Lawsuit Alleges Xarelto Hemorrhage Warnings Inadequate

A new product liability lawsuit filed against Bayer Healthcare and Johnson & Johnson’s Janssen subsidiary alleges that a California woman almost died from uncontrollable hemorrhaging after use of the anticoagulant Xarelto, despite claims by the manufacturers that their medication is safe.

The complaint (PDF) was filed by Shirley Boynton on August 29, in the U.S. District Court for the Eastern District of New York. Boynton indicates that she suffered permanent and debilitating injuries as a result inadequate Xarelto hemorrhage warnings provided to consumers and the medical community.

The case is one of a growing number of Xarelto lawsuits filed nationwide against Bayer and Johnson & Johnson, alleging that the relatively new medication is unreasonably dangerous and defective. The plaintiffs claim that the drug makers intentionally misled the medical community about the drug risks to increase use of the medication over warfarin and other available blood thinners.

Boynton first began using Xarelto in April 2012, but in August of that year she suffered a severe bleeding event that she claims caused her to suffer permanent injuries, pain and suffering. She will have to undergo life-long medical treatment, according to the complaint.

Xarelto Hemorrhaging Concerns

Xarelto (Rivaroxaban) is part of a new generation of anticoagulants, known as “direct thrombin inhibitors,” which are designed to reduce the risk of blood clots and strokes by thinning the blood.

The medication was introduced in late 2011 as a joint development by Bayer and Johnson & Johnson’s Janssen subsidiary, and it is on path to soon become a blockbuster medication, with more than $1 billion in annual sales.

Bayer and Johnson & Johnson have aggressively promoted Xarelto as a superior alternative to Coumadin (warfarin), which has been the go-to anticoagulation therapy for years.

While the manufacturers have claimed that the drug is easier to use than warfarin, since patients do not require regular monitoring during treatment, a growing number of lawsuits filed nationwide allege that the Xarelto warnings fail to adequately disclose the risk of uncontrollable hemorrhages due to the lack of an approved antidote.

Unlike warfarin, which can be quickly reversed if bleeding occurs, Xarelto lacks a reversal agent to counteract the blood thinning effects of the medication, often leaving doctors unable to control bleeding that may develop among users.

As the popularity of the medication has increased over the past two years, a growing number of complications involving hemorrhaging on Xarelto have also been associated with the medication. Boynton’s lawsuit claims Xarelto’s manufacturers misled doctors and patients into thinking the drug was safe.

“Importantly, there is no antidote to Xarelto, unlike warfarin. Therefore, in the event of hemorrhagic complications, there is no available reversal agent,” the complaint states. “The original U.S. label approved when the drug was first marketed in the U.S. did not contain a warning regarding the lack of antidote, but instead only mentioned this important fact in the drug overdosage section.”

The lawsuit pursues claims against the manufacturers for negligence, strict product liability, breach of warranty, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud and deceit, and loss of consortium.