A lawsuit has been filed against Bayer Healthcare Pharmaceuticals, Janssen Pharmaceuticals and parent company Johnson & Johnson by a woman who took Xarelto for approximately five weeks and suffered severe complications as a result of its use.

Plaintiff Demeka M.’s lawsuit states that she took Xarelto from approximately Sept. 30, 2016 to Nov. 5, 2016. “As a direct and proximate result of Plaintiff’s use of Xarelto, she suffered serious and severe injuries, including Vaginal bleeding and anemia on November 5, 2016,” the lawsuit states.

Without an available antidote to use as a Xarelto bleeding treatment, Dameka was required to undergo to blood transfusions during the time that she was hospitalized for her Xarelto injury.

Xarelto (rivaroxaban) was initially approved by the FDA in July 2011 to prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who were undergoing knee replacement or hip replacement surgeries. It was later approved to reduce the risk of stroke and systemic embolism in patients suffering from a heart rhythm disorder known as non-valvular atrial fibrillation. It was then approved to treat DVT and/or PE and reduce its recurrence.

Xarelto is one of several medications belonging to a class of drugs referred to as new oral anticoagulants, or NOACs. Eliquis and Pradaxa are two other drugs in this class. They were designed to improve upon warfarin (Coumadin), the industry standard blood thinner that had been used to prevent stroke and systemic embolism for the previous six decades.

The Xarelto lawsuit goes on to state that several studies that were used as clinical trials to gather information for FDA approval were seriously flawed. The complaint states that the authors of the study knew that the outcomes of some of the studies showed that there was a greater risk of bleeding with Xarelto over the other oral anticoagulant medications that were studied, yet these results were not properly taken into consideration.

The lawsuit also states that the FDA got involved in one particular set of studies known as the RECORD studies and that, “As a result, the FDA found that the RECORD 4 studies were so flawed that they were deemed unreliable.”

Among allegations that the makers of Xarelto failed to provide adequate warnings of the safety risks, need for dose adjustments, need for blood monitoring and more was an allegation that the manufacturers failed to disclose that there is no Xarelto bleeding treatment available to reverse the anticoagulation effects of the drug.

Due to the lack of an antidote or reversal agent, there is no way to initiate Xarelto bleeding treatment to restore the body’s natural clotting mechanisms. With warfarin, patients who are taking the drug could be administered intravenous vitamin K or fresh frozen plasma in order to start the body’s natural clotting mechanisms and reverse the effects of the drug. With Xarelto, no such antidote existed, making Xarelto bleeding treatment nearly impossible.

Dameka alleges she suffered from a lack of proper Xarelto bleeding treatment and ended up with life-threatening bleeding, causing her to suffer “damages and harm, including, but not limited to, personal injury, medical expenses, other economic harm, as well as, loss of consortium, services, society, companionship, love and comfort.”

Plaintiffs like Dameka often state that they would never have taken the medication had they known Xarelto bleeding treatment was not available in the case of life-threatening bleeding.

The plaintiff has raised claims against the manufacturers including strict liability, manufacturing defect, design defect, failure to warn, negligence, breaches of express and implied warranties, negligent misrepresentation, fraud, and violation of consumer protection laws/consumer fraud laws.

Dameka is seeking a jury trial and seeks an award of compensatory damages, economic damages, punitive and/or exemplary damages, pre-and post-judgment interest, attorneys’ fees and costs and any additional relief as deemed just and proper by the court.

The Xarelto Lawsuit is Case No. 2:17-cv-06219-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.