Defective Medical Device May Lead to Deadly Bleeds and Death

This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.

When a patient is taking Coumadin, a blood thinning drug, a medical professional must closely monitor a patient. This is to ensure they aren’t developing deadly blood clots. For many, they rely on in home devices instead of daily trips to a lab. Alere INRatio Monitoring System is one of these devices. Instead of keeping patients healthy, its inaccurate readings have been causing deadly bleeding events.

The Alere Home INR Monitoring System works by measuring the ability of a patient’s blood to clot. It measures the patient’s prothrombin time (PT) and expresses that information as an international normalized ratio. For most patients taking blood thinning drugs, they aim for international normalized ratio levels between 2.0 and 3.0. Patients considered to be at a high risk for deadly blood clots may show international normalized ratio levels of between 2.5 to 3.5. Based on these readings, a doctor can adjust a patient’s dosage of medication.

These ratios need to be so precise that any inaccuracies could bring catastrophic adverse events. If a patient is misled to believe their international normalized ratio levels are fine, they won’t seek the guidance of a doctor which leads to serious harm. Thus far, around 19,000 patients have reported the inaccurate results of this device did just that. Many reported subdural hematoma (bleeding in the brain), hematoma death (collection of blood fills outside the brain creating life-threatening pressure) and even stroke.

The most troubling is that the portable device may have not preformed the necessary tests to ensure their device could replace laboratory testing.  Instead, they fast tracked the device by using a FDA loophole. The FDA allows medical devices proven to be equivalent to another device already on the market to bypass the usual rigorous testing and clinical trials. The company promised the only difference between the new product and its predecessor was the use of test strips. The manufacturer poorly tested this “new and improved” Alere device. This resulted in inaccurate readings, which have put patients in serious danger.

Contact us today.

If you or someone you know received a false PT/INR reading from an Alere INRatio Monitoring device and was injured after going through a bleeding event, contact us today for a free consultation at 877-513-9517.

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