Alere INRatio Defect and Recall Lawyers
As a result of defects which caused inaccurate results to be displayed by Alere INRatio blood monitoring systems, it is possible that thousands of patients were given incorrect doses of anticoagulant medications. This may have put these patients at an unnecessary risk for severe and potentially fatal consequences. In fact, a number of deaths have already been attributed to defective Alere INRatio monitors, which have been recalled three times by the FDA.
If you or your loved one suffered injury or wrongful death due to inaccurate results from an Alere INRatio system or monitor, you may be owed substantial compensation for your damages.
What is the Alere INRatio Blood Monitoring Device?
The Alere INRatio (Internal Normalization Ratio) monitor is a device used to evaluate the rate at which a patient’s blood coagulates to determine whether that patient is currently taking the proper dose of an anticoagulant (blood thinner).
If a patient’s INR is too low, that patient may be at a higher risk for serious blood clots and may need an increased anticoagulant dose. A high INR may lead to severe health risks, including stroke, heart attack, deep vein thrombosis, or pulmonary embolism—each of which may be fatal. If a patient’s INR is too high, he or she may be at risk for a potentially fatal internal bleeding episode.
The INR range deemed to be safe is relatively small, so it is crucial that any monitoring of a patient’s coagulation is perfectly accurate at all times. Inaccurate readings from an Alere INRatio system may lead to injuries such as:
- Transient ischemic attack (TIA, “mini stroke”)
- Subdural hematoma
- Internal bleeding
- Deep vein thrombosis
- Pulmonary embolism
- Heart attack
Alere INRatio for Home Monitoring
Some anticoagulants such as Coumadin (warfarin) require patients to undergo regular blood monitoring to ensure the proper dosage, and blood monitoring may not be required but is recommended for patients taking other blood thinners like the newer Factor XA drugs such as Pradaxa, Xarelto, or Eliquis. Rather than report to a doctor’s office every month for a routine blood draw, some patients prefer to monitor their blood at home using a system like the Alere Home INRatio. This home monitoring system comes with test strips to help individuals identify their internal normalized ratio (INR), which is an expression of the patient’s prothrombin time (PT), or the ability of his or her blood to clot.
Alere INRatio Recalls
As early as 2005 the FDA began to warn the makers of the Alere INRatio system that test strip results may be inaccurate. Since then, three separate Class 1 FDA recalls (the most serious and urgent level of recall) have been issued to address inaccuracies with the Alere INRatio system and test strips.
In April 2014, Alere issued a voluntary recall of INRatio Professional test strips after the company received nine reports of patients suffering severe internal bleeding possibly linked to inaccurate INR readings from the Alere test strips used by doctors. Three of these cases resulted in the death of the patient.
In December 2014, the FDA issued an Alere INRatio Safety Alert to announce the recall of certain models of the Alere INRatio Monitor System as well as additional test strips. At this time, Alere reported to the FDA that they had received nearly 19,000 reports of blood monitoring system malfunctions between 2013 and 2014. Due to the history of inaccuracies associated with this device, the FDA urged patients with serious medical conditions to discontinue home monitoring and report to a doctor to have their blood tested to ensure accurate results.
In July 2016, the FDA issued another recall for the Alere INRatio and INRatio2 blood monitoring systems when Alere’s inability to fix inaccuracies since 2014 led to additional adverse event reports. In a related press release, Alere stated, “Although Alere is confident that the software enhancements it developed and submitted to the FDA at the end of 2015 effectively address this issue, the FDA notified the company that it believes the company’s studies do not adequately demonstrate the effectiveness of the software modification and advised Alere to submit a proposed plan to voluntarily remove the INRatio device from the market.”
Alere INRatio and Xarelto Clinical Trials
Xarelto (rivaroxaban) is a relatively new blood thinner which is made by the Janssen Pharmaceuticals subsidiary of Johnson & Johnson and Bayer Healthcare. This drug gained FDA approval in 2011, based largely on results from the ROCKET AF clinical trials conducted to evaluate the drug at Duke University. Xarelto quickly became a popular alternative to older blood thinners like warfarin, but now an increasing number of personal injury lawsuits have been filed based on claims of severe or fatal Xarelto side effects such as internal bleeding.
Recently, research published by the New England Journal of Medicine and the BMJ has suggested that the results of the ROCKET AF trials may have been skewed, since potentially inaccurate INRatio monitors were used during these trials. It has also been alleged that researchers and other parties behind the clinical trials were aware of potential Alere INRatio defects and inaccuracies, but that they failed to disclose this to the FDA. Now, the FDA is conducting an investigation into the ROCKET AF trials.
Speak with a Medical Device Lawyer
If you or someone you love has suffered severe or even fatal injuries due to false readings from an Alere INRatio monitoring system, you may be owed compensation for a range of damages. To learn more about your rights, please contact our dangerous medical device attorneys for a free Alere INRatio lawsuit consultation.