Gibbons v. Bristol-Myers Squibb Co.

U.S. Court of Appeals for the Second Circuit

Gibbons v. Bristol-Myers Squibb Co.

Opinion

17‐2638, et al. Gibbons v. Bristol‐Myers Squibb Co.

United States Court of Appeals for the Second Circuit

AUGUST TERM 2018

Nos. 17‐2638, 17‐2642, 17‐2643, 17‐2648, 17‐2661, 17‐2667, 17‐2677, 17‐2687, 17‐3765, 17‐3867

CATHERINE GIBBONS, ET AL., Plaintiffs‐Appellants,

v.

BRISTOL‐MYERS SQUIBB COMPANY AND PFIZER INC., Defendants‐Appellees.

ARGUED: NOVEMBER 27, 2018 DECIDED: MARCH 26, 2019

Before: LIVINGSTON, CARNEY, SULLIVAN, CIRCUIT JUDGES.

In this multi‐district litigation, Plaintiffs bring a series of products liability actions against Defendants, the makers of Eliquis, for injuries they or decedents on whose behalf they are suing suffered while taking the drug. The United States District Court for the Southern District of New York (Cote, J.) denied motions to remand many of the actions to state court and then dismissed sixty‐four suits – fifteen of which are now before this Court – for failure to state a claim. Because removal was proper and because Plaintiffs’ complaints do not meet the Rule 8 standard, we affirm.

LAWRENCE R. LASSITER, Miller Weisbrod, LLP, Dallas, TX and Lisa Causey‐Streete, Salim‐Beasley, LLC, Natchitoches, LA, for Plaintiffs‐Appellants.

NEAL KUMAR KATYAL (with Eugene A. Sokoloff and Mitchell P. Reich on the brief), Hogan Lovells US LLP, Washington, DC and Loren H. Brown (with Cara D. Edwards and Lucas P. Przymusinski), DLA PIPER LLP (US), New York, NY, for Defendants‐Appellees.

RICHARD J. SULLIVAN, Circuit Judge:

Plaintiffs in this multi‐district litigation appeal from judgments entered by

the United States District Court for the Southern District of New York (Denise L.

Cote, J.) dismissing their products liability claims for injuries allegedly caused by

the drug Eliquis (apixaban). Specifically, Plaintiffs assert that the district court (1)

incorrectly denied motions to remand forty‐four of the sixty‐four cases before it,

and (2) wrongly concluded that Plaintiffs’ state law claims were preempted by the

Food, Drug, and Cosmetics Act (“FDCA”). Because, as explained below, we agree

that removal was proper and that Plaintiffs’ state law claims are preempted, we

AFFIRM.

I. BACKGROUND

Defendants Bristol‐Myers Squibb Co. (“BMS”) and Pfizer Inc. (“Pfizer”) are

pharmaceutical companies that are incorporated in Delaware and maintain their

2 principal places of business in New York. Together, Defendants manufacture and

distribute Eliquis, a blood‐thinning medication used to reduce the risk of stroke in

patients with atrial fibrillation. As might be expected, Eliquis increases patients’

risk of bleeding. To that end, the drug, which was approved by the Food and Drug

Administration in 2012, carries warnings about the risk of serious, and possibly

fatal, bleeding events.

In 2015, plaintiffs nationwide began to bring products liability actions

against Defendants, asserting that they or their decedents had suffered excessive

bleeding after taking Eliquis that resulted in substantial injury (both physical and

financial) or even death. Although the suits arose under the laws of several states,

plaintiffs generally alleged that the injuries they or their decedents suffered were

attributable to the improper design of Eliquis and the insufficient warning labels

that accompanied the drug. Seventeen such suits made their way to the United

States District Court for the Southern District of New York, where they were

assigned to Judge Cote. The district court ordered the parties to identify a single

bellwether case, and the parties selected Utts v. Bristol‐Myers Squibb Co., No. 16‐cv‐

5688, for that purpose. Defendants moved to dismiss the complaint in that

exemplar action, and on December 23, 2016, the district court granted Defendants’

3 motion in part. See Utts v. Bristol‐Myers Squibb Co.,

226  F.  Supp.  3d  166

, 189

S.D.N.Y. 2016) (“Utts I”). The district court concluded that most of the claims in

the Utts complaint, including the failure‐to‐warn claims, were preempted by the

FDCA, and that the others simply did not meet the Rule 8 pleading threshold.

