Parker Waichman LLP

LivaNova Faces Class Action Lawsuit over Sorin 3T Heater-Cooler System

A class action lawsuit has been filed against LivaNova over its Sorin 3T Heater-Cooler system. The suit, which represents two plaintiffs so far, alleges that the Sorin 3T Heater-Cooler introduced nontuberculous mycobacterium when the device was used during heart surgeries. The plaintiffs underwent these heart surgeries with the Sorin 3T at separate hospitals. The suit […]

A class action lawsuit has been filed against LivaNova over its Sorin 3T Heater-Cooler system. The suit, which represents two plaintiffs so far, alleges that the Sorin 3T Heater-Cooler introduced nontuberculous mycobacterium when the device was used during heart surgeries. The plaintiffs underwent these heart surgeries with the Sorin 3T at separate hospitals. The suit seeks to represent individuals who suffered an infection, allegedly due to the Sorin 3T Cardiac Heater-Cooler.

The Sorin 3T Heater-Cooler is used during heart surgeries to maintain the temperature of a patient’s organs and blood. The device uses a water tank containing temperature controlled water; this fluid does not make direct contact with patients. According to the U.S. Food and Drug Administration (FDA), however, contaminants from the water can be aerosolized, or transmitted through air.

In October 2015, the FDA issued a Safety Communication warning of nontuberculous mycobacterium infections associated with heater-cooler devices. The agency noted that “Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient.” The agency said it received 32 reports of infections associated with heater-cooler devices between January 2010 and August 2015; 25 reports were submitted in 2015 alone.

Nontuberculous Mycobacteria (NTM) is normally found in the environment. In healthy individuals it is usually not harmful, but it can cause serious infection in people who are ill or who have weakened immune systems.
The FDA issued another Safety Communication in June 2016, this time specific to the Stӧckert 3T Heater-Cooler System (3T), manufactured by Sorin Group Deutschland GmbH (now known as LivaNova). According to the alert, a European study found that the Sorin 3T Heater-Coolers are associated with a risk of Mycobacterium chimaera (M. chimaera), a type of NTM. The findings indicate a direct link to the heater-coolers, the FDA said. The alert states, “The results of this paper suggest a direct link between the M. chimaera to which the European patients were exposed and became infected during open-chest cardiac surgery, and one specific heater-cooler model – the 3T.”

In October 2016, the FDA released another update, stating that the Stockert 3T Heater-Cooler was associated with M. chimaera infections in distinct geographic locations in the United States. The agency said whole genome sequencing was performed on samples taken from infected patients, water drained from the 3T and air samples collected while the 3T was being used. “Whole genome sequencing was completed on clinical isolates taken from infected patients and samples taken from 3T heater-cooler devices in hospitals where clusters of patient infections were identified. Samples of the water drained from the 3T devices and air samples collected while the devices were in operation were tested. The results strongly suggest the 3T heater-cooler units are the source of M. chimaera contamination.” the alert states.

Plaintiffs in the class action allege that LivaNova knew or should have known about the risk of infection associated with the 3T heater-cooler, and alleges the company failed to disclose this risk.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Thank you to the lawyers Parke Waichman for their professionalism, especially to Jorge Peniche, a person who was of great help to me in several aspects, very grateful, thank you again.....
Josue Portillo
5 years ago
5 Star Reviews 150
My Experience with the lawyer Jessie Salcedo has been excellent, she has helped me at all times and answered any questions I had at some point. Thank you! Jessie Salcedo Paralegal Parker Waichman LLP
Keisha Reyes
4 years ago
5 Star Reviews 150
Michele J has such a great personality and is very knowledgeable. She’s a great asset!!! The Long family is appreciative of her hard work on our case. I would surely recommend Parker Waichman to everyone I know.
Christipher Long
5 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038