Another wrongful death action has been filed in federal court in Xarelto (Rivaroxaban) Products Liability Litigation, this time by a family of a Louisiana woman who was killed by unstoppable bleeding because the manufacturers concealed their knowledge of Xarelto’s defects, from the decedent, the FDA, the public and the medical community.
The case is Terrie Toups, Duane Rochelle, Patty Buras, and the Estate of Florence Bourgeois, Case No. Case 2:14-md-02592-EEF-MBN, in MDL 2592 supervised by U.S. District Judge Eldon E. Fallon in the Eastern District of Louisiana. The current caseload is 14,465 actions. For more information Update: Federal Court Revises Xarelto Product Liability Cases for Trial
In parallel litigation, some 1,100 claims have been filed in the Philadelphia Court of Common Pleas Xarelto Consolidated Litigation to date before Judge Arnold New. For more, read Two Reasons That More Attorneys File Xarelto Claims in Philadelphia Court
The defendants include:
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- Janssen Research & Development, Janssen Ortho LLC and Janssen Pharmaceuticals, Inc.
- Johnson & Johnson
- Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG, Bayer Corporation, Bayer Healthcare LLC, Bayer Healthcare AG and Bayer AG
Florence Bourgeois began using Xarelto around September 23, 2013, up until about January 12, 2016. She suffered life-threatening bleeding, anemia, urinary tract infection, sepsis, renal failure and death on January 14, 2016.
The FDA approved Xarelto, also known as rivaroxaban, on July 1, 2011. The drug is used to reduce stroke and blood clots in patient with atrial fibrillation, a heart disorder.
In the U.S., about 1 million Xarelto prescriptions had been written by the end of 2013, when sales for Xarelto passed $1 billion. Meanwhile, for 2012 a total of 2,081 new Xarelto-associated “Serious Adverse Event” reports were filed with the FDA in its first full year on the market — and of those, 151 were deaths.
There is no antidote to Xarelto, unlike warfarin. Therefore, in the event of hemorrhagic complications, there is no available reversal agent. The original U.S. label approved when the drug was first marketed in the U.S. did not contain a warning about the lack of antidote, but instead only mentioned this important fact in the overdosage section.
“Defendants also failed to warn emergency room doctors, surgeons, and other critical care medical professionals that unlike generally-known measures taken to treat and stabilize bleeding in users of warfarin, there is no effective agent to reverse the anticoagulation effects of Xarelto, and therefore no effective means to treat and stabilize patients who experience uncontrolled bleeding while taking Xarelto,” the complaint states.