Quality of Xarelto Clinical Trials Expected to be an Issue in 2017 Court Cases

When the first lawsuits involving the blood-thinning drug Xarelto go to trial in 2017, attorneys expect the quality of the clinical trials involved in the drug’s approval to be a major issue.

Xarelto lawsuits have been filed in both federal courts and in state court in Pennsylvania. In both state and federal cases, plaintiffs who took the anticoagulant Xarelto (rivaroxaban) allege that the drug caused serious injuries, including gastrointestinal bleeding and strokes. The federally filed Xarelto cases were consolidated in a multidistrict litigation (MDL) in the Eastern District of Louisiana in December 2014 and in January 2015, a mass tort litigation was established in the Philadelphia Court of Common Pleas, the New York Legal Examiner reports.

The plaintiffs allege that Janssen Pharmaceuticals and the parent company Johnson & Johnson failed to provide adequate warnings to doctors and patients about the risks associated with Xarelto. The lawsuits also allege that the drug maker did not conduct adequate safety studies before bringing Xarelto to market.

Thousands of cases are pending in the Xarelto MDL and the first trial in Louisiana is set for February 2017. The first Philadelphia trial is expected to begin in summer 2017, according to the Legal Examiner.

When these trials begin, plaintiffs’ attorneys are expected to present information about the clinical trials that were the basis for Food and Drug Administration (FDA) approval of Xarelto. The clinical trial compared Xarelto with warfarin, which has been the standard anticoagulant treatment for 60 years. But a December 2015 report in the British Medical Journal (BMJ) said the ROCKET-AF clinical trials used a defective blood-monitoring device when measuring the amount of warfarin in a patient’s blood. The device was supposed to measure warfarin and allow researchers to adjust the warfarin dose as needed. But according to the BMJ report, the defective device gave false low readings. Incorrect readings could have resulted in patients then receiving too high a dose of warfarin, which in turn increases the risk of bleeding. Warfarin may have been linked to more bleeding events than it would have been if patients received the proper dose.

Critics say the blood-monitoring problem gave Xarelto an unwarranted advantage over warfarin in the trials. The blood-monitoring device was recalled in December 2014 after 19,000 reports of malfunctions.

In 2016, the New England Journal of Medicine published a letter from the lead investigator in the trial who said the device malfunction did not have a significant effect on the overall trial findings, according to the Legal Examiner. But Dr. Harlan Krumholz, of Yale Medical School, who is the author of the BMJ report, said he would like the researchers to release all the trial data so that other researchers could review the findings.

Since it came to market, Xarelto has been heavily promoted as an easier and more convenient drug than warfarin. Warfarin users must have regular blood monitoring to be sure they have the proper amount of the drug in their bloodstream and they must follow a restricted diet. Xarelto does not have these restrictions, but warfarin has the advantage of a readily available antidote that can be administered in the event of a bleeding episode. Xarelto users allege that the drug makers were reckless in releasing Xarelto to market without an antidote for bleeding episodes.

 

 

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