same would be true if plaintiff’s marketing allegations were allowed.  Id.  Thus, preemption:

[I]f [plaintiff] were to prevail on such claims, it would impose additional labeling requirements beyond those required by the FDA. . . .  To hold that the FDA’s regulation of acetaminophen dissolution rates ought not control simply because a drug producer markets or prices several of its qualifying ‘immediate release’ products in varying manners would be to create an end-run around the FDCA’s express preemption clause.

Id. (citation and quotation marks omitted).

In the end, therefore, it didn’t matter one iota in Collaza how the defendant chose to label and market acetaminophen products that qualified as “rapid release” under applicable FDA standards.  It was not required to use that labeling, nor could plaintiff claim some sort of sinister scheme because the defendant happened to sell some rapid release-qualifying products without that designation.  Under plaintiffs’ own theory she did not pay more for the products she bought.  Instead, other consumers got bargain prices for products that were actually “rapid release” but did not bear that label.

And now we have appellate precedent rejecting this sort of “never let a good deed go unpunished” lawsuit and affirming preemption.