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Alere Lawsuit INRatio Blood Monitoring

Alere Device next to a pricked finger with blood

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San Diego, California, March 2, 2017 — A new lawsuit alleges the Alere INRatio blood monitoring system used by patients taking blood-thinners like warfarin, produces erroneous results, which can lead to serious injury or death.

A group of plaintiffs from across the U.S. filed the lawsuit against Alere Inc., Alere Home Monitoring Inc., and Alere San Diego Inc. in San Diego County Superior Court,  alleging their personal injuries and wrongful death stemmed from inaccurate readings produced by Alere INRatio blood monitoring products.

The Alere lawsuit seeks damages based on the following allegations:

  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

What is the Alere INRatio Blood Monitoring System?

Alere manufactures and sells INRatio PT/INR Monitors, INRatio PT/INR Test Strips, INRatio2 PT/INR Monitors, and INRatio2 PT/INR Test Strips. Initially developed in the 1990s and approved by the U.S. Food and Drug Administration (FDA) in 2002, these products are used in the home to measure a patient’s blood clotting ability, which is expressed as an International Normalized Ratio (INR).

Accurate INR readings are essential to ensuring that patients taking an anticoagulant blood thinner medication, like warfarin (also known as Coumadin) receive the proper dosage, as there are serious health implications for both quick and slow blood clotting times.

A high INR (indicating a relatively slow blood clotting time) can lead to excessive bleeding, among other serious health risks, and generally indicates too high of a blood thinner dosage. A low INR (indicating a relatively quick blood clotting time) can lead to stroke and generally indicates too low of a blood thinner dosage.

In both cases, the consequences of having an irregular or erroneous INR can lead to serious injuries and death. For these reasons, many patients who take blood thinners constantly monitor their INR to ensure they are receiving the proper dosage of their medication.

Injuries and Wrongful Death Based on Alere INRatio Erroneous Results

Plaintiffs, in this case, allege they sustained injuries and were hospitalized after relying on erroneous results produced by the Alere INRatio blood monitoring system.

One of the plaintiffs from Kentucky lost her husband after relying on erroneous results from INRatio products, the lawsuit alleges. The decedent was admitted to a Florida hospital while on vacation in February 2016 due to headache and confusion that had been occurring for three or four days. At the hospital, a CT scan revealed that the decedent had a large right hemorrhagic lesion (intracerebral hematoma) in the brain with surrounding edema and shift.

According to the Alere INRatio lawsuit, the hematoma was related to warfarin use. The decedent passed away in hospice care just a couple weeks after the initial diagnosis.

A plaintiff from Pennsylvania alleges she was hospitalized after suffering a stroke due to an erroneous reading from INRatio products. A diagnosis revealed that she had a subdural hematoma. Prior to her injury, her INRatio blood monitoring system produced a “normal reading,” the complaint states.

Another plaintiff from Maryland alleges his warfarin dosage was increased after receiving low readings from his INRatio blood monitoring system. A little over a week later, he was hospitalized after a fall in the middle of the night. Lab work performed at the hospital showed a high INR reading, according to the complaint. The plaintiff says he was diagnosed with gastrointestinal bleed, weakness secondary to gastrointestinal bleed, anemia secondary to gastrointestinal bleed, and coagulopathy secondary to Coumadin.

Other plaintiff injuries detailed in the Alere lawsuit include serious bleeding incidents, scrotal hematoma, and hemopericardium, which required emergency surgery to drain excess fluid from around the heart.

Lawsuit Alleges Alere Knew About INRatio Defects but Failed to Warn the Public

According to the lawsuit allegations, almost immediately after Alere made its INRatio blood monitoring system available to the public, the company began to receive numerous complaints from consumers. Between 2002 and 2014, Alere received over 18,000 complaints from consumers over malfunctions with INRatio products.

Some consumers found that the INR results differed from the results they obtained when they sent blood from the same samples to independent labs for testing, the complaint states. These deviations between the INRatio results and the lab results were considered “clinically significant.”

