Companies accused in dozens of lawsuits of failing to adequately warn of the infection risk associated with Stӧckert 3T Heater-Cooler Systems have asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to transfer all cases to South Carolina for pre-trial handling.
What’s the Problem?
February 1, 2018 – Plaintiffs in the lawsuits allege that the Stӧckert 3T Heater-Cooler, a device used to regulate a patient’s body temperature during open-heart surgery and other invasive procedures, can infect patients with a potentially deadly strain of bacteria called M. chimaera.
It could take up to 2 months before the JPML decides whether to consolidate the 42 cases into a federal multidistrict litigation (MDL) for pretrial handling. Consolidation is intended to reduce duplicative discovery, avoid conflicting rulings by different judges, and to speed things through the litigation process as quickly as possible.
In addition to the 42 federal lawsuits, another 38 cases have been filed on the state level. All of the complaints involve similar allegations that LivaNova PLC (formerly Sorin Group Deutschland GmbH) failed to adequately warn the public and medical community about the risk of M. chimaera infection associated with use of the Stӧckert 3T Heater-Cooler device.
In 2015, the U.S. Food & Drug Administration (FDA) blocked imports into the U.S. of 3T heater-cooler devices after publishing a warning letter concerning violations by the manufacturer. FDA didn’t require U.S. hospitals to stop using existing heater-coolers, but did offer new recommendations for reducing the risk of infection by M. Chimaera and nontuberculous mycobacterium (NTM), another type of bacterium related to the use of the machines.
A report issued by the CDC in October 2016 found that Stöckert 3T heater-cooler machines were the likely source of an outbreak of rare bacterial infections. The report cited at least 28 NTM infection cases in the U.S., including 21 in Pennsylvania, 5 in Iowa and 2 in Michigan. Four deaths were reported in Pennsylvania, the agency said.