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After being prescribed an anticoagulant, patients often have to make several lifestyle changes: They revise their diet, usually opting for a stricter regimen, and have to get regular blood tests to monitor their dosage. Going too high or too low increases their risk of blood clots and other adverse events.
To simplify this process, patients prescribed Warfarin (or its brand-name variants like Coumadin or Jantoven) have been given an option to use an in-home device, such as the Alere INRatio monitoring system and test strips. Approved for personal use by the FDA in 2002, the INRatio system monitors the amount of Warfarin present in the blood based on Prothrombin Time and compares it to the International Normalized Ratio (INR).
However, as early as 2005, patients reported inaccurate readings and by 2014, manufacturer Alere recalled the INRatio. Yet, as many patients relying on the system found they had dangerously high levels of the drug in their system and later experienced spontaneous bleeding as a result, plaintiffs have been coming forward to file lawsuits against the company.
Once a physician has the results from an in-lab test or monitoring device, he or she adjusts the patient’s prescription accordingly. Yet, just a few years after the INRatio became available, multiple reports concerning its inaccuracies went to the FDA. In response, the government organization sent a warning letter to HemoSense, then the device’s manufacturer, stating the company failed to act on these complaints.
By 2014, after another group of nine similar reports (including three for related deaths) Alere did its own Class I recall of the testing strips and, later, INRatio and INRatio 2 PT/INR Monitors manufactured from 2008 through 2014. At this point, a study indicated that results from the INRatio and a standard in-lab plasma INR test differed as much as 3.1 to 12.2 units when performed within an hour of each other.
For patients, this significant disparity puts them at risk for blood clotting, as well as several spontaneous bleeding incidents:
- Subdural hematoma, which can occur when a head injury bursts a blood vessel
- Death from blood placing pressure on the brain
- A mini-stroke, which temporarily cuts off blood flow to the brain, spinal cord or retina without causing brain damage or permanent disability
- A stroke
- A minor injury, such as a cut or fall, turning into a major bleeding incident, where a patient may require a blood transfusion or bleed out to death.
Alere further clarified that patients with the following conditions should not use the INRatio or INRatio 2 PT/INR monitors, as the devices could produce lower INR results than expected:
- Acute inflammatory conditions
- Chronic inflammatory conditions
- Severe infections
- Chronically elevated fibrinogen
- Advanced-stage cancer
- End-stage renal disease requiring hemodialysis
Following the recall, the FDA released a safety warning, which cited 19,000 reports of incidents concerning the device’s test strips from 2013 to 2014. Further, the document read that the manufacturer had investigated the reports, most of which concerned its results, and had made software enhancements. But, by the end of 2015, the FDA stated that the company’s studies concerning its software didn’t demonstrate its effectiveness, so all INRatio devices were pulled from shelves by the next year. By that point, it had been linked with 1,451 adverse injury reports, including for 18 additional deaths from 2014 to 2015.
As more attention is paid to the new class of anticoagulants, data from Xarelto’s clinical trials involving the INRatio indicates that results may have been skewed, possibly erroneously indicating the drug is more effective than Warfarin.
As a result of the many reports and recalls, several patients and loved ones have started filing lawsuits against Alere, with multiple pending class action cases as of 2017. In their claims, plaintiffs allege the manufacturer knew about these risks early on, but failed to report their errors in a timely manner to the government and to alert healthcare professionals. Furthermore, these claims state Alere should have tested the INRatio more extensively and conducted additional research before marketing it to patients.