The family of a Utah woman who allegedly died in 2012 from Xarelto bleeding problems is suing Janssen Pharmaceuticals, a sister company of Bayer Corp, for failing to warn about the risk of life-threatening Xarelto side effects. They are seeking over $75,000 in damages for her death, which they claim was caused by the blood thinning medication.

Xarelto has been the subject of numerous personal injury lawsuits alleging the drug can cause unstoppable internal bleeding, particularly brain bleeds.

According to the latest Xarelto lawsuit, the decedent Margaret Armstrong began taking Xarelto in February 2012 to reduce her risk of stroke and pulmonary embolism after being diagnosed with atrial fibrillation.

Armstrong allegedly read the package labeling of Xarelto, which had no warning about the risk of life-threatening, irreversible bleeding from the use of Xarelto. Armstrong continued to use Xarelto until August 2012, when disaster struck.

On Aug. 26, 2012, Armstrong was taken to the nearest Utah hospital to be treated for what ultimately was a subdural hematoma, or a collection of blood on the surface of the brain. She was unable to recover and suffered an untimely death just days later on Aug. 30, according to the Xarelto lawsuit.

It is alleged in the Xarelto lawsuit that had Armstrong known about the risk of dangerous and irreversible internal bleeding from Xarelto use, she would have never agreed to be prescribed the drug. In addition, it is alleged that her physician was not properly warned about the high risk of internal bleeding as a result of Xarelto.

Xarelto Bleeding Reports Grow

Xarelto was approved by the Food and Drug Administration (FDA) in July 2011 for the prevention of DVT (deep vein thrombosis) and PE (pulmonary embolism) in patients that have undergone hip replacement surgery.

In November 2011, Xarelto was further approved for patients to reduce their risk of stroke and/or systemic embolism. However, this blood thinning benefit of Xarelto was not made explicit on their labeling until November 2012.

By June 2012, there were over 1,080 serious adverse event reports reported by consumers to the FDA, all involving Xarelto bleeding problems. Of those 1,080 event reports, 65 were deaths. By the end of 2012, there were over 2,000 serious adverse event reports sent to the FDA by consumers that had taken Xarelto — 151 of those cases resulted in death.

In addition, German regulators reportedly received 968 adverse event reports from consumers regarding Xarelto that same year, with 72 of those being deaths.

Dozens of Xarelto bleeding lawsuits have since been filed. Plaintiffs are seeking compensation from Janssen for failure to warn and negligent marketing, manufacture and sale of a product linked to serious injury.