The plaintiff brought this action in the United States District Court for the District of Connecticut alleging that she had been injured by defective artificial lenses manufactured and marketed by Bausch & Lomb. The plaintiff alleged that the defendants had violated the Connecticut Products Liability Act by failing to warn her of the inherent dangers of the artificial lenses, thereby causing injuries to her eyes. After the operative complaint was filed, the plaintiff filed a motion for leave to amend the complaint to add a claim that the defendants had violated Connecticut Unfair Trade Practices Act by engaging in deceptive advertising. The District Court granted the defendants’ motion to dismiss the plaintiff’s claims pursuant to the CPLA on the ground that they were preempted by federal law and denied the plaintiff’s motion for leave to amend on the ground that the amendment would be futile because federal law would also preempt that claim. The plaintiff appealed to the U.S. Second Circuit Court of Appeal, which determined that the resolution of the plaintiff’s claims depended on the interpretation of Connecticut law, and requested certification of the following questions: (1) whether a cause of action exists under the negligence or failure-to-warn provisions of the CPLA or elsewhere in Connecticut law, based on a manufacturer’s alleged failure to report adverse events to a regulator like the United States Food and Drug Administration following approval of the device, or to comply with a regulator’s post-approval requirements; and (2) whether the CPLA’s exclusivity provision bars a claim under the 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. The Connecticut Supreme Court accepted the certified questions answered “yes” to both.

Regarding the first question, the primary dispute “is whether, under the circumstances of the present case, §52-572q(d) requires manufacturers to provide warnings to the FDA, rather than a physician, as the ‘person’ in the best position to take or recommend precautions against harm to the ultimate user. We agree with the plaintiff that the defendants had a duty under the CPLA to comply with federal laws requiring them to report adverse events associated with the Trulign Lens to the FDA in order to prevent harm to users such as the plaintiff. First, nothing in the CPLA or our case law construing that statute suggests that, as a matter of law, only healthcare providers can be found to be in the best position to prevent harm to users of medical devices…. It is true that, under the common-law learned intermediary doctrine…healthcare providers are identified as the persons best able to take or recommend precautions with respect to harms caused by medical devices. But nothing in the language of §52-572q(d) or the principles animating the learned intermediary doctrine leads us to conclude that the immediate healthcare provider is the only person who can qualify as occupying the best position to take or recommend precautions. It stands to reason that the healthcare provider typically will be that person if there are no upstream obstructions to the flow of information about the known dangers of the product. If such obstructions exist, we cannot perceive why the legislature would have wanted to bar juries from looking elsewhere to identify other persons or entities that, as a factual matter, are in the best position to take or recommend precautions; any other construction would allow manufacturers to evade their duty to prevent foreseeable harm to users by withholding the necessary information from those persons or entities in a position to ensure that it reaches the end user….  Second, and relatedly, the CPLA must be read broadly to accomplish its remedial purpose of preventing injury from defective products….  Third, our conclusion in this respect is fortified by the principles that animate our legal doctrine regarding the imposition of a duty of care more generally. This court has recognized that a duty to use care may arise from a contract, from a statute, or from circumstances under which a reasonable person, knowing what he knew or should have known, would anticipate that harm of the general nature of that suffered was likely to result from his act or failure to act….  Although a simple conclusion that the harm to the plaintiff was foreseeable cannot by itself mandate a determination that a legal duty exists, the other four factors that this court considers when making that determination, namely, (1) the normal expectations of the participants in the activity under review; (2) the public policy of encouraging participation in the activity, while weighing the safety of the participants; (3) the avoidance of increased litigation; and (4) the decisions of other jurisdictions, also weigh in the plaintiff’s favor. With respect to the first factor, both users and manufacturers in this state would normally expect that the manufacturers would be required to take all reasonable steps to provide warnings about the known dangers of a product to the person or entity in the best position to take or recommend precautions. With respect to the second factor, public policy favors encouraging individuals to seek necessary medical treatment by ensuring that they can be confident that their healthcare providers have accurate, current and complete information about the risks of the medical devices that they are recommending to their patients and that, if manufacturers withhold information about inherently dangerous medical devices, patients can be compensated for foreseeable and preventable injuries caused by them. With respect to the third factor, litigation arising from a manufacturer’s failure to warn users about the inherent dangers of its products is already a familiar feature of the Connecticut legal landscape. We cannot conclude that public policy mandates or counsels an exception for medical devices. Finally, we conclude that the fourth factor – the decisions of other jurisdictions – weighs in favor of the plaintiff. Although the courts of other jurisdictions are split on this point, we find the cases cited by the plaintiff, in which federal and state courts have construed the product liability laws of our sister states as creating a duty to comply with federal law requiring manufacturers to report adverse events associated with inherently dangerous medical devices to the FDA, to be more persuasive than the cases cited by the defendants.”

With respect to the second question, the Court was not persuaded by the plaintiff’s argument that allegations of aggressive marketing – particularly of a product the conditions of approval of which the defendants had violated and ignored – are separate and distinct from those that go solely to a failure to warn of a product’s defect, and would be cognizable under CUTPA absent allegations of a product defect. “Although a claim alleging that a defendant unscrupulously advertised a defective or inherently dangerous product is arguably distinguishable from a run-of-the-mill failure to warn claim alleging that the defendant had marketed a defective or inherently dangerous product, the difference is a matter of degree rather than a matter of kind and does not warrant different treatment for purposes of the CPLA exclusivity provision. Accordingly, we conclude that the answer to the second certified question is ‘yes’.”

 

Glover v. Bausch & Lomb, 343 Conn. 513 (2022).