First Xarelto Bellwether Trial Moved up a Month

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First Xarelto Bellwether Trial Moved up a Month
First Xarelto Bellwether Trial Moved up a Month

The long-awaited Xarelto bellwether trials have been pushed back a month because of a conflict with a major event in New Orleans.

The first trial will start in March 2017 because the city is hosting the hosting the National Basketball Association All-Star game in February, Top Class Actions reports.

Bellwether trials—where a small number of representative cases in a large litigation are brought to trial—give the two sides the opportunity to see how their evidence and arguments will be received by a jury. The outcome of bellwether cases can determine how the rest of the cases are handled. All of the parties watch bellwether trials closely for indications of trends in the litigation.

Xarelto lawsuits generally center around allegations that the drug can cause uncontrollable internal bleeding, particularly brain bleeds. The plaintiffs allege that drug makers Bayer Healthcare and Janssen Pharmaceuticals (a division of Johnson & Johnson) failed to provide adequate warnings about the safety of Xarelto and the potentially life-threatening bleeding risks associated with the drug. Most plaintiffs are seeking compensation from Janssen and Bayer for failure to warn and negligent marketing, manufacture and sale of a product linked to serious injury.

Many plaintiffs allege that the manufacturers were reckless in bringing Xarelto to market without an antidote to restore clotting ability in the event of a bleeding episode, according to Top Class Actions. When someone taking Xarelto suffers internal bleeding, or is injured, or needs emergency surgery, there is no consistent way to make the blood begin to clot again. Xarelto users have suffered internal bleeding, strokes, hemorrhages, and other adverse bleeding events.

Xarelto (rivaroxaban) came to market in 2011, and quickly became a popular anticoagulant treatment because of its convenience. Warfarin, the standard treatment for six decades, requires regular blood monitoring and a careful diet so that certain foods do not interact with the drug and reduce its effectiveness. Xarelto was heavily promoted for its convenience. Patients do not need routine blood monitoring or a restricted diet. Television ads feature celebrity Xarelto users like golf legend Arnold Palmer and NBA All-Star Chris Bosh, who happily promote Xarelto’s convenience but do not warn of the bleeding risks.

Xarelto was also promoted for the convenience of a once-daily dose, but recent studies have questioned the safety of the once-daily dose. A 2015 study found that Japanese patients, in particular, were vulnerable to “peaks and troughs,” meaning that the drug was more effective at some times, less at other times. During the times Xarelto was more effective, the bleeding risk was higher. The researchers concluded that blood monitoring in these cases would be valuable. And some plaintiffs have said that the dosing should be changed to take into account differences in patients’ size and weight.

The first Xarelto bellwether trail is now scheduled to begin on March 13, 2017 in the Eastern District of Louisiana. The second trial will begin in New Orleans on April 24. More cases are scheduled to go to trial in the Southern District of Mississippi and the Northern District of Texas at dates that are yet to be determined.