Collaza v. Johnson & Johnson Consumer Inc.

• Court: Court of Appeals for the Second Circuit
• Decided: August 6, 2025
• Docket: 24-2568
• Status: Unpublished

Opinion

24-2568-cv Collaza v. Johnson & Johnson Consumer Inc.

UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT

SUMMARY ORDER RULINGS BY SUMMARY ORDER DO NOT HAVE PRECEDENTIAL EFFECT. CITATION TO A SUMMARY ORDER FILED ON OR AFTER JANUARY 1, 2007 IS PERMITTED AND IS GOVERNED BY FEDERAL RULE OF APPELLATE PROCEDURE 32.1 AND THIS COURT’S LOCAL RULE 32.1.1. WHEN CITING A SUMMARY ORDER IN A DOCUMENT FILED WITH THIS COURT, A PARTY MUST CITE EITHER THE FEDERAL APPENDIX OR AN ELECTRONIC DATABASE (WITH THE NOTATION “SUMMARY ORDER”). A PARTY CITING TO A SUMMARY ORDER MUST SERVE A COPY OF IT ON ANY PARTY NOT REPRESENTED BY COUNSEL.

At a stated term of the United States Court of Appeals for the Second Circuit, held at the Thurgood Marshall United States Courthouse, 40 Foley Square, in the City of New York, on the 6th day of August, two thousand twenty-five.

PRESENT: JOSEPH F. BIANCO, SARAH A. L. MERRIAM, MARIA ARAÚJO KAHN, Circuit Judges. _____________________________________

EVIE COLLAZA, on behalf of herself and all others similarly situated,

Plaintiff-Appellant,

v. 24-2568-cv

JOHNSON & JOHNSON CONSUMER INC.,

Defendant-Appellee. _____________________________________

FOR PLAINTIFF-APPELLANT: MITCHELL BREIT, Milberg Coleman Bryson Phillips Grossman, PLLC, New York, New York.

FOR DEFENDANT-APPELLEE: MARK A. NEUBAUER (Joseph H. Lang, Jr., Carlton Fields, P.A., Tampa, Florida, on the brief), Carlton Fields LLP, Los Angeles, California. Appeal from a judgment of the United States District Court for the Southern District of

New York (Andrew L. Carter, Judge).

UPON DUE CONSIDERATION, IT IS HEREBY ORDERED, ADJUDGED, AND

DECREED that the judgment of the district court, entered on August 28, 2024, is AFFIRMED.

Plaintiff-Appellant Evie Collaza appeals from the district court’s order granting Defendant-

Appellee Johnson & Johnson Consumer Inc.’s (“JJCI”) motion to dismiss, pursuant to Federal

Rule of Civil Procedure 12(b)(6), on preemption grounds. We assume the parties’ familiarity with

the underlying facts, procedural history, and issues on appeal, to which we refer only as necessary

to explain our decision to affirm.

This is a dispute regarding the alleged deceptive labeling, pricing, and marketing of Tylenol

Extra Strength Rapid Release Gelcaps (the “Gelcaps”). JJCI manufactures and sells Gelcaps that

have laser-drilled holes to allow for the release of medicine in a manner different from its other,

non-rapid release acetaminophen tablets. Collaza asserts that, beginning in 2005, JJCI deceptively

marketed its Gelcaps as being more effective and providing faster relief than its other

acetaminophen products. For example, Collaza contends that JJCI published various

advertisements claiming that the Gelcaps “work[] at the speed of life,” and emphasizing that “only

Tylenol® Rapid Release Gels have laser-drilled holes” that “release medicine fast for fast pain

relief.” App’x at 19. The Gelcaps are also allegedly priced higher than JJCI’s non-rapid release

products. According to Collaza, “[c]onsumers have been willing to and continue to pay this

premium because, as a result of [JJCI’s] false, misleading, unfair, and/or deceptive labeling and

other advertising, they believe the [Gelcaps] work faster than other, cheaper acetaminophen

products when in fact they do not.” Id. at 16. Collaza supports this allegation by pointing to, inter

alia, a 2018 study which found that JJCI’s Gelcaps reached 80% dissolution in 3.94 minutes, while their Tylenol tablets reached 80% dissolution in 3.56 minutes. Id. at 24.

