Pretrial Proceedings Moving Forward in First Four Xarelto Bellwether Cases

In a recent court order, Judge Eldon Fallon, who oversees the Xarelto multidistrict litigation in the Eastern District of Louisiana, outlined the schedule for the first four trials.

Judge Fallon has selected four cases to serve as the first bellwether cases. These cases will represent the thousands of other cases currently pending, and the trials are scheduled for 2017, the New York Legal Examiner reports. The first two trials will take place in Louisiana, with the third trial in Mississippi and the fourth in Texas.

The plaintiffs in the thousands of pending cases allege that Xarelto manufacturers Janssen Pharmaceuticals and Bayer AG failed to adequately warn doctors and patients of the risk of excess bleeding, particularly gastrointestinal bleeding. Plaintiffs also allege that the drug makers did not conduct adequate safety studies before releasing Xarelto in 2011.

Xarelto is one of a new generation of anticoagulant drugs, which were heavily promoted as superior to warfarin, the leading blood thinner for more than five decades. The manufacturers promoted Xarelto as a better option than warfarin because it requires no dietary restrictions or regular blood monitoring. Warfarin users must have regular blood tests to ensure they have the correct amount of warfarin in the bloodstream, and they must follow a careful diet so that certain foods do not interact with the drug and reduce its effectiveness. Xarelto was also promoted for the convenience of a once-daily dose

But patients taking Xarelto experienced serious bleeding episodes—internal and external—and they learned there was no antidote that would quickly restore clotting ability. In the event of an internal bleeding episode, an injury, or the need for emergency surgery, there is no consistent way to make a patient’s blood begin to clot again. Xarelto users have suffered internal bleeding, strokes, hemorrhages, and other adverse bleeding events.

The four bellwether cases represent plaintiffs who have suffered gastrointestinal bleeding and brain hemorrhages, two types of bleeding events most commonly alleged in Xarelto lawsuits.

The first bellwether case involves a plaintiff who took Xarelto to reduce risk of stroke and who suffered gastrointestinal bleeding. The second plaintiff also took Xarelto for this reason and suffered brain bleeding. The third and fourth cases involve gastrointestinal bleeding, the Legal Examiner reports.

Many Xarelto plaintiffs allege that Xarelto advertising overstates the drug’s convenience and benefits while downplaying the bleeding risks. Within a year of coming to market, Xarelto was associated with 346 cases of serious side effects, including pulmonary embolism (blood clot in the lung).

Recent studies have also 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 effective at other times. During the times Xarelto was more effective, the bleeding risk was higher. Researchers concluded that blood monitoring in these cases would be valuable, according to the Legal Examiner. Another 2015 study concluded that older patients with atrial fibrillation were at higher risk for gastrointestinal bleeding when taking Xarelto than with warfarin.



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