Blood Testing Device Problems in Xarelto Clinical Trials Covered Up by J&J: The BMJ

Another medical journal says that Johnson & Johnson deceived the FDA and the medical community by failing to report that a blood monitoring device used during Xarelto clinical trials may have been defective, potentially leading to miscalculations about bleeding risks with Xarelto. 

According to an investigation by The BMJ, Johnson & Johnson’s Janssen subsidiary withheld information about potential problems with the Alere INRatio device used during the phase III ROCKET AF clinical trials. The results of those trials were used to obtain approval for Xarelto from the FDA.

According to The BMJ, trial investigators were concerned about the accuracy and reliability of the INRatio shortly after the trial began, but those concerns were not forwarded to the FDA. Bayer, which was also involved in the development of the drug, shared those concerns, but the BMJ investigation determined that the company did not know that Janssen had a safety program in place, called Covance, which first raised issues about the device.

Bayer officials say Janssen was responsible for managing the clinical trials.

In March, the New York Times reported that editors at the New England Journal of Medicine had expressed concerns that they had been lied to by researchers out of Duke University, who ran the ROCKET AF trials. The report indicated that the editors felt they had been misled about the existence of data on the INRatio which would have raised questions about the accuracy of the trial’s results.

An Alere InRation recall was announced by the FDA in July 2016, after the agency found that the manufacturer of the device failed to fix inaccuracies with the blood thinner monitor in 2014, following 19,000 reports of incorrect results by consumers and health care professionals, 14 of which resulted in serious injuries.

The device was used in the Xarelto clinical trials to measure the blood’s ability to clot and the amount of time it takes to do so. The trials are now under investigation by the FDA and other global health agencies. However, the agency’s new commissioner, Dr. Robert Cardiff, was also in charge of some of those Xarelto clinical trials as well.

The Xarelto blood testing problems in the clinical trial were first reported in the medical journal The BMJ in December, with researchers warning that the device may have led to an underestimation of the rate of Xarelto bleeding complications in comparison to warfarin.

The ROCKET-AF clinical trials compared the rate of bleeding events between Xarelto (rivaroxaban) and Coumadin (warfarin). The Alere INRatio was used to measure the levels of warfarin in patients’ blood and was used to adjust their dosage.

Xarelto Lawsuits Over Bleeding Problems

Xarelto (rivaroxaban) is part of a new class of blood thinners introduced in recent years as a replacement for warfarin, which had been the go-to anticoagulation treatment for decades. Since it was approved in 2011, this new-generation treatment has been commonly prescribed instead of warfarin for reduction of the risk of blood clots and strokes among patients with atrial fibrillation, or following hip or knee replacement surgery.

Amid allegations that the drug makers failed to adequately warn about the risk of bleeding, nearly 11,000 Xarelto lawsuits have been filed in courts throughout the U.S., each raising similar allegations that plaintiffs suffered severe and sometimes fatal injuries due to uncontrollable bleeding while on the medication.

While users of warfarin can be given a dose of vitamin K to reduce the blood thinning effects of the medication, there were no similar reversal agents available for Xarelto at the time it was introduced, placing doctors in a position where they were unable to control many bleeding problems.

Lawsuits also allege that the drug makers provided false and misleading information about the importance of blood monitoring on Xarelto, marketing the drug as easier to use and indicating that it does not require close testing like warfarin. However, independent studies published after the medication was introduced have suggested that Xarelto monitoring may help identify patients at greater risk of bleeds.

As part of the coordinated proceedings in the federal Xarelto litigation, a small group of “bellwether” cases are being prepared for early trial dates, which are expected to begin early next year to help gauge how juries may respond to certain evidence that has been obtained during the discovery process.

While the outcome of these early bellwether trials will not be binding in other cases, they may facilitate Xarelto settlement negotiations that will avoid the need for thousands of individual cases to go to trial nationwide.