Sorin Group and Livanova continue to face a growing number of product liability lawsuits over contaminated 3T Heater Cooler systems used during heart surgery in recent years, which have been linked to serious and potentially life-threatening infections that may develop years after the procedure.
In a complaint (PDF) was filed in the U.S. District Court for the Southern District of Iowa last month, Ronald Reed indicates that he was exposed to a contaminated 3T Heater-Cooler during open heart surgery in June 2013, but did not begin to show signs of a Mycobacterium chimaera (M. chimaera) infection until nearly two years later.
Reed underwent an aortic graft surgery, where the 3T Heater-Cooler was used to maintain blood temperature. In March 2015, he was seen by a specialist for unexplained weight loss, following a referral by his primary care doctor. Following a comparison of CT scans of the abdomen and pelvis in 2013, 2014 and 2015, doctors noted that Reed’s gallbladder wall was thickening, and ordered an extensive workup for fungal and mycobacterial infections.
It was not until February 2016 that Reed learned about the potential link between 3T Heater-Coolers and non-tuberculous mycobacteria (NTM) infections, when the hospital where he had his open heart surgery sent a letter to approximately 1,500 patients who underwent major procedures between January 1, 2012 and January 22, 2016.
The hospital warned about the contamination risk associated with 3T Heater-Coolers used during these procedures, indicating that the patients may have been exposed to a rare and potentially fatal bacteria.
Now knowing what to look for, and with Reed’s condition worsening, his doctors found M. chimaera in his system, and began antibiotic treatment and ordered that his aortic graft be removed, as it was likely to be infected.
Since then, Reed has undergone numerous testing surgeries and treatments, and suffers from toxic optic nerve neuropathy and vision loss, which his doctors say is either due to the infection or the cocktail of drugs he’s had to take to fight off its symptoms and attempt to drive it from his body.
The 3T Heater-Cooler is a device commonly found in operating rooms nationwide, and is used to regulate blood temperature during surgery. However, according to allegations raised in the lawsuit, as well as similar claims brought on behalf of individuals nationwide who suffered an infection after open heart surgery, certain devices manufactured by Sorin Group release a contaminated mist into the air of the operating room.
“The potential for contaminated water from heater-cooler devices to infect patients intraoperatively was recognized by the medical and scientific community as early as
November 2002,” Reed’s lawsuit notes. It indicates that at least two other patients from the same hospital have died of these infections.
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 complaint filed by Reed and his family is one of a growing number of other open heart surgery infection lawsuits filed nationwide over the 3T Heater-Cooler, alleging that the manufacturers knew about the risk of contamination and failed to adequately warn the medical community, the FDA, and patients of the risks.