A Kentucky woman has filed suit against Johnson & Johnson and Bayer AG in Pennsylvania court, alleging that she suffered severe internal bleeding from the use of the blood-thinner Xarelto (rivaroxaban).
Virginia Stuntebeck’s lawsuit says the drug should not be sold because of the high risks surrounding its use, Law360 reports. Stuntebeck alleges that Bayer and Johnson & Johnson were negligent in introducing the drug. Last month, in Lance v. Wyeth, the Pennsylvania Supreme Court ruled that pharmaceutical companies can be held responsible for marketing drugs that are too harmful to be used.
Stuntebeck’s legal complaint says she was hospitalized in February 2013 for severe internal and gastrointestinal bleeding as a result of using Xarelto. “As the manufacturers and distributors of Xarelto, defendants knew or should have known that Xarelto use was associated with irreversible bleeds,” she said. In addition to arguing that Xarelto should never have been sold, the complaint says the drug’s warning label did not properly advise customers about Xarelto’s risks, according to Law360.
An attorney representing Stuntebeck compared the marketing of Xarelto to that of its competitor, Pradaxa, made by Boehringer Ingelheim. Pradaxa (dabigatran) is the subject of more than 2,000 lawsuits in a multidistrict litigation, Law360 reports. “We think there’s some serious issue with the marketing claims, similar to Pradaxa, where they’re claiming that you don’t need to monitor these people,” the attorney said.
These two drugs, along with Bristol-Myers Squibb’s Eliquis (apixaban) are competing for the market dominated by the blood-thinner warfarin, which has long been prescribed to prevent strokes in patients suffering from atrial fibrillation, a form of irregular heartbeat common especially among the elderly. One of the important selling points for Xarelto is that it does not require the frequent monitoring necessary with warfarin.
The U.S. Food and Drug Administration (FDA) approved Xarelto in July 2011 to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism after knee or hip replacement surgery, and extended the approval to treatment of abnormal heart rhythm in November 2012. But FDA staff raised safety concerns about this use and the FDA has three times refused to further expand Xarelto’s approval to include the treatment of acute coronary syndrome, Law360 reports.
