20-1156-cv Glover v. Bausch & Lomb, Inc.

UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT

August Term, 2020

Argued: March 23, 2021 Decided: July 20, 2021

Docket No. 20-1156-cv

MARJORIE GLOVER, CHARLES GLOVER,

Plaintiffs-Appellants,

JANE DOE, JOSEPH DOE,

Plaintiffs,

— v. —

BAUSCH & LOMB INCORPORATED, BAUSCH HEALTH COMPANIES INC. (F/K/A VALEANT PHARMACEUTICALS INTERNATIONAL, INC.), BAUSCH HEALTH US, LLC (F/K/A VALEANT PHARMACEUTICALS NORTH AMERICA LLC), BAUSCH HEALTH AMERICAS, INC. (F/K/A VALEANT PHARMACEUTICALS INTERNATIONAL), DOES 1 though 50, inclusive,

Defendants-Appellees.*

* The Clerk of the Court is respectfully directed to amend the caption as set forth above. B e f o r e:

LYNCH and NARDINI, Circuit Judges.**

This appeal raises questions regarding the scope of federal preemption of state tort law claims based on injuries caused by a medical device. Plaintiff- Appellant Marjorie Glover suffered post-operative injuries after she was implanted with artificial lenses during cataract surgery. She and her husband sued the manufacturer of the lenses, Defendant-Appellee Bausch & Lomb, Inc., and related entities. The Glovers now appeal an order of the United States District Court for the District of Connecticut (Kari A. Dooley, J.) granting Defendants’ motion to dismiss the Glovers’ negligence and failure-to-warn claims and denying their motion for leave to amend the complaint to add a claim based on wrongful marketing. On appeal, the Glovers argue that the district court erred in concluding that their negligence and failure-to-warn claims are preempted by federal law and further erred in denying leave to amend their complaint as futile. We conclude that the Glovers’ claims raise unresolved issues of state law that are appropriate for certification. We therefore reserve decision and certify two questions to the Supreme Court of Connecticut.

WENDY R. FLEISHMAN, Lieff Cabraser Heimann & Bernstein, LLP, New York, NY (Hugh W. Cuthbertson, Glenn A. Duhl, Zangari Cohn Cuthbertson Duhl & Grello P.C., New Haven, CT, on the brief), for Plaintiffs-Appellants.

ELLIOT H. SCHERKER , Greenberg Traurig, P.A., Miami, FL

** Judge Robert A. Katzmann, originally a member of the panel, died on June 9, 2021. The two remaining members of the panel, who agree, have determined the matter. See

(d); 2d Cir. IOP E(b); United States v. Desimone,

(2d Cir. 1998).

2 (Brigid F. Cech Samole, Miami, FL, Lori G. Cohen, Atlanta, GA, Daniel I.A. Smulian, Robert J. Kirshenberg, Sarah H. Richardson, New York, NY, on the brief), for Defendants-Appellees.

GERARD E. LYNCH, Circuit Judge:

This appeal raises questions regarding the scope of federal preemption of

state tort law claims based on injuries caused by a medical device.

Plaintiff-Appellant Marjorie Glover suffered pain and loss of vision after she was

implanted with Trulign Toric intraocular lenses (“Trulign Lenses”) in both of her

eyes to correct her vision following cataract surgery. She and her husband

(together, “the Glovers”) sued Defendant-Appellee Bausch & Lomb Incorporated

and related entities (collectively, “B&L”).1 The district court dismissed the

complaint, concluding, inter alia, that the Glovers’ negligence and failure-to-warn

claims under the Connecticut Product Liability Act (“CPLA”) were expressly and

impliedly preempted by the federal Food, Drug, and Cosmetic Act (“FDCA”).

The court also denied leave to amend the complaint to add a claim under the

1 Defendants-Appellees include Bausch & Lomb Incorporated, Bausch Health Companies Inc. (f/k/a Valeant Pharmaceuticals International, Inc.), Bausch Health US, LLC (f/k/a Valeant Pharmaceuticals North America LLC), Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International), and Does, 1 through 50, inclusive.

3 Connecticut Unfair Trade Practices Act (“CUTPA”) based on wrongful

marketing, concluding that amendment would be futile because the wrongful

marketing claim would also be preempted.

The Glovers appeal both decisions. They argue that their negligence and

failure-to-warn claims are not impliedly preempted because Connecticut law

includes a cause of action based on failure to warn a regulator, such as the FDA,

of known safety risks and failure to comply with a regulator’s post-approval

safety requirements. Therefore, they contend, those claims proceed under

traditional tort law and are not a veiled attempt to enforce federal requirements

that Congress has not provided a private right of action to enforce. They further

contend that their claims are not expressly preempted by the FDCA because they

impose no requirements different from or in addition to those imposed by federal

law. Finally, as to their CUTPA claim, the Glovers argue that amendment would

not be futile because Connecticut law permits a CUTPA claim for wrongful

marketing where a manufacturer “deceptively marketed and promoted” a

product “despite possessing information that [the product] presented a

substantial risk of causing” injury. Appellants’ Br. 33. They argue that such a

claim is not preempted for much the same reasons that their other claims are not

4 preempted, and further argue – responding to an argument that B&L made

below and renews on appeal, which the district court declined to address – that

their CUTPA claim is not barred by the exclusivity provision of the CPLA. As

explained below, we conclude that both issues turn on questions of state law for

which no controlling decisions of the Supreme Court of Connecticut exist.

