$225 million settlement reached by maker of device linked to infections at York Hospital

The manufacturer of a heater-cooler device linked to infections at York Hospital announced a $225 million settlement agreement to resolve about 75% of lawsuits against it.

In a news release March 29, LivaNova said the company will provide $225 million to settle the various lawsuits throughout the country. The company made the 3T Heater-Cooler device used during open heart surgery that could have exposed patients to infectious bacteria.

In February 2016, Jack Miller, of York, and Edward Baker, of Dallastown, filed a $5 million federal lawsuit against the company. The two claimed the devices exposed them to nontuberculous mycobacteria, or NTM.

The two of them had bypass surgeries in March 2015.

In a court filing March 27, Miller and Baker's attorney, Sol Weiss, wrote that all claims against LivaNova were voluntarily dismissed by Miller and Baker.  

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A heater-cooler device at York Hospital, Monday, Oct. 26, 2015, might have caused infections in 10 of York Hospital's open-heart surgery patients. Bill Kalina - bkalina@yorkdispatch.com

Settlement: Weiss, the lead attorney for the plaintiff's executive committee, which directed the federal lawsuits against LivaNova, said in the release that the plaintiffs are pleased with the company's decision.

"These were complicated cases and the patients involved with this litigation have difficult medical histories. Protracted litigation was in no one's interest, as the plaintiffs could benefit from settle proceeds today," his statement reads in part.

LivaNova said in the release that the settlement will resolve a multidistrict lawsuit in federal court, a related class-action case in federal court and certain cases in state courts.

Damien McDonald, CEO of LivaNova, said in the release that entering the settlement was in the best interest of the company, shareholders and patients because it will remove "ongoing costs" and uncertainty.

The company makes no admission of liability under the agreement. LivaNova stands behind the device and will "vigorously defend the product and company actions in the remaining cases," the release states.

Dr. Hal Baker sits by a heater-cooler device that has been linked to infections at York Hospital. (Photo by Bill Kalina/ The York Dispatch)

Background:. In October 2015, WellSpan sent letters to those who had open heart surgeries at York Hospital between Oct. 1, 2011, and July 24, 2015, telling them they might have been exposed to NTM.

York Hospital was the first to begin notifying its cardiac surgery patients to look out for symptoms — which include fever, night sweats and weight loss — that might indicate the infection is present.

The device, which was used to heat and cool patients' blood during surgery, was manufactured by Sorin Group, which is now owned by LivaNova.

The hospital used to use LivaNova's device — and replaced its contaminated devices with more LivaNova devices after it first identified the issue  — but it later replaced those with heater-cooler devices from another manufacturer, a WellSpan official has said.

WellSpan found 12 patients affected by the issue, and six of them died, The York Dispatch reported in March 2017.

Ryan Coyle, a WellSpan spokesman, said in an email April 1 that WellSpan has not seen additional cases and has no additional updates.

"We have been, and continue to be, committed to ensuring our patients have all the information, care and treatment they need regarding this issue," he said. "Beyond that, we do not comment on pending or active litigation."

— Reach Christopher Dornblaser at cdornblaser@yorkdispatch.com or on Twitter at @YDDornblaser.