DiCroce v. McNeil Nutritionals, LLC

United States Court of Appeals
For the First Circuit

No. 22-1910

KRISTIN DICROCE,
individually and on behalf of all persons similarly situated,

Plaintiff, Appellant,

v.

MCNEIL NUTRITIONALS, LLC and JOHNSON & JOHNSON CONSUMER INC.,

Defendants, Appellees.

APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS

[Hon. Patti B. Saris, U.S. District Judge]

Before

Kayatta, Gelpí, and Montecalvo,
Circuit Judges.

John Peter Zavez, with whom Noah Rosmarin, Brendan M.
Bridgeland, and Adkins, Kelston & Zavez, P.C. were on brief, for
appellant.
Hannah Y. Chanoine, with whom Kayla N. Haran, Matthew D.
Powers, and O'Melveny & Myers LLP were on brief, for appellees.

September 18, 2023
 GELPÍ, Circuit Judge. Plaintiff-Appellant Kristin

DiCroce ("DiCroce") challenges the district court's dismissal of

her complaint against McNeil Nutritionals, LLC and Johnson &

Johnson Consumer, Inc. (collectively, "Appellees") for their

allegedly misleading labeling and marketing of Lactaid

supplements. We agree with the dismissal outcome, albeit on

different grounds. Therefore, we affirm.

I. BACKGROUND

Given that "[t]he maze of detail" in DiCroce's complaint

is clearly laid out in the district court's opinion,1 we recite

only the facts needed "for purposes of th[is] appeal." Dukes

Bridge LLC v. Beinhocker, 856 F.3d 186, 187 (1st Cir. 2017).

Lactose intolerance is "characterized by abdominal

cramps and diarrhea after consumption of food that contains

lactose," a sugar found in dairy products. Lactose Intolerance,

Stedmans Medical Dictionary 452780, Westlaw (databased updated

Nov. 2014). Individuals who suffer from lactose intolerance do

not produce enough lactase -- an enzyme that aids in the digestion

of lactose. See id. Lactaid is a tablet form of the enzyme

lactase -- made and distributed by Appellees -- that claims to

prevent "gas," "bloating," and "diarrhea" "associated with

digesting dairy," among other things.

1 DiCroce v. McNeil Nutritionals, LLC, 640 F. Supp. 3d 182
(D. Mass. 2022).

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 DiCroce lives in Massachusetts and has purchased Lactaid

supplements "on multiple occasions within the past four years."

DiCroce filed this putative class action in October 2021

challenging certain statements on the packaging of Lactaid

products.2 Her general argument proceeds as follows:

(1) Lactose intolerance is a disease, per 21 C.F.R.
§ 101.93(g)(1)'s definition of a "disease";

(2) Lactaid, although marketed as a dietary supplement,
claims to treat the disease of lactose intolerance, thereby
violating 21 U.S.C § 343(r)(6), and making it a drug, per
§ 101.93(f);

(3) Because Lactaid is a drug under the relevant federal laws,
it is misleading, and thus violative of state law, for
Appellees to misbrand Lactaid as a dietary supplement, and to
make statements on Lactaid's label disclaiming Food and Drug
Administration ("FDA") approval, thereby implying that FDA
approval is not required;

(4) Had Lactaid's product not claimed to treat the disease of
lactose intolerance, DiCroce would not have been misled into

2 DiCroce's complaint claims that: (1) Appellees engaged in
deceptive acts or practices in violation of Mass. Gen. Laws ch.
93A (the Massachusetts Consumer Protection Act); (2) that
Appellees engaged in false advertising in violation of Mass. Gen.
Laws ch. 266, § 91; and (3) that Appellees were unjustly enriched
because, by buying Lactaid, DiCroce conferred an economic benefit
on Appellees. The district court granted Appellees' initial motion
to dismiss for lack of standing, concluding that DiCroce had failed
to plausibly allege an injury in fact because her claims that
Lactaid's labeling "affected her purchasing decisions" were
"vague," and, thus, she had no Article III standing.
With leave of court, DiCroce later filed an amended complaint,
adding to her original allegations that she paid an "unwarranted
premium" for Lactaid products because the products' "illegal
disease claims" led her to reasonably believe that they were worth
more than less expensive lactase supplements. DiCroce noted that
Lactaid products cost $0.20 per dosage, while alternative
products, which she cited specific examples of, cost at least $0.11
less. We draw the relevant facts from her amended complaint.

