The brief addressed two issues on a certified question from the Second Circuit Court of Appeals: (1) Whether a cause of action exists under the negligence or failure-to-warn provisions of the Connecticut Product Liability Act (“CPLA”), or elsewhere in Connecticut law, based on a manufacturer’s alleged failure to report adverse events to a regulator like the FDA or to comply with a regulator’s post-approval requirements: and (2) whether the exclusivity provision of the CPLA bars a claim under the Connecticut Unfair Trade Practices Act (“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.
Background: The plaintiff alleged she was injured by defective artificial lenses manufactured and marketed by the defendants. The plaintiff brought negligence and failure-to-warn claims based on the defendant’s alleged failure to report adverse events to the FDA and to comply with FDA’s post-approval requirements. The plaintiff also sought leave to add a CUTPA claim based on the alleged deceptive and aggressive marketing of the artificial lenses. The U.S. District Court for the District of Connecticut dismissed the negligence and failure-to-warn claims based on federal preemption and denied leave to amend as futile because the CPLA bars CUTPA claims based on injuries caused by allegedly defective products.
On appeal, the U.S. Court of Appeals for the Second Circuit certified two questions to the Connecticut Supreme Court based on the absence of controlling authority. First, does Connecticut law recognize a tort claim based on the alleged failure to report information to a regulator? The Second Circuit certified this question because it is potentially dispositive of the preemption issue. Specifically, if the plaintiff’s claim does not exist under traditional state tort law principles, it would be preempted by the federal Food, Drug and Cosmetic Act (“FDCA”) because the claim would be based on federal law, not state law. Second, does the CPLA bar the plaintiff’s deceptive and aggressive marketing claim under CUTPA? Generally, the CPLA is the exclusive remedy under Connecticut law for product liability claims, subject to limited exceptions.
Result: On June 7, 2022, the Connecticut Supreme Court issued its decision holding, that the alleged failure to report adverse events to the FDA or to comply with the FDA’s post-approval requirements stated a cognizable claim under the CPLA. Typically, a manufacturer’s duty to warn under Connecticut law runs to the end-user of a product or, in the case of prescription drugs and medical devices, prescribing physicians. The Connecticut Supreme Court, however, concluded that the duty to warn embodied in the CPLA could run to other parties, including a regulator like the FDA, who stand in the best position to recommend precautions to the ultimate user. The Connecticut Supreme Court explained that this result was consistent with the broad, remedial purposes of the CPLA and general tort principles regarding the duty of care. PLAC had argued, among other things, that the Connecticut Supreme Court should not recognize a duty to warn the FDA because the FDA is not required either to publish or share those reports with the end user of the medical device. The Connecticut Supreme Court concluded that it was sufficient that the FDA might act on adverse event reports or communicate this information to the public. In addition, the Connecticut Supreme Court noted that this type of argument could still be made to the jury as part of disputing the foreseeability of plaintiff’s injuries and causation.
The Connecticut Supreme Court also held that the CPLA bars a deceptive and aggressive marketing claim under CUTPA for personal injuries caused by an allegedly defective product. Generally, the CPLA is the exclusive remedy for product liability claims under Connecticut law. The Connecticut Supreme Court previously recognized exceptions that permit a plaintiff to bring an unfair trade practices claims based on the sale of a product. These exceptions apply when the plaintiff does not seek a remedy for personal injury, death, or property damage, or where the plaintiff’s injury was caused by deceptive and aggressive marketing as opposed to a defective product. Because the plaintiff in this case sought damages for personal injury caused by an allegedly defective medical device, the CPLA’s exclusivity provision barred the claim. In a concurring opinion, one of the Justices expressed his doubt that the CPLA’s exclusivity provision bars any CUTPA claims but was compelled to agree with the majority because the plaintiff had not asked the Connecticut Supreme Court to reconsider its prior decisions.
Significance: The recognition of a duty-to-warn claim based on the alleged failure to report information to the FDA could expand the scope of state law claims in prescription drug and medical device cases that survive federal preemption by the FDCA. While the Connecticut Supreme Court did not decide the preemption issue, the Second Circuit seemed prepared to let the plaintiff’s claim proceed so long as it was cognizable under Connecticut law. This decision might also lead to new types of failure-to-warn claims in other product liability cases, with plaintiffs arguing that a manufacturer’s alleged failure to submit information to a regulator or comply with a regulatory requirement caused their injuries. On the other hand, the Connecticut Supreme Court’s construction of the CPLA’s exclusivity provision affirms, for now, that a plaintiff cannot allege an aggressive and deceptive marketing claim based on injuries caused by an allegedly defective product.

In the case, a plaintiff alleging an automobile design defect against GM sought to depose GM’s CEO, Mary Barra, based on general statements she made about the safety culture at GM and new safety programs. Ms. Barra attested she had no unique personal knowledge of the issues being litigated and sought a protective order pursuant to Georgia’s discovery code. The trial court and then the Court of Appeals denied the motion, ruling Ms. Barra could be deposed.
The Georgia Supreme Court granted review to decide whether Georgia rules support a version of the “apex doctrine,” which limits the circumstances in which a party may depose a high-level corporate executive. Although the Court stopped short of formally adopting the doctrine, it said the trial court must address the elements associated with the apex doctrine and, here, the trial court failed to do so. These elements include whether the executive’s high rank, lack of unique personal knowledge of relevant facts, and the availability of information from other sources demonstrate good cause for a protective order. The Georgia Supreme Court then remanded the case for reconsideration.
At bottom, this ruling is useful in that it requires trial courts to meaningfully assess the apex doctrine factors. Unlike in some other apex doctrine states, though, the factors are not dispositive. It will likely take time for jurisprudence to develop over how restrictive these factors will be in practice.

PLAC argued plaintiffs’ complaint described experiences indistinguishable from those of millions of owners of every complex consumer product sold in modern times: they had a problem with their products (laptop computers) after the express warranty expired and they had to pay for the necessary repairs (or replacements). Plaintiffs failed to distinguish the defect alleged in this case from the countless other defects that inevitably occur in all complex products and that are routinely repaired at the manufacturer’s expense (if they occur in the express warranty period) or at the consumer’s expense (if they occur after the warranty period). Binding decisions of Ninth Circuit and the California Court of Appeal squarely hold that there is no duty to disclose such defects unless they create an unreasonable safety risk. Williams v. Yamaha Motor Co., 851 F.3d 1015, 1025 (9th Cir. 2017); Wilson v. Hewlett-Packard Co., 668 F.3d 1136, 1142 (9th Cir. 2012); Daugherty v. Am. Honda Motor Co. 144 Cal. App. 4th 824 (2006), review denied, 2007 Cal. LEXIS 1472 (Feb. 7, 2007).

On May 19, 2022, the Ninth Circuit issued an unpublished decision agreeing with Apple and PLAC that its prior decisions were binding and that a duty to disclose an alleged defect arises only if it creates an unreasonable risk to safety. .