$5M suit against maker of device used in surgeries at York Hospital

Katherine Ranzenberger

Two York County men have filed a $5 million lawsuit against the maker of a heater-cooler device used during open-heart surgeries that might have exposed them to an infectious bacteria.

WellSpan York Hospital. (Bill Kalina - bkalina@yorkdispatch.com)

The lawsuit was filed in U.S. District Court for the Middle District of Pennsylvania in Harrisburg on Friday against LivaNova, PLC, the maker of the device intended to provide temperature-controlled water to heat-exchange devices used during the surgeries. The men claim they were exposed to nontuberculous mycobacterium, or NTM.

Edward Baker of Dallastown and Jack Miller of York are attempting to make the suit a class action suit for the at least 3,600 patients they believe had open heart surgery from October 2011 to November 2015. These patients had surgery at WellSpan York Hospital or at Penn State Milton S. Hershey Medical Center.

“Because NTM is a slow-growing bacterium, it generally takes anywhere from two weeks to four years before manifestation of an NTM infection, which most commonly results in pulmonary or cardiovascular disease,” court documents read.

Baker underwent a quadruple bypass at York Hospital on March 18, 2015, according to court documents. Miller underwent a triple bypass at York Hospital on March 27, 2015.

Device: Court documents claim the two men were exposed to NTM because of the use of the Sorin 3T Heater-Cooler System during their surgeries.

On Oct. 26, WellSpan sent letters to 1,300 patients who had open-heart surgery at York Hospital between Oct. 1, 2011, and July 24, 2015, alerting them of possible exposure to NTM, according to a company news release.

At the time, WellSpan had identified eight patients with an NTM infection, four of whom had died. One additional infected patient has since died.

On Nov. 10, Penn State Hershey Medical center began alerting approximately 2,300 patients who had open-heart surgery at the center between Nov. 5, 2011, and Nov. 5, 2015, of possible NTM exposure. The hospital has identified three infected patients, two of whom have died.

The class-action lawsuit would cover Pennsylvania residents who underwent open-heart surgery at York Hospital and Hershey Medical Center and are currently asymptomatic, the court document reads.

“Claims for actual injury from an NTM infection are excluded from the claims brought from this class action,” it reads. “Plaintiffs allege that their exposure to NTM occurred in substantially the same way.”

Cases:Similar cases of NTM infections were investigated beginning in May 2014 at Greenville Memorial Hospital in South Carolina, where 15 patients were infected, four of whom died.

University of Iowa Hospitals and Clinics began notifying approximately 1,500 patients of possible exposure to NTM, according to a hospital news release. Hospital officials were unable to immediately confirm that the device being mentioned is the same heater-cooler device that was identified in Pennsylvania as linked to the infections.

German Sorin Group, now owned by London-based LivaNova, updated its cleaning and disinfection protocols for the devices after they were first linked to the NTM infections in Europe. The FDA recently sent the manufacturer a warning letter indicating that its new protocols are insufficient.