HARTFORD, Conn. (Legal Newsline) – A Connecticut woman’s lawsuit over Bausch & Lomb’s Trulign Lenses has answered a question closely watched by the state’s trial lawyers.
The Connecticut Supreme Court ruled June 7 to allow Marjorie Glover to continue her lawsuit, which alleges violation of the Connecticut Product Liability Act. The U.S. Court of Appeals for the Second Circuit had asked the court whether a failure-to-warn action under the CPLA could be sustained if the plaintiff alleged the company failed to report adverse events to regulators like the FDA after it was approved for market.
The Supreme Court answered such a cause of action exists while also noting the CPLA’s exclusivity provision bars the plaintiff from adding claims under the state’s Unfair Trade Practices Act.
Federal circuit courts of appeal are split on the issue of whether federal law preempts failure-to-warn claims based on allegations that a defendant failed to report adverse events. Glover’s case drew the attention of the Connecticut Trial Lawyers Association and the Product Liability Advisory Council, which each filed amicus briefs.
The primary dispute in Glover’s case is whether Bausch & Lomb was supposed to report adverse events to physicians or the FDA.
“(N)othing in the CPLA or our case law construing that statute suggests that, as a matter of law, only health-care providers can be found to be in the best position to prevent harm to users of medical devices,” the suit says.
“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.”
Glover’s lawsuit says Trulign Lenses implanted during cataract surgery caused her to experience vision loss. She was diagnosed with “Z syndrome,” which is caused when part of the lens moves forward toward the surface of the eye and part of it stays in place or moves backwards.
Glover underwent multiple surgeries to correct the damage but she suffered permanent impairment in both eyes. Her lawsuit says the defendants knew about Z syndrome in numerous cases but failed to report all of them to the FDA in a timely manner.
She says she never would have undergone the surgery if she knew the truth about Trulign Lenses. Bausch & Lomb argued her claims were preempted by federal law and was successful in getting a federal judge to toss the case.
But the state Supreme Court’s answers to the Second Circuit will allow Glover and her lawyers at Lieff Cabraser and Zangari Cohn to pursue their theory.
“(T)he plaintiff in the present case can prevail at trial if she establishes 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 substances 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,” the ruling says.