A recent investigation report says a drug manufacturer withheld information about a faulty device used in Xarelto clinical trials.

The report, published in the journal BMJ in September 2016, says pharmaceutical manufacturer Janssen Pharmaceuticals never reported to the U.S. Food and Drug Administration about problems with the INRation device used in the ROCKET AF clinical trials for the anticoagulant medication Xarelto.

The FDA used data from this clinical trial in the course of approving Xarelto for sale in the U.S.

Xarelto is a relatively new anticoagulant drug designed to be an alternative to warfarin. Since being approved for sale by the FDA, Xarelto has generated enormous revenue for Janssen and its parent company Johnson & Johnson. Sales of Xarelto almost reached $2 billion in 2015.

Xarelto Clinical Trials Called into Question

The INRation device is a point-of-care device used to monitor patients receiving warfarin, a different anticoagulant medication and a competitor to Xarelto.

The FDA ultimately issued a recall of the INRation device in 2014, saying it generated results that differed significantly from those produced by lab methods.

The report says problems with the device could have put trial participants at unnecessary risk.

Shortly after the Xarelto clinical trials got underway, investigators expressed concern about the device’s accuracy and reliability. In response to the investigators’ concerns, Janssen set up a safety program called the Covance recheck program.

Despite having this recheck program in place, Janssen failed to share data related to the suspect device with the FDA, according to the report. The company also failed to share data from the recheck program with the clinical trial’s safety monitoring board, the report says.

The report also suggests Janssen withheld information from its partner company Bayer Pharmaceuticals. Bayer is a Germany-based company that cooperated in the development of Xarelto and had an interest in the outcome of the Xarelto clinical trials.

Although Bayer executives were similarly concerned about the INRation device, Janssen apparently never told them about the existence of the recheck program.

One Bayer official said as much in his testimony during a Xarelto lawsuit, reporting that Janssen kept the existence of the recheck program to itself.

Bayer balked at any suggestion that it would have similarly withheld information. In a formal statement, the company says it “[e]xpressly contradicts with the allegation that Bayer would have withheld safety data from drug regulators and the safety monitoring board of the ROCKET AF trial.”

Ongoing Xarelto Litigation

The report could become one more card in the hands of plaintiffs already bringing a large number of Xarelto lawsuits.

Generally, these plaintiffs allege they suffered excessive bleeding injuries as a side effect of Xarelto. Many plaintiffs raise allegations of severe gastrointestinal bleeding and hemorrhage inside the skull. Some survivors of Xarelto patients who died from their injuries have filed wrongful death claims.

The plaintiffs claim Janssen and its parent company Johnson & Johnson failed to properly warn them of the bleeding risk associated with the drug. They allege the companies actually misled patients about Xarelto’s safety and efficacy.

Many patients allege they were never properly warned that, unlike warfarin, Xarelto has no available antidote that can get its anticoagulant effect under control in case of emergency.