Victims of alleged Pradaxa injuries are awaiting word on whether their lawsuits will be consolidated in a multidistrict litigation. According to a report from The Madison Record, so far just over two dozen Pradaxa bleeding lawsuits have been filed in federal courts throughout the U.S.
All of the lawsuits allege Pradaxa caused users to suffer severe internal bleeding that in some cases was fatal. Boehringer Ingelheim Pharmaceuticals, Inc. is accused of failing to properly warn users of the risks associated with Pradaxa. According to the Madison Record, 12 Pradaxa bleeding lawsuits were filed in federal court in East St. Louis, and are pending before Judge David Herndon in U.S. District Court, Southern District of Illinois. Other lawsuits are pending in federal courts in Connecticut, Florida, Kentucky, Louisiana, Oklahoma and Tennessee.
The U.S. Judicial Panel on Multidistrict Litigation will take up the question of a Pradaxa MDL on July 26. The Panel is expected to make a decision on the consolidation by late July or early August.
Pradaxa was approved by the U.S. Food & Drug Administration (FDA) in October 2010 to prevent strokes in patients with an irregular heartbeat called atrial fibrillation. It was meant replace to decades-old warfarin, which requires regular blood monitoring or frequent doctor follow-up. Among other things, Boehringer has promoted Pradaxa based on evidence from clinical trials that indicated Pradaxa caused fewer brain bleeds compared to warfarin. However, serious internal bleeding is still a known side effect of the drug, and there is no known antidote for Pradaxa bleeding. Warfarin bleeding, on the other hand, can be stopped via the administration of vitamin K.
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.
Last month, Reuters reported that some doctors have grown wary of Pradaxa’s bleeding side effects. Physicians interviewed said patients using Pradaxa should undergo testing ahead of time to make sure their kidneys are functioning well, as weak kidneys allow Pradaxa to build to unsafe levels in the bloodstream. They also said patients should be educated about the drug’s potential dangers and be seen by doctors periodically, especially after a switch is made from warfarin.
“The good news is you now have an alternative to warfarin,” Dr. Alan Jacobson, director of anti-coagulation services at the Veterans Administration (VA) healthcare system in Loma Linda, California, told Reuters. “The bad news is you can kill a patient as easily with the new drug as you could with the old drug” if it is not handled properly.