Plaintiffs who had open-heart procedures, and then fell victim to deadly infections are filing complaints in federal courts for their injuries.
Several of these cases have been filed in recent months, with plaintiffs claiming that Stockert 3T heating-cooling systems, which are often used in operating rooms to help regulate patient temperature, were contaminated, and caused nontuberculosis mycobacteria (NTM) infections. Two of the cases involve wrongful death claims.
On October 13, 2016, the Food and Drug Administration (FDA) released a safety communication warning that surgery with these devices had been linked with Mycobacterium chimaera (M. chimaera) infections. M. chimaera is a type of NTM, and can cause dangerous, drug-resistant infections that can lead to serious illness and even death.
Plaintiff Undergoes Bypass Procedure, Develops Infection
One of the recent cases was filed by a husband who blames the 3T heating-cooling device for his wife’s death. A resident of South Carolina, the plaintiff states that his wife went through a bypass procedure on September 2, 2013. A 3T heater-cooler system was used during that procedure.
On March 7, 2014, the decedent was readmitted to the hospital for shortness of breath and a possible ruptured aorta. On March 10, 2014, doctors diagnosed a large pseudoaneurysm of the aorta and noted that the decedent had “toxic-appearing” tissue that were concerning. They biopsied the tissue and found it tested positive for mycobacterium. Doctors weren’t sure at the time what had caused the infection.
They placed the decedent on a rigorous treatment of antibiotics, but on May 5, 2014, she was transferred back the hospital where she underwent repair for the damaged aorta. She was placed on more antibiotics and transferred to another medical center.
On June 17, 2014, the decedent was discharged to home hospice care. Despite continuous treatment, she succumbed to the infection and died on June 23, 2014.
Hospital Warns Patients of Exposure to Dangerous Bacterium
Stockert 3T heating-cooling devices are designed to provide temperature-controlled water to heat exchanger devices (like thermal regulating blankets) to warm or cool a patient during bypass procedures.
On June 20, 2014, the Greenville Health System Hospital (GHS) in Greenville, South Carolina, where the decedent was treated, announced that around 14 patients had tested positive for a rare NTM infection. Most of those patients had been exposed to the bacterium during open-heart surgeries.
GHS indicated that there had been three deaths related to the infection; and then on July 21, 2014, increased that number to four. On that date, they also sent out letters to about 180 patients who were at risk for potential exposure to the bacterium, including the plaintiff.
On July 15, 2015, the FDA issued a Class II recall of the 3T system used in the decedent’s operation. The recall included new instructions for hospital staff regarding cleaning and disinfection of the medical device.
On October 13, 2016, in response to the FDA and CDC warnings, LivaNova PL (formerly Sorin Group Deutschland GmbH), manufacturers of the Stockert 3T heating-cooling devices, released a “field safety notice update” warning surgeons and hospitals of potential risks associated with the machines. They noted that they had “learned a great deal” over the past two years about the infection risk to open-heart surgery patients.