Xarelto Intracranial Bleeding Caused To Grandmother’s Death, Lawsuit Claims

Bayer Healthcare and Johnson & Johnson’s Janssen subsidiary face a new wrongful death lawsuit brought by a Louisiana woman, which alleges that side effects of Xarelto caused intracranial bleeding for her grandmother. 

The complaint (PDF) was filed in the U.S. District Court for the Eastern District of Louisiana on November 12, indicating that Hattie Deville-Goodwin’s November 2014 death was caused by the drug makers’ failure to adequately warn about the bleeding risks associated with the new-genearation anticoagulant Xarelto.

The wrongful death lawsuit was filed by Ashlie Fluitt, on November 12 in the . According to the lawsuit, her grandmother, Hattie Deville-Goodwin, died of Xarelto intracranial bleeding on November 14, 2014.

Deville-Goodwin was prescribed Xarelto for treatment of deep vein thrombosis in September 2014, according to the lawsuit filed by her granddaughter. About two months later, Deville-Goodwin developed severe bleeding on the brain, and died two days later, because doctors were unable to stop or control the intracranial hemorrhage.

The case joins hundreds of similar Xarelto bleeding complaints 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 anticoagulant and the lack of an approved reversal agent to help control bleeding problems that may develop among users.

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.

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.

As part of the coordinated pretrial proceedings in the Xarelto MDL, a small group of representative cases are being prepared for early trial dates that are scheduled to begin next year. While the outcomes of these bellwether trials will not be binding on Fluitt’s Xarelto intracranial bleeding lawsuit or other similar claims in the litigation, it will help gauge how juries may respond to similar evidence and testimony that will be presented in the cases.

Following the bellwether trials, if Xarelto settlements or another resolution for the litigation are not reached following discovery and a small number of bellwether trials, Bayer and Johnson & Johnson may face hundreds of individual trials throughout the country.