Tamara Burns  |  March 13, 2017

Category: Legal News

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A man has filed a lawsuit on behalf of his deceased spouse against the makers of Xarelto anticoagulant medication, saying the drug manufacturers’ product caused the wrongful death of his wife.

Plaintiff David W. filed his Xarelto lawsuit on behalf of his deceased wife, Suzanne W. According to the lawsuit, Suzanne took Xarelto from approximately November 2014 until December 2015. On December 7, 2015, Suzanne suffered from an irreversible Xarelto bleedout that ultimately led to her death in December 2015.

Xarelto is one of several new generation oral anticoagulant drugs that has been released onto the market within the last several years. It was intended to be a more effective alternative to warfarin (Coumandin) that was also easier to administer.

Xarelto is used primarily to treat patients who have atrial fibrillation, in order to reduce the risk of their abnormal heart rhythm causing a stroke or systemic embolism. It is also used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE), and is used preventatively for patients undergoing hip or knee surgery so they do not develop DVT or PE.

While warfarin was effective, it was not the easiest drug to administer; it had been the staple for anticoagulant treatment for the last 60 years. Patients taking warfarin had to have close blood monitoring to make sure their levels were appropriate for treatment, and they had to follow a special diet so that their food choices would not interfere with the drug treatment.

Patients and physicians were initially very pleased to find an alternative drug that offered easier use and did not require any dietary restrictions for patients. That was before patients began experiencing problems, like Suzanne’s Xarelto bleedout, that the safety of the drug began to be questioned.

David states in his Xarelto bleedout lawsuit that the studies used to facilitate Xarelto’s approval for the market were flawed and conducted negligently. One such study, referred to as the RECORD study, was targeted by the FDA in an Official Action Indicated (OAI) rated inspection back in 2009.

According to David’s lawsuit, the OAI “disclosed rampant violations including, ‘systemic discarding of medical records,’ unauthorized and blinding, falsification and ‘concerns regarding improprieties and randomization.‘” As a result, the FDA found that the RECORD four studies were so flawed that they were deemed unreliable.

Another study, referred to as the ROCKET AF study, was also cited in the lawsuit as one of questionable integrity. “The poor management of the warfarin group in the ROCKET AF study was not lost on the FDA, which noted ‘the data comparing [Xarelto] to warfarin are not adequate to determine whether [Xarelto] is as effective for its proposed indication in comparison to warfarin when the latter is used skillfully,’” the lawsuit reads.

Additional studies conducted on Xarelto were also cited, with David noting the results of the studies not fully disclosing the bleeding risks that were uncovered in the course of the trials.

David also highlights the fact that Xarelto has no antidote to reverse a potential Xarelto bleedout like warfarin does. “The original U.S. label, approved when the drug was first marketed, did not contain a warning regarding the lack of antidote, but instead only mentioned this important fact in the overdose section,” the complaint states.

Patients who used warfarin could have the anticoagulant effects of the drug reversed by having fresh frozen plasma or intravenous vitamin K administered in order to provide an antidote to the drug.

“By reason of the foregoing acts and omissions, Plaintiff was caused to suffer from life-threatening bleeding, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, expenses for hospitalization and medical treatment, and loss of earnings, among other damages including death,” the Xarelto bleedout lawsuit states.

David has brought up a number of counts against the Defendants including strict liability, manufacturing defect, design defect, failure to warn, negligence, breaches of express and implied warranties, negligent misrepresentation, fraud, violation of consumer protection laws, loss of consortium (spousal companionship), wrongful death and survival action.

The plaintiff is seeking compensatory, economic, punitive and or exemplary damages, pre-and post-judgment interest, attorneys’ fees and costs and any additional relief deemed appropriate by the Court.

The Xarelto Bleedout Lawsuit is Case No. 2:17-cv-01171-EMF-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.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Xarelto attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or Xarelto class action lawsuit is best for you. [In general, Xarelto lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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If you or a loved one took Xarelto (rivaroxaban) and suffered injuries such as uncontrollable internal bleeding, gastrointestinal bleeding, hemorrhaging, deep vein thrombosis or pulmonary embolism, you may have a legal claim. See if you qualify by filling out the short form below.

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