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Texas Woman Blames Xarelto for Life-Threatening Bleeding Incident

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Another lawsuit has joined the Xarelto MDL in the Eastern District of Louisiana.

The consolidated Xarelto litigation was centralized in December 2014, for cases in which plaintiffs claim they were injured after taking the anticoagulant Xarelto (rivaroxaban). There are currently over 5,000 cases pending in the court, with U.S. District Judge Eldon Fallen overseeing the proceedings.

The plaintiff in this newly filed case is a resident of Texas. She claims that after taking Xarelto, she suffered serious injuries. She names as defendants manufacturers Janssen Pharmaceuticals, parent company Johnson & Johnson, and Bayer Pharma.

Plaintiff Suffers Xarelto Bleeding Within Just Two Months

According to the complaint, the plaintiff started using Xarelto in April 2014, and used it for only a couple months before suffering from life-threatening bleeding on June 25, 2014. She alleges that her injuries were caused by Xarelto, and is seeking in excess of $75,000.

The FDA first approved Xarelto in 2011 for the prevention of blood clots in patients going through knee or hip replacement surgery. It was later approved for reducing the risk of stroke in patients with non-valvular atrial fibrillation, and for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).

All of these approvals were based on clinical trials submitted by the drug manufacturers. The “ROCKET” trials which were used to secure approval for Xarelto’s use for the treatment of atrial fibrillation found that Xarelto was similarly effective to warfarin (the leading anticoagulant) at preventing stroke, but that patients who took it were more likely to suffer from gastrointestinal bleeding.

Other clinical trials showed similar results, with Xarelto resulting in an increased risk of adverse events, including those that resulted in permanent discontinuation of the drug or prolonged hospitalization.

Plaintiff Claims Manufacturers Downplayed Xarelto Risks

The plaintiff in this case claims that the manufacturers aggressively advertised Xarelto while failing to adequately warn of its risks, including the fact that the drug increased risk of gastrointestinal bleeding more than alternative treatments.

The manufacturers also allegedly touted Xarelto’s more convenient once-a-day dosing as an advantage, but the plaintiff points out that FDA reviewers questioned this dosing scheme at the time of the drug’s review, stating that blood vessel studies had shown peaks and troughs that could have been eliminated by twice-a-day dosing.

Xarelto, in addition, has no readily available antidote. Whereas patients taking warfarin can be treated for excessive bleeding with injections of vitamin K that promote blood clotting, patients taking Xarelto have no such treatment available, making bleeding events much more dangerous and potentially deadly. The plaintiff also claims that the drug labeling when it was first marketed “did not contain a warning regarding the lack of antidote, but instead only mentioned this important fact in the overdosage section.”

Xarelto Associated with Thousands of Adverse Event Reports

The plaintiff cites a 2013 FDA warning letter in which the FDA warned the manufacturers of Xarelto for producing misleading advertisements that minimized the risks associated with the drug. They were told to immediately cease distribution of certain materials.

According to the complaint, at the close of the 2012 fiscal year, a total of 2,081 new Xarelto-associated adverse event reports had been filed with the FDA. This ranked Xarelto as 10th among all pharmaceuticals in number of adverse event reports, of which 151 resulted in death, compared with 56 deaths associated with warfarin.

The plaintiff brings counts of negligence, strict products liability, breach of warranties, fraudulent misrepresentation and concealment, negligent misrepresentation, and fraud and deceit. She seeks both compensatory and punitive damages.