The current multidistrict litigation (MDL) comprised of more than 7,000 Xarelto (rivoxaban) lawsuits filed against the Johnson & Johnson subsidiary, Janssen Pharmaceuticals, and Bayer AG is being overseen by the Honorable Judge Eldon E. Fallon in the Eastern District of Louisiana.
Xarelto is an anticoagulant used to prevent the risk of blood clots and related injuries, including stroke and heart attack, in patients who have been diagnosed with atrial fibrillation, deep vein thrombosis (DVT), and pulmonary embolism, or in patients who have undergone recent knee or hip replacement surgery. Xarelto received U.S. Food and Drug Administration (FDA) clearance in 2011.
Plaintiffs allege that Xarelto makers made misleading statements concerning Xarelto, and failed to fully disclose bleeding risks to patients and their doctors. Plaintiffs involved in the cases that comprise the MDL also similarly allege that the blood thinner, Xarelto, may induce abrupt, spontaneous internal and external uncontrollable bleeding. These bleeds have allegedly led to numerous deaths.
Judge Fallon has scheduled a target date of February 2017 to commence the first bellwether trials against Janssen Pharmaceuticals and Bayer AG, which are to be selected from a pool of 40 cases.
The Court of Common Pleas in Philadelphia, Pennsylvania has also created a group litigation comprised of nearly 1,000 cases pending in a mass tort program. Janssen Pharmaceuticals and Bayer AG are named as defendants and plaintiffs in these lawsuits similarly allege uncontrollable Xarelto bleeding issues.
Lawsuits also allege that Xarelto, which is part of a class of new generation blood thinners, was promoted as being superior to Coumadin (warfarin). For about 50 years, the anticoagulant, Coumadin (warfarin), has been used in patients who are diagnosed with atrial fibrillation, which is an irregularity of the heartbeat. Coumadin (warfarin) is also prescribed to people who are at an increased risk for developing potentially fatal blood clots.
Pradaxa (dabigatran), another new-generation blood thinner that was released by Boehringer Ingelheim in 2010 is prescribed to reduce stroke and blood clot risks in patients diagnosed with non-valvular AF. Pradaxa inhibits thrombin, which is the central coagulation activator in the body’s blood clotting system. Soon after its release, Pradaxa was the focus of over 4,000 lawsuits tied to thousands of adverse event reports; 750 of these involved deaths allegedly associated with Pradaxa.
While all these drugs may cause internal bleeding, antidotes are readily available for warfarin bleeds. As in the Xarelto lawsuits, Pradaxa bleeding lawsuits alleged the drug caused serious, uncontrollable bleeding side effects. In the case of Pradaxa, these include GI bleeding and cerebral hemorrhaging, for which no possible reversal or reversal agent exists.
On the eve of the first day of trial, Pradaxa’s manufacturer agreed to a $650 million settlement rather than proceed to trial. Xarelto plaintiffs hope for a repeat of the Pradaxa litigation outcome in their Xarelto cases.