Jackson-Mau v. Walgreen Co.

UNITED STATES DISTRICT COURT

EASTERN DISTRICT OF NEW YORK

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THEDA JACKSON-MAU, on behalf of

herself and all others similarly situated MEMORANDUM AND ORDER

Plaintiff, Case No. 1: 18-cv-4868 (FB)(VMS)

-against-

WALGREEN CO. and

INTERNATIONAL VITAMIN

CORPORATION,

Defendants.

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Appearances:

For the Plaintiff: For the Defendant:

WOLK POPPER LLP BRYAN CAVE LEIGHTON

MATTHEW INSLEY-PRUITT, ESQ. PAISNER LLP

845 Third Ave. COURTNEY J. PETERSON, ESQ.

New York, New York 10022 1209 Avenue of the Americas

New York, New York 10104

BLOCK, Senior District Judge:

Plaintiff Theda Jackson-Mau brings this action against International Vitamin

Corporation (“IVC”) for violations of New York General Business Law §349 related

to its manufacturing of glucosamine sulfate. The defendant moves to dismiss the

state claim against it based on federal preemption under Federal Rules of Civil

Procedure 12(b)(6) and the claim for injunctive relief under 12(b)(1). For the

following reasons, the defendant’s motion is granted in part and denied in part.

I.

“A case is properly dismissed for lack of subject matter jurisdiction under

Rule 12(b)(1) when the district court lacks the statutory or constitutional power to

adjudicate it,” Makarova v. United States, 201 F.3d 110, 113 (2d Cir. 2000), such as

for lack of standing to seek injunctive relief. Pungitore v. Barbera, 506 F. App’x 40,

41 (2d Cir. 2012). Plaintiff bears the burden of establishing standing. All. for Open

Soc’y Int’l, Inc. v. U.S. Agency for Int’l Dev., 651 F.3d 218, 227–28 (2d Cir. 2011),

aff’d sub nom. Agency for Int’l Dev. v. All. for Open Soc’y Int’l, Inc., 570 U.S. 205,

133 S. Ct. 2321, 186 L. Ed. 2d 398 (2013) (citing Lujan v. Defenders of Wildlife,

504 U.S. 555, 561, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992).

For dismissal under 12(b)(6), the Court must take as true all the allegations of

the complaint and must draw all inferences in plaintiff’s favor. See Weixel v. Board

of Educ., 287 F.3d 138, 145 (2d Cir. 2002). A complaint “does not need detailed

factual allegations,” but “a formulaic recitation of the elements of a cause of action

will not do.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). The “[f]actual

allegations must be enough to raise a right to relief above the speculative level.” Id.

at 555. Federal preemption is an affirmative defense; therefore, the defendant bears

the burden of proof. See Bruesewitz v. Wyeth LLC, 562 U.S. 223, 251 n. 2 (2011).

II.

Plaintiff’s relevant testing allegations are as follows: (1) she purchased a

bottle labeled Glucosamine Sulfate at Walgreens, (2) she brought the bottle to her

counsel, who had the pills professionally analyzed, (3) the lab tests uncovered “that

there was no Glucosamine Sulfate in the pills that were tested” despite the bottle

stating the pills contained Glucosamine Sulfate, and (4) “[i]t is implausible to

consider that [the lab test result] is the result of simple manufacturing variance.”

Amended Complt. ¶¶22-24 (emphasis in original).

IVC contends that Plaintiff’s claim must be dismissed because it is preempted

by federal regulation. IVC argues that this Court’s decision in Walgreen’s motion to

dismiss (the “Walgreen’s decision”) only held that “Plaintiff’s complaint should not

be dismissed for failure to plead compliance with the federal testing requirements

set out in 21 C.F.R. §101.9(g),” in other words, that Plaintiff’s omission was not

sufficient for dismissal. IVC now asks the Court to address two variations of the

preemption argument: 1) whether Plaintiff must affirmatively plead compliance with

the federal testing requirement to avoid dismissal, and 2) whether the complaint

“affirmatively pleads facts establishing an affirmative defense-preemption of her

claim.” The Court’s answer to both questions is no.

a. Plaintiff is not required to plead compliance with federal

testing requirements to state a claim

IVC argues that Plaintiff must affirmatively plead compliance with federal

testing requirements to state a claim for mislabeling and avoid dismissal due to

preemption. However, the only new case IVC cites since the Walgreen’s decision

that is on point is not controlling. See Melendez v. ONE Brands, LLC, 2020 WL

1283793 (E.D.N.Y. Mar. 16, 2020). Instead IVC cites Lexmark to assert what

amounts to a legal truism: if a plaintiff does not allege the elements of a claim, the

claim must be dismissed. See Lexmark Int’l, Inc. v. Static Control Components, Inc.,

572 U.S. 118, 134 n.6 (2014). No one disputes that. But the district courts remain

split on the issue,1 and the Second Circuit still has not addressed whether affirmative

pleading of compliance with federal testing requirements is required to survive a

motion to dismiss.