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 purchasing Lactaid products, which are more expensive than
other lactase supplements.

The district court granted Appellees' second motion to

dismiss, despite finding that DiCroce's amended complaint

sufficiently alleged an injury in fact for purposes of Article III

standing. DiCroce, 640 F. Supp. 3d at 185, 187-88. The district

court held that DiCroce's false advertising and deceptive trade

practices claims both failed because "no reasonable consumer could

find Lactaid's product labels deceptive, nor has DiCroce

identified a misrepresentation of fact." Id. at 188. Nor was the

district court convinced by DiCroce's disclaimer argument,

explaining that her "conclusory allegation d[id] not accord with

the language of the disclaimers" and that no "reasonable consumer's

purchasing decision" would be swayed by the fact that the product

required FDA evaluation given that the label disclosed that the

product is not FDA approved. Id. at 188-89.

DiCroce timely appealed.

II. DISCUSSION

Before we proceed to the merits of DiCroce's appeal, we

pause to address the issue of standing. See United States v.

Catala, 870 F.3d 6, 9 (1st Cir. 2017) ("Because Article III

standing is a sine qua non to federal judicial involvement, a

federal court must resolve any doubts about such standing before

proceeding to adjudicate the merits of a given case."). Contested

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by the parties is whether DiCroce has plausibly pled an injury in

fact, as required for Article III and statutory standing, under

chapter 93A of the Massachusetts General Laws. See Hochendoner v.

Genzyme Corp., 823 F.3d 724, 731 (1st Cir. 2016) (explaining the

injury requirement for standing in the Article III context);

Shaulis v. Nordstrom, Inc., 865 F.3d 1, 10 (1st Cir. 2017)

(discussing cognizable injuries under chapter 93A). We begin with

DiCroce's Article III standing.

"[A]t the pleading stage, the plaintiff bears the burden

of establishing sufficient factual matter to plausibly demonstrate

h[er] standing to bring the action." Hochendoner, 823 F.3d at

731. For an injury in fact to be plausibly pled, it "must be both

concrete and particularized and actual or imminent, not

conjectural or hypothetical." Id. (cleaned up). Concreteness

requires that the injury "actually exist[s]." Id. (alteration in

original) (quoting Spokeo, Inc. v. Robins, 578 U.S. 330, 340

(2016)). And particularization demands that, in addition to

alleging "injurious conduct attributable to the defendant," a

plaintiff must also claim to be "among the persons injured by that

conduct." Id. at 731-32.

DiCroce's second amended complaint satisfies both

requirements. DiCroce claims that she personally purchased

Lactaid supplements on multiple occasions during the four years

preceding the complaint. She further alleges that Lactaid

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supplements cost at least $0.11 more per tablet than other brands

and that she was misled into purchasing overpriced lactase

supplements because of Appellees' purportedly unlawful marketing

statements. Put another way, DiCroce claims that she has

personally suffered economic harm in the past as a result of

Appellees' alleged misconduct. At the pleading stage, we find

these allegations sufficient to meet the minimal plausibility

standard for establishing Article III standing. See In re Evenflo

Co., Inc., Mktg., Sales Pracs. & Prods. Liab. Litig., 54 F.4th 28,

35 (1st Cir. 2022) ("This court has repeatedly recognized

overpayment as a cognizable form of Article III injury.");

Gustavsen v. Alcon Lab'ys, Inc., 903 F.3d 1, 7-8 (1st Cir. 2018)

(holding that plaintiffs sufficiently pled a concrete, actual,

particularized injury for standing purposes where they claimed

that they, themselves, had suffered "out-of-pocket loss of money"

in the past because of defendants' conduct).

Appellees' remaining standing arguments are statutory in

nature, insofar as they pertain to whether DiCroce "has a cause of

action" under chapter 93A. Catala, 870 F.3d at 10. Because

statutory standing is not determinative of "a court's power to

adjudicate a case," we choose to forgo this inquiry, "in the

interest of efficiency," given our ultimate conclusion that

DiCroce's claims were properly dismissed by the district court.

