Bossetti v. Allergan Sales, LLC

UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF OHIO

WESTERN DIVISION

LAUREN BOSSETTI, et al.,

Plaintiffs,

Case No. 1:22-cv-523

v. JUDGE DOUGLAS R. COLE

ALLERGAN SALES, LLC,

Defendant.

OPINION AND ORDER

Lauren Bossetti, Deborah DiMeglio, and Tara Guida all took the drug Lexapro

while pregnant. All subsequently gave birth to a child with autism spectrum disorder.

Each then sued Allergan Sales, LLC, who designed1 and manufactures Lexapro. They

assert a host of statutory and common-law claims under the laws of their respective

states (Ohio, New Jersey, and Virginia). In support of these claims, Plaintiffs allege,

among other theories, that Allergan defectively designed Lexapro in a way that

caused their children’s disorders.

Allergan now moves to dismiss but in a targeted fashion. The company asks

the Court to (1) preclude Plaintiffs, on federal preemption grounds, from relying on a

design defect theory to support their claims, (2) dismiss certain of Plaintiffs’ common-

law claims as abrogated by state statute, and (3) dismiss Plaintiffs’ request for

punitive damages. And Plaintiffs have acquiesced in part—they voluntarily

1 Technically, Plaintiffs allege a predecessor company designed Lexapro. (Doc. 1, #3). No

party disputes that Allergan may bear liability, though, as a successor in interest. For

purposes of this Opinion, the Court will refer to Allergan as Lexapro’s designer.

dismissed those common-law claims that Allergan claimed were abrogated. Thus,

only the first and third requests above remain pending. For the reasons discussed

below, the Court GRANTS Allergan’s Motion to Dismiss (Doc. 5) on these issues.

BACKGROUND

Lexapro is an FDA-approved antidepressant and anti-anxiety drug.2 (Compl.,

Doc. 1, #2–3). Allergan designed, labeled, markets, and sells Lexapro. (Id. at #3).

Lauren Bossetti of Ohio, Deborah DiMeglio of New Jersey, and Tara Guida of Virginia

all took Lexapro while pregnant. (Id. at #1–2). But when they gave birth, medical

professionals diagnosed each Plaintiff’s child with autism spectrum disorder.3 (Id. at

#16). Plaintiffs believe Lexapro caused their children’s disorders.

Bossetti, DeMeglio, and Guida sued Allergan in a nine-count Complaint

asserting common-law and statutory claims under Ohio, New Jersey, and Virginia

law. (Id. at #14–27). As noted, Allergan then moved to dismiss in three limited ways.

(Doc. 5). First, Allergan claims federal law preempted any theory of relief tied to an

alleged design defect in Lexapro’s formulation. (Id. at #47–52). Second, it says that

state law abrogated certain of Plaintiffs’ common-law claims (Counts I–V as to

Bossetti, Counts I–III and V as to DeMeglio, and Count I as to Guida). (Id. at #52–

2 When deciding a motion to dismiss for failure to state a claim, the Court assumes that the

complaint’s factual allegations are true. Thus, the Court largely relies on the facts in

Plaintiffs’ Complaint for this decision but with the caveat that these facts are not yet

established and may never be. Koren v. Neil, No. 1:21-cv-9, 2022 WL 974340, at *1 (S.D. Ohio

Mar. 31, 2022).

3 The Complaint at one point alleges Plaintiffs themselves developed autism spectrum

disorder from taking Lexapro. (Doc. 1, #15). But reading the Complaint as a whole, the Court

believes this is a typo and that Plaintiffs rather meant their children developed this disorder.

55). Finally, Allergan argues that Plaintiffs cannot pursue punitive damages under

any theory. (Id. at #55–57). Beyond that, though, Allergan did not seek to dismiss the

Complaint outright.

Plaintiffs responded in two ways. First, they moved to sever and dismiss the

common-law claims Allergan challenged. (Doc. 11). The Court granted that motion.

(Not. Order 3/17/2023). As a result, Counts I–V as to Bossetti, Counts I–III and V as

to DeMeglio, and Count I as to Guida are no longer part of this case.

