Stockert 3T Lawsuit

What Stockert 3T Lawsuits Are There?

LivaNova is facing several Stockert 3T infection lawsuits for the injury and deaths caused by the devices. Federal Stockert 3T lawsuits against LivaNova have been consolidated into multidistrict litigation (MDL) in the U.S. District Court for the Middle District of Pennsylvania, but other cases may be pending in state and local courts as well. The lawsuits claim that LivaNova:

• Manufactured defective devices
• Sold devices that were already contaminated
• Failed to conduct appropriate safety tests
• Failed to provide appropriate procedures for disinfection and cleaning of units
• Failed to warn patients and the medical community about risks the device may pose
• Continued to sell devices after problems were discovered

Why Did People File Stockert 3T Lawsuits?

After patients undergoing heart surgery were exposed to bacteria from the Stockert 3T device, many of them became ill due to the contamination links between the device and bacterial traces. Plaintiffs are seeking compensation for damages including medical costs, lost wages, pain and suffering, and wrongful death, and may be asking for punitive damages.

What Stockert 3T Lawsuit Settlements Are There?

In December 2018, a Settlement Master was appointed to discuss possible settlement terms for Sorin 3T lawsuits in federal court, but no settlement has yet been announced. As of 2023, legal cases for the Stockert 3T device have slowed.

What Is the Stockert 3T Heater-Cooler Device?

The Stockert 3T is a heater-cooler device used in certain types of cardiac or thoracic surgery to maintain body temperature during the procedure. It uses 3 tanks to circulate both heated and cooled water to slow and preserve the heart in cardioplegia or planned, temporary cessation and to warm the body at the same time.

How Does the Stockert 3T Device Work?

As the separate tanks circulate the different temperatures, each circuit can be run simultaneously to create an optimal surgical temperature. During surgeries, patients keep their temperature stable with two device circuits, while the system itself runs off of one circuit. 

Who Manufactures Stockert 3T Devices?

Stockert devices are designed by the pharmaceutical company LivaNova. LivaNova is domiciled in the UK but has a presence in over 100 countries. The company was formed in 2015 but merged with the Italian medical company Sorin Group, now Sorin Medical in a 2.7 billion dollar merger to continue specializing in cardiopulmonary and neuromodulation.

The device itself is manufactured in Sorin Group’s German factory facilities, Sorin Group Deutschland GMBH in Munich.

When Was the Stockert 3T Device Invented?

The Stockert 3T device was invented and approved by the FDA in 2006. It wasn’t until 2010 that the U.S. Food and Drug Administration (FDA) received reports of 79 infection events and 12 deaths associated with Stockert 3T usage.

What Is Cardioplegia?

Cardioplegia is when the heart is deliberately stopped temporarily. It’s a medical technique commonly used in heart surgeries in order to prevent damage to the heart. Surgeons may not be able to operate on a heart effectively if it’s actively beating so cardioplegia is used to pause the heart’s movements for safety in surgery.

Can Stockert 3T Devices Become Contaminated?

As early as 2002, scientists in Germany found that Mycobacterium chimaera (M. chimaera) may grow in the Stockert 3T’s water tanks. Once the unit is contaminated, bacteria may be spread through vapor emitted from the machine. This bacteria-laden vapor can be spread into previously sterile surgical rooms and may expose vulnerable surgical patients to potentially deadly bacterial infections.

What Is Mycobacterium Chimaera?

Mycobacterium chimaera is a bacteria similar to the same bacteria that causes tuberculosis but in healthy people is generally non-threatening. In patients who are ill or whose immune systems may be compromised, it can pose a serious threat. Patients who are undergoing invasive surgery with the Stockert 3T device, may be at risk of serious infection or death.

Each year in the U.S., over 250,000 cardiac bypass procedures are performed and nearly two-thirds of these have traditionally employed a Stockert 3T device. This means that between 2010 and the 2016 safety alert, 500,000 patients were potentially placed at risk of exposure to a serious infection.

How Is a Mycobacterium Chimaera Infection Treated?

The treatment for a mycobacterium chimaera infection is commonly an intensive round of antibiotics. In some cases, treatment could take several months to a year to fully eradicate the infectious bacteria. In rare cases, treatment could last years. Fatalities are a possible occurrence with the presence of this bacteria if adequate treatment is not administered promptly.

What Are the Signs of a Mycobacterium Chimaera Infection?

For those who are exposed to M. chimaera and who are at risk of infection, between 1 in 100 to 1 in 1000 will develop an infection. In  2015, the U.S. Centers for Disease Control and Prevention (CDC) issued an informational kit to doctors to aid in infection identification but infections are still challenging to treat and may be fatal. The risk is greatest in patients who have valves or other prosthetic implants and once infected, there are several key indicators of an M. chimaera infection to look out for such as fatigue and fever.