Therefore, we certify two questions to the Supreme Court and reserve decision

on this case.

BACKGROUND

I. Factual and Legal Background

A. Regulation of Medical Devices

In 1976, Congress passed the Medical Device Amendments (“MDA”) to the

FDCA, which authorized federal regulation of medical devices. 21 U.S.C. § 360c

et seq. The FDCA, as amended by the MDA, divides medical devices into three

classes. As relevant here, Class III, the most stringently regulated class,

encompasses devices for which lesser controls are not clearly sufficient to assure

their safety and effectiveness, and which are “for a use in supporting or

sustaining human life or . . . of substantial importance in preventing impairment

5 of human health” or which “present[] a potential unreasonable risk of illness or

injury.” Id. § 360c(a)(1)(C)(i)-(ii).

Class III devices are subject to a pre-market approval (“PMA”) process, in

which the manufacturer must present to the FDA information about the device’s

safety and effectiveness, as well as proposed labeling for the device. Id.

§ 360e(c)(1). The FDA must determine whether approval is appropriate,

“weighing any probable benefit to health from the use of the device against any

probable risk of injury or illness from such use.” Id. § 360c(a)(2)(C).

The FDCA and its implementing regulations provide that the FDA may

approve a Class III device subject to additional post-approval conditions. See

, 814.82. If a manufacturer fails to comply with the FDA’s

regulations or any post-approval conditions, the agency may withdraw approval.

§ 814.82(c). Once a device has been approved, the manufacturer must submit a

supplemental application before making any change to the device that would

“affect[] safety or effectiveness.” 21 U.S.C. § 360e(d)(5)(A)(i).

Finally, the FDCA contains a provision expressly preempting state law.

The provision states that, save for exceptions not relevant here,

6 no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement-- (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

Id. § 360k(a).

B. The Trulign Toric Intraocular Lens

B&L’s Trulign Lens is a prescription medical device used to treat cataracts.

A cataract occurs when the naturally clear lens in a patient’s eye becomes cloudy.

The Trulign Lens is surgically implanted in a patient’s eye to replace the clouded

natural lens. The Trulign Lens is an “accommodating” lens – a lens that can flex

to change focus, allowing the patient to see clearly objects at different distances.

The Trulign Lens is classified as a Class III medical device under the

FDCA. Accordingly, B&L was required to seek FDA approval for the device.

Because B&L had already obtained approval for a predecessor device, the

Crystalens Intraocular Lens, B&L sought approval for the Trulign Lens through a

7 PMA supplement.2 The Glovers allege that during the PMA process for the

Trulign Lens, B&L “downplay[ed]” risks of the device. J.A. 179. Specifically, they

allege that B&L failed to alert the FDA to the extent of the risk of a condition

called Z Syndrome, a post-operative complication which occurs when one side of

the implanted lens pulls forward, while the other side remains in the normal

position or is pushed backward, resulting in a “Z” shape. The Glovers assert that

B&L was aware of several instances of Z Syndrome complications attributable to

the predecessor device, Crystalens.

In 2013, B&L received approval from the FDA for the Trulign Lens, subject

to certain post-approval conditions. The FDA required B&L to conduct a

post-market safety study specifically regarding Z Syndrome risk, to submit the

protocol for that study within 30 days of approval, and to submit progress

reports regarding the study every six months for the first two years. The FDA

also required that the results from that study be included in the labeling for the

2 A PMA supplement “means a supplemental application to an approved PMA for approval of a change or modification in a class III medical device, including all information submitted with or incorporated by reference therein.”

(g).

8 Trulign Lens as data became available and that updated labeling be submitted to

the FDA for approval.

Finally, B&L, like all manufacturers of medical devices, was required to

submit adverse event reports “no later than 30 calendar days after” becoming

aware of any information that:

[R]easonably suggests that a device that [B&L] market[ed]: (1) May have caused or contributed to a death or serious injury or (2) Has malfunctioned and this device or a similar device that [B&L] market[ed] would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.

(a).

C. Plaintiffs’ Injuries

In September 2014, Marjorie Glover underwent two successive cataract

surgeries during which her physician surgically implanted a Trulign Lens in each

eye. Shortly after her surgeries, she began to experience significant loss in visual

acuity, blurriness, hazing, halos, and eye pain. She was ultimately diagnosed

with Z Syndrome in both of her eyes. Her vision is permanently impaired, and

she has endured numerous procedures in the unsuccessful effort to correct her

9 condition. During these procedures, her doctors have been unable to remove

some components of the Trulign Lenses from her eyes.

The Glovers allege that Glover’s injuries were caused by the Trulign

Lenses. They further allege that B&L was aware that there was a substantial risk

that patients would develop Z Syndrome after the lenses were implanted and

failed to inform the FDA of the extent of that risk during the PMA process.

Finally, they allege that B&L failed to comply with the post-approval conditions

set by the FDA, including by failing to begin the FDA-required Z Syndrome

study until 2015, after Glover’s lenses were already implanted, and by failing to

inform the FDA of adverse events that occurred after approval. As a result, the

Glovers allege, Glover and her physician were unaware of the risk of Z

Syndrome when she chose to have the lenses implanted.

