Glover v. Bausch & Lomb, Inc. ( 2022 )

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 28 U.S.C. § 46(d); 2d Cir. IOP E(b); United States v. Desimone, 140 F.3d
457, 458-59 (2d Cir. 1998).
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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), 6 F.4th 229, 243-44 (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), 343 Conn. 513, 537-38 (2022).
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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. Id. at 563. 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, 6 F.4th at 233-35. In brief, the
Glovers brought negligence and failure-to-warn claims against Bausch & Lomb
Incorporated and related entities (collectively, “B&L”) under the CPLA, Conn.
Gen. Stat. §§ 52-572h 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, Conn. Gen. Stat. § 42-110a, et seq., based
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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, 6 F.4th at 237-38. 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.” Id. at 244. 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. Id. The Connecticut Supreme Court
answered both questions in the affirmative. Glover II, 343 Conn. at 563.
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
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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, 343 Conn. at 551 (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.
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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,
343 Conn. at 532 (internal citations omitted). That “person,” the Court held, is not
restricted to healthcare providers, and may include regulators such as the FDA.
Id. at 537-39. 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. Id. at 551. 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.” Id. 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
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report adverse events to a regulator like the FDA, or to comply with
post-approval requirements set by that regulator.” Glover I, 6 F.4th at 239. 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.” Id. at 237 (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[].” Id.
(quoting Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 353 (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.
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