Lawsuits alleging the maker of Pradaxa failed to adequately warning users of its association with life-threatening, uncontrolled bleeding have been consolidated in a multidistrict litigation in U.S. District Court, Southern District of Illinois. All Pradaxa injury lawsuits filed in federal district courts now and in the future will be transferred to the Southern District of Illinois, where they will be presided over by U.S. District Judge David R. Herndon. The case is entitled IN RE: Pradaxa (Dabigatran Etexilate) Products Liability Litigation.
Pradaxa was approved by the U.S. Food & Drug Administration (FDA) in October 2010 to prevent strokes in patients with an irregular heartbeat called non-vavular atrial fibrillation. It was meant replace decades-old warfarin, which requires regular blood monitoring or frequent doctor follow-up. While both Pradaxa and warfarin can cause internal bleeding, there are readily available antidotes for warfarin bleeding. That is not the case with Pradaxa, however, and reports have been emerging since its approval that Pradaxa patients have died as a result of uncontrollable internal hemorrhaging. Among other things, Pradaxa lawsuits allege that the drug’s maker, Boehringer Ingelheim, failed to warn of its lack of an effective reversal agent to stop bleeding problems.
Last year, Boehringer Ingelheim acknowledged that since March 2008, it had received 260 reports of bleeding-related deaths in patients taking Pradaxa. In December, the FDA launched a review of Pradaxa over reports of bleeding-related side effects, while regulators in Europe and Japan have directed Boehringer Ingelheim to strengthen warnings for the drug. Most recently, European regulators asked Boehringer Ingelheim to update the Pradaxa label with additional information regarding its bleeding side effects.
An MDL allows lawsuits associated with a particular product to be coordinated under one judge for pretrial litigation to avoid duplicative discovery, inconsistent rulings and to conserve the resources of the parties, witnesses and the court. When lawsuits are consolidated as a multidistrict litigation, each retains its own identity. If the multidistrict litigation process does not resolve the cases, they are transferred back to the court where they originated for trial.
Judge Herndon is currently presiding over thousands of lawsuits filed in the Yaz and Yasmin multidistrict litigation in the Southern District Illinois. In choosing to transfer the Pradaxa litigation to Judge Herndon, the U.S. Judicial Panel on Multidistrict Litigation praised his handling of the Yaz and Yasmin lawsuits.