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.