Alere INRatio Lawsuits Claim: Inaccuracies Increased Risk of Injury

The law firm of Baum, Hedlund, Aristei & Goldman has filed claims on behalf of several people who allege Alere INRatio blood monitoring products were defective and produced erroneous results, which caused serious injury or death.

In late December, Plaintiffs’ attorneys Bijan Esfandiari and Michael L. Baum filed the lawsuit (Case No. 37-2017-0050070-CU-PO-CTL) in San Diego County Superior Court against Abbott Laboratories and subsidiaries, Alere Inc., Alere Home Monitoring Inc. and Alere San Diego Inc. Abbott Laboratories announced in October 2017 that it had acquired Alere Inc. after negotiating the terms of the deal for more than a year.

In their lawsuits, the plaintiffs allege their personal injuries and wrongful death stemmed from inaccurate readings from several Alere blood monitoring products, including the INRatio PT/INR Monitors, INRatio PT/INR Test Strips, INRatio2 PT/INR Monitors and INRatio2 PT/INR Test Strips.

Plaintiffs have alleged the following claims:

  1. Fraud
  2. Negligence
  3. Negligence Per Se
  4. Breach of Warranty
  5. Strict Liability – Failure to Warn
  6. Strict Liability – Manufacture and Design
  7. Unfair Competition Laws
  8. Loss of Consortium
  9. Wrongful Death
  10. Survival Action

The Alere INRatio lawsuits seek punitive damages. The latest complaint is one of three that Baum Hedlund has filed against the defendants in the last 12 months in San Diego County Superior Court.

What is the Alere INRatio Blood Monitoring System?

Alere blood monitoring products are used in the home to measure a patient’s blood clotting ability when taking Coumadin (brand name for warfarin) or generic products, blood thinner medications. The measurement is expressed as an International Normalized Ratio (INR).

Accurate INR readings are essential to ensuring that patients taking blood thinners receive the proper dosage. High INRs (indicating a relatively slow blood-clotting time) can lead to excessive bleeding and generally indicate too high a dosage of blood-thinners. On the other hand, a low INR (indicating a relatively quick blood-clotting time) can lead to blood clots or strokes, and generally indicates too low a dose of blood-thinners. In both cases, the consequences of having an irregular INR results can lead to serious injury and death, which is why many patients who take blood thinners regularly monitor their INRs—to ensure they are receiving the proper dosage.

FDA Sent Defendants Multiple Warning Letters Citing Failure to Report Adverse Events

The INRatio blood monitoring system was originally manufactured by HemoSense Inc. Alere purchased HemoSense in 2007, and Abbott acquired Alere in 2017. Almost immediately after HemoSense received approval from the U.S. Food and Drug Administration (FDA) for the INRatio system in 2002, the company began receiving numerous complaints about the products’ effectiveness and accuracy.

In particular, some consumers allegedly found that the INR results they received when using the INRatio products differed from the results they obtained when they sent blood from the same samples to independent labs for testing. The deviations between the results from INRatio products and those of independent labs were “clinically significant.” Between 2002 and 2014, the defendants received numerous complaints concerning malfunctions with the INRatio products, with three deaths reported.

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

FDA’s letter further stated:

“Our record indicates your firm had information indicating that INRatio devices were generating clinically significant erroneous values … [i]f the INR is too low, a patient will be prone to blood clots or strokes. If the INR is too high, a patient will be prone to excessive bleeding. Therefore, both high and low test results have the potential to cause or contribute to a death or serious injury because they may result in erroneous dosing and thus improper control of [clotting].”

The FDA sent another letter in 2006 admonishing the defendants for failing to investigate complaints involving possible failures of devices to meet any of its specifications; failing to promptly review, evaluate and investigate complaints; and failing to file adverse event reports with the FDA.

Alere INRatio Recall

In 2014, Alere issued a voluntary recall notice to healthcare professionals for its INRatio2 Test Strips citing the disparity between INR results obtained with the INRatio2 system versus significantly higher INR results when re-testing was performed by an independent laboratory.

By singling out the INRatio2 Test Strips, the plaintiffs claim that Alere made a partial representation while suppressing material facts. In particular, the lawsuits allege that Alere’s INRatio2 recall failed to disclose what the company had known for years: the defective qualities of the INRatio products were not limited to the INRatio2 Test Strips.

At the time of the recall, Alere allegedly knew that the INRatio PT/INR Monitors, the INRatio 2 PT/INR Monitors and the INRatio PT/INR Test Strips all produced false and erroneous results. However, by directing consumers to substitute the INRatio2 PT/INR Test Strips for the earlier INRatio PT/INR Test Strips, the plaintiffs claim that Alere knowingly misrepresented to consumers and healthcare professionals that both systems worked properly, when in fact, they both caused false and erroneous results.

On July 11, 2016, the defendants finally issued a recall notice withdrawing its INRatio products from the market. According to the complaint, the recall notice stated that the FDA had “advised” (i.e. required) the defendants to remove the INRatio products from the marketplace.

Allegations in Alere INRatio Lawsuits

Despite the repeated warnings from the FDA and despite thousands of complaints received concerning malfunctions that either caused or were likely to have caused serious injuries or death (including three malfunctions which did, in fact, result in deaths), the Alere INRatio lawsuits make the following allegations against the defendants:

  • Failing to properly submit adverse event reports to the FDA.
  • Failing to advise consumers, plaintiffs and the medical community of the FDA’s admonishments and the defects plaguing the INRatio products.
  • Continuing to sell the INRatio products unabated, at all times falsely representing that the devices were safe, accurate, reliable and effective, when such representations were, in fact, false.
  • Misrepresenting INRatio monitoring system as safe and effective.
  • Omitting, suppressing and actively concealing the fact that INRatio products produced erroneous INRs.
  • Failing to disclose that INRatio products contained specific defects which produced false and erroneous results.
  • Failing to timely remove INRatio products from the market.

Were it not for these misrepresentations, omissions and failures, the plaintiffs allege they would never have purchased or used the INRatio products and would not have been exposed to the risks and injuries caused by the devices.

“For years, the defendants stood idly by and watched as its INRatio blood monitoring products continued to produce erroneous results putting consumers in harm’s way,” says attorney Bijan Esfandiari. “Their failure to warn our clients, the medical community and the general public about known defects increased the likelihood that individuals using these products could be seriously injured or killed.”

The complaint is captioned Bassett, et al. v. Abbott Laboratories, et al., Case No. 37-2017-0050070-CU-PO-CTL