The Pritzker Hageman infectious disease lawyers have been investigating an outbreak of M. chimaera infections among patients who had open heart surgery performed with LivaNova 3T heater-cooler devices at the University of Kansas Hospital.
If you or a loved one developed an M. chimaera infection after a cardiothoracic procedure (including open heart surgery, valve replacement, coronary artery bypass surgery, or a heart transplant), you may be eligible for significant compensation. An experienced infectious disease attorney will thoroughly investigate your case to lay the groundwork for a lawsuit against the responsible parties, including the company whose contaminated medical device caused your illness and the hospital where the procedure took place.
The Pritzker Hageman infectious disease legal team has filed multiple M. chimaera lawsuits for patients who developed serious infections after being exposed to M. chimaera bacteria from contaminated LivaNova heater-cooler devices during open heart surgery.
Did you develop an M. Chimaera infection after open heart surgery?
What You Need to Know About M. Chimaera and Heater-Cooler Devices
Mycobacteria chimaera is a rare, slow-growing type of bacteria called nontuberculous mycobacterium (NTM). NTM is a group of bacteria that are related to the bacteria that cause tuberculosis, but NTM does not cause the same type of disease.
Heater-cooler devices are used in open-heart surgery to regulate the patient’s body temperature. These devices have water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets. The water does not come into direct contact with the patient, but bacteria can be released into the air if the device is contaminated with M. chimaera, which can infect the patient’s open wound.
Infections in exposed patients can appear months or even years after surgery. Symptoms of an M. chimaera infection may include:
- Chronic cough and respiratory problems
- Weight loss
- Night sweats
- Muscle and joint pain
- Wound infections
- Non-healing surgical wounds
M. chimaera infections can be difficult to diagnose because the symptoms start slowly and are often mistaken for general fatigue after a procedure. Health officials recommend that patients who may have been exposed to M. chimaera see their doctor right away to get tested.
For decades, severe bacterial infections have been reported among patients whose surgeries involved a LivaNova, Stöckert, or Sorin 3T heater-cooler device. According to data from the CDC, out of the 250,000 heart bypass procedures performed with a LivaNova heater-cooler device, about 60 percent of patients developed an M. chimaera infection.
Kansas M. Chimaera Outbreak
From June 2017 to October 2020, the Kansas Department of Health and Environment (KDHE) notified the CDC of 14 M. chimaera infections among patients who were exposed to LivaNova 3T heater-cooler devices at the University of Kansas Hospital. There were also four infections reported at a hospital in California. Whole genome sequencing matched this outbreak strain to an M. chimaera outbreak in 2015 that was linked to LivaNova 3T heater-cooler devices.
After the 2015 outbreak, an FDA investigation found that design flaws allowed LivaNova’s 3T heater-cooler devices to trap bacteria in its water reservoirs, allowing the contaminated water to aerosolize and contaminate the surrounding air with M. chimaera bacteria.
An onsite inspection at the University of Kansas Hospital found that the LivaNova 35 heater-cooler devices were not placed and maintained according to the FDA’s recommendations and the manufacturer’s updated cleaning and disinfection protocols. In fact, most of the heater-cooler devices had not been upgraded to reduce the spread of M. chimaera bacteria in the operating room, even though the hospitals had asked the manufacturer to do so.
Contact an Experienced Infectious Disease Lawyer
Pritzker Hageman is one of the few law firms in the country with experience representing clients in infectious disease lawsuits. Our legal team has won hundreds of millions of dollars for people harmed by unsafe medical devices.
If you or a loved one contracted M. chimaera after having open heart surgery, it is important to talk to an experienced infectious disease lawyer as soon as possible to protect your legal rights. Laws called “statutes of limitations,” which vary by state, may limit the amount of time you have to file a claim.