II. Procedural Background

In October 2017, the Glovers sued B&L in federal court in California. On

B&L’s motion, the case was transferred to the United States District Court for the

District of Connecticut. The Glovers filed an amended complaint in March 2018

and a second amended complaint (the “SAC”) in June 2018. In the SAC, the

Glovers alleged claims for failure to warn and negligence under the CPLA, Conn.

10 Gen. Stat. §§ 52-572h and 52-572q, along with related loss of consortium, and

other claims not at issue in this appeal.

On July 5, 2018, B&L moved to dismiss the SAC. The district court held

oral argument on the motion on January 17, 2019. On July 16, 2019, before the

motion was decided, the Glovers moved to amend their complaint to add a cause

of action under CUTPA,

-110a, et seq.; B&L opposed the

motion.

On March 11, 2020, the district court (Kari A. Dooley, J.) granted B&L’s

motion, dismissed the Glovers’ claims with prejudice, and denied leave to amend

the complaint. Doe v. Bausch & Lomb, Inc.,

(D. Conn. 2020). As

relevant here, the district court concluded that the Glovers’ failure-to-warn claim

was both expressly and impliedly preempted by federal law. The court

concluded that, to the extent the claim alleged that B&L failed to warn Glover and

her physicians, it was expressly preempted by § 360k of the FDCA because federal

law imposes no duty to warn patients and physicians of risks presented by

medical devices, apart from those warnings included on FDA-approved labels.

To the extent the claim alleged that B&L failed to warn the FDA of post-approval

adverse events, the district court concluded that it was impliedly preempted

11 because any such claim was “wholly derivative of the FDCA” and the Glovers

failed to identify a corresponding duty to warn the FDA under Connecticut law.

Id. at 273.

The court concluded that the Glovers’ negligence claim, which it

understood – similarly to the failure-to-warn claim – as based on failure to report

adverse events to the FDA, though “likely not expressly preempted,” was

impliedly preempted for much the same reason as the failure-to-warn claim. Id.

Finally, the district court denied leave to amend the complaint, concluding

that amendment to add a claim under CUTPA would be futile because

“[r]egardless as to whether the exclusivity provision of the CPLA bars CUTPA

claims, . . . [the Glovers’ claim] would be dismissed as expressly preempted by

§ 360k(a).” Id. at 275. The court reasoned that the CUTPA claim, if successful,

would require B&L to give warnings different from or in addition to those

approved by the FDA, which is impermissible under § 360k.

This appeal followed.

12 DISCUSSION

The Glovers appeal the dismissal of their failure-to-warn and negligence

claims under the CPLA and the related loss of consortium claim, as well as the

district court’s denial of leave to amend their complaint to add a claim under

CUTPA. They do not appeal the dismissal of their other claims. “We review de

novo a district court’s application of preemption principles.” Goodspeed Airport

LLC v. E. Haddam Inland Wetlands & Watercourses Comm’n,

, 209 n.3

(2d Cir. 2011) (internal quotation marks omitted).3 We also review de novo a

district court’s denial of a request for leave to amend based on futility. Orchard

Hill Master Fund Ltd. v. SBA Commc’ns Corp.,

(2d Cir. 2016).

The Glovers argue that the district court erred in dismissing their failure-

to-warn and negligence claims under Connecticut law as impliedly preempted

because they contend that Connecticut law “recognize[s] a medical device

manufacturer’s duty to timely and accurately report adverse events to the FDA”

3 As the district court correctly noted, preemption is “an affirmative defense,” Ricci v. Teamsters Union Loc. 456,

(2d Cir. 2015) (internal quotation marks omitted). However, preemption “can still support a motion to dismiss if the statute’s barrier to suit is evident from the face of the complaint.”

Here, because the district court concluded that the defense was apparent on the face of the complaint, and because the Glovers have not objected to the manner in which B&L raised the issue, we assume that the defense was properly raised.

13 and to comply with the FDA’s post-approval requirements. Appellants’ Br. 19.

They further contend that their failure-to-warn claim does not create additional

requirements for B&L beyond those imposed by the FDA and therefore that the

district court erred in concluding that the claim was expressly preempted.

Finally, as to their CUTPA claim, the Glovers argue that the district court erred in

concluding that amendment would be futile, because the Supreme Court of

Connecticut’s recent decision in Soto v. Bushmaster Firearms Int’l, LLC,

(2019), explicitly clarifies that CUTPA permits recovery for personal injuries

caused by wrongful marketing, and such a claim would not be expressly

preempted.

Because, as we explain below, the Glovers’ arguments ultimately turn on

questions of state law for which no controlling decisions of the Supreme Court of

Connecticut exist, we reserve decision and certify two questions to the Supreme

Court. See

-199b(d); 2d Cir. Local R. 27.2(a).

I. CPLA Claims

The Glovers contend that their negligence and failure-to-warn claims

under the CPLA are based on “overlapping conduct,” Appellants’ Br. 27, namely,

“B&L’s failures to conduct a required post-approval study and to report adverse

14 events,” which, they argue “not only constituted negligence, but also deprived

Mrs. Glover and her doctors of accurate information,” Appellants’ Reply Br. 6.

