Collaza v. Johnson & Johnson Consumer Inc.

DOC#: □□

DATE FILED: _8/27/2024 _

UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF NEW YORK

COLLAZA,

Plaintiff,

23-cv-06030 (ALC)

-against-

ORDER

JOHNSON & JOHNSON CONSUMER, INC.,

Defendant.

ANDREW L. CARTER, JR., United States District Judge:

Plaintiff Evie Collaza (‘Plaintiff’) brings this putative class action suit against Defendant

Johnson & Johnson Consumer, Inc. (“Johnson & Johnson” or “Defendant”) alleging (1) violation

of New York General Business Law § 349, (2) violation of New York General Business Law §

350, (3) unjust enrichment, and (4) seeking declaratory relief. ECF No. 1 (“Complaint”).

Defendant moved to dismiss Plaintiff's Complaint pursuant to Fed. R. Civ. P. 12(b)(6) or,

alternatively, to transfer this action to the District of New Jersey. For the reasons discussed herein,

the Court finds that Plaintiff’s claims are preempted by the Federal Food, Drug, & Cosmetic Act,

U.S.C. §§ 301 et seg, and, subsequently, does not consider the Parties’ arguments as to transfer.

Therefore, Defendant’s Motion is GRANTED.

BACKGROUND

1, Procedural Background

Plaintiff filed the Complaint and request for issuance of summons as to Defendant

Johnson & Johnson on July 13, 2023. ECF No. 1. Plaintiff’s counsel then filed an affidavit of

service of the Summons and Complaint on July 26, 2023. ECF No. 11. The Parties jointly

moved to extend Defendant’s time to file a responsive pleading by sixty days. ECF No. 12. The

Court subsequently granted the request. ECF No. 14. Johnson & Johnson’s counsel requested

and was granted leave to file the instant motion to dismiss. ECF Nos. 32-34. Defendant filed

their motion on December 12, 2023, ECF Nos. 37, 38 (“Mot.”), alongside an affidavit from

defense counsel, ECF No. 39, and a Request for Judicial Notice of certain documents.1 ECF No.

40. On January 12, 2024, Plaintiff filed their opposition to the motion to which was appended as

an exhibit the Central District Court of California’s decision in Edwards v. Walmart, Inc., No. 18-

09655-GW (N.D. Cal. Apr. 18, 2019). ECF No. 41. (“Opp.”). Defendant filed their Reply on

February 2, 2024. ECF No. 42 (“Reply”).

II. Factual Background

All facts contained within this factual background section are taken from Plaintiff’s

Complaint, and, as is required at the dismissal stage, are taken as true for purposes of deciding

the motion.

Defendant’s Rapid Release Tylenol product fetches a higher sale price in comparison to

their non-rapid release products, even those labeled as “Extra Strength,” and “Regular Strength.”

Complaint at ¶ 31-33. Defendant also advertises that the Rapid Release Gelcaps are designed

with “laser-drilled holes to release medicine quickly” and releases medicine “even faster than

before.” Id. at ¶¶ 37-38; see also id. at ¶¶ 42-51 (describing in detail Defendant’s marketing of

Rapid Release Tylenol as “fast working” and “dissolv[ing] in seconds”).

Plaintiff purchased Tylenol Extra Strength Rapid Release Gelcaps over the many other

acetaminophen products which Defendant produces and advertises because “she hoped for faster

relief of pain.” Complaint at ¶ 67; see also id. at ¶ 21, 26, 29 (discussing Defendant’s other

1 The Court takes judicial notice of the three documents appended to Defendant’s motion as most of them were

official publications issued by government agencies and, separately, the facts contained with them are not subject to

reasonable dispute. See In re Zyprexa Prods. Liab. Litig., 549 F. Supp. 2d 496, 501 (E.D.N.Y. 2008) (“Public

documents issued by government agencies such as the Food and Drug Administration ("FDA") may also be

considered.”)

acetaminophen products). Plaintiff now alleges that, despite Defendant’s labeling and

advertising of the Rapid Release Gelcaps, the product does not work faster than their cheaper

tablet alternatives. Id. at ¶ 69. In support of her assertion, Plaintiff relies on a 2018 study

analyzing the comparative dissolution rates of Rapid Release Tylenol against one of its non-rapid

release Johnson & Johnson counterparts and other acetaminophen products on the market. Id. at

¶ 57. The 2018 study found that the Rapid Release gelcaps and tablets reached 80% dissolution

in 3.94 minutes whereas Defendant’s Tylenol tablets reached the same dissolution in only 3.56

minutes. See Mot., Ex. A, at 1, 2, 4.

