In a new lawsuit filed in the U.S. District Court for the Eastern District of Louisiana, a patient that came down with a pulmonary valve replacement infection alleges that it was secondary to the use of a Stockert 3T heater-cooler unit in surgery.

The plaintiff, Kyle H., filed his legal action on July 18, 2018, against LivaNova PLC and Sorin Group USA, defendants—manufacturers, marketers, and distributors of the named medical device.

According to the narrative of the lawsuit, Kyle H.—a resident of the State of Louisiana—was subject to open heart surgery on July 20, 2017. The goal of the procedure was to replace a pulmonary valve. Kyle says has since been treated for a pulmonary valve replacement infection known as mycobacterium abscessus.

Because Kyle attributes his pulmonary valve replacement infection to the use of the Stockert 3T heater-cooler unit, he is seeking damages from the defendants for their role in causing him physical as well as mental pain and anguish, permanent impairment and disfigurement, lost wages as a result of needing additional time for medical intervention, healing, and recovery, and lost money spent for medical care and hospitalizations, loss of enjoyment of life, companionship of society, and consortium with his partner.

History of the Stockert 3T Heater-Cooler Device

In September of 2005, Sorin Group Deutschland alerted the U.S. Food and Drug Administration (FDA) that they intended to commercially market the Stockert 3T cardiopulmonary bypass temperature controller—also known as a heater-cooler device.

The notification was submitted with the FDA’s 510(k) approval application. The 510(k) application is a shortcut that relies upon the safety record of similar medical devices or drugs that are already approved. Without the usual clinical trials to ensure its safety, the FDA approved the device in June 2006.

According to the pulmonary valve replacement infection lawsuit, the Sorin Co. had a responsibility to label and provide directions for the device’s use, cleaning, and disinfection in all possible circumstances. Purportedly, water quality conditions outside of Germany were not taken into consideration.

In the first half of 2014, open heart surgery patients that had had their procedures assisted by a Stocker 3T heater cooler device started to come down with infections that were suspicious. The bacteria involved in the infection—mycobacteria chimaera—were allegedly traced back and found to be present in device tanks in the hospital where the surgeries took place.

Another medical center in early summer of 2014 discovered the same infection in up to 15 former open heart surgery patients where a Stockert 3T device had been used. Four of the 15 infected people eventually succumbed to the infection or related complications.

While the Sorin Co. immediately attempted to update hygienic disinfection protocols with a warning and instruction letter in July 2014, those instructions proved to be inadequate in the long run. In September, an investigation of the factory where the devices were manufactured found that the contamination was actually occurring on site.

The FDA sent out a warning to hospitals and medical centers that Stockert 3T devices made prior to September 2014 may have been contaminated at the factory. Follow-up testing of the facility a few months later found the facility had cleared up the problem.

Nevertheless, the damage had been done. Many have attempted to hold the defendants liable as Kyle has in his pulmonary valve replacement infection lawsuit.