Xarelto Bellwether Trial and its Consequences

Defective Drugs
Xarelto Bellwether Trial

The dust is finally beginning to settle after the April 24, 2017 verdict of the first Xarelto bellwether trial.  This outcome has opened floodgates in the minds of both the plaintiffs and defendant lawyers, who are now dissecting the case to understand what impact it might have on their cases. The outcome created ripples across the country as it was evident that the plaintiff’s injury was caused by Xarelto and was backed by medical evidence. What shielded the defendant is winning on the grounds of ‘learned intermediary doctrine,’ one of the most potent legal doctrines used by defense lawyers.

Xarelto (Rivaroxaban) was launched in 2011 as an anticoagulant that works by blocking certain clotting proteins in the blood. It is mainly prescribed to patients for atrial fibrillation, deep vein thrombosis (DVT) or pulmonary embolus (PE) conditions wherein it prevents the formation of a blood clot, thereby, prevents it from reaching the heart and lungs.

Patients readily took to Xarelto from a standard anticoagulant, Warfarin, which required a rigorous routine of blood level monitoring. Xarelto came with the ease of an average single dose per day, without any hassles of regular blood level monitoring of the patient. Soon it became the top grossing anticoagulant on the market. This trend continued until reports started pouring in from different parts of the country about the serious internal bleeding injuries. The lack of any reversal agent to treat the patient was another factor that brought unwanted attention to Xarelto. Today, Xarelto lawsuit filings have exceeded 18,000.

Although adverse events were reported to the FDA, it did not result in any recall of the product, but the FDA did release two serious ‘black-box’ warnings in 2013 and 2014 along with many other safety warnings regarding the use of Xarelto. The FDA also investigated the clinical trial data submitted by the manufacturer when it received reports of the data being inaccurate. After reviewing this situation, FDA declared that the data was unreliable. Many research studies have also been conducted in parallel to this investigation, all pointing at the makers and marketers for withholding important information. There is also a serious allegation, that in spite of having knowledge the drugmakers concealed data that a measuring device used during clinical trials was defective.

Not surprisingly failure to provide adequate warnings about the safety risks, specifically uncontrolled bleeding and the related complications, is one of the strongest allegations faced by the defendants along with showing inadequacy in testing, researching and studying the drug, increased risk of gastrointestinal bleeds, to name a few.

The ‘learned intermediary doctrine’ was the only recourse left for the defendants that had a chance to stand against the allegations. It bore fruit as the jury couldn’t deny the fact that the drug makers did not fail to provide the plaintiff’s cardiologist, adequate instructions for the safe use of Xarelto; the jury rejected the singular claim regarding a blood clotting test that neither the FDA nor any other health regulator has said should be used by doctors to check whether patients should use or continue with Xarelto.

Winning the first bellwether trial might be a big victory for Xarelto manufacturers. This verdict, however, has not deterred the confidence and morale of the lawyers for remaining 39 cases to be heard soon. The second bellwether case began in the last week of May and it will be followed by third in August.

This article was submitted by Neural IT. Neural IT provides cost effective and timely medical reviews for screening potential mass tort cases. For more information, please visit www.neuralit.com. You may email us at info@neuralit.com or call +1-844-NIT-TEAM (648-8326). 

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