III. Relevant Regulations

The Food, Drug, & Cosmetic Act, 21 U.S.C. §§ 301 et seq. (“FDCA”), grants the Food &

Drug Administration (“FDA”) the power to regulate the labeling and marketing of over-the-

counter (“OTC”) drugs. See also 21 C.F.R. § 201.66. The FDCA also contains an express

preemption clause which bars “state[s]” and “political subdivision[s]” thereto from:

Establish[ing] or continu[ing] in effect any requirement – (1) that relates to the

regulation of a drug that is not subject to the requirements of section 353(b)(1) or

252(f)(1)(A) of this title [including OTC drugs]; and (2) 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). From 1972 to 2020, The FDA employed a four-step process when

issuing binding regulations on OTC drugs. Bischoff v. Albertsons Co., 678 F. Supp. 3d 518, 523

n.2 (S.D.N.Y. 2023) (citing In re Acetaminophen - ASD-ADHD Prods. Liab. Litig., No. 22-CV-

8830, 2023 U.S. Dist. LEXIS 69605 (S.D.N.Y. Apr. 20, 2023)). That process includes the

following steps:

(1) an advisory review panel [is] established to evaluate the safety and

effectiveness of the OTC drug; (2) the advisory review panel submit[s] its report

to the FDA Commissioner; (3) the FDA publishe[s] a tentative final monograph

("TFM"); and (4) after receiving comments on the TFM, the FDA publishe[s] a

final monograph.

Id. The FDA published a tentative final monograph on acetaminophen in 1988 which set

the “conditions under which a category of OTC drugs or specific OTC drugs [including

acetaminophen] are generally recognized as safe and effective and not misbranded.” 21 C.F.R. §

330.10(a)(7)(i). The 1988 monograph sets forth dissolution standards for acetaminophen tablets.

In order to be lawfully referred to as “immediate release,” the acetaminophen tablet must

dissolve by at least 80% after 30 minutes. See Sapienza v. Albertson's Co., Inc., No. 22-10968-

RGS, 2022 U.S. Dist. LEXIS 217368, at *2 (D. Mass. Dec. 2, 2022). The 1988 tentative

monograph then became a final order upon the passage of the CARES Act in 2020. See Bischoff,

678 F. Supp. at 524.

The FDA has also published two non-binding guidance documents on acetaminophen

dissolution rates. One guidance states that “immediate release solid oral drug products” have a

“dissolution criterion [of] Q=80% in 30 minutes” and the other states that an immediate release

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.” ECF No. 40-3 at 3

LEGAL STANDARD

When considering a 12(b)(6) motion, a court should “draw all reasonable inferences in

[the plaintiff’s] favor, assume all well-pleaded factual allegations to be true, and determine

whether they plausibly give rise to an entitlement of relief.” Faber v. Metro Life Ins. Co., 648

F.3d 98, 104 (2d Cir. 2011) (internal quotation marks omitted). Thus, “[t]o survive a motion to

dismiss, a complaint must contain sufficiently factual matter accepted as true, to ‘state a claim to

relief that is plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl.

Corp v. Twombly, 550 U.S. 544, 570 (2007)). The Court’s function on a motion to dismiss is

“not to weigh the evidence that might be presented at a trial but merely to determine whether the

complaint itself is legally sufficient.” Goldman v. Belden, 754 F.2 1059, 1067 (2d Cir. 1985). A

reviewing court ought not dismiss a complaint where “enough facts to state a claim to relief that

is plausible on its face” have been plead.” Twombly, 550 U.S. at 570. “A claim has facial

plausibility when plaintiff pleads factual content that allows the court to draw the reasonable

inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678.

Moreover, “the tenet that a court must accept a complaint’s allegations as true is inapplicable to

threadbare recitals of a cause of action’s elements, supported by mere conclusory statements.”

Id. at 663.

State laws that conflict with federal law are without effect under the Supremacy Clause.

Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 516, 112 S. Ct. 2608, 120 L. Ed. 2d 407 (1992).

While there is a general presumption against preemption, Truss v. Bayer Healthcare Pharms.

