Heater-cooler systems are vital during open pulmonary or cardiac surgeries. The system ensures the patient remains warm, while cold water allows the heart and lungs to rest for a brief period.
The Sorin Stöckert 3T System is a popular Heater-Cooler device that uses three circuits and separate water tanks. Unfortunately, this device potentially causes contamination through a microorganism called mycobacterium chimera. The device could release bacteria in open-chest surgeries, infecting the patient’s tissues. The patients develop deadly infections that are nearly 50% fatal.
Affected patients are still filing lawsuits against LivaNova, the device’s manufacturer. If you or your loved one developed mycobacterial infections after using the device in open surgery, you should consider taking legal action.
History of the Sorin Stöckert 3T
A heater-cooler unit (HCU) is a medical device used in cardiothoracic surgeries such as:
- Lung transplant
- Heart transplant
- Heart valve replacement
- Aortic anomaly surgery
- Lung resection
- Left ventricular assist device or LVAD implant
- Pulmonary artery banding
- Cardiopulmonary bypass surgeries
- Coronary artery bypass graft or CABG
- Extracorporeal membrane oxygenation or ECMO
The device controls the patient’s organ and blood temperature during surgery. It has two water tanks that supply temperature-controlled water to warming or cooling blankets.
The closed circuits ensure the patient has no direct contact with the water. However, the water can vaporize and enter the air in the operating room through the external vent system and fans.
If the water has contaminants, the bacteria can penetrate the patient’s chest cavity during the open surgery.
Stöckert 3T devices account for about six out of ten heating-cooling devices in the US. The FDA estimates about 2000 Stöckert 3T Systems in medical centers and hospitals. LivaNova PLC, the device manufacturer, has been aware of the cases of severe infection and fatalities caused by their device since 2014.
According to Consumer Reports, four out of 15 patients who developed the rare mycobacteria infection after open surgery at Greenville Memorial Hospital in South Carolina passed away.
The hospital determined that the patients developed an infection from contaminated heater-cooler devices. There have been similar cases in other hospitals across the country, such as Iowa, Michigan, and Pennsylvania, since January 2010.
In 2016, a Euro Surveillance study discovered that LivaNova’s devices leaving the production site were already contaminated. This exposed thousands of surgery patients to severe NTM infections and possible fatalities.
All Names the 3T Heater-Cooler Goes By
The FDA approved the Sorin Stöckert 3T device in 2006 as the first heater-cooler device. The initial brand name was Stöckert 3T Heater-Cooler System, which later changed to Sorin 3T devices.
Sorin Group, the original manufacturer, merged with Cyberonics Inc to form a new company, LivaNova, in October 2015. The Sorin group includes the German branch, Sorin Group Deutschland GmbH, and the US branch Sorin Group USA Inc.
There are other heater-cooler devices in the market from different manufacturers, including:
- Heater-Cooler Unit HCU 40 by Maquet
- Biotherm Heat Exchanger and ECMOtherm II Heat Exchanger by Medtronic, Inc.
- Thermoguard XP by Alsius Corporation
- Jostra HCU 30 by Jostra AB
- Cincinnati Sub-Zero Hemotherm 400CE Dual Reservoir Cooler by Cincinnati Sub-Zero Products, Inc.
- Terumo HX@ Heater Cooler by Terumo (Sarns) Cardiovascular Group
However, most lawsuits involve LivaNova’s Stöckert 3T device.
Overview of Research Findings
A team of German researchers first discovered that M. chimaera could grow inside the water tanks in heater-cooler systems in 2002.
NTM infections are generally uncommon in the US, affecting two out of every 100,000 people annually. However, researchers noticed a spike over the last three decades in 2014, as highlighted in the Journal of Thoracic Disease.
There are now between 50,000 and 90,000 people with NTM infection, with the majority being the elderly. Every year, the number increases by nearly 8%, as Insmed, the biopharmaceutical company, cautions.
