More Than 4,500 Xarelto Lawsuits Consolidated

New Orleans, LAThe number of Xarelto lawsuits consolidated for pretrial proceedings sits at more than 4,500, and a lawsuit alleging patients suffered from Xarelto side effects has now been filed in Canada. Meanwhile, the New York Times (3/1/16) reports that some researchers are concerned about data apparently left out of a vital Xarelto study. Whether more Xarelto lawsuits are on the way remains to be seen.

Xarelto is an anticoagulant medication used to reduce the risk of blood clots and strokes. The drug has been linked to an increased risk of uncontrollable bleeding, a frequent side effect in anticoagulant medications. However, whereas an older anticoagulant - Warfarin - has an antidote, Xarelto has no commonly accepted antidote to stop uncontrolled bleeding events.

Patients and their loved ones have filed lawsuits against the makers of Xarelto, alleging they were not adequately warned about the risk of serious side effects, and suffered severe bleeding episodes as a result. According to court records, 4,579 lawsuits were consolidated for pretrial proceedings as of April 15, 2016 in MDL 2592. That’s up from 3,987 consolidated as of February 16, 2016.

And while lawsuits continue to be filed in the United States, Xarelto lawsuits are also being filed in Canada. Gordon Gibb, writing for LawyersandSettlements, notes one lawsuit was recently filed in Calgary, with the plaintiff alleging she nearly suffered a heart attack after taking Xarelto and developing internal bleeding. A lawsuit may also be filed in Ontario on behalf of the family of an 83-year-old woman who reportedly bled to death in her shower while on Xarelto therapy.

Concerns have also been raised about the study that was used to approve Xarelto therapy. Xarelto was approved for the market based heavily on a trial called the ROCKET AF trial. That trial found that Xarelto (known generically as rivaroxaban) was at least as good as warfarin in preventing stroke and embolism, and superior to warfarin in decreasing the risk of bleeding in the brain and fatal bleeding events. But one of the tools used in the trial, the Alere INRatio Monitor System, was recalled in 2014 due to abnormal readings.

Those abnormal readings could have resulted in patients’ warfarin doses being unnecessarily increased, also increasing the risk of serious side effects. Although researchers wrote a letter to The New England Journal of Medicine defending the trial results, the New York Times (3/1/16) notes that plaintiffs’ attorneys argue that vital lab data was left out of that letter, making the researchers’ claims inaccurate.

While researchers and critics argue over the validity of the ROCKET AF trial findings, plaintiffs file lawsuits arguing they were never properly warned about the risk of side effects associated with Xarelto.