As for the remaining claims, Plaintiffs labeled Allergan’s preemption argument

premature. Accordingly, Plaintiffs asked the Court to deny Allergan’s Motion on that

basis and allow Plaintiffs to take discovery in support of their design defect theory.

(Resp., Doc. 10, #83–84). Plaintiffs did not respond, however, to Allergan’s arguments

directed at punitive damages.

All matters are now ripe.4

LEGAL STANDARD

To survive a motion to dismiss under Fed. R. Civ. P. 12(b)(6), a “complaint must

present sufficient facts to ‘state a claim to relief that is plausible on its face.’” Robbins

v. New Cingular Wireless PCS, LLC, 854 F.3d 315, 319 (6th Cir. 2017) (quoting Bell

4 The Court earlier raised concerns that Plaintiffs had filed their Complaint in an improper

venue, and the Court ordered the parties to explain why it should not sua sponte transfer the

matter to a different venue under 28 U.S.C. §§ 1404, 1406(a). (Not. Order 4/26/2023). In a

joint response, the parties notified this Court—for the first time—that they previously had

litigated this matter in Illinois. (Doc. 15). In that case, the parties agreed that Plaintiffs would

voluntarily dismiss and further agreed Plaintiffs may refile “in federal court in Ohio.” (Id. at

#135). However, Plaintiffs did not attach this agreement to their Complaint. For future

reference, it is helpful when plaintiffs attach to their complaints any agreements that bear

on a court’s ability to hear a given dispute.

Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)). In making that determination, the

Court “construe[s] the complaint in the light most favorable to the plaintiff.” Bassett

v. Nat’l Collegiate Athletic Ass’n, 528 F.3d 426, 430 (6th Cir. 2008) (quoting Directv,

Inc. v. Treesh, 487 F.3d 471, 476 (6th Cir. 2007)) (internal quotation marks omitted).

LAW AND ANALYSIS

Allergan’s Motion originally placed three issues before the Court. (Doc. 5). But

as noted, Plaintiffs have already resolved one of them by dismissing those common-

law claims that Allergan attacked. (Doc. 11; Not. Order 3/17/2023). So that leaves two

questions. First, whether federal law preempts Plaintiffs’ ability to rely on design

defect theories to support their various claims. And second, whether Plaintiffs can

pursue punitive damages under any theory. The Court addresses them in that order.

A. Federal Law Bars Plaintiffs’ Pre-Approval Design Defect Theories.

Plaintiffs’ Complaint contains a host of allegations aimed at Allergan’s design,

manufacture, labeling, and sale of Lexapro. Among these allegations, Plaintiffs say

that Allergan defectively designed Lexapro in a dangerous manner. (Doc. 1, #1–2).

And although only Bossetti brings a claim specifically labeled “Design Defect”—

Count VI—all three Plaintiffs allege design defect theories as support for their

various statutory and (remaining) common-law claims. (Doc. 1, #14–27). That is,

Plaintiffs seek to prove their claims through, among other things, reference to

Allergan’s formulation and design of Lexapro. Allergan, on the other hand, argues

that federal law preempts any design defect claim or theory of relief. Thus, Allergan

says, the Court can rule, based on Plaintiffs’ Complaint, that any portion of a claim

that relies on an alleged design defect is preempted and fails as a matter of law. (Doc.

5, #48–49; Doc. 14, #117). The Court agrees.

The United States Constitution makes federal law supreme. U.S. Const., Art.

VI, cl. 2. Courts operationalize this principle using the rubric of preemption. Federal

law can expressly or impliedly preempt state law. Yates v. Ortho-McNeil-Janssen

Pharms., Inc., 808 F.3d 281, 293 (6th Cir. 2015). Express preemption arises when

Congress states an intent to displace state law in statute. Altria Grp., Inc. v. Good,

555 U.S. 70, 76 (2008). Federal law impliedly preempts state law in at least two

circumstances: “when Congress intends federal law to occupy the field, or when state

law conflicts with a federal statute.” Crosby v. Nat’l Foreign Trade Council, 530 U.S.

363, 372–73 (2000) (cleaned up). Courts generally refer to the latter of these two as

“conflict preemption.” See, e.g., Mut. Pharm. Co., Inc. v. Bartlett, 570 U.S. 472, 479–

80 (2013) (“[S]tate laws that conflict with federal law are without effect.”) (citations

and internal quotation marks omitted).

