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Failure to report adverse events of medical products to the FDA can give rise to a cause of action for failure to warn

Connecticut

,

United States

In Glover v. Bausch & Lomb, Inc., No. SC 20607 (Conn. 2022), the plaintiff had a Trulign Lens implanted in each of her eyes. Several weeks later, she began to experience significant loss of vision. Her physician ultimately diagnosed her vision problems as "Z syndrome," a postoperative complication unique to the Trulign Lens. Following additional surgeries, she was left with permanent impairment of both eyes. 

One of the issues before the Connecticut Supreme Court was whether a cause of action exists under the negligence or failure-to-warn provisions of CPLA § 52-572q, or elsewhere in Connecticut law, based on a manufacturer's alleged failure to report adverse events to a regulator like the FDA following approval of the device, or failure to comply with a regulator's post-approval requirements.

Holding

The Connecticut Supreme Court held that a cause of action exists for the failure of a manufacturer to report adverse events to a regulator (at 7).

The CPLA

The Connecticut Supreme Court noted that subsection 52-572q of the CPLA (the duty to warn provision) does not clearly and unambiguously indicate whether it provides for a cause of action based on a manufacturer's alleged failure to report adverse events related to a product to a regulator (at 10). However, the Court noted that the statutory scheme of the CPLA was intended to protect anyone who is injured by a defective product and that a manufacturer has a duty to provide suitable warnings to the person best able to take or recommend precautions against the potential harm (at 10-11). 

Manufacturers’ duties

The Court rejected the defendant’s argument that, under the learned intermediary doctrine, the duty to warn about the known dangers of medical devices is limited only to physicians and other healthcare providers (at 13). The Court noted that nothing in the CPLA or Connecticut caselaw construing the CPLA 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 (at 14). 

The Connecticut Supreme Court also ruled that the CPLA must be read broadly to accomplish its remedial purpose of preventing injury from defective products, including products such as medical devices that are inherently dangerous and that, therefore, must be accompanied by adequate warnings (at 15).

Finally, the Connecticut Supreme Court noted that the 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 they knew or should have known, would anticipate that harm of the general nature of that suffered was likely to result from their act or failure to act (at 15).

Required elements of a successful claim for failure to report adverse events

The Court concluded that the plaintiff could prevail in her claim against the manufacturer for its failure to report adverse events to the FDA if she was able to establish that it is more likely than not that, if the defendants had complied in a timely manner with the federal laws requiring them to report adverse events to the FDA and to perform a postmarket safety study, the FDA would have required the defendants to change the labeling of the Trulign Lens or otherwise made the substance of the reports available to healthcare providers before the plaintiff's surgery and that, as a result, she and her physician would not have chosen that device (at 22-23).

July 19, 2022
Glover v. Bausch & Lomb, Inc., No. SC 20607 (Conn. 2022)
Author: Carli Kadish