Even though they are facing hundreds of Xarelto lawsuits, Bayer and Janssen Pharmaceuticals continue to seek out new indications for their novel anticoagulant. According to a report from RTT News, the companies are preparing to investigate Xarelto for the prevention and treatment of pulmonary embolism and deep vein thrombosis in cancer patients.
Cancer patients are four to seven times more likely to experience venous thromboembolism, and chemotherapy treatments increase the risk further.
Bayer and Janssen’s Callisto Clinical Research Program is a multi-trial prospective clinical research initiative aimed at generating new evidence to help manage cancer-associated thrombosis. The program will consist of nine initiatives, including both clinical trials and registries, and involve more than 4,000 patients.
Xarelto was initially approved by the U.S. Food & Drug Administration in 2011, and is now indicated for the prevention of strokes in people with atrial fibrillation; the treatment of deep vein thrombosis and pulmonary embolism; and the prevention of deep vein thrombosis in patients undergoing hip or knee replacement surgery. The drug’s label includes a black box warning that contains information about the increased risk of blood clot formation after premature discontinuation of the medication in the absence of adequate alternative anticoagulation.
Court records indicate that more than 430 Xarelto lawsuits have been filed in the U.S. District Court, Eastern District of Louisiana, where federally-filed product liability claims involving the blood thinner have been consolidated for coordinated pretrial proceedings. All of the complaints accuse Bayer and Janssen of failing to provide adequate warnings regarding Xarelto’s association with uncontrollable internal bleeding and other serious side effects. The lawsuits take particular issue with marketing claims that plaintiffs say positioned Xarelto as a superior alternative to warfarin. They point out that while warfarin bleeding can be stopped via the administration of vitamin K, there is no approved antidote to reverse Xarelto bleeding.
Discovery in the federal Xarelto litigation is beginning to move forward, and the Court has begun the process for selecting individual lawsuits for its first bellwether trials. The litigation’s next Case Management Conference has been scheduled for June 10th, and will be followed by “Science Day” on June 11th. At that time, the parties will have an opportunity to apprise the Court of the scientific and medical issues relevant to the cases pending in the proceeding.
The attorneys at Bernstein Liebhard LLP are actively filing Xarelto lawsuits in U.S. courts. If you experienced uncontrollable bleeding, deep vein thrombosis, pulmonary embolism, or other complications while using this medication, please call for a free, no-obligation legal review.