Conflict preemption can arise in one of two ways: (1) “when it is impossible for

a private party to comply with both state and federal law,” or (2) when the state law

is “an obstacle to the accomplishment and execution of the full purposes and

objectives of Congress.” Yates, 808 F.3d at 294 (cleaned up) (quoting Crosby, 530 U.S.

at 372–73). Here, Allergan relies solely on impossibility preemption.

Impossibility preemption is a demanding and narrow defense. Id. First, the

court opens with an assumption the state retains its “historic police powers … unless

[a different result] was the clear and manifest purpose of Congress.” Id. (quoting

Wyeth v. Levine, 555 U.S. 555, 573 (2009)). Second, the court identifies the actions

state law would compel the defendant to take. Id. And third, the court asks whether

the defendant cannot take those actions because federal law expressly forbids it. Id.

If federal law does not expressly do so, the court ends by asking “whether the

defendant has presented ‘clear evidence’ that [a federal agency] would have

prohibited the defendant from taking the necessary steps under state law.” Id. (citing

Levine, 555 U.S. at 571). Along those lines, courts have held that “when a party

cannot satisfy its state duties without the Federal Government’s special permission

and assistance, which is dependent on the exercise of judgment by a federal agency,

that party cannot independently satisfy those state duties for pre-emption purposes.”

PLIVA, Inc. v. Mensing, 564 U.S. 604, 623–24 (2011).

Start with the state law. Plaintiffs bring multiple claims under Ohio, New

Jersey, and Virginia law. But at this stage, no party has articulated the elements of

these claims. Rather, all concede that the three states would impose some state-law

duty, whether by statute, common law, or both, on Allergan to design a reasonably

safe drug when it intends to sell that drug to the public. And the parties concede those

state-law duties would generally apply both before and after FDA approval. So for

this discussion, the Court will assume that is the case.

Turn next to federal law—the Food, Drug, and Cosmetic Act (FDCA). Relevant

here, that Act requires drug manufacturers to gain approval from the FDA before

marketing a drug in interstate commerce. Bartlett, 570 U.S. at 476. A manufacturer

receives that approval by submitting a new drug application, including data related

to the drug’s safety and efficacy. Id. The FDA can approve the drug only if it finds the

drug “safe for use” under “the conditions of use prescribed, recommended, or

suggested in the proposed labeling thereof” with the “probable therapeutic benefits

[] outweigh[ing] its risk of harm.” Id. (quoting 21 U.S.C. § 355(d) and FDA v. Brown

& Williamson Tobacco Corp., 529 U.S. 120, 140 (2000)). Once the FDA approves a

drug, a manufacturer cannot change the drug’s “qualitative or quantitative

formulation of the drug product” without prior approval from the FDA. Id. at 298

(quoting 21 C.F.R. § 314.70(b)(2)(i)).

“As a general matter, plaintiffs injured by brand-name prescription drugs

retain state-law tort remedies against the manufacturer of those drugs, provided it is

not impossible for the drug manufacturer to comply with both state and federal law.”

Yates, 808 F.3d at 294. For example, federal law will not preempt a plaintiff’s state-

law claim where a drug manufacturer can meet the state duty by acting on its own

volition without permission from the FDA. See PLIVA, Inc., 564 U.S. at 624. But

federal law will preempt a claim where the state-imposed duty would require a drug

manufacturer to unilaterally design or redesign a safer drug in a way that conflicts

with a manufacturer’s federal law obligations. Yates, 808 F.3d at 294. And, as

discussed below, a state duty cannot require a drug manufacturer to simply stop

selling an already FDA-approved drug to comply with that duty. See Bartlett, 570

U.S. at 488 (“Our pre-emption cases presume that an actor seeking to satisfy both his

federal- and state-law obligations is not required to cease acting altogether in order

to avoid liability.”).

In their response, Plaintiffs concede federal law likely preempts any state

duties requiring changes to a drug’s composition following FDA approval. (Doc. 10,

#84). Plaintiffs are right to do so. Redesigning Lexapro’s chemical composition

following FDA approval would constitute a “major” change, 21 C.F.R. § 314.70(b)(2)(i),

and Allergan cannot make such a change without FDA permission. See Yates, 808

F.3d at 298. So post-approval design-defect claims are clearly preempted.

