A trial over the blood thinner Xarelto, made by Janssen Pharmaceuticals Inc. and Bayer Pharma AG, is underway in the Philadelphia Court of Common Pleas, where more than 1,500 Xarelto bleeding claims have been centralized in a mass tort program.
Lynn Hartman of Indiana charges she suffered serious gastrointestinal bleeding after using the novel anticoagulant for a little over a year. (Case No. 160503416)
During the opening statements, the plaintiff attorney Gary Douglas of Douglas & London asserted that the drug's manufacturers manipulated clinical trial data and downplayed important safety information to make Xarelto appear safer and more effective than competing blood thinners, such as warfarin.
"Our firm is representing a number of plaintiffs who are pursuing similar Xarelto claims. We will be watching the Philadelphia trial closely for any developments that could impact our clients' cases," says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP.
Approved by the U.S. Food & Drug Administration in October 2011, Xarelto is jointly marketed by Bayer and Johnson & Johnson's Janssen Pharmaceuticals subsidiary. The blood thinner is currently indicated for the prevention of strokes in people with atrial fibrillation; the treatment of patients suffering from deep vein thrombosis and pulmonary embolism; and the prevention of deep vein thrombosis in people undergoing hip or knee implant surgery.
Like other new-generation blood thinners, Xarelto has been touted as an improvement over decades-old warfarin. However, internal bleeding caused by warfarin can be stopped by the administration of vitamin K. There is currently no approved agent to reverse Xarelto bleeding.
Johnson & Johnson's most recent earnings statement indicates that more than 21,000 Xarelto lawsuits have been filed in courts throughout the United States.
Plaintiffs involved in this litigation claim that the drug's manufacturers downplayed the potential for Xarelto bleeding and wrongly promoted the drug as a superior alternative to warfarin. In addition to noting the lack of a reversal agent for Xarelto bleeding, plaintiffs take issue with the medication's one-size-fits-all dosing regimen and dispute the defendants' assertions that there is no need to subject Xarelto patients to routine blood monitoring.
The majority of Xarelto lawsuits are currently pending in a federal multidistrict litigation underway in the U.S. District Court, Eastern District of Louisiana, where three trials have already concluded with defense verdicts. There are 18,526 lawsuits pending before US District Judge Eldon E. Fallon in MDL 2592, IN RE: Xarelto (Rivaroxaban) Products Liability Litigation. Additional Xarelto bleeding claims have been filed in Delaware, California and Missouri state courts.
Xarelto patients who allegedly experienced bleeding-related complications may be entitled to compensation for their medical bills, lost wages, pain and suffering, and more.
