Stockert 3T Heater-Cooler System Lawsuits

Claims continue to be filed against LivaNova PLC, the manufacturer of the 3T heating and cooling system, because it may expose patients who have undergone heart surgery to contract potentially-deadly infections. The suits claim the LivaNova failed to warn hospitals and doctors of these risks.

Heater-cooler devices are used during various cardiothoracic surgeries to regulate a patient’s body temperature in order to improve patient conditions. They utilize water tanks to heat or cool water, which is then supplied to heat exchangers or warming/cooling blankets to modulate the temperature of the body.

However, it has been revealed through independent and FDA-sanctioned studies that a potentially-deadly strain of bacteria, Mycobacterium chimaera (M. chimaera), can contaminate the water inside these tanks and become aerosolized into the sterile environment of an operating room, opening up the patient to the risk of contracting infections from the bacteria.

The Stockert 3T Heater-Cooler System, in particular, has been involved in 91 FDA reports in between January 2010 and August of 2016, including 79 infection incidents and 12 deaths linked to use of contaminated systems.

Infection with M. chimaera is not usually life-threatening to otherwise healthy individuals, however the infection is a major cause for concern in patients who have compromised health – such as those undergoing invasive heart, lung, esophagus and other chest-oriented surgeries to fix serious health problems.

German scientists knew as early as 2002 that this deadly strain of bacteria could grow inside the water tanks used in the 3T system, and it has been determined that some of the systems were actually contaminated during their production at the manufacturing facility.

A recall was issued in June of 2015 by the Sorin Group for 3T systems, and the FDA and CDC have sent out multiple warnings to hospitals about the risk of infection from using these systems.

According to the class action suit against LivaNova, there are about 250,000 heart bypass surgeries conducted annually, and 60% of those are conducted with the aid of a 3T heating/cooling device. As a result, the CDC estimated that there are more than half a million patients at risk of serious infection.

What is more concerning is that infection with M. chimaera may not become immediately apparent. Some of those who have been infected do not show signs or symptoms until years after their procedure and exposure. The risks of contracting this bacteria and its accompanying infection are anywhere from 1 in 100 to 1 in 1,000. The FDA warns all hospitals to inform patients who underwent relative surgeries that they may have been exposed.

Symptoms of M. chimaera infection include:

• Fatigue
• Persistent cough or coughing with blood
• Difficulty breathing
• Fever
• Pain
• Redness, heat or pus at the surgical site
• Muscle, abdominal or joint pain
• Night sweats
• Weight loss
• Nausea or vomiting

Lawsuits in these cases allege that LivaNova designed a flawed product that directly causes a deadly bacteria to grow and expose patients to its infection. They allege that these flaws stemmed directly from the manufacturing plant of these systems. They allege that the company failed to conduct adequate safety testing, failed to provide proper disinfecting procedures for the systems and they failed to adequately warn hospitals, doctors and patients about the potential risks associated with their product.

These suits, filed directly from people that were negatively – sometimes fatally – affected by these cooling/heating systems, paint a tragic picture of a medical device that actually threatened the lives of patients it intended to aid. These failures are directly the result of negligence on behalf of its manufacturer.

If you or somebody you love underwent an invasive surgery where a 3T heating/cooling system was implemented, and they suffered additional health complications or passed away as a result, you are entitled to join a class action suit or file a suit of your own to collect financial compensation for your pain and suffering.

At Altman & Altman LLP, we have over 40 years of experience holding negligent manufacturers accountable for their mistakes; mistakes that have potentially-deadly consequences. Our team of legal professionals is standing by to hear your case and help you move forward in the most effective manner.

Call us for a free consultation today at 617.492.3000 or toll-free at 800.481.6199. We are available 24/7.