The U.S. Judicial Panel on Multidistrict Litigation has scheduled a hearing regarding the consolidation of all Pradaxa lawsuits filed in U.S. District Courts across the country. The hearing will be heard at the Carl B. Stokes U.S. Courthouse in Cleveland, Ohio on July 26.
Hundreds of lawsuits have been filed against drug manufacturer Boehringer Ingelheim over the anticoagulant Pradaxa. The drug entered the market in 2010 as an alternative to Coumadin for the prevention of stroke in people who suffer non-valvular atrial fibrillation. Since entering the market, the FDA has recorded over 2,000 adverse event reports of patient hemorrhaging, and the Institute for Safe Medicine says there were 542 patient death reports in 2011 alone.
Recently, a study published in the Archives of Internal Medicine linked Pradaxa to an increased risk of heart attack, and when compared to warfarin (Coumadin), enoxaparin and placebo, the risk was up to 33 percent higher. Researchers recommended further studies be completed.
The lawsuits allege that the drug can cause uncontrolled bleeding. Another issue with the drug is that there is no antidote, so patients who hemorrhage face little to no treatment options. Many of the lawsuits accuse the drug maker of failing to adequately research the effects of Pradaxa, failing to warn consumers and physicians about the severe bleeding risks, and failing to provide information regarding the lack of an antidote for bleeding events.