1 Compare cases that required dismissal where plaintiff did not plead compliance with the FDA

protocol, Parker v. Wal-Mart Stores, Inc., 367 F.Supp.3d 979 (E.D. Mo. 2019); Welk v.

Nutraceutical Corp., 3:17-CV-02266-BEN-KSC, 2018 WL 3818033 (S.D. Cal. Aug. 10, 2018);

In re Whole Foods Mkt., Inc., 163 F.Supp.3d 385 (W.D. Tex. 2016); Dougherty v. Source Nats.,

Inc., 148 F. Supp. 3d 831 (E.D. Mo. 2015); Mee v. I A Nutrition, Inc., No. C-14-5006 MMC, 2015

WL 2251303 (N.D. Cal. May 13, 2015); Baker v. NNW, LLC, No. 15-00222-CV-W-GAF, 2015

WL 12843827 (W.D. Mo. July 8, 2015); Bruaner v. MusclePharm Corp., No. 14-cv-8869-FMO,

2015 WL 4747941 (C.D. Cal. Aug. 11, 2015) with cases where pleading compliance was not

required for court to infer defendant’s liability. Carrol v. S.C. Johnsons & Son, Inc., No. 17-CV-

05828, 2018 WL 1695421 (N.D. Ill. Mar. 29, 2018); Gubala v. CVS Pharmacy, Inc., No. 14-cv-

9039, 2016 WL 1019794 (N.D. Ill. Mar. 15, 2016); Gubala v. HBS Int'l Corp., No. 14-cv-9299,

2016 WL 2344583 (N.D. Ill. May 4, 2016); Clay v. Cytosport, Inc., No. 15-cv-165 L(DHB), 2015

WL 5007884 (S.D. Cal. Aug. 19, 2015); Smith v. Allmax Nutrition, Inc., No. 1:15–cv–00744–

SAB, 2015 WL 9434768 (E.D. Cal. Dec. 23, 2015).

At the summary judgment stage, the Court may need to determine whether the

federal requirements were used or whether Plaintiff’s test was an appropriate

substitute.2 But at this juncture, viewing the allegations in the light most favorable

to the plaintiff, the Court will assume that Plaintiff’s testing is adequate.

b. Plaintiff did not plead Defendant’s affirmative defense.

IVC argues that Plaintiff has established Defendant’s affirmative defense of

preemption by supporting her allegations with a testing method different than the

federal requirement. IVC points to Eleventh and Ninth Circuit cases that were

already considered in the Walgreen’s decision to support its argument. In Hi-Tech

Pharmaceuticals, Inc. v. HBS International Corp., the claims were dismissed based

on preemption, but they did not reach the issue of whether dismissal was warranted

based on a failure to allege federally compliant testing nor did they even mention

dismissal based on Plaintiff’s pleading the use of a different test. 910 F.3d 1186

(11th Cir. 2018). In Durnford v. MusclePharm Corp., the full quote IVC cites is:

We need not address whether plaintiffs are ever required to allege, at

the pleading stage, that there are tests contradicting the nutrition panel

that comply with the FDA’s testing protocols. We note, however, that

plaintiffs are generally not expected to provide evidence in support

of their claims at the pleading stage, see Cafasso, U.S. ex rel. v. Gen.

Dynamics C4 Sys., Inc., 637 F.3d 1047, 1055 (9th Cir. 2011), nor are

they required to plead the “probability” of their entitlement to relief,

2 If Plaintiff can show that this case indeed challenges only the name of the dietary supplement

and not the stated “Supplement Facts,” this testing regime may not apply at all. See Amavizca v.

Nutra Mfg., LLC, No. 8:20-cv-01324-RGK-MAA, 2021 U.S. Dist. LEXIS 36009, at *1 (C.D. Cal.

