In New Lawsuit, Son Alleges Xarelto Caused His Mother’s Death

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As executor for his mother’s estate, a son has filed a lawsuit against several pharmaceutical companies alleging that the anticoagulant drug Xarelto caused his mother’s death.

The lawsuit names Janssen Research & Development LLC, Janssen Ortho LLC, Janssen Pharmaceuticals Inc., and Bayer Healthcare Pharmaceuticals Inc. as defendants. The suit was filed on May 25, 2016 in the U.S. District Court for the Eastern District of Louisiana, where Xarelto cases have been consolidated into a multidistrict litigation (MDL). The lawsuit alleges strict liability, manufacturing defect and other claims, the Louisiana Record reports.The legal complaint says the deceased woman took Xarelto (rivaroxaban) from around June 30, 2014, to July 6, 2014. After suffering severe internal bleeding, she died on July 6, 2014. The son says the defendants are responsible because they designed, manufactured, tested, advertised, marketed, distributed and sold Xarelto, and they failed to properly investigate the safety of the drug. In addition, the defendants failed to adequately test Xarelto or provide adequate warnings of bleeding risk, and they failed to disclose the need for dose adjustments; and failed to provide adequate instructions for the drug’s use, according to the Louisiana Record.

Xarelto and other new blood thinners in its class have captured a large share of the market from the long-established drug warfarin, largely because these drugs claim greater convenience. The doctor does not have to order regular blood monitoring and the patient does not need to adhere to a set of dietary restrictions. Warfarin requires both blood monitoring and dietary restrictions. But despite its greater convenience, Xarelto has a significant risk: there is no known antidote in the event of a bleeding episode.

In their lawsuits, Xarelto users say the company’s advertising fails to give crucial information about the bleeding risk. A series of television ads feature celebrity Xarelto users, like golf legend Arnold Palmer, who happily speak about being able to eat what they want and not having to have regular blood tests. But the celebrities do not mention the bleeding risks and the lack of an antidote.

Janssen also faces controversy over the clinical trial that seemed to establish Xarelto’s superiority to warfarin. The clinical trial conducted by Duke University researchers is now under investigation and the results of the trial are being questioned. The trial used blood-testing device that may have resulted in warfarin patients being given an incorrect dose, which gave an unfair advantage to Xarelto.

More than 5,000 Xarelto bleeding cases have been filed by Xarelto users themselves or surviving family members. The first trials in the multidistrict litigation are scheduled begin in early 2017. In a large litigation like this, the first cases—bellwether cases—are chosen as representatives of a large number of similar claims against the defendants. The outcome of bellwether cases can guide what happens in the remaining cases. Depending on the jury decisions in early cases, the parties may choose to work on a settlement or they may go forward with more individual trials.

In the new case, the plaintiff is requesting a jury trial and her seeks compensatory damages, attorneys’ fees, court costs and any further relief that the court deems appropriate.