Xarelto Lawsuits Reportedly Filed

Dallas, TXThe first Xarelto lawsuits alleging patients were not adequately warned about the risk of Xarelto side effects have reportedly been filed. Although the number of lawsuits alleging Xarelto bleeding complications is small, it could grow as the number of reports of bleeding events grows.

According to Reuters (6/14/14), Bayer AG faces fewer than 10 lawsuits alleging patients suffered from Xarelto side effects but were not adequately warned about the risks. Xarelto, like other anticoagulant medications, reportedly comes with an increased risk of bleeding events. Because anticoagulant medications are designed to prevent blood from clotting - thereby reducing the risk of stroke - they also come with a risk that a relatively minor bleeding event will turn into uncontrolled bleeding.

One anticoagulant, Coumadin (known generically as warfarin), has an antidote in the form of vitamin K. This means that a patient who takes Coumadin and begins bleeding uncontrollably can have the effects of Coumadin reversed if he or she gets medical attention quickly enough. Xarelto and Pradaxa (a similar anticoagulant) do not currently have an antidote and therefore could put patients at risk of uncontrolled bleeding.

Only a handful of lawsuits have been filed concerning Xarelto, alleging the defendants knew or should have known about the risks associated with the drug. Plaintiffs claim they suffered from Xarelto side effects but were not properly warned about the risks they faced while taking Xarelto.

Despite the lack of an antidote to Xarelto, the FDA says it believes the benefits of the drug outweigh the risks. According to the FDA, Xarelto has less risk of hemorrhagic bleeding than Coumadin. Furthermore, the FDA says that most bleeding events linked to Xarelto are not serious, especially when compared with the risk of a stroke.

Although the number of lawsuits concerning Xarelto is small, it could grow if more patients suffer adverse events linked to the anticoagulant. Word from the Institute for Safe Medicine Practices (5/7/14) is that the number of Xarelto adverse event reports is now higher than the number of Pradaxa reports. The Institute notes that it could be because the number of Xarelto prescriptions now outnumbers Pradaxa’s.

One lawsuit, filed by Virginia Stuntebeck, argues that Xarelto should not be available for sale because of the serious risks linked to its use. Stuntebeck said she suffered severe internal and gastrointestinal bleeding after using Xarelto.

The lawsuit is Stuntebeck v. Janssen Research & Development LLC et al., case number 140201754, in the Court of Common Pleas of Philadelphia County.