Stockert 3T Lawsuit Information

As a result of nontuberculous mycobacteria infections diagnosed in connection with the Stockert 3T heater-cooler system, attorneys across the country are investigating claims on behalf of patients who believe the manufacturer of the medical device, LivaNova PLC (formerly Sorin Group USA), was negligent in exposing patients to dangerous bacterial infections with its defective heater-cooler systems. According to a safety communication issued by the U.S. Food and Drug Administration (FDA) in October 2016, “[…] there is the potential for contaminated water to enter other parts of the [heater-cooler] device and aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.”

To date, a handful of patients have brought complaints against LivaNova and Sorin, alleging that the companies manufactured a defective device and failed to warn patients and the medical community about the risk of NTM infections from the Stockert 3T heater-cooler system. One such lawsuit was brought on behalf of a man named David Inners, who underwent open-heart surgery in December 2014, and the following year died from an NTM infection that doctors linked to the use of a heater-cooler device during his surgery.

“The FDA has issued several warnings associated with the use of the 3T, and has recommended detailed safety procedures that hospitals and doctors should take to prevent injuries.”

Reasons to File a Stockert 3T Heater-Cooler Lawsuit

Lawsuits filed over alleged side effects of the Stockert 3T heater-cooler System allege that the manufacturer:

  • Designed, manufactured and sold a defective product
  • Failed to adequately research the risk of infection from the heater-cooler system
  • Knew about the potential for the heater-cooler system to cause nontuberculous mycobacteria infections
  • Failed to warn doctors and hospitals about the potentially life-threatening infection being caused by its heater-cooler system during cardiothoracic surgeries
  • Misrepresented the safety of the Stockert 3T system and downplayed its potential risks
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What is the Stockert 3T Heater-Cooler?

Heater-cooler units like the Stockert 3T system are machines used during cardiothoracic surgeries to regulate a patient’s body temperature, providing temperature-controlled water via a closed-water circuit to external heat exchangers or blankets, which then provides cooling or warmth to the patient’s body. According to the U.S. Centers for Disease Control and Prevention (CDC), more than 250,000 surgical procedures using cardiopulmonary bypass are performed in the United States every year, with the Stockert 3T heater-cooler system representing approximately 60% of the U.S. market. The Stockert 3T system is manufactured by LivaNova and is designed to optimize medical care and improve patient outcomes following surgery. However, there have been serious concerns in recent years about the potential for the Stockert 3T system to cause invasive cardiovascular infections in patients exposed to invasive bacteria from the heater-cooler unit.

How a Stockert 3T Lawsuit Could Help

Filing a Stockert 3T heater-cooler lawsuit against LivaNova could help cover the cost of:

  • Ongoing medical care due to an NTM infection
  • Surgery to remove infected tissue or implants
  • Pain and suffering
  • Lost wages
  • Funeral costs

Risk of NTM Infections from the Stockert 3T System

The main concern raised in connection with the Stockert 3T heater-cooler system is the potential for the device to transmit Mycobacterium chimaera to patients during surgery, which can cause life-threatening nontuberculous mycobacteria infections (NTM). According to reports, the water in the heater-cooler unit’s tanks may be contaminated with M. chimaera, and while the water in the circuits never comes in direct contact with patients, the bacterium can be released into the air through the device’s exhaust vent and into the operating room and sterile surgical site. Although Mycobacterium chimaera occurs naturally in the environment and rarely causes problems for healthy individuals, it poses a serious risk for individuals with weakened immune systems, such as those undergoing invasive surgeries, and may result in nontuberculous mycobacteria infections.

Patients who have undergone cardiac surgery with a heater-cooler system should be aware of the possible symptoms and complications of NTM infections, which can occur years after the initial surgery, including fever, night sweats, weight loss, joint pain, fever, surgical site infection, endocarditis, and renal insufficiency. Unfortunately, because there can be a long delay between the time a patient is exposed to the Mycobacterium chimaera and when the patient begins to exhibit symptoms of an NTM infection, the infection can be difficult to detect, which increases the likelihood of serious illness or death.