They argue that the district court erred in interpreting their failure-to-warn claim

in part as a challenge to the FDA-approved labeling. On appeal, they explicitly

limit their claims to those based on failure to comply with the FDA’s post-

approval requirements. Accordingly, we limit our analysis to that issue.4 B&L

contends that both claims, however interpreted, are preempted.

The MDA “swept back some state obligations and imposed a regime of

detailed federal oversight” of medical devices. Riegel v. Medtronic, Inc.,

(2008). Since its passage, the Supreme Court has several times

addressed the scope of federal preemption of state law regulation of medical

devices. In Medtronic, Inc. v. Lohr,

(1996), the Court interpreted the

FDCA’s express preemption provision, § 360k, which prohibits claims based on

state law that impose requirements “different from, or in addition to, any

requirement applicable . . . to the device” under federal law. The Court

concluded that § 360k did not preempt the Lohr plaintiffs’ “manufacturing and

4 However, to the extent that the SAC can be read to plead a labeling claim, we agree with the district court that any such claim is expressly preempted. See 21 U.S.C. § 360k; Riegel v. Medtronic, Inc.,

(2008).

15 labeling claims to the extent that they rest on claims that [the manufacturer]

negligently failed to comply with duties equal to, or substantially identical to,

requirements imposed under federal law” because “[n]othing in § 360k denies [a

state] the right to provide a traditional damages remedy for violations of

common-law duties when those duties parallel federal requirements.”

(internal quotation marks omitted). Importantly, the Court explained

that the scope of express preemption under the Act is limited: Ҥ 360(k) simply

was not intended to pre-empt most, let alone all, general common-law duties

enforced by damages actions.” Id. at 491 (plurality opinion).

Shortly thereafter, in Buckman Co. v. Plaintiffs’ Legal Committee,

(2001), the Court addressed implied preemption. The FDCA provides that “all . . .

proceedings for the enforcement, or to restrain violations, of [the FDCA] shall be

by and in the name of the United States.”

(a). In Buckman, the

Court explained that the FDA has the sole authority “to police fraud consistently

with the Administration’s judgment and objectives.”

. The Court

held that the Buckman plaintiffs’ claims that the manufacturer had misled the

FDA during the approval process were preempted because those “fraud-on-the-

FDA” claims “exist[ed] solely by virtue of the FDCA disclosure requirements”

16 and permitting such claims to proceed would “skew[] . . . [the] delicate balance of

statutory objectives” the FDA seeks to achieve in enforcing the FDCA’s

requirements.

. To avoid implied preemption, the Court

explained, claims must be based not on the FDCA, but on “traditional state tort

law which . . . predated the federal enactments in question[].”

Finally, in Riegel, the Court returned to the question of express preemption,

holding plaintiffs’ state common law claims preempted because they asserted

that the device in question “violated state tort law notwithstanding compliance

with the relevant federal requirements” and accordingly, imposed requirements

in addition to those imposed by federal law, contravening § 360(k).

. However, the Court again affirmed that Ҥ 360k does not prevent a State

from providing a damages remedy for claims premised on a violation of FDA

regulations.”

. Such claims would not be expressly preempted

because “the state duties in such a case parallel, rather than add to, federal

requirements.”

Together, express and implied preemption under the FDCA, “operating in

tandem, have created what some federal courts have described as a ‘narrow gap’

for pleadings.” Mink v. Smith & Nephew, Inc.,

(11th Cir. 2017),

17 quoting In re Medtronic, Inc.,

(8th Cir. 2010). “The plaintiff

must be suing for conduct that violates the FDCA (or else his claim is expressly

preempted by § 360k(a)), but the plaintiff must not be suing because the conduct

violates the FDCA (such a claim would be impliedly preempted under

Buckman).” In re Medtronic,

, quoting Riley v. Cordis Corp.,

(D. Minn. 2009).

Applying the Supreme Court’s analysis from Lohr, Buckman, and Riegel,

three of our sister circuits have concluded that state tort claims premised on a

failure to comply with the FDA’s post-approval requirements are not preempted.

The Fifth Circuit, in Hughes v. Boston Scientific Corp., concluded that a claim based

on a manufacturer’s failure to report adverse events to the FDA was not

expressly preempted by the FDCA because it did not “purport[] to impose

liability despite [the manufacturer’s] compliance with FDA regulations.”

(5th Cir. 2011). The court further concluded that the claim was not

impliedly preempted because the plaintiff was not “attempting to assert a

freestanding federal cause of action based on violation of the FDA’s regulations”

but rather “[wa]s asserting a Mississippi tort claim based on the underlying state

duty to warn about the dangers or risks of [a] product.”

.

18 Similarly, in Stengel v. Medtronic Inc., the plaintiffs alleged that the

manufacturer “had a continuing duty to monitor the product after pre-market

approval and to discover and report to the FDA any complaints about the

product’s performance and any adverse health consequences of which it became

aware and that are or may be attributable to the product” and that because the

manufacturer “failed to comply with its duty under federal law, it breached its

duty to use reasonable care under Arizona negligence law.”

(9th Cir. 2013) (en banc) (internal quotation marks omitted). The Ninth Circuit

concluded that plaintiffs’ negligence claim was not expressly or impliedly

preempted because “Arizona law contemplate[d] a warning to a third party such

as the FDA,” and therefore they had properly pleaded a “parallel” claim based

on state, not federal law.

.

