Crommelin v. Takeda Pharmaceuticals U.S.A., Inc.

UNITED STATES DISTRICT COURT

DISTRICT OF MASSACHUSETTS

CIVIL ACTION NO. 24-10552-RGS

GUNTER CROMMELIN,

individually and on behalf of all

others similarly situated

v.

TAKEDA PHARMACEUTICALS U.S.A., INC.;

TAKEDA PHARMACEUTICALS AMERICA, INC.; and

TAKEDA MANUFACTURING U.S.A., INC.

MEMORANDUM AND ORDER ON

DEFENDANTS’ MOTION TO DISMISS

September 4, 2024

STEARNS, D.J.

Plaintiff Gunter Crommelin filed this putative class action against

defendants Takeda Pharmaceuticals U.S.A., Inc.; Takeda Pharmaceuticals

America, Inc.; and Takeda Manufacturing USA, Inc. (collectively, Takeda) on

behalf of herself and all others similarly situated. She alleges that Takeda

breached an express warranty (Count I) and violated the consumer

protection laws of Massachusetts (Count II) and Alabama (Count III) by

selling her “empty capsules [of medication] or capsules containing less of the

active ingredient than indicated.” Am. Compl. [Dkt # 14] ¶ 5. Takeda moves

to dismiss Counts II and III pursuant to Federal Rule of Civil Procedure

12(b)(6), and to strike the class allegations pursuant to Federal Rule of Civil

Procedure 12(f). For the following reasons, the court will allow both motions.

BACKGROUND

Takeda manufactures and sells the prescription medicine Vyvanse, “an

FDA-approved central nervous system stimulant prescription medication

containing lisdexamfetamine dimesylate.” Id. ¶ 100. Relevant here,1

Vyvanse “is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD)

in children and adults, age six or older.” Id. ¶ 1.

Crommelin suffers from ADHD and was prescribed 40 mg of Vyvanse

(with an as-needed supplement of Dextroamphetamine) by her doctor.

Crommelin “did not take Vyvanse every day but instead, primarily took it

during the week while she was at school or work.” Id. ¶ 14. She routinely

supplemented the Vyvanse dose with Dextroamphetamine two to three times

each week.

On September 12, 2023, Crommelin paid $60 to fill her prescription at

a local pharmacy in her home state of Alabama (September Refill). She

received a bottle labeled “Vyvanse 40 MG Capsule,” id. ¶ 16, which contained

twenty-eight capsules matching the physical appearance of Takeda-

manufactured Vyvanse, see id. ¶¶ 16, 64, 71, 75, 76. While using the pills from

1 Vyvanse also is approved to treat Binge Eating Disorder in adults.

her September Refill, Crommelin “felt her medicine was not performing

properly to treat her ADHD.” Id. ¶ 18. She found herself needing to

supplement her dosage with Dextroamphetamine every day rather than her

typical two to three times a week.

When only five pills remained in the September Refill, Crommelin

learned that a friend of hers had received empty Vyvanse capsules from a

different local pharmacy. At her friend’s urging, Crommelin opened all five

capsules and discovered that they were empty. Her mother called the

pharmacy to report the issue, but Crommelin received neither a refund for

the cost of the refill nor a replacement for the empty capsules.

On November 17, 2023, Crommelin again paid $60 to fill her

prescription at a local pharmacy (November Refill). She opened five of the

pills from this refill and “observed that there was some medication inside,

but only about half of each capsule was filled.” Id. ¶ 25. Crommelin does not

appear to have commissioned any laboratory testing to determine how much,

if any, lisdexamfetamine dimesylate was present in these partially-filled

capsules.

DISCUSSION

I. Motion to Dismiss

“To survive a motion to dismiss, a complaint must contain sufficient

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). Two basic principles guide the

court’s analysis. “First, the tenet that a court must accept as true all of the

allegations contained in a complaint is inapplicable to legal conclusions.”

Iqbal, 556 U.S. at 678. “Second, only a complaint that states a plausible claim

for relief survives a motion to dismiss.” Id. at 679. A claim is facially

plausible if its factual content “allows the court to draw the reasonable

inference that the defendant is liable for the misconduct alleged.” Id. at 678.

a. Massachusetts Consumer Protection Act (Count II)

Count II asserts a claim under the Massachusetts Consumer Protection

Act, Mass. Gen. Laws ch. 93A (Chapter 93A), which prohibits “[u]nfair

methods of competition and unfair or deceptive acts or practices in the

conduct of any trade or commerce.” Id. § 2(a). Conduct is unfair within the

scope of this provision “if it is (1) within the penumbra of a common law,

statutory, or other established concept of unfairness; (2) immoral, unethical,

oppressive, or unscrupulous; or (3) causes substantial injury to [consumers,]

competitors or other business people.” Tomasella v. Nestle USA, Inc., 962

F.3d 60, 79 (1st Cir. 2020) (alteration in original), quoting Heller Fin. v. Ins.

