A woman has filed a Xarelto GI bleed lawsuit against Janssen Pharmaceuticals and Bayer Healthcare Pharmaceuticals and their related companies after reportedly suffering personal injury due to her use of the anticoagulant medication.

Plaintiff Amber S. states that she began taking Xarelto on May 29, 2015 and on June 1, 2015, she suffered from gastrointestinal bleeding and rectal bleeding which caused her to be hospitalized for treatment.

Xarelto is one of several new oral anticoagulation medications that has been released into the market since 2010. Xarelto and its contemporaries were developed as alternatives to warfarin, the industry standard anticoagulant for the past 60 years.

Xarelto was marketed as a more convenient and effective alternative. It is used to thin the blood of patients who are at risk of suffering a stroke or heart attack as a result of atrial fibrillation, an abnormal heart rhythm. Xarelto is also used to treat and prevent deep vein thrombosis and pulmonary embolism in susceptible patients and in patients who undergo major near hip replacement surgery.

However, Amber and the thousands of other plaintiffs she joins filed a Xarelto GI bleed lawsuit or Xarelto cerebral hemorrhage lawsuit stating that Xarelto caused irreversible bleeding in patients who use the drug.

Amber’s Xarelto GI bleed lawsuit states that the clinical trials that were used to support the safety and efficacy of Xarelto prior to its release onto the market were flawed, and relevant information from the studies was not made widely available to physicians and patients.

The ROCKET AF study, the RECORD studies and several EINSTEIN studies allegedly showed that Xarelto was noninferior to warfarin and that patients taking Xarelto were more likely to suffer from leading events than those who were taking warfarin.

The Xarelto GI bleed lawsuit states that despite using the positive results in marketing materials, “Defendants’ promotional materials failed to similarly highlight the increased risk of gastrointestinal bleeding and bleeding that required transfusion, among other serious bleeding concerns.”

One main concern that the Xarelto lawsuit raises is the lack of availability of a reversal agent to treat patients who suffer from gastrointestinal bleeding or cerebral hemorrhage. For patients who suffered internal bleeding due to warfarin, an antidote was used that could reverse the blood thinning effects and restore the body’s natural clotting mechanisms. Fresh frozen plasma or intravenous vitamin K were used for this purpose.

Xarelto has no reversal agent or antidote to curtail bleeding once it starts. Emergency room personnel must simply provide supportive measures to patients suffering from internal bleeding until the body metabolizes the remaining Xarelto in the body and the body’s natural clotting mechanisms are restored. For some patients, unfortunately, serious injuries or even death result due to the physicians’ inability to stop the bleed.

Amber has brought forth a number of allegations against the defendants including strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud, violation of consumer protection laws/consumer fraud laws, unjust enrichment and outrageous conduct.

The plaintiff is seeking relief in the form of compensatory damages for pain, suffering, emotional distress, loss of enjoyment of life and other noneconomic damages, economic damages for medical expenses, out of pocket expenses, lost earnings and other economic damages, punitive and/or exemplary damages, pre-and post-judgment interest, attorneys’ fees and costs and any additional relief deemed just and proper by the Court.

The Xarelto GI Bleed Lawsuit is Case No. 2:17-cv-04978 and is part of the Xarelto MDL In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592, in the U.S. District Court for the Eastern District of Louisiana.