The Alere INRatio lawsuit claimed the Alere monitoring system and test strips were providing an artificially low International Normalized Ratio (INR), potentially causing severe medical repercussions.
What is the Lawsuit Involving the Alere INRatio Monitoring System and Test Strips
The Alere INRatio Lawsuit concerns the use of the Alere INRatio and INRatio 2PT/INR Monitor System and INRatio Test Strips, and the device’s relationship to incorrect INR readings. The lawsuit alleges that the manufacturer of the Alere INRatio system knew of this potential problem, but failed to timely inform the United States government and healthcare providers, and additionally the monitoring system required further testing and research before being widely marketed and prescribed to patients who had better alternative choices.
What is the Alere INRatio Monitoring System and Why is it Utilized
Alere's INRatio and INRatio 2PT/INR Monitor System and INRatio Test Strips are used to measure how quickly a patient's blood clots, and specifically measures a patient’s Prothrombin Time when taking warfarin, a blood-thinning medicine. The International Normalized Ratio (INR) is used to compare the results of the patient’s Prothrombin Time.
Anticoagulant medicine (such as warfarin) is often prescribed to patients who have undergone replacement or mechanical heart valve surgery; have irregular heartbeats such as atrial fibrillation (arrhythmia of the heart); have had heart attacks; or are trying to prevent deep vein thrombosis (blood clots deep within the body) and pulmonary embolisms (blood clots in the lungs).
What are the Medical Issues with Using the Alere INRatio Monitoring System and Test Strips
Patient’s using some of the older model Alere's INRatio and INRatio 2PT/INR Monitor System and INRatio Test Strips can receive significantly lower INR readings than those correctly analyzed through a centralized laboratory plasma INR test, with readings anywhere between 3.1 to 12.2 units lower than clinical laboratory results when tested within one hour to one day of each other. Such misreadings can result in severe medical repercussions, including death, because patients may be at risk for spontaneous bleeding. Alere, Inc. admits to having received, at minimum, 18,924 reports of incidents in which the device malfunctioned.
Has There Been a Recall of the Alere INRatio Monitoring System and Test Strips
Yes. On April 16, 2014, Alere Inc. recalled certain Alere INRatio2 PT/INR Professional Test Strips due to complaints of patients who received a therapeutic or near therapeutic INR when using the test strips, but had a significantly higher INR when performed by a central laboratory. The affected test strips were manufactured from August 22, 2013 through April 2, 2014 and distributed from August 26, 2013 through April 2, 2014.On December 5, 2014, Alere issued an additional recall involving the Alere INRatio and INRatio2 PT/INR Monitor System, specifying that the system should not be used on patients with any of the following conditions:
- Anemia of any type with hematocrit less than 30%
- Any bleeding or unusual bruising, clinically observed or reported by the patient
- Any conditions associated with elevated fibrinogen levels including:
(i) Acute inflammatory conditions (examples may include acute viral or bacterial infections such as pneumonia or influenza)
(ii) Chronic inflammatory conditions (examples may include rheumatoid arthritis, Crohn’s disease, ulcerative colitis, infectious liver diseases such as hepatitis, or inflammatory kidney diseases such as diabetic nephropathy and glomerulonephritis)
(iii) Severe infection (e.g., sepsis)
(iv) Chronically elevated fibrinogen for any reason
(v) Hospitalized or advanced stage cancer or end stage renal disease patients requiring hemodialysis
This recall involved Alere's INRatio Monitor, INRatio 2 Monitor, and INRatio Test Strips manufactured and distributed between April 1, 2008 and December 4, 2014.
Both recalls of the Alere INRatio monitoring system and test strips are listed as a "Class I" recall. A Class I recall is defined by the FDA as "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
FDA and Scientific Studies Regarding Alere INRatio
2014-December 8: Alere Initiates Voluntary URGENT CORRECTION for Use of Alere INRatio® and INRatio®2 PT/INR Monitor System: Alere Inc. (NYSE:ALR) has initiated a voluntary correction to inform U.S. users of the Alere INRatio® and INRatio®2 PT/INR Monitor system of certain medical conditions that should not be tested with the system (INRatio® Monitor or INRatio®2 Monitor and INRatio® Test Strips). In certain cases an INRatio® and INRatio®2 PT/INR Monitor system may provide an INR result that is clinically significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions or can occur if the instructions in the labelling for performing the test are not followed.
2014-December 5: Alere San Diego Inc., Alere INRatio and INRatio2 PT/INR Monitor System (Professional and Prescription Home Use) - Falsely Low INR Test Results: 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.
2014-April 16: Alere INRatio2 PT/INR Professional Test Strips - Results Disagree with the Confirmed PT/INR Reference Test Results Performed by Central Laboratory: The Alere INRatio2 PT/INR Professional Test Strips are part of the Alere lNRatio2 PT/INR Monitoring System (Professional Use) which also consists of the INRatio2 Monitor. This recall is expected to cause a shortage of test strips for the Alere INRatio2 professional PT/INR testing. Alere will transition customers from the current Alere INRatio2 PT/INR Professional Test Strip to the Alere INRatio PT/INR Test Strip (PN 100139) because the Alere INRatio PT/INR Test Strip is not affected by this recall.
News Regarding Alere INRatio
2015, January 9: Alere Test Strips, Monitor System Recalled by FDA: Alere's INRatio and INRatio 2PT/INR Monitor System and INRatio Test Strips, used to measure how quickly a patient's blood clots, was recalled by the Food and Drug Administration last month. The test strips are used to measure a patient's blood clots (Prothrombin Time) when taking warfarin, a blood-thinning medicine; and the International Normalized Ratio test is used to compare the results of the patient's Prothrombin Time (PT), how long it takes the blood to clot. To read more, click Headlines & Global News
2014, May 7: Urgent Product Recall For Patients On Blood Thinners: Patients taking the oral anticoagulant drug warfarin (Coumadin) or being given heparin injections and their in-office and home healthcare teams should check the brand of their PT/INR test strips and monitoring system this morning. To read more, click Forbes