On April 7, 2017, a North Carolina man filed a new Eliquis lawsuit on behalf of himself and his deceased wife. The case is now pending in the Southern District of New York, the court in which all federally filed Eliquis lawsuits have been centralized.
The plaintiff claims that after taking Eliquis, his wife suffered serious injuries and died. He seeks $10 million in damages.
Woman Takes Eliquis and Dies of Excessive Bleeding Only Months Later
According to the complaint, the decedent started taking Eliquis in March 2015, and continued to take it through June 2015. Eliquis has been FDA-approved to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation, to treat and prevent deep vein thrombosis and pulmonary embolism, and to help prevent blood clots in patients undergoing hip and knee replacement surgeries.
After taking the drug for just a few months, the decedent suffered a life-threatening bleed on June 22, 2015. She was hospitalized for the condition, but doctors were ultimately unable to save her. She passed away on June 25, 2015.
The plaintiff claims that the defendants misrepresented their product in the healthcare community and failed to provide adequate warnings about the risks. He further asserts that the drug manufacturers failed to perform sufficient safety tests and clinical trials to ensure the drug was safe for use before releasing it onto the market.
No Readily Available Antidote to Eliquis Bleeding
Eliquis manufacturers Bristol-Myers Squibb and Pfizer, Inc. first received FDA approval for the drug in 2012. At that time, the FDA approved it for reducing the risk of stroke and blood clots in patients with non-valvular atrial fibrillation. They later approved it for the other uses in March 2014 and August 2014.
Eliquis is one of several “newer generation” anticoagulants that work as a Factor Xa inhibitor. Unlike warfarin, the leading anticoagulant for decades, which works by decreasing the production of several vitamin K-dependent blood clotting proteins, Eliquis works by inhibiting individual clotting proteins. That means that patients taking Eliquis do not have to modify their diet like patients taking warfarin.
During a bleeding event, however, patients taking warfarin can be treated with vitamin K injections, which allow the blood to clot again and stops the bleeding. Eliquis and other similar Factor Xa inhibitors have no such readily available antidote. For this reason, bleeding events are more dangerous and can be deadly when taking a Factor Xa inhibitor. Because there is no reversal agent, Doctors may give blood transfusions until the drug washes out of patient’s systems.
The manufacturers of Eliquis have advertised the drug as being more convenient because unlike warfarin, it doesn’t require regular blood monitoring. The plaintiff in this case, however, notes that some studies suggest that blood monitoring would be wise with Eliquis because it could help identify patients at risk for excessive bleeding.
In the Institute for Safe Medication Practices QuarterWatch publication for the fourth quarter of 2014, the authors noted that the risks of bleeding were so high with new-generation blood thinners that “individualizing the dose” would help improve safety.
The plaintiff asserts negligence, strict products liability, breach of warranties, fraudulent misrepresentation and concealment, negligent misrepresentation, fraud and deceit, and wrongful death claims.