Id.

The district court dismissed the design defect allegations with prejudice, but

granted leave to amend the remaining claims.

Id.

The Utts plaintiffs filed their

first amended complaint on January 20, 2017.

Following the district court’s dismissal of the original complaint in Utts, the

Judicial Panel on Multidistrict Litigation transferred all Eliquis products liability

actions pending in federal court to the Southern District of New York and assigned

them to Judge Cote. See S.D.N.Y. Case. No. 17‐md‐2754 (DLC), Doc. No. 1. Judge

Cote thereafter determined that the best procedure for the MDL would be to (1)

allow the plaintiffs in Utts to amend their complaint again, (2) have the parties

brief a motion to dismiss that complaint, and then, (3) following its ruling on the

motion to dismiss the amended complaint in Utts, permit the parties either to (a)

proceed to discovery in all cases (if the motion were denied) or (b) have the non‐

Utts plaintiffs show cause why their similar complaints should not also be

dismissed on the grounds set out in the Utts opinion. The parties agreed.

4 The plaintiffs in Utts amended their complaint on February 24, 2017, setting

out ten claims for: (1) manufacturing defect; (2) failure to warn; (3) strict liability;

(4) negligence; (5) breach of express warranty; (6) breach of implied warranty; (7)

fraudulent concealment; (8) negligent misrepresentation; (9) violation of the

California consumer protection laws; and (10) loss of consortium. Defendants

again moved to dismiss, and the district court again granted the motion, rejecting

all of the Utts plaintiffs’ claims under Federal Rule of Civil Procedure 12(b)(6). See

Utts v. Bristol‐Myers Squibb Co.,

251 F. Supp. 3d 644, 684

(S.D.N.Y. 2017) (“Utts II”).

Following the entry of Utts II, the district court gave the plaintiffs in the other

pending MDL suits two weeks to (1) amend their complaints and (2) show cause

why those complaints should not be dismissed in light of Utts II. Out of sixty‐

eight then‐pending actions, just nineteen plaintiffs attempted to show cause why

dismissal was not warranted. None was successful.

As it had earlier in the case, the district court set out its reasoning in an

exemplar opinion – this time, Fortner v. Bristol‐Myers Squibb Co., No. 17‐cv‐1562

(DLC),

2017 WL 3193928

(S.D.N.Y. July 26, 2017). In that decision, the district court

concluded that (1) Plaintiffs’ negligence and strict liability claims were preempted

by the FDCA to the extent they were based on a design defect theory, and to the

5 extent they were based on a “failure to warn” theory, they were preempted by the

FDCA and failed due to the label’s adequacy as a matter of law; (2) the breach of

warranty claims failed to state a claim; (3) the fraudulent concealment and

negligent misrepresentation claims failed under Rule 9(b); and (4) the state law

consumer protection claims were preempted and, in any event, failed to state a

claim.

Id.

at *2–5. The district court then applied that reasoning to dismiss the

other eighteen suits before it. Plaintiffs timely appealed those dismissals, which

were consolidated in this Court on September 15, 2017.

However, at the time the district court dismissed the nineteen actions before

it, not all Eliquis cases pending nationwide had become part of the MDL. Thus, at

least thirty‐three cases – all brought by the same counsel, Salim‐Beasley, LLC –

were pending in federal court in California awaiting transfer to the MDL at the

time of Utts II. Following the district court’s dismissal order in Utts II, the plaintiffs

in these thirty‐three California actions voluntarily dismissed their suits without

prejudice and refiled them in Delaware state court. Two days later, Defendants –

who had not yet been served with the Delaware complaints – removed the actions

to the United States District Court for the District of Delaware and requested that

they be transferred and consolidated into the MDL before Judge Cote. For their

6 part, the plaintiffs in the thirty‐three Delaware actions asked the District of

Delaware to remand their cases to state court, arguing that because the only basis

for federal court jurisdiction was diversity of citizenship, Defendants’ status as

citizens of Delaware meant that removal was prohibited under

28  U.S.C.  § 1441

(b)(2). The District of Delaware denied the plaintiffs’ motions, see Young v.

