Relatives of James Hibisch filed a lawsuit against Xarelto’s manufacturers alleging product liability, design defect, failure to warn, breach of express warranty, and fraudulent misrepresentation.
Mr. Hibisch was prescribed the blood thinner Xarelto on May 8, 2014. Just three days later, Mr. Hibisch suffered a severe bleeding event that caused hemorrhaging and anemia. Because the FDA approved Xarelto without a reversal agent, there is no consistent method available to reverse the effects of the medication. Mr. Hibisch is one of thousands of patients who experienced uncontrollable bleeding while taking Xarelto.
When the Food and Drug Administration (FDA) approved Xarelto in 2011, it quickly became the preferred blood thinner by most doctors and patients because it did not require routine blood monitoring.
Xarelto was heavily marketed in the United States, but only two years after the drug’s approval, the FDA sent Xarelto’s manufacturers a warning letter for false and misleading advertising claims. Rather than complying with the FDA warning, Xarelto’s manufacturers continued to use misleading statements in advertisements, including in televisions commercials with celebrity endorsements.
Xarelto might best be known by its star-studded commercials that include golfer Arnold Palmer, NBA player Chris Bosh, NASCAR star Brian Vickers, and Saturday Night Live comedian Kevin Nealon.
But misleading advertising isn’t Xarelto’s only problem. In 2014, a blood monitoring device used in the Xarelto clinical trials was recalled because it provided erroneous readings. Since that monitor was used in a trial that helped Xarelto gain FDA approval, the approval may have been obtained with false information. If compromised clinical trial data wasn’t bad enough, a recent study found Xarelto readmission rates were slightly higher than patients taking an alternative blood thinner, Lovenox.
Plaintiffs have suffered a variety of Xarelto bleeding events, including intestinal bleeding, brain hemorrhaging, rectal bleeding, and other internal bleeding. There are currently more than 5,300 lawsuits alleging Xarelto’s manufacturers failed to warn doctors and the patients of the risks associated with the drug. The next Xarelto trials are scheduled to begin in early 2017.