Lawsuits claim the Sorin 3T Heater-Cooler System spread bacteria during heart and lung surgeries, causing serious infections and deaths. The majority of the lawsuits have been combined into a single federal litigation.
If you experienced any of the following complications after undergoing an operation in which a heater-cooler device was used, you may be entitled to compensation.
Number of Lawsuits More than 70
Plaintiff Injuries Infection, death
Defendants Sorin Group USA Inc.; Sorin Group Deutschland GmbH; LivaNova PLC
Bellwether Trial Date Date not yet set
MDL Location Middle District of Pennsylvania
Class-Action Status One class action lawsuit active
Litigation Status MDL formed Feb. 1, 2018
Top Settlement No publicly disclosed settlements at this time
In February 2018, a federal panel consolidated nearly 40 lawsuits that claim Sorin 3T Heater-Cooler devices spread nontuberculous mycobacteria (NTM) infections during open chest surgeries. The panel transferred the lawsuits to a single federal court in Pennsylvania to streamline the proceedings.
People suing Sorin and LivaNova say they became infected or a loved one died after surgeries using the companies’ heater-cooler devices.
NTM infections can take months or years to show up. At least one other federal lawsuit, filed as a class action, demands that the devices’ manufacturer provide monitoring for people who had surgery with the devices.
As of February 2018, there were at least 73 lawsuits filed over injuries blamed on the Sorin 3T Heater-Cooler System. Because of the large number of surgeries performed with Sorin 3T devices — and the fact that NTM infections can take years to show up — there is the potential for dozens or even hundreds more lawsuits.
Lawsuits over Sorin 3T injuries have been consolidated in a Pennsylvania federal court.
Heater-cooler lawsuits are still in the early stages. No trial dates have been set. Lawyers are continuing to file lawsuits on behalf of people who believe a Sorin 3T Heater-Cooler device injured them or a loved one during surgery.
In February 2018, a federal panel combined 39 Sorin 3T Heater-Cooler System federal lawsuits from around the U.S. into a multidistrict litigation (MDL) in Pennsylvania federal court. MDLs allow cases to move more quickly and efficiently through the legal process.
The Judicial Panel on Multidistrict Litigation said more than 30 cases already filed in state courts could be included in the MDL in the future.
There is also an active Sorin 3T Heater-Cooler class action lawsuit that demands the devices’ manufacturer arrange for monitoring for patients who underwent surgery with the devices.
Sorin 3T Heater-Cooler lawsuits claim the devices spread NTM bacteria, causing a variety of infections.
People filing lawsuits say they were seriously injured or a loved one died after developing an infection caused by a Sorin 3T machine.
NTM Bacteria Infections Can Cause:
The Sorin 3T devices were originally branded as the Stockert 3T Heater-Cooler System. The Sorin Group originally manufactured the devices.
Sorin merged with Cyberonics Inc. in October 2015 to create a new company called LivaNova.
Lawsuits have been filed against the new company as well as U.S. and German branches of Sorin.
Manufacturers named in the lawsuits are:
People who filed Sorin 3T Heater-Cooler lawsuits say the manufacturers knew or should have known the devices could spread infection. Their lawsuits claim Sorin and LivaNova did not properly warn people of the risks the devices posed.
Lawsuits claim Sorin and LivaNova should have known the Sorin 3T Heater-Cooler System design or manufacturing defects made the devices “susceptible to bacterial colonization, specifically Mycobacteria, despite any cleaning and disinfections procedures utilized.”
Sorin 3T Heater-Cooler lawsuits are still in the early stages of litigation, and there have not been any trials or large settlements. The amount of any possible award is impossible to predict. A product liability lawyer should be able to help you determine whether filing a lawsuit could be worthwhile for you.
There have been at least three Sorin 3T Heater-Cooler class action lawsuits filed. Only one of them is still active.
In March 2016, Edward Baker and Jack Miller filed a lawsuit that sought class action status in federal court for the Middle District of Pennsylvania. Baker and Miller claim they and thousands of other patients were potentially exposed to bacteria during surgeries using Sorin 3T devices.
A Sorin 3T Heater Cooler class action lawsuit sought medical monitoring for about 3,600 Pennsylvania patients potentially exposed to NTM.
A second class action, filed in January 2017 in South Carolina, was later withdrawn by the man who filed it. Plaintiff Steven Foster gave no reason for his decision to withdraw the lawsuit.
In May 2017, Jeri Pickrell filed the third heater-cooler class action lawsuit. Like the Baker lawsuit, Pickrell’s sought medical monitoring for people potentially exposed to infectious bacteria. A federal court in Iowa dismissed Pickrell’s class action lawsuit in January 2018, after Pickrell was unable to show she had actually been injured.
In October 2016, the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration issued safety notifications about Sorin 3T devices.
The CDC reported a genetic similarity between strains of NTM found in patients and in the devices used at hospitals in Iowa and Pennsylvania. The report asserted that the devices made before Aug. 18, 2014, may have been contaminated during the manufacturing process.
The FDA has confirmed that NTM can cause infections in patients with compromised immune systems. This includes patients requiring heart or lung surgeries.
Sorin recalled the 3T Heater-Cooler System in June 2015, citing the potential for contamination that could lead to NTM infections in patients.
The FDA discovered that the affected devices may have been distributed as late as 2014. The agency also found the first incident was reported as early as 2012, and it estimated that over a half million patients may have been exposed to NTM.
The FDA inspected LivaNova’s Munich manufacturing plant in August 2015 and its Arvada facility in August and September 2015. The agency later issued a notice that inspectors found conditions that did not conform to FDA standards in the Munich facility.
Please seek the advice of a medical professional before making health care decisions.
Terry Turner is an Emmy-winning, former television journalist. He is an associate member of the American Bar Association, the ABA’s Health Law group and a member of the Alliance of Professional Health Advocates. He holds six certificates in Health Literacy for Healthcare Professionals from the Centers for Disease Control and Prevention. As a Washington-based investigative reporter, he routinely reported on health and medical policy issues before Congress, the FDA and other federal agencies. Terry received his B.A. in Media Arts from Lyon College.
Did you develop an infection after undergoing an operation in which a Heater-Cooler device was used?