Anyone who had a procedure that required a heating-cooling device should watch out for symptoms of NTM chimera infection, such as:
- Weight loss
- Night sweats
- Vomiting
- Nausea
- Redness, heat, or pus near the surgical area
- Joint pain
- Abdominal pain
- Muscle pain
- Fatigue
- Fever
- Difficulty breathing
- Lack of appetite
- Loss of energy
- Persistent cough with blood spots
Most cardiothoracic surgery patients are unaware of the risk of a deadly infection after the procedure. The bacteria can remain dormant for extended periods without detection.
The CDC warns that patients experience nonspecific or general symptoms for months. This delays diagnosis or causes misdiagnosis.
Once the bacteria resume activity, it causes severe infection complications such as:
- Inflammation in the bones or osteomyelitis
- Bacteria in the blood or bacteremia
- Abscess
- Inflammation of the heart’s inner lining or endocarditis
- Surgical site infection
- Pancytopenia
- Renal insufficiency
- Myalgia
- Hepatitis
- Splenomegaly
Recalls
So far, there are no official FDA total recalls for the Stöckert 3T Heater-Cooler Systems or other heating-cooling devices. However, Sorin Group voluntarily withdrew 3T heater-cooler devices from the market on 15th June 2015.
This decision prompted the FDA to inspect Sorin’s production plant in Munich in August 2015 and the Arvada plant in August and September. The investigators detailed multiple violations, and the FDA issued a warning letter to the company on 29th December 2015.
The agency highlighted three primary violations, including:
- The company did not act on multiple design change orders for the device’s cleaning IFU between 2012 and 2015.
- Sorin also disapproved of a new disinfection and drying process for T3 devices.
- They also lacked effective internal systems to communicate medical device reports.
Although there were no total recalls, the CDC and FDA published a Field Safety Notice Update in October 2016. They alerted the medical community about the potential risks of the Heater-Cooler device in open surgeries.
The FDA recommended precautions such as:
- Testing all devices for mycobacteria chimera and removing any contaminated devices
- Directing the device’s exhaust fans in the operating room away from the patient during the procedure
- Determining the potential sources of dirty water, including the environment and accessories
According to the FDA, these precautions help to reduce the risk of exposing patients to deadly bacteria.
On 25th October 2019, the FDA announced Class II recall for the Heater-Cooler System 3T 120V~/60Hz REF 16-02-85. Class 2 recalls are for devices with a low possibility of causing adverse health consequences. The recall followed more reports of severe infections from patients who used the Stöckert 3T device during open surgery.
The FDA discovered that the water preservatives or disinfectants used in the water tanks allowed NTM bacteria to thrive. Although unintended, this flaw encouraged the growth of NTM and other microorganisms.
General Physician Sentiment
Non-tuberculosis mycobacteria (NTM) chimaera infections may remain unnoticed for months or years after exposure. The symptoms also advance slowly over time and are often similar to various lung conditions.
Although the symptoms can go away, the infection worsens without proper treatment.
These organisms are harmless in healthy people. However, they can cause life-threatening infections in patients with weak immune systems.
As doctor Daire Cantillon highlights, NTM infections require intensive treatment using various drug combinations. The bacteria are either resistant or develop resistance to antibiotic treatments. Doctors have to combine two or more antibiotics.
The treatment must be continuous until the test results are negative for NTM for a minimum of twelve months.
The potent antibiotics have severe side effects, so patients require a regular hearing, vision, and blood tests.
The initial infection can sometimes relapse or recur due to new NTM strains. Some patients have to undergo additional surgery to control the condition.
If you underwent open cardiac or chest surgery and developed such symptoms, ensure you inform your doctor. Particular diagnostic tests confirm NTM infections. You should also contact Join the Many to discuss filing a Sorin 3T Heater-Cooler lawsuit.
Brief Sorin 3T Heater-Cooler Lawsuit History
Sorin Group, including LivaNova PLC and Cyberonics Inc., are currently facing lawsuits involving their 3T Heater-Cooler device.
