On October 5, 2015, a couple from Morrow County, Ohio, filed a lawsuit in the U.S. District Court for the Southern District of Ohio. They claim that manufacturers Janssen Pharmaceuticals, owned by Johnson & Johnson, and Bayer AG are responsible for the wife’s serious life-threatening injuries. The couple is seeking close to $150,000 in compensation.
Wife Suffers Severe Xarelto Injuries
According to the lawsuit, the plaintiff was prescribed Xarelto for treatment of her chronic atrial fibrillation. The FDA approved Xarelto back in 2011 for the purpose of reducing blood clots in patients undergoing knee and hip replacement surgery. Later that same year, Xarelto was approved in the use of non-valvular atrial fibrillation to reduce the risk of stroke.
Just two months after she began taking Xarelto, the patient alleges she suffered serious injuries including gastrointestinal bleeding, anemia, and mental anguish. In addition, she has experienced a diminished enjoyment of life, and continues to require medical treatment.
All federal Xarelto lawsuits were consolidated into the Eastern District of Louisiana in December 2014, so it’s expected the case will be transferred there for pre-trial proceedings.
Xarelto Linked to More Deaths Than Warfarin
The plaintiff notes that the defendants regularly overstated the efficacy of Xarelto throughout their marketing campaign, while failing to provide adequate warnings about the risks of excessive bleeding. In addition, the company neglected to properly warn that Xarelto, unlike the leading anticoagulant, warfarin, has no readily available reversal agent for bleeding. Since Xarelto has no antidote for uncontrollable bleeding, it can be very serious and even fatal.
The complaint claims that on June 6, 2013, the defendants received a warning letter from the FDA telling them that their promotional material for Xarelto’s treatment of atrial fibrillation was false and misleading, and played down the risks linked to the drug. The FDA requested that the manufacturers immediately cease distribution of Xarelto.
In 2012, the FDA Medwatch Serious Adverse Events department received close to 1,080 reports of issues associated with Xarelto, with at least 65 of those involving patients who’ve died from their severe injuries. Of the amount of hemorrhage events linked to Xarelto, 8% resulted in death, which is close to twofold the risk of warfarin.
By the end of 2012, Xarelto was linked to over 2,000 adverse event reports, with 151 leading to fatalities. Warfarin, in comparison, only had 56 deaths linked to the drug. Concern over these numbers led the Institute for Safe Medicine Practices to warn the public and the scientific community to be cautious of Xarelto, and that the manufacturers should conduct further studies to determine the safety of the drug.
Couple Seeks Punitive Damages in Xarelto Lawsuit
The plaintiffs bring forth counts of liability, breach of warranties, failure to warn, design defect, negligence, negligent misrepresentation, fraud, and fraudulent concealment. They will be seeking compensatory and punitive damages.
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