The Alere INRatio and INRatio2 PT/INR Monitor Systems are used to gauge how a patient’s blood is clotting. These devices are used for patients taking warfarin, a blood thinner that has been available for over 60 years for the prevention of blood clots and stroke in patients with atrial fibrillation.
Indications for Warfarin
Warfarin (Coumadin) is the established anticoagulant used to prevent blood clots that may lead to life-threatening situations. This medication must be carefully monitored by regular blood tests to ensure that the patient is receiving appropriate doses. Too much may cause uncontrolled bleeding and too little may be ineffective to prevent a blood clot. Physicians can adjust a patient’s dosage of warfarin depending on the results of the reading. There is also a somewhat restricted diet required for individuals taking warfarin.
Monitoring Devices Recalled
The Alere INRatio Monitor System (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips) have been recalled for giving allegedly inaccurate readings. The devices were recalled in 2014 and a voluntary withdrawal was initiated in 2016.
The U.S. Food and Drug Administration (FDA) issued a notification in 2014, that the device may give falsely low readings. “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 1 recalls are the most serious kind of recall. They indicate that exposure to a recalled product presents a reasonable risk of serious injury or death. The notification in 2014 warned that “Use of the affected devices may delay treatment and cause severe or life-threatening injuries, including death.” Alere received almost 19,000 complaints concerning the INRatio Test Strips between 2013 and 2014, according to the alert. Not all reports are linked to the recall.
Parker Waichman LLP is a national law firm with extensive experience in product liability litigation. Attorneys at the firm are actively reviewing potential lawsuits on behalf of individuals who have been injured by allegedly defective medical devices.
In order to correct the issue of falsely low readings, Alere worked on a software update. But, these “enhancements” were found to be 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 Lawsuits and Xarelto
The INRatio recall has also affected Xarelto litigation where plaintiffs allege that the blood thinner triggered bleeding injuries such as brain and gastrointestinal hemorrhaging. As the recalled device was used during clinical trial to approve Xarelto, questions were raised whether falsely low readings may have inadvertently compromised data to favor Xarelto over warfarin. In 2016, the FDA launched an investigation into whether the Alere monitoring system could have affected the clinical trials, known as Rocket AF.
Bayer and Johnson & Johnson are facing over 14,000 Xarelto bleeding lawsuits in the Eastern District of Louisiana. Judge Eldon E. Fallon is presiding over the litigation.
Xarelto was approved by the FDA in 2011. Along with Pradaxa and Eliquis, Xarelto is part of a new generation of blood thinners. Lawsuits filed involving these newer blood thinners allege that drug manufacturers neglected to disclose the lack of an antidote to reverse the medication’s blood-thinning effects. Until recently, there were few options to stop excessive bleeding in a patient using Pradaxa, Xarelto or Eliquis. In October 2015, the FDA approved a Pradaxa reversal agent called Praxbind (idarucizumab).
Plaintiffs allege they would have opted for a different medication if they had known there was a risk with uncontrollable bleeding with Xarelto. Lawsuits indicate that although warfarin may not be as convenient as the newer generation of blood thinners that do not require stringent monitoring or dietary restrictions, it can be successfully reversed with vitamin K.
In 2015, in a letter to the FDA, Public Citizen (a non-profit organization) argued that there were reports of problems regarding INRatio testing for years, including the FDA sending a letter to the device’s then-manufacturer, HemoSense Corporation. The letter noted “clinically significant erroneous values” related to the INRatio testing. Among the patients who experienced adverse events associated with the INRatio device was a patient who suffered lower body paralysis and another patient who died, according to Public Citizen.
Legal Information and Advice for Xarelto Users
If you or someone you know suffered uncontrollable bleeding following the use of Xarelto, you may have valuable legal rights. Parker Waichman personal injury lawyers offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).