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Mycobacterium Chimaera Lawsuit

Mycobacterium Chimaera Lawsuit

At least 50 hospital patients who had open-heart surgery developed infections with Mycobacterium chimaera (NTM) due to 3T Heater-Cooler Units. Thousands of patients were exposed, but symptoms may not appear for up to 6 years.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting heater-cooler induced injury cases in all 50 states. If you or somebody you know has been diagnosed with a Mycobacterium chimaera infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Overview

Lawyer for Heater-Cooler Infections

Diagram of How a Heater-Cooler Works

The Sorin 3T Heater-Cooler System is a machine that regulates the body temperature of a patient who is anesthetized during very long surgeries. It has been on the market since 2006 in the United States. The FDA stopped imports in 2016 due to NTM infections.

What is the problem?

3T Heater-Cooler Units are used at 60% of hospitals that perform open-heart surgery in the U.S., or about 150,000 patients per year.

Multiple hospitals around the world have traced deadly outbreaks of M. chimaera infections to contaminated heater-coolers. It has been called a “hidden epidemic” because they were rarely diagnosed until the FDA issued warnings in 2015 and 2016.

Transmission of Mycobacterium Chimaera

Heater-cooler devices use water to heat or cool a patient’s blood. The water never directly touches the patient, but water-vapor — and bacteria like M. chimaera — can blow out from exhaust vents, land on a patient, and cause infections deep inside their body.

What is My Risk?

The risk of infection is very low — less than 1% — but it can take up to 6 years for symptoms to appear, so patients need to be monitored if they were exposed. Tens of thousands of patients have been exposed, but only around 50 infections have been reported in the U.S.

Machines Were Contaminated During Manufacturing

M. chimaera was found in the water and a production line at the 3T manufacturing plant in Germany in 2014. After new machines tested positive, the FDA banned imports and said evidence “strongly suggests” a common source of contamination.

Most Heart Surgery Patients Exposed to M. Chimaera

In January 2017, a study in Denmark found M. chimaera in 86% of heater-cooler machines (18 out of 21) located at 5 heart surgery departments in Denmark. The researchers said it was likely that most heater-coolers made in the last 8-10 years were contaminated with M. chimaera, and it may be a general problem with heater-coolers. The contaminated machines included the Sorin 3T (14 out of 16 were contaminated) and a Maquet Heater-Cooler (4 out of 5 were contaminated).

What is Mycobacteria Chimaera?

Mycobacteria chimaera infections are caused by a type of Non-Tuberculosis Mycobacterium (NTM) — a common bacteria that is naturally found in soil and water. Healthy people are not at risk. Normally, NTM only infects people who are very sick, or people who have had surgery.

Heart Surgery Infection Complications

  • Wound infection
  • Surgical site infections (SSI)
  • Heart valve infection
  • Infected graft or VAD
  • Endocarditis
  • Bloodstream infection
  • Blood clots
  • Stroke
  • Osteomyelitis (bone infection)
  • Death

Mycobacterial Lung Infections

M. chimaera was previously known to cause chronic lung infections, usually in very sick people with cystic fibrosis who were exposed to it on ventilators or breathing it in the air. Pulmonary infections cause inflammation, cough, and progressive lung disease.

Mycobacterial Heart Infections

Cardiac infections are also known as infective endocarditis, a condition in which the inner lining of the heart is inflamed. M. chimaera infections are most likely after open-heart surgery, cardiopulmonary bypass surgeries. The risk is highest for patients who have something implanted in their heart, such as a prosthetic valve, vascular graft, or a Ventricular Assist Device (VAD).

Diagnosis & Treatment for M. Chimaera Infections

Treatment for M. chimaera infections requires antibiotics for 1 to 2 years. Diagnosis is challenging — it requires a lab that can sequence DNA. Symptoms are vague and can take years to appear, which often delays diagnosis until the infection is much harder to treat.

Symptoms of M. Chimaera Infections

  • Fever (persistent, recurrent, or unexplained)
  • Fatigue
  • Difficulty breathing
  • Pain (muscle, joint, abdominal)
  • Weight-loss
  • Shortness of breath
  • Joint or muscle pains
  • Nausea, vomiting
  • Night sweats
  • Heat, redness, or pus at surgical site

More Information & Resources

Do I have a Mycobacterium Chimaera Lawsuit?

The Schmidt Firm, PLLC is currently accepting heater-cooler induced injury cases in all 50 states. If you or somebody you know has been diagnosed with a Mycobacterium chimaera infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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