Plaintiffs pursuing lawsuits over infections allegedly caused by the Stöckert 3T Heater-Cooler System are seeking to have all such federal claims centralized in a single jurisdiction, preferably the U.S. District Court, District of South Carolina. In a January 30th Petition filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML), they argue that consolidation of the federal docket will promote judicial efficiency and preserve the resources of the courts, parties and witnesses involved in the growing litigation.
The Stöckert 3T Heater-Cooler system is designed to warm and cool patients undergoing cardiac thoracic surgery and other medical procedures. The device is manufactured by LivaNova PLC (formerly Sorin Group USA , a subsidiary of Sorin Group Deutschland GMBH), and was cleared for sale via the U.S. Food & Drug Administration’s 510(k) clearance program in 2016.
In June 2015, the FDA issued a Class II recall for the Sorin 3T System due to the “potential colonization of organisms, including Mycobacteria” in the devices. The agency issued a new safety communication in June 2016, after a study suggested a direct link between Stӧckert 3T Heater-Coolers and M. chimaera infections reported among open-heart patients in Europe. The alert also noted that tests performed at Sorin’s manufacturing facility two years earlier had detected the same bacteria on the production line and in the water supply. In October, the U.S. Centers for Disease Control and Prevention (CDC) announced that its own testing had implicated Stӧckert 3T Heater-Coolers in infection outbreaks reported among cardiothoracic surgery patients in this country.
According to the JPML Petition, there are currently 15 heater-cooler lawsuits involving the Sorin 3T system pending in the federal courts around the U.S, all of which were filed on behalf of patients who allegedly developed serious post-surgical infections caused by bacteria dispersed from the device. Ten of those claims have been filed in the District of South Carolina.
“The potential claims arising from patients whose surgical procedures involved a Sorin 3T Heater-Cooler System could conceivably be filed in a number of additional federal jurisdictions,” the Petition states. “Consequently, consolidation in the District of South Carolina, where witnesses and documents are available, the first substantial outbreak involving this medical device occurred, and the CDC has inspected the devices, and which is a location convenient for the majority of parties and counsel, would serve the interests of all parties in ensuring the just and efficient conduct of all actions.”