Finally, in Bausch v. Stryker Corp., the Seventh Circuit concluded that the

plaintiff had successfully pleaded a claim that was not preempted, though based

on somewhat different factual allegations.

(7th Cir. 2010). There, the

plaintiff alleged that the FDA “conducted an inspection at the defendants’ . . .

manufacturing facility . . . [and] informed the defendants of numerous

deficiencies in the [device’s] manufacturing and inspection processes.”

.

19 Subsequently, “the FDA issued a letter to defendants . . . warning that the

[device] was adulterated due to manufacturing methods not in conformity with

industry and regulatory standards.”

The plaintiff alleged claims based on

Illinois strict product liability and negligence law, arguing that the defendants

knew or should have known that the device was defective before it was

implanted in her.

The court concluded that the plaintiff’s claims were not

expressly preempted because although the complaint “d[id] not specify the

precise defect or the specific federal regulatory requirements that were allegedly

violated,” the court reasoned that “if the problem turns out to be a failure to

comply with the FDA’s legally enforceable conditions for approval of the device,

section 360k will not protect the manufacturer.”

. The court also

determined that the claims were not impliedly preempted because they “[we]re

tort law claims based on manufacturing defects, not fraud on a federal agency.”

. The court explained that there was “no indication that Congress

intended preemption of state claims based on violations of federal law, beyond

the limitations set forth in the express preemption clause.”

In contrast, at least three circuits have concluded that claims arguably

similar to the Glovers’ claims here may not proceed. Examining those decisions

20 closely, however, it appears that those courts were doubtful that a traditional

state-law cause of action existed for failure to report adverse events to a regulator

like the FDA, and believed instead that the plaintiffs were attempting to directly

enforce the FDCA, a type of claim clearly foreclosed by Buckman and by the text

of the FDCA.

For example, the Eighth Circuit, in In re Medtronic, concluded that a claim

that “[the manufacturer] failed to provide the FDA with sufficient information

and did not timely file adverse event reports . . . [was] simply an attempt by

private parties to enforce the MDA” and therefore was impliedly preempted.

. Similarly, the Eleventh Circuit, in Mink, determined that a tort claim

based on failure to report adverse events to the FDA was impliedly preempted

because the manufacturer’s “duty [wa]s owed to the FDA,” not the plaintiff, and

the plaintiff’s “theory of liability [wa]s not one that state tort law has traditionally

occupied.”

.5 Finally, the Tenth Circuit, in Brooks v. Mentor

5 However, earlier in the opinion the court concluded that the plaintiff’s “‘failure to report adverse events’ theory [was] properly pled under Florida law.” Mink,

. Accordingly, it may be that the Mink court was drawing a distinction between claims that are “properly pled” under state law but are nonetheless preempted, and those that are in an area “state tort law has traditionally occupied” and therefore are not preempted.

.

21 Worldwide LLC, concluded that because the plaintiffs “ha[d] not identified a

state-law duty to comply with FDA-imposed post-approval requirements such as

testing and reporting” and because “the government retains the exclusive right to

enforce post-approval requirements for continued testing, including the right to

revoke approval for noncompliance,” those claims were impliedly preempted.

(10th Cir. 2021).

Considering these decisions, and the Supreme Court’s precedents in Lohr,

Buckman, and Riegel, it is clear that the Glovers’ claims can proceed, if at all, only

if the CPLA provides a cause of action based on a manufacturer’s failure to report

adverse events to a regulator like the FDA, or to comply with post-approval

requirements set by that regulator. Critically, to avoid express preemption any

such state-law cause of action may not impose requirements “different from, or

in addition to” the requirements imposed by federal law. 21 U.S.C. § 360k.

Moreover, the cause of action may not exist “solely by virtue of the FDCA

disclosure requirements” and must be based on “traditional state tort law,” or the

claim will be impliedly preempted. Buckman,

; see also Desiano v.

Warner-Lambert & Co.,

(2d Cir. 2006) (applying Buckman and

concluding that plaintiffs’ claims were not preempted because they were

22 “asserting claims that sound in traditional state tort law”), aff’d sub nom.

Warner-Lambert Co., LLC v. Kent,

(2008).

The Glovers argue that their claims under the CPLA meet these

requirements. They rely on the text of the CPLA’s negligence and failure-to-warn

provisions, and in particular § 52-572q(d), which provides in relevant part that

“[a] product seller may not be considered to have provided adequate warnings

or instructions unless they were devised to communicate with the person best

able to take or recommend precautions against the potential harm.” They argue

that here, “the person best able to take or recommend precautions against the

potential harm” is the FDA and, accordingly, under the CPLA, B&L has a duty to

report adverse events to the FDA, and to conduct the post-approval testing that

the FDA required.

B&L disagrees with the Glovers’ interpretation of Connecticut law and

contends that we should affirm the district court’s conclusion that “[t]here is no

general or background duty under Connecticut law to report risks to a regulatory

body” like the FDA. Appellees’ Br. 24, quoting Doe, 443 F. Supp. 3d at 273

(emphasis in original). B&L relies in part on Connecticut’s learned intermediary

doctrine, which provides that “adequate warnings to prescribing physicians

23 obviate the need for manufacturers . . . to warn ultimate consumers directly.”

