A new lawsuit against drug manufacturers alleges that Xarelto dosage side effects can cause severe and uncontrollable bleeding events, as allegedly happened to a now deceased woman.

Plaintiff Zane W. recently filed a lawsuit against Janssen Pharmaceuticals, Johnson & Johnson, and Bayer, alleging that Xarelto dosage side effects contributed to his wife Carolyn W.’s severe adverse bleeding event and eventual death.

Carolyn allegedly took Xarelto from November 2013 to July 2014. In January 2014, Zane says Carolyn suffered from a severe adverse bleed as an alleged result of her Xarelto ingestion. In January 2017, Carolyn passed away allegedly as a result of Xarelto dosage side effects.

“[Carolyn] was caused to suffer from life-threatening bleeding, as well as other severe and personal injuries, physical pain and mental anguish, including diminished enjoyment of life, expenses for hospitalization and medical treatment, and death, among other damages,” the Xarelto dosage side effects lawsuit claims.

Xarelto is a modern blood thinner approved for the prevention of clotting and stroke in at risk patients. Like most modern blood thinners, Xarelto directly competes with warfarin. Warfarin has been the industry standard blood thinner for around 60 years, making it trusted by both doctors and patients. To compete with this drug, Xarelto manufacturers allegedly chose to market their drug with the “Xarelto Difference”.

The “Xarelto Difference” is once a day dosing and less blood monitoring. Although these benefits make the drug a competitive opponent to warfarin, evidence suggests that these usage recommendations make Xarelto far more dangerous. Clinical trials utilizing once a day dosing showed that Xarelto was associated with an increased risk for internal bleeding when compared to warfarin. However, FDA reviewers noted that the drug’s safety profile was much more favorable when twice a day dosing was utilized.

“There is clinical information from Phase 2 trials […] and from clinical pharmacology studies suggesting that twice daily dosing, which would produce lower peak blood levels and higher trough blood levels of [Xarelto], might have been associated with greater efficacy and/or a better safety profile,” noted the FDA in a statement.

Despite the evidence supporting the safety of Xarelto when used with twice a day dosing, manufacturers allegedly chose the more dangerous, once a day dosing option for marketing purposes.

“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,” one doctor on an FDA committee stated following the manufacturers’ decision.

Zane concurs with this doctors statement in his Xarelto dosage side effects lawsuit, arguing that the drug manufacturers have prioritized their potential profits over the safety of their consumers.

On behalf of his deceased wife, Zane accuses the defendants of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of warranties, negligent misrepresentation, fraud, violation of consumer protection laws, loss of consortium, and wrongful death. The Xarelto dosage side effects lawsuit seeks compensatory damages, economic damages, punitive damages, court costs, and attorneys’ fees.

The Xarelto Dosage Side Effects Lawsuit is Case No. 2:18-cv-07413-EEF-MBN in the United States District Court for the Eastern District of Louisiana.