In a lawsuit filed this week in Pennsylvania against Johnson & Johnson and Bayer AG, a Kentucky woman claims the blood-thinner Xarelto (rivaroxaban) caused her severe internal bleeding.
Virginia Stuntebeck’s lawsuit, filed in the Pennsylvania Court of Common Please, says the drug should not be sold because of the serious risks surrounding its use, according to Law360. The suit alleges that Bayer and Johnson & Johnson were negligent in introducing the drug. The filing comes shortly after a ruling by the Pennsylvania Supreme Court that a pharmaceutical company can be held responsible for marketing a drug that too harmful to be used.
According to Stuntebeck’s legal complaint, she was hospitalized in February 2013 for severe internal and gastrointestinal bleeding, which she alleges is a result of using Xarelto. Stuntebeck claims “the defendants knew or should have known that Xarelto use was associated with irreversible bleeds.” The complaint further states that the drug’s warning label did not properly advise users about the bleeding risks, according to Law360.
Stuntebeck’s attorney compared Xarelto’s marketing with that of a competing drug, Boehringer Ingelheim’s Pradaxa (dabigatran), which is the subject of more than 2,000 lawsuits in a multidistrict litigation, according to Law360. The attorney said there is a “serious issue with the marketing claims, similar to Pradaxa, where they’re claiming that you don’t need to monitor these people.”
Xarelto and Pradaxa are two of a new group of blood thinners, which, along with Bristol-Myers Squibb’s Eliquis (apixaban), are competing for the market long dominated by warfarin (Coumadin). Warfarin has been prescribed for decades to prevent strokes in patients suffering from atrial fibrillation, an irregular heart rhythm that is common especially among the elderly. Xarelto does not require the regular blood monitoring that warfarin users must have, and this is a major selling point for the manufacturer.
Xarelto received U.S. Food and Drug Administration (FDA) approval in July 2011 to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism after knee or hip replacement surgery. In November 2012, approval was extended to the treatment of abnormal heart rhythm. But FDA staff raised concerns about this use, and the FDA has refused three times to further expand Xarelto’s approval to include the treatment of acute coronary syndrome, Law360 reports.