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On December 28, 2015, another Xarelto lawsuit joined the centralized litigation in the Eastern District of Louisiana. The plaintiff, a resident of New Jersey, brought claims against manufacturers Janssen Pharmaceuticals, parent company Johnson & Johnson, and Bayer Pharma AG.

There are currently over 2,400 Xarelto lawsuits pending in Louisiana, in which plaintiffs claiming that the manufacturers failed to warn about serious risks associated with the blood-thinning drug, including serious gastrointestinal bleeding that can lead to death.

Plaintiff Claims Xarelto Caused Life-Threatening Bleeding

According to her complaint, the plaintiff took Xarelto as prescribed from around November 2013 to April 2014. On March 11, 2014, and again on April 2, 2014, she suffered severe gastrointestinal bleeding, which she claims was caused by Xarelto.

As a result of her injuries, the plaintiff alleges that she had to be hospitalized for the bleeding, and suffered life-threatening effects. She seeks compensation for medical expenses and other non-economic damages.

ROCKET AF Study Poorly Managed to Show Xarelto’s Superiority

The FDA first approved Xarelto in July 2011 to help reduce the risk of blood clots in patients undergoing knee and hip replacement surgery. It later approved the drug for patients with non-valvular atrial fibrillation, to reduce the risk of stroke, and in 2012, to help treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE).

The plaintiff points out that even in the early clinical trial used to gain FDA approval for patients with non-valvular atrial fibrillation (the ROCKET AF trial), Xarelto was associated with an increased risk of gastrointestinal bleeding, which occurred more often in patients taking Xarelto than in those taking warfarin, the leading anti-coagulant for decades.

She also alleges that the warfarin group in that study was poorly managed: “The warfarin group in the ROCKET AF study was the worst managed warfarin study group in any previously reported clinical trial involving warfarin.” She adds that the FDA noted the data comparing Xarelto to warfarin “was not adequate to determine whether Xarelto is as effective for its proposed indication in comparison to warfarin when the latter is used skillfully.”

Consumer watchdog group Public Citizen strongly opposed FDA approval of Xarelto, nothing that the ROCKET AF trial “had a suboptimal control arm…”

Plaintiff Questions Once-a-Day Dosing Rationale

When the manufacturers released Xarelto on the market, they advertised it as a superior option to warfarin because it was more convenient to use. Whereas those taking warfarin need to undergo regular blood monitoring, those taking Xarelto were given a once-a-day dose.

FDA clinical reviewers also questioned the once a day dosing and stated that data from early trials suggested that twice daily dosing might have been associated with greater efficacy and possibly a better safety profile. The plaintiff quotes Dr. Steven E. Nissen, who on an FDA advisory meeting transcript, stated “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…”

Finally, the plaintiff accuses Xarelto manufacturers of overly aggressive marketing of the drug, during which the manufacturers overstated the efficacy of the drug while downplaying the potential side effects. Specifically, she says they failed to tell patients and doctors that there was “no drug, agent, or means to reverse the anticoagulation effects of Xarelto,” effectively making the drug’s effects non-reversible if uncontrolled bleeding occurs in a patient. That makes any bleeding events associated with the drug not only dangerous but potentially life-threatening.

The plaintiff brings counts of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of warranties, negligent misrepresentation, and fraud.

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