Alere INRatio System Recalled
The Alere INRatio and INRatio2 PT/INR Monitor System are devices used to measure how fast a patient’s blood is clotting. This system is used in patients taking warfarin, a decades-old anticoagulant used to prevent blood clot and stroke in patients with atrial fibrillation. The Alere INRatio and INRatio2 were recalled in 2014, and a voluntary withdrawal was initiated in 2016.
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Warfarin, sold under the brand name Coumadin, is used to prevent life-threatening blood clots. However, the drug must be monitored to ensure that it is present in appropriate doses; too much can cause excessive bleeding and too little may be ineffective to prevent a blood clot. Depending on the results of the reading, doctors can adjust a patient’s dosage of warfarin to ensure that they are getting the appropriate amount.
However, these devices have been recalled for giving falsely low readings. In 2014, a Class I recall was issued for the Alere INRatio Monitor System (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips). According to a 2014 U.S. Food and Drug Administration (FDA) notification, the device may give falsely low readings. “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,” the notification read. “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.”
Class I recalls are the most serious type of recall. They indicate that exposure to a recalled device presents a reasonable risk of serious injury or death. The 2014 notification warned that “Use of the affected devices may delay treatment and cause severe or life-threatening injuries, including death.” The recall was essentially a correction.
According to the alert, Alere received nearly 19,000 complaints regarding the INRatio Test Strips between 2013 and 2014. However, not all reports are linked to the recall.
Alere worked on a software update to address the issue of falsely low readings. However, these “enhancements” were deemed insufficient by the FDA. The agency “notified the company that it believes the company’s studies do not adequately demonstrate the effectiveness of the software modification and advised Alere to submit a proposed plan to voluntarily remove the INRatio® device from the market.”
Alere INRatio and Xarelto Lawsuits
The INRatio recall has also raised questions in the Xarelto litigation, in which plaintiffs allege that the anticoagulant caused bleeding injuries such as gastrointestinal and brain hemorrhaging. Since the recalled device was used during clinical trials to approve Xarelto, some have wondered whether falsely low readings could have inadvertently skewed data to favor Xarelto over warfarin.
Xarelto was introduced in 2011. It is part of a new generation of blood thinners, alongside Pradaxa and Eliquis. Lawsuits filed over these new anticoagulants allege that drug makers failed to disclose the lack of an antidote to reverse the drugs’ blood-thinning effects. Until recently, doctors were left with few options to stop uncontrollable bleeding in a patient taking Pradaxa, Xarelto or Eliquis. The FDA approved a Pradaxa reversal agent in October 2015.
Plaintiffs allege they would have chosen a different drug if they knew there was a risk of uncontrollable bleeding with Xarelto.
Lawsuits point out that warfarin, while having its drawbacks, can be reversed with vitamin K. In addition to regular blood monitoring, warfarin patients cannot eat certain foods. Some medications can also react with the anticoagulant.
Last year, the FDA launched an investigation into whether the Alere INRatio monitoring system could have affected Xarelto clinical trials. Among other things, regulators questioned whether there was evidence of the device’s malfunction during the trial, known as Rocket AF.
Bayer and Johnson & Johnson are facing over 14,000 Xarelto bleeding lawsuits as part of a multidistrict litigation in the Eastern District of Louisiana. Judge Eldon E. Fallon is presiding over the litigation.
Filing a Xarelto Lawsuit
If you or someone you know suffered uncontrollable bleeding related to the use of Xarelto, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).