Last week, two lawsuits were filed at the York (Pa.) County Court of Common Pleas against WellSpan Health and medical device manufacturer LiveNova. The complaints come eight months after WellSpan York Hospital notified 1,300 open-heart surgery patients they may have been exposed to harmful bacteria between 2011 and 2015, according to the York Daily Record.
The nontuberculosis mycobacteria infections are connected to LiveNova-made heater-cooler machines used to regulate patients' body temperature during open-heart surgery. The machines have been tied to NTM infections at two hospitals — York Hospital and Penn State Hershey Medical Center — and some of the affected patients at both hospitals have died. The Food and Drug Administration issued a safety communication about the devices, and the CDC also issued interim practical guidance on the devices.
These two lawsuits were filed by former York Hospital patients who contracted infections after surgery. One patient is suing along with his wife, while the other lawsuit was filed by an attorney representing another patient's estate.
According to the Daily Record, Tom Kline, an attorney, said, "This tragedy should have been avoided but for design flaws and human error."
A spokesman for WellSpan Health told the Record the organization does not discuss pending litigation. Spokesman Dan Carrigan said, "Our focus continues to be that insuring 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."
In February, two York County men filed a more than $5 million lawsuit against LivaNova. The case is pending.
Editor's note: This article was updated June 28 at 4 p.m. CT to clarify that the NTM infections have not been identified as the direct cause of death in the affected patients.
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