On July 13, 2023, Collaza initiated the instant action against JJCI, alleging in a putative

class action complaint that the company’s false and misleading conduct in connection with the

labeling, advertisements, and pricing of the Gelcaps violates New York General Business Law

§§ 349 and 350. The complaint also asserts an unjust enrichment claim under the same theory.

The complaint seeks declaratory, monetary and injunctive relief, including “[a]n order requiring

[JJCI] to adequately represent the true nature, quality, and capability of the Class Rapid Release

Gelcaps” and “[a]n order . . . immediately discontinuing any false, misleading, unfair, and/or

deceptive advertising, marketing, or other representations described herein.” Id. at 39–40.

On December 12, 2023, JJCI moved to dismiss the complaint, pursuant to Rule 12(b)(6),

arguing that Collaza’s claims were preempted under 21 U.S.C. § 379r(a). Specifically, JJCI

asserted that 21 U.S.C. § 379r(a) explicitly preempts “any requirement” set by a state for over-the-

counter drugs that “is different from or in addition to, or that is otherwise not identical with” those

prescribed by the Federal Food, Drug, & Cosmetic Act, 21 U.S.C. §§ 301 et seq. (“FDCA”). Dist.

Ct. Dkt. No. 38 at 7 (quoting 21 U.S.C. § 379r(a)). Therefore, according to JJCI, each of the claims

in the complaint is expressly preempted because each relies on state laws that would, in effect,

result in additional requirements for the labeling of their products beyond those established by the

FDCA. On August 27, 2024, the district court granted JJCI’s motion to dismiss, concluding that

all of Collaza’s claims were preempted by the FDCA. See generally Collaza v. Johnson & Johnson

Consumer, Inc., 23-cv-6030 (ALC), 2024 WL 3965933 (S.D.N.Y. Aug. 27, 2024). This appeal

followed.

For purposes of this appeal, Collaza concedes that her labeling claim is preempted under

Section 379r(a), and thus, she has abandoned it. Collaza therefore seeks review of only her

2 marketing and pricing claims. Accordingly, the sole issues on appeal are whether the district court

properly determined that Collaza’s marketing and pricing claims are preempted under Section

379r(a).

“We review de novo the grant of a Rule 12(b)(6) motion to dismiss for failure to state a

claim, accepting all factual allegations as true and drawing all reasonable inferences in favor of

the plaintiff.” Sierra Club v. Con-Strux, LLC, 911 F.3d 85, 88 (2d Cir. 2018) (internal citation

omitted).

It is well settled that “state law that conflicts with federal law is without effect.” Cipollone

v. Liggett Grp., Inc., 505 U.S. 504, 516 (1992) (internal quotation marks and citation omitted).

“The question of whether federal law preempts state law is fundamentally a matter of Congress’s

intent.” Jackson-Mau v. Walgreen Co., 115 F.4th 121, 125 (2d Cir. 2024) (internal quotation

marks and citation omitted). Thus, “we are to begin as we do in any exercise of statutory

construction, with the text of the provision in question.” In re WTC Disaster Site, 414 F.3d 352,

371 (2d Cir. 2005) (alteration adopted) (internal quotation marks and citation omitted).

The FDCA gives the Food and Drug Administration (“FDA”) the power to regulate the

labeling and marketing of over-the-counter (“OTC”) drugs. See 21 U.S.C. § 393(b)(2)(A). The

FDCA contains an express preemption provision for nonprescription drugs, which provides, with

some exceptions not relevant to this appeal, that:

no State or political subdivision of a State may establish or continue in effect any requirement – (1) that relates to the regulation of a drug [including an OTC drug] that is not subject to the requirements of section 353(b)(1) or 353(f)(1)(A) 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.

21 U.S.C. § 379r(a). We have emphasized, when analyzing near-identical language in an FDCA

preemption provision for cosmetic drugs, that “the FDCA preempts not only those state laws that

3 are in conflict with it (i.e., any law that is ‘different from’ the FDCA), but also any state law that

provides for [] requirements that are not exactly the same as those set forth in the FDCA and its

regulations (i.e., any law that is ‘in addition to’ the FDCA).” Critcher v. L’Oreal USA, Inc., 959

F.3d 31, 35–36 (2d Cir. 2020) (quoting 21 U.S.C. § 379s(a)). The statute defines “requirement”

to include “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).

