Xarelto is a blood thinner that was approved for use by the U.S. Food and Drug Administration (FDA) in 2011. It’s manufactured by Bayer and marketed in the United States by Johnson & Johnson’s, Janssen Pharmaceuticals, Inc. It’s now alleged to be connected to hundreds of injuries and deaths. Xarelto is used as an anticoagulant that was marketed as an alternative to warfarin which has been in use for over 60 years now. It’s used for treatment or prevention of blood clots, deep vein thrombosis, and pulmonary embolisms. Xarelto purports to distinguish itself from warfarin that it doesn’t require frequent daily monitoring of blood levels and adjustments. It need only be taken in pill form once or twice a day. Xarelto costs about $3,000 per year while generic warfarin costs about $200. From the day that Xarelto was released, the drug’s sales skyrocketed. In 2013, sales reportedly exceeded $2 billion. They’re expected to exceed $3 billion by 2018.
Possible adverse effects of Xarelto
Adverse effects allegedly tied to Xarelto were first announced in Germany in September of 2013, where it was said to be connected to 72 deaths and over 750 other complications. As per the Safe Medicine Practices’ May 2014 report, 680 severe adverse effect cases were reportedly related to the drug in the first quarter of 2013. By the middle of 2014, the first lawsuits were being filed in the United States against the manufacturer and distributor of Xarelto.
Xarelto and the FDA
On June 6, 2013, the FDA issued a warning letter to Johnson & Johnson regarding false advertising claims connected with Xarelto. The letter stated that the advertisement was false or misleading because it minimized the risks associated with Xarelto and made a misleading claim regarding no necessity for blood monitoring and dosage adjustments. FDA black box safety warnings are the strongest mandated safety warnings for medications that stress risks of serious or grave side effects; no black box warning exists that warns prescribing physicians and their patients about Xarelto’s suspected role in uncontrollable bleeding.
Allegations in the lawsuits
The lawsuits in the United States against Xarelto’s manufacturer and distributor allege that as opposed to warfarin, once bleeding begins on a patient using Xarelto, there is no substance known to man to stop that bleeding. A person can bleed to death even after sustaining only a minor cut. Bleeding from a patient using warfarin is stopped relatively simply and quickly with an administration of vitamin K. These lawsuits accuse the manufacturer and distributor of withholding information from the FDA, healthcare providers and patients regarding the want of anything to reverse the uncontrollable bleeding that might occur with Xarelto patients.
Future of Xarelto litigation
Xarelto product liability lawsuits are highly complex litigation, all of which are in embryonic stages. Most of 2015 are expected to involve discovery coordination and management of the cases as innovation is supposed to include millions of pages of documents involving research and development of the product. On that basis, it’s highly unlikely that any settlements or verdicts will be seen shortly. A motion is presently pending in the U.S. District Court for Southern Illinois to consolidate Xarelto cases into centralized multidistrict litigation. As opposed to a class action, this permits plaintiffs the benefit of combined information while still retaining control over their cases. As discovery progresses, scores of Xarelto lawsuits will follow.
Sources: Federal Institute for Drugs & Medical Devices, Executive Summary, Data from
2012 Quarter 4 Annual Report
FDA 6-6-16 FDA Warning Letter to Johnson & Johnson