Pennsylvania Consolidates Xarelto Lawsuits Into Mass Tort

On December 12, 2014, the United States Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal Xarelto lawsuits into the Eastern District of Louisiana for pre-trial proceedings. The consolidation is intended to reduce the risk of duplicative discovery and conflicting rulings, while serving the convenience of all parties involved. So far, at least 86 cases are pending there.

Now, Pennsylvania state Xarelto lawsuits have also been consolidated into a mass tort. On January 14th, Philadelphia Court of Common Pleas Administrative Judge Kevin Dougherty transferred a total of about 75 cases to the state’s Complex Litigation Center.

Drug Makers Object to Xarelto Mass Tort

Manufacturers Bayer and Janssen Pharmaceuticals argued against consolidation in a December 2014 opposition statement. They said it wasn’t appropriate to bring the cases together in Philadelphia when company headquarters were in New Jersey, and when most plaintiffs, as well, were from out-of-state, with no ties to Pennsylvania. They also questioned whether the cases shared any common issues or questions of fact.

The Judge disagreed, apparently believing that a mass tort would streamline the process. Now all cases filed in the state will be transferred to the same location for pre-trial proceedings. This will allow attorneys to work together for the most efficient resolution of the cases. It is expected that litigation will grow as more people come forward claiming to have suffered serious injuries while using Xarelto.

Xarelto Bleeding Events

The FDA approved Xarelto in 2011 for the prevention of stroke and blood clots in patients who had just undergone knee or hip replacement surgery. Similar to the leading anticoagulant, warfarin, Xarelto is a new-generation blood thinner that doesn’t require blood monitoring or special diets. It was also approved in 2012 to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation.

While the drug makers advertised Xarelto as being a more convenient option to warfarin, with a “one-size-fits-all” dosage, they downplayed the potential side effects, which included excessive bleeding, hemorrhage, and death. Plaintiffs who have filed Xarelto lawsuits add that the manufacturers failed to warn patients that there was no readily available antidote to Xarelto bleeding.

Whereas doctors can treat warfarin bleeding with injections of vitamin K, there is no such treatment for patients experiencing Xarelto bleeding, making it much more dangerous and potentially deadly. Early clinical studies on the drug also showed that it was more likely to cause gastrointestinal bleeding that warfarin, but plaintiffs agree that the manufacturers didn’t do enough to make that fact clear.

Drug Makers Downplayed Xarelto Side Effects

In 2013, the FDA sent a warning letter to the manufacturers, stating that one of their print advertisements was false and misleading, and that it minimized the risks associated with Xarelto. In the first quarter of 2012, the Institute for Safe Medication Practices identified over 350 reports of serious, disabling or fatal injuries related to Xarelto.

Later research revealed that even though Xarelto was advertised as more convenient than warfarin, because it didn’t require blood monitoring, certain high-risk patients would have benefited from having their blood checked regularly to be sure they weren’t suffering adverse effects.

In 2014, for example, a study published in the Journal of Cardiology found that some patients with non-valvular atrial fibrillation who took Xarelto (rivaroxaban) experienced prolonged blood-thinning effects, making them more susceptible to bleeding events. These patients could have been identified with blood monitoring, and risks potentially lowered, had the manufacturers suggested blood monitoring for certain populations.