Update: Alere Seeks Dismissal of INRatio Class Action Lawsuit
March 21, 2017 – Alere Inc. is seeking dismissal of a class action lawsuit alleging that it misled consumers by knowingly selling inaccurate home blood coagulation tests. Plaintiffs claim that the INRatio PT/INR monitoring system often provided “significantly inaccurate results” and exposed users to risks caused by inaccurate warfarin dosing.
Overview
The Alere INRatio and INRatio2 monitoring systems are used by doctors and patients for anticoagulation management. Patients who take blood-thinning drugs like warfarin use home monitoring systems in order to monitor their blood levels at home or a doctor’s office rather than going to a laboratory. The dosage of blood-thinner can be adjusted in accordance with the device’s test results.
What’s the Problem?
For patients with certain medical conditions, a false INR test result could lead to serious health complications including subdural hematoma, stroke and other bleeding events. Studies have found that readings from INRatio test strips can be 3.1 to 12.2 units lower than laboratory results when tests were performed in tandem. In a number of cases, patients died from hematoma after they mistakenly believed their INR levels were safe, when, in fact, their levels were far too high.
Which Products are Affected by the Recall?
The Class I Recall issued on July 12, 2016, affects the following products:
- Alere INRatio2 PT/INR Professional Monitoring System (55128A)
- Alere INRatio2 PT/INR Home Monitoring System (0200432)
- Alere INRatio2 Replacement Monitor (Home) (0200457)
- Alere INRatio2 PT/INR Professional Testing System (0200431)
- Alere INRatio/INRatio2 PT/INR Test Strips (99007EU, 99007G1, 99007G3,99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5,99008G7)
- Alere INRatio PT/INR System Professional (0100004)
- Alere INRatio Prothrombin Time (PT) Monitoring System (0100007)
- Alere INRatio Replacement Monitor (0100137)
- Alere INRatio PT/INR Test Strips (0100071, 0100139)
2014 Recalls
In addition to the recent action, Alere has issued at least 2 other recalls for its INRatio Monitoring System and Test Strips:
- April 16, 2014 – Alere recalled its INRatio2 PT/INR Professional Test Strips (PN 99008G2). Affected products were manufactured between August 22, 2013 and April 2, 2014 and distributed from August 26, 2013, until April 2, 2014.
- December 5, 2014 – Recall issued for the Alere INRatio and INRatio2 PT/INR Monitor System. Affected products were distributed from April 1, 2008 to December 4, 2014. According to the FDA, consumers should stop using the devices if they have anemia, conditions associated with elevated fibrinogen levels, unusual bleeding or bruising, and other conditions.
Class Action Alleges INRatio Blood Test Monitors are Defective
A class action lawsuit filed in California federal court in May 2016 alleges that INRatio blood test monitors and testing strips produce erroneous results. Plaintiffs Dina Andren and Sidney Bludman filed the complaint against Alere Inc., Alere Home Monitoring Inc. and Alere San Diego Inc. on behalf of themselves and a class of consumers who purchased INRatio PT/INR Monitors, INRatio TP/INR Test Strips, INRatio2 PT/INR Monitors and INRatio2 PT/INR Test Strips.
According to the lawsuit, Alere received over 18,000 complaints that INRatio monitors and test strips produced erroneous results. Additionally, the defendants reportedly received multiple warning letters from the FDA informing them that the results produced by the devices differed from laboratory results, according to the suit.
The class action is: Dina Andren, et al. v. Alere Inc., et al., Case No. 16-cv-01255-GPC-NLS, in the U.S. District Court for the Southern District of California.
BMJ Report Questions ROCKET-AF Clinical Trial Results
October 19, 2016 – A new report from The BMJ suggests that Janssen and Bayer knew about problems with INRatio monitors and test strips used during the Rocket AF clinical trial, which was used to approve Xarelto (generic: rivaroxaban). The trial concluded that Xarelto had no significant difference in regards to the bleeding risk compared to warfarin, but did link warfarin to an increased risk for fatal bleeding in the brain. However, if patients were exposed to unnecessarily higher doses of warfarin due to incorrect data from an INRatio device, results of the study could be skewed, making Xarelto appear safer than it actually is.
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 recall 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 lawsuit and we can help.