The Alere lawsuit states that in most cases, the INRatio monitoring system’s INR results were incorrectly low, although in numerous other instances, the INRatio system produced results that were incorrectly high. Some of the consumer complaints indicated that malfunctions either caused or were likely to have caused serious injuries or death (including three malfunctions which did, in fact, result in deaths), according to the lawsuit.

Alere also received multiple warning letters from the FDA, admonishing the company for failing to file adverse event reports concerning erroneous INRatio results, and failing to properly investigate, evaluate, and review consumer complaints.

Despite the many thousands of complaints and multiple warning letters from the FDA, Alere failed to submit false event reports and failed to advise consumers and the medical community about the FDA’s admonishments and the defects plaguing the INRatio products, the Alere lawsuit alleges.

Instead, Alere withheld this material information from the public and continued to sell its INRatio products unabated, and marketed and advertised them to patients and the medical community, including its INR monitor, as “accurate,” “convenient,” “effective,” “reliable,” “optimal,” and “safe,” according to the allegations.

Alere INRatio Recall

In 2014, Alere issued a voluntary recall notice to healthcare professionals for its INRatio2 Test Strips, citing the disparity between the product’s results and the results obtained in laboratory settings.

By singling out the INRatio2 Test Strips, Alere made a partial representation while suppressing material facts, the lawsuit alleges. In particular, the Alere lawsuit states that the Alere 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 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, according to the complaint. By directing consumers to substitute the INRatio2 PT/INR Test Strips for the earlier INRatio PT/INR Test Strips, the plaintiffs claim Alere knowingly misrepresented to consumers and healthcare professionals that both systems worked properly, when in fact, they both caused false and erroneous results.

Alere Lawsuit Allegations

The plaintiffs in this lawsuit used the Alere INRatio blood monitoring system, believing it would allow them to safely and accurately monitor their INRs. According to the plaintiffs, Alere engaged in the following:

  • Misrepresented INRatio monitoring system as safe and effective.
  • Omitted, suppressed, and actively concealed the fact that Alere knew its INRatio products produced erroneous INRs.
  • Failed to disclose that INRatio products contained specific defects that produced false and erroneous results.
  • Failed to timely remove INRatio products from the market.

The plaintiffs in the Alere lawsuit are seeking general damages, specific damages including but not limited to past future medical expenses, loss of earnings and loss of earning capacity, restitution and disgorgement of profits, punitive and exemplary damages and statutory damages as allowed by law.

Plaintiffs are seeking punitive damages against Alere, based on allegations that Alere willfully, maliciously, fraudulently and knowingly promoted and continued to sell and distribute Alere INRatio products with reckless indifference to the safety and welfare of Plaintiffs and the general public and with the specific knowledge that the devices were defective and could potentially cause serious or even fatal injuries to all patients using the products. Were it not for this misrepresentation, Plaintiffs would not have used INRatio products.

“Believing the results produced by INRatio products to be accurate, patients and medical professionals relied on erroneous blood monitoring results and improperly adjusted blood thinner dosages, increasing the risk and likelihood of serious bodily injury or death,”

“Because of Alere’s defective INRatio products, our clients and thousands of other vulnerable and unsuspecting patients may have been seriously and permanently injured or lost their lives.”

Bijan Esfandiari, a shareholder of the law firm Baum Hedlund Aristei & Goldman and lead attorney for the plaintiffs in the Alere INRatio lawsuit.

The lawsuit is captioned Otto, et al. v. Alere Inc., et al., case no. 37-2017-00007021-CU-PL-CTL, filed in the San Diego County Superior Court.

About Baum Hedlund Aristei & Goldman

The law firm of Baum Hedlund Aristei & Goldman has successfully handled thousands of personal injury and wrongful death cases across the nation, securing over $1.5 billion in verdicts and settlements for their clients.

Since the late 1980’s the firm has handled cases against some of the largest pharmaceutical and medical device companies in the world, including Alere Inc., Alpha Therapeutic, Armour Pharmaceutical Co., Baxter Healthcare Corporation, Bayer, Eli Lilly, Forest Labs, GSK, Medtronic, Pfizer, Schering-Plough, Stryker Biotech, Takeda Pharmaceuticals, and Wyeth Pharmaceuticals, among others.


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