With dozens of lawsuits moving forward in the federal court system involving heart surgery infections linked to 3T Heater-Cooler systems, the U.S. District Judge presiding over the coordinate pretrial proceedings has appointed a group of plaintiffs’ attorneys to serve in various leadership roles in the federal multidistrict litigation (MDL).
There are currently at least 54 cases filed throughout the federal court system, which have all been centralized before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, to reduce duplicative discovery, avoid conflicting pretrial rulings and serve the convenience of witnesses, parties and the court systems.
However, as product liability lawyers continue to review and file complaints for individuals who developed nontuberculous mycobacterim (NTM) infections following exposure to contaminated 3T Heater-Coolers used during open heart surgery, it is ultimately expected that several hundred more cases may be added to the litigation.
Each of the complaints raise similar allegations that a 3T Heater-Cooler, which is commonly used to regulate blood temperature during cardiac surgery and other procedures, caused patients to develop the infection months after their procedure. The litigation emerged after federal health regulators confirmed in late 2015 that certain devices sold in recent years were contaminated, potentially introducing bacteria from a mist released by the device into the sterile operating room.
On May 31, Judge Jones issued a case management order (PDF) naming one attorney to a serve as lead and liaison counsel, and creating a plaintiffs’ executive committee that includes six additional attorneys who will take certain actions during the litigation that will benefit all cases. However, each individual plaintiff’s own lawyer will remain responsible for deadlines and establishing causation in the separate cases.
The establishment of a leadership group for plaintiffs counsel is common in complex medical device litigation, where a large group of cases raise similar questions of fact and law.
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.