A couple alleges the dangers associated with the anticoagulant medication Xarelto exceed what’s described on the drug’s warning label.

In their Xarelto lawsuit–which joins Multidistrict Litigation (MDL) No. 2592 Xarelto Products Liability Litigation—the primary plaintiff Wanda W. alleges she suffered a Xarelto hematoma.

Her husband James W. joins her in this legal action by claiming loss of consortium. Together, they have named Janssen Research and Development LLC, Johnson & Johnson Co., and Bayer Healthcare Pharmaceuticals Inc. as well as all related subsidiaries as defendants in the case.

The couple are citizens and residents of Louisville, Ky., where Wanda purportedly developed a Xarelto hematoma. A Xarelto hematoma is an unusual collection of blood in the tissues outside of a vessel secondary to uncontrolled bleeding often associated with this anticoagulant drug. A hematoma likely reflects vessel or capillary wall compromise through tearing or other trauma.

Wanda was prescribed Xarelto by her family physician, who, according to the narrative of the lawsuit, relied upon the promotions of the defendants when making his medication decision on her behalf.

She took the anticoagulant drug from Feb. 7, 2014 to Sept. 17, 2016. It was on Sept. 17 that she allegedly developed the Xarelto hematoma, and the blood-thinner was immediately discontinued.

The History of Xarelto and Its Associated Side Effects

Xarelto became commercially available in the U.S. on July 1, 2011. It was approved by the U.S. Food and Drug Administration (FDA) for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in total hip or total knee arthroplasty patients.

Four months later, the FDA approved Xarelto to be used to reduce the risk of stroke in patients diagnosed with non-valvular atrial fibrillation.

Xarelto—along with Pradaxa and Eliquis—are part of a class of drugs known as the New Oral Anticoagulants (NOACs) designed to compete with warfarin, a well-established blood-thinner used for six decades successfully. The approval of Xarelto by the FDA was based upon a clinical trial known as the RECORD studies.

These studies—later allegedly deemed flawed by the drug oversight agency—supposedly showed superior results when it came to the prevention of blood clots after joint replacement surgery, but revealed a tendency for greater bleeding, lower hemoglobin and need for subsequent blood transfusion.

The first year on the market which ended on June 30, 2012 was filled with negative reports of adverse medical events with Xarelto. There were supposedly 1,080 of these adverse reports, of which 65 led to death—which was 8% or double the rate of warfarin.

The year 2012 was even more distressing, according to the lawsuit documentation. There were 2,081 adverse medical event reports and 151 associated deaths were included in that number.

The Plaintiffs’ Claims

Wanda and James claim that the defendants put this drug on the market and knew of its dangers. The are holding them liable on the following counts: Strict Liability, Design Defect, Manufacturing Defect, Failure to Warn, Negligence, Breach of Express and Implied Warranty, Negligent Misrepresentation, Fraud, Violation of State Consumer Protection Laws and Loss of Consortium.

They are asking for compensatory, economic and punitive damages along with prejudgment and post-judgment interest, and attorney and court fees.

The Xarelto Hematoma Lawsuit is Case No. 2:18-cv-03267-EEF-MBN, in the U.S. District Court, Eastern District of Louisiana.