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Case Management Plan for 3T Heater-Cooler Infection Cases Proposed in MDL

Parties involved in the federal heart surgery infection lawsuits over 3T Heater-Cooler Systems have proposed a case management plan, which would guide the litigation for the next several months. 

There are currently at least 56 product liability lawsuits filed against the manufacturers of the Sorin 3T Heater-Cooler in the federal court system, each raising similar allegations that the devices were contaminated, releasing a mist into the air of operating rooms during open heart surgery that resulted in the development of serious infections that often do 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.

On June 19, plaintiffs and defendants issued a joint proposed case management order (PDF), setting goals for case-specific and generic discovery over the next 120 days.

The order seeks to have parties agree on the contents of a Plaintiff fact sheet and Defendant fact sheet by the end of the month, as well as agreement on any possible protective order revisions. It also calls for Plaintiff fact sheets to be served 30 days after the court approves of the sheets, and the serving of completed Defendant fact sheets 60 days after that.

In addition, the agenda sets an October 5, 2018 date for plaintiff to conduct depositions of Defendant personnel, beginning discovery of two hospitals, and to begin written discovery and possible depositions of federal regulators, researchers and laboratories that may impact the litigation.

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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