Vitanza v. Upjohn Co.,

(2001); see also Hurley v. Heart Physicians,

P.C.,

(2006) (applying the doctrine to medical devices). B&L

argues that because the learned intermediary doctrine provides that

manufacturers owe a duty to warn physicians rather than end consumers,

Connecticut law has identified physicians as “the person[s] best able to take or

recommend precautions against the potential harm,” and thus cannot be

interpreted to require manufacturers also to warn regulators.6

However, neither party points to any binding Connecticut authorities on

the question of whether manufacturers have a duty to warn a regulator, nor are

we able to locate any. The Glovers cite our decision in Densberger v. United

Technologies Corporation,

(2d Cir. 2002), for the proposition that there

is a post-sale duty to warn sounding in negligence, which is cognizable under the

CPLA. But that decision certainly does not address whether Connecticut law

provides a cause of action for post-sale failure to warn a regulator. Both sides also

point to a number of federal district court decisions that they contend support

6 B&L also argues that we should affirm on the alternative ground that the Glovers failed to adequately plead causation. The district court did not reach that question and we decline to address it for the first time on appeal.

24 their respective positions.7 But those decisions are inconclusive with regard to the

question before us, and in any event are not authoritative sources of Connecticut

law.

We also observe that many of the previous decisions of our sister circuits

do not include extensive discussions of whether the relevant state law provided a

cause of action for failure to report adverse events to a regulator. See, e.g., Hughes,

(“[a]ssuming that a failure to warn claim may be pursued under

7 B&L points to two cases concluding that there is no duty under Connecticut law to report risks to a regulatory body like the FDA. Norman v. Bayer Corp., No. 16- cv-253,

at *3-*4 (D. Conn. Jul. 26, 2016); Pratt v. Bayer Corp., No. 19-cv-1310,

at *8 (D. Conn. Sept. 25, 2020). The Glovers, for their part, rely on several cases where the district court concluded that the plaintiff failed to identify a duty under state law, or failed to allege sufficient facts to support a claim, without deciding that no such duty exists under Connecticut law. The Glovers argue that those cases “signal[]” that “failure-to-warn claims, pled with enough specificity, would state a non-preempted parallel claim under Connecticut law,” Appellants’ Br. 19. See Simoneau v. Stryker Corp., No. 13-cv-1200,

, at *11 (D. Conn. Mar. 31, 2014) (noting that plaintiff “identifie[d] no separate state law duty to warn the FDA,” but permitting plaintiff to replead); Nagel v. Smith & Nephew, Inc., No. 15-cv-927,

, at *7 (D. Conn. July 28, 2016) (concluding that the facts alleged were “insufficient to indicate that defendant failed to comply with FDA requirements regarding reporting adverse events that would provide the basis for a parallel state law claim”); McConologue v. Smith & Nephew, Inc.,

(D. Conn. 2014) (dismissing claims without prejudice where plaintiff failed to allege facts showing that defendants “violated any duty of continuing reporting pursuant to the FDA’s premarket approval process”).

25 Mississippi law” without expressly addressing that issue). That appears to be a

significant omission, given that the preemption analysis turns on whether

plaintiffs successfully pleaded a traditional state law cause of action that exists

separately from the FDCA but does not impose requirements “different from, or

in addition to” the requirements imposed by federal law. 21 U.S.C. § 360k.

The Ninth Circuit’s decision in Stengel is particularly illuminating in that

regard. Several years after the Stengel court concluded that “Arizona law

contemplate[d] a warning to a third party such as the FDA,”

, the

Supreme Court of Arizona considered the issue and held that Arizona law in fact

imposed no such duty to warn the FDA. In Conklin v. Medtronic, Inc.,

, 508 (2018), the Supreme Court of Arizona explicitly disagreed with Stengel,

explaining that “[b]ecause only federal law, not state law, imposes a duty on [a

manufacturer] to submit adverse event reports to the FDA,” a failure-to-warn

claim was “at bottom . . . an attempt to enforce a federal law requirement” and

therefore was impliedly preempted.8

8 Intermediate courts of appeal in several other states have addressed whether the law of their state recognizes a duty to report adverse events to the FDA, reaching divergent conclusions. See Coleman v. Medtronic, Inc.,

(Cal. 2014) (concluding that, in light of a parallel California law duty, the plaintiff’s “failure to warn claim based on [the manufacturer’s] failure to file

26 Taking Stengel as a cautionary tale, we seek guidance on the issue of

whether Connecticut law imposes a duty on a manufacturer, enforceable in tort,

to warn the relevant regulator of potential dangers from its products. The answer

to that question is potentially dispositive of this appeal because, if Connecticut

law does not impose such a duty, then the Glovers’ claims here are an effort to

enforce the FDCA, which only the FDA may do. Accordingly, we certify the

following question to the Supreme Court of Connecticut: Whether a cause of action

exists under the negligence or failure-to-warn provisions of the Connecticut Product

Liability Act,

-572h, 52-572q, or elsewhere in Connecticut law,

based on a manufacturer’s alleged failure to report adverse events to a regulator like the

FDA following approval of a product, or to comply with a regulator’s post-approval

safety requirements for the product.9

adverse event reports with the FDA is not subject to express or implied preemption”); Norabuena v. Medtronic, Inc.,

(Ill. 2018) (concluding that plaintiffs’ claims were impliedly preempted because “there is no Illinois requirement” that the manufacturer “report adverse events to the FDA”). 9 Because preemption is a question of federal law, see Desiano,

, we certify only the question of whether Connecticut law recognizes such a cause of action, and not whether that cause of action would be preempted under the FDCA.

