Lawsuit Filed Alleging Infection from LivaNova. Another lawsuit has been filed against LivaNova, known formerly as Sorin Group, alleging infection from the company’s 3T heater-cooler device. Most plaintiffs suing over the device underwent heart surgery. The recent lawsuit was filed on behalf of a South Carolina man who underwent a liver transplant in June 2015 to treat his end-stage liver disease. The LivaNova 3T heater-cooler was used to maintain the temperature of his blood and organs. According to the lawsuit, the device caused a serious infection.
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.
LivaNova heater-cooler devices have been implicated in a global outbreak of nontuberculous mycobacterium (NTM), a slow-growing bacterium. Specifically, patients have suffered infections from Mycobacterium chimaera (M. Chimaera), a type of NTM.
According to the complaint, the plaintiff suffered a fever and abdominal pain after his liver transplant. He returned to the hospital days after his operation. The plaintiff says he continued to visit the hospital throughout the year, with repeated symptoms of fever and abdominal complications. He alleges that he was prescribed antibiotics.
The plaintiff says a CT scan was performed, revealing an abscess inside the abdomen. Doctors collected culture samples, which tested positive for Mycobacterium abscessus. Physicians performed a wound debridement. He was given an antibiotic treatment over the court of 13 months.
This lawsuit is among the latest to be filed over LivaNova 3T heater-cooler devices. Another case was filed on behalf of a man who underwent cardiac surgery in December 2014 in Pennsylvania. He suffered a stroke after his procedure, allegedly due to the bacterial infection. According to his lawsuit, a physician informed him in March 2016 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.
LivaNova is also facing a class action lawsuit alleging infections from its Stockert 3T heater-cooler devices. The first two plaintiffs underwent procedures at different hospitals. They both developed NTM infections, allegedly due to the heater-cooler systems.
The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have warned of infections potentially linked to contaminated heater-cooler systems. The FDA says that, although the water from the device does not make contact with patients directly, contaminants can be aerosolized into the air. “Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient.” the agency said in October 2015.
The FDA has been issuing warnings on the issue since 2014.
Study Links Global Outbreak of NTM Infections to Heater-Cooler Devices
Regulators have been aware for some time that NTM infections may be linked to contaminated heater-cooler devices. A recent study published in Infection Control & Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America, confirmed that heater-cooler devices are the likely source of a global outbreak of Mycobacterium chimaera.
Rami Sommerstein, MD, of Inselspital, Bern University Hospital in Switzerland, led the study. “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.
Since M. chimaera grows slowly, infections can be hard to diagnose. There are several steps researchers recommend to minimize the risk of further NTM infections, 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.
500,000 Patients May be at Risk
According to the Washington Post, as many as half a million surgery patients may be at risk for heater-cooler infections. Genetic fingerprinting recently showed that M. chimaera infections came from a single source where the Stöckert 3T Heater-Coolers were manufactured in Germany. In October, FDA said these findings “strongly suggest the 3T heater-cooler units are the source of M. chimaera contamination”.
The CDC also addressed the issue, 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
Treatment often requires surgery and prolonged periods of antibiotics. Since the bacteria grows slowly, infections are hard to identify and symptoms may easily be mistaken for another medical condition.
FDA also notified the public of European study findings in June 2016, stating “The results of this paper suggest a direct link between the M. chimaera to which the European patients were exposed and became infected during open-chest cardiac surgery, and one specific heater-cooler model – the 3T.”