43 F.4th 304
2d Cir.2022Background
- Plaintiffs Marjorie and Charles Glover sued Bausch & Lomb under the Connecticut Product Liability Act (CPLA) alleging injuries from Trulign Toric intraocular lenses and failure-to-warn/neglect to report adverse events.
- The district court dismissed the CPLA claims as preempted by the federal Food, Drug, and Cosmetic Act (FDCA) and denied leave to add a Connecticut Unfair Trade Practices Act (CUTPA) claim.
- The Second Circuit held preemption turned on unsettled Connecticut law and certified two questions to the Connecticut Supreme Court about (a) whether CPLA encompasses a duty to report adverse events or comply with FDA post‑approval requirements, and (b) whether CPLA precludes the proposed CUTPA claim.
- The Connecticut Supreme Court answered that CPLA does provide a cause of action rooted in traditional tort law for failing to warn or report to regulators like the FDA, and that the proposed CUTPA claim is precluded by the CPLA.
- In light of that decision, the Second Circuit vacated the district court’s dismissal of the CPLA claims, affirmed denial of leave to amend to add CUTPA (as futile), and remanded for further proceedings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether CPLA supplies a cause of action for a manufacturer's failure to report adverse events to a regulator or to comply with post‑approval FDA requirements, and thus whether FDCA preempts the CPLA claims | Glover: CPLA recognizes a state‑law duty to warn/report to the person best able to mitigate risk (which may be the FDA); claims are traditional tort claims, not federal‑law claims | Bausch & Lomb: Any duty to report to the FDA exists only because of the FDCA, so state claims are impliedly or expressly preempted | Held: Connecticut Supreme Court and 2d Cir. — CPLA provides that cause of action based on traditional state tort duties; claims are not preempted by the FDCA because they are grounded in state law, not federal violations |
| Whether the proposed CUTPA claim (wrongful marketing) is barred by the CPLA exclusivity provisions | Glover: Proposed CUTPA claim should be allowed as an alternative remedy for wrongful marketing | Bausch & Lomb: CUTPA claim is preempted or otherwise barred by CPLA exclusivity | Held: Proposed CUTPA claim is precluded by the CPLA; amendment would be futile, so denial of leave to amend affirmed |
Key Cases Cited
- Glover v. Bausch & Lomb, Inc., 6 F.4th 229 (2d Cir. 2021) (prior panel opinion explaining preemption framework and certifying questions to Connecticut Supreme Court)
- Glover v. Bausch & Lomb, Inc., 343 Conn. 513 (Conn. 2022) (Connecticut Supreme Court: CPLA creates state‑law duty to warn/report to the person best able to take precautions, which can include regulators; CUTPA claim precluded)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (U.S. 2001) (distinguishes state‑law torts rooted in traditional state duties from claims that conflict with or are derivative of federal regulatory schemes)
