Sorin Group USA is facing a heart surgery class action lawsuit led by an Iowa man alleging he developed a potentially deadly bacterial infections. The man is filing this heart surgery class action lawsuit on behalf of himself and others similarly situate who developed bacterial infection after undergoing surgery that used the Sorin 3T Heater Cooler System.

Lead plaintiff Kevin S. is filing this heart surgery class action lawsuit alleging the Sorin 3T Heater Cooler System is unreasonably dangerous for patient use. Kevin says he underwent open heart surgery on June 19, 2016, and was allegedly exposed to NTM bactera as a result of using the Sorin 3T Heater Cooler System.

Kevin opted to file the heart surgery class action lawsuit after discovering other patients may have suffered similar injuries. Each of the proposed Class Members had reportedly underwent cardiac surgery using the Sorin 3T Heater Cooler System, and had allegedly developed potentially fatal nontuberculous mycobacterium (NTM) infections.

These infections are allegedly caused by M. chimaera bacteria that had contaminated the Sorin 3T Heater Cooler System devices during the manufacturing process.

Overview of Cardiac Heater Cooler Bacterial Infection

This particular bacterium, normally found in ground and water, allegedly contaminated many Sorin 3T Heater System devices during the manufacturing process.

According to the FDA and CDC, the manufacturing plant in Germany reportedly became contaminated with M. chimaera at some point and was discovered during routine testing in September 2014.

The issue was reportedly resolved in July 2015 when the facility tested negative. The FDA stated there should not be contamination in devices manufactured after September 2014.

These heater cooler devices consisted of temperature-controlled water tanks. The water does not directly touch the patients, but the FDA states “there is potential for contaminated water to enter other parts of the device and aerosolize.”

The FDA issued its first warning regarding this problem in October 2015, stating the agency received 32 Medical Device Reports (MDR) regarding patients who had developed bacterial infections in alleged result of heater cooler devices.

The FDA released a later warning in June 2016, the FDA stated that the bacterial concerns stemmed from M. chimaera allegedly contaminating the Sorin 3T Heater Cooler manufactured by LivaNova.

The FDA issued its most recent warning on Oct. 13, 2016, providing health officials with recommendations to help prevent infection from spreading. On Feb. 2, 2016, the hospital Kevin had his cardiac surgery in announced that approximately 1,500 patients who underwent major heart, lung, or liver surgeries between Jan. 1, 2012 and Jan. 22, 2016 may be at risk.

These patients may have been exposed to the potentially fatal M. chimaera bacteria from the Sorin 3T Heater Cooler System. Kevin opted to file the heart surgery class action lawsuit after learning about large number of impacted patients.

Kevin is asking the court for establishment of a medical monitoring program for potential bacterial contamination with Sorin 3T Heater Cooler System devices, and he seeks an acknowledgment that the device was defective and unsafe for its intended us.

Kevin states that he never would have agreed to use the Sorin 3T Heater Cooler System if he had known about potentially fatal bacterial infections.

This Heart Surgery Class Action Lawsuit is Case No. 6:17-cv-02056-LTS, in the U.S. District Court for the Northern District of Iowa, Eastern Division.