In Xarelto MDL, Judge Extends Deadline to File Complaints

Certain groups of plaintiffs in the Xarelto multidistrict litigation (MDL) have more time to file a lawsuit against manufacturers Janssen Pharmaceuticals and Bayer Healthcare. According to a recent order issued by Judge Eldon Fallon, who is overseeing the MDL in the Eastern District of Louisiana, the filing deadline has been extended for 90 days for certain groups looking to sue over the blood thinner.

The order was issued after the first cases were selected for bellwether trials. The deadline was extended “due to an influx of complaints” in the clerk’s office, court records indicate. More than 7,000 lawsuits have been consolidated into the Xarelto MDL. The first lawsuit is scheduled for trial February 2017.

An MDL is established when there are a number of lawsuits with similar allegations. The cases are consolidated to one court before one judge. Streamlining lawsuits in this manner makes the process more efficient, speeding up complex litigation. The first several lawsuits to go to trial are known as bellwether cases. They are selected in order to predict how the majority of the litigation would proceed. As such, bellwether lawsuits are representative of the entire litigation.

In addition to the MDL, there is a mass tort program for Xarelto lawsuits underway in Philadelphia. Roughly 950 cases have been consolidated there so far. In both the mass tort and the MDL, plaintiffs allege that Xarelto presented a risk of uncontrollable, sometimes fatal bleeding. The lawsuits allege that the manufacturers were aware of this risk but failed to inform the patients, their physicians or the public.

The U.S. Food and Drug Administration (FDA) approved Xarelto in July 2011 to reduce the risk of blood clots, deep vein thrombosis and pulmonary embolism in patients undergoing knee and hip replacement surgeries. In November 2011, the agency approved the anticoagulant to reduce the risk of blood clots and related injuries in patients with atrial fibrillation, a type of abnormal heart rhythm.

The plaintiffs in the litigation allege that Xarelto was marketed as a superior alternative to warfarin, an older anticoagulant that requires regular blood monitoring and dietary restrictions. Xarelto and other new generation anticoagulants do not have these limitations, but plaintiffs take issue with the lack of an antidote to reverse the drug’s effects. This means that if a Xarelto patient suffers internal bleeding, there are no effective interventions to stop it, plaintiffs allege. Warfarin, plaintiffs point out, can be reversed with vitamin K. The lawsuits allege that the manufacturers failed to adequately warn patients or their physicians about these risks.

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