Due to contaminated heater-cooler devices used in many operating rooms, a large number of open-heart surgery patients have developed a severe and potentially deadly infection known as Mycobacterium chimaera, or M. chimaera.
Free Confidential Lawsuit Evaluation: If you or a loved one developed an M. chimaera infection, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Update: Pennsylvania Man Alleges M. Chimaera Infection from Stӧckert 3T heater-cooler
October 4, 2017 – A married couple from Hanover, Pennsylvania, has filed suit against LivaNova, claiming that its Stӧckert 3T heater-cooler caused the man to develop a life-threatening M. Chimaera infection. The complaint names both LivaNova Deutschland GMBH and Sorin Group USA Inc., as defendants, bringing claims of negligence, design defects and other damages.
What’s the Problem?
Lawsuits are now being filed against LivaNova PLC, the manufacturer of the Stӧckert 3T heater-cooler system, alleging that the devices transmitted a specific type of life-threatening bacteria during invasive surgeries, particularly open-chest cardiac procedures. The bacterium is called Mycobacterium chimaera, and can result in nontuberculous mycobacteria (NTM) infections, which are extremely serious, capable of causing death even after years of antibiotic treatment.
Studies Link Heater-Cooler Units to M. Chimaera Infection
A case report published in the Journal of Clinical Microbiology in June 2013 detailed the cases of 2 patients who underwent heart surgery and were subsequently diagnosed with bloodstream infections caused by M. chimaera. The researchers concluded that the potential for infection should be considered when patients with biomechanical or mechanical heart valves present with symptoms of endocarditis or septicemia. However, they were unable to draw a clear link between the infections and heater-cooler units based on the 2 case studies.
It was not until M. chimaera bacteria was found in the production line and water supply at the 3T manufacturing facility that the connection started to become clear. This resulted in a “corrective action” by the manufacturer in July 2015, providing instructions to healthcare facilities about how to determine whether the devices were contaminated. The U.S. Food & Drug Administration (FDA) later classified this action as a 3T Heater-Cooler recall, although the machines remained in place in many operating rooms across the U.S.
M. Chimaera Symptoms
- Fever – 100.4F or above
- Unexplained weight loss
- Cough / shortness of breath
- Night sweats
- Joint or muscle pain
- Feeling sick or vomiting
- Feeling unusually tired (malaise)
- Pain, redness, warmth or pus around where you had your operation
M. Chimaera Treatment
Treatment for M. chimaera infections typically involves a combination of antibiotic medications. However, in some cases the infection is so deep that it can take months or even years for antibiotics to cure. If left untreated, these infections can be fatal.
Is There a Class Action?
No class action lawsuits have been filed to date over M. chimaera infections alleged from heater-cooler devices. However, there was an attempt to consolidate all federal complaints into a multidistrict litigation (MDL) for pretrial handling in a single jurisdiction. A panel of federal judges in April 2017 denied the bid for centralization, claiming that the docket is already undergoing successful informal coordination.
Have There Been Any Settlements?
The heater-cooler litigation is still in its preliminary stages, and there have been no reports of any settlement offers from LivaNova. However, our lawyers feel that as the number of lawsuits filed over M. chimaera heater-cooler infections continues to grow, the company will eventually be forced into settlement negotiations with the plaintiffs.
Do I Have a M. Chimaera Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in M. Chimera lawsuits. We are handling individual litigation nationwide and currently accepting new heater-cooler infection cases in all 50 states.
Free Case Evaluation: Again, if you were diagnosed with M. chimaera, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.