Livanova has agreed to pay $225 million to settle most heart surgery infection lawsuits filed over problems with 3T Heater-Cooler systems commonly used in recent years during cardiac procedures, which were contaminated and caused devastating infections that could surface months or years later.
The manufacturer issued a press release on March 29, announcing that it had reached an agreement to resolve about 75% of the pending cases filed nationwide in recent years. The settlement involves a total payment of up to $225 million, with $135 million paid no earlier than July 2019, and the rest paid in January 2020.
It is unclear how many cases are resolved in the deal, but there are currently at least 85 product liability lawsuits pending in the federal court system, which are centralized before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, as part of an MDL, or multidistrict litigation.
Each of the complaints filed in recent years raise similar allegations, indicating that certain 3T Heater-Cooler Systems were contaminated, releasing a mist into the air of operating rooms during open heart surgery, which has allegedly caused plaintiffs to develop serious and life-threatening infections following heart surgery.
Livanova notes that it had established a reserve of $294 million in the fourth quarter to pay for the ongoing 3T Heater Cooler litigation.
“We believe entering into the settlement is in the best interest of the Company, its shareholders and patients, because it will remove ongoing costs and uncertainty as we focus on executing our strategy to deliver quality care to patients around the world,” Damien McDonald, Chief Executive Officer of LivaNova, said in the press release.
The agreement does not include an admission of guilt by Livanova.
3T Heater Cooler Infection Risks
The Sorin 3T Heater-Cooler designed to help regulate blood temperature. However, concerns over the safety of the devices emerged in late 2015, when the FDA warned about reports of heart surgery infections linked to heater-coolers, indicating that a large number of adverse event reports had been received by the agency.
In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.
Late last year, the federal regulators issued a safety communication, warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.
The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.