Following damning reports from the FDA and the Centers for Disease Control and Prevention, the first lawsuit against the Sorin Stöckert 3T Heater-Cooler medical device for open-heart surgery has been filed in US District Court in South Carolina.
Thomas Fowler of Greenville, SC, had a coronary artery bypass grafting procedure during which the Sorin Group Stöckert 3T Heater-Cooler System caused a bacterial infection, according to Thomas Fowler and Roseann Fowler vs. LivaNova PLC, Sorin Group Deutschland GMBH and Sorin Group USA Inc., Docket No. 6:16-cv-02307-BHH, US District Court, South Carolina, Greenville Division.
The defective medical devices, made by LivaNova in Munich, Germany, were contaminated with Mycobacterium chimaera. Two months after Fowler had the cardiac bypass procedure on April 2, 2014, doctors discovered the infection at the surgical wound site. He had to undergo many more surgeries and antibiotic therapy.
The lawsuit filed by attorneys Ashlee Edwards Winkler, Mackenzie Brooke Archenhold, and Robert W. Jones of Parham Smith & Archenhold in Greenville, SC, alleges negligence, breach of express warranty, breach of implied warranties, negligent misrepresentation, misrepresentation by omission, violation of South Carolina Unfair Trade Practices and loss of consortium.
More than 250,000 heart bypass procedures using heater-cooler devices are performed in the US every year. Approximately 60 percent of heart bypass procedures performed in the U.S. use the Sorin Group Stöckert 3T heater-cooler devices.
The devices regulate a patient’s body temperature. Scientists believe that some of the systems have contaminated water that evaporates into the air, exits the machine through a vent, and enters the patient’s lungs or open chest cavity. The infection can take days, weeks, or months to develop and must be treated with a one-to-two year round of antibiotics.
Evidence is mounting against the device:
- The CDC warned healthcare providers and patients on October 13, 2016 about the potential risk of infection from the Stöckert 3T.
- The Greenville Health System Hospital on July 21, 2014 outlined safety measures for a “cardioplegia machine” connected to a rare non-tuberculosis mycobacterium infection that infected 14 patients during open heart surgeries. GHS indicated that there had been four deaths resulting from the same infection.
- On July 15, 2015, the FDA issued a Class II Recall of the Sorin 3T System due to the “potential colonization of organisms, including Mycobacteria” in Sorin Heater Cooler Devices.
- On December 29, 2015, the FDA issued a Warning Letter to the defendants, which indicated that its inspection of Sorin’s Germany and Colorado facilities revealed that the Sorin 3T System devices had been “adulterated.”
Not surprisingly, the device was approved in a short-cut 510(k) application by the FDA on June 6, 2006, which means it did not go through clinical trials because it was “equivalent” to a predicate device.
“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 toand after the marketing and sale of the System,” the complaint states.