Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary, the manufacturers of the novel oral anticoagulant (NOACS) Xarelto, are exposed to several Xarelto product liability personal injury lawsuits, filed nationwide.
Illinois Xarelto Wrongful Death Lawsuit
The plaintiffs allege similar claims that the manufacturers failed to provide adequate warnings about the bleeding side effects of Xarelto, and failed to provide information about the lack of a FDA approved reversal agent.
Martha McMunn filed in the U.S. District Court for the Southern District of Illinois on behalf of her husband, Richard McMunn Jr, who passed away from Xarelto bleeding complications last year.
McMunn developed uncontrollable bleeding after using Xarelto for only a week. Xarelto was given following a knee replacement surgery, to prevent blood clots post surgery. McMunn developed life-threatening bleeding and bilateral pulmonary embolism. He died shortly afterwards from bleeding complications.
What is Xarelto?
Xarelto (also known as Rivaroxaban) is a factor Xa (ten) inhibitor which reduces the risk of blood clots and strokes by thinning the blood. Xarelto along with Pradaxa and Elquis are new oral anticoagulants, designed to reduce the risks of strokes, deep vein thrombosis and pulmonary embolisms in certain medical conditions.
The blockbuster drug was approved by the FDA in 2011, and is a joint development by Bayer and Johnson & Johnson’s Janssen subsidiary.
Xarelto: Blockbuster Drug
Bayer and Johnson & Johnson have aggressively touted Xarelto in direct to consumer advertisements as a superior replacement to Coumadin (warfarin). Warfarin was the gold standard of care for oral anticoagulation medication for the past 60 years.
Its biggest selling point for Xarelto, is that patients do not require regular blood monitoring of anticoagulation levels. Warfarin therapy needs to have the medication dosage adjusted on a frequent basis based on blood thinning levels, or protime.
The protime, which is a measure of the efficacy of the anticoagulation had to be kept in a narrow range or 2 to 3 times the INR. If the INR was greater than 3, then the patient would be at risk of major bleed or hemorrhage; if the INR was below 2, then the patient would be at risk to developing blood clots.
Lawsuits allege that the Xarelto warning label fails to inform about the risk of uncontrollable bleeding due to the lack of an approved antidote. Warfarin, can be quickly reversed if bleeding occurs, with vitamin K and blood products. Xarelto has no reversal agent to counteract the blood thinning effects of the drug, creating a nightmare scenario for emergency room doctors and first responders.
According to experts, several thousand lawsuits are expected to be filed in the coming months, over the side effects and warning issues surrounding the medication.