A Indiana woman who allegedly suffered a serious gastrointestinal bleed due to Xarelto continued to present her case this week in the Philadelphia Court of Common Pleas, where Pennsylvania’s first trial involving the blooding thinner is currently underway.
On Tuesday, a former U.S. Food & Drug Administration (FDA) commissioner testifying on her behalf told the assembled jury that Xarelto’s warning labels were inadequate, asserting that they downplayed the potential for internal bleeding that had been observed in the drug’s clinical trials.
Most of Dr. David’s Kessler’s’ testimony focused on the ROCKET-AF study, which was key to Xarelto’s FDA approval in October 2011. Though the results from the trial showed a 3.6% rate of a bleeding event among Xarelto users globally, patients in the U.S. experienced bleeding side effects at a rate exceeding 8%.
Kessler, who served as FDA commissioner during both the George H.W. Bush and Bill Clinton administrations, criticized Bayer and Janssen Pharmaceuticals for failing to inform U.S. doctors of the findings.
“It’s important information to me,” he said. “I would want to know about it. It’s a clinically significant adverse event, it’s a demographic characteristic, and it should be in the label.”
More than 1,800 Xarelto lawsuits have been consolidated in a mass tort program now underway in the Philadelphia Court of Common Pleas. The case currently at trial was filed on behalf of an Indiana woman who took Xarelto for just over a year before she experienced a gastrointestinal hemorrhage. According to her complaint, the plaintiff spent four days in the hospital and underwent two blood transfusions while her doctors tried to find the source of her bleeding.
Nationwide, Bayer and Janssen are named defendants in more than 21,000 Xarelto lawsuits, all of which accuse the companies of downplaying the risk of internal bleeding and wrongly promoting it as a superior alternative to a much older blood thinner called warfarin.
While both warfarin and Xarelto can cause dangerous episodes of internal bleeding, warfarin-related hemorrhaging can be stopped via the administration of vitamin K. However, there currently exists no FDA- approved antidote to stop bleeding events linked to Xarelto.
The majority of U.S. Xarelto lawsuits are pending in the U.S. District Court, Eastern District of Louisiana, where all federally-filed product liability claims involving the blood thinner have been centralized for coordinated pretrial proceedings. So far, that litigation has convened three trials, all of which were decided for the defense.