Bristol‐Myers Squibb Co., No. 17‐609‐LPS,

2017 WL 2774735

, at *3 (D. Del. June 27,

2017), and transferred the actions to Judge Cote, who eventually dismissed them

with prejudice for the reasons articulated in Utts II. Plaintiffs have not appealed

the dismissal of those actions.

Nevertheless, additional Eliquis plaintiffs – also represented by Salim‐

Beasley, LLC – adopted a new strategy whereby they filed a series of new suits in

Delaware state court. When Defendants again removed the cases to federal court

in Delaware before service, the new plaintiffs consented to the transfer of these

removed actions to the MDL, and then asked Judge Cote to remand the suits to

Delaware state court. See, e.g., Cheung v. Bristol‐Myers Squibb Co.,

282 F. Supp. 3d  638, 641

(S.D.N.Y. 2017) (addressing four such actions). The district court denied

Plaintiffs’ remand motions, see

id. at 644

, and then applied the earlier reasoning of

Utts II and Fortner to dismiss all forty‐five actions that came to it by this route (the

7 “Transferred Actions”). The plaintiffs in the Transferred Actions timely appealed,

and the forty‐five Transferred Actions were consolidated on appeal with the

nineteen Eliquis actions already pending before this Court, of which fifteen now

remain.1

II. STANDARD OF REVIEW

“We review a district court’s denial of a motion to remand de novo.”

O’Donnell v. AXA Equitable Life Ins. Co.,

887  F.3d  124,  128

(2d Cir. 2018). “In

reviewing a denial of a motion to remand, ‘the defendant bears the burden of

demonstrating the propriety of removal.’”

Id.

(quoting Cal. Pub. Emps.’ Ret. Sys. v.

WorldCom, Inc.,

368 F.3d 86, 100

(2d Cir. 2004)). We also “review de novo a district

court’s decision to grant a motion under Federal Rule of Civil Procedure 12(b)(6).”

Spinelli v. Nat’l Football League,

903 F.3d 185, 196

(2d Cir. 2018) (emphasis added).

III. DISCUSSION

A. Removal

Plaintiffs first challenge the district court’s denial of their motions to remand

the Transferred Actions. Specifically, Plaintiffs argue that because the only basis

The other forty‐nine cases were voluntarily dismissed prior to oral argument. See Motion 1

Order, No. 17‐2638 (2d Cir. June 20, 2018), ECF No. 128.

8 for federal court jurisdiction is diversity of citizenship,2 and because BMS and

Pfizer were sued in the state courts of their home state (Delaware), removal was

barred by the forum defendant rule,

28 U.S.C. § 1441

(b)(2), and the cases therefore

should be remanded to state court. We disagree.

Generally, any civil suit initiated in state court over which a district court

would have had original jurisdiction “may be removed by . . . the defendants, to

the district court of the United States for the district . . . embracing the place where

such action is pending.”

28 U.S.C. § 1441

(a). Section 1441 permits removal on the

basis of either federal question jurisdiction or diversity of citizenship. See Marcus

v. AT&T Corp.,

138 F.3d 46

, 52 (2d Cir. 1998). But where, as here, the only basis for

federal subject‐matter jurisdiction is diversity of citizenship under

28  U.S.C.  § 1332

, “the forum defendant rule applies.” Encompass Ins. Co. v. Stone Mansion

Rest. Inc.,

902 F.3d 147, 152

(3d Cir. 2018). Under that rule, which is set out at

28  U.S.C. § 1441

(b)(2), a suit that is “otherwise removable solely on the basis of . . .

[diversity of citizenship] may not be removed if any of the parties in interest

properly joined and served as defendants is a citizen of the State in which such

action is brought.”

