This litigation has concluded and we are proud to report that our clients' claims have been successfully resolved. The amounts of all individual client recoveries are confidential, both by settlement agreement and by attorney-client privilege. MLG is no longer accepting cases involving this product.
Published on Wednesday, February 24, 2016 by Staff
The following is a summary of an article written by Katie Thomas that was published in the February, 22, 2016 issue of The New York Times.
The results of a key "non-inferiority" clinical trial in which the safety and efficacy of Xarelto® (rivaroxaban) were compared to warfarin are being reviewed by the US Food and Drug Administration (FDA) as well as the European Medicines Agency (EMEA). The reviews are being undertaken to determine if the accuracy of the overall results and conclusions of the clinical trial have been compromised by a blood-clotting measuring device used by the study investigators.
In December, 2014 the FDA issued a recall of the Alere INRatio and INRatio 2Pt/INR Monitor System. These two devices are used to measure how long it takes for blood to clot. “INR” or International Normalized Ratio, is the universal measurement used by laboratories and physicians to determine a patient’s clotting time when he/she is taking warfarin. Too low of an INR means that blood clots will likely form. Too high of an INR means that the patient is at risk for excessive bleeding. An optimum INR is the range where the risk of blood clots and the risk of excessive bleeding are minimized – so somewhere in the middle. For most patients taking warfarin, physicians usually target an INR of 2.0 as being optimal.
According to the FDA, the Alere INRatio and INRatio 2Pt/INR Monitor System devices were recalled because:
"The Alere INRatio Monitor System (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips) may provide an INR result that is lower than expected result obtained using a laboratory INR method. Incorrect results can also occur if a patient has certain medical conditions. These conditions include, anemia, conditions associated with elevated fibrinogen levels, or unusual bleeding or bruising. Incorrect results can also occur if the instructions in the labeling for performing the test are not followed.”
In the Xarelto® clinical trial, patients taking Xarelto® (rivaroxaban) to prevent blood clots were compared to patients taking warfarin. Some of the patients taking warfarin had their INR measured by using the Alere INRatio and INRatio 2Pt/INR Monitor System. If inaccurate INR measurements (“lower than expected”) were recorded using these devices and physicians based their treatment on these patients on such inaccuracies, the results reported for each such patient would not be reliable. If the Alere INRatio and INRatio 2Pt/INR Monitor System devices were used to measure INR in a significant number of the warfarin patients, the reliability and accuracy of the results and conclusions of the entire clinical trial would be called into question. If that occurs, this key clinical trial could no longer be used to demonstrate that Xarelto® (rivaroxaban) is non-inferior to warfarin and would likely call into question both the safety and efficacy of Xarelto® (rivaroxaban).
Updates will be provided as new developments in these investigations are announced.
This litigation has concluded and we are proud to report that our clients' claims have been successfully resolved. The amounts of all individual client recoveries are confidential, both by settlement agreement and by attorney-client privilege. MLG is no longer accepting cases involving this product.