Janssen Pharmaceuticals and Bayer AG, the makers of the new-generation blood thinner Xarelto, face thousands of lawsuits over alleged bleeding risks associated with the drug.
The appeal of Xarelto (rivaroxaban) and other new-generation anticoagulants is that they do not require the restrictions faced by people taking the older drug warfarin. Xarelto is promoted for its convenience and a series of Xarelto commercials feature celebrities touting the benefits of the drug. One commercial shows NBA star Chris Bosh, golf legend Arnold Palmer, Saturday Night Live personality Kevin Nealon, and NASCAR driver Brian Vickers. The celebrities happily speak about the benefits of Xarelto but they do not mention the serious risks that many Xarelto users face.
Xarelto (rivaroxaban) came to market in 2011. It is one of a new class of anticoagulants that were hailed as a more convenient alternative to warfarin. Warfarin has been the standard blood-thinning treatment for more than 60 years, but many patients and doctors find the drug highly inconvenient. Patients taking warfarin must have regular blood monitoring to make sure they have the proper amount of warfarin in their blood. They must also follow a restricted diet to avoid interactions that counteract the effects of the drug. Xarelto users do not have the blood testing and dietary restrictions.
Xarelto prevents blood clots in patients due to deep vein thrombosis in the legs and pulmonary embolism (blood clot to the lung). Xarelto is also prescribed to prevent strokes in patients who suffer atrial fibrillation, a heart rhythm problem. But since Xarelto received Food and Drug Administration (FDA) approval, the FDA has ordered drug makers to put two black box warnings on the drug label. A black box warning is the FDA’s most serious warning and is sometimes a precursor to a drug being pulled from the market.
But despite the positive advertising claims, many Xarelto patients have reported severe and even fatal bleeding complications. Thousands of Xarelto users have filed lawsuits over bleeding and other health complications. More than 2,800 Xarelto cases have been consolidated into a multidistrict litigation (MDL) in federal court in Louisiana. The first trials are scheduled to begin in February 2017, the Legal Examiner reports. These first trials are known as bellwether trials. Bellwether cases are chosen as representative cases and the outcome of these trials can influence how the remaining cases are handled. Depending on how juries respond to the evidence and arguments in the bellwether cases, additional cases may go to trial or the parties will try to reach a settlement.
Court documents in the Xarelto lawsuits allege that the medical community and prospective patients were not adequately warned about the possibility of uncontrollable bleeding. In addition, plaintiffs say Bayer and Johnson & Johnson failed to adequately warn doctors about the lack of an antidote to stop bleeding. In the event of an injury or a spontaneous bleeding episode, doctors need to restore the body’s clotting ability. Warfarin has a readily available antidote. A number of plaintiffs in Xarelto lawsuits say they would have accepted the inconvenience of warfarin if they had known about the dangerous bleeding risks associated with Xarelto.