The parties do not contest that the plaintiffs in all fifteen actions now before this Court are 2

diverse from Defendants.

9 In the usual case, application of the forum defendant rule is straightforward:

a defendant is sued in a diversity action in the state courts of its home state, is

served in accordance with state law, attempts to remove the case, and is rebuffed

by a district court applying Section 1441(b)(2). See, e.g., Wilmington Tr., N.A. v.

Pearson, No. 18‐cv‐4845 (PAC),

2018 WL 3918182

, at *1 (S.D.N.Y. Aug. 16, 2018).

Here, however, Defendants removed each of the Transferred Actions to federal

court after the suit was filed in state court but before any Defendant was served.

The district court, reasoning from the text of the statute, concluded that such

removal was proper. Cheung, 282 F. Supp. 3d at 641–42;3 see also Stan Winston

Creatures, Inc. v. Toys ‘R’ Us, Inc.,

314 F. Supp. 2d 177, 180

(S.D.N.Y. 2003). Other

district courts in this Circuit have reached the opposite conclusion. See, e.g.,

Torchlight Loan Servs., LLC. v. Column Fin., Inc., No. 12‐cv‐8579 (RWS),

2013  WL  3863887

, at *2 (S.D.N.Y. July 24, 2013); In re IntraLinks Holdings, Inc. Derivative Litig.,

No. 11‐cv‐9636 (TPG),

2013  WL  929836

, at *1–2 (S.D.N.Y. Mar. 11, 2013).

Nevertheless, in resolving this split among district courts, we agree with the

district court here that

28  U.S.C.  § 1441

(b)(2) is no barrier to the removal of the

3 The District of Delaware reached the same conclusion – that the text of Section 1442(b)(2) was no barrier to pre‐service removal by a home‐state defendant – in denying the motion to remand the thirty‐three California actions. Young,

2017 WL 2774735

, at *2. However, those actions are not before this Court.

10 Transferred Actions.

“Every exercise in statutory construction must begin with the words of the

text.” Saks v. Franklin Covey Co.,

316  F.3d  337, 345

(2d Cir. 2003). As the Third

Circuit – the only other Court of Appeals to address the propriety of pre‐service

removal by a defendant sued in its home state – recognized in Encompass Insurance,

“the language of the forum defendant rule in section 1441(b)(2) is unambiguous.”

902 F.3d at 152

. The statute plainly provides that an action may not be removed

to federal court on the basis of diversity of citizenship once a home‐state defendant

has been “properly joined and served.”

28 U.S.C. § 1441

(b)(2) (emphasis added). By

its text, then, Section 1441(b)(2) is inapplicable until a home‐state defendant has

been served in accordance with state law; until then, a state court lawsuit is

removable under Section 1441(a) so long as a federal district court can assume

jurisdiction over the action.

In fact, Plaintiffs do not even attempt to argue that the text of Section

1441(b)(2) supports their position. Instead, Plaintiffs argue that the Court should

depart from the plain meaning of Section 1441(b)(2) because applying the text of

the statute (1) produces an absurd result and (2) will lead to non‐uniform

application of the removal statute depending on the provisions of state law.

11 Neither argument is persuasive.

“It is, to be sure, well‐established that ‘[a] statute should be interpreted in a

way that avoids absurd results.’” Sec. Exch. Comm’n v. Rosenthal,

650 F.3d 156, 162

(2d Cir. 2011) (quoting United States v. Venturella,

391 F.3d 120, 126

(2d Cir. 2004)).

That being said, a statute is not “absurd” merely because it produces results that a

court or litigant finds anomalous or perhaps unwise. To the contrary, courts

should look beyond a statute’s text under the canon against absurdity “only

‘where the result of applying the plain language would be, in a genuine sense,

absurd, i.e., where it is quite impossible that Congress could have intended the

result and where the alleged absurdity is so clear as to be obvious to most

anyone.’” Catskill Mountains Chapter of Trout Unlimited, Inc. v. Envtl. Prot. Agency,

846 F.3d 492, 517

(2d Cir. 2017) (quoting Pub. Citizen v. U.S. Dep’t of Justice,

491 U.S.  440

, 470–71 (1989) (Kennedy, J., concurring in the judgment)).

