FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

Janssen, Bayer Facing Another Lawsuit Over Blood Thinner Xarelto

Sept. 18, 2015

Janssen and Bayer are facing yet another lawsuit over alleged gastrointestinal bleeding with their blood thinner Xarelto, this time from 25 plaintiffs in six states.

The plaintiffs have requested that they be part of multidistrict litigation being heard in the U.S. District Court for the Eastern District of Louisiana.

The complaint filed last week maintains that the “Xarelto Difference” once-daily dose and no blood testing requirements went against case studies that showed the drug is safer and more effective when there is blood monitoring, dose adjustments and twice-a-day dosing. It also claims that the drugmakers failed to provide adequate warnings about safety risks. Unlike warfarin, Xarelto’s anticoagulant effects cannot be reversed by drugs or other means.

Xarelto achieved blockbuster status with sales of about $2 billion in 2013, bolstered by an $11 million advertising blitz aimed at U.S. prescribers and consumers, the plaintiffs charge in Kimberly Adams, et. al v. Janssen Research & Development, et. al.

A similar lawsuit, Mary Walker et al v. Janssen, was filed in March by 12 plaintiffs in California. They also requested that their case be transferred to the multidistrict litigation, In Re Xarelto (Rivaroxaban) Liability Litigation.

Janssen and Bayer maintain that Xarelto’s safety warnings are adequate. — John Bechtel