More than 770 Xarelto cases have now been filed in Philadelphia’s Complex Litigation Center, joining another 2,800 that have been centralized in multidistrict litigation (MDL) in the U.S. District Court, Eastern District of Louisiana before Judge Eldon E. Fallon.
The Xarelto lawsuits share similar allegations against Johnson & Johnson and Bayer, the manufacturers of Xarelto. These allegations include:
- The lack of a Xarelto antidote was not properly communicated to consumers and the medical community.
- Although Xarelto was promoted as requiring less monitoring than warfarin, given the lack of an antidote, the need for monitoring is actually more important.
- The manufacturers of Xarelto are putting patient lives at risk by irresponsibly failing to provide product labeling that sufficiently warns consumers about the possibility of uncontrollable hemorrhaging caused by Xarelto use.
The plaintiffs suing the drug companies over the safety of Xarelto also allege that the companies deliberately mislead editors in a letter published in The New England Journal of Medicine and written primarily by researchers at Duke University by leaving out critical laboratory data. They claim that by staying silent, the companies were able to deceive the editors while providing the very same data to regulators in the United States and Europe.
What is Xarelto?
Xarelto is a new generation anticoagulant developed in 2011 as a superior alternative to warfarin (Coumadin), the blood thinner used widely since the 1950s for the prevention of strokes. Xarelto is prescribed to patients suffering from atrial fibrillation (irregular heart beat) who are at increased risk of formed a blood clot in the heart, which can travel to the brain and cause a stroke. Xarelto works by thinning the blood, lowering the chance of clots forming.
All blood thinners increase the risk of bleeding problems, but Xarelto has been linked to an increased number of uncontrollable blood injuries because there is no approved antidote available for patients who use Xarelto, and many of the side effects have been severe because the bleeding cannot be effectively controlled. Portola Pharmaceuticals has posted the application for the drug, andexanet alfa, which may quickly reverse the anticoagulant effects of Xarelto. Once approved, the drug is expected to enter the market sometime in 2016.