Plaintiffs argue that applying the plain text of Section 1441(b)(2) produces

an absurd result in light of the overarching purpose of the removal statute, which

is to allow an out‐of‐state defendant to escape prejudice in the state courts of the

plaintiff’s home state by ensuring that a fair federal tribunal is available. In light

of this broad purpose, Plaintiffs frame the forum defendant rule as a carve‐out,

12 premised on the understanding that defendants are unlikely to be “home‐towned”

in their home state’s courts. Plaintiffs then explain the inclusion of the phrase

“properly joined and served” as Congress’s further recognition that crafty

plaintiffs might take advantage of the forum defendant rule to secure a state‐court

trial by naming an unnecessary home‐state defendant against which they did not

intend to proceed. Thus, Plaintiffs assert that it is absurd to allow a home‐state

defendant to use an exception meant to protect defendants from unfair bias (in the

courts of a plaintiff’s home state) and language designed to shield them from

gamesmanship (in the form of fraudulent joinder) to remove a lawsuit to federal

court.

Plaintiffs are, of course, correct about the general purposes of the removal

statute. See Lively v. Wild Oats Mkts., Inc.,

456  F.3d  933,  940

(9th Cir. 2006)

(“Removal based on diversity jurisdiction is intended to protect out‐of‐state

defendants from possible prejudices in state court.”). But while it might seem

anomalous to permit a defendant sued in its home state to remove a diversity

action, the language of the statute cannot be simply brushed aside. Allowing a

defendant that has not been served to remove a lawsuit to federal court “does not

contravene” Congress’s intent to combat fraudulent joinder. Encompass Ins., 902

13 F.3d at 153. In fact, Congress may well have adopted the “properly joined and

served” requirement in an attempt to both limit gamesmanship and provide a

bright‐line rule keyed on service, which is clearly more easily administered than a

fact‐specific inquiry into a plaintiff’s intent or opportunity to actually serve a

home‐state defendant. See Cheung,

282 F. Supp. 3d at 643

. Absurdity, then, cannot

justify a departure from the plain text of the statute.

Plaintiffs also urge us to look past the language of Section 1441(b)(2) to avoid

“non‐uniform application” of the forum defendant rule based on the vagaries of

state law service requirements. Plaintiffs are correct that allowing home‐state

defendants to remove on the basis of diversity before they are served might mean

that defendants sued in some states – those that require a delay between filing and

service, like Delaware – will be able to remove diversity actions to federal court

while defendants sued in others – those that permit a plaintiff to serve an action

as soon as it is filed – will not. But state‐by‐state variation is not uncommon in

federal litigation, including in the removal context, see, e.g., Murphy Bros., Inc. v.

Michetti Pipe Stringing, Inc.,

526 U.S. 344

, 354–55 (1999) (discussing state‐specific

variations in connection with the deadline to remove a suit to federal court), and

it does not follow from the existence of variation that we must look beyond the

14 plain text of Section 1441(b)(2).

Put simply, the result here – that a home‐state defendant may in limited

circumstances remove actions filed in state court on the basis of diversity of

citizenship – is authorized by the text of Section 1441(b)(2) and is neither absurd

nor fundamentally unfair. We therefore have no reason to depart from the

statute’s express language and must affirm the district court’s denial of Plaintiffs’

motions to remand.

B. Dismissal

Plaintiffs also challenge the district court’s dismissal of the remaining sixty‐

four suits – fifteen of which are now before us – on the grounds that their failure‐

to‐warn claims are preempted by the FDCA. Because we agree with the district

court that Plaintiffs’ negligence and strict liability claims, as alleged, are

preempted, we affirm the dismissal of those claims.4

4 While Plaintiffs purport to contest the dismissal of their complaints in their entirety, they make no arguments regarding the district court’s conclusion that their breach of warranty, fraud, or state consumer protection law claims were inadequately pled. For that reason, we decline to address those claims. See Norton v. Sam’s Club,

145  F.3d  114,  117

(2d Cir. 1998) (“Issues not sufficiently argued in the briefs are considered waived and normally will not be addressed on appeal.”). And while Plaintiffs do challenge the district court’s purported error in “sua sponte considering, ruling on, and granting motions that Appellees never made in their cases,” as well as its finding that the adequacy of Eliquis’s label could be determined at this stage in the proceeding, we need not reach these arguments given our affirmance of the district court’s conclusion as to preemption.

