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California Man Blames Xarelto for Subdural Hematoma

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In December 2014, all federally filed Xarelto lawsuits were consolidated into the Eastern District of Louisiana for pre-trial proceedings. Since then, the court has seen a steady increase in the number of cases there.

Another new lawsuit joined the MDL on March 16, 2016. The plaintiff is a resident of California, and claims that after using Xarelto, he suffered serious injuries. He seeks damages in excess of $75,000.

Plaintiff Suffers Subdural Hematoma After Taking Xarelto

According to his complaint, the plaintiff started using Xarelto in July 2013, to reduce the risk of stroke associated with atrial fibrillation. The FDA approved Xarelto for this use in November 2011. A so-called “new-generation” blood thinner, the drug help is intended to help to reduce the risk of blood clots.

The plaintiff continued to use the drug until about April 2014. At that time, he claims he suffered life-threatening bleeding and subdural hematoma, causing severe and permanent physical injuries. A subdural hematoma is a type of brain hemorrhage that occurs when the blood vessels rupture between the brain and the other membrane layers that cover it. The resulting blood can build up in this area and compress the brain tissue. It’s a serious condition that can cause loss of consciousness, brain damage, and even death in some cases.

The plaintiff blames manufacturers Janssen Pharmaceuticals, parent company Johnson & Johnson (J&J), and Bayer AG for failing to provide adequate warnings concerning the risks of excessive bleeding.

Plaintiff Points Out Ways that Manufacturers Downplayed Risks

The plaintiff claims that approval for Xarelto for reducing the risk of stroke in patients with non-valvular atrial fibrillation was based on a clinical study known as the “ROCKET AF” trial. The study’s findings showed that Xarelto (rivaroxaban) was similar to warfarin—the leading anticoagulant for decades—for the prevention of stroke in this population, with a similar risk of major bleeding. But researchers noted that gastrointestinal bleeding occurred more frequently in those participants taking Xarelto.

According to the plaintiff, manufacturers used the results in their marketing materials, but failed to highlight this increased risk of gastrointestinal bleeding. They also advertised Xarelto as being a more convenient alternative to warfarin, since it didn’t require regular blood monitoring or dietary changes, and since it came in an easy once-a-day dose. The plaintiff notes that even in the FDA review process, however, some reviewers questioned the wisdom of this dose, stating that blood levels studies had shown peaks and troughs that could be eliminated by twice-daily dosing.

Finally, the plaintiff alleges that unlike warfarin, Xarelto has no readily available antidote to treat excessive bleeding. Whereas patients taking warfarin can be treated with injections of vitamin K to encourage blood to clot, patients taking Xarelto have no such solution. That means they must simply wait it out while the body gradually metabolizes the drug—which can make excessive bleeding potentially much more dangerous and even deadly.

There was no warning on the label alerting physicians to this important risk, the plaintiff asserts. He brings counts of negligence, strict products liability, breach of warranties, fraudulent misrepresentation and concealment, negligent misrepresentation, fraud and deceit. He further asserts that, had he known about the true facts with respect to the dangerous safety concerns associated with Xarelto, he says he never would have used the drug.