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April 8, 2019

LivaNova Agrees to $225M Settlement for 3T Heater-Cooler System Injuries

Global medical tech company LivaNova PLC agreed to pay $225 million to settle lawsuits over heart surgery infections caused by 3T heater-cooler systems. On March 29, LivaNova released a statement declaring the company agreed to resolve approximately 75% of pending 3T heater-cooler system lawsuits filed across the U.S. over the past few years. However, Livanova’s agreement includes no admission of guilt.

“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,” Chief Executive Officer of LivaNova Damien McDonald stated in the March press release. LivaNova created a general reserve for the 3T Litigation with a sum amount of $294 million in the fourth quarter of the fiscal year 2018.

The pending cases filed claim 3T heater cooler systems (commonly used during cardiac procedures) were contaminated and the source of heart surgery patients’ severe infections. Sometimes these infections laid dormant for months or years before surfacing, patients and surgeons unaware of the heather-cooler’s harmful defects.

In a statement released by the CDC in 2016, every year in the U.S. surgeons perform over 250,000 heart bypass procedures that use heater-cooler devices. Of that 250,000, the faulty 3T heater-coolers link to approximately 60% of heater-cooler devices used in America.

Defective 3T Heater-Cooler System

According to research and recent allegations, Mycobacterium chimarea (M. chimarea) worked its way into LivaNova’s manufacturing process and contaminated the 3T heater-coolers. In 2015, a series of studies suggested M. chimarea may have be aerosolized by the water circuits in the heater-cooler devices, therefore causing infections in open-heart surgery patients. Mycobacterium chimarea, a rare type of nontuberculous mycobacterium (NTM) usually found in water or soil, can cause adverse side effects in humans, many of them life threatening. Patients who experienced the following symptoms should seek medical care immediately:

  • Night sweats
  • Muscle aches
  • Unexplained weight loss
  • Fatigue
  • Unexplained fever

Settlement Breakdown

Per the agreement, LivaNova’s settlement includes a total payment of up to $225 million by January 2020. $135 million of that total is to be paid no earlier than July 2019. The company also agreed to settle personal injury cases currently pending in the multidistrict litigation in the U.S. federal court system, specific cases in U.S. state courts, and a related class action case pending in the U.S. federal court. Despite the numerous complaints against the 3T heater-cooler system, LivaNova maintains its assurance of quality and faith in the heater-cooler system.

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