An atrial fibrillation patient has filed a claim alleging internal bleeding on Xarelto nearly cost him his life.

Xarelto is part of the class of medications known as the new anti-coagulants that were created to compete with Coumadin—generically known as warfarin—a blood-thinning drug used successfully for decades.

The plaintiff, George S., alleges he suffered internal bleeding on Xarelto while taking the medication for atrial fibrillation according to his physician’s instructions. He is joined by his spouse in this complaint, Ruth S., who is raising a claim for loss of consortium.

Both bring their allegations against Janssen Research and Development, one of the many affiliated companies of Johnson and Johnson Inc. responsible for the research, development, manufacturing, and promotion of Xarelto. In addition, Bayer Healthcare Inc. is also a named defendant.

George and Ruth accuse Janssen and other defendants of promoting the efficacy and overall safety and superiority of Xarelto over Coumadin while knowing the results of one of their own studies pointed in a different direction.

After running the ROCKET AF study, one of Janssen’s clinical trials, data allegedly indicated that internal bleeding on Xarelto—specifically, gastrointestinal bleeding—happened more frequently than in patients taking warfarin.

According to the lawsuit narrative, not only was there a greater chance for internal bleeding on Xarelto as demonstrated by the ROCKET AF study, but there was a greater need for several follow-up blood transfusions.

The complainants allege that the defendants omitted this information while playing up the positive elements of the drug in advertising and marketing materials that they felt set it apart from the competition. The positives that they focused on included the fact the drug needed no dietary modifications and patients could engage in convenient once-a-day dosing without regular blood-monitoring.

According to the complaint, the Xarelto label still does not have a black box warning about the increased risk of internal bleeding on Xarelto.

Also, according to the plaintiffs, the defendants forgot to mention on the label that, unlike Coumadin, internal bleeding on Xarelto could not be corrected by an antidote.

Coumadin—like all blood-thinners—comes with a certain amount of bleeding risk as well by its action on the body, but the medical community has known for decades that a rapid infusion of vitamin K can bring this under control.

The plaintiffs are bringing the following counts against the defendants: Count One—Strict Liability; Count Two—Manufacturing Defect; Count Three—Design Defect; Count Four—Failure to Warn; Count Five—Negligence; and Count Six—Breach of Express Warranty.

They are also bringing these additional counts against them: Count Seven—Breach of Implied Warranty; Count Eight—Fraud; Count Nine—Fraudulent Misrepresentation; Count Ten—Fraudulent Concealment; Count Eleven—Punitive Damages; Count Twelve—Negligent Misrepresentation; Count Thirteen—Loss of Consortium; and Count Fourteen—Violation of Consumer Protection Laws.

George and Ruth are asking for a trial by jury and damages in excess of jurisdictional amount of $75,000. They additionally are asking for a return of all court and attorney fees.

This Xarelto Lawsuit is Case No. 2:17-cv-17174 in the U.S. District Court for the Eastern District of Louisiana.