As regular blog readers know, we love a clean grant of a motion to dismiss on preemption grounds. They are relatively common, so it sometimes puzzles us that the plaintiffs' bar keeps filing plainly preempted claims.
Perhaps some of these plainly preempted lawsuits get filed because the express preemption provision of the FDCA related to over-the-counter ("OTC") medicines is somewhat less well known than the express preemption provision related to Class III, premarket approved medical devices.
Whatever the reason, it is not unusual for plaintiffs to run to court with a putative economic loss class action attacking some aspect of an OTC drug: its marketing or labeling, which allegedly deceived consumers; or the drug's price, which allegedly should be partly or fully reimbursed for some reason, perhaps because the drug allegedly was less safe or less efficacious than represented. And then a motion to dismiss gets filed, and far more often than not, those plaintiffs get promptly bounced back out of court due to OTC preemption.
To recap,OTC medicines have an express preemption provision, 21 U.S.C. § 379r(a), providing 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).
Unfortunately, OTC express preemption doesn't reach personal injury/product liability claims, but—relevant here—it does apply to claims for fraud, consumer fraud, breach of warranty and the like.
The putative class in Musikar-Rosner v. Johnson & Johnson Consumer Inc., No. 23-cv-11746-ADB, 2024 U.S. Dist. LEXIS 135171, 2024 WL 3596897 (D. Mass. July 31, 2024), sued over the defendant's marketing of its OTC acetaminophen gelcaps as "rapid release". Like some plaintiffs before them, the putative class plaintiffs in Musikar-Roener contended the gelcap's rapid release just wasn't fast enough, and they sought recovery using claims for violation of Massachusetts General Laws Chapter 93A, breach of implied warranty of merchantability under Mass. Gen. Laws ch. 106, § 2-314, breach of express warranty under Mass. Gen. Laws ch. 106, § 2-313, unjust enrichment, and declaratory relief.
We always are heartened when a discussion of express preemption begins with the recognition that there is no presumption against preemption when Congress has expressly declared state law to be preempted, and that is how the analysis began in Musikar-Roener:
"In determining whether federal preemption applies, courts must start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act." However, "where . . . [as in the instant case], Congress has expressly manifested its intent to preempt state law, no presumption against preemption arises." In such circumstances "[w]here a federal statute contains a clause expressly purporting to preempt state law, '[the Court] focus[es] on the plain wording of the clause, which necessarily contains the best evidence of Congress' preemptive intent.'"
Musikar-Rosner, 2024 U.S. Dist. Lexis 135171, at *6 (citations omitted). Rightly so.
With the presumption against preemption out of the way, the Musikar-Rosner judge turned to whether, and what, federal requirements applied to this OTC drug, and whether the state law claims would impose requirements different from, in addition to, or not identical with, those federal requirements.
On the federal requirement side of the equation, the FDA regulates OTC drugs through monographs, "which establish the parameters or conditions under which certain categories of OTCs may be marketed." The monograph system sometimes is a bit clunky. It starts with notice of proposed rulemaking, then a "tentative final monograph", prepared by an advisory review panel and published by the FDA for public review and comment. Sometimes, the process stalls at this point for years (and years); sometimes the agency pushes ahead and promulgates a "final monograph" by publishing it in the Code of Federal Regulations.
The OTC regulatory history for acetaminophen and related medicines reflects some of that clunkiness, and a fair amount of rule-making activity by the FDA. Most relevant for purposes of Musikar-Rosner, the FDA published a tentative final monograph (or "TFM") in 1988 entitled the " Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Tentative Final Monograph." This TFM established the conditions under which OTC acetaminophen drug products are "generally recognized as safe and effective and not misbranded" and it incorporated a standard from the United States Pharmacopeia ("USP") defining "immediate release" acetaminophen tablets as those dissolving by at least 80% in 30 minutes.
Then, Congress stepped in and itself moved the regulatory process along by deeming this tentative final monograph (and some others) to be a final administrative order in March 2020, via the COVID-19 pandemic-era Coronavirus Aid, Relief, Economic Security ("CARES") Act.
Given the FDA's monograph was a final order establishing federal requirement for OTC acetaminophen, the existence of federal requirements with preemptive effect would seem to be pretty darn obvious.
The plaintiffs, however, contended the monograph did not impose any federal requirement regarding "rapid release gelcaps" products in particular. The Court disagreed.
First, the monograph applied to acetaminophen tablets, and gelcaps were, by definition, gelatin-coated, capsule-shaped tablets, so plaintiffs' argument there was no federal "gelcap" standard was unavailing. Next, the monograph also set standards for tablet dissolution generally, so arguing there was no federal "rapid release" standard also was unavailing.
The bottom line, the court found, was that the FDA had set federal standards, and the Musikar-Rosner plaintiffs' claims were "different from or in addition to, or ... otherwise not identical with" those federal standards. Preemption applied, the defense motion to dismiss was granted, and another set of plaintiffs was promptly booted out of court. Just the kind of result we like to see.
This article is presented for informational purposes only and is not intended to constitute legal advice.