Due to the increased number of Xarelto lawsuits being filed, Judge Eldon Fallon, who is overseeing the multidistrict litigation (MDL), has extended the filing deadline by another 90 days. The MDL, centralized to the Eastern District of Louisiana, contains more than 7,000 lawsuits. Plaintiffs in the litigation allege that Bayer and Janssen, a subsidiary of Johnson & Johnson, failed to warn about the risk of uncontrollable bleeding with the anticoagulant Xarelto.
The first lawsuits in the MDL are scheduled to go to trial in February 2017. Meanwhile, nearly 1,000 cases are pending in a Philadelphia mass tort. Plaintiffs in both the MDL and Philadelphia mass tort make similar allegations; they claim that Xarelto led to uncontrollable bleeding and that the drug makers failed to warn them or their doctors about this risk.
The U.S. Food and Drug Administration (FDA) approved Xarelto in 2011. The blood thinner is used to prevent blood clots in patients undergoing hip and knee replacement surgery and patients with atrial fibrillation, an abnormal heart rhythm. A blood clot can lead to life-threatening complications such as pulmonary embolism, where a clot lets stuck in the lungs, heart attack or stroke.
Xarelto is part of a class of new generation blood thinners, along with Pradaxa and Eliquis. These medications, plaintiffs allege, were marketed as being superior to warfarin. Warfarin, sold under the brand name Coumadin, is a decades-old blood thinner that requires regular blood monitoring and dietary restrictions. Drugs such as Xarelto do not have these limitations, but plaintiffs allege that the drug carries another risk that manufacturers failed to adequately disclose. Xarelto lacks a reversal agent, meaning there is no antidote to stop its effects if a patient suffers from internal bleeding. Warfarin can be reversed with vitamin K.
Plaintiffs in the litigation have also questioned the integrity of data used to approve Xarelto, because a device used during the ROCKET-AF clinical trials was recalled. The device, called the INRatio, was used measure the amount of warfarin in a patient’s blood and adjust dosage appropriately. However, the device was later recalled because it gave low readings.
The recall raised concerns about whether low readings during the trials could have caused clinicians to give more warfarin than necessary. As a result, the data may have been inadvertently skewed to favor Xarelto over warfarin, plaintiffs allege. In December 2015, the British Medical Journal published a report stating that the data would be reanalyzed in light of the defective device. The European Medicines Agency also began investigating the issue. In February 2016, a lead investigator of the trials published a letter in NEJM stating that the recalled device did affect the overall findings. The author of the BMJ report, however, said that he wished further research were done. He also called for all data to be released publicly so other researchers could conduct their own analysis.