New Lawsuits Filed, Heater-Cooler Devices Blamed for Infections
LivaNova, known formerly as Sorin Group, continues to face lawsuits alleging infections from its Stockert 3T Heater-Coolers. The device, which is used to maintain the temperature of a patient’s blood and organs, has been a subject of contamination concerns for some time. A recent study found that a global outbreak of bacterial infections is likely from tainted heater-cooler devices manufactured by LivaNova.
Parker Waichman LLP personal injury attorneys are keeping up-to-date with news and litigation involving LivaNova Stockert 3T Heater-Cooler systems. The firm continues to offer free legal consultations to individuals with questions about filing a lawsuit.
One lawsuit was filed on behalf of a man who underwent cardiac surgery in December 2014 at Penn Presbyterian Medical Center in Pennsylvania. A 3T heater-cooler device was used during his operation. Although his procedure was successful, he suffered a stroke afterwards. According to his lawsuit, the stroke stemmed from infection by the slow-growing nontuberculous mycobacterium (NTM). He alleges that in March 2016, a physician informed him that the infection likely came from the contaminated 3T heater-cooler device. The complaint states that some 1,100 patients at the hospital may have been exposed to the bacteria from October 2013 to December 2015.
Court records indicate that, in addition to individual lawsuits, a class action lawsuit has also been filed against LivaNova over the Stockert 3T heater-cooler devices. According to the complaint, the first two plaintiffs developed NTM infections after undergoing procedures involving the heater-cooler systems. The procedures took place at different hospitals.
The FDA has been aware of infection concerns regarding the heater-coolers since 2014. Although the water from the device itself does not make contact with patients, pathogens can be aerosolized and cause infection, the agency said.
Study: Global Outbreak of Bacterial Infections Linked to Heater-Cooler Devices
Recently, a study published in Infection Control & Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America, found that LivaNova heater-cooler devices are the likely source of a global outbreak of Mycobacterium chimaera (M. Chimaera), a type of NTM.
The study was led by Rami Sommerstein, MD, of Inselspital, Bern University Hospital in Switzerland. “It is surprising that a global outbreak like this could go unnoticed for years. This dangerous infection has put many patients at risk all over the world,” said Sommerstein. “Now that we know HCDs are the source, individual action from the different players (healthcare institutions, manufacturers, etc.) is needed to contain the ongoing patient risk. The most important action a hospital can take is to remove contaminated HCDs from the operating room and other critical areas. That is the only way to ensure that patients are protected from this infection moving forward.”
“While our understanding of the causes and the extent of the M. chimaera outbreak is growing, several aspects of patient management, device handling and risk mitigation still require clarification,” Sommerstein said.
Infections caused by M. chimaera can be hard to identify because the bacteria grows slowly. The researchers advised several measures to reduce the risk of contaminations, including removing contaminated heater-coolers from air near critical medical areas, education for clinicians so they know about the risks associated with M. chimaera, and screening for patients with unexplained fevers who had open heart surgery, heart transplantation or those who were exposed to ventricular assist devices.
Regulators Warn of Heater-Cooler Infections
The FDA has been issuing warnings regarding heater-cooler devices in 2014. A strong piece of evidence emerged recently when genetic fingerprinting showed that M. chimaera infections stemmed from a single source where the Stöckert 3T Heater-Coolers were manufactured in Germany. According to the Washington Post, the finding implies that as many as half a million surgery patients may be at risk.
The findings “strongly suggest the 3T heater-cooler units are the source of M. chimaera contamination”, FDA said in October.
The Centers for Disease Control and Prevention also addressed the severity of the situation, stating “Although thousands of patients in the United States have been notified regarding potential exposure to contaminated heater-cooler devices, the number who were exposed might be much larger,”
Symptoms of NTM infection include:
• Night sweats
• Muscle aches
• Weight loss
• Unexplained fever
Patients with NTM infection usually must be treated with surgery and prolonged periods of antibiotics. Symptoms may easily be mistaken for another medical condition. Some patients with infections were not diagnosed for four years.
Filing a LivaNova 3T Heater-Cooler Lawsuit
If you or someone you know suffered an infection after undergoing surgery involving a LivaNova (formerly Sorin Group) 3T heater-cooler system, you may have valuable legal rights. Parker Waichman offers free, no-obligation case evaluations. For more information about filing a heater-cooler lawsuit, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).