$225M settlement to resolve federal lawsuits spurred by infection scare at Hershey Med, WellSpan and across the U.S.

Multiple federal lawsuits prompted by an infection scare at two central Pennsylvania medical centers are among the legal battles set to be resolved via a just-announced $225 million settlement with a major international medical equipment manufacturer.

The accord announced by LivaNova covers about 75 percent of lawsuits filed throughout the U.S. over the company’s 3T Heater-Cooler. U.S. Middle District Judge John E. Jones III oversaw that nationwide litigation.

LivaNova, based in London, England, agreed to the settlement even though it continues to deny there are any defects in its machines. In a statement, the firm vowed to “vigorously” defend against suits not covered by the settlement.

“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 settlement proceeds today,” said Sol Weiss, lead counsel for the executive committee for the Americans who sued LivaNova. “We especially appreciate the guidance from U.S. District Judge John E. Jones III.”

One of the central Pennsylvania lawsuits against LivaNova was filed in 2016 over infection scares involving open heart surgery patients at Penn State Milton S. Hershey Medical Center and WellSpan York Hospital. Officials at both medical facilities alerted thousands of patients about the infection risks in late 2015.

The plaintiffs in that case, Edward Baker and Jack Miller, both of York County, contended faults with the 3T machines exposed at least 3,600 patients to drug-resistant and potentially fatal bacteria. Those machines regulate blood temperature for those undergoing open heart surgery.

Miller and Baker claimed in their suit that a design flaw in the 3T machines allowed a dangerous bacteria known as NTM to grow within the devices. Their claims mirrored those in other midstate suits.

Several patients at WellSpan and Hershey were diagnosed with NTM infections and at least five died, Miller and Baker said. In December 2015 the U.S. Food and Drug Administration issues a warning letter to LivaNova regarding the contamination concerns. An alert also was issued to medical facilities by the Pennsylvania Department of Health.

The Miller/Baker suit sought $5 million in compensation for patients who underwent open heart surgery at WellSpan between Oct. 1, 2011 and July 24, 2015, and for patients who had the same procedure at Hershey between Nov. 5, 2011 and Nov. 5, 2015.