Alere INRatio Lawsuit

Patients who used an Alere INRatio device to monitor their blood are filing lawsuits after test results lead to false positives causing serious injuries and even death.

Bellwether Trial Date:        April 2017

Injury: Bleeding Accidents, stroke, and death.

Manufacturer:  Pfizer and Bristol-Myers

Settlement Amounts: EST – $60,000 over $1,025,000

What is the Alere INRatio

Alere INRatio 2PT/INR Monitor System and INRatio Test Strips are medical devices used to monitor patients’ blood coagulability while taking the anticoagulant Warfarin. Formerly known as HemoSense when Alere started marketing it in 2008, this instrument measures the anticoagulation status and coagulation time in patients treated with this drug. However, the Food and Drug Administration (FDA) recently recalled it since it provided false results with potentially catastrophic consequences.

How does the Alere INRatio work?

When a person is under treatment with Warfarin (also known as Coumadin), monitoring his International Normalized Ratio (INR) and prothrombin time (PT) is critical to determine the adequate daily dose he or she needs to take to avoid harmful side effects. If the dose is too strong, this medicine may cause a lethal internal bleeding, while if the dose is too low its effect may not be potent enough to prevent blood clots from forming with life-threatening consequences. The INR and PT are two values that measure the blood’s ability to coagulate. The INR is just a ratio, so it has no units, and its value is used only to determine whether the patient is taking the right amount of medication or not. In subjects who take no blood thinners, the normal INR range is 0.8-1.2. The target range for INR in patients under anticoagulation therapy is 2-3, although in some instances even a 2.5-3.5 range may be required. To avoid complications, doctors need to keep their patients within a dose range called Time in Therapeutic Range (TTR) as much as possible. The correct dose is, in fact, established by measuring the time required for the blood to clot. Usually, this is achieved by periodical measurements of various blood parameters in special clinics. However, many self-testing devices have been recently introduced to let patients perform their own home monitoring, increasing both their quality of life as well as their TTR.

The dangerous consequences of the inaccurate readings

Inaccurate results provided by malfunctioning instruments may cause physicians not to make the adequate changes to the subject’s blood thinner dosage. Even a few points of difference can have serious medical repercussions. The defective Alere INRatio devices provided readings which showed significantly lower INR values than those correctly analyzed in clinical laboratory settings. Some results were off by up to 12.2 units compared to plasma readings taken in centralized labs just 1 to 24 hours later. The FDA and the European Medicine Agency (EMA) started an inquiry in 2016 to investigate about the potential repercussions of the use of this defective monitoring device in the ROCKET-AF clinical trial. During this large study Bayer AG and Janssen Pharmaceuticals tried to demonstrate their drug Xarelto’s superiority over its competitor Warfarin. Since the readings for the older anticoagulant were taken with the unreliable Alere INRatio, however, many doctors may have inadvertently increased this drug’s dosage skewing the final opinion of the reviewers on its safety and effectiveness.

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The device recall

After receiving thousands of complaints, on April 16, 2014, Alere voluntarily recalled all INRatio2 PT/INR Professional Test Strips manufactured from August 22, 2013, through April 2, 2014. Shortly afterwise, on December 5, 2014, all the strips manufactured between 2008 and 2014 were also removed from the market. Since the device’s unreliability could cause serious health issues or even death, the FDA listed the two recalls as “Class I recalls.” Many patients under treatment with anticoagulant medications risked their lives by using this instrument, especially the most vulnerable ones as those affected by anemia, hepatitis, end-stage cancer, severe infections, and chronic inflammatory conditions.