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Following the recent consolidation of all 3T Heater-Cooler infection lawsuits filed throughout the federal court system, an application has been filed by a group of plaintiffs attorneys who seeking leadership roles in the multidistrict litigation (MDL).
The 3T Heater-Cooler is a medical device commonly used during open heart surgery, which has been linked to reports of 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 long 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.
There are currently more than 50 product liability lawsuits pending against the makers of the 3T Heater-Cooler, which have all been centralized before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, for coordinated discovery and pretrial proceedings.
On May 15, a group of plaintiffs’ attorneys filed a joint application (PDF), calling for the establishment of a plaintiffs’ leadership group, including the appointment of an attorney as lead and liaison counsel, and the formation of a Plaintiffs’ Executive Committee, consisting of six other attorneys. These attorneys would take certain actions during the litigation that benefit all cases, while each individual plaintiff’s own lawyer would be responsible for deadlines and establishing causation in the separate cases.
The organization of the leadership positions will be discussed at an case management conference scheduled for May 31, according to a proposed agenda (PDF) filed this week.
On May 16, the parties also filed a proposed case management plan (PDF), which addresses the potential consolidation or grouping of cases or issues, the scope of discovery and dispute resolution, proposed protective orders, proposed mediation procedures and other issues.
The plan notes that a number of cases have already been given trial dates throughout 2019 and 2020, by Chief District Judge John A. Jarvey of the Southern District of Iowa, before the claims were consolidated. The plaintiffs request that Judge Jones accelerate case specific discovery in those cases, and maintain the established trial order, but push back the original trial dates.
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.