FDA Assurances Likely Not Enough to Satisfy Xarelto Litigants

December 5, 2016, 7:45PM. By Gordon Gibb

Washington, DCIn spite of assurances by the US Food and Drug Administration (FDA) that a recall of a monitoring device used to help determine the safety and effectiveness of Xarelto did not adversely affect outcomes, some 7,200 Xarelto lawsuits have been filed and consolidated in multidistrict litigation. The first bellwether Xarelto lawsuit is now only months away, scheduled for February of next year.

Xarelto was approved by the FDA in November, 2011 for use in patients with atrial fibrillation – an irregular heartbeat – a condition that can foster increased risk for blood clots and stroke. Xarelto was heralded as a breakthrough in achieving safe and effective anticoagulation without the intensive monitoring required for an older blood thinner, Coumadin (warfarin).

Xarelto, however was brought to market without a readily available reversing agent akin to warfarin, whose blood thinning properties are reversed with an infusion of Vitamin K. Thousands of plaintiffs bringing a Xarelto lawsuit assert they were negatively impacted by a Xarelto bleeding issue, and in some cases Xarelto bleedout has been linked to Xarelto Death.

Plaintiffs further assert that Xarelto bleeding complications were exacerbated by the unavailability of an antidote, and further allege that Janssen Pharmaceuticals, Johnson & Johnson and Bayer AG were negligent in claiming that less monitoring was required, suggesting that additional monitoring would have been prudent given the lack of an antidote.

Now, Xarelto lawsuit plaintiffs have more fodder with the recall of the INRatio anti-coagulation monitoring device by Alere Inc. The concern surrounds warfarin patients enrolled in the ROCKET-AF study who were monitored using the INRatio device – and that a suspected inaccuracy in some of the readings involving warfarin patients may have skewed the data in rivaroxaban’s favor (Xarelto).

The FDA has since gone on record as saying that after closely scrutinizing the issue, the federal agency is satisfied the allegedly faulty INRatio device did not have a substantial effect on the outcome of the ROCKET-AF trial, did not favor Xarelto in any significant way, and in the FDA’s view rivaroxaban continues to be a safe and effective alternative to warfarin in patients suffering from atrial fibrillation.

That’s not likely to stem additional Xarelto side effects lawsuits, or placate existing plaintiffs.

The bellwether Xarelto trial set to begin in February was originally filed in 2014 by a plaintiff who claims to have been on Xarelto for just one month, before he began to experience a Xarelto bleeding issue.

The Xarelto bleedout, described as severe gastrointestinal bleeding, landed the man in hospital where he underwent several blood transfusions. The plaintiff’s Xarelto lawsuit is expected to be heard in US District Court for the Eastern District of Louisiana, in February.