The U.S. Judicial Panel on Multidistrict Litigation (JPML) has declined to grant multidistrict litigation (MDL) status to the growing number of Sorin 3T cardiac heater-cooler lawsuits. The JPML has recently decided that the claims regarding the contaminated heater-cooler devices did not warrant the status of a centralized litigation.

The official announcement came in the JPML’s Order Denying Transfer on April 5, 2017. The panel pointed out that South Carolina’s 3T Heater-Cooler docket was already in the process of informal coordination. The JPML also pointed out that none of the parties involved in the cardiac heater-cooler lawsuits filed outside of jurisdiction had supported the motion for centralization.

There are currently at least 15 Sorin 3T cardiac heater-cooler lawsuits in five U.S. district courts, seeking compensation for the alleged damages inflicted by the contaminated heater-cooler devices.

“Opponents of centralization argue that unique factual and legal issues will predominate in this litigation, and that informal coordination is sufficient to minimize any overlap in pretrial proceedings. [W]e are persuaded that any overlapping pretrial proceedings have been and can continue to be handled through informal coordination,” the JPML order states.

These Sorin 3T cardiac heater-cooler lawsuits allege the claimants developed dangerous cardiac infections after their heart surgeries due to the use of contaminated heater-cooler devices.

Over the years, these Sorin 3T cardiac heater-cooler lawsuits have been building up, with these contaminated heater-cooler devices being subject to a Class II medical device recall.

Overview of Contaminated Heater-Cooler Devices

Sorin 3T cardiac heater-coolers utilize water tanks filled with temperature controlled water, which are meant to regulate the patient’s body temperature during cardiac surgery.

The device is manufactured by LivaNova PLC, and earned expedited FDA approval so it could enter the market very quickly. However the FDA and other health officials warn that “there is potential for contaminated water to enter other parts of the device and aerosolize,” which means that the bacterial cells can affect the patient by entering into the air.

The U.S. Centers for Disease Control and Prevention (CDC) announced its own warning in October 2016. According to the CDC’s warning, the contaminated heater-cooler devices contained an M. chimaera bacteria that is linked to rare forms of non-tuberculosis bacterial infections.

M. chimaera is a slow-growing tuberculosis mycobacterium that can spread through blood, bone marrow, and organs. Victims and investigators have alleged these contaminated heater-cooler devices have allowed the bacterial cells to colonize in the device, ultimately infecting patients when used.

After was contamination discovered during testing in September 2014, the FDA and CDC now believe these devices may have been contaminated at some point during their manufacturing process in Germany.

Patients who underwent cardiac surgery while using the Sorin 3T cardiac heater-cooler have developed potentially deadly bacterial infections. Even though these contaminated heater-cooler devices can cause potentially fatal bacterial infections, some patients claim LivaNova failed to adequately warn the public.

Persons who developed a mycobacteria infection after open heart surgery may benefit from a consultation with a knowledgeable medical device lawyer to determine eligibility for a Sorin 3T cardiac heater-cooler lawsuit.