According to allegations raised in a recent product liability lawsuit filed against Bayer Healthcare, Johnson & Johnson and it’s Janssen subsidiary, side effects of Xarelto caused an uncontrollable intracranial hemorrhage for a Louisiana woman, joining about 15,000 similar cases brought against the drug makers over failure to warn about the risks associated with their controversial anticoagulant.

The complaint (PDF) was filed late last month in the U.S. District Court for the Eastern District of Louisiana by Joseph Grefer, on behalf of himself and his deceased wife, Patsy Ruth Mole Grefer, who used Xarelto from August 2015 until January 2016, when she suffered an intracranial hemorrhage.

Following the bleeding complications, Patsy Grefer required surgery and extended hospitalization before she passed away on June 13, 2016.

The case raises claims nearly identical to those presented in thousands of other Xarelto lawsuits pending throughout the United States, alleging that the drug makers withheld warnings about the bleeding risk from consumers or the medical community, including information about the lack of a reversal agent for the new-generation anticoagulant.

Xarelto (rivaroxoaban) is part of a new generation of blood thinners, which was introduced in 2011 as an alternative to Coumadin (warfarin), which has been the go-to anticoagulation treatment for decades. However, while the blood thinning effects of warfarin can be quickly reversed with a known antidote, there was no approved reversal agent for Xarelto or other members of this new class of anticoagulants when they were introduced. This left doctors unable to control or stop bleeds or hemorrhages that occurred among users.

Joseph Grefer alleges that the drug makers knew or should have known about the Xarelto intracranial hemorrhage risk before introducing and marketing their blood thinner, yet failed to inform doctors about the lack of a reversal agent or warn about the importance of blood monitoring to maintain appropriate dose.

“Importantly, Xarelto’s significant risk of severe, and sometimes fatal, internal bleeding has no antidote to reverse its effects, unlike warfarin,” according to the complaint. “Therefore, in the event of hemorrhagic complications, there is no available reversal agent. The original U.S. label, approved when the drug was first marketed, did not contain a warning regarding the lack of antidote, but instead only mentioned this important fact in the overdose section.”

Given the similar questions of fact and law raised in complaints filed in U.S. District Courts nationwide, the Xarelto litigation is currently consolidated in the federal court system, with all cases centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana for coordinated discovery and pretrial proceedings.

Grefer’s complaint will be included in the federal multidistrict litigation (MDL), which all cases are stayed while a small group of representative lawsuits are being prepared for a series of “bellwether” trials, which are designed to help gauge how juries will respond to evidence and testimony that is likely to be repeated throughout thousands of claims.

The first trial is expected to begin in March 2017. While the outcome will not binding on other claims, it may help the parties negotiate Xarelto settlements to avoid the eventual need for 15,000 separate trials to be set throughout the country.

Tags: Bayer, Bleeding, Blood Thinner, Brain Hemorrhage, Johnson & Johnson, Xarelto