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More than 400 lawsuits are currently pending in the Xarelto Multidistrict Lawsuit (MDL), in the Eastern District of Louisiana, with U.S. District Judge Eldon E. Fallon presiding. These lawsuits were first consolidated in December 2014 under the name Xarelto (Rivaroxaban) Products Liability Litigation (MDL No. 2592), according to court documents.

One such lawsuit alleges that Xarelto’s maker, Janssen Research and Development, wrongfully represented the drug by failing to share knowledge about Xarelto’s safety risks. The plaintiff in the case allegedly suffered severe internal bleeding and other life-threatening side effects as a result of Xarelto use, according to court documents.

Another Xarelto case involves a Tennessee resident who filed a wrongful death lawsuit on behalf of his father, who died in 2013 from uncontrollable internal bleeding after using Xarelto to reduce his risk of stroke. The case alleges that the drug maker failed to warn the plaintiff’s father about the risks of Xarelto use, and seeks compensatory and punitive damages.

Xarelto Lawsuit Allegations

The Xarelto lawsuits all have similar allegations, which include:

  • Failure to warn
  • Design defects
  • Negligence
  • Negligent design
  • Negligent misrepresentation
  • Breach of warranty

The lack of a reversal agent is a major part of the Xarelto lawsuits, along with concerns about the reliability of the data obtained from limited clinical trials submitted to the U.S. Food and Drug Administration (FDA) in support of the approval of Xarelto in the U.S.

Xarelto was first approved by the FDA in 2011 and is jointly marketed by Janssen Pharmaceuticals, a division of Johnson & Johnson, and Bayer Corporation. It was heralded as an improvement over Coumadin (warfarin), which has been used for decades to prevent strokes, but requires frequent blood testing


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