Glover v. Bausch & Lomb, Inc.

• Decision Date: 07 June 2022
• Docket Number: SC 20607
• Parties: Marjorie GLOVER et al. v. BAUSCH & LOMB, INC., et al.
• Court: Connecticut Supreme Court

343 Conn. 513

275 A.3d 168

Marjorie GLOVER et al.

v.BAUSCH & LOMB, INC., et al.

SC 20607

Supreme Court of Connecticut.

Argued October 22, 2021

Officially released June 7, 2022

Wendy R. Fleishman, pro hac vice, with whom were Daniel E. Seltz, pro hac vice, Hugh W. Cuthbertson, New Haven, and, on the brief, Glenn A. Duhl, New Haven, and Leslie A. Brueckner, pro hac vice, for the plaintiffs (appellants).

Jeffrey R. Babbin, New Haven, with whom were Daniel Smulian, pro hac vice, Robert M. Langer, Hartford, and, on the brief, Lori G. Cohen, pro hac vice, for the defendants (appellees).

Sarah A. Ricciardi filed a brief for the Connecticut Trial Lawyers Association et al. as amici curiae.

John W. Cerreta, James H. Rotondo and Matthew J. Letten, Hartford, filed a brief for the Product Liability Advisory Council, Inc., as amicus curiae.

Robinson, C. J., and McDonald, D'Auria, Mullins, Kahn, Ecker and Keller, Js.

ROBINSON, C. J.

This case presents two questions of law certified to us by the United States Court of Appeals for the Second Circuit, pursuant to General Statutes § 51-199b (d),¹ regarding the interpretation the Connecticut Product Liability Act (CPLA), General Statutes § 52-572m et seq., and the Connecticut Unfair Trade Practices Act (CUTPA), General Statutes § 42-110a et seq. The plaintiff, Marjorie Glover,² brought this action in the United States District Court for the District of Connecticut, alleging that she had been injured by defective artificial lenses manufactured and marketed by the defendants, Bausch & Lomb, Inc., Bausch & Lomb Holdings, Inc., Valeant Pharmaceuticals International, Valeant Pharmaceuticals International, Inc., Valeant Pharmaceuticals North America, LLC, and the "Doe defendants."³ The plaintiff alleged, inter alia, that the defendants had violated the CPLA by failing to warn her of the inherent dangers of the artificial lenses, thereby causing injuries to her eyes. After the operative complaint was filed, the plaintiff filed a motion for leave to amend the complaint to add a claim that the defendants had violated CUTPA by engaging in deceptive advertising. The District Court granted the defendants’ motion to dismiss the plaintiff's claims pursuant to the CPLA on the ground that they were preempted by federal law. The court also denied the plaintiff's motion for leave to amend the complaint to add a CUTPA claim on the ground that the amendment would be futile because federal law would also preempt that claim.

The plaintiff appealed from the judgment of dismissal to the United States Court of Appeals for the Second Circuit. That court determined that the resolution of the plaintiff's claims depended on the interpretation of Connecticut law for which there was no controlling precedent in this court's decisions, and it requested certification of the following questions of law for our consideration: (1) "[w]hether a cause of action exists under the negligence or failure-to-warn provisions of the [CPLA, General Statutes §] 52-572q, 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 the device, or to comply with a regulator's [postapproval] requirements."⁴ And (2) "[w]hether the [CPLA's] exclusivity provision, [General Statutes] § 52-572n, bars a claim under [CUTPA] based on allegations that a manufacturer deceptively and aggressively marketed and promoted a product despite knowing that it presented a substantial risk of injury." Glover v. Bausch & Lomb, Inc. , 6 F.4th 229, 244 (2d Cir. 2021). We accepted the certified questions of law and answer "yes" to both.

The record reveals the following factual allegations made by the plaintiff, which we construe in her favor for purposes of answering the certified questions of law, and procedural history.⁵ See, e.g., Burton v. Dominion Nuclear Connecticut, Inc. , 300 Conn. 542, 550, 23 A.3d 1176 (2011) ("[i]n ruling [on] whether a complaint survives a motion to dismiss, a court must take the facts to be those alleged in the complaint, including those facts necessarily implied from the allegations, construing them in a manner most favorable to the pleader" (internal quotation marks omitted)). The defendants manufacture a product known as the Trulign Lens, which was designed and marketed as a medical device that is surgically implanted in a patient's eye to treat cataracts. In September, 2014, the plaintiff, who resides in Connecticut, underwent two successive cataract surgeries

