A Xarelto cerebral bleeding lawsuit has been filed by a woman who suffered the brain bleed just days after starting the blood thinner.

Karen N. was prescribed Xarelto (rivaroxaban) and began using it on June 16, 2017. She took the anticoagulant through June 20, 2017, which is when she experienced cerebral bleeding.

Xarelto is a product of pharmaceutical giants Johnson & Johnson, Janssen and Bayer. Known as one of the New Oral Anticoagulants (NOACs), Xarelto has been advertised as a breakthrough blood-thinning drug designed to replace warfarin (Coumadin), an established drug used to prevent stroke and systemic embolism for the past 60 years.

Warfarin has faced criticism because a patient’s blood must be monitored with periodic testing to ensure a therapeutic level is maintained. Users also face some dietary restrictions and must adhere to a twice daily dose. However, in the event of an injury or accident, the blood clotting effects of warfarin can be halted with an IV dose of vitamin K. No such antidote for Xarelto’s clotting inhibition exists.

According to the cerebral bleeding lawsuit, the drug makers failed to warn doctors that there is “no effective means to treat and stabilize patients who experience uncontrolled bleeding while taking Xarelto.”

As a result, “if serious bleeding occurs, it may be irreversible, permanently disabling, and life-threatening.”

The FDA reportedly received 1,080 Serious Adverse Event Medwatch reports from June 2011 to June 2012, including at least 65 deaths. Of the reported uncontrollable bleeding events, eight percent ended in death, nearly twice as many hemorrhage-related deaths as seen with warfarin.

Possibility of Cerebral Bleeding Not Disclosed

In 2013, the drug companies spent a minimum of $11 million advertising Xarelto. Their efforts produced $582 million in global sales during the drug’s first full year on the market.

While marketers promoted “The Xarelto Difference,” the same promotional materials failed to indicate “that it is difficult or impossible to assess the degree and/or extent of anticoagulation in patients taking Xarelto.”

Even though Xarelto was promoted as a one-dose-fits-all medication, patients would experience different results based on their own biological makeup. A dose that could effectively prevent one person from having a stroke could cause another patient to suffer cerebral bleeding.

Karen’s cerebral bleeding caused by Xarelto has left her with permanent injuries that have diminished her ability to enjoy life and caused her to incur extensive financial expenses for hospitalization and subsequent medical care.

The cerebral bleeding lawsuit contends that Johnson & Johnson, Janssen and Bayer knew that Xarelto was a defective medication that “posed a risk of serious injury and death.”

The drug companies knew or should have known that Xarelto was more apt to induce uncontrollable cerebral bleeding that could be life-threatening than other blood thinners on the market.

The Cerebral Bleeding Lawsuit is Case No. 2:18-cv-00744-EEF-MBN, in the U.S. District Court for the Eastern District of Louisiana.