The lawsuits involve various product liability claims. For instance, some claim that LivaNova distributed the 3T devices to hospitals and medical facilities. They did so, yet they knew or should have known that the water tanks could cause deadly infections.
The German study highlighting possible M. chimaera contamination has been available since 2002, so there’s no excuse. The lawsuits also claim that after LivaNova discovered the contamination, they did not recall the 3T devices.
The company failed to notify the medical facilities that bought the 3T devices about the contamination issue. Since they were unaware, the devices remained in use for several years, exposing numerous patients to the risk of fatal infections.
Some lawsuits also mention hospitals where NTM infections occurred. For instance, the York Hospital in Pennsylvania reported twelve NTM infections. The hospital contacted over 1,300 people who underwent open surgeries from 2011 to 2015. They also modified inspection procedures and removed the LivaNova devices but faced legal action.
The lawsuits against LivaNova cover various injuries, including:
- Aortic root abscess – A severe aortic valve infection that requires surgery to treat
- Myocutaneous Thoracotomy Flap Infection
- Endocarditis
- Pericardial abscess – A complication that damages the sac around the heart and the roots of primary blood vessels close to the heart
- Abdominal abscess – A pocket of pus and infected fluids that forms in the belly
- Mycotic Aortic Arch Pseudoaneurysm- An infection that has similar symptoms as an aneurysm
- Empyema- A condition where the pus accumulates between the inner chest wall and the lungs
Sorin 3T Heater Cooler Class Action Lawsuits
The first-class action lawsuit against the Sorin Group was by Jack Miller and Edward Baker. The lawsuit filed in a Pennsylvania federal court seeks a $5 million settlement.
The funds will cover medical monitoring costs for 3,600 patients in Pennsylvania at risk of NTM infection.
In February 2018, the US Judicial Panel on Multidistrict Litigation merged the Sorin 3T device lawsuits into multidistrict litigation (MDL).
The cases are under MDL 2816 and presented to the Middle District of Pennsylvania.
Unlike class action lawsuits, the cases in an MDL remain separate. The panel consolidates the cases to fasten the process and streamline discovery.
If the court awards damages, everyone gets a different amount based on their particular case.
Sorin 3T Settlement
As part of the MDL order, the presiding judge instructed both sides to discuss possible settlements for all the lawsuits included in the MDL.
LivaNova agreed to settle about 75% of the open cases filed in the US for $225 million. This settlement included all the claims in the MDL, the federal class action lawsuit, and some state-level lawsuits.
The payments were in two batches, with the first batch of $135 million rolling out in July 2019. The company released the second batch of $90 million in January 2020.
What Compensation Can I Get in a Stöckert 3T Lawsuit?
If you or your loved one had open surgery that required a 3T heater-cooler device, you might qualify to file a lawsuit.
You can pursue compensation for the following, depending on the extent of your injuries:
- Lost wages due to medical appointments and hospital stays
- Medical expenses incurred due to post-surgery complications
- Pain and suffering due to the infection
- Loss of enjoyment of life and emotional distress
- Economic damages for your injuries
Who Qualifies for a Sorin 3T Lawsuit?
Most lawsuits involving the Sorin 3T Heater-Cooler System fall under three primary categories.
- Patients who had open surgery using a Sorin 3T device then confirmed mycobacterium chimera diagnosis.
- Patients who underwent open surgery have not yet confirmed mycobacteria infection but received letters warning of exposure to the deadly disease.
- Patients who had open surgery and have a confirmed mycobacterium abscessus diagnosis.
There’s Power in Numbers. Join the Many
Join the Many gives people harmed by the products of negligent corporations power and the ability to fight back without the typical frustration and confusion most victims usually face when going up against big businesses.
We believe the justice system exists to protect people like you and your loved ones and not established corporations that want to avoid taking responsibility for their negligence.