At least 18 deaths and 1,500 injuries from major bleeding have occurred when the recalled INRatio Monitor gave inaccurately low readings, resulting in patients overdosing on blood-thinning drugs.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting INRatio induced injury cases in all 50 states. If you or somebody you know was diagnosed with severe bleeding, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What is INRatio?
Alere Inc. manufactures INRatio® and INRatio2®, a handheld device that tells patients what dose of the blood-thinner warfarin they must take every day.
How Does INRatio Work?
INRatio analyzes a drop of blood on a test strip to measure blood-clotting times — also known as Prothombin Time (PT) and International Normalized Ratio (INR). Patients on warfarin must frequently check their PT/INR to adjust the dose of warfarin.
Alere INRatio Recall
July 2016 — Alere has issued a Class I recall for the entire INRatio System, including monitors and test strips, because they may produce inaccurately low readings.
In December 2014, Alere issued a Class I recall for INRatio Test Strips. The company reported receiving 18,924 complaints about low readings since 2013, including three deaths.
False Readings and Major Bleeding
Erroneously low INR readings can result in a patient taking too much warfarin and experiencing “major or fatal bleeding,” according to the FDA. The FDA received 1,451 injury reports from 2002 to 2015, including 18 deaths in 2014 and 2015.
Complaints About Inaccurate Readings Ignored
Problems with inaccurate readings have been known for over a decade. The original manufacturer, HemoSense, received warnings from the FDA in 2005 and 2006 for failing to investigate complaints about erroneous readings. Even so, the INRatio devices were used in clinical trials comparing Xarelto to warfarin.
What is the problem?
The Schmidt Firm, PLLC is nationally recognized as a class action law firm, but we are not filing an INRatio class action against Alere Inc. Instead, we are filing individual lawsuits on behalf of people who were injured by severe bleeding due to inaccurate readings.
About Class Actions
Class actions are useful when a lot of people are seeking refunds for a defective product. Lawyers choose a “class representative” and use that person’s case to fight for compensation. Any payout is divided equally among everyone in the class action.
Why Our Law Firm is Filing Individual Lawsuits as Opposed to a Class Action
INRatio bleeding injuries range from relatively minor events to severe injuries, hospitalization, permanent disability, or death. These cases need to be handled individually because they are so different.
Class actions improve efficiency, but they are not designed to maximize compensation for individuals with the most severe injuries. This is why we are filing individual lawsuits rather than a class action.
Our lawyers specialize in helping victims of defective devices seek compensation for their medical expenses, pain and suffering, long-term injuries, lost income, wrongful death of family members, and more.
Do I have an INRatio Lawsuit?
The Schmidt Firm, PLLC is currently accepting INRatio induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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