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The federal Judicial Panel on Multidistrict Litigation will decide whether each individual Stockert 3T lawsuit will go forward or whether 42 lawsuits will be consolidated into a federal MDL.
Defendant LivaNova PLC says it prefers the consolidation rather than enduring 42 separate trials. However, several dates already have been set for some of the individual trails to begin. Lawyers for each individual Stockert 3T lawsuit say some of their patients are very ill and demand the original trial dates be honored.
The Stockert 3T heater-cooler device manufactured by LivaNova (formerly Sorin Group Deutschland) in Germany allegedly transmitted a rare and often deadly bacteria, Mycobacterium chimera (M. chimaera), during open heart surgeries.
The heater-cooler device uses water to regulate the temperature of the body’s organs and blood during surgery. Even though the water does not come into contact with the patient, the device emits a mist that enters the air and can settle into the open chest cavity. The bacteria is sealed inside the patient once the patient is sewn back together. The bacterial seeds of infection can fester for months or years before the patient realizes he or she is ill.
Each Stockert 3T lawsuit alleges the heater-coolers became contaminated with the non-tuberculosis bacteria during production and service in Germany. Tests done there concluded the same strain found in the factor was found in the machines in the United States. M. chimaera occurs naturally in soil and water, and no one knows how the bacteria entered and subsequently contaminated the heater-coolers.
According to the FDA, the heater-cooler units have been linked to patient deaths as a result of bacterial infection after heart surgery since January 2014.
The FDA’s first safety warning regarding the Stockert 3T devices was issued in October 2015. The FDA had received 32 reports of the post-heart surgery infection at that time.
In June 2016, investigators narrowed the heater-coolers to be the German versions named in the Stockert 3T lawsuit.
To fend off any onset of new infections, the FDA issued guidelines in October 2016 that instructed doctors to always use new accessories, connectors, and tubes each time the devices were used and to always direct the exhaust fan away from the patient.
At least one hospital places the device in a separate room away from the operating room to ensure the mist cannot enter the patient’s open chest cavity.
Nearly 250,000 open-heart surgeries are performed each year. Approximately 60 percent of the time, doctors use the heater-cooler units that are subject to the Stockert 3T lawsuit.
Although thousands of patients have received notifications that they could have been exposed to the bacteria, many more could remain unidentified. The bacteria can remain dormant for so long, it is difficult to ascertain how many more potential victims exist.
If you have undergone open heart surgery and developed an M. chimaera bacterial infection, you could qualify to participate in a Stockert 3T lawsuit.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The cardiac heater-cooler attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, cardiac heater-cooler lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
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