LivaNova PLC, manufacturers of the Stockert 3T Heater-Cooler System, face a recent lawsuit filed by a mother and father on behalf of their daughter as she was diagnosed with an infection after open heart surgery.

Plaintiffs Tanika C. and Kerry L. file their infection after open heart surgery lawsuit on behalf of the daughter, Lailaa, who is still underage. Filed in Louisiana federal court on July 2, 2018, the case alleges that the cardiac heater cooler device caused her to suffer severe adverse side effects and complications including the contraction of a bacterial infection.

According to the lawsuit, Lailaa underwent open-heart surgery in June 2017. However, since then she has been treated for Mycobacterium abscessus, believed to have stemmed from use of a cardiac heater cooler device, known as the Stockert 3T device, during the procedure.

The parents claim LivaNova is liable for violations of the Louisiana Products Liability Act. They are specifically alleging liability for: failing to warn of the dangers and side effects associated with the Stockert 3T; failure to ensure the safety of patients using the Stockert 3T; manufacturing an inadequate product; failing to avoid causing an unreasonable risk of harm; and the breach of other duties held by a medical device manufacturer.

Overview: Infection after Open Heart Surgery Lawsuit

Thousands of lawsuits have been filed against LivaNova, the manufacturer of the Stockert 3T heater cooler device, alleging that the device causes patients to contract a subspecies of nontuberculous mycobacteria (NTM) known as M. chimaera or M. abscessus. While the subspecies are found in the environment and rarely do cause illness, they pose a unique risk for patients who are exposed to them in the hospital while undergoing invasive surgical procedures.

In fact, via notifications sent out by hospitals across the country in October 2015, thousands of patients were notified that they may have been exposed to a bacterium linked to the LivaNova Stockert 3T Heater Cooler System. These patients may have undergone any number of invasive procedures such as operations on the heart, lung, and liver.

The Stockert 3T heater cooler device is used to help regulate and maintain a patient’s body temperatures during invasive procedures. The device thereby helps maintain and uphold the safety of a patient’s vital organs through the proper circulation of blood at proper temperature levels.

The device design works by storing water in a tank that can be regulated and set at a specific temperature to heat or cool a patient’s body temperature as required. However, the water in the tank can be a reservoir for bacteria; if aerosolized water enters the operating area, the bacteria in the air can enter the site and cause the patient infection.

Patients who have suffered and contracted an NTM infection have the eligibility to file an infection after open heart surgery lawsuit. Filing a lawsuit can help with damages suffered such as permanent impairment; mental anguish; permanent scarring; past, current, and future medical expenses; and past, present, and future pain and suffering.

The Infection After Open Heart Surgery Lawsuit is Case No. 2:18-cv-06414-EEF-KWR, in the U.S. District Court for the Eastern District of Louisiana.