New information released by the British Medical Journal states that Janssen Pharmaceuticals, owned by Johnson & Johnson, hid its knowledge of a faulty testing device used in a key regulatory trial of Xarelto, an anticoagulant generating billions of dollars in sales annually.
During the trial, researchers utilized INRation devices to monitor trial participants receiving warfarin, an anticoagulant previously considered the standard of care.
The INRation device was recalled in 2014 by the Food and Drug Administration (FDA), due to its generation of much lower numbers than those reported in controlled lab testing. The defective device may have altered data and put patients at risk.
A recent investigation conducted by the British Medical Journal discovered that Johnson & Johnson and co-developer Bayer were aware the INRation device was defective, yet failed to notify the FDA.
Janssen initiated a safety recheck program for trial participants in 2008 as investigators became concerned about the accuracy of the INRation device’s ability to track blood clotting. The company, however, failed to notify the FDA or affected participants, putting their safety at risk.
Approximately 11,000 U.S. plaintiffs have filed lawsuits against Janssen, Johnson & Johnson, and Bayer, claiming the companies misrepresented Xarelto’s safety and effectiveness. Patients taking Xarelto reportedly suffered internal bleeding, which resulted in hospitalization and death in some cases.
A new study conducted this year also raises concerns over bleeding dangers associated with Xarelto use. Patients ages 65 and over with nonvalvular atrial fibrillation who take Xarelto have a 15 percent higher risk of death, a 65 percent higher possibility of brain bleeds and a 48 percent increased risk of major brain bleed.
If you have suffered side effects after taking Xarelto, you may be entitled to compensation for your medical bills, lost wages, and pain and suffering. The dangerous drug attorneys at Gordon & Doner are committed to holding manufacturers accountable for faulty products that cause harm – we will fight for the justice and compensation you deserve.