Federal law doesn't bar Connecticut lawsuit over Bausch lens implant -appeals court

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A doctor holds up a contact lens at his practice in Massachusetts June 10, 2008. REUTERS/Brian Snyder

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  • Court finds Connecticut law allows device makers to be sued for failing to warn regulators
  • Bausch argued federal approval of Trulign lens preempted the state claim

(Reuters) - A federal appeals court on Monday revived a lawsuit by a Connecticut woman who said she suffered permanent vision damage from a defective Bausch & Lomb Inc lens implant, finding that federal law does not prevent her from suing under Connecticut's product liability law.

The decision from the 2nd U.S. Circuit Court of Appeals came after a ruling by Connecticut's Supreme Court that state law claims like those brought by Marjorie Glover and her husband Charles Glover are not necessarily preempted by the federal Food, Drug and Cosmetic Act (FDCA).

Lawyers for the Glovers and for New York-based Bausch did not immediately respond to requests for comment.

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According to the Glovers' 2017 lawsuit in New Haven, Connecticut federal court, Marjorie Glover underwent surgeries to implant Bausch's Trulign lenses in both eyes in 2014 to treat cataracts.

Following the surgeries, they said, both lenses became tilted, a complication known as "Z syndrome" unique to the Trulign lens. Further surgeries to remove the Trulign lenses left parts of the devices in Marjorie Glover's eyes, resulting in permanent damage to her vision.

The Glovers brought claims under the Connecticut Product Liability Act (CPLA), which requires medical device makers to warn the person or entity best positioned to protect consumers of the risks of their products. They said Bausch violated the law by failing to report adverse events to the U.S. Food and Drug Administration.

Bausch moved to dismiss the lawsuit, arguing it was preempted by the FDCA, which empowers the FDA to approve and regulate devices.

The U.S. Supreme Court has held that state law claims are preempted if they impose duties on manufacturers that go beyond those in the FDCA, and also if they simply allege violations of the FDCA. This leaves only a narrow class of claims which target conduct that violates the FDCA, but are not directly based on the FDCA.

U.S. District Judge Kari Dooley agreed with Bausch, granting its motion in March 2020.

On appeal, the 2nd Circuit found that whether the CPLA allowed claims that fell under the narrow non-preempted category was an unresolved question of state law, which it sent to the Connecticut Supreme Court.

In June, that court found that the obligation under the CPLA to report adverse events to the person or entity best positioned to protect consumers was independent of the FDCA — even if the entity might be the FDA in a particular case.

Circuit Judge Gerard Lynch wrote Monday that the ruling was enough to save the Glovers' lawsuit. He was joined by Circuit Judge William Nardini. The third judge on the panel that heard the case, Robert Katzmann, died in June.

The case is Glover v. Bausch & Lomb Inc, 2nd U.S. Circuit Court of Appeals, No. 20-1156.

For the Glovers: Wendy Fleishman of Lieff Cabraser Heimann & Bernstein

For Bausch & Lomb: Elliot Scherker of Greenberg Traurig

Read more:

Former chief judge of U.S. 2nd Circuit Robert Katzmann dies at 68

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Brendan Pierson reports on product liability litigation and on all areas of health care law. He can be reached at brendan.pierson@thomsonreuters.com.