Alere INRatio Lawsuit
A blood-testing device known as the Alere INRatio has been associated with many serious health complications in users. The class action attorneys with Baron & Budd are investigating this device and may be able to help if you or someone close to you has purchased it. Contact us online or call 866-520-2755 to learn more.
How the Alere INRatio Works
The Alere INRatio device is used to measure the speed at which blood clots in people taking blood thinning drugs like warfarin, marketed under the brand name Coumadin, and Xarelto.
The INRatio device is supposed to make it much more convenient for warfarin users to have their blood monitored. With the simple prick of a finger, the device can let a user know whether or not the drug is working correctly. Previously, the only way to get such results was to send a blood sample to an outside laboratory.
It is vital that people taking blood thinners such as warfarin and Xarelto closely monitor the ability of their blood to clot properly in order for them to reduce the risk of suffering a stroke or a serious bleeding problem. Doctors often use the results provided by the INRatio device to adjust the amount of the drug provided to their patients. Those results are extremely important; if too little blood thinner is prescribed, the patient will be at a higher risk of a stroke. But if too much is prescribed, the patient will face an increased risk of bleeding to death.
The Problem with the Alere INRatio?
The INRatio device has been shown too often to provide erroneous results, which can lead to a substantially increased risk of serious injury or death. Doctors across the country became concerned about the accuracy of the INRatio device and contacted the FDA to voice those concerns.
The New York Times reported on March 18, 2016 that the FDA has received more than 9,000 reports of INRatio malfunctions, according to an analysis performed by the Public Citizen Health Research Group. The group also found that injuries associated with the INRatio occur at a far higher rate than similar devices on the market.
The Alere INRatio and the FDA
According to the article, problems with the INRatio device started to surface not long after it received FDA approval. For example, the FDA issued warning letters to HemoSense (the original maker of the device) in 2005 and 2006. These letters stated that HemoSense did not properly act on complaints that the INRatio system was providing inaccurate results.
Then, a study conducted by researchers in England showed that of the five different blood-testing devices analyzed, the INRatio performed the worst.
During this time, the FDA continued to receive reports of adverse events associated with the INRatio. The Times reported that doctors criticized the agency for failing to properly monitor the device once it came to market, and also acting too slowly once problems were reported. One doctor was quoted in the article as saying, “What would it take for this device to be taken off the market?”
Then, in 2014, the FDA announced a Class I recall for the INRatio device and all test strips that were manufactured between April 2008 and December 2014. This is the most serious type of recall because it is issued when a device could result in serious health complications or death.
Alere issued its own warning about INRatio in 2014, stating that patients should not use the system if they had the flu, rheumatoid arthritis and/or several other conditions.
But neither the FDA nor Alere’s recall offers any compensation or reimbursement for consumers who purchased the device.