A Florida woman who suffered from Xarelto internal bleeding is suing the makers of the drug including Janssen Pharmaceuticals, Bayer HealthCare and Johnson & Johnson.

Plaintiff Mattie W. says she began taking Xarelto in July 2014 and continued taking it through January 2016. She claims that as a result of this drug, she experienced severe Xarelto internal bleeding including a large hematoma of her leg, ecchymosis and acute blood loss anemia.

Mattie believes that she has suffered various injuries including serious physical pain and suffering, hospital and surgical expenses, and loss of consortium as a result of her Xarelto bleeding.

Xarelto Internal Bleeding Side Effects

In 2011, the FDA approved Xarelto as part of a new class of drugs called New Oral Anticoagulants, or NOACs. Xarelto has been marketed as part of a new generation of blood thinners that are supposedly an improvement over warfarin (Coumadin), which has been a staple blood thinning treatment for decades.

When the FDA first approved Xarelto, it was mainly used for the prevention of deep vein thrombosis and pulmonary embolism for those patients who have undergone knee or hip replacement surgery. Later it was approved for use in patients to prevent stroke or systemic embolism.

But very soon after Xarelto was approved and entered into wide use, the FDA began receiving adverse event reports. In fact, by June 2012, they had received well over 1,000 reports of excessive bleeding. Of those reports, 65 resulted in death.

By the end of that year, the number of Xarelto adverse event reports grew to 2,000, and the death count more than doubled. Worldwide, this trend continued. German agencies reported nearly 1,000 Xarelto internal bleeding events including 72 fatalities.

Plaintiff Mattie claims that the makers of Xarelto knew that the study upon which the approval of Xarelto was based was flawed and that the manufacturers were negligent in their treatment of the information. In fact, she claims, the FDA found this study so flawed that they deemed it unreliable.

Regardless, Xarelto was still approved for use. Other studies, including the ROCKET AF study, were performed with similar results including claims of flawed management and rationale.

Reportedly, the defendants were aware of connections between Xarelto use and internal bleeding risks, but chose not to utilize this information.

Mattie brings forth claims of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud and violation of consumer protection laws.

This Xarelto Internal Bleeding Lawsuit is Case No. 2:17-cv-02940 in the United States District Court for the Eastern District of Louisiana.