A new lawsuit alleges that a Florida woman taking Xarelto suffered severe side effects, including nosebleeds.
According to the lawsuit, Jeanne S., took Xarelto from Feb. 13, 2015 to Jan. 21, 2016 to treat atrial fibrillation; however, she began suffering nosebleeds from Xarelto and was instructed by her physician to stop taking the drug.
Jeanne alleges she had to undergo numerous blood transfusions due to her injuries from Xarelto as well.
The lawsuit claims that the drug makers, Janssen, Johnson & Johnson and Bayer, knew of the increased risks of bleeding, including nosebleeds from Xarelto, but failed to warn patients and doctors about those risks.
“Plaintiff brings this case against Defendants for damages associated with Plaintiff‘s ingestion of the pharmaceutical drug Xarelto, which was designed, manufactured, marketed, sold and distributed by Defendants. Specifically, Plaintiff suffered various injuries, serious physical pain and suffering, financial expenses for hospitalization and medical care, among other damages, as a direct result of her use of Xarelto,” states the lawsuit.
The lawsuit alleges that the defendant drug makers improperly researched the drug to push Xarelto through the approval process. Drug makers, alleges the plaintiff, failed to identify and warn about the risks, including severe nosebleeds from Xarelto that the plaintiff suffered.
The lawsuit alleges that shortly after the Food and Drug Administration approved the use of the drug, numerous complaints were filed. As a result, the agency reviewed the research drug makers used to push through the approval of Xarelto.
According to the plaintiff, the agency discovered “‘systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties in randomization.’”
Further, says the lawsuit, the alternative treatment to Xarelto, Coumadin, also known as warfarin, is less risky.
Although warfarin is more labor intensive for the patient, requiring blood monitoring and limitations to patients’ diets, Xarelto was marketed as a safe alternative. “Defendants’ aggressive and misrepresentative marketing of a ‘Xarelto Difference’ lead to an explosion in sales,” states the complaint.
“The ‘Xarelto Difference,’ i.e., was once a day dosing without blood monitoring. In fact, the ‘Xarelto Difference’ was nothing more than a marketing campaign based on flawed science.”
However, says the plaintiff, the research indicates that Xarelto is safer and more effective if taken twice a day and when there is blood monitoring.
Further, there is no antidote to nosebleeds from Xarelto and other severe bleeding problems, alleges the lawsuit.
The plaintiff claim that after learning of the risks of bleeding from Xarelto, instead of fixing the problem, drug makers continued to push the drug on to consumers.
“Defendants overstated the efficacy of Xarelto with respect to preventing stroke and systemic embolism, failed to disclose the need for dose adjustments, failed to disclose the need for blood monitoring, and failed to adequately disclose to patients that there is no drug, agent, or means to reverse the anticoagulation effects of Xarelto, and, that such irreversibility could have permanently disabling, life-threatening and fatal consequences,” alleges the complaint.
The Xarelto Lawsuit is Jeanne S. v. Janssen Research & Development LLC, et al., Case No. 2:17-cv-17468, in the U.S. District Court for Eastern District of Louisiana.
If you or a loved one suffered nosebleeds from Xarelto or other side effects, contact the attorneys at McDonald Worley.