For the third time in a row, Bayer and Janssen Pharmaceutical won the Xarelto bellwether trial scheduled for August 2017. A federal jury in the U.S. District Court, Southern District of Mississippi, handed a favorable verdict to the manufacturers against a plaintiff who claimed that her bleeding accident was caused by the blood thinner’s side effects.
The lawsuit was filed on behalf of Dora Mingo who was prescribed rivaroxaban to prevent blood clots after she underwent a hip replacement surgery. The plaintiff’s lawyers claim that the medication was responsible for a severe gastrointestinal bleed that required emergency hospitalization to avoid more serious injuries. The trial was presided by Honorable Judge Eldon E. Fallon. The case is: Dora Mingo v. Janssen Research & Development LLC et al., case number 2:15-cv-03469.
Xarelto is a Novel Oral Anticoagulant (NOAC) recently introduced in the American Market. According to its manufacturers, this blood thinner is a safer and better alternative to the traditional medications used to treat conditions such as atrial fibrillation, deep vein thrombosis and pulmonary embolism. However, many patients who used it found this drug to be much more dangerous than advertised.
According to the many claims centralized in the Xarelto Products Liability Litigation (MDL No. 2592), rivaroxaban was, in fact, linked with dangerous side effects such as uncontrolled bleeding, internal hemorrhages and heart attacks. Since no antidote can reverse the effects of the Bayer’s blood thinner, once a severe bleeding occurs, there’s no way for doctors to save a patient’s life. Attorneys alleged that the pharmaceutical companies failed to warn the public about this danger, purposely downplaying its risks to increase their profits.
During the trial, which began on Aug. 7, the woman testified that when Xarelto was first marketed, the manufacturers advertised it as a medication that did not require any clinical test to evaluate a potential risk of bleeding. Her attorney pointed out that the advertising campaign aggressively marketed the drug despite its risks.
However, Bayer and argued that they had no authority to modify the medication’s label and that Mingo’s state law claims were preempted by federal law.
The other two bellwether trials both ended in a victory for the defense. In the second trial, a federal jury concluded that the Xarelto’s label warned the public adequately about the potential consequences of the NOAC. Although this is the third bellwether trial that cleared the drugmakers of any liability, more than 18,000 lawsuits are still pending in U.S. District Court, Eastern District of Louisiana. A fourth exploratory case is scheduled is pending for trial in January in Texas federal court.
Article by Dr. Claudio Butticè, Pharm.D.