The controversy over Alere INRatio PT/INR monitoring systems and test strips continues after a report published in The BMJ questioned the validity of data in Xarelto clinical trials.
Free Confidential Lawsuit Evaluation: If you or a loved one was injured by an Alere Inratio monitor, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What’s the Problem?
October 19, 2016 – The BMJ report (PDF) warns that INRatio monitors made by Alere Inc., which were used during clinical trials, may have skewed data by underestimating bleeding events associated with Xarelto.
The INRatio device was used during the ROCKET-AF clinical trials, which compared rates of bleeding with Xarelto and warfarin. INRatio was used to measure the amount of warfarin present in test subjects’ blood in an effort to monitor dosing requirements.
In December 2014, Alere recalled its INRatio Test Strips after receiving at least 18,924 false reading reports associated with the products. The company reported 9 adverse events, including 3 deaths.
The BMJ report stated that the ROCKET-AF trial raised serious concerns even before the INRatio recall was associated with the study. Many concerns focused on patients’ use of warfarin in the study that was used to obtain approval for Xarelto from the U.S. Food & Drug Administration (FDA).
“Even before the recall, the ROCKET-AF trial had been criticized for the relatively short time that participants taking warfarin were in the correct therapeutic range of the drug,” The BMJ report stated. “The implication of the criticism was that patients’ use of warfarin was not adequately controlled, which, if correct, would have the effect of making rivaroxaban seem safer and more effective.”
Do I Have an Inratio Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Inratio lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you or a loved one was injured, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.