With a growing number of lawsuits over open-heart surgery infections being filed in courts nationwide against the makers of the 3T Heater-Cooler System, each raising similar allegations that contaminated devices caused the development of severe and life-threatening nontuberculous mycobacterium (NTM) infections that developed months after surgery, the manufacturer has filed a request to centralize the litigation before one judge for coordinated pretrial proceedings.
The 3T Heater-Cooler is a device commonly found in operating rooms nationwide, and is used to regulate blood temperature during surgery. However, in late 2015, it was discovered that certain 3T Heater-Cooler systems distributed to hospitals may be contaminated with bacteria, which is then released in a mist that may enter the sterile surgical site.
The bacteria may cause difficult to treat internal infections, which typically do not surface until months, or even years after exposure. As a result of the risk, hospitals nationwide have sent letters to thousands of heart surgery patients who may have been exposed to a contaminated 3T Heater-Cooler, recommending continued medical monitoring.
Over the past year, a steadily increasing number of product liability lawsuits have been filed against Sorin Group and Livanova, indicating that the manufacturers knew or should have known about the infection risks, yet withheld information from consumers and the medical community. The lawsuits also claim the manufacturers released a defective device onto the market by not preventing the contamination, which appears to have taken place inside the manufacturing facilities where the devices were made.
In a motion to transfer (PDF) filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) on November 6, the defendants ask that all of the complaints filed throughout the federal court system be transferred to the U.S. District Court for the District of South Carolina for coordinated discovery and pretrial management.
In complex medical device litigation, where a large number of complaints are brought by individuals who suffered the same or similar injuries from the same device, it is common for the cases to be coordinated as part of a federal multidistrict litigation (MDL) to reduce duplicative discovery into common issues raised in the cases, avoid contradictory pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the judicial system.
The JPML rejected a previous attempt at consolidate the 3T Heater-Cooler lawsuits, which was filed by a group of plaintiffs in April 2017. At that time, the manufacturers maintained that there were too few cases to warrant formal consolidation. However, the new motion indicates that the litigation has grown substantially since that time, noting that there are now 73 total claims, including 42 federal lawsuits filed across 21 different court districts.
“The number of 3T Device cases in the federal courts has nearly tripled, with at least one new 3T Device case filed on average every week for the last forty weeks, and six new cases filed in just (the) last two weeks alone,” the motion argues. “This dramatic addition of new cases, filed in new judicial districts by new plaintiffs’ counsel, has disrupted the parties’ informal coordination to date, and the resulting complexity threatens to cause significant inconvenience and undue expense to the parties, their counsel, and the courts.”
The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.
In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.
Late last year, the federal regulators issued a safety communication, warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.
The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.
It is expected that the JPML will consider oral arguments on the motion during an upcoming hearing session in January 2018.