A Texas woman joined the multidistrict litigation against Xarelto manufacturers, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) and Bayer AG, after suffering severe complications from taking the popular blood thinner. The woman alleges the drug’s manufacturers failed to warn the public of the serious bleeding risks associated with Xarelto.
The woman began taking Xarelto in April 2014 to manage her risk of blood clots. However, in only a few months time, she experienced a life-threatening bleeding event requiring hospitalization.
Although all blood thinners come with the risk of excessive bleeding, Xarelto is particularly dangerous because it has no antidote. In the event of uncontrollable bleeding, there is no consistent way to reverse Xarelto’s effects. This has led many to believe the FDA should never have approved Xarelto.
When Xarelto was granted approval by the FDA in 2011, it wasn’t without controversy. Medical reviewers originally voted against Xarelto’s approval, but an advisory committee later granted it.
Adding to the controversy was the recall of the blood monitoring device used in the pivotal 2014 Xarelto clinical trial. The device was recalled for providing erroneous readings. Plaintiffs allege the erroneous readings compromised Xarelto’s clinical trial data. To make matters worse, a recent study found Xarelto patients were twice as likely to experience uncontrollable bleeding events than patients taking Warfarin, another type of blood thinner. For plaintiffs in the Xarelto litigation, the risks of the drug far outweigh the benefits.
In December 2014, thousands of Xarelto lawsuits were consolidated in the Eastern District of Louisiana with District Judge Eldon Fallen overseeing the proceedings. Since then, the number of lawsuits has grown to more than 5,300. Four bellwether trial dates have been scheduled for 2017 and both sides are working on selecting cases.