Side Effects of Xarelto Led To Hematuria, Lawsuit Indicates

While a series of “bellwether” Xarelto lawsuits are set for trial over the coming weeks, new cases continue to be filed by individuals who indicate they suffered serious bleeding problems due to side effects of the controversial novel oral anticoagulant.

In a complaint (PDF) filed earlier this month in the U.S. District Court for the Eastern District of Louisiana, Tanza Rhine indicates that she suffered a hematuria from Xarelto, which is a serious bleeding emergency involving blood in the urine.

Rhine indicates that she began taking Xarelto in December 2013, and continued to use the anticoagulant until mid-September 2016, when she suffered the hematuria.

The lawsuit raises allegations similar to those presented in more than 18,000 other complaints filed against Bayer Healthcare, Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary, indicating that the drug makers failed to adequately warn consumers and the medical community about the potential side effects of Xarelto, which has been linked to a large number of adverse event reports involving uncontrollable and life-threatening bleeding problems since it was introduced in 2011.

Xarelto (rivaroxoaban) is part of a new generation of oral anticoagulants marketed as a superior alternative to Coumadin (warfarin), which has been the go-to anti-clotting 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 has left doctors unable to control or stop bleeds or hemorrhages that occurred among users.

In addition to failing to warn about the bleeding side effects or the lack of an effective reversal agent, Rhine indicates that the drug makers provided false and misleading information by claiming that patients do not require close blood monitoring during treatment, to maintain the appropriate dose.

“Defendants market and promote Xarelto as a single daily dose pill that does not require the need to measure a patients blood plasma level, touting it as more convenient than warfarin, and does not limit a patient’s diet. The single dose and no blood testing requirements or dietary constraints are mareketed by Defendants as the ‘Xarelto Difference’,” according to the complaint filed by Rhine. “However, Xarelto’s clinical studies show that Xarelto is safer and more effective when there is blood monitoring, dose adjustments and twice a day dosing.”

The lawsuit filed by Rhine will be consolidated with the federal Xarelto litigation, which is centralized before U.S. District Judge Judge Eldon Fallon in New Orleans for coordinated pretrial discovery and a series of bellwether trials that are underway to help gauge how juries will respond to certain evidence and testimony that is likely to be repeated throughout many different cases.

The first Xarelto bellwether trial ended in a defense verdict earlier this month, after a jury found that one specific plaintiff failed to meet the necessary burden of proof. However, additional cases are set for trial to begin later this month in New Orleans, next month in Mississippi and later this summer in Texas.

While the outcomes of these bellwether cases are not binding on the thousands of other cases pending nationwide, they may influence eventual negotiations to reach Xarelto settlements and avoid the expense and unpredictability of individual jury trials nationwide.