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Florida doctor Gary Goldstein is one of many physicians throughout the country to express concerns over a blood testing device manufactured by Massachusetts-based Alere Inc. The device in question, the INRatio monitoring system, is used by doctors and patients for anticoagulation management. Alere INRatio accuracy is especially important for managing patients on warfarin, a blood thinner used to treat or prevent blood clots, which can reduce the risk of heart attack or stroke.
Dr. Goldstein knew that something wasn’t right when the Alere INRatio monitoring system he used in his office started giving perplexing results. His suspicion was confirmed when he checked the INRatio results against the results from an outside laboratory, finding a discrepancy between the two.
Alarmed by the discovery, Dr. Goldstein reached out to Alere, alerting the company of the problem. After sensing a lack of interest from Alere, he decided to file a report with the Food and Drug Administration (FDA). His report was far from the only one the agency had received regarding Alere INRatio's accuracy.
Since the Alere INRatio monitor and its successor, the Alere INRatio2 received FDA approval in 2002, the agency has received upwards of 9,000 reports of malfunctions. More than 1,400 of those reports resulted in patient injury. These statistics are far in excess of similar products currently on the market.
Many people who have been affected by complications resulting from Alere INRatio accuracy issues have made the decision to file an Alere INRatio lawsuit, alleging that the manufacturer knew the device was defective, yet failed to warn the public.
Why Alere INRatio Accuracy is Crucial to Patient Health
The Alere INRatio monitoring system measures a patient’s blood clotting ability, specifically measuring their prothrombin time (PT), which is expressed as an ‘international normalized ratio’ (INR). The device was conceived to allow doctors and patients the ability to get blood clotting results quickly, rather than having to send samples to an outside laboratory and wait for the results to come in.
For many patients taking warfarin, INR levels between 2.0 and 3.0 produce necessary blood thinning levels for preventing certain conditions associated with blood clotting. If a patient’s INR strays from the norm, their doctor can adjust the patient’s warfarin prescription accordingly.
This is why Alere INRatio's accuracy is so vitally important—if too much warfarin is prescribed, a patient could bleed to death, and too little warfarin could cause a patient to suffer a stroke. Put simply, checking someone’s blood clotting ability isn’t like checking their cholesterol; it could mean the difference between life and death.
Alere INRatio Recall
Records show that Alere INRatio's accuracy problems began to surface shortly after the device went to market in 2002. The FDA sent two letters in 2005 and 2006 to HemoSense, the company that manufactured INRatio at the time, stating that the company had failed to address the growing number of complaints regarding INRatio malfunctions.
In 2007, doctors in England tested the accuracy of five point-of-care blood testing devices on the market at the time. INRatio performed the worst of the five.
The FDA is charged with keeping track of issues with medical devices to ensure that they are safe after they are approved and go to the market. The agency can issue warning letters to manufacturers, as well as apply pressure on them to issue recalls or restrictions when appropriate.
Many people have been highly critical of the FDA for being too slow to take action against medical device manufacturers when their products are reportedly harming people. One of those who have spoken out against the FDA with regard to INRatio is Dr. Sidney Wolfe, senior advisor and founder of the Public Citizen Health Research Group.
The Public Citizen Health Research Group sent a letter to the FDA last December, raising concerns about Alere INRatio's accuracy. The letter includes examples of patients who suffered severe bleeding from the nose, gums, and even the rectum after INRatio devices produced faulty test results.
“What would it take for this device to be taken off the market?” Dr. Wolfe recently said in an interview.
It wasn’t until 2014—a year after Dr. Goldstein complained to Alere—that the company finally issued a recall for its INRatio2 device, saying it was producing erroneous test results. Alere then referred doctors and patients to the original INRatio device until later in the year when the company issued a warning, saying the product shouldn’t be used by patients with certain medical conditions.
More questions arose last year when it was revealed that INRatio was used as part of a large clinical trial for the Johnson & Johnson drug, Xarelto, an alternative to warfarin. An analysis of blood samples from over 5,000 patients involved with the clinical trial found that INRatio test results were clinically different from test results reported by a central laboratory 35 percent of the time. According to the New York Times, J&J said the company gave the results to Alere after the completion of the clinical trial. Xarelto ended up receiving FDA approval.
The Xarelto clinical trial was headed by Dr. Robert Califf, who is now the head of the FDA.