A man has filed a lawsuit against the makers of Xarelto after his wife died following a Xarelto internal bleeding injury.

Plaintiff Vern H. says his late wife Voncile started using Xarelto in August 2012. She suffered life-threatening bleeding on Feb. 7, 2014 and died on Feb. 10, 2014.

Xarelto is made and backed by a conglomerate of Janssen Research & Development, Johnson and Johnson, and Bayer Healthcare, all of whom are defendants in this case.

The Xarelto lawsuit contends the “defendants negligently and improperly failed to perform sufficient tests, if any, on humans using Xarelto during clinical trials, forcing Plaintiff-decedent, and Plaintiff-decedent’s physicians, hospitals, and/or the FDA, to rely on safety information that applies to other non-valvular atrial fibrillation treatment and DVT/PE treatment and prophylaxis, which does not entirely and/or necessarily apply to Xarelto whatsoever.”

Plaintiff: Xarelto Studies Had Issues

Vern alleges that studies named the ROCKET AF Study, the RECORD studies, and the EINSTEIN studies have been used to promote Xarelto.

But “the promotional materials fail to similarly highlight the increased risk of gastrointestinal bleeding and bleeding that required transfusion, among other serious bleeding concerns,” alleges the Xarelto internal bleeding injury lawsuit.

Vern alleges that within the RECORD studies, the FDA found that there was “’systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties in randomization.’” As a result, he says, the FDA found that the RECORD 4 studies were so flawed that they were deemed unreliable.

The Institute for Safe Medication Practices said that during the approval process, FDA reviewers “questioned the convenient once-a-day dosing scheme (of Xarelto), saying blood level studies had shown peaks and troughs that could be eliminated by twice-a-day dosing.”

The defendants’ Xarelto marketing efforts were in part based on the ease of taking it once a day.

Plaintiff: Xarelto Internal Bleeding Injury Risk Hidden by Big Money Marketing

Xarelto became available in the U.S. in 2011. It belongs to a class of drugs called New Oral Anticoagulants (NOACs). This group of drugs has been heavily marketed as the next generation of blood-thinners to replace warfarin (Coumadin).

Defendants spent at least $11,000,000 in 2013 alone on advertising in journals aimed at prescribers and consumers in the United States. In its first full year of being available on the market, Xarelto generated approximately $582 million in global sales.

Xarelto was touted as being a better drug than the older anticoagulant, warfarin. Warfarin needs blood monitoring in order to verify a therapeutic level of the drug stays in the system. Warfarin has been established as a relatively safe treatment to prevent stroke and systemic embolism for 60 years.

In the event warfarin’s anticoagulant properties need to be reversed, vitamin K is the antidote used. However, there is no available antidote for Xarelto, which is why a Xarelto internal bleeding injury can be a life-threatening condition.

The Xarelto lawsuit states, “At the close of the 2012 fiscal year, a total of 2,081 new Xarelto-associated serious adverse event reports were filed with the FDA in its first full year on the market, ranking tenth among other pharmaceuticals in direct reports to the FDA. Of those reported events, 151 resulted in death, as compared to only 56 deaths associated with warfarin.”

The Xarelto Internal Bleeding Injury Lawsuit is Case No. 2:17-cv-00347-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.