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Judge Promises To Expedite Pradaxa Bleeding Lawsuits

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The judge involved in the multidistrict litigation (MDL) over controversial blood thinner, Pradaxa, has promised to expedite Pradaxa bleeding lawsuits. Pradaxa has allegedly been associated with life-threatening, uncontrolled bleeding.

The MDL now includes 78 cases, said The Madison Record. As NewsInferno recently explained, lawsuits alleging that Boehringer Ingelheim Pharmaceuticals, the maker of Pradaxa, neglected to sufficiently warn users of the blood thinner’s links to deadly bleeding ,were consolidated in an MDL in U.S. District Court, Southern District of Illinois. This means that every Pradaxa bleeding lawsuit filed in federal district courts will now, and in the future, be transferred to the Southern District of Illinois. The cases will be presided over by U.S. District Judge David R. Herndon. The case is entitled IN RE: Pradaxa (Dabigatran Etexilate) Products Liability Litigation.

MDLs enable the lawsuits connected with a particular product to be collaborated under one judge for pretrial litigation. This avoids redundant discovery and inconsistent rulings and allows for limiting party, witness, and court resources, said NewsInferno. Each lawsuit retains its own identity; however, if the MDL does not resolve the cases, they are transferred back to their originating court for trial.

Last month, when the panel issued its transfer order, 21 Pradaxa bleeding lawsuits were pending in 11 different districts courts. Now, the 78 cases are from at least 19 jurisdictions, according to the U.S. District Court of Southern Illinois’ website, said The Madison Record. While the suits come from across the nation, most have been filed in the East 
St. Louis federal court, which is where the panel chose to serve as the center for the MDL based on both geographic location and Herndon’s MDLs experience.

The lawsuits also assert that Boehringer Ingelheim Pharmaceuticals not only never warned users about Pradaxa’s risks, it failed to warn that there is no reversal agent to counteract the blood thinner’s anticoagulation effects, said The Madison Record.

While early in the litigation phase, Herndon indicated—in fact, stressed, said The Madison Record—in his first case management order, issued August 17, that he hopes to proceed expediently. Herndon also set an October 3 initial conference date, writing that the objective of that meeting “will center on the philosophy of this court that this litigation must move expeditiously.”

“The Court’s initial finding that this litigation shall move expeditiously is grounded from the Court’s reading of the record as it now stands,” Herndon also wrote, adding, “It is clear that whether the number of plaintiffs remain static or increase, the allegations that have been made are quite serious.” Herndon noted that “The plaintiffs and potential plaintiffs will benefit from an expeditious resolution to the factual allegations made in this case, whether the plaintiffs’ allegations are proven or disproven,” according to The Madison Record. Herndon indicated that he is looking to try the first case 18-24 months from when the scheduling order is set, said The Madison Record.

The U.S. Food & Drug Administration (FDA) approved Pradaxa in October 2010, said NewsInferno, to prevent strokes in patients diagnosed with non-vavular atrial fibrillation, a type of irregular heartbeat. Pradaxa was meant to replace warfarin, a decades-old drug that mandates regular blood monitoring or frequent physician follow-up. Both Pradaxa and warfarin can cause internal bleeding; however antidotes for warfarin bleeds are readily available, while there is no antidote for Pradaxa bleeding.

Reports indicate that Pradaxa patients have died as a result of uncontrollable internal hemorrhaging. In fact, Boehringer Ingelheim acknowledged in 2011 that, since March 2008, it had received 260 reports of bleeding-related deaths in patients taking Pradaxa.

In December, the FDA implemented a review of Pradaxa over reports of bleeding-related side effects and regulators in Europe and Japan directed Boehringer Ingelheim to strengthen the drug’s warnings. European regulators asked Boehringer Ingelheim to update Pradaxa’s label with information about bleeding side effects, said NewsInferno.

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