In 1988, the FDA published a tentative final monograph (“TFM”) on acetaminophen that

set forth the conditions under which acetaminophen products “are generally recognized as safe and

effective and not misbranded.” 21 C.F.R. § 330.10(a)(7)(i). The TFM also set the dissolution

standards needed for acetaminophen tablets to lawfully be referred to as “immediate release,”

establishing that such acetaminophen tablets must dissolve by at least 80% after 30 minutes. The

TFM became a final administrative order in 2020, upon the enactment of the Coronavirus Aid,

Relief, and Economic Security (“CARES”) Act, Pub. L. No. 116-136, 134 Stat. 281 (2020).

Additionally, the FDA has published two non-binding guidance documents regarding

acetaminophen dissolution rates. One of these guidance documents states that “immediate release

solid oral drug products” have a “dissolution criterion [of] Q=80% in 30 minutes.” App’x at 78.

The other guidance document states that an immediate release solid oral drug is “considered

rapidly dissolving when a mean of 85 percent or more of the labeled amount of the drug substance

dissolves within 30 minutes,” and “considered very rapidly dissolving when a mean of 85 percent

or more of the labeled amount of the drug substance dissolves within 15 minutes.” Id. at 85

(emphases omitted). 1

1 Collaza does not challenge the district court’s reliance on non-binding FDA guidance for purposes of the preemption inquiry. In any event, the analysis would be the same using only the TFM, which has the force of law under the CARES Act. 4 Here, Collaza concedes that the Gelcaps are properly labeled as “Rapid Release,” pursuant

to the FDA’s TFM and guidance on the dissolution standards for acetaminophen OTC tablets.

Moreover, Collaza’s counsel acknowledged during oral argument that, as other courts have found,

Section 379r preempts any state law claim regarding the Gelcaps that would effectively require

additional or different information on the federally-approved labels for that product. For example,

in Morgan v. Albertsons Companies, No. 22-cv-02948-JST, 2023 WL 3607275 (N.D. Cal. Mar.

13, 2023), the plaintiffs alleged that the defendants deceptively labeled and marketed their

acetaminophen gelcaps as “rapid release” and charged a premium for them, despite the fact that

these products did not work any faster than the non-rapid release versions of the same product. Id.

at *1. In dismissing the claims, the court held that “regardless of whether the alleged

misrepresentation appears in the label, on the packaging, or in advertisements elsewhere [for

acetaminophen], Section 379r preempts state law claims to the extent that those claims would

effectively require a manufacturer to include additional or different information on a federally

approved label.” Id. at *5 (internal quotation marks and citation omitted).

Similarly, in Sapienza v. Albertsons Companies, No. 22-cv-10968-RGS, 2022 WL

17404919 (D. Mass. Dec. 2, 2022), the plaintiffs alleged that the defendants misrepresented their

“rapid release” acetaminophen gelcap tablets while advertising, marketing, and selling the tablets

because in actuality they dissolve more slowly than the company’s cheaper non-rapid-release

acetaminophen products. Id. at *1. The court held that the gelcaps at issue were governed by –

and met – the standards set forth in the TFM and other FDA guidance, and therefore, the plaintiffs’

claims were preempted because they were “attempt[ing] to augment the existing approved labeling

requirement[s].” Id. at *3. In reaching that determination, the court explained that the gelcaps

“are advertised as rapidly dissolving, which is, by any FDA guidance, accurate” and “[t]hat similar

5 [] products may dissolve just as (or even more) rapidly is no more relevant as a comparison than

is a bag of ice labeled ‘frozen’ as opposed to one simply branded as ‘ice.’” Id.; see also Bischoff

v. Albertsons Cos., 678 F. Supp. 3d 518, 527 (S.D.N.Y. 2023) (“Because the FDA regulates the

subject of dissolution standards, and because the TFM does not require any specific disclaimers

concerning the comparative rate of dissolution among products, Plaintiff’s claims are preempted

because she seeks to impose additional obligations on Defendant not imposed by the TFM.”