But, Plaintiffs say, state-law duties can also attach before FDA approval. (Id.).

And here, Plaintiffs claim Allergan designed Lexapro defectively from the start,

thereby violating those state duties. (Id. at #86). In other words, Plaintiffs essentially

view federal law as creating a floor for safety standards, allowing states to impose

safety requirements going above that threshold. With that in mind, Plaintiffs argue

that federal law would not have stopped Allergan from designing an even safer

Lexapro in the first instance—before the FDA evaluated the drug. So Plaintiffs ask

for discovery on their pre-approval design defect rationale to find evidence supporting

that theory.

The Sixth Circuit, though, has already closed that road. In Yates v. Ortho-

McNeil-Janssen Pharmaceuticals, Inc., the circuit addressed whether a plaintiff may

recover for injuries relating to a defendant’s design choices made before FDA

approval. 808 F.3d at 298. The circuit said no, labeling any hypothetical pre-approval

duty as “too attenuated”:

To imagine such a pre-approval duty exists, we would have to speculate

that had defendants designed [the drug] differently, the FDA would

have approved the alternate design. Next, we would have to assume that

[plaintiff] would have selected this [drug for use]. Further yet, we would

have to suppose that this alternate design would not have caused

[plaintiff] to suffer [an injury]. This is several steps too far.

Id. at 298–99. Beyond that, the circuit also found that the Supreme Court decision in

Mutual Pharmaceuticals Co., Inc. v. Bartlett, 570 U.S. (2013), had tacitly foreclosed

the pre-approval theory. See Yates, 808 F.3d at 300. In Bartlett, the high Court

rejected a “stop-selling” rationale as a proposed alternative path for a defendant to

comply with a state-law duty, on the grounds that “[o]ur pre-emption cases presume

that an actor … is not required to cease acting altogether in order to avoid liability.”

570 U.S. at 488. According to Yates, that reasoning also prevented plaintiffs from

relying on a pre-approval design-defect theory:

In contending that defendants’ pre-approval duty would have resulted

in a [drug] with a different formulation, [plaintiff] essentially argues

that defendants should never have sold the FDA-approved formulation

of [the drug] in the first place. We reject this never-start selling rationale

for the same reasons the Supreme Court in Bartlett rejected the stop-

selling rationale.

808 F.3d at 300.

Yates is directly on point. Like the plaintiff in Yates, Plaintiffs argue Allergan

had a state-law duty to design a safer Lexapro before seeking FDA approval. That is

the very theory Yates rejected, meaning Plaintiffs cannot rely on it here.5 See, e.g.,

Fleming v. Janssen Pharms., Inc., 186 F. Supp. 3d 826, 833 (W.D. Tenn. 2016).

Seeking to avoid that outcome, Plaintiffs point to Yates’s procedural posture.

(Doc. 10, #85). There, the circuit reviewed an opinion granting summary judgment,

5 The Court acknowledges some out-of-circuit courts have cast doubt on Yates. See, e.g., Holley

v. Gilead Scis., 379 F. Supp. 3d 809 (N.D. Cal. 2019). But if Plaintiffs wish to challenge Yates,

that is a matter they must take up with the Sixth Circuit.

meaning the parties had already developed the record. 808 F.3d at 286. And the Yates

court chastised the plaintiff for failing to precisely explain “what a pre-approval claim

would look like in her case.” Id. at 300. Plaintiffs argue that here they have not fully

benefited from discovery, nor have they had an opportunity to “precisely” explain the

duty they claim Allergan violated. Thus, discovery is needed, they say, before the

Court rules on Allergan’s preemption defense. (Doc. 10, #85–86).

The Court disagrees. Sure, impossibility preemption is a demanding defense,

and in some (perhaps many) cases facts matter to that defense. But the Yates panel

stated that it could not “conceive of any coherent pre-approval duty that defendants

would have owed to [the plaintiff] when it was developing” the drug at issue. Yates,

808 F.3d at 300. And Yates spoke in terms of law, not fact, when labeling the pre-

approval rationale akin to the “stop selling” rationale that Bartlett rejected. Simply

put, a state-law duty that would require a drug manufacturer to stop selling—or

indeed never start selling—a drug that ultimately received FDA-approval collides

with the FDCA as a matter of law.

