Device Linked to Serious Health Problems Due to Erroneous Results
DALLAS (March 24, 2016) – The national law firm of Baron & Budd is investigating a potential class action lawsuit regarding the Alere INRatio blood-testing device. There have been many reports of serious health complications due to erroneous test results, putting users potentially at risk of increased chances of suffering strokes or severe bleeding events.
Patients taking the blood thinning drug warfarin (marketed under the brand name Coumadin) use devices such as the Alere INRatio system to see how quickly their blood clots. This is extremely important, because doctors use the results to determine whether or not the drug is working properly, and whether or not the dosage needs to be adjusted. If too much of the drug is taken, the patient will be at an increased risk of a serious bleeding event. However, if too little is prescribed, there will be a heightened risk of stroke.
Alere began receiving reports about inaccurate results from the INRatio device, and the potential for serious complications, soon after the U.S. Food and Drug Administration (FDA) approved the device for use in 2002. The FDA issued warning letters to HemoSense, the original maker of the INRatio device, in 2005 and 2006. Then, in 2014, the FDA issued a Class I recall of the INRatio monitoring system as well as all INRatio test strips manufactured between April 2008 and December 2014.
According to a consumer organization known as the Public Citizen Health Research Group, the FDA has received more than 9,000 reports of INRatio system malfunctions as well as more than 1,400 injury reports associated with the device.
“The number of adverse reports associated with the Alere INRatio device is extremely alarming,” said Roland Tellis, head of the Consumer Class Action group at the national law firm of Baron & Budd. “Consumers should have been told that the INRatio device was linked to erroneous blood-testing results, and devastating health consequences, at the time they purchased the device. We will fight passionately to ensure their rights are protected.”
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The law firm of Baron & Budd, P.C., with offices in Dallas, Baton Rouge, New Orleans, Austin and Los Angeles, is a nationally recognized law firm with a nearly 40-year history of "Protecting What’s Right" for people, communities and businesses harmed by negligence. Baron & Budd’s size and resources enable the firm to take on large and complex cases. The firm represents individuals and government and business entities in areas as diverse as dangerous pharmaceuticals and medical devices, environmental contamination, the Gulf oil spill, financial fraud, overtime violations, deceptive advertising, automotive defects, trucking accidents, nursing home abuse, and asbestos-related illnesses such as mesothelioma.