Glover v. Bausch & Lomb Inc.

Decision Date20 July 2021
Docket NumberDocket No. 20-1156-cv,August Term, 2020
Parties 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.
CourtU.S. Court of Appeals — Second Circuit

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

Before: Lynch and Nardini, Circuit Judges.**

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 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. AppellantsBr. 33. They argue that such a claim is not preempted for much the same reasons that their other claims are not 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.

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 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,

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 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 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 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...

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