A multi district litigation (MDL) alleging the blood thinner Pradaxa caused serious and fatal bleeding events has grown to include 78 cases. The lawsuits claim that the drug’s manufacturer, Boehring Ingelheim Pharmaceuticals, failed to warn users of the drug’s risks, including the potential for hemorrhaging, and that there is no antidote available that can reverse the drug’s anticoagulant effects.
The U.S. Panel on Multi District Litigation approved last month an Illinois plaintiff’s request for the MDL. U.S. Chief Judge David Herndon was assigned to handle the suits. At that time, the 21 claims were pending in 11 different district courts. Another 57 cases from an additional 8 jurisdictions were added to the MDL. The lawsuits span from New York to California, but the majority of cases have been filed in the East St. Louis federal court.
Pradaxa was approved by the Food and Drug Administration (FDA) in 2010 as the first alternative to warfarin in more than 50 years for the prevention of strokes in patients with a heart condition known as atrial fibrillation. Pradaxa has fewer food and drug interactions than warfarin and does not require regular monitoring, making it a more desirable option for patients who required the medication. However, unlike warfarin, there is no reversal agent doctors can give to counter the effects of the medication when internal bleeding occurs.
A review of 2011 reports to the FDA adverse event reporting program shows more deaths were associated with Pradaxa that year than any other monitored medication.
Judge Herndon stressed a desire to move forward as expeditiously as possible with the litigation. “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 wrote. “It is clear that whether the number of plaintiffs remain static or increase, the allegations that have been made are quite serious.”
Source: The Madison-St. Clair Record