LivaNova faces another recent Mycobacterium chimaera lawsuit in federal court filed by a woman on behalf of her deceased husband.

The Mycobacterium chimaera lawsuit joins a growing number of complaints being filed against the company over severe adverse effects and complications, including subsequent fatalities following mycobacterial infections linked to the Sorin 3T Heater-Cooler System.

Plaintiff Elizabeth A. filed the Mycobacterium chimaera lawsuit in the U.S. District Court of Colorado. The lawsuit was filed on May 29, 2018. She files the lawsuit on behalf of her deceased spouse, demanding jury trial.

According to the Mycobacterium chimaera lawsuit, the plaintiff’s husband, Bois, underwent an open-heart procedure on or around April 1, 2014 at The Center for Heart & Vascular Health located in Newark, Delaware.

During the procedure, the Sorin 3T was used to cool and warm Bois’ body temperature. However, following the procedure, Bois allegedly developed an M. chimaera infection in December 2017 or early 2018, the lawsuit states. Over time, Elizabeth claims, his condition worsened and on March 24, 2018, Bois passed away from complications following his M. chimaera infection.

The Mycobacterium chimaera lawsuit was filed on multiple counts including design defect, manufacturing defect, failure to warn, negligence, loss of consortium, wrongful death, and punitive damages.

Overview: Filing a Mycobacterium Chimaera Lawsuit

Each year, there are thousands of heart surgeries performed. According to a recent report, within the last year there have been almost 500,000 coronary bypass surgeries performed, and each year there are almost 2,300 people that undergo heart transplant procedures.

The Sorin Stockert 3T heater-cooler system is a commonly used medical device during invasive procedures that helps keep a patient’s body temperature warm or at proper body temperatures.

The Stockert 3T device works to regulate and maintain a patient’s body temperature by storing water in a tank. The water in the tank can, therefore, be regulated to a specific temperature, as required or needed to heat or cool a patient’s body temperature.

It is used while a patient undergoes something called a cardioplegia, or the intentional and temporary cessation of cardiac activity which is done specifically during cardiac surgery. The Sorin 3T is used during bypass surgeries and other, for example. involving the heart, lungs, esophagus.

However, the device has been linked to a bacterial strain known as Mycobacterium chimaera that can grow within the 3T heater-cooler.

It can be transmitted during an invasive procedure as it stems and populates directly from inside the unit. As the inside of the unit becomes contaminated, bacteria aerosolize potentially causing patient infection. Mycobacterium chimaera can cause a serious infection that can subsequently lead to patient death and fatalities.

The U.S. Food and Drug Administration (FDA) received 91 adverse event reports pertaining to the 3T heater-cooler system between January 2010 and August 2016. Of these 91 adverse event reports, 12 of these were allegedly linked to patient death and 79 were associated with incidences of infection.

The Mycobacterium Chimaera Lawsuit is Case No. 1:18-cv-01306-WYD-NYW, in the U.S. District Court for the District of Colorado.