Xarelto Bleeding Problems Result in Lawsuits Against Bayer, J&J

Amid continuing reports of problems with uncontrollable bleeding from side effects of Xarelto, it appears likely that Bayer and Johnson & Johnson will face a large number of product liability lawsuits over the warnings provided for their controversial anticoagulant.

While only a handful of Xarelto lawsuits have been filed nationwide, the number of cases is expected to increase dramatically in the coming months and years.

According to a recent report by the German news agency Frankfurter Allgemeine Zeitung, Bayer executives acknowledged recently that they are aware of about ten product liability lawsuits filed in the U.S. over the drug. All of the claims involve similar allegations that information was withheld from consumers and the medical community about the lack of an effective reversal agent to stop bleeding problems on Xarelto.

Xarelto (rivaroxaban) is part of a new generation of anticoagulants, known as “direct thrombin inhibitors,” which are used to reduce the risk of blood clots and strokes. The medication was jointly developed by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary, and introduced in late 2011.

Pradaxa was the first member of this new class of medications, introduced by Boehringer Ingelheim in October 2010. More than 4,000 Pradaxa lawsuits have been filed over bleeding problems, which the drug maker recently agreed to settle for $650 million.

While Pradaxa had an early market advantage, Xarelto has quickly grown to surpass sales of the competitor and has been associated with similar reports of uncontrollable bleeding problems.

Earlier this month, a federal judge in Pennsylvania remanded one of the first lawsuits filed over Xarelto back to state court, involving a claim filed by Virginia Stuntebeck, who was hospitalized for several days in February 2013 due to bleeding that doctors were unable to stop.

U.S. District Judge Joel Slomsky, sent the case back to the Philadelphia Court of Common Pleas on June 6, indicating that Janssen removed the case before other defendants in Pennsylvania were served with the complaint, in an effort to side step rules governing whether cases should be tried in state or federal courts.

As more former users and family members learn about the link between Xarelto and bleeding problems suffered while using the medication, it is expected that hundreds, if not thousands, of complaints may be filed in courts nationwide.

Xarelto Health Risks

Xarelto was first introduced in 2011 for prevention of strokes and blood clots among individuals with atrial fibrillation and following hip and knee replacements.

Although Xarelto and Pradaxa have been promoted as superior alternatives to Coumadin (warfarin), which has long been the standard anticoagulation therapy, the medications lacks an approved reversal agent that allows doctors to control bleeding problems that may develop during use. As a result, a large number of severe and often life-threatening injuries have been associated with the medications.

Shortly after Pradaxa was introduced in October 2010, it quickly earned the dubious distinction as the medication most commonly associated with adverse event reports submitted to the FDA.

According to a recent report by the Institute for Safe Medication Practices (ISMP), Xarelto has since surpassed Pradaxa in both sales and reports of problems to the FDA, with at least 680 serious adverse events reported last year.

In February the FDA rejected attempts to expand Xarelto approved use for the treatment of acute coronary syndrome, saying that they had failed to show that the drug was both safe and effective for such a use. It was the third time the agency had refused to expand the drug’s approved use, raising questions during the process about the risks of Xarelto bleeding events.

While Bayer and Johnson & Johnson have indicated that they are now working with a company called Portola Pharmaceuticals to develop an Xarelto reversal agent, lawsuits allege that the medication was unreasonably dangerous and defective as originally formulated.

In addition to allegations that inadequate warnings were provided about bleeding problems and the lack of a reversal agent, many plaintiffs also allege that the benefits provided by the medication do not justify the risks associated with the medication, indicating that the drug maker should have issued an Xarelto recall.