Xarelto Dangerous Product Liability Lawsuit

Bayer HealthCare and Johnson & Johnson subsidiary Janssen Pharmaceuticals have been marketing the anticoagulant Xarelto since its approval in 2011. This blood-thinning drug is marketed for use in treating pulmonary embolism; deep vein thrombosis (DVT), including DVT prophylaxis after knee or hip replacement surgery; reducing stroke risk in patients with nonvalvular atrial fibrillation; and preventing blood clots.

Xarelto was developed as an alternative to warfarin (Coumadin), a widely prescribed anticoagulant since the 1950s.  All drug-thinning pharmaceuticals, including Xarelto and warfarin, have a risk of uncontrollable bleeding.  However, warfarin’s anticoagulation effect may be reversed with a dose of vitamin K:  administered intravenously, vitamin K has proven safe and effective in reversing the effects of warfarin oral anticoagulation.  (Shetty HGM, Backhouse G, Bentley DP, Routledge PA. Effective reversal of warfarin-induced excessive anticoagulation with low dose vitamin K. Thromb Haemost 1992;67:13-15)

But there is no known reversal agent for the uncontrollable bleeding linked to Xarelto, and, consequently, Xarelto has been linked to hundreds of injuries and deaths since its approval in 2011.  People have died, been disabled, or suffered serious injury because doctors could not stem the hemorrhaging:  356 cases associated with Xarelto in the first quarter of 2012 alone, according to a report published by the Institute for Safe Medicine Practices (ISMP).

Additionally, Der Spiegel, the German weekly news magazine, and one of Europe’s largest publications of its kind, highlighted Bayer (headquartered in Germany) and their Xarelto in 968 cases of adverse effects with 72 deaths in the first 8 months of 2012 alone. Der Spiegel Bayer Xarelto.

The FDA declined to approve the drug makers’ proposed wider uses for Xarelto, including prevention of new heart attacks and strokes, and also to prevent clogging of heart stents.  Johnson & Johnson revised their marketing application and appealed, but, in January of 2014, the FDA again declined to approve their appeal.  Panelists in January 2014 said the “data did not alter their view that the benefit of the drug was not shown to outweigh an increased risk of bleeding…” Reuters, 2/14/2014.Reuters 2/14/14 Xarelto

Perhaps most shocking is the fact that Xarelto was approved by the FDA for use in treating blood clots after knee or hip replacement surgery, but the same ISMP study cited above noted the most common problem with Xarelto was not bleeding, but rather severe blood clots in patients generally younger than those typically affected by anti-coagulant medications:  “The primary complaint seen has been… serious blood-clot-related events that the drug is intended to prevent.”

Thousands of prescriptions for Xarelto have been written since its approval and release.  Now doctors and patients alike share concern that Xarelto may cause serious bleeding with no known antidote, and no effective means to stop it and that Xarelto may actually cause blood clots after hip or knee replacement surgery.

If you or a member of your family have taken Xarelto, and suffered side effects such as

  • Internal bleeding
  • Gastrointestinal bleeding
  • Brain Hemorrhage
  • Kidney Bleeding
  • Death Resulting from Severe Bleeding

Contact our office to confidentially discuss a Xarelto lawsuit.  We typically represent our Dangerous Drug lawsuits on a contingency basis, meaning no legal fees or costs until you win your case.  For more information please contact Bernheim & Dolinsky at 1-800-474-4089 or contact us online.

  • Free, no-obligation case evaluation. No fee unless we win your case.
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Product liability litigation has been featured on:

Bernheim & Dolinsky: American Association of Justice.
Bernheim & Dolinsky: Miami-Dade Justice Association. Bernheim & Dolinsky: Broward County Bar Association. Bernheim & Dolinsky: Broward County Justice Association.
Bernheim & Dolinsky: Million Dollar Associates Forum.