15 The federal government regulates the manufacture, labeling, and sale of

pharmaceuticals pursuant to the FDCA.

21 U.S.C. § 301

et seq.; see also Merck KGaA

v. Integra Lifesciences I, Ltd.,

545 U.S. 193, 196

(2005). To bring a drug to market, a

manufacturer must file a new drug application, which must explain the

drugmaker’s tests and studies, demonstrate that the drug is “safe for use under

the conditions prescribed,” and include proposed labeling language.

21  U.S.C.  § 355

(b)(1)(A), (b)(1)(F), (d). “The FDA’s premarket approval of a new drug

application includes the approval of the exact text in the proposed label.” Wyeth

v. Levine,

555 U.S. 555, 568

(2009).

The FDA can direct a pharmaceutical manufacturer to change a drug’s label

after it has entered the market, see

21 U.S.C. § 355

(o)(4), but “manufacturers, not

the FDA, bear primary responsibility for their drug labeling at all times,” Wyeth,

555 U.S. at 579

. Nevertheless, drug manufacturers are limited in their ability to

unilaterally change the labels on their products. Specifically, to make a change on

their own, a manufacturer must comply with the “changes being effected” (“CBE”)

regulation, set forth at

21 C.F.R. § 314.70

(c)(6)(iii). That regulation

allows drug manufacturers to change [a label] without the FDA’s preapproval if the changes ‘add or strengthen a contraindication, warning, precaution, or adverse reaction,’ or ‘add or strengthen an instruction about dosing and administration that is intended to

16 increase the safe usage of the drug product,’ in order to ‘reflect newly acquired information.’

Wyeth,

555  U.S.  at  591

(internal citations omitted) (quoting

21  C.F.R.  § 314.70

(c)(6)(iii)(A), and

21  C.F.R.  § 314.70

(c)(6)(iii)(C)). “Newly acquired

information” can include either new data or new analyses of previously submitted

data. See

21 C.F.R. § 314.3

(b).

“The Supremacy Clause establishes that federal law ‘shall be the supreme

Law of the Land . . . any Thing in the Constitution or Laws of any State to the

Contrary notwithstanding.’” PLIVA, Inc. v. Mensing,

564  U.S.  604,  617

(2011)

(quoting U.S. Const. art. VI, cl. 2). Where federal and state law conflict – that is,

where it is impossible for a party to follow both federal and state law – state law

must give way.

Id.

Because manufacturers may unilaterally update a drug’s label

if the change complies with the CBE regulation, a state law failure‐to‐warn claim

that depends on newly acquired information – information that Defendants could

have added to their label without FDA approval – is not preempted. See Wyeth,

555 U.S. at 568–72; see also In re Celexa & Lexapro Mktg. & Sales Practices Litig.,

779  F.3d 34

, 40–41 (1st Cir. 2015).

Following Wyeth, PLIVA, and a third case that addressed FDCA preemption

of state law failure‐to‐warn claims in connection with generic drugs, Mutual

17 Pharmaceutical Co., Inc. v. Bartlett,

570 U.S. 472

(2013), the Courts of Appeals have

synthesized the requirements to properly plead and then prove a state law failure‐

to‐warn claim based on post‐drug‐release information. Thus, to state a claim for

failure‐to‐warn that is not preempted by the FDCA, a plaintiff must plead “a

labeling deficiency that [Defendants] could have corrected using the CBE

regulation.” In re Celexa,

779 F.3d at 41

; see also Dolin v. GlaxoSmithKline LLC,

901  F.3d 803, 812

(7th Cir. 2018). If the plaintiff meets that standard, the burden shifts

to the party asserting a preemption defense to demonstrate that there is “‘clear

evidence that the FDA would not have approved a change’ to the [prescription

drug’s] label.” In re Fosamax (Alendronate Sodium) Prods. Liab. Litig.,

852 F.3d 268,  283

(3d Cir. 2017) (quoting Wyeth,

555 U.S. at 571

).

