A Tennessee man who allegedly lost his father to Xarelto bleeding side effects has joined hundreds of other plaintiffs who have filed product liability lawsuits in a multidistrict litigation underway in Louisiana federal court. The March 20th filing seeks more than $75,000 in damages from Bayer Healthcare Pharmaceuticals, Johnson & Johnson and its Janssen Pharmaceuticals subsidiary.
According to the complaint, the decedent suffered from non-valvular atrial fibrillation, and began taking Xarelto in November 2012 to reduce his risk of stroke. In March 2013, he began to experience internal bleeding, which could not be stopped. He passed away just two days later as a result of the hemorrhaging.
Like other Xarelto lawsuits pending in the U.S. District Court, Eastern District of Louisiana, the complaint asserts that a boxed warning on the Xarelto label did not address the risk for serious and fatal bleeding, despite the fact that during early clinical trials, the medication caused more gastrointestinal bleeds than warfarin. The lawsuit also alleges that the defendants misleadingly marketed Xarelto as being superior to warfarin. While patients taking the older blood thinner may be treated with vitamin K to stop internal bleeding, there is currently no approved remedy for Xarelto bleeding.
“Defendants merely indicated that there was a risk for bleeding,” the lawsuit states, “and side-stepped the important issue of reversing the effects of Xarelto should a bleed occur.”
Xarelto was first approved by the U.S. Food & Drug Administration (FDA) to treat patients with non-valvular atrial fibrillation in November 2011. The medication’s approved indications have since been expanded to include the prevention of blood clots in patients who have undergone knee or hip replacement surgery, as well as the treatment of deep vein thrombosis and pulmonary embolism. A black box warning on the Xarelto label includes, among other things, information about the increased risk of blood clot formation after premature discontinuation of the medication in the absence of adequate alternative anticoagulation.
Currently, some 434 Xarelto lawsuits are pending in the federal litigation underway in Louisiana. More than 200 similar complaints have been filed in a mass tort program established earlier this year in Pennsylvania’s Philadelphia Court of Common Pleas.
Individuals who allegedly suffered Xarelto bleeding and related side effects may be entitled to file their own lawsuits against the drug’s manufacturers. If you would like assistance with such a claim, please call Bernstein Liebhard LLP at .