Inc., No. 21-CV-9845, 2022 U.S. Dist. LEXIS 207421 at *6 (S.D.N.Y. Nov. 15, 2022), that

presumption is overcome “where . . . Congress has expressly manifested its intent to preempt

state law.” Canale v. Colgate-Palmolive Co., 258 F. Supp. 3d 312, 319 (S.D.N.Y. 2017). When

considering whether a federal statute expressly preempts state laws, “courts focus on the plain

wording of the clause, which necessarily contains the best evidence of Congress’ preemptive

intent.” Id. A federal statute which overrides a state’s “requirements,” preempts not only

statutory law and regulations but also covers “common-law duties.” Cipollone, 505 U.S. at 443

(quoting Bates v. Dow Agrosciences LLC, 544 U.S. 431, 443 (2005)). “A common law rule that

‘requires that manufacturers label or package their products in [a] particular way’ qualifies as a

requirement with respect to labeling.” Bischoff, 678 F. Supp. at 523 (citing Bates, 544 U.S. at

443). Said succinctly, “[a] state law that applies to drugs . . . is preempted if it imposes a

requirement that is not identical to the requirements of the FDCA and the FDA's regulations.”

Bimont v. Unilever U.S., Inc., No. 14-CV-7749, 2015 U.S. Dist. LEXIS 119908, at *6 (S.D.N.Y.

Sept. 9, 2015).

DISCUSSION

Defendant argues that the 1988 monograph’s requirements for “immediate release”

labeling on OTC drugs like acetaminophen preempts Plaintiff’s New York state common law

claims. In support of their argument, Defendants encourage this Court to follow the decisions

made in Bischoff v. Albertsons Co., 678 F. Supp. 3d 518 (S.D.N.Y. 2023), Sapienza v. Albertson's

Co., Inc., No. 22-10968-RGS, 2022 U.S. Dist. LEXIS 217368 (D. Mass. Dec. 2, 2022), and

Morgan v. Albertsons Co., No. 22-cv-02948-JST, 2023 U.S. Dist. LEXIS 93108 (N.D. Cal. Mar.

13, 2023).

The Bischoff, Sapienza, and Morgan courts all came to the same conclusion that similar

allegations as to “rapid release” acetaminophen products were preempted by the FDCA’s

regulation of “immediate release” tablets. These Courts came to the same conclusion through

similar analytical means. The Bischoff and Sapienza Courts found that the “immediate release”

and “rapid release” terms both referred to the products dissolution rate and were sufficiently

similar such that they were covered by the FDA regulations. 2022 U.S. Dist. LEXIS 217368, at

*8; see also 678 F. Supp. at 527 (“[I]t would be nonsensical to allow a manufacturer to evade an

FDA requirement simply by coming up with a phrase that addresses the subject matter of the

regulation but in different phraseology.”) The Morgan Court, on the other hand, went so far as to

find that “[a]s a matter of logic,” the FDA regulation’s “designation of the gelcaps as ‘immediate

release’ encompasses a representation of those gelcaps as ‘rapid release.’” 2023 U.S. Dist.

LEXIS 93108, at *16.

Plaintiff, as was the case before the Bischoff, Sapienza, and Morgan Courts, draws a

strong distinction between the Tentative Final Monograph’s usage of the term “immediate

release” and the Defendant’s “Rapid Release” product. Plaintiff alleges that the FDA’s

dissolution regulation does not apply where the exact same nomenclature is not employed.

Plaintiff attempts to distinguish Bischoff, Sapienza, and Morgan by alleging that these cases

improperly “minimize[d] the consequential—and highly deceptive—effect of conflating such

terms when used in labeling and advertising.” Opp. at 5. Plaintiff then asks this Court to follow

the Northern District of California’s decision in Bailey v. Rite Aid Corporation which interpreted

the FDA’s aforementioned guidance documents as “suggest[ing] that ‘immediate’ and ‘rapid’ are

not synonymous.” No. 18-cv-06926-YGR, 2019 U.S. Dist. LEXIS 153498, at *13 (N.D. Cal.

Sep. 9, 2019). Holding so, in Plaintiff’s eyes, would cause this Court to find that the Tentative

Final Monograph and guidance documents’ differing standards for “immediate release” and

“rapidly dissolving” products renders the FDA’s regulations inapplicable to Defendant’s “rapid

release” product.

This Court disagrees with Plaintiff’s argument and joins the majority of its sister district

courts in their holdings here. As this Court has previously held,

Where federal requirements address the subject matter that is being challenged

through state law claims, such state law claims are preempted to the extent they

do not impose identical requirements. Thus, although the standard of identity does

not define the term "pure" or specify when it is permissible to place a cartoon-like

image of a mountain range on a purified water label, the FDA considered

misrepresentations regarding source and chose to regulate the labeling

requirements for the disclosure of source information, and in so doing it

determined that purified water should be exempted. Accordingly, any state law

claims premised on a misrepresentation about the source of purified water are

preempted.

