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The U.S. District Judge recently appointed to preside over all federal 3T Heater-Cooler lawsuits has scheduled an initial status conference for May 31, at which time Court will review the coordination of pretrial proceedings for cases filed by individuals nationwide who have suffered severe infections following heart surgery due to allegedly contaminated devices.
The 3T Heater-Cooler is a surgical device commonly used during open heart surgery, which has been linked to problems with 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 at least 40 Sorin 3T Heater-Cooler lawsuits that have been transferred to the U.S. District Court for the Middle District of Pennsylvania, where U.S. District Judge John E. Jones III has been assigned to coordinate discovery and pretrial proceedings.
In a case management order (PDF) on February 26, Judge Jones indicated that an initial case management conference will be held on May 31. The order calls for counsel to familiarize themselves with the Manual for Complex Litigation 4th before the conference.
The order also indicates that attorneys for both plaintiffs and defendants should seek a consensus in developing a proposed case management plan and agenda for the initial conference, and should file the plan and agenda on or before May 16. The plan and agenda should discuss the feasibility of consolidating all cases in a single or several actions, the scope of discovery procedures and a discovery plan, protective orders, proposed mediation procedures, and a list of attorneys who will be present.
Judge Jones also wants the parties to submit a collective preliminary report by May 16, addressing the factual and legal background of the 3T Heater-Cooler infection cases, indicating where transferred claims currently stand, and critical factual and legal issues likely to be important in the litigation. The report should also identify other related pending actions, pending motions, recommendations on committees and their appointments and what information should be made public on a website the court intends to create for the litigation.
The Court also notes that it intends to appoint a number of plaintiffs’ attorneys to leadership roles in the litigation, and calls for applications to those positions to be submitted by May 16. Only attorneys who have filed a civil action in the litigation will be considered. These attorneys will take certain actions to represent all plaintiffs involved in 3T Heater-Cooler infection litigation.
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.