Xarelto

  • Xarelto Medical Record Review & Outsourcing Services

Xarelto (Rivaroxaban) is an anticoagulant that got its U.S. Food and Drug Administration (FDA) approval in November 2011. Xarelto is manufactured by Bayer and jointly marketed by Johnson & Johnson's subsidiary Janssen Pharmaceutica. It works by blocking certain clotting proteins in the blood and was promoted as a replacement for Warfarin, a blood thinner that had been on the market for a number of years.

Xarelto is indicated in Atrial fibrillation, for people who have just had hip or knee replacement surgery to reduce the risk of forming a blood clot, and also to treat Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). It is the first orally administered active direct factor Xa inhibitor slowing down blood clot formation. It was heavily marketed and equivalently the usage also increased, until it was noticed that it causes uncontrollable bleeding. As Xarelto has no antidote that can help stop the bleeding, it led to unexpected serious injuries leading to death.

Serious Alleged Injuries may include:

  • Rectal bleeding
  • Intestinal bleeding
  • Brain hemorrhaging
  • Death caused by uncontrolled bleeding

FDA SAFETY WARNINGS:

Multiple safety warnings have been issued by the FDA over the last several years regarding Rivaroxaban. The FDA issued the first black box warning for Xarelto in August 2013 and the second in March 2014.  In 2014, the FDA also demanded a new language be added to the warnings and precautions for Xarelto, including at least one update to the black box warning. December 2014 FDA warning added thrombocytopenia (platelet deficiency) and hepatitis to the list of post-marketing adverse reactions. Xarelto has not been recalled by the FDA despite these warnings.

Lawsuit Allegations:

An estimated 20,000 Xarelto lawsuits are lying in federal and state courts. MDL 2592 (MDL NO. 2592- IN RE: XARELTO (RIVAROXABAN) PRODUCTS LIABILITY LITIGATION) was established in the U.S. District Court for the Eastern District of Louisiana for centralization of federally-filed product liability lawsuits in  December 2014. Three bellwether trials have been awarded in favor of the defendants as of November 2017.

The Philadelphia Xarelto trial that began on November 2017 was the first verdict that awarded $28 million to the plaintiff.

Evidences:

  • Indication of Usage in Medical and Pharmacy Records
  • Duration of Usage
  • Complications and their treatment after intake

Medical Record Review and claim validation of Xarelto case should take approximately 4 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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