The U.S. Judicial Panel on Multidistrict Litigation (JPML) had determined that the growing product liability docket involving Sorin 3T Heater-Coolers does not warrant the creation of a centralized litigation in a single U.S. District Court. As such, claims filed on behalf of patients who allegedly developed dangerous heart surgery infections due to bacterial contamination of the 3T system will continue to move forward on an individual basis in various federal jurisdictions throughout the country.
The 3T Heater-Cooler is used to warm and cool patients undergoing cardiothoracic (open heart) surgery. The device is manufactured by LivaNova PLC (formerly Sorin Group USA , a subsidiary of Sorin Group Deutschland GMBH), and was brought to market via the U.S. Food & Drug Administration’s 510(k) clearance program. 510(K) clearance does not require a medical device to undergo human clinical trials if a manufacturer can demonstrate that it is “substantially equivalent” in design to another product that was previously approved b y the agency.
In recent years, the 3T Heater-Cooler has been the subject of several FDA alerts, including a Class II medical device recall. Last October, the U.S. Centers for Disease Control and Prevention (CDC) announced that its own testing had implicated the system in M. chimaera outbreaks reported among open heart surgery patients in the U.S. Similar outbreaks have been reported in a number of other countries, including the United Kingdom, Australia and New Zealand.
M. chimaera is a slow-growing and potentially deadly form of nontuberculous mycobacterium that spreads to the blood, bone marrow and organs. Victims of these infections and their surviving loved ones claim that the 3T Heater-Cooler suffers from manufacturing and design defects that allowed the bacteria to colonize within the apparatus. They have filed at least 15 heater-cooler infection claims in five U.S. District Courts that seek to obtain compensation from manufacturers of the device, including the Southern District of Iowa (2), the Western District of North Carolina (1), the Middle District of Pennsylvania (1), the District of South Carolina (10), and the District of South Dakota (1).
In its April 5th Order Denying Transfer, the JPML pointed out that the South Carolina’s 3T Heater-Cooler docket already undergoing informal coordination. The Panel also noted that none of the parties to lawsuits filed outside of that jurisdiction supported centralization.
“Opponents of centralization argue that unique factual and legal issues will predominate in this litigation, and that informal coordination is sufficient to minimize any overlap in pretrial proceedings,” the Order states. “We are persuaded that any overlapping pretrial proceedings have been and can continue to be handled through informal coordination.”