LivaNova PLC (formerly Sorin Group Deutschland) faces a legal claim over allegations that its heater-cooler device caused a serious infection in a young patient following an invasive surgical procedure.

Plaintiff Liric J. files the heater-cooler device lawsuit in Louisiana federal court, joining many other surgical patients who have filed similar claims. The lawsuit was filed on June 20, 2018.

According to the heater-cooler device lawsuit, Liric files the lawsuit on behalf of her daughter Symphony J., both residents of Jefferson Parish, La.

“After the open-heart surgeries performed on the minor, Symphony… has been treated for mycobacterium abscessus,” the heater-cooler device lawsuit states. She was treated for this infection in June 2017, Liric says.

Lirica argues that LivaNova has violated the Louisiana Products Liability Act in the following ways: for failing to warn of the dangers in using the heater-cooler device; failure to ensure the Stockert 3T device’s safety; failure to ensure that the device would not cause a patient infection; and failing to manufacture the Stockert 3T to avoid unreasonable risk of harm.

Some of the claims being raised against LivaNova include: past and future pain and suffering; current, past, and future medical expenses; permanent scarring; mental anguish; emotional distress; lost wages; permanent impairment; loss of enjoyment of life; loss of society and consortium.

Overview: Heater-Cooler Device

LivaNova PLC is facing a multitude of surgery infection lawsuits filed by patients alleging that they were infected with a serious bacterial infection. The heater-cooler device has been associated with nontuberculous mycobacteria (NTM) infections. They sometimes affect patients that undergo cardiothoracic surgical procedures, such as open heart surgery.

The Stockert 3T heater cooler device is one of the most popular heater-cooler devices used during invasive surgeries. These devices are used to warm or cool a patient, thereby improving patient outcomes and optimizing medical care.

According to the U.S. Food and Drug Administration (FDA), the heater-cooler device includes a water tank that provides temperature controlled water. The water is then linked to external warming blankets or heat exchangers.

The issue then comes through bacterial contamination transmitted through the air. Patients do not ever come into contact with the water tank itself. But bacteria inside the device may aerosolize through the heater-cooler’s exhaust vent, making their way towards a patient.

The surgical bacterial infection linked to the Stockert 3T heater-Cooler device is Mycobacterium chimaera (M. chimaera). Although the bacteria is relatively safe and found in water and soil, it is one that can cause serious illness in a surgical patient.

According to the FDA, “mycobacteria are found in much higher concentrations in water droplets emitted into the air from air bubbles rising and bursting in the tank, as compared to the concentration of mycobacteria found in the water in the tank.”

“In addition, these water droplets containing NTM bacteria may remain suspended in the air, which may increase the chances of entering the patient’s open surgical cavity or contaminating a sterile implant such as a heart valve.”

The Heater-Cooler Device Lawsuit is Case No. 2:18-cv-06112-JTM-JVM, in the U.S. District Court for the Eastern District of Louisiana.