June 17, 2014 — Germany’s Bayer AG and Johnson & Johnson have reported a small number of lawsuits involving Xarelto (rivaroxaban), a blood-thinning drug that has been linked to hundreds of severe bleeding events and dozens of deaths.
Bayer declined to comment, but said that Xarelto was performing as expected based on clinical trials involving more than 75,000 patients.
According to German newspaper Frankfurter Allgemeine Zeitung, less than 10 lawsuits involving Xarelto are pending against the company. One of the most recent cases was filed last month in Pennsylvania on behalf of a woman who bled to death after taking Xarelto.
Plaintiffs in the litigation allege that drug-makers failed to adequately warn that Xarelto has no reversal agent. In a bleeding emergency, doctors may struggle to reverse Xarelto’s blood-thinning effects. In comparison, warfarin can be reversed with Vitamin K and Pradaxa (dabigatran) can be reversed with a few hours of dialysis.
The allegations raised in Xarelto lawsuits are very similar to those raised against Boehringer Ingelheim’s Pradaxa. Last month, Boehringer agreed to resolve up to 4,000 Pradaxa lawsuits for about $650 million. Those cases were centralized in federal court in Illinois. Lawsuits involving Xarelto have not yet been centralized.
Lawyers expect the number of lawsuits involving Xarelto to continue growing. According to the Institute for Safe Medicine Practices (ISMP) QuarterWatch report for May 2014, prescriptions for Xarelto now outpace Pradaxa. Adverse events involving Xarelto are also outpacing Pradaxa at a rate of 2-to-1 in 2013. The U.S. Food and Drug Administration (FDA) received 680 adverse event reports for Xarelto last year.