A wrongful death lawsuit recently filed by the widow of a Texas man indicates that a contaminated 3T Heater Cooler System caused a nontuberculous mycobacteria (NTM) infection to develop following heart transplant surgery.
The complaint (PDF) was filed by Benji Nelson in the U.S. District Court for the Northern District of Texas on October 30, indicating that the widely used heart surgery device increased the risk for complications and infections, which may develop weeks to years later.
Nelson brings the claim on behalf of herself and the estate of her late husband, Terry Nelson, who allegedly was expected to a contaminated 3T Heater-Cooler during a heart transplant in May 2016. The device was used to regulate the temperature of his blood during the procedure, but during the weeks after the surgery he required treatment for crypto pneumonia, recurrent crypto meningitis, nocardia pneumonia and atypiccal mycobacterial infection in the lung.
In September 2016. Terry Nelson was hospitalized and diagnosed with a nontuberculous mycobacteria (NTM) infection. After experiencing acute respiratory failure and other health issues, Nelson was hospitalized again in January 2017 and ultimately died on February 27, 2017, after suffering multi-organ.
Sorin 3T Heater-Coolers are often used during heart bypass surgery, valve replacement surgery and other cardiac procedures. However, in recent years it has been discovered that certain devices manufactured prior to September 2014 were be contaminated with a slow growing bacteria, which may be enter the sterile operating room through vapors released by the devices.
For individuals with compromised immune systems and an open chest cavity during heart surgery, this has resulted in reports of Mycobacterium chimaera or Mycobacterium abscessus infections that surface long after the procedure, all of which are forms of NTM infections like the one that killed Nelson.
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.
“Defendants knew prior to 2015, and continue to know, that its disclosures to the FDA, the public, and Plaintiff were, and are, incomplete and misleading and that the Sorin 3T System was and is causing numerous patients severe injuries and complications, which violates Federal and State requirements,” Nelson’s lawsuit states. “Defendants suppressed this information and failed to accurately and completely disseminate or share this and other critical information with the FDA, the medical community, health care providers, and patients.”
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.
Given similar questions of fact and law presented in lawsuits filed nationwide, the dozens of cases filed throughout the federal court system have been centralized as part of a multidistrict litigation (MDL) before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, to reduce duplicative discovery, avoid conflicting pretrial rulings and serve the convenience of witnesses, parties and the court systems.