Stockart and Sorin 3T Heater-Cooler NTM Infection Lawsuits

The Food and Drug Administration (FDA) started receiving reports about NTM infections caused by heater-cooler devices in 2010. “Between January 2010 and August 2015, the FDA received 32 Medical Device Reports (MDRs) of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination. Twenty-five of these MDRs were reported to the FDA in 2015.”

3T heater-cooler devices regulate body temperature during heart and other bypass surgeries. According to the FDA, “heater-cooler devices include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits.”

The bacteria is Mycobacterium Chimaera (M. chimaera), which is a species of Nontuberculous Mycobacterium (NTM). NTM is very common in soil and water. It rarely causes illnesses, but can in patients who have had extremely invasive procedures such as bypass surgeries, as well as those with weak immune systems. It is not contagious.

According to the FDA, “although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or to aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.”

According to the CDC, “in hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000.” Patients with prosthetic implants have a greater risk.

The symptoms include abdominal pain, difficulty breathing, fatigue, fever, joint pain, loss of appetite and energy, muscle aches, nausea, night sweats, pus and redness around a surgical incision, vomiting, and weight loss. According to the CDC, “patients have presented with a variety of clinical manifestations including endocarditis, surgical site infection, or abscess and bacteremia. Other clinical manifestations have included hepatitis, renal insufficiency, splenomegaly, pancytopenia, and osteomyelitis. Patients have also presented with granulomatous disease and have been misdiagnosed with sarcoidosis.”

According to the CDC, most patients “who become infected from exposure to these devices will develop symptoms within months of their exposure.” But symptoms can take months or even years to develop because the bacteria grow very slowly. “There is no test to determine whether a person has been exposed to the bacteria. Infections can be diagnosed by detecting the bacteria by laboratory culture; the slow-growing nature of the bacteria can require up to two months to rule out infection.”

No. According to the CDC, “there is no antibiotic treatment available to ward off this specific infection.”

The FDA and the CDC have both made extensive recommendations to hospitals and patients about how to minimize the risk of infection. According to the CDC, “hospitals should consider notifying patients in writing if they were exposed to the Stöckert 3T devices during open-chest cardiac surgery at their institution since January 1, 2012. Hospitals that did not use the Stöckert 3T device during this entire time period should adjust the patient notification timeframe accordingly. Patients who were exposed to Stöckert 3T devices manufactured after September 2014 should also be notified. While the risks associated with these newer devices may be lower, some have tested positive for M. chimaera, possibly as a result of cross-contamination from accessory devices.”

No. According to the CDC, “in 2015, the manufacturer recalled the instructions for use, but not the device itself.” The FDA also issued a notification of the Class 2 device recall initiated by LivaNova.

These lawsuits have just begun. It is impossible to ascertain the settlement value of your potential 3T Heater-Cooler lawsuits. But if these cases do eventually reach a global settlement, there will a number of different settlement tiers because the injuries will invariably be so very different. These nontuberculous mycobacteria infections are going to vary wildly when it comes to the scope of the injury. Some cases may be rather minor and some may result in death. You can expect the settlement values to vary accordingly if these cases are able to reach a global out-of-court-settlement.

Many lawsuits have been filed against LivaNova, as well as its predecessor Sorin Stockert. The lawsuits claim that the bacterial contamination happened because its 3T heater-cooler device was improperly manufactured.

As the CDC and FDA recommend, you should contact your doctor and hospital if you had a surgery that used a heater-cooler device. They can tell you if the device was a LivaNova Stöckert 3T. You should contact them even if you are not currently suffering any of the symptoms associated with an NTM infection. The linked CDC website includes a wealth of information about what questions you should ask and how to proceed.

Our lawyers are not involved in this litigation. In 2024, very few attorneys seem to have an interest in these cases.