Co. of N. Am., 410 Mass. 400, 408 (1991). Conduct is deceptive, on the other

hand, “when it has the capacity to mislead consumers, acting reasonably

under the circumstances, to act differently from the way they otherwise

would have acted (i.e., to entice a reasonable consumer to purchase the

product).” Dumont v. Reily Foods Co., 934 F.3d 35, 40 (1st Cir. 2019),

quoting Aspinall v. Philip Morris Cos., 442 Mass. 381, 396 (2004).

Here, however artfully framed, see Am. Compl. ¶ 117 (separately

alleging that Takeda: (1) represented the pills as containing a quality or

ingredient they did not have; (2) failed to reveal to consumers that the

product did not contain the represented 40 mg of lisdexamfetamine

dimesylate;2 and (3) misrepresented that the pills contained a specified

2 To the extent Crommelin also alleges that Takeda “failed to reveal to

consumers that its capsules did not comply with cGMPs and/or were

adulterated and/or misbranded,” id., the Amended Complaint is devoid of

any factual support for her conclusory assertion that Takeda failed to comply

with good manufacturing practices. At best, Crommelin pleads that Takeda

must have violated good manufacturing practices because empty capsules

found their way into the market. See, e.g., id. ¶¶ 52-53, 58. But precedent is

clear that this type of “merely consistent with” allegation is insufficient to

plausibly establish liability at the pleading stage. Iqbal, 556 U.S. at 678,

quoting Twombly, 550 U.S. at 545. The court needs something more

substantial than the mere fact that Crommelin (or even Crommelin, her

friend, and her brother, assuming they received brand-name Vyvanse and

not a generic version) received empty pills in one refill to reasonably infer

dosage of lisdexamfetamine dimesylate and could treat ADHD),

Crommelin’s Chapter 93A claim at its core hinges on a single act: the receipt

of empty Vyvanse capsules in her September Refill.3 Although it is troubling

to contemplate a consumer receiving empty capsules in the place of

prescribed medication, the court agrees with Takeda that nothing in the

Amended Complaint plausibly establishes that any error on Takeda’s part

“rose above the level of mere negligence.” Brown v. Bank of Am. Corp., 2011

WL 1311278, at *3 (D. Mass. Mar. 31, 2011). Crommelin does not, for

example, allege that Takeda knew that it was supplying empty capsules at the

time Crommelin’s prescription was filled (much less that it intended to sell

its customers short). Nor does she plead any factual basis from which the

court could reasonably infer that Takeda should have known, e.g., because it

that Takeda failed to meet its quality control and sampling obligations –

especially where, as here, the capsules passed through other hands on the

way to the point of sale.

3 The court can reasonably infer from the mere fact that the five

capsules from the September Refill were empty that they did not contain the

advertised 40 mg of lisdexamfetamine dimesylate. There is no basis,

however, for the court to infer that the partially-filled capsules from the

November Refill lacked the represented 40 mg of lisdexamfetamine

dimesylate. Crommelin does not, for example, allege that the capsules had

been tested and found to contain less than 40 mg of lisdexamfetamine

dimesylate or that she had usually found her 40 mg capsules to have been

completely filled. She does not even allege that she felt the pills in her

November Refill were lacking in potency, as was the case with the pills from

the September Refill.

knowingly or recklessly continued to operate in the face of glaring and known

manufacturing defects. See supra note 2. There is nothing, in short, to

suggest that Takeda’s representation, hollow as it may have been, was

“unfair” or “deceptive” within the scope of Chapter 93A. See Darviris v.

Petros, 442 Mass. 274, 278 (2004) (noting that, while Chapter 93A “is a

statute of broad impact, the limits of which are not precisely defined, a

violation . . . requires, at the very least, more than a finding of mere

negligence”) (internal quotation marks and citations omitted).

b. Alabama Deceptive Practices Act (Count III)

Count III asserts a claim under the Alabama Deceptive Practices Act

(ADTPA), Ala. Code §§ 8-19-1, et seq., which, as relevant here, prohibits:

(5) Representing that goods or services have sponsorship,

approval, characteristics, ingredients, uses, benefits, or qualities

that they do not have . . . .

