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The U.S. Judicial Panel on Multidistrict Litigation (JPML) has decided that all heart surgery infection lawsuits filed over the Sorin 3T Heater-Cooler System will be transferred to one federal judge for coordinated management during pretrial proceedings.
The 3T Heater-Cooler is a surgical device commonly used during open heart surgery, which has been linked to problems with severe and life-threatening nontuberculous mycobacterim (NTM) infections, which may develop months or even years after surgery
The devices are used to regulate blood temperature during surgery. However, in late 2015, it was discovered that certain Sorin 3T Heater-Cooler systems were 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.
There are currently at least 40 Sorin 3T Heater-Cooler lawsuits pending in 21 different U.S. District Courts nationwide, each raising similar questions of fact and law.
Following oral arguments held last week, a panel of federal judges issued a transfer order (PDF) on February 1, indicating that the litigation will be centralized in the Middle District of Pennsylvania under U.S. District Judge John E. Jones III for pretrial proceedings.
In the motion to transfer, filed by Sorin Group and Livanova, the defendants had requested the cases be consolidated in South Carolina. However, the JPML disagreed.
“We select the Middle District of Pennsylvania as the transferee district for this litigation. Two actions are pending there, including the Whipkey action, which has the first pending trial date of any action,” the judges noted. “Judge John E. Jones, III, is an experienced jurist who has not had the opportunity to preside over an MDL. Judge Jones also presides over Baker, a Sorin 3T device case seeking medical monitoring and, therefore, is familiar with many of the factual and legal issues in this litigation.”
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.
3T Heater Cooler Infection Risks
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.