343 Conn. 513
Conn.2022Background
- Plaintiff Marjorie Glover underwent bilateral cataract surgery in 2014 in which the defendants’ Trulign Lens (a Class III medical device) was implanted; she developed postoperative "Z syndrome," underwent multiple corrective procedures, and suffered permanent vision impairment.
- The operative complaint alleged defendants knew of numerous Z syndrome incidents, failed to timely report adverse events to the FDA and delayed a required postmarket safety study, and that labeling was later revised to disclose risks.
- Defendants moved to dismiss in federal court asserting federal preemption under the FDCA/MDA; the District Court dismissed and denied leave to amend a CUTPA claim as futile.
- The Second Circuit found Connecticut law unclear on whether a manufacturer has a state-law duty to report adverse events or comply with postapproval requirements and certified two questions to the Connecticut Supreme Court: (1) whether a CPLA/negligence/failure-to-warn cause exists for failure to report to a regulator, and (2) whether the CPLA exclusivity provision bars a CUTPA claim premised on deceptive marketing of a dangerous product.
- The Connecticut Supreme Court held that (1) the CPLA can encompass a duty to report adverse events to the FDA (and compliance with postapproval requirements) where that reporting is the means to warn the person/entity best able to prevent harm, and (2) the CPLA’s exclusivity provision bars a CUTPA claim for personal injuries caused by unscrupulous marketing of an allegedly defective product.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Connecticut law (CPLA § 52-572q or common law) recognizes a negligence/failure-to-warn cause based on a manufacturer's failure to report adverse events to a regulator or to comply with postapproval requirements | Glover: CPLA's duty-to-warn extends to the person best able to take precautions; the FDA can be that person when manufacturers withhold information upstream, so failure to report (and to conduct required postmarket study) is actionable | Bausch & Lomb: Learned intermediary doctrine limits duty to physicians; no general state-law duty to report to FDA; recognizing such a duty would intrude on federal regulatory regime | Held: Yes. The CPLA and common-law duty framework can give rise to a claim for failure to report to the FDA or comply with postapproval requirements where a reasonable factfinder could conclude reporting would have (more likely than not) led to dissemination of the information (e.g., label change) and prevention of the plaintiff’s injury. |
| Whether CPLA exclusivity (§ 52-572n) bars a CUTPA claim alleging deceptive/aggressive marketing of a product known to present substantial risk of injury (seeking personal-injury damages) | Glover: CUTPA claim is distinct from a CPLA failure-to-warn claim and alleges wrongful marketing conduct; Soto allows CUTPA wrongful-advertising claims for personal injury | Bausch & Lomb: CPLA exclusivity displaces other claims seeking recovery for personal injury caused by a defective product; CUTPA cannot subsume a CPLA remedy | Held: Yes. The CPLA exclusivity provision bars a CUTPA claim that seeks personal-injury damages for deceptive marketing of an allegedly defective product; Gerrity and Soto carve out limited exceptions that do not cover the plaintiff’s claim here. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (MDA preemption framework for state-law claims about PMA devices)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) (state-law fraud-on-the-FDA claims impliedly preempted where they exist solely by virtue of FDCA)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (MDA not intended to displace general common-law duties broadly)
- Vitanza v. Upjohn Co., 257 Conn. 365 (2001) (adoption of learned intermediary doctrine under CPLA duty-to-warn analysis)
- Hurley v. Heart Physicians, P.C., 278 Conn. 305 (2006) (medical devices considered inherently unsafe; warnings to physicians can satisfy duty)
- Soto v. Bushmaster Firearms Int'l, LLC, 331 Conn. 53 (2019) (CPLA exclusivity does not bar CUTPA claims for wrongful marketing when product is not defective)
- Gerrity v. R.J. Reynolds Tobacco Co., 263 Conn. 120 (2003) (CPLA exclusivity does not bar CUTPA where plaintiff does not seek remedy for personal injury caused by a defective product)