Medical technology firm LivaNova has agreed to pay up to $225m to resolve certain litigation related to its 3T Heater-Cooler device in the US.
LivaNova has entered into an agreement to settle around 75% of its previously disclosed litigation related to the 3T Heater-Cooler device, which includes three circuits for rapid and efficient heating and cooling to meet patient and cardioplegia temperature requirements.
The system’s compressor-based cooling and three independent water tanks will help avoid the requirement for ice and water supply in the operating room, as well provide separate settings for warm cardioplegia, cold cardioplegia and patient temperature.
LivaNova CEO Damien McDonald said: “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.”
As per terms of the deal, which is subject to certain conditions including acceptance of the settlement by individual claimants, the firm has agreed to a settlement framework to resolve a pending multi-district litigation in the US federal court, as well as certain cases in state courts across the country.
The settlement framework will help offer a comprehensive resolution to the personal injury cases in the US courts.
Via settlement, the company will pay up to $225m to resolve the claims, including $135m by the end of this year and the remaining amount by January 2020.
LivaNova noted that it established a reserve of $294m in the fourth quarter of fiscal year 2018 in relation with the 3T Heater-Cooler litigation.
In addition, LivaNova said it made makes no admission of liability as part of the agreement and can void the agreement if certain conditions, including participation rates by 95% of each of the categories of plaintiffs, are not met.
Plaintiffs’ executive committee lead counsel Sol Weiss said: “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.”