Medical device company faces $5M+ lawsuit

LivaNova, formerly known as Sorin Group, made the machines that have been linked to a series of bacterial infections at York Hospital.

Two men from York County have filed a more than $5 million federal lawsuit against the manufacturer of a medical device that’s been linked to a series of bacterial infections at York Hospital.

Edward Baker, of Dallastown, and Jack Miller, of York, allege they were exposed to nontuberculous mycobacteria after undergoing heart surgery last March at York Hospital. Though commonly found in nature, the bacteria can cause infections in people who are sick or have weak immune systems. The lawsuit was filed on Friday in the U.S. District Court for the Middle District of Pennsylvania.

In the 21-page lawsuit, they allege that LivaNova, formerly known as Sorin Group, knew or should have known that its machine causes bacteria to colonize, and thus poses “a significant risk of bodily injury or death.” The men are also asking for a declaration stating that the device — the Sorin 3T Heater-Cooler System — is defective and unsafe.

Neither Baker nor Miller could immediately be reached late Tuesday. Sol Weiss and William Audet, the two attorneys who signed the complaint, also could not be reached.

Court records do not list any lawyers who are representing LivaNova.

In October, York Hospital announced it was sending out letters to about 1,300 people who had open-heart surgery between Oct. 1, 2011, and July 24, 2015, letting them know that they could have been exposed to the bacteria. The issue, the hospital said, was likely due to the device — which heats and cools the blood during surgery.

There have now been 10 total confirmed cases of the infections at York Hospital, WellSpan Health spokesman Brett Marcy said on Tuesday. Four of those patients are still alive, he said, and one is no longer showing any signs of the infection.

Just more than three weeks later, Penn State Hershey Medical Center said it was notifying approximately 2,300 patients who had open-heart surgery between Nov. 5, 2011, and Nov. 5, 2015, about the same issue.

Three of those patients were infected — but the center said at the time there was no evidence that they were related to the machines. Two later died, though their deaths had not been linked to the problem.

Scott Gilbert, a spokesman for Hershey Medical Center, said in a text message that those numbers haven’t changed.

The complaint in the case looks to open the lawsuit up to any of the approximately 3,600 people who had open-heart surgery during those times at the two hospitals.

Contact Dylan Segelbaum at 771-2102.

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This article is part of a content-sharing partnership between York Daily Recordand WITF. A note of disclosure: WellSpan underwrites WITF’s Transforming Health website.