In July 2011, the Federal Drug Administration (FDA) approved Xarelto, an oral anticoagulant prescribed for prevention of deep vein thrombosis, pulmonary embolism, and strokes in patients with atrial fibrillation. Based on sales of more than $2 billion, Xarelto has reached “blockbuster” status because of large multimillion-dollar direct to consumer (DTC) advertising campaigns.
Xarelto’s manufacturers also advertised the drug as a superior alternative to warfarin because Xarelto is taken orally and does not require monitoring with blood tests or any dietary restrictions. The studies revealed an increased risk of internal bleeding compared to individuals who were given a placebo. However, the findings were allegedly downplayed in promotional materials for Xarelto.
There were more than 1,000 Xarelto associated serious adverse event Medwatch reports filed with the FDA in the year immediately following the drug’s approval. According to these reports, there were 65 patients’ deaths resulted from the use of Xarelto. The number of adverse event reports jumped to more than 2,000 by the end of 2012.
Several plaintiffs have filed lawsuits against the makers of Xarelto and the Judicial Panel on Multidistrict Litigation (“JPML”) has granted Plaintiffs’ request to centralize all the federal Xarelto cases in the United States District Court for the Eastern District of Louisiana before Judge Eldon E. Fallon.
The JPML order states that the lawsuits “present a number of individual factual issues.” It also stated that there are several common issues, including the adequacy of Xarelto’s warning label as to the risk of severe bleeding, the results of certain clinical studies, and the alleged need for blood monitoring.
The lawyers of Searcy Denney represent a number of plaintiffs and their survivors in individual personal injury and wrongful death lawsuits relating to GI bleeds, intracranial hemorrhage, and other bleeding-related injuries attributable to ingestion of Xarelto.