Fever

A fever is often the first sign of infection to look out for with M. chimaera bacteria. Fevers are typically characterized by a rise in body temperature in response to your immune system working harder to fight any potential threats such as viruses or bacteria.

What Are the Symptoms of a Fever?

Many different illnesses can cause a fever, so it’s important to assess your other simultaneously occurring symptoms to detect whether the M. chimaera bacteria is the root cause. Symptoms of a fever can include:

• Chills
• Sweating
• Shivering
• Headache
• Muscle aches
• Dehydration

Pneumonia

Pneumonia is a respiratory infection that can be caused by viruses, fungi, or bacteria such as M. chimaera. Pneumonia can be serious or even life-threatening if not addressed quickly. As the infection ensures, breathing becomes progressively more difficult as the air sacs of the lungs become filled with fluid.

What Are the Symptoms of Pneumonia?

Pneumonia is frequently marked by trouble breathing, chronic coughing, whole-body weakness, chest pain, or sometimes confusion in older adults. If you start developing a painful cough always contact a medical professional immediately. The symptoms of pneumonia can include:

• Chest pain when breathing
• Chest pain when coughing
• Changes in mental awareness
• Confusion (especially in adults over 65)
• Fatigue
• Fever
• Chills
• Cough, especially producing phlegm
• Sweating
• Shaking chills
• Lower body temperature
• Nausea
• Vomiting
• Diarrhea
• Shortness of breath

Endocarditis

After open-heart surgery, some patients may develop endocarditis. Endocarditis is when an individual’s heart valves become seriously inflamed, caused by infectious bacteria reaching the bloodstream. Without proper treatment, the heart’s tissues can become permanently damaged.

What Are the Symptoms of Endocarditis?

Some of the symptoms of endocarditis are localized to the chest, such as shortness of breath or pain in the chest. Other symptoms include aching joints, swelling of the feet or legs, and flu-like symptoms such as night sweats or chills.

Abdominal Abscess

An abdominal abscess occurs in the bowels or belly of a patient in the form of infected fluid and inflamed tissue. There are several different types of abdominal abscesses such as post-operative, spontaneous, and intrabdominal. Each abscess contains cellular debris that is confined to a specific region of the body.

What Are the Symptoms of an Abdominal Abscess?

Symptoms of a serious abdominal abscess caused by M. chimaera bacteria are nausea, belly pain, vomiting, a feeling of fullness, and a loss of appetite. Abdominal cramps could be a symptom of several other gastrointestinal diseases, so it’s always important to seek professional testing and diagnosis to rule out any other causes.

Lymph Node Inflammation

Lymph node inflammation is usually a signal to the body that it’s trying to fight an infection. When unwanted bacteria or viruses invade, the immune system kicks into high gear and becomes swollen. The lymph nodes in the neck or armpits are the parts of the body that most often become inflamed.

What Are the Symptoms of Lymph Node Inflammation?

The symptoms of lymph nodes in the body are most frequently pain or swelling under the neck or armpits. Other symptoms may mimic respiratory illness such as runny nose or fever. Lymph node inflammation is a key indicator that the body is trying to fight off an infection.

Fatigue

Some people equate the word fatigue with tiredness, however, fatigue is usually associated with being tired for no apparent reason. Tiredness on the other hand usually has a clear cause such as lack of sleep. M. chimaera bacteria has been said to cause fatigue in many patients with an ongoing infection.

What Are the Symptoms of Fatigue?

The most clear symptom of fatigue is feeling tired, no matter how much rest you get. Other symptoms may be frequent napping, sleepiness, dizziness, and lack of energy to perform normal tasks.

Wound Drainage

Wound drainage is a sign that an infection may be getting worse, instead of better. Healing wounds usually stop producing excess pus or fluid over time, but when an infection is serious wounds will have a large amount of fluid drainage coming from the skin.

What Are the Symptoms of Wound Drainage?

Symptoms of wound drainage are excess fluid on the skin. Anyone with wound drainage must work to close the wound and protect it from further infection from other bacteria exposure.

Has the Stockert 3T Been Recalled?

In June 2015, after multiple deaths had been attributed to the Stockert 3T device, a recall was issued for some of the devices. Information accompanying the notice stated that the device posed a potential threat to colonization if proper maintenance and disinfection were not performed. The company had been previously warned by the FDA and informed that the devices may be subject to a future ban if they were deemed “adulterated” or “misbranded”. This is a possible result that occurs when a manufacturer fails to follow good manufacturing practices known as GMP in its manufacturing, packaging, or storage facilities.

Has the FDA Issued Any Stockert 3T Warnings?

In June 2016, an FDA safety alert was issued to healthcare facilities and providers concerning the infection risk of Stockert 3T devices. In October 2016, the FDA recommended that older Stockert 3T devices be replaced with new units as soon as possible.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.