According to sources, several Alere INRatio wrongful death claims are being investigated and prepared for filing. The Alere INRatio Monitoring System is a handheld device used by patients in their homes to monitor effects of the blood-thinning drug Warfarin (brand name Coumadin and Jantoven).
Warfarin and its brand name equivalents prevent blood clots, but like all anticoagulants too little or too much can be life-threatening and can lead to serious or deadly side effects.
So accurate monitoring is key and typically patients on Warfarin would go to a laboratory once a month to measure their International Normalized Ratio or INR. The Alere device was marketed and touted for patients to check the effectiveness of Warfarin in their homes and report the results to their doctors, saving a visit to the laboratory.
What is INR?
The test used to monitor the effects of warfarin is called the INR. It is a blood test that checks how long it takes for blood to clot. The higher the INR, the longer it will take blood to clot (and the higher the risk of bleeding). A Prothrombin time (PT) test may also be called an INR test.
Patients on Warfarin have to their blood to clot slower than folks not on Warfarin. In healthy people an INR of 1.1 or below is considered normal. An INR range of 2.0 to 3.0 is considered an effective therapeutic range for people taking warfarin for medical conditions such as atrial fibrillation or a blood clot in the leg or lung.
What was the problem with Alere INRatio 2 System
Patients who were using the INRatio and INRatio 2 PT/INR Monitor Systems were getting INR test results that significantly different from those they got from blood tests performed by their laboratory.
Alere INRatio and INRatio 2 Recall
In May 2014, Alere Inc. initiated a voluntary Class 1 recall to its INRatio and INRatio 2 PT/INR Monitor System, and announced in December 2014 that patients with certain medical conditions should not be tested with the system.
Many patients had a therapeutic or near therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
Alere reported nine serious adverse event reports, including three patient deaths. Alere warned in its recall that the INRatio system could provide inaccurate results. Inaccurate results could lead doctors not to adjust a patient’s warfarin dose, putting that patient at risk of a major bleeding event.
Alere INRatio and FDA Warnings
After Alere’s May recall, the FDA issued a safety warning about differences in test results between the Alere INRatio2 PT/INR Professional Test Strip and the laboratory INR test. According to the FDA, Alere received almost 19,000 reports of “incidents” from 2013 through 2014 about the INRatio Test Strips.
The Alere device was approved for home use in 2002. Problems regarding inaccurately low readings were reported as early as 2005, when the FDA issued warnings to Alere for failing to act on complaints. But the INRatio Test Strips weren’t recalled until over ten years after those first complaints.
According to The New York Times, as of March, 2016 the InRatio device had been linked to more than 1,451 injury reports. False readings were also linked to 18 deaths in 2014 and 2015.
In July 2016 the FDA announced that Alere initiated a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR Monitor System because the problem could not be fixed.
The use of Alere device that was used in the new blood-thinner Xarelto clinical trials, may have resulted in false data, according to the BMJ. As a result, Xarelto may have been shown to be more effective than it really was, and more effective than Warfarin. The INRatio Monitors were used in the clinical trial comparing Warfarin to Xarelto. Some experts say false readings may have biased results against Warfarin.
The flawed data from the Xarelto clinical trial was also sent to medical journals, including New England Journal of Medicine which also left out critical data in Xarelto’s effectiveness analysis. The Xarelto trial was led by Dr. Robert M. Califf, now head of the FDA.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.