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First Xarelto Bellwether Trial Goes to the Defense

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New Orleans, LAThe long-anticipated first bellwether trial in multidistrict litigation for Xarelto side effects has gone to the defendants. Plaintiff Joseph Boudreaux’s trial commenced April 24 and all eyes were on the litigation as an indicator as to how other bellwether trials might go.

This Xarelto lawsuit was a win for Johnson & Johnson, Janssen Pharmaceuticals and Bayer HealthCare Pharmaceuticals Inc.

Xarelto is one of the so-called new-age blood thinners approved by the US Food and Drug Administration (FDA) as a competitor against Coumadin (warfarin), a long-standing anti-coagulant that has been used for 50 years or more. Coumadin has proven effective for a generation in the prevention of stroke and blood clots, but requires intensive and ongoing management to ensure optimum dosage that is deemed safe for the patient.

Xarelto was heralded as the breakthrough many doctors and their patients were seeking, claiming to be safe and effective in thinning blood without the degree of management required for warfarin.

Xarelto plaintiffs, however have a different view. They claim to have been unaware Xarelto was brought to market without an effective antidote in the event of a Xarelto bleeding issue (the clotting properties of warfarin can be reversed with an infusion of Vitamin K), and in so doing should have required even more stringent monitoring in view of the risk for Xarelto bleeding complications – even Xarelto death.

Plaintiff Boudreaux was prescribed Xarelto in January, 2014 for atrial fibrillation. According to court documents he was hospitalized less than a month later for what was deemed a dangerous gastrointestinal Xarelto bleedout, and Boudreaux required blood transfusions.

He sued, asserting that Janssen – a unit of Johnson & Johnson – and Bayer misrepresented the safety and efficacy of the drug to both the FDA and the consumer. Boudreaux also claimed there were issues at play surrounding the clinical trials undertaken prior to the approval of Xarelto.

Additionally, Boudreaux claimed in his Xarelto side effects lawsuit that the defendants were negligent in not employing a clotting factor test as a prerequisite to prescribing Xarelto. In the bellwether trial, however, the jury rejected that claim. Bayer noted that neither the FDA nor any other health regulator in 130 countries require such a clotting factor test as a condition of prescribing Xarelto.

In the days leading up to Boudreaux’s bellwether trial, the defendants moved motions for partial summary judgement. However US District Court Judge Eldon Fallon denied the motions, citing federal preemption as a defense to claims over the alleged Xarelto mis-dosing and a label with allegedly inadequate warnings.

Judge Fallon indicated in his ruling that Janssen and Bayer had not made a sufficiently convincing case that FDA regulations stood in the way of updating labels, or for that matter the creation of more tailored dose-analysis guidelines.

Xarelto was brought to market in 2011, earning a respectable $582 million for its creators in its first year. By 2013, sales had risen to in excess of $2 billion. However, to temper that success were reports of Xarelto side effects that numbered into the thousands by the end of Xarelto’s second year on the market. To that end there were more than 2,000 reports filed with the FDA’s Adverse Events Reporting System (AERS) of Xarelto bleeding complications and other adverse events.

Xarelto lawsuit plaintiffs claim 151 of those cases resulted in Xarelto death.

Janssen and Bayer stand behind their product.

There are Xarelto lawsuits filed at the state level, with thousands of federal lawsuits housed in multidistrict litigation before Judge Fallon. All eyes will be on the next Xarelto bellwether trial, to see if the pendulum of justice swings a different way.

The Xarelto bleeding complications MDL is In re: Xarelto (Rivaroxaban) Products Liability Litigation, Case No. 2:14-md-02592, in the US District Court for the Eastern District of Louisiana.


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