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Heart Surgery Infection Settlements To Be Discussed in Litigation Over 3T Heater-Coolers

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The U.S. District Judge overseeing all 3T Heater Cooler System heart infection lawsuits filed in federal courts nationwide has appointed a settlement master to oversee ongoing negotiations aimed at resolving the litigation, avoiding the need for dozens of individual cases to go before juries nationwide. 

There are currently at least 85 product liability lawsuits filed against the manufacturers of the Sorin 3T Heater-Cooler in the federal court system, each raising similar allegations that the surgical devices were contaminated, releasing a mist into the air of operating rooms during open heart surgery, which has allegedly caused plaintiffs to develop serious infections that may not surface until months, or even years, after the procedure.

Given similar questions of fact and law presented in the cases, the claims have been centralized as part of a federal multidistrict litigation (MDL) 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.

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 there may be several hundred cases involved in the litigation.

In a case management order (PDF) filed on December 3, Judge Jones appointed Randi Ellis to work as a special master in the litigation, to explore possible heart surgery infection settlements. The order requires the parties to meet and confer on a monthly basis with Ellis to work toward a settlement agreement, and Ellis will report any progress back to the Court.

The order notes that Ellis is a member of the Academy of Court Appointed Special Masters, and has served in that capacity in numerous federal and state cases. Plaintiffs and defendants have been ordered to split her fees evenly.

3T Heater Cooler Infection Risks

The Sorin 3T Heater-Cooler is a medical device commonly used during cardiac surgery and other procedures to help regulate blood temperature. However, litigation over the heater-coolers emerged after it was discovered that certain devices sold in recent years may have contaminated sterile operating rooms.

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.

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