Joseph Boudreaux will be the first plaintiff to have his trial go forward. According to court documents, Boudreaux began taking Xarelto for treatment of atrial fibrillation in January, 2014. Within a month, or so it is alleged, Boudreaux was hospitalized with a Xarelto bleeding issue, requiring multiple blood transfusions to stem the bleeding.
Boudreaux takes the defendants – Janssen Pharmaceuticals Inc. and Bayer Corp. – to task for allegedly misrepresenting the safety of Xarelto (rivaroxaban) to the public, to the medical community and to the US Food and Drug Administration (FDA), while referencing issues surrounding certain clinical trial results.
Those issues were not immediately identified. However the safety and efficacy of Xarelto, when compared with warfarin (Coumadin), has come into question in recent months after the recall this past July of Alere Inc.’s INRatio measuring device that was deployed for the ROCKET-AF trial and specifically, trial participants in the warfarin control group.
Allegations suggest the INRatio readings may have resulted in patients in the warfarin control group receiving too much warfarin, which in turn may have cast rivaroxaban (Xarelto) in a more favorable light. The FDA has since opined that in its view, any potential variations in the INRatio readings were insufficient to skew the trial results in Xarelto’s favor.
Xarelto was one of two, latter-generation anticoagulants brought to market in recent years. Xarelto appeared in 2011 with FDA-approved indications for stroke risk reduction in patients suffering from non-valvar atrial fibrillation (irregular heartbeat). Xarelto was originally approved for prevention of deep vein thrombosis in the legs of knee, or hip replacement patients.
Xarelto was introduced into a market pining for an easier, less-intensive way to manage the monitoring of warfarin patients in order to ensure proper levels of warfarin were administered: too little would be ineffective in reducing risk for DVT and stroke from atrial fibrillation. However, too much warfarin would thin the blood too intently, risking hemorrhage and other bleeding events.
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Xarelto made a big splash when it arrived on the market amidst high expectations: rivaroxaban earned $582 million in its first full year of availability, quadrupling to $2 billion by the end of 2013.
The MDL is In re: Xarelto (Rivaroxaban) Products Liability Litigation, Case No. 2:14-md-02592, in the US District Court for the Eastern District of Louisiana.