Case Info
Xarelto Linked to Serious Health Risks, Including Death
Xarelto (rivaroxaban) is an anticoagulant approved in 2011 to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce stroke risk in patients with non-valvular atrial fibrillation. It was also used by patients undergoing knee or hip replacement surgery. Manufactured by Bayer Healthcare and marketed by Janssen Pharmaceuticals, a division of Johnson & Johnson, Xarelto was developed as a modern alternative to warfarin (Coumadin).
Patients prescribed Xarelto faced significant health risks, including severe bleeding events that resulted in long-term disability or death. The drug’s prescribing information includes a black-box warning, the U.S. Food & Drug Administration’s most serious warning, about the risk of spinal bleeding following procedures or trauma, potentially leading to permanent paralysis. Additionally, elderly patients were at heightened risk of cranial bleeding and other severe complications.
Litigation Against Bayer and Johnson & Johnson
More than 32,000 individuals filed lawsuits against Bayer and Johnson & Johnson, alleging the companies failed to adequately warn consumers and healthcare professionals about Xarelto’s risks and the absence of a reversal agent. These lawsuits highlighted cases of severe injuries, including fatal bleeding episodes.
In November 2017, an Indiana couple won a $28 million verdict, which was later overturned on appeal. Despite this, the growing pressure of thousands of lawsuits led Bayer and Johnson & Johnson to agree to a $775 million settlement in March 2019. This resolution provided compensation to victims nationwide and marked a significant victory in mass tort litigation.