LivaNova Settles U.S. Litigation Around 3T Heater-Cooler Device

LivaNova PLC announced an agreement to settle approximately 75 percent of the previously disclosed litigation in the U.S. related to the company’s 3T Heater-Cooler device.
 
Under the terms of the agreement and subject to certain conditions, including acceptance of the settlement by individual claimants, the company has agreed to a settlement framework that provides for a comprehensive resolution of the personal injury cases pending in the multi-district litigation in U.S. federal court, a related class action case pending in U.S. federal court, as well as certain cases in state courts across the U.S. The agreement provides for a total payment of up to $225 million to resolve the claims covered by this settlement, with up to $135 million to be paid no earlier than July 2019 and the remainder in January 2020. LivaNova established a reserve of $294 million in the fourth quarter of fiscal year 2018 in connection with the 3T Heater-Cooler litigation generally.
 
“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,” said Damien McDonald, CEO of LivaNova.
 
“We are pleased with the manner in which LivaNova has responded to these claims,” said Sol Weiss, Lead Counsel for the Plaintiffs’ Executive Committee, which had been directing the federal litigation for the claimants. “These were complicated cases and the patients involved with this litigation have difficult medical histories. Protracted litigation was in no one’s interest, as the plaintiffs could benefit from settlement proceeds today. We especially appreciate the guidance from U.S. District Judge John E. Jones III, who oversaw the federal litigation.”
 
LivaNova makes no admission of liability under the agreement and can void the agreement if certain conditions, including participation rates by 95 percent of each of the categories of plaintiffs, are not met. The company continues to stand behind the 3T Heater-Cooler device, and will vigorously defend the product and company actions in the remaining cases.