Jan. 27, 2021).

Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868

(2009). In addition, FDCA preemption, like all federal preemption, is

an affirmative defense. Lusnak v. Bank of Am., N.A., 883 F.3d 1185,

1194 n.6 (9th Cir. 2018). “Only when the plaintiff pleads itself out of

court—that is, admits all the ingredients of an impenetrable

defense—may a complaint that otherwise states a claim be

dismissed under Rule 12(b)(6).” Xechem, Inc. v. Bristol-Myers Squibb

Co., 372 F.3d 899, 901 (7th Cir. 2004); see also Scott v. Kuhlmann, 746

F.2d 1377, 1378 (9th Cir. 1984) (per curiam).

907 F.3d 595, 604 n.8 (9th Cir. 2018) (emphasis added). Even if it were controlling

authority, it does not compel the Court to dismiss the claims at this stage. Plaintiff

has not pleaded “all the ingredients of an impenetrable defense. Id. For example, she

has not alleged that the tests are unreliable or inappropriate. See 21 C.F.R. §101.9(g)

(“[C]omposites shall be analyzed by appropriate methods as given in the ‘Official

Methods of Analysis of the AOAC International,’ or, if no AOAC method is

available or appropriate, by other reliable and appropriate analytical procedures.”).

For these reasons, the Court denies IVC’s motion to dismiss based on preemption.

III.

Defendant IVC argues Plaintiff lacks standing to seek injunctive relief

because she fails to allege future injury.

In order for a plaintiff to have Article III standing, she “must have (1) suffered

an injury in fact, (2) that is fairly traceable to the challenged conduct of the

defendant, and (3) that is likely to be redressed by a favorable judicial decision.”

Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547 (2016). Plaintiff has standing to pursue

injunctive or declaratory relief only if she is able “to establish a ‘real and immediate

threat’ of injury.” Nicosia v. Amazon.com, Inc., 834 F.3d 220, 239 (2d Cir. 2016)

(quoting City of Los Angeles v. Lyons, 461 U.S. 95, 111–12 (1983)). Past injuries are

insufficient to confer Article III standing “unless the plaintiff can demonstrate that

she is likely to be harmed again in the future in a similar way.” Id.

Since Defendant Walgreen Co.’s motion to dismiss, the Second Circuit has

addressed a plaintiff’s standing to assert claims for preliminary and permanent

injunctive relief when the plaintiff has alleged that she would purchase the product

in the future if the packaging were corrected:

[P]ast purchasers of a product…are not likely to encounter future harm

of the kind that makes injunctive relief appropriate. In the first place,

past purchasers are not bound to purchase a product again—meaning

that once they become aware they have been deceived, that will often

be the last time they will buy that item. Past purchasers do not have the

sort of perpetual relationship with the producer of a consumer good that

is typical of plaintiffs and defendants in Rule 23(b)(2) class actions.

…[T]here is no reason to believe that all, or even most, of the class

members—having suffered the harm alleged—will choose to buy it in

the future.

But even if they do purchase it again, there is no reason to believe that

all, or even most, of the class members will incur a harm anew.

Supposing that they have been deceived by the product’s packaging

once, they will not again be under the illusion that the boxes of the

newer pastas are filled in the same way as the boxes of the older pastas.

Instead, next time they buy one of the newer pastas, they will be doing

so with exactly the level of information that they claim they were owed

from the beginning.

Berni v. Barilla S.p.A., 964 F.3d 141, 146-48 (2d Cir. 2020). This authority is

controlling. Here, as in Berni, the Second Circuit’s determination precludes Plaintiff

from injunctive relief. Id.

On that basis, the Court modifies its prior decision regarding Defendant

Walgreen Co. and grants Walgreen’s motion to dismiss Plaintiff’s injunctive relief

claim against it. See Fort Knox Music Inc. v. Baptiste, 257 F.3d 108, 110–11 (2d Cir.

2001) (Under FRCP 60(b), “nothing forbids the court to grant such relief sua

sponte.”)

CONCLUSION

For the foregoing reasons, IVC’s motion to dismiss is GRANTED in part, and

DENIED in part; and the Court sua sponte dismisses the claim for injunctive relief

against Walgreen Co.

SO ORDERED.

_/S/ Frederic Block___________

FREDERIC BLOCK

Senior United States District Judge

Brooklyn, New York

July 7, 2022