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The U.S. District Judge presiding over all Pradaxa cases pending in the federal multidistrict litigation (MDL) has appointed a mediator to meet with the parties at least once a month to discuss the possibility of settling cases that allege consumers were inadequately warned about the risk of uncontrollable bleeding from Pradaxa.
More than 1,100 lawsuits filed in U.S. District Courts throughout the United States have been centralized before Judge David R. Herndon in the Southern District of Illinois, where the cases are being coordinated during pretrial proceedings to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
All of the cases involve similar allegations that plaintiffs suffered serious or fatal injuries when doctors were unable to reverse the blood thinning effects of the anticoagulant, which has been heavily promoted as a superior alternative to Coumadin or warfarin. However, plaintiffs indicate that Boehringer Ingelheim failed to adequately warn about the hemorrhage risk or disclose that there is no reversal agent for Pradaxa to allow doctors to stop bleeding events that may develop.
In the Pradaxa MDL, a small group of lawsuits are being prepared for early trial dates, known as “bellwether” trials because they are designed to help gauge the relative strengths and weaknesses of the cases. In advance of those trials, Judge Herndon has ordered the parties to meet at least one time a month over the next year to discuss potential Pradaxa settlements.
In a case management order (PDF) issued July 15, Judge Herndon appointed John Perry to serve as mediator during the negotiations, with the parties directed to have at least one in-person negotiation session no later than September 2013.
If negotiations to settle Pradaxa cases are unsuccessful, Judge Herndon has scheduled a series of four trials that will be held in the MDL between August 2014 and February 2015. If the litigation does not settle or otherwise resolve following these early trial dates, hundreds of individual cases may be remanded back to the U.S. District Courts where they were originally filed for individual jury trials.
Pradaxa (dabigatran) was introduced by Boehringer Ingelheim in October 2010, as the first member of a new class of anticoagulants promoted as a superior alternative to warfarin for stroke prevention, as it is easier to take and requires less medical monitoring.
Warfarin, sold under the brand name Coumadin, has been the go-to anticoagulant for decades. While Pradaxa does require less monitoring, concerns have emerged about the lack of an effective reversal agent to stop the blood thinning effects of the medication.
Unlike warfarin, which can be quickly reversed with a dose of vitamin K and plasma, there is no available reversal agent for Pradaxa. While some studies have shown that the chances of bleeding may be about the same with the two drugs, evidence continues to emerge highlighting how Pradaxa bleeding problems may pose a more serious risk, since hemorrhages are typically harder to stop.