In late 2015, 3,600 heart surgery patients in Pennsylvania received notifications from Wellspan York Hospital and Penn State Milton S. Hershey Medical Center warning them they might have been exposed to a Nontuberculous Mycobacterium, a potentially deadly type of bacteria, during heart surgery operations that took place between October 2011 and November 2015.
Nontuberculous Mycobacterium (NTM) post-operative infections in open heart surgery patients have been connected to the use of the Stockert 3T. According to the Centers for Disease Control Prevention (CDC) Stockert 3T may have been contaminated during the manufacturing process and it warns that patients who had chest surgeries may be at risk of infection.
Operating theaters routinely use heater-coolers to control the temperature of a patient’s blood and organs during surgery.
An NTM bacterial infection is notoriously resistant to common antibiotics. Even patients who survive the infection can be left with lifelong debilitating effects.
Edward Baker had bypass surgery in March of 2015 and was one of those people that received a letter. Another man, Jack Miller also had cardiac surgery in March of 2015. In both surgeries, the Stockert 3T was used. They felt fine but when the warning letters arrived it was like someone told them they had been implanted with a time bomb.
They went knocking on the door of attorney Sol Weiss at ANAPOLWEISS in Philadelphia for advice and help.
“People came to us worried,” says Weiss.
“The hospitals offered to do some screening,” says Weiss, a long time lawyer and expert in the area of medical device litigation. “We don’t think it’s enough. We believe that the wrongdoers should pay for the screening not the hospitals.”
Weiss filed a class action on behalf of Baker and Miller against LivaNova PLC (formerly Sorin Group), the makers of the Stockert 3T, the heater-cooler that was used during the cardiac surgery operations.
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The NTM bacteria has no effect on healthy individuals. However, night sweats, fever, muscle aches, weight loss could be signs that a chest surgery post-operative patient has contracted the bacteria.
In addition to proper monitoring the lawsuit wants Pennsylvania to declare the Stockert 3T a defective medical device. The suit also alleges that LivaNova failed to properly test the machine and failed to warn patients about the potential for an NTM bacterial infection.
He’s expecting class certification in April, 2017.