Xarelto Gastrointestinal Bleeding Followed Use for Atrial Fibrillation, Lawsuit Alleges

An Ohio woman has filed a product liability lawsuit alleging that side effects of Xarelto caused her to suffer gastrointestinal bleeding and other problems, after using the novel oral anticoagulant for chronic atrial fibrillation.

The complaint (PDF) was brought in the U.S. District Court for the Southern District of Ohio on October 5, on behalf of Molly Ann Harr and her husband, Daniel Harr, Jr.

Harr indicates that she was prescribed Xarelto in September 2013, for treatment of atrial fibrillation. Just two months later, she experienced severe gastrointestinal bleeding, and subsequently anemia, which have left her with on-going health problems.

The case joins hundreds of similar Xarelto bleeding lawsuits filed throughout the federal court system, which each allege that the manufacturers of the new-generation anti-coagulant failed to adequately warn consumers and the medical community about the risks associated with the medication and the lack of an approved reversal agent to help control bleeding problems that may develop among users.

Harr indicates that she narrowly avoided being one of the growing number of deaths linked to Xarelto, pointing out that there were at least 2,081 similar adverse events reported involving users of the drug in 2012, including 151 deaths. However, by the time she began using the medication in 2013, the Xarelto warning label still failed to adequately warn about the potential bleeding risk.

The lawsuit will be consolidated with about 1,700 claims pending in a federal multidistrict litigation (MDL), which is currently centralized for pretrial proceedings before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana. However, if Xarelto settlements or another resolution for the litigation are not reached following discovery and a small number of bellwether trials, Harr’s complaint and other similar lawsuits may be remanded back to the U.S. District Courts where they were originally filed for separate trial dates.

Xarelto Bleeding Problems

Xarelto (rivaroxoaban) was introduced in 2011 as a superior replacement for Coumadin (warfarin), designed to reduce the risk of blood clots among individuals at risk for deep vein thrombosis or pulmonary embolism. Since it hit the market, the drug has been aggressively marketed and has quickly grown to become one of the top selling medications in the United States.

While all blood thinners carry a risk of bleeding injury, Xarelto has been linked to a surprising number of problems involving severe and uncontrollable bleeds, sometimes resulting in death.

Xarelto has been promoted as easier to use than warfarin, since it does not require regular blood monitoring. However, several recent studies have raised questions about those claims, with researchers suggesting that Xarelto blood monitoring may actually help doctors identify patients at the greatest risk of bleeding.

In addition to failing to warn about the risk of bleeding and importance of blood monitoring, plaintiffs pursuing bleeding lawsuits over Xarelto allege that the drug makers withheld information about the lack of a reversal agent, which doctors could use to stop hemorrhaging that may develop among users.

While warfarin’s blooding thinning effects can be quickly reversed in an emergency, there is no antidote for Xarelto.