A South Carolina man who developed a dangerous bacterial infection following open-heart surgery is pursuing a lawsuit against the manufacturer of the Stöckert 3T Heater-Cooler device. The case, which is now pending in the U.S. District Court, District of South Carolina, appears to be one of the first federal claims filed after U.S. health regulators warned of a possible link between certain 3T Heater-Coolers and a type of Nontuberculous Mycobacteria (NTM) infection called M. chimaera. (Case No. 6:16-cv-02307-BHH)
According to his filing, Thomas Fowler underwent a cardiac bypass procedure on April 2, 2014 at the Greenville Health System Hospital (GHS). Two months later, he was diagnosed with an infection at the surgical wound site, forcing Fowler to undergo several more surgeries and antibiotic therapy. On July 21, 2014, GHS outlined safety measures for a “cardioplegia machine” connected to a rare form of NTM that had infected 14 patients during open- heart surgeries. At least four deaths were tied to the infections. The U.S. Food & Drug Administration (FDA) issued a Class II recall for the Sorin 3T System in June 2015 due to the “potential colonization of organisms, including Mycobacteria” in the devices.
“Despite Defendants’ knowledge of the catastrophic injuries, conditions, and complications caused by the Sorin 3T System, in violation of Federal and State requirements, it continued to manufacture, market, provide inadequate instructions for use, and sell the Sorin 3T System, and also failed to adequately warn, label, instruct, and disseminate information with regard to Defendants’ Sorin 3T System both prior to and after the marketing and sale of the System,” the complaint states.
The Stöckert 3T Heater-Cooler system is designed to warm and cool patients undergoing cardiac thoracic surgery and other medical procedures. The FDA issued a new safety communication in June 2016, after a study suggested a direct link between Stӧckert 3T Heater-Coolers and M. chimaera infections reported among open-heart patients in Europe. According to the alert, tests performed at the Stӧckert 3T manufacturing facility in 2014 had detected the same bacteria on the production line and in the water supply. The FDA was trying to determine whether or not the 3T Heater-Cooler devices played any role in similar infections reported among cardiothoracic surgery patients in the U.S. In October 2016, the U.S. Centers for Disease Control and Prevention (CDC) announced that its tests had implicated Stӧckert 3T Heater-Coolers in those outbreaks