Against that backdrop, discovery that is meant to prove Allergan could have

designed Lexapro better from the start provides no help. Taking their allegations at

face value, Plaintiffs claim that Allergan should have never sold Lexapro in its

current formulation in Ohio, New Jersey, or Virginia—even after the FDA approved

it. That is the same legal argument the Sixth Circuit found incompatible with federal

law. Factual discovery cannot change that result. For that reason, dismissal on the

pleadings is proper. See, e.g., Brashear v. Pacira Pharms., Inc., No. 1:21-cv-700, 2023

WL 3075403, at *3 (S.D. Ohio Apr. 25, 2023); Fleming, 186 F. Supp. 3d at 833.

In a last-ditch effort, Plaintiffs point to Wimbush v. Wyeth, 619 F.3d 632 (6th

Cir. 2010). There, a district court had held that state-law tort claims against drug

manufacturers conflict with the FDA’s general authority to regulate the safety and

efficacy of prescription drugs. Id. at 641–42. The Wimbush panel reversed, holding

that “as a general proposition, we can discern no physical impossibility between

complying with a state law duty to exercise reasonable care in the process leading up

to placing a drug on the market and complying with the federal government’s process

for approving drugs,” and that “we are not persuaded that it is always impossible to

comply with both state law duties and FDA regulations in the process leading up to

FDA approval.” Id. at 643 (emphasis added). But the ruling stood on narrow terms:

“We hold merely that FDA approval does not automatically preempt state law tort

claims for negligence.” Id. at 646.

Plaintiffs emphasize that Yates concedes “Wimbush is still good law.” Yates,

808 F.3d at 300. From this, they say dismissal on the pleadings is premature given

Winbush’s conclusion that the FDA’s purpose and approval process do “not

automatically preempt state law.” 619 F.3d at 646.

Again, the Court does not agree. Wimbush and Yates are admittedly in tension.

And Wimbush, as the earlier published decision, controls. See Wright v. Spaulding,

939 F.3d 695, 700 (6th Cir. 2019) (“Like most circuits, this circuit follows the rule that

the holding of a published panel opinion binds all later panels unless overruled or

abrogated en banc or by the Supreme Court.”). But Wimbush explored whether “as a

general proposition” a manufacturer can comply with both FDA and state-law duties

in the pre-approval context, while Yates specifically targeted the viability of pre-

approval design-defect claims. And the latter context is the one that matters here.

Putting a point on that distinction, Wimbush preceded the Supreme Court’s

2013 decision in Bartlett. And, as noted, the Yates court expressly relied on Bartlett’s

“stop selling” rationale when rejecting a proposed pre-approval design-defect duty.

See Yates, 808 F.3d at 293 (“[W]e find that Yates’s design defect claim is preempted

under Bartlett.”). Under the law of this circuit, then, Bartlett freed the Yates panel to

rule contrary to the Wimbush panel, at least as to pre-approval design-defect claims.

See Wright, 939 F.3d at 700. In short, Yates and Bartlett together close the door on

Plaintiffs’ pre-approval design defect theory, Wimbush notwithstanding.

Accordingly, the Court holds that Plaintiffs cannot advance claims against

Allergan based on a design defect theory. The remaining question, then, is how to

implement that decision here. After all, Plaintiffs label only one count “Design

Defect”—Count VI. That said, other counts rely on a design defect theory, at least in

part. And Sixth Circuit precedent makes clear the Court can dismiss a portion of

count where appropriate without dismissing the entire count. See, e.g., O’Neill v.

Louisville/Jefferson Cnty. Metro Gov’t, 662 F.3d 723, 735–36 (6th Cir. 2011).

Accordingly, the Court dismisses Count VI in its entirety, and also dismisses any

portion of any remaining count that asserts liability based on arguments that

Allergan should have designed Lexapro differently—whether pre- or post-approval.

