A married couple has filed a lawsuit against the makers of the popular drug thinner Xarelto  (rivaroxaban) alleging the husband suffered a severe Xarelto bleeding injury related to the drug’s use.

Plaintiff Harold W. and his wife Barbara W. has brought forth this action against Janssen Pharmaceuticals, parent company Johnson & Johnson and Bayer Healthcare in their related companies as part of the Xarelto multidistrict litigation currently underway in Louisiana federal court.

Harold is an 82-year-old man who took Xarelto from January 2014 to February 2014. According to the claim, Harold suffered a severe Xarelto bleeding injury.

“As a result of using Defendants’ Xarelto, Plaintiff Harold [W.], was caused to suffer from life-threatening bleeding on or about February 22, 2014, and was caused to sustain severe and permanent personal injuries, pain, suffering, and emotional distress,” the Xarelto lawsuit states.

Xarelto is an anticoagulant medication used to reduce the risk of stroke and systemic embolism in patients suffering from a condition known as non-valvular atrial fibrillation, an abnormal heart rhythm.

It is also used prophylactically to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone major surgery, such as hip or knee replacement surgery.

Xarelto was initially approved by the FDA in 2011 as part of a class of drugs referred to as new generation oral anticoagulants.

Xarelto and other drugs in its class were developed as alternatives to warfarin, an oral anticoagulant drug used almost exclusively for the past 60 years prior to the development of the new generation drugs.

Xarelto and its drug class members were seen as a positive, ground-breaking alternative to warfarin, an effective but high-maintenance drug.

Patients who were on warfarin needed constant blood monitoring to determine if the levels of warfarin were appropriate for treatment. Warfarin patients were also required to undergo a specific diet while they were on the drug.

Xarelto and the new blood thinners had more standardized dosing that did not require frequent blood monitoring nor dietary restrictions, making it a better choice in the mind and physicians and patients.

Allegations in the Xarelto Bleeding Injury Lawsuit

Xarelto was approved based on several studies, the RECORD studies, the ROCKET AF studies and the EINSTEIN studies.

The lawsuit alleges that these studies were flawed and they did not disclose that patients taking Xarelto, as opposed to warfarin, were more likely to sustain a Xarelto bleeding injury, and warfarin bleeding injuries were less common.

Perhaps the biggest concern is the lack of an antidote for Xarelto. “Importantly, there is no antidote to Xarelto, unlike warfarin. Therefore, in the event of hemorrhagic complications, there is no available reversal agent. The original U.S. label approved when the drug was first marketed in the U.S. did not contain a warning regarding the lack of antidote, but instead only mentioned this important fact in the overdosage section,” the lawsuit states.

Harold and Barbara have brought forth a number of counts against the Defendants including negligence, strict products liability, breaches of express and implied warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud and deceit and loss of consortium (spousal companionship).

The couple is seeking compensatory damages for past and future damages related to pain and suffering, healthcare costs, medical monitoring and more, punitive and/or exemplary damages, attorneys’ fees and costs and any additional relief as deemed just and proper by the Court.

The Xarelto Bleeding Injury Lawsuit is Case No. 2:17-cv-00346-EEF-MBN, and is filed in the Xarelto MDL, MDL No. 2592, in the U.S. District Court for the Eastern District of Louisiana.