A Pennsylvania jury was expected to begin deliberations today in the state’s first trial involving Xarelto and internal bleeding.
The plaintiff, an Indiana woman, claims that she suffered a serious gastrointestinal bleed after taking Xarelto for a little over a year. She has accused Bayer and Johnson & Johnson of manipulating clinical trial data to make the new-generation blood thinner appear safer and more effective than competing drugs.
The plaintiff also alleges that the companies understated the true potential for Xarelto to cause internal bleeding.
During Friday’s closing statements in the Philadelphia Court of Common Pleas, one of the plaintiff’s attorneys urged the jury to reject what he asserted were the defendants’ false arguments.
“We live in a world today where it’s getting harder every day to tell that which is fact from that which is fake. It’s getting harder and harder to keep all that straight, and it happened right here in this courtroom,” he said. “Bayer comes from a world where fact is fake and fake is fact.”
“It says Xarelto can cause bleeding in all their labels. This is fact. They can tweet it, they can say it as loud as they want that it’s not true, but that’s what it says,” the lawyer continued.
The Xarelto lawsuit is the first to go to trial in a mass tort program currently underway in the Philadelphia Court of Common Pleas that includes more than 1,800 similar cases.
Nationwide, Bayer and Johnson & Johnson have been named defendants in more than 2,100 lawsuits filed on behalf of individuals who suffered gastrointestinal bleeds, brain hemorrhages, hemorrhagic stroke, or other serious episodes of internal bleeding while taking Xarelto.
The majority of Xarelto lawsuits are pending in a federal multidistrict litigation now underway in the U.S. District Court, Eastern District of Louisiana. So far three cases have gone to trial in that proceeding, all of which concluded with defense verdicts.
Xarelto was approved by the U.S. Food & Drug Administration in October 2011. Its current indications include:
When it was first brought to market, Xarelto was touted as an improvement over a decades-old blood thinner called warfarin. Unlike those taking warfarin, Xarelto’s one-size-fits-all dosing regimen purportedly allows patients to avoid regular blood testing.
While both warfarin and Xarelto can cause episodes of internal hemorrhaging, bleeding associated with the older drug can be stopped via the administration of vitamin K. However, there currently exists no antidote to stop Xarelto-related bleeding.