Some 3T heater-cooler devices manufactured by LivaNova, PLC may have caused dangerous and deadly Nontuberculous Mycobacteria (NTM) infections in many patients. 3T heater-cooler devices are used in cardiothoracic surgeries, which usually involve the heart, lungs, or esophagus. The common nature of these surgeries means that more than 500,000 patients may have a cause for concern.
What Is Going On?
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.”
The FDA and the Centers for Disease Control and Prevention (CDC) have issued many alerts about this danger. In October 2016, the CDC issued an alert “warning healthcare providers and patients about the potential risk of infection from certain devices used during open-heart (open-chest) surgery.” The warning followed new information indicating that some LivaNova Stöckert 3T heater-cooler devices “might have been contaminated during manufacturing.” Along with the alert, the CDC also issued several additional documents, including a heater-cooler notification tool kit, and questions and answers for hospitals and health departments. The FDA issued a similar alert in June 2016, and another in October of that year.
Additional testing by the CDC and National Jewish Health showed that bacteria from the 3T heater-cooler devices matched “bacteria found in patients in several states.” Those results were consistent with a European study that the devices might have been contaminated “during manufacturing in Germany.” The CDC also noted that “testing conducted by the manufacturer in August of 2014 found M. chimaera contamination on the production line and water supply at the 3T manufacturing facility.”
The Stöckert 3T heater-cooler device is used in about 60% of the 250,000 heart bypass surgeries performed in the United States each year. The device was originally manufactured by the German company Sorin Group Deutschland GmbH (Sorin). Sorin merged with Cyberonics, Inc., in 2015, at which time the combined companies formed LivaNova, PLC.
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What is a 3T heater-cooler device?
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.”
What is the bacteria?
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.
How does the infection happen?
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.”
What is the risk of infection?
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.
What are the symptoms?
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.”
How long does it take for symptoms to develop?
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.”
Late diagnosis not surprisingly makes the infection more difficult to treat, and many patients never fully recover. The antibiotics used to treat the infection also have many side effects. Treatment usually continues unabated until the patient’s respiratory cultures produce consistently negative results for at least a year if not longer.
Can anything be done to prevent the infection before surgery?
No. According to the CDC, “there is no antibiotic treatment available to ward off this specific infection.”
What recommendations have been made?
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.”
Was the device recalled?
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.
What is the settlement value of the 3-T Heater-Cooler infection lawsuits?
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.
What lawsuits have been filed?
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.
More than 70 lawsuits had been filed by February 2018. A federal panel consolidated 39 lawsuits that same month into multidistrict litigation in a federal court in Pennsylvania. More than 30 state court cases may also be consolidated into the MDL. A separate class action lawsuit demands that the manufacturer arrange medical monitoring for patients whose surgeries used the Stöckert 3T. Additional lawsuits are expected to be filed as more patients discover that they have been infected. This litigation is referred to as MDL No. 2816, In Re: Sorin 3T Heater-Cooler System Products Liability Litigation (No. II). All cases in the 3-T Heater-Cooler litigation filed in federal court also automatically to Judge John E. Jones, III in Scranton, Pennsylvania.
What should you do?
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.
Are your lawyers handling 3T Heater Cases?
Our lawyers are not involved in this litigation. In 2020, very few attorneys seem to have an interest in these cases.
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