A woman has filed a blood thinner lawsuit against Janssen Pharmaceuticals, Bayer Healthcare Pharmaceuticals and the related companies after she suffered injury related to Xarelto dangerous side effects.

Plaintiff Sarah G. filed her lawsuit within the Xarelto multidistrict litigation currently taking place in a Louisiana federal court, joining thousands of others with similar allegations. Sarah alleges that after taking Xarelto for two months, she suffered a gastrointestinal bleed and anemia which caused her to require a blood transfusion.

Xarelto (rivaroxaban) is part of a class of medications known as new oral anticoagulants, or NOACs. These drugs were designed to offer increased efficacy and ease-of-use over warfarin, the predecessor medication that has been the industry standard for the last six decades. Pradaxa and Eliquis are included in this class of medications.

The FDA approved Xarelto for use in 2011 to treat atrial fibrillation, abnormal heart rhythm, deep vein thrombosis and pulmonary embolism. The FDA approval of Xarelto was based on a number of studies.

One such group of studies is known as the RECORD studies. According to the Xarelto lawsuit, these studies “were flawed in design and conducted in a negligent manner.” In fact, FDA inspections conducted in 2009 disclosed “rampant violations including ’systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties in randomization,’” the complaint alleges.

The ROCKET AF studies showed that Xarelto dangerous side effects were present ─ specifically, “bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the rivaroxaban group, as did bleeding that led to a drop in a global level or bleeding that required transfusion,” the complaint states. Xarelto’s efficacy was deemed comparable to warfarin’s in the study.

Further studies, known as the EINSTEIN studies, also claimed that Xarelto was noninferior to warfarin. But according to this Xarelto lawsuit, those studies “also demonstrated an increased risk of adverse events with Xarelto, including those that resulted in permanent discontinuation of Xarelto or prolonged hospitalization.”

Xarelto’s claims were that it was easier to use than warfarin and did not require a diet change, routine blood monitoring or varying levels to reach a therapeutic dose. Patients and physicians additionally were pleased with these apparent improvements over warfarin, but soon, Xarelto dangerous side effects began to surface.

The main danger in using Xarelto is that it can cause irreversible bleeding, particularly in the gastrointestinal tract and in the brain. Warfarin presents a similar risk. However, there is a way to reverse warfarin’s anti-clotting effects on the body by administering intravenous vitamin K or fresh frozen plasma to restore the body’s natural clotting mechanisms.

When Xarelto was released, it did not have a reversal agent or antidote to control irreversible bleeding, and to this day, it still does not have an available antidote. The lawsuit criticizes the makers of Xarelto for failing to properly warn patients and physicians that no such drug to reverse the anticoagulant effects of Xarelto is available.

Sarah has raised a number of allegations against Xarelto’s manufacturers including strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud and violation of consumer protection laws/consumer fraud laws.

In her lawsuit alleging Xarelto dangerous side effects, Sarah is seeking compensatory and economic damages related to her pain, suffering, emotional distress, loss of enjoyment of life, medical expenses, lost earnings and more.

She is also seeking punitive and/or exemplary damages “for the wanton, willful, fraudulent, reckless acts of the Defendants who demonstrated a complete disregard and reckless indifference for the safety and welfare of the general public and to the Plaintiff in an amount sufficient to punish Defendants and deter future similar conduct,” pre- and post-judgment interest, attorneys’ fees and costs and any additional relief as deemed just and proper by the court.

The Xarelto Dangerous Side Effects Lawsuit is Case No. 2:17-cv-05402-EEF-MBN, 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.