Sixteen lawsuits filed in the wake of infection outbreaks will not be consolidated, despite a common link to heater-cooler devices.
By Laurence Banville
Government researchers have traced a series of strange bacterial outbreaks back to a machine used in open heart surgeries. Used to regulate body temperature, heater-cooler devices can harbor virulent pathogens, releasing harmful bacteria into the air of an operating room.
Virulent Bacteria Spread By Heater-Cooler Machines, FDA SaysOutbreaks of Nontuberculous Mycobacteria have been reported in three Pennsylvania hospitals, as well as locations in Iowa and Michigan, according to The Product Lawyers. Internationally, similar bacterial infections have been described in Australia, Switzerland, Germany and the Netherlands. At least 25 infections have been confirmed worldwide, with over 13,300 patients potentially-exposed during procedures. Five deaths have already been attributed to heater-cooler-related infections. The class of bacteria known as Mycobacteria also includes the pathogens that lead to tuberculosis and leprosy.
Troubling new evidence has now linked the vast majority of these outbreaks to a single heater-cooler unit, the Stöckert 3T manufactured by London-based medical device company LivaNova. In fact, extensive analyses of bacterial strains from the United States, United Kingdom and Denmark suggest that the exact same bacterium had appeared in all three countries. This is strong evidence that Stöckert 3T heater-coolers were contaminated at some point during the manufacturing process, not afterward.
Lawsuits Won't Be Transferred To South CarolinaMore than a dozen patients have now filed lawsuits against LivaNova, the world's leading manufacturer of heater-coolers. In 16 federal complaints, plaintiffs blame the machine's design and manufacturing process for allowing life-threatening bacteria to enter the operating theater. The lawsuits are scattered across federal courts in at least five states.
The claims, however, will not be consolidated, according to the Judicial Panel on Multi-District Litigation (JPML). On April 5, 2017, the committee of federal judges denied a petition submitted by a group of plaintiffs, who had asked the Panel to transfer every federally-filed heater-cooler lawsuit to the US District Court of South Carolina.
The decision does not appear to have been difficult. The bulk of the litigation began and remains in South Carolina. In fact, ten of the lawsuits have been assigned to the same federal judge in that State and are already proceeding in a "coordinated fashion," the Panel writes. Of the six other claims, four were filed by the same plaintiffs' counsel, a fact that has already led to significant gains in efficiency. In this context, formally coordinating the litigation seemed unnecessary, the JPML says.
According to the Centers for Disease Control & Prevention, more than 250,000 bypass surgeries employ a heater-cooler unit every year in the United States. The vast majority of these devices are manufactured by LivaNova and marketed under the Stöckert brand name.