In re Pepsico, Inc., 588 F. Supp. 2d 527, 538 (S.D.N.Y. 2008). And as Bischoff counsels,

That the FDA did not use the exact words “rapid release” in its regulations surely

cannot mean that the FDA does not regulate the subject matter of OTC

acetaminophen dissolution standards where, as described in detail above, it has

published regulations and guidance addressing when an OTC acetaminophen

product can be considered “immediate release,” “rapidly dissolving,” and “very

rapidly dissolving.”

678 F. Supp. 3d at 526-527. Just as a different district court in the Northern District of California

declined to apply Bailey because it improperly “relied on . . . non-binding FDA guidance,” 2023

U.S. Dist. LEXIS 93108, at *18, and just as Bischoff declined to do this because Bailey’s holding

could not be squared with In re Pepsico, Inc.’s rejection of “the principle that state requirements

are permitted as long as the federal standard does not specifically address the terms or images at

issue,” this Court does the same. 588 F. Supp. 2d at 538.2

2 Plaintiff’s reliance on McFall v. Perrigo Company and Canale v. Colgate-Palmolive Company is also

unconvincing. The Court in McFall, considering similar claims as to acetaminophen products labeled for use by

“children” and “infants,” denied defendant’s preemption argument largely on the grounds that the FDA’s regulations

clearly delineated between the two classes of end users. No. 2:20-cv-07752-FLA (MRWx), 2021 U.S. Dist. LEXIS

109451, at *27-28 (C.D. Cal. Apr. 15, 2021) (interpreting the FDA’s 1988 Tentative Final Monograph in accordance

with a previously-issued regulation directing OTC drug manufacturers to “qualify any reference to ‘infant’” in a

particular way). No such duly-enacted regulation delineating between “immediate release” and “rapid release”

acetaminophen products exists here.

Canale, which considered similar consumer claims relating to whitening toothpaste, ultimately denied defendant’s

preemption claims because the FDA had not issued any regulations as to teeth whitening. 258 F. Supp. 3d 312, 320-

321 (S.D.N.Y. June 23, 2017). The Canale defendant was only able to present a regulation on anticaries toothpaste

which was distinct from whitening. Id. The 1988 Tentative Final Monograph, on the other hand, clearly applies to

the product and feature at issue in this case (i.e. acetaminophen dissolution rates).

Perhaps in hopes of side-stepping this precedent and the issue of preemption altogether,

Plaintiff advances an additional theory of this case. This theory proceeds by characterizing the

FDA’s regulations as singularly governing acetaminophen drug labeling and having no effect on

the advertisement, marketing, or pricing of acetaminophen products. In support of their view of

the law, Plaintiff cites to Edwards v. Walmart, Inc. in which defendant’s preemption defense was

denied on substantially the same facts as here. No. CV 18-9655-GW(FFMx), 2019 U.S. Dist.

LEXIS 230993 (C.D. Cal. Apr. 18, 2019). As an initial matter, the Court notes Edwards’

inapplicability to this case. Edwards denied preemption because of defendant’s failure to

“provide[] any binding regulation (or other applicable federal law).” 2019 U.S. Dist. LEXIS

230993 at *15. In so doing, the Edwards defendant failed to make out their affirmative defense.

Clearly no such pleading deficiency exists in this case. Zooming out, the Court also finds

Plaintiff’s larger theory wholly unworkable. 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. Much ink has been spilled on the separation of

powers interests which undergird the Court’s decision on this front. Sapienza notes that

“Congress's adoption of a preemptive scheme . . . ensures that the legal rules governing complex

areas of the economy or products are formulated by expert regulators with a broad national

perspective and needed scientific or technical expertise, rather than by decision makers—such as

municipal officials, elected state judges, and lay juries—who may have a far more parochial

perspective and limited set of information.” 2022 U.S. Dist. LEXIS 217368, at *9 (citing Alan

Untereiner, The Defense of Preemption: A View from the Trenches, 84 Tul. L. Rev. 1257, 1262

(2010)).

CONCLUSION

Therefore, the Court grants Defendant’s motion to dismiss on preemption grounds.

Dismissal is granted with prejudice. “The problem[s] with [Plaintiff’s] causes of action [are]

substantive . . . [and] better pleading will not cure [them].” Cuoco v. Moritsugu, 222 F.3d 99,

112 (2d Cir. 2000).

SO ORDERED.

Dated: August 27, 2024 [Ayuda

New York, New York Che xy,

ANDREW CARTER, JR.

United States District Judge