As the Xarelto lawsuits continue to pile up, BloodThinnerHelp.com has recently released a report regarding Xarelto clinical trials.

Conducted by European regulators, an investigation is currently being launched to evaluate the blood thinner’s clinical trials. This inquiry was launched due to the increasing number of Xarelto lawsuits, filed against Bayer Pharmaceuticals and Janssen Pharmaceuticals.

Each of the claims allege that the blood thinner increases the risk of internal bleeding without the availability of a reversal agent. The investigation is currently being conducted at Duke Institute for Clinical Research, and is focusing on evaluating the clinical Xarelto study information that led to the drug’s approval.

The investigation so far has found that the clinical Xarelto study outcomes had relied on blood testing devices that had been the subject of two FDA warning letters with “one before the trial began and an FDA recall notice after the study ended”, according to the Project on Government Oversight (POGO).

These blood testing devices were from the INRation product line, with the FDA accusing the products of delivering false test results and that the use of the devices could result in life-threatening bleeding injuries and death.

The European Medical Association is investigating the INRatio data, and whether or not it could have impacted the results of Xarelto study data. POGO also reported that the FDA is reviewing the clinical trials surrounding the blood thinner and allegations that they could have been falsified.

POGO officials have taken notice that at the time of Xarelto’s approval in 2011, a number of representatives had expressed concerned over the safety and efficacy of the blood thinner. The reviews of the report also argued that Xarelto may present greater risks than Warfarin, which has an established bleeding antidote.

According to a 2011 statement from a memo from the FDA Deputy Division Director Stephen M. Grant, the division had been “made difficult by the limitations in the design and conduct” of the clinical Xarelto studies.

Xarelto Lawsuits

As the Xarelto study investigation continues, patients continue to file Xarelto claims alleging major internal bleeding injuries. Currently there are over 3,400 Xarelto lawsuits filed making up two major litigation groups.

Over 2,800 federal Xarelto lawsuits have been transferred and consolidated to Eastern Louisiana, while the other group consists of over 600 Xarelto lawsuits consolidated in Philadelphia, Pennsylvania by the Court of Common Pleas to form a mass tort movement.

The litigation is being overseen by Judge Eldon Fallon, with consolidation forming into MDL No. 2592. Bellwether trials for the Xarelto litigation, are expected to begin in early 2017.

As plaintiffs continue through the litigation movement, attorneys involved with the Xarelto lawsuits encourage any patients who suffered side effects from the blood thinner to file legal action. Potential claimants should contact a specialized lawyer, to determine if they a have a Xarelto lawsuit.