Open heart cardiac bypass surgery

Update: Stӧckert 3T Heater-Cooler Lawsuits May Be Consolidated into MDL

February 1, 2018 – The U.S. Judicial Panel on Multidistrict Litigation (JPML) is deciding whether to consolidate 42 lawsuits alleging severe infections from Stӧckert 3T Heater Cooler Machines for pretrial handling. LivaNova PLC has argued in favor of a multidistrict litigation rather than fight 42 separate lawsuits which more or less all argue the same thing.

Study Finds M. Chimaera Contamination in Stöckert Heater-Coolers

A study published in the journal Clinical Infectious Diseases in March 2015 detailed an outbreak of M. chimaera infections among patients in Switzerland who had undergone open-heart surgery with a heater-cooler device. The researchers determined that the water used in the devices was contaminated with the bacteria based on how the fan on the unit aerosolized the organism into the air. While the water never came into contact with the patient, the aerosol spread by the fan directly contaminated the surgical wound. Patients in the study presented with nonlocalizing symptoms, such as fever, myalgias, arthralgias, fatigue and weight loss. The mortality rate was approximately 50%, according to the study.

What are Heater-Cooler Devices Used For?

Heater-cooler devices are used during surgeries to warm or cool patients as part of their care. The machines are especially important for cardiothoracic procedures involving the heart and lungs. Heater-coolers include tanks that provide temperature-controlled water to external heat exchangers or to warming/cooling blankets through closed water circuits.

What’s the problem?

The problem is that certain Stöckert 3T heater-cooler devices made by LivaNova PLC, may have become contaminated during the manufacturing process. This may result in the release of vapor into the air of the operating room, where exposure to the open chest cavity may cause an M. chimaera infection.

Heater-Cooler Recall

In June 2015, LivaNova (formerly known as Sorin Group) issued a Class 2 Recall for its Sorin Stӧckert 3T heater-cooler systems over a potential risk of life-threatening infections. The official reason for the recall, according to the FDA, was “Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.”

FDA Warning

Just 4 months after the heater-cooler recall was issued, FDA issued a Safety Communication indicating that the devices had been linked to severe infections, especially in patients undergoing cardiothoracic surgery. The agency’s warning came in response to at least 32 adverse event reports of infections associated with heater-coolers from January 2010 to August 2015.

Symptoms of M. Chimaera

  • 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

M. chimaera infections are usually treated with a combination of powerful antibiotics. In severe cases, however, the infection may be so deep that it can take months or even years for antibiotics to cure. If left untreated, M. chimaera infections can be fatal.

Has a Class Action Been Filed?

No class action lawsuits have yet been filed over M. chimaera infections alleged from heater-cooler units. However, a multidistrict litigation (MDL) was proposed to consolidate all federal cases into a single jurisdiction for pretrial handling. In April 2017, the JPML denied the bid for centralization, claiming that the docket is already undergoing successful informal coordination.

Iowa Woman Files Class Action Over Heater-Cooler Infection

August 11, 2017 – A woman from Iowa who underwent heart surgery with a Stӧckert 3T heater-cooler device has filed a class action lawsuit against the manufacturers for allegedly exposing her to life-threatening bacteria. The new complaint seeks class action status for more than 4,100 plaintiffs who are or were citizens of Iowa at the time of their alleged exposure. The class members’ claims total more than $5 million.

Do I Have an M. Chimaera Lawsuit?

The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in M. Chimaera 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 developed an M. chimaera infection after surgery with a heater-cooler device, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

FREE Confidential Case Evaluation

To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 588-0600.