Approved by the FDA to successfully reduce the risk of stroke and blood clots, Xarelto has been on the market since 2011. Since then it has endured severe ongoing litigation developing multi-million dollar verdicts for those who have suffered on behalf of the manufacturer’s negligence.
The blood-thinning drug is usually prescribed to those who recently went though a knee or hip replacement surgery. At the time, the known serious risks were few and limited: uncontrolled bleeding, muscle pain, numbness or tingling and liver problems. Today, the litigation claims that the manufacturer did not inform the public that there were links to taking the drug and suffering from internal bleeding, wound leaks, and infections.
Originally, a sub-company of Johnson and Johnson, Janssen Pharmaceuticals, filed for approval of Xarelto to the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). The drug was approved as a prevention for deep vein thrombosis and pulmonary embolisms after surgical procedures of the hip or knee. It has been discovered that the FDA experienced problems with the manufacturer claiming problems with data integrity.
In a study published in the American Medical Association in February of 2015, “Research Misconduct Identified by the US Food and Drug Administration,” by Charles Seife, MS, evidence shows that there was a blatant negligence on behalf of FDA clinical trials in following clinical protocol. One trial in particular, The Xarelto Regulation of Coagulation in Orthopedic Surgery to Prevent Deep-Venous Thrombosis and Pulmonary Embolism (RECORD 4) trial, was under severe scrutiny after medical records were discarded and the data sets falsified.
There have been over 20,800 law suits filed against the manufacturer Johnson and Johnson and Bayer Corporation on behalf of Xarelto users. Throughout each trail and claim, the risks for taking Xarelto have become clearly marked on packaging. In 2014, The Black Box warning, the FDA’s most prominent and serious warning, was applied to Xarelto packaging.
If you or a loved one experienced serious side effects due to Xarelto, you may be entitled to compensation from the manufacturer. Contact the Law Offices of Rudolph F.X. Migliore, for a free consultation to see if you have a case.
By Aleksandra Aronova