The Xarelto multidistrict litigation (MDL) continues to move forward in the Eastern District of Louisiana before Judge Eldon Fallon. Janssen Pharmaceuticals and parent company Johnson & Johnson are facing over 7,000 lawsuits alleging that anticlotting drug Xarelto presented an uncontrollable risk of bleeding. Plaintiffs allege that the drug makers knew about this risk, but failed to warn patients or the medical community. The court recently selected the first four lawsuits that will go to trial in 2017.
MDLs are a type of mass tort where numerous lawsuits with similar allegations are consolidated to one court in order make proceedings more efficient. The first lawsuits selected for trial are known as “bellwether” cases. Because the outcome of bellwether trials is used to predict the majority of the litigation, bellwether cases are selected because they represent most plaintiffs.
In a recent court order, Judge Fallon outlined the schedule for the trials. The first two bellwether trials will take place in Louisiana. The third bellwether trial will be held in Mississippi and the fourth will take place in Texas.
The U.S. Food and Drug Administration (FDA) approved Xarelto in 2011. It is used to reduce the risk of blood clot, stroke and heart attack in patients with atrial fibrillation, an abnormal heart rhythm.
Xarelto is a newer generation anticoagulant manufactured by Johnson & Johnson’s Janssen Pharmaceuticals and Bayer AG. It is used to reduce the risk of blood clots and related injuries, such as heart attack and stroke. Xarelto is also prescribed to patients at risk for pulmonary embolism, a life-threatening condition where a blood clot becomes stuck in the lungs; this includes patients with deep vein thrombosis (where a blood clot forms in a deep vein, usually in the legs).
Plaintiffs allege that Xarelto, part of a new generation of anticoagulants, was marketed in an effort to replace warfarin. Warfarin has been on the market for decades, but requires patients to undergo blood monitoring and dietary restrictions. These restrictions are not required in patients taking Xarelto. However, plaintiffs point out that unlike with warfarin, there is no antidote to reverse the effects of Xarelto. This means that if internal bleeding occurs in a Xarelto user, physicians have no reliable way to stop it. Lawsuits allege that Janssen failed to inform patients and physicians about this caveat.
The most common alleged injuries in the Xarelto MDL are gastrointestinal bleeding and brain bleeding. The first two bellwether cases involve plaintiffs who took Xarelto to reduce the risk of stroke associated with non-valvular atrial fibrillation. One of the plaintiffs suffered gastrointestinal bleeding and the other suffered bleeding in the brain, allegedly due to Xarelto. The third plaintiff took Xarelto to prevent complications from deep vein thrombosis and suffered gastrointestinal bleeding. The fourth plaintiff took Xarelto for atrial fibrillation and suffered gastrointestinal bleeding. Lawsuits similarly allege that plaintiffs and their physicians were unable to make a fully informed decision because drug makers did not adequately disclose the risks.