According to a recent article in the Pennsylvania Record, lawyers for the plaintiffs in consolidated mass tort Xarelto litigation in Philadelphia likened one of the early clinical trials conducted by manufacturers as a “total mess” and similar to a school science fair project.

All federally filed Xarelto lawsuits were consolidated into the Eastern District of Louisiana in December 2014.In January 2015, the Philadelphia Court of Common Pleas established a Xarelto mass tort for litigation after 75 complaints had been filed there.

Today, there are over 800 Xarelto lawsuits pending in Philadelphia, with plaintiffs claiming to have taken the anticoagulant and then to have suffered from serious injuries, often gastrointestinal bleeding or stroke. The plaintiffs accuse the drug manufacturers Janssen Pharmaceuticals, parent company Johnson & Johnson, and Bayer AG of failing to provide adequate warnings as to the risks associated with the drug, and for failing to conduct adequate safety studies before releasing the product on the market.

The first Philadelphia bellwether trial is expected to begin in summer, 2017, while the first trial in the Xarelto MDL in Louisiana—where over 6,000 cases are pending—is expected to begin in February 2017.

Defective Device Could Have Skewed Xarelto Clinical Trial Results

In December 2015, the British Medical Journal (BMJ)  published a report warning that during the ROCKET-AF clinical trials, which compared the rate of bleeding events between Xarelto (rivaroxaban) and Coumadin (warfarin), the scientists used a defective device. The device was supposed to measure the amount of warfarin in a patient’s blood, after which researchers could adjust the dosage accordingly.

Turns out, however, that the device could deliver results that were falsely low. The company that made the device—Alere— recalled it in December 2014 because this defect, after the company had received 19,000 reports of malfunctions.

BMJ stated that data from the trial “is being reanalyzed because of the use of a faulty device,” and that the European Medicines Agency had launched an investigation into the trial. The incorrect readings could have resulted in patients receiving a dose that was too high, which would increase their risk of bleeding, making it look like warfarin was linked to more excessive bleeding events than perhaps it should have been.

This also could have created false results for Xarelto, which according to the study results, was similarly effective to warfarin for the prevention of stroke and blood clots in patients with atrial fibrillation.

And this was the main clinical trial used to gain FDA approval for Xarelto in the treatment of non-valvular atrial fibrillation.

Concerns Put to Rest?

The NEJM published a research letter in February 2016 in which a ROCKET-AF lead investigator concluded that any potential malfunctions in the Alere device didn’t have any significant effect on the overall trial findings.

The author of the BMJ report, Dr. Harlan Krumholz, stated that the new data didn’t alleviate his concerns. He explained that though the analysis proved the trial valid, he wished they had done further studies, and would release all data to the public so that other researchers could also review the findings.

Whatever the eventual outcome of the situation, there is no doubt that the quality of the Xarelto clinical studies will be a major topic of contention in the upcoming Xarelto trials.