A lawsuit alleges that a Washington man suffered severe rectal bleeding in November 2015 after taking Xarelto.
According to the Xarelto bleeding lawsuit, the plaintiff took the drug from approximately June 12, 2014 until Nov. 9, 2015. The plaintiff says he suffered severe injuries from taking Xarelto and began suffering from rectal bleeding at that time.
The bleeding lawsuit alleges “Plaintiff was caused to suffer from life-threatening bleeding, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, expenses for hospitalization and medical treatment, and loss of earnings, among other damages.”
The plaintiff claims that Xarelto was inadequately researched and over-promoted, leading to his severe injuries. According to the Xarelto bleeding lawsuit, drug makers, including Janssen, Bayer, and Johnson & Johnson, failed to adequately warn the medical community and the public about the risks of severe bleeding from taking Xarelto.
In addition, alleges the lawsuit, the companies aggressively marketed the drug to patients using a direct-to-consumer approach touting the ease and simplicity of taking the drug.
“As part of their marketing of Xarelto, Defendants widely disseminated direct-to-consumer (‘DTC’) advertising campaigns that were designed to influence patients to make inquiries to their prescribing physicians about and/or request prescriptions for Xarelto,” alleges the bleeding lawsuit
The U.S. Food and Drug Administration (FDA) approved on July 1, 2011; however, alleges the plaintiff, FDA approval was based on negligently conducted research.
In fact, according to the complaint, a 2009 review of the studies drug makers used to support approval of the drug was found to be so flawed by the FDA that the results of one study had to be discarded.
“Xarelto is the second most prescribed drug for treatment of atrial fibrillation, behind only Coumadin (warfarin), and achieved blockbuster status with sales of approximately $2 billion dollars in 2013,” points out the Xarelto bleeding lawsuit.
According to the plaintiff, Coumadin, also known as warfarin, has been in use for 60 years; however, warfarin requires blood monitoring and limitations to patients’ diets, according to the lawsuit.
Xarelto was marketed as a more convenient alternative to warfarin. The “Xarelto Difference” was advertised as single daily dose pill that does not require blood monitoring or changes in diet. But, alleges the lawsuit, research shows that Xarelto is safer and more effective if taken twice a day and while patients are undergoing blood monitoring.
“Defendants’ aggressive and misrepresentative marketing of a ‘Xarelto Difference’ lead to an explosion in sales,” alleges the bleeding lawsuit.
“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.”
The plaintiff alleges that drug makers overstated the efficacy of Xarelto, while failing to disclose important pieces of information to patients about taking the drug safely, including dose adjustments, blood monitoring, and the lack of an antidote for Xarelto bleeding problems.
If you or a loved one experienced bleeding, contact the attorneys at McDonald Worley to help evaluate any legal claims you may have.
Disclaimer: McDonald Worley is not representing the plaintiff in this lawsuit.