Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) and Bayer AG now face nearly 6,000 lawsuits over controversial anticoagulant Xarelto, with more lawsuits being regularly filed every day. Lawsuits allege drug manufacturers failed to adequately warn patients of the bleeding risks associated with Xarelto and failed to warn patients that there is no antidote to reverse its effects.
While all anticoagulants come with some risk of excessive bleeding, plaintiffs in the Xarelto litigation allege Xarelto is more dangerous than other types of anticoagulants like Warfarin. A recent study found patients taking Xarelto were twice as likely to experience a bleeding event than patients taking Warfarin.
Patients taking Xarelto believed the medication was safe because its manufacturers aggressively marketed the drug with clever tactics, including celebrity endorsements. Television ads with golfer Arnold Palmer, NBA player Chris Bosh, NASCAR star Brian Vickers, and Saturday Night Live comedian Kevin Nealon boasted that Xarelto was the “first and only once-a-day prescription blood thinner for patients with AFib not caused by a heart valve problem, that is proven to reduce the risk of stroke – without routine blood monitoring.”
The problem with this statement is that it’s misleading, and the FDA thought so too. In 2013 the FDA sent Xarelto’s manufacturers a warning letter regarding the statement saying it was “false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim.” While the warning letter also asked the manufacturers to discontinue using the statement, the companies ignored the request.
If there’s any consolation for the nearly 6,000 plaintiffs, it’s that the bellwether trial dates are quickly approaching. The first is scheduled to begin in early 2017 and will help set the tone for the Xarelto litigation.