A Texas woman has filed a Xarelto lawsuit that alleges many of the claims used to market the blood thinner were deceptive. Among other things, the complaint points out that even the U.S. Food & Drug Administration (FDA) once cited one of the drug companies behind Xarelto for making misleading statements in promotional materials.
According to the lawsuit, which was filed on July 29th in the U.S. District Court, Eastern District of New York, the Plaintiff took Xarelto for only four months before she suffered a serious episode of internal bleeding that caused severe and permanent injuries, pain, suffering and emotional distress. The complaint charges that Bayer Healthcare and Johnson & Johnson’s Janssen subsidiary promoted the drug to doctors via marketing materials that highlighted positive results from three studies that were used to garner FDA approval. However, these “promotional materials fail to similarly highlight the increased risk of gastrointestinal bleeding and bleeding that required transfusion, among other serious bleeding concerns.”
The complaint also points to an FDA letter that Johnson & Johnson received in 2013, which faulted the company for downplaying the serious risks associated with Xarelto.
The Xarelto lawsuit also states that adverse event reports made to the FDA involving the blood thinner have risen since its 2011 approval.
“In the year leading up to June 30, 2012, there were 1,080 Xarelto-associated ‘Serious Adverse Event’ (‘SAE’) Medwatch Reports filed with the FDA, including at least 65 deaths,” the complaint says. “At the close of the 2012 fiscal year, a total of 2,081 new Xarelto-associated SAR reports were filed with the FDA in its first full year on the market, ranking tenth among other pharmaceuticals in direct reports to the FDA. Of those reported events, 151 resulted in death, as compared to only 56 deaths associated with warfarin.”
According to the complaint, the adverse event reports also indicate that Xarelto bleeding was fatal in 8% of the cases reported to the FDA. That is double the rate of fatal bleedings events reported to the agency involving warfarin, a blood thinner that has been on the market for decades.