Canadian Class Action Lawsuit alleges the Sorin 3T Heater-Cooler System manufacturers failed to adequately warn hospitals of risk to open-heart surgery patients
Toronto, ONA class action lawsuit certified by an Ontario Superior Court judge accuses LivaNova (formerly Sorin), the manufacturer of Sorin 3T Heater-Cooler System, a medical device used to regulate the temperature of fluids during open heart surgeries, of failure to adequately warn hospitals of severe infection risk to open-heart surgery patients.
In early 2010, M. chimaera, a subspecies of Nontuberculous Mycobacterium (NTM), was identified in post-surgical patients who underwent open-heart procedures. After patient deaths in Europe and the United States in which M. chimaera was present, researchers worked to find the cause of these particular and peculiar infections. By August 2014, M. chimaera was identified on the production line at the Sorin facility in Germany where the heater-cooler devices (HCUs) were manufactured, and LivaNova was aware of the contamination, according to the class action. Almost one year later, In June 2015, the company told hospitals and Health Canada that bacteria could be aerosolized when the device was in operation. LivaNova said the "disinfection practices … that some users have been performing are not always conducted according to our instructions."
When Paul Johnson--who is part of the class action--had open heart surgery in 2015 he was exposed to M. chimaera, the same deadly bacteria that contaminated the water tanks on the Sorin 3T Heater-Cooler System at the manufacturing facility in Germany and had piggybacked on the heater-cooler devices into at least 35 Canadian hospitals. Johnson is now 68 years old and is suffering constant pain, takes an antibiotic and painkiller cocktail every day, and his wife has become his full-time caregiver as he cannot even move in the house by himself.
More Patients Infected
About a dozen former patients with confirmed infections, or their families, have joined Johnson in the class action against LivaNova. Margaret Waddell, one of the lawyers in Toronto leading the class action, told CBC News “There's still the possibility of more people becoming infected.” This type of bacteria is slow-growing –like mesothelioma, an infected patient may not display symptoms for several years. Research indicated that infections caused by this bacteria are severe and can result in death.
The Centers for Disease Control and Prevention (CDC) reports that more than 250,000 heart bypass procedures are performed in the U.S. every year using heater-cooler devices routinely. An estimated 60 percent of these procedures performed utilize an HCU that has been associated with these infections. And patients who had valves or prosthetic products implanted are at higher risk of these infections.
In November 2016 two cases of M. chimaera infection were confirmed in Canada. At least eight people in Canada have died from an M. chimaera infection, and others have suffered serious injuries and illnesses, according to Waddell.
Health Canada and FDA Warnings
The FDA on October 13, 2106, issued a warning to health care providers and hospitals to “immediately pull any device that had tested positive for M. chimaera, and "strongly consider" not using the devices for open chest cardiac surgery. One week later, Health Canada issued a “risk communication” warning of infections linked to various heater-cooler devices, adding a reminder to follow the manufacturer's cleaning instructions, and advised that any devices suspected of contamination should be removed "from the operating room, or if feasible, from service as soon as practical." And again in 2017 it issued a medical device recall advising a potential risk of NTM infections with the HCUs.
The Canadian Class Action Lawsuit
The class action against Sorin Group Deutschland GMBH and LivaNova Canada Corp claims the defendants were negligent in the design, manufacture, pre and after-market testing, and the distribution and sale of the Sorin Stockert 3T Heater-Cooler Systems, which put patients at risk of serious infection or death from M. chimaera bacteria.
According to court documents, the claim is brought on behalf of every person in Canada who underwent surgery during which the Sorin 3T Heater-Cooler System (the “HCU”) was used, during the period between January 1, 2010 and the date the last HCU at each hospital or cardiac surgery facility was equipped with vacuum canister modifications or was taken out of service at the hospital or cardiac surgery facility where the surgery took place, (the Patient Class) and their close family members. The last unit was repaired or taken out of service on October 19, 2018.
LivaNova in March 2019 paid $225 million to settle similar lawsuits in the U.S. Under the agreement, LivaNova made "no admission of liability."
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