Stockert 3T Lawsuit and M. Chimaera Infections
Heater-cooler devices, including the Stockert 3T, are most commonly used to warm and cool patients during cardiothoracic surgeries. However, the devices have been reportedly associated with an increased risk of potentially dangerous nontuberculous mycobacterium infections. Affected patients and their families may be able to file a lawsuit and pursue damages with the help of a defective medical device attorney.
For more information, contact Attorney Group today. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated Stockert heater-cooler lawsuit attorney who can assist you throughout the legal process.
Have You Seen a Stockert 3T Commercial?
You may have seen a Stockert heater-cooler lawsuit commercial on television and wondered whether you or a loved one have been affected by a Stockert 3T heater-cooler system and, if so, whether you are eligible to pursue a claim against the manufacturer or others. The purpose of this article is to provide you with additional information so that you have a better understanding of your options.
What is a Stockert 3T Heater-Cooler System?
According to the U.S. Food and Drug Administration (FDA), heater-cooler systems are used during surgeries to warm or cool patients to improve patient medical care. Heater-cooler systems are particularly used during surgical procedures involving the heart, lungs, esophagus and other chest organs (procedures commonly referred to as cardiothoracic surgeries).
Heater-cooler systems consist of water tanks that provide temperature-controlled water to external heat exchangers or to warming/cooling blankets through closed water circuits. Heater-cooler systems are intended to maintain specific temperatures of organs during surgical procedures.
Stockert 3T heater-cooler systems are manufactured by LivaNova PLC, a medical device company based in London, England, that develops medical devices used for cardiac surgery, neuromodulation and cardiac rhythm management. According to the manufacturer’s website, Stockert 3T heater-cooler systems “provide three circuits for fast and efficient heating and cooling” to meet patient temperature needs.
Stockert 3T heater-cooler systems use compressor-based cooling and three independent water tanks to eliminate the need for ice and water supply in the operating room, thereby providing separate settings for accurate patient temperature control. Until October 2015, Stockert 3T heater-cooler systems were manufactured by the Sorin Group.
Stockert Heat-Cooler System Infection Risks
Heater-cooler devices, including the Stockert 3T heater-cooler system, have been linked to an increased risk for a potentially fatal bacterial infections. The bacteria in question is known as Mycobacterium chimaera (M. chimaera), a type of nontuberculous mycobacterium (NTM) found in soil and water.
According to the FDA, signs and symptoms of NTM infection include:
- Fatigue
- Fever
- Pain
- Redness, heat or pus at the surgical site
- Muscle pain
- Joint pain
- Night sweats
- Weight loss
- Abdominal pain
- Nausea
- Vomiting
While the water used in heater-cooler systems does not come in direct contact with the patient, contaminated water could potentially enter other parts of the system or transmit harmful bacteria through the air via the device’s exhaust vent into the operating room and to the patient.
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FDA Warnings
The risk of infection associated with heater-cooler devices in general has been noted by the FDA since October 2015 when the agency issued a safety communication regarding the risk of NTM infection associated with heater-cooler devices. In their communication, the FDA notes that between January 2010 and August 2015, the agency received 32 Medical Device Reports (MDRs) of patient infections associated with heater-cooler devices or bacterial contamination of the systems.
In June 2016, the FDA released a safety communication specifically addressing alleged associations between M. chimaera infections and the use of Stockert 3T heater-cooler systems. The agency stated that, in August 2014, testing conducted by the manufacturer found M. chimaera contamination on the production line and water supply at the 3T manufacturing facility. As a result, the company added cleaning procedures to their facility production line, however, the FDA is aware of some device contamination after September 2014, when cleaning and disinfection procedures were added to the facility production line.
The June 2016 safety communication also noted that patients in the United States reported infections due to M. chimaera after undergoing surgical procedures involving the Stockert 3T heater-cooler systems. According to the FDA, each of the reports were related to devices that were manufactured before September 2014.
