The heir of a man who died after an acute gastrointestinal bleed caused by Xarelto is suing the drug makers.

Plaintiff Sydell S. is the surviving spouse of Sheldon S. and the administrator of Sheldon’s estate. Sydell claims Sheldon took the blood thinner Xarelto from Jan. 19, 2015 through Feb. 8, 2015.

He allegedly developed anemia, required blood transfusions, and suffered an acute gastrointestinal bleed caused by Xarelto on or about Feb. 8, 2015.

Sheldon died on July 4, 2015.

Plaintiff: Drug Manufacturer Hides Fact Xarelto Is Dangerous

Xarelto is backed by Janssen Research & Development LLC, a subsidiary of Johnson & Johnson, and by Bayer. These big companies invested millions of dollars into the marketing of Xarelto as a convenient blood thinner that does not require blood monitoring and is taken as a single daily dose.

According to the Xarelto lawsuit, “[t]he single dose and no blood testing requirements or dietary constraints rare marked by defendants as the ‘Xarelto Difference.’ However, Xarelto’s clinical studies show that Xarelto is safer and more effective when there is blood monitoring, dose adjustments and twice a day dosing.”

Plaintiffs claim the defendants’ promotional materials did not adequately represent that Xarelto is dangerous. In fact, Xarelto is accused of misleading the public and medical community by claiming the drug was more effective than warfarin and that no blood monitoring was needed to ensure its safety.

However, many patients have reported suffering from an acute gastrointestinal bleed caused by Xarelto.

Xarelto One of New Oral Anticoagulants

Xarelto became available in the U.S. in 2011. It belongs to a class of drugs called New Oral Anticoagulants (NOACs). Pradaxa and Eliquis are also NOACs, all of which have been heavily marketed as the next generation of blood-thinners to replace warfarin (Coumadin).

Warfarin needs blood monitoring in order to verify a therapeutic level of the drug stays in the system. It has been established as a reliable 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.

Xarelto Studies Had Issues, Plaintiffs Say

According to the Xarelto litigation, studies named the ROCKET AF Study, the RECORD studies, and the EINSTEIN studies have been used to promote Xarelto. But “the RECORD studies were flawed in design and conducted in a negligent manner,” alleges the Xarelto lawsuit.

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

The lawsuit addresses findings in the ROCKET AF study as well.

“The ROCKET AF study showed that Xarelto was non-inferior to warfarin” to prevent stroke or PE with a similar bleeding risk. “However, ‘bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the rivaroxaban group, as did bleeding that led to a drop in the hemoglobin level or bleeding that required transfusion,’” according to the New England Journal of Medicine in 2011.

If you or someone you love has taken the blood thinner and developed an acute gastrointestinal bleed caused by Xarelto, you may be able to benefit from speaking with a lawyer.

The Xarelto Gastrointestinal Bleed Lawsuit is filed within MDL No. 2592 in the U.S District Court for the Eastern District of Louisiana.