The Stockert 3T heater-cooler device manufacturer, LivaNova PLC (formerly Sorin Group Deutschland GmbH), has argued in for consolidation rather than fight 42 separate lawsuits and go through 42 individual trials.
No Time to Waste
Trial dates have already been set for 5 to 10 individual Stockert 3T heater-cooler lawsuits and some plaintiffs have made it clear they have no time to waste in a complicated MDL procedure.
“Unfortunately with the M. chimaera type of infections there is a 50 percent death rate,” says Kate Jaycox, from the Minneapolis, Minnesota law firm of Robins Kaplan. “There is concern that an MDL will slow down the process.”
Attorney Jaycox represents several plaintiffs who were exposed to the bacteria during surgeries where the Stockert 3T heater-cooler device was used.
“If the cases are consolidated those trial dates will be wiped off the schedule,” says Jaycox. “Some of these cases involve people who are quite ill.”
The Stockert 3T
The Stockert 3T heater-cooler devices are commonly used in operating rooms across the US to control a patient’s temperature during cardiothoracic surgery.
In 2015, unexplained infections began to appear in patients in Pennsylvania and Iowa who had undergone open-heart surgery. The infection was eventually identified as a rare type of Mycobacteria known as Nontubercular Mycobacterium or NTM.
The potential source of the bacteria was tracked directly back to the LivaNova manufacturing plant in Munich, Germany. The same type of NTM infections in cardiac surgery patients had already been linked to the Stockert 3ET heater-cooler in Switzerland several months before the Pennsylvania cluster of cases was discovered in the US.
Beginning in October 2016, the FDA updated a safety communication, warning that the infections were linked to the Stockert 3T heater-cooler devices, and asking health care facilities to report adverse events to the FDA.
Hospitals were advised to alert patients to the potential infection and warning letters began going to patients who might have been exposed to the deadly bacteria.
Nontuberculosis Mycobacterium (NTM)
NTM is a specific strain of Nontuberculosis Mycobacterium. It has no effect on healthy individuals. However, NTM can make people with weak immune systems or heart and lung problems extremely ill or even cause death.
Signs of NTM infection include low-grade, fever, night sweats, coughing, weight loss, and shortness of breath. NTM has an unusually long latency period. It can take up to four years before the infection produces symptoms.
“It is a difficult type of infection to catch because the infections systems can occur so long after the exposure to NTM bacteria,” says Jaycox. “It is not an automatic connect either for patients or doctors.”
Still Undetected Cases
Since then, thousands of patients have been notified about the potential dangers. The long latency period means there may be infected patients that have yet to be identified.
Some 250,000 cardiopulmonary bypass operations are performed in the US every year. These procedures usually require the patient’s temperature and heart rate to be controlled with a heater-cooler system.
“I don’t know there is a good way to know how many cases are out there. The Stockert 3T was used in 100s of thousands of surgeries,” says Jaycox. “LivaNova has the largest market share of these kinds of devices. There certainly could be many more cases out there.”
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“We tell people to go into their doctor with the letter and some information from the CDC which has guidelines on what doctors should be looking for.
“It is an unusual injury -- unusual in that you have a latency process like this. Our hope is that doctors do the testing when asked about this. Of course, we hope that people are not infected and don’t become our clients but that has happened,” says Jaycox.
In addition to the 42 federal lawsuits an additional 38 lawsuits have been filed in state courts. The lawsuits allege LivaNova PLC (formerly Sorin Group Deutschland GmbH) failed to warn doctors and patients about the risk of M. chimaera infection as a result of being exposed to the Stockert 3T heater-cooler device.