27 II. CUTPA Claims

The Glovers also appeal the district court’s denial of their motion for leave

to amend, through which they sought to plead an additional claim under

CUTPA. They argue that amendment would not be futile because an intervening

decision of the Supreme Court of Connecticut, Soto v. Bushmaster Firearms Int'l,

LLC,

(2019), “held . . . as a matter of first impression, that

CUTPA permits recovery for personal injuries” and that “the exclusivity

provision of the CPLA does not bar plaintiffs’ CUTPA personal injury claims.”

Appellants’ Br. 31 (internal quotation marks and alterations omitted), and

therefore, that they had a newly viable claim under CUTPA.

The Glovers’ CUTPA claim is based on B&L’s alleged “wrongful conduct

of suppressing known safety risks associated with the Trulign Lens.” Appellants’

Br. 33. Specifically, the Glovers allege that “[a]t the time of Mrs. Glover’s implants

in 2014, consumers did not have access to any information about Z Syndrome

complications associated with Trulign Lens usage” because of B&L’s “failure to

report these complications to the FDA and its failure to begin a safety study.”

They further allege that “B&L deceptively marketed and promoted” the lens,

“despite possessing information that Trulign Lens presented a substantial risk of

28 causing Z Syndrome complications.”

Before the district court, B&L argued that the Glovers’ motion for leave to

amend should be denied as futile, because their CUTPA claim was barred by the

exclusivity provision of the CPLA and also because it was preempted by the

FDCA. The district court denied the motion, concluding that the CUTPA claim

was expressly preempted by § 360k(a) of the FDCA, and declining to decide

whether it was barred by the CPLA’s exclusivity provision.

On appeal, the Glovers argue that the district court erred in concluding

that their CUTPA claim is preempted. B&L contends that the claim is preempted,

for the same reasons the Glovers’ CPLA claims are preempted, and that in any

event, it is barred by the exclusivity provision of the CPLA because it is, at

bottom, based on a defective product and under Connecticut law such claims

may be brought only under the CPLA. Therefore, to determine whether the

district court erred in denying the Glovers’ motion, we must determine whether

the CPLA’s exclusivity provision bars their claim under CUTPA. If it does, then

we need not address the question of whether the claim is preempted. Resolution

of the question of Connecticut law is thus potentially dispositive; if the CUTPA

claim is barred by the CPLA, the question of federal preemption will be moot.

29 The CPLA’s exclusivity provision states that the CPLA is the exclusive

remedy under Connecticut law “for harm caused by a product.”

-572n. The Supreme Court of Connecticut has made clear that the provision

bars claims not brought under the CPLA “that seek[] to recover damages for

personal injuries, including wrongful death, or for property damages, including

damage to the product itself, caused by the defective product.” Hurley v. Heart

Physicians, P.C.,

(2006). It permits claims not brought under

the CPLA, including those brought under CUTPA, only if they are “for an injury

not caused by the defective product, or if the party is not pursuing a claim for

personal injury, death or property damage.”

.

In Soto, the plaintiffs, administrators of the estates of decedents killed in

the Sandy Hook Elementary School shooting, sued Bushmaster, the maker of the

semiautomatic rifle used in the shooting.

. The court ruled, as

relevant here, that the plaintiffs’ CUTPA claim, which alleged that Bushmaster

“marketed the [rifle] by promoting the gun’s use for illegal purposes – offensive,

military style assault missions” could proceed and, in particular, was not barred

by the CPLA’s exclusivity provision.

. The court reasoned that

plaintiffs had not alleged that the product was defective, and notably, that

30 “[t]here [wa]s no allegation . . . that the marketing for the [rifle] contained

inadequate warnings that made the weapon unreasonably dangerous.”

.

The Court noted that such claims would “represent veiled product liability

claims” subject to the CPLA’s express preemption provision.

. The court

further concluded, as a matter of first impression, that plaintiffs could seek

damages for personal injuries under CUTPA.

.

The Glovers’ CUTPA claim may proceed only if it falls into the class of

CUTPA claims permitted under Soto – those for “wrongful advertising,” which

are not “masked product defect claims.”

. The Glovers argue that their

claim does fall into that category, because it alleges that B&L engaged in

wrongful advertising insofar as it “deceptively marketed and promoted its

Trulign Lens, despite possessing information that Trulign Lens presented a

substantial risk of causing Z Syndrome complications,” and that its marketing

was “particularly aggressive.” Appellants’ Br. 33. That, they argue, is precisely

the type of personal injury claim that Soto permits.

B&L argues that the Glovers’ CUTPA claim is foreclosed by the exclusivity

provision of the CPLA because unlike in Soto, the Glovers’ claim is based on an

allegedly defective product – the Trulign Lens – which caused Glover’s injuries.

31 They argue that Connecticut courts have routinely dismissed such claims as

barred by the CPLA’s exclusivity provision.