B. Plaintiffs Cannot Pursue Punitive Damages.

The Court moves next to punitive damages. In its Motion to Dismiss, Allergan

argued Plaintiffs had not stated a plausible claim for punitive damages. (Doc. 5, #55).

Plaintiffs elected not to respond to that argument. When plaintiffs fail to respond to

an argument raised in a motion to dismiss, courts routinely find the plaintiffs have

waived any arguments they could have made. See, e.g., Lloyd v. Pokorny, No. 2:20-cv-

2928, 2020 WL 4455547, at *9 (S.D. Ohio Aug. 3, 2020). The Court finds such waiver

here.

Still, “[t]he law in this Circuit is not entirely clear whether a party’s mere

failure to respond to a dispositive motion constitutes a sufficient ground for granting

the motion.” LaDrigue v. City of Bay City, No. 1:19-cv-11196, 2022 WL 1205000, at *7

(E.D. Mich. Apr. 22, 2022). So the Court will briefly address whether Plaintiffs have

plausibly alleged a demand for punitive damages.

Plaintiffs’ Complaint seeks punitive damages under both Ohio and New Jersey

law. (Doc. 1, #18–19, 21–27). Ohio law does not permit punitive damages against a

manufacturer of a drug if that drug was “manufactured and labeled … in accordance

with” FDA guidelines. Monroe v. Novartis Pharms. Corp., 29 F. Supp. 3d 1115, 1129

(S.D. Ohio 2014) (quoting Ohio Rev. Code §§ 2307.80, 2307.80(C)(1)). Still, the Ohio

statute provides a narrow exception where a plaintiff can show by a preponderance

of the evidence that the manufacturer fraudulently withheld information from the

FDA related to the plaintiff’s alleged harm. Id. The same is true in New Jersey. N.J.

Stat. Ann. § 2A:58C–5(c). Plaintiffs presumably seek to rely on those exceptions.

But the Supreme Court has held that federal law largely preempts such “state-

law fraud-on-the-FDA claims.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341,

348–49 (2001) (concluding that the “federal statutory scheme amply empowers the

FDA to … investigate suspected fraud”). This includes both Ohio’s and New Jersey’s

statutes. Brashear, 2023 WL 3075403, at *6–7; McDarby v. Merck & Co., Inc., 949

A.2d 223, 276 (N.J. Super. Ct. App. Div. 2008). And following Buckman, the Sixth

Circuit recognized that such a claim may only proceed if “some federal agency” has

already acknowledged fraud against the FDA. In re Aredia & Zometa Prods. Liab.

Litig., 352 F. App’x 994, 995 (6th Cir. 2009).

In other words, Plaintiffs may receive punitive damages under Ohio or New

Jersey law only if the FDA (or some other federal agency) has already discovered that

Allergan made a fraudulent representation about Lexapro to the FDA. See Monroe,

29 F. Supp. 3d at 1130. Yet Plaintiffs have provided no allegations along those lines.

At most, they say Allergan “deliberately concealed the causal relationship between in

utero exposure to Lexapro … and neurodevelopmental delay.” (Doc. 1, #27). But they

do not allege that Allergan concealed that causal link from the FDA—let alone allege

that some agency uncovered any such concealment. Accordingly, Plaintiffs have not

alleged a plausible claim for punitive damages, and the Court dismisses any claim for

them here.

CONCLUSION

For the reasons discussed, the Court GRANTS Allergan’s Motion to Dismiss

(Doc. 5). Accordingly, Plaintiffs may proceed on these claims: for Bossetti, Counts VII

and VIII; for DiMeglio, Counts IV and IX; and for Guida, Counts II, III, IV, and V.

But in proving those claims, Plaintiffs may not pursue a theory of relief relating to

an alleged design defect in Allergan’s formulation of Lexapro. And Plaintiffs may not

pursue punitive damages. Finally, as no Plaintiff currently proceeds under Counts I

or VI, the Court dismisses those counts in their entirety. In its Answer, Allergan may

respond to the Complaint’s allegations as though the dismissed counts and theory

had not been included in the Complaint.

SO ORDERED.

June 15, 2023 □

DATE DOUGLAS R. COLE

UNITED STATES DISTRICT JUDGE

15