Xarelto Lawsuits Continue to be Filed Over Bleeding Injuries, Deaths

Over the past month, Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary have been been hit with at least a half-dozen Xarelto lawsuits filed on behalf of individuals nationwide who suffered a severe injury or death due to uncontrollable bleeding problems while on the medication.

All of the claims involve similar allegations that the drug makers provided inadequate warnings about the potential bleeding side effects of Xarelto, and failed to provide sufficient information about the lack of an available reversal agent for the anticoagulant.

One of the most recent complaints (PDF) was filed by Martha McMunn in the U.S. District Court for the Southern District of Illinois on September 26, following the February 2013 death of her husband, Richard McMunn Jr.

According to the lawsuit, Richard McMunn suffered uncontrollable bleeding after using Xarelto for only a week. The anticoagulant was prescribed following a knee replacement surgery, to prevent blood clots that are a common complication of procedure. Three days after his first use of the medication, McMunn suffered life-threatening bleeding and developed an acute bilateral pulmonary embolism. He was taken off Xarelto on February 18, but died on February 23.

Martha McMunn and other plaintiffs pursuing Xarelto lawsuits in courts throughout the country allege that the severe bleeding problems could have been avoided if the manufacturers had not withheld critical safety information from consumers and the medical community.

Uncontrollable Xarelto Bleeding Events

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, lawsuits 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.

“In the year leading up to June 30, 2012, there were 1,080 Xarelto-associated ‘Serious Adverse Event’ Medwatch reports filed with the FDA, including at least 65 deaths,” the McMunn lawsuit notes. “Of the reported hemorrhage events associated with Xarelto, 8% resulted in death, which was approximately twofold the risk of a hemorrhage-related death with warfarin.”

A similar Xarelto wrongful death lawsuit was filed on September 25 in federal court in Louisiana, by Joann Varnado and Christian Varnado, whose husband and father, respectively, Gerald Varnado died due to injuries from a life-threatening bleeding event suffered on July 26.

The complaint (PDF) states that Varnado began taking the drug to reduce the risk of stroke and embolism due to atrial fibrillation. He was first prescribed Xarelto in February 2013 as well, and used it through July 25 of this year.

Both lawsuits claim that Xarelto was rushed to the market before a reversal agent was developed, putting patients at risk. The lawsuits allege that the label did not adequately warn of the risks of uncontrollable bleeding and that doctors were not given the proper tools to deal with the potential side effect.