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See id. Having "resolve[d] any doubts" about DiCroce's Article

III standing, we proceed to the merits. Id. at 9.

We review de novo the district court's order granting a

motion to dismiss under Federal Rule of Civil Procedure 12(b)(6).

Sullivan v. etectRx, Inc., 67 F.4th 487, 491 (1st Cir. 2023).

Accordingly, "we ask whether the well-pleaded factual allegations,

viewed in the light most favorable to the

plaintiff, . . . 'plausibly narrate a claim for relief.'" Id.

(quoting Germanowski v. Harris, 854 F.3d 68, 71 (1st Cir. 2017)).

In reaching a conclusion, we are not tied to the district court's

reasoning "but may affirm the order of dismissal on any ground

made manifest by the record." González v. Vélez, 864 F.3d 45, 50

(1st Cir. 2017) (quoting Katz v. Pershing, LLC, 672 F.3d 64, 71

(1st Cir. 2012)).

Before us, DiCroce argues that the district court's

ruling was incorrect and continues to press her claim that

Lactaid's label is misleading because it fails to comply with

federal labeling requirements. DiCroce further contends that the

district court should have allowed the matter of whether lactose

intolerance is a disease to go beyond the pleading stage. Such

arguments lack merit. DiCroce's claims are impliedly preempted by

the FDA's statutory enforcement authority.

We begin with the relevant regulatory background. The

Food, Drug, and Cosmetic Act ("FDCA") was enacted to protect

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consumers from "harmful products." In re Zofran (Ondansetron)

Prods. Liab. Litig., 57 F.4th 327, 330 (1st Cir. 2023) (quoting

Wyeth v. Levine, 555 U.S. 555, 574 (2009)). The FDA regulates

dietary supplements through the FDCA, as amended by the Dietary

Supplement Health and Education Act of 1994 ("DSHEA") and FDA

regulations.3 Ferrari v. Vitamin Shoppe Indus. LLC, 70 F.4th 64,

67–68 (1st Cir. 2023) (citing Dietary Supplement Health and

Education Act of 1994, Pub. L. No. 103-417, 108 Stat. 4325, 4325–

26 (1994)). In Ferrari, we examined the legislative history

related to DSHEA before concluding that "Congress intended dietary

supplements to escape the regulatory gauntlet that drugs must go

through." Id. at 73-74 ("It enacted the DSHEA to 'ensur[e] that

the Federal Government erects no barriers that impede the ability

of consumers to improve their nutrition through the free choice of

safe dietary supplements' and 'to clarify that dietary supplements

are not drugs . . . [and] should not be regulated as drugs.'"

(alterations in original) (quoting S. Rep. No. 103-410 (1994),

1994 WL 562259, at *2)).4 Unlike dietary supplements, drugs, which

3 DSHEA defines a dietary supplement as a product that is
"intended to supplement the diet" and that contains certain
"dietary ingredients." 21 U.S.C. § 321(ff).
4 Under the FDCA and DSHEA, manufacturers are allowed to make

"structure/function claims" about dietary supplements. Kaufman v.
CVS Caremark Corp., 836 F.3d 88, 92 (1st Cir. 2016). DiCroce does
not allege that Lactaid does not perform as advertised in the
label. Therefore, we need not delve into whether Appellees possess
substantiation for Lactaid's label claims.

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are also regulated under the FDCA, require prior FDA approval

before they can be sold or marketed to consumers. In re Zofran,

57 F.4th at 330 (explaining that the FDA reviews a drug's efficacy

and proposed label).

Importantly, only the FDA may enforce the FDCA, meaning

that the FDCA provides no private right of action. 21 U.S.C.

§ 337(a); see Plourde v. Sorin Grp. USA, Inc., 23 F.4th 29, 33

(1st Cir. 2022) (explaining that § 337(a)'s "language shows 'that

Congress intended that the [FDCA] be enforced exclusively by the

Federal Government.'" (quoting Buckman Co. v. Plaintiffs' Legal

Comm., 531 U.S. 341, 352 (2001))).

DiCroce's legal action hinges on her assumption that

Lactaid's labels violate the FDCA's labeling requirements and are

therefore misleading to consumers. But we have made it clear that

"§ 337(a) preempts any state-law claim that exists 'solely by

virtue' of an FDCA infraction." Plourde, 23 F.4th at 33.

