David Haynes, The Cochran Firm, D.C.’s managing attorney, was recently interviewed on Ring of Fire about Alere INRatio lawsuits and the FDA recall of the home PT/INR monitoring device. Ring of Fire is broadcast throughout the United States on Free Speech TV and also distributed on radio stations throughout the country. Mike Papantonio is a senior partner…
The Alere INRatio PT/INR monitor system is used by patients prescribed to the anticoagulant medication (blood thinner) warfarin. It is an electronic device powered by battery or power supply which tracks the PT/INR levels in a patient’s blood. The Alere INRatio PT/INR monitor system works by inserting a test strip into the device then applying…
Alere lobbied Medicare aggressively to expand the market for its INRatio PT/INR monitor system The Alere INRatio PT/INR monitor system is a medical device used to monitor the anticoagulation effects of warfarin on a patient’s blood by tracking clotting time (PT/INR). Physicians who demonstrate to patients how to use the INRatio, and similar devices, are…
In December 2014, the Food and Drug Administration issued a Class I recall for the Alere INRatio and INRatio2 monitor system and test strips. Alere admitted to receiving almost 19,000 complaints of malfunction with its INRatio monitor system and test strips, which are linked to six serious injuries and three deaths. Users report they received erroneously…
Warfarin users put at risk by drug, INRatio monitor system The Alere INRatio PT/INR monitor system, which is currently subject to an FDA recall, was originally developed by San Jose, California-based medical device manufacturer HemoSense. Patients taking the blood thinning drug warfarin use the INRatio monitor to measure the clotting time, known as PT/INR levels….
FDA’s 510(k) program allows medical device makers to skip clinical trials Under a little-known FDA process, medical device makers selling products similar to previously-approved devices are able to forego the burdensome and costly traditional approval process. The FDA’s Premarket Notification program allows medical device makers like Alere to sell their products to consumers more rapidly, but critics say…
Before Alere owned the INRatio monitor, ownership of the medical device changed many hands The Alere INRatio PT/INR monitor system was developed and marketed by San Jose, California-based biotechnology firm Hemosense. HemoSense was originally named Cardiosense, Inc. when it was incorporated in March 1997, but took the name HemoSense in January 1998. The INRatio PT/INR monitor was…
Was Alere aware that the INRatio provided dangerously inaccurate INR readings for almost a decade? The International Normalization Ratio (INR) is an important measure used to monitor blood coagulation and adjust anticoagulation medications such as warfarin. If a person’s INR level is too low, he or she could be at risk of blood clots or…