(6) Representing that goods are original or new if they are

deteriorated, reconditioned, reclaimed, used, secondhand, or

altered to the point of decreasing their value or rendering the

goods unfit for the ordinary purpose for which they were

purchased . . . .

(7) Representing that goods or services are of a particular

standard, quality, or grade, or that goods are of a particular style

or model, if they are of another.

(9) Advertising goods or services with intent not to sell them as

advertised.

(27) Engaging in any other unconscionable, false, misleading, or

deceptive act or practice in the conduct of trade or commerce.

Id. § 8-19-5. The parties agree that knowledge is a necessary component of

a successful ADTPA claim, although knowledge may be constructive rather

than real. See id. § 8-19-3(9) (defining knowledge as “[e]ither actual

awareness or such awareness as a reasonable person should have

considering all the surrounding circumstances”).

Crommelin argues that Takeda should have known4 she would receive

empty pills because, for empty pills to make it into the market, Takeda must

have been violating good manufacturing practices. This is a classic res ipsa

loquitur argument that, standing alone, does not suffice to satisfy

Crommelin’s pleading burden in the context of a claim of unfair business

practices. The court needs something more than the mere fact that

Crommelin received empty pills in one refill to reasonably infer that Takeda

knew or should have known that it was violating sound manufacturing

practices. See supra note 2; cf. Bolling v. Mercedes-Benz USA, LLC, 2024

WL 371876, at *15-16, *18 (N.D. Ga. Jan. 30, 2024) (finding knowledge

sufficiently pled where plaintiffs alleged, inter alia, that defendants had

conducted pre-sale durability testing that would have revealed the defect;

4 Crommelin does not assert (either in the Amended Complaint or her

Opposition) that Takeda had actual knowledge.

monitored the NHTSA’s website, which was replete with consumer

complaints about the defect; and reimbursed dealerships for repairs related

to the defect). The Alabama claim accordingly must be dismissed.

c. Choice of Law

Although the court doubts whether Massachusetts substantive law

should govern here under proper application of choice of law principles, it

need not decide the issue considering its finding that a Massachusetts

Chapter 93A claim, even if viable, is insufficiently pled.

II. Motion to Strike

Takeda moves to strike the class allegations under Federal Rule of Civil

Procedure 12(f). The court approaches the request with caution, as striking

class allegations is generally disfavored in the early stages of litigation. See

Manning v. Bos. Med. Ctr. Corp., 725 F.3d 34, 59 (1st Cir. 2013). This

caution should not, however, deter the court from “delet[ing] the complaint’s

class allegations” if “it is obvious from the pleadings that the proceeding

cannot possibly move forward on a classwide basis.” Id.; see also Camey v.

Force Factor, LLC, 2016 WL 10998440, at *2 (D. Mass. May 16, 2016).

Takeda argues that it is obvious from the pleading that no class action

can exist here because, given how extensively state warranty law varies from

state to state, individualized issues of fact are certain to predominate.5

Crommelin does not appear to substantively dispute the premise that

“[t]here are tremendous differences among state warranty laws.”6 Camey,

2016 WL 10998440, at *7. She nonetheless seeks to postpone any ruling on

the validity of her class allegations because that issue is “neither necessary

nor appropriate for the Court or the parties to attempt to analyze, at the

pleading stage.” Opp’n at 17. The problem is this: Crommelin offers no

explanation for how further development of the factual record would have

any impact on whether – and how – warranty laws vary from state to state.

The court accordingly sees no reason to delay resolution of the issue. And

because the court agrees with Takeda on the merits that significant variations

among state warranty law will preclude the establishment of any viable class

as to Count I, it allows the motion to strike the class allegations.

5 Because the court has allowed the motion to dismiss Counts II and

III, it addresses only the portion of the motion to strike addressed to Count

I.

6 Crommelin’s substantive argument largely relies on Chapter 93A to

“provide[] a sufficient basis for a nationwide claim.” Pl.’s Opp’n to Mot. for

Summ. J. (Opp’n) [Dkt # 21] at 16. Because the court found this claim

insufficiently pled, it is unavailing to her here.

ORDER

For the forgoing reasons, Takeda’s motions are ALLOWED. Counts II

and III are dismissed without prejudice, and Count I will proceed to

discovery only on an individual basis.

SO ORDERED.

/s/ Richard G. Stearns___ _____

UNITED STATES DISTRICT JUDGE