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On May 3, 2017, a North Carolina woman filed a new Xarelto lawsuit against manufacturers Janssen Pharmaceuticals, parent company Johnson & Johnson, and Bayer AG. She joined the current Xarelto MDL underway in the Eastern District of Louisiana, where the second bellwether trial began on May 30, 2017.

North Carolina Plaintiff Blames Xarelto for Bleed Injury

Over 18,000 other Xarelto lawsuits are currently pending in the consolidated MDL litigation. In the new complaint, the North Carolina plaintiff alleges that she took Xarelto from December 2013 to September 17, 2016. On September 15, 2016, she developed hematuria (blood in the urine) and required related medical treatment and care as result of her Xarelto use.

In her complaint, the plaintiff cites that the RECORD clinical studies for Xarelto were used to gain FDA approval of the drug for the prevention of blood clots in patients undergoing hip and knee replacement surgeries. This study showed that Xarelto was more likely to lead to bleeding problems than other similar anticoagulant drugs. She also notes that FDA inspections in 2009 for certain clinical trial testing sites disclosed violations, including systematic discarding of medical records and falsification in the study, and found the RECORD 4 studies so flawed the FDA deemed them to be unreliable.

Plaintiff Points Out Flaws in Xarelto Clinical Trials

The plaintiff also points out shortcomings in the ROCKET study, which was used to gain FDA approval for Xarelto to reduce risk of stroke and blood clots in patients with non-valvular atrial fibrillation. This study demonstrated that Xarelto and warfarin (the leading anti-coagulant for decades) had similar outcomes terms of their ability to prevent stroke and blood clots, but Xarelto was more likely to cause gastrointestinal bleeding.

This study,  however, was also fraught with problems. The warfarin group was found to be poorly managed, and the FDA noted in an Advisory Committee briefing document that the data comparing Xarelto to warfarin wasn’t adequate for determining whether Xarelto was as effective as warfarin for people with non-valvular atrial fibrillation.

The Public Citizen group, which acts as a consumer watchdog, was so concerned about the study that it wrote to the FDA strongly opposing Xarelto’s approval of for this purpose.

The plaintiff also notes that the FDA expressed concern about Xarelto’s once-a-day dosing, stating, for example, that twice daily dosing would produce a more steady action in the patient’s blood that that this may be associated with greater efficacy and/or a better safety profile.

Plaintiff Claims Xarelto Was Over-Promoted

According to the plaintiff, the drug manufacturers also over-promoted Xarelto, despite its health risks. In 2013 alone, the defendants spent at least $11 million on targeted advertising to induce prescribers and consumers to use Xarelto. The defendants’ marketing claims were allegedly based on “flawed science” . The drug manufacturers marketed the fact that patients using Xarelto didn’t have to undergo regular blood monitoring, even though blood monitoring would have been beneficial. By failing to disclose the fact that there was no readily available antidote for excessive bleeding, the defendants also overstated the drug’s benefits.

Because of their aggressive marketing, Xarelto earned around $582 million in sales globally in its first full year on the market. On June 6, 2013, the FDA sent the manufacturers a warning letter stating that their promotional material was false and misleading because it minimized the risks associated with Xarelto.

The plaintiff seeks compensatory, economic, and punitive damages.

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