6 F.4th 229
2d Cir.2021Background
- Plaintiff Marjorie Glover received bilateral Trulign Toric intraocular lenses (Class III devices) in 2014 and developed Z Syndrome causing permanent visual injury.
- Plaintiffs allege Bausch & Lomb (B&L) knew of Z Syndrome risk from a predecessor device, downplayed risks in the PMA process, delayed required post-approval Z‑Syndrome study, and failed to timely report adverse events to the FDA.
- The Trulign PMA supplement was approved with specific post-approval conditions (a safety study, periodic progress reports, and labeling updates); manufacturers must file adverse event reports under FDA regulations.
- District court dismissed the Glovers’ CPLA negligence and failure‑to‑warn claims and denied leave to add a CUTPA wrongful‑marketing claim, concluding those claims were preempted by the FDCA and therefore futile.
- On appeal the Second Circuit reserved decision and certified two questions to the Connecticut Supreme Court: (1) whether Connecticut law recognizes a state tort duty to report adverse events to a regulator or to comply with post‑approval requirements; and (2) whether the CPLA’s exclusivity provision bars a CUTPA wrongful‑marketing claim based on knowing deceptive promotion despite a product’s substantial risk.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Connecticut law provides a CPLA‑based cause of action for a manufacturer’s failure to report adverse events to a regulator or to comply with FDA post‑approval requirements | Glover: Connecticut law recognizes a traditional state‑law duty (negligence / failure to warn) that can include reporting to the regulator or complying with post‑approval conditions, so the claims are parallel to federal law and not impliedly or expressly preempted | Bausch & Lomb: Connecticut law imposes no general duty to report to regulators (learned intermediary focuses warnings to physicians); plaintiffs are effectively trying to enforce the FDCA, which only the FDA may do | Court reserved decision and certified to CT Supreme Court whether such a state‑law cause of action exists (preemption to be decided after state law determination) |
| Whether CPLA exclusivity bars a CUTPA claim alleging deceptive, aggressive marketing despite knowledge of substantial risk | Glover: Soto v. Bushmaster allows CUTPA recovery for wrongful marketing and CUTPA personal‑injury claims; their alleged deceptive marketing is the type Soto permits and is not a masked product‑defect claim | Bausch & Lomb: The CUTPA claim is a veiled product‑liability claim grounded in the product’s defect and thus barred by the CPLA exclusivity provision; also it would be preempted by FDCA | Court reserved decision and certified to CT Supreme Court whether Conn. Gen. Stat. § 52‑572n bars a CUTPA claim premised on deceptive/aggressive marketing despite known substantial risk |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (state common‑law claims that impose requirements different from or additional to federal PMA requirements are expressly preempted)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (state claims that exist solely by virtue of the FDCA’s federal requirements — e.g., fraud‑on‑the‑FDA theories — are impliedly preempted)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (§ 360k does not preempt traditional state common‑law duties that parallel federal requirements)
- Soto v. Bushmaster Firearms Int’l, LLC, 331 Conn. 53 (2019) (CUTPA permits personal‑injury recovery for wrongful marketing; not every advertising claim is barred by product‑liability exclusivity)
- Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc) (held negligence claim based on post‑approval monitoring/reporting can be a parallel state‑law claim not preempted where state law contemplates warnings to third parties such as the FDA)
- Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) (held failure‑to‑report adverse events to FDA can support a non‑preempted state failure‑to‑warn claim when pleaded as a traditional tort)