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Number of Cases Increasing in Xarelto Mass Tort

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In December 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all federal Xarelto lawsuits into one court in the Eastern District of Louisiana. At the time, about 50 product liability lawsuits were pending in the court. That number has now increased to about 400.

Not long after the Xarelto MDL was established, Philadelphia consolidated all state Xarelto lawsuits into a mass tort in the Philadelphia County Court of Common Pleas. What started as about 70 cases has now increased to about 200.

Defendants Resisted Formation of Mass Tort

Plaintiffs involved in Xarelto lawsuits claim that Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer Healthcare Pharmaceuticals—manufacturers of the drug—should be held liable for damages associated with serious Xarelto side effects, including severe gastrointestinal bleeding and sometimes death.

The defendants initially resisted consolidating cases in Philadelphia, arguing that New Jersey would be a better location, since that’s where the company headquarters are located. They added that most plaintiffs also lived in other states, so it didn’t make sense to bring all cases to Pennsylvania.

The cases all do not involve common issues of fact, either, the defendants argued, since Xarelto is approved for multiple purposes. These include the prevention of blood clots after hip and knee replacement surgery, and the reduction of stroke risk in patients with non-valvular atrial fibrillation.

The court disagreed, stating the cases did share common issues of fact, that the defendants had strong ties to Pennsylvania, and that the Philadelphia court was an appropriate forum for the mass tort.

The companies expressed their intentions to defend against the claims brought in litigation, maintaining that Xarelto has a favorable benefit-risk profile.

Drug Makers Failed to Warn About Serious Xarelto Side Effects

The FDA approved Xarelto in 2011. Manufacturers immediately marketed it as a more convenient option to warfarin, the leading anti-coagulant for decades, because it came in a once-daily dose and required no dietary restrictions.

Within just a year, however, reports of excessive bleeding began coming in, numbering more than 1,000 by June 30, 2012—at least 65 of those involving the death of the patient. By the end of that year, more than 151 people had died in events related to Xarelto.

Plaintiffs filed lawsuits to recover damages, claiming that the drug makers had failed to provide proper warnings on the labels. Patients were left in the dark, for instance, on the fact that there was no readily available antidote to Xarelto bleeding. While all blood thinners carry some risk of bleeding, patients taking warfarin can have that bleeding stopped with vitamin K injections. There is no such solution for patients on Xarelto, making bleeding events much more serious and potentially deadly.

State and Federal Courts to Coordinate Pre-Trial Proceedings

Both parties plan to coordinate the mass tort with the Xarelto MDL. In a recent case management conference, for instance, held in April 2015, the MDL court noted that five days before each future status conference, the defendants are to identify and share any Xarelto lawsuits pending in state courts, to facilitate coordination.