A man has filed a lawsuit against the makers of blood thinner Xarelto after he suffered severe bleeding episodes.

Plaintiff David S. began taking Xarelto in 2014, and he has experienced internal and rectal bleeding since taking the anticoagulant. He’s been hospitalized at least once for uncontrollable bleeding.

The lawsuit against blood thinner Xarelto states David “suffered various injuries, serious physical pain and suffering, medical, hospital and surgical expenses, and loss of consortium as a direct result of Plaintiff’s use of Xarelto.”

Drug Manufacturer Denies Xarelto Is Dangerous

Xarelto (rivaroxaban) 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 blood thinner Xarelto as a convenient drug that does not require blood monitoring and is taken as a single daily dose.

According to the Xarelto lawsuit, Dr. Steven E. Nissen was quoted in an FDA Advisory Meeting transcript as saying, “my concern was that the dose was selected more for a marketing advantage rather than for the scientific data that was available, and was a mistake…”

In its ads, no mention was made that Xarelto was dangerous. In fact, the maker of the blood thinner 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 acute internal bleeding 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 relatively safe treatment to prevent stroke and systemic embolism for 60 years. In the event the anticoagulant properties need to be reversed, vitamin K is the antidote used.

Xarelto Studies Had Issues

Studies named the ROCKET AF Study, the RECORD studies, and the EINSTEIN studies as being 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 developed internal bleeding caused by blood thinner Xarelto, you could benefit from speaking with a lawyer.

The Blood Thinner Xarelto Lawsuit is Case No. 2:16-cv-17867, in the U.S. District Court for the Eastern District of Louisiana.