A new lawsuit was filed last month in a federal court in Louisiana that points to possible Xarelto dangerous side effects.

Xarelto, part of the new oral anticoagulant class of drugs (NOACs), was created by Janssen Research and Development—a subsidiary of Johnson & Johnson Inc. Also named as a defendant in the lawsuit is the Bayer Corp.

The complainants in the lawsuit—the newest to join multidistrict product liability litigation No. 2592—are plaintiffs Catherine and Gerald P., a married couple. Catherine alleges she suffered injury from Xarelto dangerous side effects. Her spouse, Gerald joins the suit with a loss of consortium claim. The couple are citizens and residents of the State of Minnesota.

The Plaintiff’s Story

Catherine was prescribed Xarelto and ingested it, according to the factual section of the lawsuit, from September 2013 to May 2015. She says she stopped taking the NOAC after experiencing first hand some of the alleged Xarelto dangerous side effects. The plaintiff says she developed bleeding in the brain which led to a stroke on May 28, 2015—an incident which she believes was a direct consequence of taking the drug.

The plaintiff, through her counsel, claims that her encounter with Xarelto dangerous side effects was life-endangering at the moment and left her with permanent painful injuries and a burden of mental anguish. Catherine believes that her enjoyment of life after her stroke has been significantly diminished.

According to their complaint, she and her husband will carry the psychological and financial baggage from this event for life. They allege that they continue to have high medical bills and suffer a loss of her income-earning ability.

Xarelto’s History

According to the factual section of the lawsuit, the U.S. Food and Drug Administration (FDA) approved Xarelto in two phases over a four-month period from July to November 2011. The first approval phase was for the prevention of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) for total hip arthroscopy (THA) and total knee arthroscopy (TKA) patients. The second approval phase was for reducing the risk of stroke and systemic embolism in non-valvular atrial fibrillation patients.

The basis for the first approval phase was a clinical trial known as the RECORD studies which compared warfarin—a long-standing blood-thinning medication to Xarelto. The RECORD data indicated that there were similar rates of bleeding between the two drugs, but for prevention of thrombosis, Xarelto had a clearly positive advantage.

What also was shown, however, was that Xarelto dangerous side effects included a greater number of occurrences of bleeding which led to lower blood hemoglobin test results and a need for blood transfusion more often.

The FDA had allegedly discovered during a 2009 clinical trial inspection that the RECORD data had been subject to multiple violations including falsification, destruction of medical records, and removal of blinding mechanisms between the two drugs. Their conclusion had been that the RECORD studies produces unreliable results as a consequence. Despite this assessment, the FDA moved to approve the drug in 2011.

Xarelto Dangerous Side Effects Lawsuit

Catherine is bringing 10 counts against the named defendants in her case in addition to her husband’s loss of consortium claim. Among those counts are accusations of fraud, breach of express and implied warranties, and negligent misrepresentation.

She and her spouse are requesting a trial by jury with a favorable award on her behalf that includes compensatory damages with a return of all litigation costs and punitive damages.

The Janssen Research & Development Lawsuit is Case No. 2:18-cv-04988-EEF-MBN in U.S. District Court, Eastern District of Louisiana. This lawsuit is part of Multidistrict Litigation No. 2592.