Question

I live in California where Alere Inc. is named as a defendant in lawsuits over alleged defects with its INR blood home monitoring system. What should I do if I used the Alere InRatio Test Strips and INR meter?

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Bijan Esfandiari - Personal Injury - Products - Super Lawyers

Answered by: Bijan Esfandiari

Located in Los Angeles, CABaum, Hedlund, Aristei & Goldman, PC

Los Angeles, CA
Phone: 310-207-3233
Fax: 310-820-7444

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Answer

If you sustained injuries after using the Alere INRatio home monitoring system, it is in your best interest to speak with an experienced personal injury attorney about filing a claim. You should also collect any relevant medical records from your doctor that document your health history and injuries, as these will be useful in building your case.

The U.S. Food and Drug Administration (FDA) has identified Alere’s INRatio recall as a Class I recall – the most serious of all recalls in the U.S. According to the FDA, use of these devices “may cause serious injuries or death.”

The Alere INRatio blood monitoring system was designed for patients taking blood-thinners to accurately monitor their blood clotting times. The measurement is expressed as an International Normalized Reading (INR). Accurate INR readings are essential to ensuring that patients on blood thinners receive a proper dosage.

A high INR (indicative of a relatively slow blood-clotting time) can lead to excessive bleeding and generally indicates too high a dosage of blood-thinners. A low INR (indicative of a relatively fast blood-clotting time) can lead to blood clots or strokes and generally indicates too low a dosage of blood-thinners. In either case, the consequences of having irregular INR results can lead to serious injury or death.

Almost immediately after the INRatio product line became available to the public, the company learned that its blood monitoring system produced erroneous results. As a matter of fact, between 2002 and 2014, Alere received numerous complaints concerning malfunctions with INRatio products, with three deaths reported.

The FDA sent repeated letters to Alere, admonishing the company for failing to file adverse event reports. A 2005 letter labeled letter the INRatio PT/INR Test Strips as “misbranded” due to “a serious regulatory problem involving INRatio Test Strips and INRatio Test Meters.”

On July 11, 2016, Alere issued a recall notice withdrawing INRatio products from the market.

Baum, Hedlund, Aristei & Goldman has filed multiple lawsuits in California against Alere Inc. and its successor, Abbott Laboratories (Abbott acquired Alere in October of 2017). If you would like to speak with me about filing an Alere INRatio lawsuit, please call 800-827-0087 or Join the Alere InRatio lawsuit. Free case evaluation.

Disclaimer: The answer is intended to be for informational purposes only. It should not be relied on as legal advice, nor construed as a form of attorney-client relationship.

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