Whether the Glovers’ CUTPA claim may proceed turns on whether that

claim is barred by the CPLA’s exclusivity provision. That is a question of

Connecticut law that the State’s highest court has not answered.10 Accordingly,

we certify the following question to the Supreme Court of Connecticut: Whether

the Connecticut Product Liability Act’s exclusivity provision,

-572n, bars a claim under the Connecticut Unfair Trade Practices Act,

-110a, et seq., based on allegations that a manufacturer deceptively and

aggressively marketed and promoted a product despite knowing that it presented a

10 B&L points to several lower-court Connecticut decisions following Soto, which concluded that arguably similar CUTPA claims were barred by the exclusivity provision of the CPLA, despite Soto. See Phillips-Moldex Co. v. Beaulieu Co., LLC,

, at *5 (Conn. Super. Ct. Dec. 6, 2019) (concluding that where the plaintiffs sought to bring a CUTPA claim based on the failure of their roof, “[u]nlike the plaintiffs in Soto, the plaintiffs in the present action are seeking to recover damages caused by a defective product”); Appiah v. Home Depot U.S.A., Inc., 20-cv-489,

, at *5 (D. Conn. Oct. 23, 2020) (dismissing CUTPA claim that defendant had “wrongfully market[ed] the subject tile for use in bathrooms and kitchens with the knowledge that such tile was unsafe and unsuitable for that purpose” because it was barred by the CPLA’s exclusivity provision). However, these decisions do not offer an interpretation of Connecticut law binding on us, and in any event address claims arguably distinguishable from those presented in this case.

32 substantial risk of injury.

III. Certification

“Although the parties did not request certification, we are empowered to

seek certification nostra sponte.” CIT Bank N.A. v. Schiffman,

, 537 (2d

Cir. 2020) (internal quotation marks omitted). “We have long recognized the

appropriateness of according to state courts the opportunity to decide significant

issues of state law through the certification process.” Corsair Special Situations

Fund, L.P. v. Pesiri,

(2d Cir. 2017). The rules of the Supreme

Court of Connecticut provide that it “may answer a question of law certified to it

by a court of the United States . . . if the answer may be determinative of an issue

in pending litigation in the certifying court and if there is no controlling appellate

decision, constitutional provision or statute of this state.”

-199b; see also 2d Cir. R. 27.2(a) (“If state law permits, the court may certify a

question of state law to that state’s highest court.”).

Certification is an exercise of our discretion. In considering whether to

certify a question for review, we have “traditionally considered”:

[1] whether a state court decision has ever provided an authoritative answer[;] [2] the extent to which the question implicates the weighing of policy concerns of

33 particular importance[;] and [3] if the Connecticut Supreme Court’s answer may be determinative of the appeal.

Corsair,

(internal quotation marks, citations and alterations

omitted).

All three factors counsel in favor of certification here. First, the Supreme

Court of Connecticut has not, as noted above, provided an “authoritative

answer” to either of the questions for which we seek certification. Second, the

issues before us in this appeal implicate “policy concerns of particular

importance” because they will determine the extent to which plaintiffs are able to

proceed with tort claims based on allegedly defective medical devices under

Connecticut law. Finally, as explained in the preceding sections, the Supreme

Court’s responses may well be determinative of the issues in this appeal. If

Connecticut law does not recognize a cause of action based on failure to report

adverse events to a regulator, or to comply with a regulator’s post-approval

safety conditions, then the Glovers’ negligence and failure-to-warn claims are

likely foreclosed by Buckman. Conversely, if Connecticut law does recognize such

a cause of action, and the requirements imposed by Connecticut law are the same

as those imposed by federal law, then the Glovers’ claims may not be preempted.

34 Similarly, as to the second question, if the CPLA’s exclusivity provision bars a

CUTPA claim based on allegations that a manufacturer “deceptively” and

“aggressive[ly]” marketed and promoted a product despite knowing that it

presented a substantial risk of injury, then the Glovers’ claim under CUTPA

cannot proceed and the district court’s judgment must be affirmed.

Accordingly, we reserve decision and respectfully certify the following

questions to the Supreme Court of Connecticut.

Question 1:

Whether a cause of action exists under the negligence or failure-to-warn

provisions of the Connecticut Product Liability Act,

-572h,

52-572q, or elsewhere in Connecticut law, based on a manufacturer’s alleged

failure to report adverse events to a regulator like the FDA following approval of

the device, or to comply with a regulator’s post-approval requirements.

Question 2:

Whether the Connecticut Product Liability Act’s exclusivity provision,

-572n, bars a claim under the Connecticut Unfair Trade

Practices Act,

-110a, et seq., based on allegations that a

manufacturer deceptively and aggressively marketed and promoted a product

35 despite knowing that it presented a substantial risk of injury.

We invite the Supreme Court of Connecticut to construe liberally and, if

necessary, expand these certified questions to address related or other relevant

issues in connection with this appeal. We retain jurisdiction over the case once

the Supreme Court has either ruled on the certified questions or has declined

certification.

CONCLUSION

It is hereby ORDERED that the Clerk of this Court transmit to the Clerk of

the Supreme Court of Connecticut this opinion as our certificate, together with a

complete set of briefs, appendices, and the record filed in this case by the parties.

This panel retains jurisdiction for purposes of resolving this appeal after the

disposition of the certification by the Supreme Court of Connecticut.

CERTIFICATE

The foregoing is hereby certified to the Supreme Court of Connecticut

pursuant to

-199b and 2d Cir. R. 27.2(a), as ordered by the

United States Court of Appeals for the Second Circuit.

36