Nearly 5,400 cases are now pending in the Xarelto multidistrict litigation in U.S. District Court for the Eastern District of Louisiana.
These cases allege that the anticoagulant drug Xarelto, prescribed for patients at risk for stroke from conditions such as atrial fibrillation, was responsible for episodes of uncontrolled bleeding.
Some experts expect the lawsuits to continue to mount because of the way Xarelto has been marketed and because there is no antidote for Xarelto bleeding.
Xarelto (rivaroxaban) came to market with the promise of being a more convenient alternative to the long-established blood thinner warfarin (Coumadin). Warfarin has long been the leading treatment for patients with atrial fibrillation or those at risk for stroke. But warfarin users must undergo regular blood monitoring and they must follow a careful diet to maintain the balance between effective blood thinning and sudden bleeding episodes. Xarelto came to market with the freedom from such restrictions and it quickly became a popular alternative to warfarin. Like warfarin, Xarelto can also pose a serious bleeding risk, but, unlike warfarin, Xarelto does not have an antidote for bleeding. Many Xarelto users have suffered bleeding complications and even death.
When a warfarin user experiences bleeding, vitamin K can restore the blood’s ability to clot and give the patient a reasonable chance of survival. With careful blood monitoring and attention to diet, warfarin has proved to be a reasonably safe treatment. But doctors and patients had been seeking a drug that provided the blood-thinning benefits of warfarin without the restrictions.
Among the thousands of lawsuits in the multidistrict litigation are two cases filed by families of people who died because of Xarelto bleeding. One case was filed by the daughter of a man who suffered a serious brain bleed and died a month after he began taking Xarelto to reduce his risk of stroke. A Florida woman filed a case over her husband’s death. The man suffered a serious brain bleed while taking Xarelto for atrial fibrillation. Doctors breached his skull in an effort to relieve the building pressure, but they were not able to save the man’s life.
The plaintiffs in these and similar cases allege that defendants Janssen Pharmaceuticals and Bayer AG, the makers of Xarelto, were negligent not only in bringing Xarelto to market without an available antidote, but also in not adequately warning doctors and patients about the lack of an antidote. Plaintiffs also say that the defendants were negligent in saying less monitoring was required when, given the lack of an antidote, Xarelto monitoring could be crucial.
Plaintiffs in Xarelto cases say that ads for Xarelto, in particular television ads featuring celebrity Xarelto users, stress Xarelto’s convenience but fail to warn about bleeding risks and lack of an antidote. Golf legend Arnold Palmer and basketball all-star Chris Bosh who happily proclaim Xarelto’s convenience without mentioning the risk of uncontrollable bleeding. Plaintiffs say they should have been have been warned about the bleeding risks and many also say that if they had known there was no bleeding antidote, they would have asked their doctor for another treatment.