In Buckman, plaintiffs claimed injuries related to the

placement of "orthopedic bone screws" in their spines. 531 U.S. at

343. Specifically, they alleged that a consulting company made

fraudulent representations to the FDA during the screws' approval

process, resulting in the FDA's subsequent approval of the devices.

Id. The Court concluded that plaintiffs' "state-law fraud-on-the

FDA" claims were impliedly preempted because "[p]olicing fraud

against federal agencies is hardly 'a field which the States have

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traditionally occupied'" and said claims conflicted with the

federal statutory scheme, which "amply empowers the FDA to punish

and deter fraud against the Administration." Id. at 347-48

(quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230

(1947)).

More recently, we had the opportunity to consider

Buckman's holding in the food-labeling context, in Dumont v. Reily

Foods Company. 934 F.3d 35, 41-43 (1st Cir. 2019). There, we

applied, without formally adopting, the Eighth and Ninth Circuits'

test for deciding whether a state-law claim avoids preemption:

"The plaintiff must be suing for conduct that violates the FDCA

(or else his claim is expressly preempted by [the FDCA's medical

device preemption provision, 21 U.S.C. § 360k], but the plaintiff

must not be suing because the conduct violates the FDCA (such a

claim would be impliedly preempted under Buckman))." Dumont, 934

F.3d at 42 (alteration in original) (quoting In re Medtronic, Inc.,

Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200, 1204 (8th

Cir. 2010)) (citing Perez v. Nidek Co., 711 F.3d 1109, 1120 (9th

Cir. 2013)). We explained that, based on this test, a "complaint

is preempted unless the conduct it pleads: (1) violates FDCA

labeling requirements and (2) would also violate chapter 93A even

if the FDCA did not exist."5 Id. at 42. We approvingly referred

5States are prohibited from imposing food labeling
requirements beyond what the FDCA requires. Kaufman, 836 F.3d at

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to this test again in Plourde, where we were confronted with state-

law negligence and failure-to-warn claims related to a medical

device. 23 F.4th at 33-34.

Returning to DiCroce's complaint, we hold that her state

law claims -- for unfair or deceptive trade practices, false

advertising, and unjust enrichment6 -- "exist[] 'solely by virtue'

of an FDCA infraction" and thus are impliedly preempted. Id. at

33. DiCroce, like the plaintiffs in Buckman, is alleging fraud

under the FDCA, given that her claim that Lactaid's label is

misleading is premised entirely on her belief that said label

violates the FDCA.7 See id. And DiCroce provides no other grounds

on which her claims could survive. She does not contend that

Lactaid did not perform as promised, nor does she provide any

basis, independent of federal labeling laws, from which we could

conclude that a consumer would be misled by Lactaid's label. In

fact, DiCroce's complaint acknowledges that Lactaid's disclaimer

91 (citing 21 U.S.C. § 343-1(a)(5)). Thus, if a manufacturer
complies with the FDCA's labeling requirements, a plaintiff has no
cause of action under state law for labeling claims. Id. at 92.
6 An unjust enrichment claim that "rests on the same improper

conduct alleged in another claim . . . will stand or fall with the
related claim." Kaufman, 836 F.3d at 96 (quoting Cleary v. Philip
Morris, Inc., 656 F.3d 511, 517 (7th Cir. 2011)).
7 While "state-law claim[s] based on 'traditional state tort

law' that happen[] to 'parallel' the FDCA" are not necessarily
preempted, Plourde, 23 F.4th at 33 (quoting Buckman, 531 U.S. at
353), DiCroce does not plead such a claim here.

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statements are "literally true" before arguing that they are

nevertheless misleading because they violate the FDCA.

If Lactaid's label conflicts with the FDCA's labeling

requirements -- an issue we decline to take a position on -

- Congress tasked the FDA with addressing said violations when it

enacted § 337(a), not private citizens. See Blackman, 531 U.S. at

348; Plourde, 23 F.4th at 33.

III. CONCLUSION

Because we conclude that violation of the FDCA "is a

critical element in [DiCroce's] case," we hold that her claims are

impliedly preempted. Blackman, 531 U.S. at 353 (emphasis added).

Thus, the district court's dismissal of DiCroce's amended

complaint is

Affirmed.

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