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Lawsuit filed in relation to infection death at hospital in York

CBS 21 file

A lawsuit has been filed against a hospital in York County and against the maker of a device used in open-heart surgeries, that is believed to have been linked to the spread of an infection that resulted in a patient's death.

Attorney Tom Kline filed the lawsuit on behalf of David Inners, 62, of York, who had surgery at York Hospital in December of 2014 and contracted a nontuberculous mycobacteria (NTM) infection while undergoing the open-heart and aortic valve surgery. Inners died 11 months after his operation.

According to Kline, in 2015, WellSpan Health, who now owns York Hospital, and Milton S. Hershey Medical Center notified patients who underwent open-heart surgeries between Oct. 1, 2011, and July 21, 2015, that patients may have been exposed to NTM due to issues with a heater-cooler device made by LiveNova, PLC.

The LiveNova machine, the Sorin 3T Heater-Cooler System, was used at York Hospital by patients who underwent those surgeries, with five York Hospital patients since dying, Kline said. Three other patients have been diagnosed with NTM.

In addition to the 1,300 patients notified from York Hospital, it was another 2,300 notified through Penn State Hershey, Kline said. Two Hershey patients have died from NTM infections.

In November, the Pennsylvania Department of Health noted the bacterial infections are linked to heater-cooler devices used during open-heart surgeries to warm and cool patients' blood during cardiopulmonary bypass.

"This tragedy should have been avoided but for design flaws and human error," Kline said.

In July 2014, LiveNova sent a notification to hospitals noting that its own investigations found that some devices were contaminated and warned that without proper cleaning, disinfection and maintenance, NTM bacteria "can multiply" in a heater-cooler system, Kline said.

"The lawsuit filed on behalf of Inners' estate claims that not only was the device defective but also that LivaNova knew or should have known of the association of the device and NTM infections based on its own investigation and/or testing," Kine's statement said. "The lawsuit also claims that WellSpan York Hospital was negligent in its maintenance and cleaning of the device and in failing to earlier warn exposed patients of their risk of NTM infections."

Kline and is representing Inners' estate along with attorney Andy Youman.

"There was a failure here to take the steps needed to protect patients and David Inners paid the ultimate price for those mistakes," Youman said.

A WellSpan Health spokesman released the following statement to CBS 21:

We do not comment on active or pending litigation. That said, our focus continues to be on ensuring our patients get all the information, care and treatment they need related to this issue.

The safety, health and well-being of our patients is our highest priority.

That is why we acted swiftly and responsibly to protect patient safety, upon first identifying this as an issue. And it is why we have provided comprehensive health care resources for the 1,300 individuals who may have been potentially exposed to this bacteria. These resources include a toll-free nurse call center, a dedicated website with updated information and a specialized clinic for follow-up care.

WellSpan is committed to providing reliably safe and exceptional care to every patient, every time.

NTM bacteria are commonly found in soil and water, including tap water, the DOH said. NTM are usually not harmful, but can cause infections in patients who have had invasive health care procedures and those with weakened immune systems.

Symptoms of infections caused by NTM can include pain, redness, heat, or pus around a surgical incision; weight loss; night sweats; joint pain; muscle pain; and loss of energy, the DOH said.

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