Glover v. Bausch & Lomb, Inc. ( 2021 )

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 28 U.S.C. § 46(d); 2d Cir. IOP E(b); United States v. Desimone, 140 F.3d
457, 458-59 (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 21
C.F.R. §§ 814.80, 814.82. If a manufacturer fails to comply with the FDA’s
regulations or any post-approval conditions, the agency may withdraw approval.
Id. § 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.” 21 C.F.R.
§ 814.3(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.
21 C.F.R. § 803.50(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, Conn. Gen. Stat. § 42-110a, 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., 443 F. Supp. 3d 259 (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, 634 F.3d 206, 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., 830 F.3d 152, 156 (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, 781 F.3d 25, 28 (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.” Id. 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, 331 Conn.
53 (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 Conn. Gen. Stat. § 51-199b(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., 552 U.S.
312, 315-16 (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, 518 U.S. 470 (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., 552 U.S. 312, 329 (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.” 518 U.S. at
495, 497 (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, 531 U.S. 341(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.” 21 U.S.C. § 337(a). In Buckman, the
Court explained that the FDA has the sole authority “to police fraud consistently
with the Administration’s judgment and objectives.” 531 U.S. at 350. 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. 531 U.S. at 352-53. 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[].” Id.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). 552 U.S. at
330. 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.” 552 U.S. at 323. Such claims would not be expressly preempted
because “the state duties in such a case parallel, rather than add to, federal
requirements.” Id.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., 860 F.3d 1319, 1327 (11th Cir. 2017),
17
quoting In re Medtronic, Inc., 623 F.3d 1200, 1204 (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, 623 F.3d at 1200, quoting Riley v. Cordis Corp., 625 F.
Supp. 2d 769, 777 (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.” 631 F.3d
762, 770 (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.” Id. at 775.
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.” 704 F.3d 1224, 1232
(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. Id. at 1233.
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. 630 F.3d 546 (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.” Id. at 559.
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.” Id. 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. Id. 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.” Id. at 560. 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.”
Id. at 557. 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.” Id.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. 623
F.3d at 1203. 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.” 860 F.3d at 1330.5 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,
860 F.3d at 1329. 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. Id. at 1329-30.
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.
985 F.3d 1272, 1281 (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, 531 U.S. at 353; see also Desiano v.
Warner-Lambert & Co., 467 F.3d 85, 95 (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, 552 U.S. 440 (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., 257 Conn. 365, 376 (2001); see also Hurley v. Heart Physicians,
P.C., 278 Conn. 305, 317 (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, 297 F.3d 66 (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,
631 F.3d at 769 (“[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, 2016 WL 4007547 at *3-*4 (D. Conn. Jul. 26, 2016); Pratt v. Bayer Corp., No.
19-cv-1310, 2020 WL 5749956 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, 2014 WL 1289426, 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, 2016 WL
4098715, 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., 8 F. Supp. 3d 93, 108 (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,” 704 F.3d at 1233, 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., 245 Ariz.
501, 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., 223 Cal. App. 4th
413, 428 (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, Conn. Gen. Stat. §§ 52-572h, 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., 2017 IL App (1st) 162928 (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, 467 F.3d at 91, 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, 331 Conn. 53, 109 (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.” Id.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.” Id.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.” Conn. Gen. Stat.
§ 52-572n. 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., 278 Conn. 305, 325 (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.” Id. at 325-26.
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. 331 Conn. at 65. 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. Id. at 107-08. 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.” Id. at 107.
The Court noted that such claims would “represent veiled product liability
claims” subject to the CPLA’s express preemption provision. Id. at 109. The court
further concluded, as a matter of first impression, that plaintiffs could seek
damages for personal injuries under CUTPA. Id. at 110.
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.” Id. at 109. 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, Conn. Gen. Stat.
§ 52-572n, bars a claim under the Connecticut Unfair Trade Practices Act, Conn. Gen.
Stat. § 42-110a, 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,
2019 WL 7499960, 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, 2020 WL 6263544, 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, 948 F.3d 529, 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, 863 F.3d 176, 183 (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.” Conn. Gen. Stat. §
51-199b; 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, 863 F.3d at 183 (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, Conn. Gen. Stat. §§ 52-572h,
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,
Conn. Gen. Stat. § 52-572n, bars a claim under the Connecticut Unfair Trade
Practices Act, Conn. Gen. Stat. § 42-110a, 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 Conn. Gen. Stat. § 51-199b and 2d Cir. R. 27.2(a), as ordered by the
United States Court of Appeals for the Second Circuit.
36