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With a growing number of heart surgery infection lawsuits being filed throughout the federal court system, each involving allegations that contaminated Sorin 3T Heater-Cooler Systems caused the spread of M. chimaera and other non-tuberculosis mycobacteria (NTM) infections, a request has been filed to centralize the litigation before one judge for coordinated pretrial proceedings.
In a motion to transfer (PDF) filed with the U.S. Judicial Panel on Multidistrict Litigation, a group of plaintiffs have requested that all lawsuits over Sorin 3T Heater-Cooler infections pending throughout the federal court system be centralized in the U.S. District Court for the District of South Carolina, to reduce duplicative discovery into common issues raised in the complaints, avoid contradictory pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the judicial system.
The Sorin 3T Heater-Cooler is a medical device used to regulate blood temperature during open heart surgery, which has been widely used in recent years. However, the device has also been linked to a number of severe heart surgery infections, which may surface months or even years after bypass surgery, heart valve replacement or other cardiac procedures where contaminated systems were used.
Last year, it was discovered that certain devices manufactured prior to September 2014, may be tainted with Mycobacterium chimaera or Mycobacterium abscessus, which are slow growing bacteria that can be extremely risky for individuals with compromised immune systems. As a result of the problems, the devices may release a contaminated vapors into the air in the operating room, exposing individuals to a risk of infection that may take anywhere from several months to several years before symptoms manifest.
The motion indicates that there are currently at least 15 Sorin 3T Heater-Cooler lawsuits pending throughout the federal court system, each involving similar allegations that individuals developed the severe and life-threatening infections following heart surgery. However, as M. chimaera infection lawyers continue to review and file cases in the coming months and years, as problems continue to surface, the size and scope of the litigation is expected to continue to increase.
“Plaintiffs respectfully request that the Panel transfer the individual cases arising out of Defendants’ negligence and misrepresentation to the District of South Carolina, Greenville Division, because it is the location most likely to serve the convenience of the parties, witnesses and counsel in the numerous actions,” according to the motion. “A majority of the cases are pending in the District of South Carolina. The potential claims arising from patients whose surgical procedures involved a Sorin 3T Heating-Cooling System could conceivably be filed in a number of additional federal jurisdictions. Consequently, consolidation in the District of South Carolina, where witnesses and documents are available, the first substantial outbreak involving this medical device occurred, and the CDC has inspected the devices, and which is a location convenient for the majority of parties and counsel, would serve the interests of all parties in ensuring the just and efficient conduct of all actions and the greatest convenience to witnesses, parties and counsel.”
Each of the claims raise similar questions of fact and law, including whether the Defendants were negligent in the design, manufacture and sale of the 3T Heater-Cooler, as well as whether the manufacturers knew or should reasonably have known that their device caused M. chimaera or M. abscesssus infections or concealed information from consumers, doctors and federal regulators.
3T Heater-Cooler Heart Surgery Infection Problems
The litigation began to take shape after heart surgery patients nationwide received hospital letters last year, warning that they may have been exposed to the risk of severe infections due to the use of certain 3T Heater/Cooler devices, which may be contaminated NTM bacteria.
The FDA first warned about the heart surgery infection risk from heater-cooler devices 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.
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.
The FDA is now advising facilities using 3T devices to remove the devices and any accessories from service if they have tested positive for the bacteria, or have been linked to patients who later were identified as infected. The agency also recommends using new accessories, tubing and connectors if using a new heater-cooler device, channeling exhaust from the devices away from patients and into an operating room exhaust vent, and to review the recommendations in the CDC’s health advisory.
The U.S. JPML is expected to consider oral arguments on the motion to centralize all of the heart surgery infection lawsuits during an upcoming hearing on March 30, in Phoenix, Arizona.