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

UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT

August Term, 2020

Argued: March 23, 2021 Fully Submitted Post-Certification: July 22, 2022

Decided: August 8, 2022

Docket No. 20-1156-cv

MARJORIE GLOVER, CHARLES GLOVER,

Plaintiffs-Appellants,

— 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 through 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.**

Plaintiffs-Appellants appeal from a district court judgment dismissing, as preempted by the federal Food, Drug, and Cosmetic Act (“FDCA”), their claims under the Connecticut Product Liability Act (“CPLA”) for injuries caused by a medical device, and denying leave to amend the complaint to include a claim under the Connecticut Unfair Trade Practices Act (“CUTPA”). Because both issues turned on unresolved questions of state law, we certified two questions to the Supreme Court of Connecticut to clarify the scope of the CPLA and CUPTA. In view of the Connecticut Supreme Court’s answers to those questions, we hold: (1) that the Plaintiffs-Appellants’ CPLA claims are not preempted by the FDCA because traditional Connecticut tort law provides a cause of action for failing to provide adequate warnings to regulators such as the United States Food and Drug Administration; and (2) that Plaintiffs-Appellants’ proposed CUTPA claim would be precluded by the CPLA. Accordingly, we vacate the district court’s dismissal of the CPLA claims, affirm the district court’s denial of leave to amend the complaint, and remand for further proceedings.

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 (Brigid F. Cech Samole, Miami, FL, Lori G. Cohen, Atlanta, GA, Daniel I.A. Smulian, Robert J. Kirshenberg,

** 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 Sarah H. Richardson, New York, NY, on the brief), for Defendants-Appellees.

GERARD E. LYNCH, Circuit Judge:

Plaintiffs-Appellants Marjorie Glover and Charles Glover appeal from a

judgment of the United States District Court for the District of Connecticut (Kari

A. Dooley, J.) dismissing, as preempted by the federal Food, Drug, and Cosmetic

Act (“FDCA”), their claims under the Connecticut Product Liability Act

(“CPLA”) for injuries allegedly resulting from use of a medical device, and

denying leave to amend the complaint to include a claim under the Connecticut

Unfair Trade Practices Act (“CUTPA”). Because both issues turned on unresolved

questions of state law, we certified two questions to the Supreme Court of

Connecticut to clarify the scope of the CPLA and CUTPA. Glover v. Bausch &

Lomb, Inc. (Glover I),

(2d Cir. 2021).

The Connecticut Supreme Court confirmed that the CPLA creates a cause

of action, rooted in traditional Connecticut tort law, against medical device

manufacturers that fail to provide adequate warnings to the relevant regulators

best positioned to take or recommend precautions against the potential harm.

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

(2022).

3 Accordingly, in view of the principles laid out in our previous decision, we

conclude that the Glovers’ CPLA claims are not preempted by the FDCA, and

VACATE the district court’s dismissal of the CPLA claims. The Connecticut

Supreme Court also held that the proposed CUTPA claim would be precluded by

the CPLA.

. Accordingly, we conclude that the proposed amendment

would be futile, and AFFIRM the district court’s denial of leave to amend the

complaint. The matter is REMANDED to the district court for further

proceedings.

DISCUSSION

We assume the parties’ familiarity with the procedural history and facts of

the case set forth in our prior opinion. See Glover I,

. In brief, the

Glovers brought negligence and failure-to-warn claims against Bausch & Lomb

Incorporated and related entities (collectively, “B&L”) under the CPLA,

-572h and 52-572q, for injuries allegedly resulting from the use of

B&L’s Trulign Toric intraocular lenses. The district court dismissed the

complaint, concluding that the Glovers’ claims under the CPLA were expressly

and impliedly preempted by the FDCA. The court also denied leave to amend the

complaint to add a claim under CUTPA,

-110a, et seq., based

4 on wrongful marketing, concluding that the CUTPA claim would also be

preempted by the FDCA. This appeal followed.

