Houston Stockert 3T Lawyer

Stockert 3T systems have reportedly caused some patients to develop serious M. chimaera infections, which can have deadly outcomes for those with compromised immune systems (like surgery patients).

Stockert 3T systems made in a specific German manufacturing facility were contaminated with M. chimaera bacteria. M. chimaera is a nontuberculous mycobacterium (NTM). Symptoms of these infections can take months to years to present themselves after initial exposure.

In some cases, however, this contamination reportedly occurred at hospitals when unsterile water was added to these systems.

Though patients do not have direct contact with the contaminated water, it can aerosolize in certain parts of these systems, transmitting bacteria via the air and the device’s exhaust vents. Once the contaminated air leaves the vent, it can be inhaled by patients and lead to potentially life-threatening infections.

An October 2016 report from the Washington Post found that as many as 500,000 surgery patients could have been exposed to contaminated Stockert 3T systems.⁶

Mounting patient reports regarding serious infections allegedly caused by Stockert 3T systems have spurred the FDA to take various actions against LivaNova, including (but not limited to):

• Issuing LivaNova a Warning Letter – In December 2015, the FDA sent a warning letter to LivaNova regarding Stockert 3T systems, pointing out “significant issues, including quality system and premarket clearance violations.”³

• Issuing a Public Safety Communication – In June 2016, the FDA’s Safety Communication specifically warned about the risk of chimaera infections due to contaminated water supplies in some Stocker 3T systems. Those at risk included patients who had undergone “cardiothoracic surgeries.”⁴ Officials at the Centers for Disease Control and Prevention (CDC) also issued a warning regarding the contamination and risk of infection associated Stockert 3T systems.²

The FDA continues to “actively monitor this situation and will provide updates as appropriate.” It also strongly urges anyone who has developed a serious infection after use of a Stockert 3T system in surgery to report the event to their Adverse Event Reporting program.⁵

Many who have been developed serious infections due to contaminated Stockert 3T systems have filed lawsuits against LivaNova PLC, alleging that LivaNova:

• Misrepresented the safety and efficacy of the Stockert 3T systems
• Knew or should have known about the manufacturing flaws and the serious risks these systems posed to patients
• Failed to warn the public about the risks associated with Stockert 3T systems.

While multidistrict litigation (MDL) has yet to be set up for Stockert 3T claims, those who have been injured by these systems continue to file lawsuits against LivaNova, seeking damages for (but not limited to):

• Past and future medical bills
• Lost earnings
• Pain and suffering
• Loss of consortium
• Funeral and burial costs (in the event of deadly outcomes).

If you or a loved one has developed a serious infection after use of a Stockert 3T system, you can turn to an experienced defective medical device lawyer at the Amaro Law Firm for effective advocacy in the pursuit of justice and financial recovery.

Call (713) 352-7975, text (281) 612-8024 or email our firm for your FREE consultation and important answers regarding your potential claim.

Representing individuals and families from across the U.S. in Stockert 3T claims, we have a proven record of success in defective medical device (and other personal injury) claims, as affirmed by testimonials from our former clients, as well as our 5-star ratings on Google and Facebook.

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1: FDA approval of Stockert 3T system
2: According to reports & warnings from the Centers for Disease Control & Prevention (CDC)
3: FDA Warning Letter to LivaNova
4: FDA Safety Communication regarding Stockert 3T systems
5: FDA Activities & Monitoring of Stockert 3T systems
6: Washington Post report on contaminated Stockert 3T systems