Stockert 3T Heater-Cooler Lawsuit – Infectious Diseases
The Players:
The Stockert 3T heater-cooler system is used to regulate the patient’s body temperature during cardioplegic surgeries that intentionally stop the patient’s blood flow. The Sorin group originally developed the Stockert 3T, so the device is sometimes called the Sorin 3T. Sorin merged with another European medical device manufacturer in 2015 to become LivaNova, PLC. LivaNova owns the Stockert 3T.
Background:
Through analysis of adverse event reports, the medical literature, and information from national and international health agencies, the FDA became aware that the use of heater-cooler devices during cardiopelgic surgery is associated with Nontuberculous Mycobacteria (NTM) infections. On October 15, 2015, the FDA issued a Safety Communication concerning the association between heater-cooler devices and NTM. On June 1, 2016, the FDA issued another Safety Communication associating Mycobacterium chimaera infections (a type of NTM) with the use of the Stockert 3T Heater-Cooler System in patients who have undergone cardiothoracic surgeries. The FDA updated this Safety Communication on October 13, 2016, and concluded that “[t]he results strongly suggest the 3T heater-cooler unites are the source of M. chimaera contamination.” See summary of FDA’s investigation of NTM infections associated with heater-cooler devices here.
Stockert 3T Heater-Cooler Lawsuits:
Claims are being filed alleging that the Stockert 3T is unreasonably dangerous because it can transmit infectious NTM into patients during open-chest surgeries. NTM infections such as Mycobacteriuam chimaera, can cause serious injury, illness, or death. The claims are being filed against LivaNova, PLC, the manufacturer of the 3T heater-cooler device.
Who is at Risk?
More than 500,000 patients who had cardioplegic surgery in the U.S. since 2012 could be at risk for this deadly NTM infection. NTM infections are slow to develop and can be fatal. In a case series studying four large U.S. healthcare systems, nearly 50% of the 24 cardiac surgery patients known to have become ill with NTM infection following cardiothoracic surgery using a contaminated heater-cooler device died. Investigation showed that all four systems used the LivaNova machines, i.e., the Stockert 3T heater-cooler device.
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