A class action lawsuit has been filed in California federal court alleging that Alere INRatio monitors and test strips produce false results, which could lead users to incorrectly adjust the dose and suffer a stroke, major bleeding events or other serious side effects.
What’s the Problem?
According to the lawsuit (PDF), the International Normalized Ratio (INR) is a standardized measurement used to determine how fast a patient’s blood is clotting. This metric is critical to ensure that a patient is receiving the accurate dose of a blood-thinner medication, as there are significant health risks associated with both high and low blood-clotting times. High blood-clotting times can cause major bleeding and low blood-clotting times can lead to stroke, according to the complaint.
Alere’s INRatio and INRatio2 monitoring systems are designed to help patients who use anticoagulants monitor their blood-clotting times to ensure they are taking the correct dose. The monitors and blood test strips were first developed in the late 1990s, and approved by the FDA for home use in 2002.
In May 2015, Plaintiff Dina Andren allegedly relied on the results of her INRatio2 test kit and did not take her anticoagulant medication. Later that day, she was hospitalized after suffering a stroke, according to the class action. She continued using the device until she was hospitalized again in March 2016 for a mini-stroke, after which she was informed that the INRatio2 testing kit was the subject of an FDA Class 1 recall.
Sidney Bludman, the other lead plaintiff in the class action, also claims to have suffered a mini-stroke after reducing his blood-thinner dosage based on the results of his INRatio testing kit.
Andren and 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. Plaintiffs accuse the defendants of violating the California Consumers Legal Remedies Act, Unfair Competition Law, fraud and unjust enrichment.
The complaint 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.