(alterations adopted) (internal quotation marks and citation omitted)); Muskiar-Rosner v. Johnson

& Johnson Consumer Inc., No. 23-cv-11746-ADB, 2024 WL 3596897, at *7 (D. Mass. July 31,

2024) (holding that claims of false and misleading statements about rapid release gelcaps in

advertisements were preempted); but see Edwards v. Walmart, Inc., No. 2:18-cv-09655-GW, 2019

U.S. Dist. LEXIS 230993 at *8 (C.D. Cal. Apr. 18, 2019) (unpublished decision) (attached as an

addendum to Appellant’s Brief) (holding that claims of false and misleading statements about rapid

release gelcaps in advertisements were not preempted because, inter alia, the TFM and FDA

guidance do not govern the issue).

Notwithstanding these decisions by other courts dismissing analogous claims as

preempted, Collaza argues that her marketing and pricing claims are separate from the abandoned

labeling claim and are not preempted under Section 379r(a) because they do not implicate JJCI’s

labeling of its Gelcaps. We disagree.

The gravamen of Collaza’s claims is that JJCI uses certain false and misleading terms in

its marketing—such as “[t]out[ing] on its website that the rapid release gelcaps are specially

designed with ‘laser-drilled holes to release medicine quickly’” and statements in advertisements

that the Gelcaps provide “[r]apid release” and “rapid relief”—and this “[f]alse, misleading, and

deceptive marketing campaign has been successful in getting the public to believe that the rapid

6 release gelcaps are faster acting than other Tylenol® products, when in fact they are slower.”

App’x at 16–17, 20–21 (citations omitted). However, as noted above, Collaza does not dispute

that the Gelcaps meet the criteria established by the FDA to be labeled as a “rapid release” product.

Therefore, if Collaza were to prevail on her claim that the use of that “rapid release” term or similar

terms or phrases (such as “release[s] medicine fast”) is misleading, JJCI would be unable to market

its product using its federally-approved labeling and would effectively be required to place a

disclaimer on the label and in advertising stating that the “rapid release” Gelcaps are not faster

than the non-rapid release products. App’x at 10. Similarly, if marketing the Gelcaps at a higher

price than other products were the basis for a successful deceptive practices claim, the same

disclaimer about comparative dissolution rates would be necessary on the label of the Gelcap

product, as well as any advertisements, to avoid such liability. Thus, contrary to Collaza’s

assertion otherwise, the district court correctly determined that her marketing and pricing claims

were preempted under Section 379r(a) because, if Collaza were to prevail on such claims, it would

impose additional labeling requirements beyond those required by the FDA. As the district court

explained, “[t]o 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.” Collaza, 2024 WL 3965933, at *5.

Accordingly, because the marketing and pricing claims are preempted under Section

379r(a), the district court properly dismissed the complaint. 2

2 To the extent Collaza argues that the complaint includes allegations of affirmative false and misleading advertising statements that go beyond FDA-approved terms related to the rapid or immediate nature of the release of the medicine, and thus, her marketing and pricing claims are not preempted because such allegations do not implicate a disclaimer, we find no allegation of that nature in the complaint. Collaza contends that the complaint alleges that JJCI has affirmatively and falsely claimed in advertisements that 7 * * *

We have considered the remaining arguments on appeal and conclude that they are without

merit. Accordingly, we AFFIRM the judgment of the district court.

FOR THE COURT: Catherine O’Hagan Wolfe, Clerk of Court

its Gelcaps release medicine faster than its non-rapid release tablets. At oral argument, Collaza’s counsel attempted to support that contention by pointing to an advertisement stating that the Gelcaps allow “the release [of] powerful medicine even faster than before,” suggesting that the Gelcaps release medicine faster than traditional Tylenol tablets. App’x at 17. However, claims under GBL §§ 349 and 350 are subject to a three-year statute of limitations period, see Lucker v. Bayside Cemetery, 979 N.Y.S.2d 8, 18 (1st Dep’t 2013) (citing Corsello v. Verizon N.Y., Inc., 18 N.Y.3d 777, 789 (2012)), and the complaint does not allege that any advertisement contained such a statement after 2009. Indeed, the complaint does not provide a link to the Tylenol website for that alleged statement, but rather cites to another website with an undated photo of an advertisement. Thus, even assuming arguendo that the marketing claim based on this alleged statement was not preempted, Collaza still has failed to allege that any such statement was contained in an advertisement that existed within the limitations period. 8