Plaintiffs’ claims here fail at the first step because, as the district court

recognized, they consist of “conclusory and vague” allegations and do not

plausibly allege the existence of newly acquired information that could have

justified Defendants’ revising the Eliquis label through the CBE regulation. For

example, the operative complaint in Fortner v. Bristol‐Myers Squibb Co. & Pfizer Inc.,

which is representative of all the pleadings now before us, alleges that “[b]efore

and after marketing Eliquis, [D]efendants became aware of many reports of

18 serious hemorrhaging in users of [their] drugs” and that “[n]umerous . . . studies

published after Eliquis’ approval in 2012 confirm the problematic bleeding events

associated with Eliquis.” Joint Appendix 1345–46, ¶¶ 62, 66. However, for these

“reports” and “studies” to constitute newly acquired information, as the term is

defined in

21 C.F.R. § 314.3

(b), they must have “reveal[ed] risks of a different type

or greater severity or frequency than previously included in submissions to the

FDA.”

Id.

As the district court observed, the Fortner complaint provides no basis

upon which the court could conclude that the bleeding events covered by the

alleged “reports” and “studies” presented a different type of risk than those the

company had discussed with the FDA, or were more severe or more frequent than

bleeding events that the government already knew about. See In re Celexa, 779 F.3d

at 42–43. Accordingly, Plaintiffs’ complaints were properly dismissed.

On appeal, Plaintiffs attempt to make hay out of the district court’s

references to Utts II in its Fortner opinion. Specifically, Plaintiffs argue that the

Utts complaint attached nine “reports, studies, and articles” that the district court

relied on in concluding that the Utts plaintiffs had failed to allege “newly acquired

information” within the meaning of the relevant regulations. Utts II, 251 F. Supp.

3d at 663–72. But because the Fortner complaint removed all references to the

19 reports, studies, and articles that were attached to the Utts complaint (compare

S.D.N.Y. Case. No. 16‐cv‐5668 (DLC), Doc. No. 33 with Joint Appendix 1335–72),

Plaintiffs now argue that the district court’s reliance on Utts II in Fortner must have

improperly considered the reports, studies, and articles, which Plaintiffs assert

were not part of the pleadings in Fortner.

Plaintiffs misread Fortner. Although the district court explained that the

allegations in the operative complaint in that case simply amounted to a less‐

detailed restatement of the Utts II allegations, it did not dismiss the Fortner

complaint because of the insufficiency of the sources cited in the second amended

Utts complaint. Instead, it reasoned that the Fortner complaint – and, by extension,

the other complaints now before this court – did not provide enough information

about the existence of newly‐acquired information to meet the Rule 8 threshold of

“a short and plain statement of the claim showing that the pleader is entitled to

relief.” Fed. R. Civ. Proc. 8(a)(2). Because we agree that Plaintiffs’ complaints lack

sufficient factual allegations to state a claim that is not preempted, we affirm the

judgments below.

Moreover, had the district court erred in the manner Plaintiffs suggest

(which it did not), we would still affirm, since – as discussed above – Plaintiffs’

20 complaints simply do not contain sufficient factual information to state a claim,

and we “may affirm on any grounds for which there is a record sufficient to permit

conclusions of law.” Mitchell v. City of New York,

841  F.3d  72,  77

(2d Cir. 2016)

(quoting Holcomb v. Lykens,

337 F.3d 217, 223

(2d Cir. 2003)).

IV. CONCLUSION

For the foregoing reasons, we AFFIRM the district court’s denial of the

motions to remand the Transferred Actions and AFFIRM the district court’s

dismissal of the fifteen actions now before this Court.

21

Reference

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