Like the longer-established Pradaxa, Xarelto (rivaroxaban) is a member of the family of anticoagulants known as “direct thrombin inhibitors,” which are used to reduce the risk of blood clots and strokes. And like its sister drugs, it is alleged to cause uncontrollable internal bleeding.

Pradaxa is the focus of thousands of lawsuits involving victims who have suffered irreversible internal bleeding. Xarelto lawsuits are starting to add up, too. Kentucky plaintiff Virginia Stuntebeck filed a Xarelto lawsuit raising similar allegations against Bayer and Janssen (a subsidiary of Johnson & Johnson) for its drug.

Stuntebeck was prescribed Xarelto in July 2012 to treat atrial fibrillation. Less than a year later, in February 2013, she was hospitalized with severe internal and gastrointestinal bleeding that the doctors had difficulty stopping. Her Xarelto lawsuit says that the “Defendants concealed their knowledge that Xarelto can cause life threatening, irreversible bleeds from the Ingesting Plaintiff, other consumers, the general public, and the medical community.” It adds that the marketing for Xarelto indicated that it was easier to use because it didn’t require monitoring for internal bleeding, and the warning label was insufficient as well.

Stutebeck’s Xarelto bleeding lawsuit accuses the defendants of negligence, product liability, breach of implied and express warranties, unreasonable marketing, and unreasonable failure to remove the drug from the market.

New Class of Medications

Xarelto and Pradaxa are part of a new class of anticoagulation therapy drugs that are supposedly easier to use and require less monitoring than their predecessor Coumadin (warfarin). Pradaxa (dabigatran), introduced by Boehringer Ingelheim in October 2010, was the first drug in this class to hit the market.

Bleeding risks are common with all blood thinners, but there has always been a way to stop this effect. With warfarin, doctors can use Vitamin K to stop the bleeding. However, this new breed of drugs does not have a reversal agent.

With no prescribed way to stop Xarelto side effects, doctors have to improvise treatments to stop the bleeding effects. These on-the-fly or off-label treatments can help, but have, according to plaintiffs and experts, led to confusion over appropriate treatment, as well as serious injuries and death. Xarelto was marketed as a drug that didn’t need supervision and was easy for a patient to use.

This allegedly false marketing and lack of sufficient warning sits at the heart of Xarelto and Pradaxa lawsuits. According to Stutebeck, the defendants “fervently marketed Xarelto using print advertisements, online marketing on their website, and video advertisements with no regard to the accuracy and repercussions of their misleading advertising in favor of increasing sales.” Moreover, for her and others like her, the drugs’ risks for irreversible, fatal bleeding are missing from the public eye and the warning label.