Xarelto Case Alleges Bleeding Risks Were Hidden by Drug Maker

A new Xarelto case alleges the drug’s makers knew the risks of dangerous internal bleeding but failed to warn consumers and health care workers.

Generically known as rivroxaban, Xarelto is a blood thinner that was designed, manufactured, researched, marketed and sold by a combination of companies, including Janssen Research & Development, Johnson & Johnson, and Bayer.

Xarelto has been marketed as a superior alternative to Coumadin, generically known as warfarin, which is a blood thinner has been around for about 50 years.

When taking warfarin, a patient needs to take blood tests to determine how fast the blood clots. This test assures the right dosage is maintained.

If for some reason a patient needs to have warfarin’s anticoagulant properties cease due to accident or injury, a number of options for reversal are available, including vitamin K.

One of Xarelto’s biggest selling points is that it does not need any testing in order to ensure a therapeutic level is maintained. This—along with its once-daily dosing—has been marketed as “the Xarelto Difference.”

However, patients tolerate Xarelto differently, which means some patients are more prone to Xarelto internal bleed injuries.

In Sherri’s Xarelto case, documents note she began taking the drug around Jan. 5, 2015 for the treatment of deep vein thrombosis. She took Xarelto as directed through mid-April 2015.

However, Sherri “experienced an acute gastrointestinal bleed on or about April 14, 2015, and suffered a life-threatening, irreversible uterine bleed and hemorrhagic shock, from the use of Xarelto, as well as severe pain and suffering.”

History of Xarelto Injuries

Xarelto bleeding injuries and failure to prevent a stroke or pulmonary embolism topped the list of adverse events submitted to the FDA in 2015, according to the Institute for Safe Medication Practices (ISMP).

Prior to these adverse event reports, the drug’s marketing department spent more than $11 million in 2013 promoting the drug. In the third quarter of the 2013 fiscal year, Xarelto was the number one pharmaceutical promoted in professional health journals based on pages and dollars spent.

Xarelto brought in $582 million in global sales in its first full year of being on the market.

The Xarelto case points out that the Institute for Safe Medication Practices noted in 2012 that during the FDA’s review process of Xarelto, “reviewers questioned the convenient once-a-day dosing scheme” of Xarelto because blood level studies had suggested that “blood level studies had shown peaks and troughs that could be eliminated by twice-a-day dosing.”

Currently, there is no antidote for Xarelto. If a person experiences excessive bleeding, there is no reversal agent available to counteract it.

According to clinical trials for Xarelto’s approval for treatment of deep vein thrombosis and pulmonary embolism, Xarelto showed an “obvious increased risk of bleeding events as compared to placebo” and “an increased risk of adverse events with Xarelto, including those that resulted in permanent discontinuation of Xarelto or prolonged hospitalization.”

The Xarelto case says that “defendants failed to either alert the public and the scientific community or perform further investigation into the safety of Xarelto.”

The Xarelto Case is Case No. 2:17-cv-02040-EEF-MBN filed in the U.S. District Court Eastern District of Louisiana.

If you or a loved one suffered an injury after taking Xarelto or another drug, you may be entitled to compensation. Contact Bradley/Grombacher today for more information.

Note: Bradley/Grombacher is not representing the plaintiff in this lawsuit.