Xarelto Lawsuit Filed

New York, NYA Xarelto lawsuit alleging patients were not adequately warned about the risk of Xarelto side effects has been filed in New York. The lawsuit is one of only a handful filed so far, although some critics say more lawsuits are expected.

The lawsuit was filed by Shirley and James Boynton against Janssen Research & Development, a subsidiary of Johnson & Johnson, and Bayer Pharmaceuticals on August 29, 2014. According to court documents filed in the case, Shirley Boynton took Xarelto in 2012 and later suffered a bleeding event.

“As a result of using Defendants’ Xarelto, Plaintiff Shirley Boynton, was caused to suffer from life-threatening bleeding on or about August 31, 2012, and was caused to sustain severe and permanent personal injuries, pain, suffering, and emotional distress,” the lawsuit alleges.

Xarelto was approved to reduce the risk of blood clots and strokes. It was marketed as being superior to Coumadin (warfarin) because according to the marketing, patients who take Xarelto do not require regular blood monitoring. Unlike warfarin, however, Xarelto does not currently have an approved antidote, meaning if a patient suffers an uncontrollable bleeding event, there is nothing that can be given to the patient to reverse the effects of Xarelto.

“In the event of hemorrhagic complications, there is no available reversal agent,” court documents state. “The original U.S. label approved when the drug was first marketed in the U.S. did not contain a warning regarding the lack of antidote, but instead only mentioned this important fact in the overdosage section.”

The lawsuit cites “significant money” spent by the defendants in promoting Xarelto. According to the lawsuit, both Shirley Boynton and her prescriber saw promotional materials concerning Xarelto before she was prescribed the medication. Those promotional materials were allegedly the same ones the defendants were warned by the US Food and Drug Administration (FDA) for using due to minimizing the risks associated with Xarelto.

Boynton alleges that the defendants failed to warn critical care medical professionals that there is no effective agent to reverse the effects of Xarelto, and failed to warn patients that if serious bleeding occurs, there is a chance the effects would be irreversible and life-threatening.

According to the lawsuit, during the 12 months before June 30, 2012, the FDA received 1,080 adverse event reports linked to Xarelto, including 65 deaths.

The lawsuit claims that the defendants knew or should have known about the link between Xarelto and bleeding events, and that the defendants did not properly test Xarelto before filing for approval. Based on the allegations made in the lawsuit, Boynton seeks compensatory and punitive damages.

The lawsuit is Shirley Boynton and James Boynton v. Janssen Research & Development, et al. case number 1:14-cv-05133, US District Court, Eastern District of New York.