during which her physician surgically implanted one Trulign Lens in each eye. Several weeks later, she began to experience significant loss of vision. Her physician ultimately diagnosed her vision problems as "Z syndrome," a postoperative complication unique to the Trulign Lens in which part of the lens moves forward toward the surface of the eye and part of the lens stays in place or moves backwards, creating a distinctive "Z" shape. The plaintiff was required to undergo multiple surgeries and other medical procedures and treatments in an unsuccessful attempt to correct the damage to her vision. Part of each lens was surgically removed, but fragments of the lenses remain, causing permanent impairment of both eyes.

The plaintiff brought this action against the defendants in the United States District Court for the Central District of California, where the defendants operated various offices and facilities. After the action was transferred to the United States District Court for the District of Connecticut, the plaintiff amended the complaint to include a claim that the defendants had violated the CPLA by failing to warn the plaintiff and her physicians about the dangers of the Trulign Lens, as well as other claims not relevant to the issues before us. In support of this claim, the plaintiff alleged in the operative complaint that the defendants were aware that the Trulign Lens had caused Z syndrome in numerous cases and that they had failed to report all of those cases to the FDA in a timely manner, as required by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq.⁶ The plaintiff further alleged that the defendants had failed to comply in a timely manner with an FDA condition of approval for the Trulign Lens requiring the defendants to conduct a postmarket safety study related to Z syndrome and to submit progress reports to the FDA. As a result of the defendants’ failure to report all of the known cases of Z syndrome to the FDA and to conduct the safety study in a timely manner, the plaintiff alleged that she and her physician were unaware of the true dangers of the Trulign Lens at the time of surgery.

She further alleged that, if she had known of the true risks, she would not have undergone the surgery. Finally, she alleged that, after the surgery, the labeling of the Trulign Lens was changed to reflect the true frequency of Z syndrome and to include instructions for minimizing risk and for treatment.

The defendants moved to dismiss all of the plaintiff's claims on the ground that they were preempted by federal law. Thereafter, the plaintiff moved for leave to amend the complaint to include a CUTPA claim based on allegations of unscrupulous marketing. The District Court granted the defendants’ motion to dismiss as to all counts. With respect to the failure to warn claim under the CPLA, the court observed that federal law "expressly preempts state law claims [when] ... (1) the FDA has established requirements applicable to the particular medical device; and (2) the state law claims would impose requirements with respect to the device that are different from, or in addition to the federal requirements that relate to either ... (i) safety or effectiveness; or (ii) any other matter included in a requirement applicable to the device." (Internal quotation marks omitted.) Doe v. Bausch & Lomb, Inc ., 443 F. Supp. 3d 259, 272 (D. Conn. 2020). In addition, the court observed that "a litigant's [state law] claim may be impliedly preempted when the [state law] claim is in substance (even if not in form) a claim for violating the FDCA—that is, when the state claim would not exist if the FDCA did not exist." (Emphasis in original; internal quotation marks omitted.) Id. Accordingly, the court concluded that, to the extent that the plaintiff claimed that the defendants had a duty to warn consumers or physicians of the dangers of the Trulign Lens, the claim was expressly preempted by federal law because it imposed a requirement that the FDCA did not imply. Id. With respect to the plaintiff's claim that the defendants violated the CPLA by failing to comply with federal law requiring them to report adverse events to the FDA, the court concluded that, "under Connecticut law, manufacturers do not have a duty to report adverse events to regulatory entities such as the FDA." Id., at 273. The court therefore concluded that the claim was impliedly preempted because it was wholly derivative of the FDCA. Id. With respect to the plaintiff's CUTPA claim, the court concluded that, because the claim was premised on the allegation that the defendants had inadequately warned of the dangers associated with the Trulign Lens, and because the plaintiff had not alleged that the warnings provided deviated from those approved by the FDA, the claim was expressly preempted by the FDCA. Id., at 275.

The plaintiff appealed from the judgment of dismissal to the United States Court of Appeals for the Second Circuit, contending that Connecticut law recognizes claims based on a failure to comply with (1) laws and regulations requiring a defendant to warn a government regulator, such as the FDA, of a product's known safety risks, and (2) the regulator's postapproval safety requirements. The plaintiff contended that, because this requirement of Connecticut law was both independent of and coextensive with the requirements of the FDCA, the failure to warn claim...