Since issuing the October 2015 safety communication, the FDA has continued to monitor and evaluate the causes and risk factors associated with heater-cooler devices and the spread of bacteria to help other agencies and health care professionals develop ways to combat patient exposure. According to the FDA’s ongoing investigation, infections associated with M. chimaera associated with the Stockert 3T heater-cooler system are rare, however, those types of infections can be difficult to detect because patients who are infected may not develop symptoms or signs of infection for months or years after initial exposure.
FDA Recommendations
In an October 2016 update to the FDA’s June 2016 safety communication, the agency added a number of recommendations, advising facilities to take certain precautions, including:
- Immediately removing any devices that have tested positive for M. chimaera or have been associated with known M. chimaera infections
- Direct exhaust away from the patient
- Be aware that device contamination may also occur from other sources such as environmental contamination or contact with contaminated accessories
- Use the FDA’s recommendations to help mitigate the risks of patient infection
Heater-cooler systems are important to patient care, and the benefits of temperature control can outweigh the risks associated with cardiothoracic surgical procedures in appropriately selected patients.
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Lauren A. on May 16, 2016
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Has There Been a Stockert Heater-Cooler Recall?
Although there has not been Stockert 3T heater-cooler recall, the Sorin Group (now LivaNova PLC) issued an ongoing corrective action for the 3T heater-cooler device in July 2015. The manufacturer noted that there is a potential colonization of organisms, including M. chimaera if devices are not properly cleaned and disinfected. More information regarding updates about the devices can be found in the FDA medical device recall database. Failure to warn of possible contamination of a 3T heater-cooler device can be a basis of product liability, regardless of whether the device has been recalled.
Is There a Stockert Heater-Cooler Class Action?
A Stockert heater-cooler lawsuit attorney notes that there is no Stockert heater-cooler class action pending as of October 2016. Stockert heater-cooler lawsuit attorneys are doubtful that a class action will be certified for patients who are adversely affected by the drug. Instead, if multiple Stockert heater-cooler lawsuits are filed against the device manufacturers alleging injuries and other damages caused by Stockert heater-coolers and similar devices, it is anticipated that these lawsuits will be consolidated for discovery and other pretrial proceedings.
When cases are consolidated in this way in federal court it is called multidistrict litigation (MDL), and on a state level it is known as a state court consolidated proceeding. MDLs are distinct from class actions, and it is generally agreed that consolidating cases instead of proceeding in a class action is a more efficient and effective way of handling claims arising from injuries caused by defective medical devices.
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Stockert Heater-Cooler Lawsuit News
- October 2016FDA updates its June 2016 safety communication to provide new information about M. chimaera infections associated with the use of Stockert 3T Heater-Cooler Systems in patients who have undergone cardiothoracic surgical procedures.
- October 2016Centers for Disease Control and Prevention (CDC) issues a report regarding M. chimaera contamination associated with heater-cooler devices used during cardiac surgical procedures.
- October 2016CDC issues a statement advising hospitals to alert patients who are potentially at risk from contaminated heater-cooler devices and provides recommendations for health care providers, hospitals and health departments.
- May 2016CDC issues guidance intended to help facilities identify patients with NTM infections associated with the use of heater-cooler devices to ensure timely diagnosis and treatment of patients.
- December 2015The FDA issues a warning letter to LivaNova PLC after inspections conducted at facilities in Germany and Colorado revealed significant issues related to its Stockert 3T Heater-Cooler Systems, including quality systems and premarket clearance violations.
- July 2015Sorin Group, now LivaNova PLC, initiated an ongoing corrective action for the Stockert 3T and included updates to instructions for use with new cleaning instructions and instructions for determining if a device is contaminated with M. chimaera.
- October 2015CDC issues a notice to all health departments, health care facilities and individual health care providers identifying the need for increased action against NTM infections associated with heater-cooler devices.
How a Stockert Heater-Cooler Lawsuit Can Help
Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by a defective Stockert heater-cooler system may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those killed may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one
