More Xarelto Lawsuits Filed, As MDL Grows

New Orleans, LAMore Xarelto lawsuits alleging patients suffered serious bleeding events after using the anticoagulant have been filed, with the multidistrict litigation now sitting at more than 2,200 consolidated cases. Plaintiffs say they were not adequately warned about the risk of Xarelto side effects, nor were they warned that Xarelto, unlike its predecessor, did not have an approved antidote.

According to court documents from the Judicial Panel on Multidistrict Litigation, as of November 16, 2015, there were 2,266 lawsuits consolidated in MDL 2592, before US District Judge Eldon Fallon. That’s up significantly from the 1,698 lawsuits consolidated as of October 15, 2015.

Xarelto, known generically as rivaroxaban, is a newer-generation anticoagulant, used to reduce the risk of blood clots and strokes. It, like other newer anticoagulants, were developed as an alternative to Coumadin (known generically as warfarin), because Coumadin required regular blood monitoring. Because anticoagulants prevent blood clots, however, they are associated with an increased risk of serious bleeding events.

Coumadin has an antidote in the form of vitamin K. Patients who took Coumadin and experienced a serious bleeding event could be given vitamin K and have the anticoagulant effects reversed. Newer-generation anticoagulants, however, were approved for use on the market without an antidote. That means if patients experienced a bleeding event, they would have to wait for the drug to leave their system. Plaintiffs allege if they had known there was no antidote to Xarelto, they would not have used the medication.

The first bellwether Xarelto trials are expected to go to court early in 2017, meaning there is still time for patients who were affected by Xarelto to file lawsuits.

One such lawsuit was filed by Ashlie Fluitt, whose grandmother died while on Xarelto therapy. The patient, Hattie Deville-Goodwin, was prescribed Xarelto in September 2014 to treat deep vein thrombosis. Only two months after she began using Xarelto, Deville-Goodwin experienced an intracranial bleed, which became an “irreversible and fatal bleed.” She died on November 14, 2014, according to court documents.

The lawsuit claims Xarelto caused life-threatening bleeding, physical pain, extreme mental anguish, and financial expenses for hospitalization and medical care. In her lawsuit, Fluitt alleges that Bayer used the results of various studies to promote Xarelto but did not highlight the increased risk of gastrointestinal bleeding and other serious bleeding events, and did not warn emergency room doctors about the lack of an effective reversal agent for Xarelto. Furthermore, the lawsuit alleges Xarelto marketing “overstated the efficacy of Xarelto with respect to preventing stroke and systemic embolism.”

The lawsuit is Fluitt v. Janssen Research & Development, et al, case number 2:15-cv-05874 in the US District Court, Eastern District of Louisiana.