Sorin Group Inc. is facing a new cardiac surgery infection lawsuit from an Alabama man alleging his late brother developed a bacterial infection soon after his cardiac surgery.

The man filed this claim soon after discovering the device was linked to similar cases in which the patients allegedly developed rare non-tuberculous myobacterial (NTM) bacterial infections.

Plaintiff Alfonso G. is filing this cardiac surgery infection lawsuit on behalf of his brother Anthony G., who allegedly developed the bacterial infection soon after his cardiac surgery. Anthony underwent a cardiac surgery on June 23, 2015, during which a Sorin 3T Heater-Cooler was used to keep his body temperature under control.

Even though Anthony had been sent home from the hospital just days after his procedure, he had to go back to the hospital soon after. According to the cardiac surgery infection lawsuit, Anthony was running a fever when he went to have his stitched removed but was still sent home.

However, on July 13, 2015, Anthony was once against admitted to the hospital after his leg swelled up and began experiencing severe fever and lethargy. Even though Alfonso and his sister had managed to get Anthony to the hospital, he passed away just minutes after getting there.

At the time of his death, Anthony had reportedly exhibited signs and symptoms of NTM infection. Alfonso opted to file a cardiac surgery infection lawsuit after discovering the company may known about bacterial contamination issues since 2011.

Overview of Cardiac Surgery Infection Lawsuit

The Sorin 3T cardiac heater cooler is a temperature control device consisting of two water tanks, which do not reach over a certain temperature and do not directly contact the patient.

Even though the heater cooler devices do not touch the patients, the FDA warned “there is potential for contaminated water to enter other parts of the device and aerosolize.” This means bacterial cells can enter the air form the device’s exhaust vent and possibly find their way to the patient.

Both the FDA and CDC have released safety warnings regarding this complication, stating the devices may have been contaminated at some point during the manufacturing process. The contamination was discovered in September 2014 during routine testing, with the company reportedly resolving it in July 2015.

Even though the FDA stated there were no bacterial cells found during these later tests, the agency states devices manufactured before September 2014 could be contaminated. The FDA issued its first safety communication in October 2015, stating it had received 32 Medical Device Reports (MDR) regarding patients who allegedly developed cardiac heater cooler infections.

At the time, the FDA did not specify the medical device in question and that it would “monitor the situation.” The agency would later release another warning in June 2016, warning patients the myobacterial infections were linked to 3T heater cooler devices by LivaNova.

According to the FDA, at least 12 patients have died in result of the infections and is encouraging patients and medical providers to be cautious.

Alfonso is filing this cardiac surgery infection lawsuit alleging multiple counts of negligence and failure to warn. He further states his brother’s death was directly caused by the 3T cardiac heater cooler device.

This Cardiac Surgery Infection Lawsuit is Case No. 2:17-cv-01427-JHE, in the Circuit Court of Jefferson County, Alabama, Birmingham Division.