A new Xarelto lawsuit has been recently filed against Bayer AG and Janssen Pharmaceutical by a woman who lost his husband to the side effects of this dangerous blood thinner. Plaintiff Anita F. (Case No. 2:16-cv-14021) is seeking compensation in court on behalf of her deceased loved one Franklin C., who allegedly suffered a lethal internal hemorrhage after being prescribed the drug on March 2014. According to the claim, the man closely followed the prescription instructions provided by his physician and diligently took its pills every day as scheduled. After just a few months since he began his new treatment, on August 26, 2014, Franklin suffered from a serious complication wich ultimately resulted in his wrongful death. His wife Anita claims that the company never provided sufficient information about the purportedly lethal dangers of Xarelto.
Xarelto (rivaroxaban) has been widely prescribed since it was approved in 2011, to treat several conditions such as Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). After a few years, though, the Novel Oral Anticoagulant’s (NOAC) indications widened to include also the prevention of risk of stroke in patients affected by atrial fibrillation (AFib). Since then, millions of patients received this prescription, even though the U.S. Food and Drug Administration (FDA) issued two different black box warnings. Although it has never been recalled, in fact, mounting evidence showed that the blood thinning medication proved to be much more dangerous than initially expected. The regulator received thousands of reports of serious adverse reactions such as brain bleedings, internal hemorrhages, and emergency hospitalizations. Since no antidote can reverse rivaroxaban’s effects, even a relatively mild trauma can lead to an uncontrolled bleeding wich may have fatal consequences.
However, Bayer keeps claiming that the controversial NOAC is a safe drug and recently disclosed new information that allegedly reaffirms its positive benefit-risk profile. According to data provided in the XAPASS study, a large clinical trial that tested Xarelto’s safety and effectiveness in real-world settings, the Factor Xa inhibitor shows lower rates of bleeding and stroke in Afib patients. The company claims that the evidence presented at recent ESC Congress 2016, comes from routine clinical practice, and it is consistent with results coming from the latest Japanese trial, the J-ROCKET AF.
To date, almost 5,000 Xarelto litigations have been centralized in the Multidistrict Litigation as MDL No. 2592 in the Eastern District of Louisiana. To speed up proceedings, another 550 litigations have been merged in a mass tort in the Philadelphia Court of Common Appeals. All cases filed so far, claim that Bayer and Janssen Pharmaceuticals never properly warned the public about the blood thinner’s dangers, and concealed its negative traits overstating its safety to increase sales. After the first four bellwether trials have already been selected, the first cases will be heard in court as early as 2017.
Article by Dr. Claudio Butticè, Pharm.D.