Our previous opinion explained that the Glovers’ CPLA claims would not

be preempted provided that they: (1) were cognizable causes of action under

traditional state tort law; and (2) did not impose additional requirements beyond

the FDCA. See Glover I,

. Because the preemption analysis turned

on unresolved questions of state law, we certified a question to the Supreme

Court of Connecticut asking “[w]hether a cause of action exists under the

negligence or failure-to-warn provisions of the [CPLA], or elsewhere in

Connecticut law, based on a manufacturer’s alleged failure to report adverse

events to a regulator like the [United States Food and Drug Administration

(“FDA”)] following approval of [a] device, or to comply with a regulator's

post-approval requirements.”

. We also certified a second question

asking whether, as a matter of state law, the CPLA’s exclusivity provisions

barred the Glovers’ proposed CUTPA claim.

The Connecticut Supreme Court

answered both questions in the affirmative. Glover II,

.

On July 6, 2022, we ordered the parties to show cause why, in light of the

Connecticut Supreme Court’s opinion, we should not vacate the district court’s

5 dismissal of the Glovers’ CPLA claims and affirm the denial of leave to amend

the complaint to include an additional claim under CUTPA. See Order to Show

Cause, No. 20-1156, Dkt. 108, (2d Cir. July 6, 2022). The parties agree that the

Connecticut Supreme Court’s opinion effectively forecloses the CUTPA claim. See

Appellants’ Letter Br. at 2-3; Appellees’ Letter Br. at 3. We agree: the proposed

amendment would be futile and we therefore affirm the district court’s denial of

leave to amend.

However, B&L maintains that we should affirm the dismissal of the CPLA

claims for being preempted by federal law. We reject that contention.

In the course of its analysis, the Supreme Court of Connecticut stated that

while there would be no duty for a manufacturer “to report adverse events

associated with the device to the FDA in the absence of federal law requiring such

reports,” it does not follow that “no state law duty to report adverse events to the

FDA exists.” Glover II,

(emphasis in original). B&L points to that

statement as evidence that the duty to warn under the CPLA exists “solely by

virtue of the FDCA” reporting requirements and is thus preempted by the FDCA.

Appellees’ Letter Br. at 1. That argument misreads the Connecticut Supreme

Court’s opinion.

6 The Connecticut Supreme Court explained, inter alia, that the CPLA

imposes a duty on manufacturers “to provide suitable warnings to the person

best able to take or recommend precautions against the potential harm.” Glover II,

(internal citations omitted). That “person,” the Court held, is not

restricted to healthcare providers, and may include regulators such as the FDA.

. The Court did not create a cause of action against parties that violate

the FDCA or fail to comply with orders of the FDA. Rather, the portion of the

opinion cited by B&L highlights that a manufacturer may need to report “to the

FDA,” as opposed to some other learned intermediary, because the role of that

agency under federal law renders it the entity best able to take or recommend

precautions against the dangers posed by certain medical devices.

. The

duty recognized by the Supreme Court of Connecticut does not exist solely by

virtue of the FDCA; rather, it is “based on well established state law principles

governing the statutory and common-law duty to provide warnings about a

product to the person in the best position to take or recommend precautions and

the general duty to use care.”

at 551 n.26.

We previously stated that the Glovers’ CPLA claims “can proceed, if at all,

only if the CPLA provides a cause of action based on a manufacturer's failure to

7 report adverse events to a regulator like the FDA, or to comply with

post-approval requirements set by that regulator.” Glover I,

. The

Supreme Court of Connecticut has advised that the CPLA provides precisely that

cause of action. The CPLA claims pleaded in the complaint thus fall into the

“narrow gap” that is neither implicitly nor explicitly preempted under the FDCA:

the Glovers are “suing for conduct that violates the FDCA . . . , but [they are not]

suing because the conduct violates the FDCA.”

(internal quotation marks

omitted; emphasis added). Rather, their cause of action is based on “traditional

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

(quoting Buckman Co. v. Plaintiffs' Legal Comm.,

(2001)).

CONCLUSION

For the reasons set forth above, we VACATE the district court’s dismissal

of the Glovers’ CPLA claims, AFFIRM its denial of leave to amend the complaint

to include a claim under CUTPA, and REMAND for further proceedings to

adjudicate the Glovers’ CPLA claims.

8