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Sorin Group faces a class action lawsuit over it’s open heart surgery heater-cooler device, which has been linked to reports of nontuberculous mycobacterium (NTM) infections at hospitals nationwide.
The complaint (PDF) was filed by Kevin Sawvel in the U.S. District Court for the Northern District of Iowa on September 25, seeking to pursue damages for all individuals in Iowa who were exposed to contaminated 3T Heater-Coolers, which are commonly used to regulate blood temperature during bypass surgery and other heart procedures.
Allegations raised in the class action lawsuit are similar to those presented in dozens of individual open heart surgery NTM infection lawsuits filed on behalf of individuals nationwide, which allege that certain 3T Heater-Coolers released a contaminated mist into the air of the operating room.
Sawvel that he was exposed to a potentially contaminated 3T Heater-Cooler during open heart surgery in June 2016, at the University of Iowa Hospitals and Clinics (UIHC). While Sawvel does not allege that he has been diagnosed with an NTM infection, the lawsuit note that symptoms often do not manifest for a long time following exposure, calling on Sorin Group to provide medical monitoring for himself and other class members, who could develop an NTM infection months or even years after open heart surgery.
In February 2016, UIHC was one of a number of hospitals to send letters to individuals who had undergone open heart surgery, warning about 1,500 former patients that they may have been exposed to a 3T Heater Cooler that was contaminated with the bacteria that causes NTM infections.
“The risk of NTM transmission with the 3T System is not unique to UIHC. For
example, in October and November 2015, two Pennsylvania hospitals notified approximately 3,600 patients who underwent open heart surgeries between October 1, 2011 and November 5,2015 of their exposure to NTM through use of the 3T System,” the lawsuit notes. “To date, there have been eleven confirmed NTM infections in Pennsylvania which have resulted in five deaths.”
The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.
In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.
Late last year, the federal regulators issued a safety communication warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.
The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.
The CDC later confirmed that the 3T system used at UIHC was in fact contaminated.
The open heart surgery class action lawsuit filed by Sawvel alleges that the manufacturers of the 3T Heater-Cooler knew or should have known about the risk of contamination, and failed to adequately warn the medical community, the FDA, and patients of the risks.