Alere INRatio Lawsuit

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Consumers on blood thinners are filing Alere INRatio lawsuits because their Alere INRatio blood-testing strips are not providing accurate readings of their blood clotting ability.

Some of people taking blood thinners like Coumadin, Jantoven and Warfilone (warfarin), choose to monitor their blood levels at home instead of at a lab, by using the Alere INRatio, INRatio2 PT/INR Monitor System, or INRatio Test Strips (collectively the Alere INRatio Monitoring System) to monitor their international normalized ratio (INR) while undergoing anticoagulation therapy.

The Alere INRatio Monitoring System, which has been recalled, frequently displays therapeutic international normalized ratio levels for patients when, in fact, their international normalized ratio levels are dangerously high (beyond the therapeutic range) when testing is performed in a laboratory.

Simply put, the Alere INRatio Monitoring System is inaccurate. The Alere INRatio Monitoring System, which has been recalled, frequently displays therapeutic international normalized ratio levels for patients when, in fact, their international normalized ratio levels are dangerously high (beyond the therapeutic range) when testing is performed in a laboratory.

For certain medical conditions, this variance in INR can lead to serious medical complications. Deaths have been reported for people who mistakenly believed their international normalized ratio levels were safe, when in fact they were dangerously high. An Alere INRatio lawsuit involves allegations that the manufacturer knew of this potential problem, but failed to timely inform the U.S. government, healthcare providers and the public at large that Alere INRatio, INRatio2 PT/INR Monitor System, or INRatio Test Strips should not be used by patients undergoing specific therapies.

What Is the Alere INRatio Monitoring System?

The Alere Home INR Monitoring System is a portable monitoring system that can be used at home for anticoagulation management. Alere home monitoring measures the ability of a patient’s blood to clot, specifically measuring a patient’s prothrombin time (PT) and expresses that information as an international normalized ratio.

For most patients taking blood thinning drugs like warfarin, international normalized ratio levels of between 2.0 and 3.0 produce adequate blood thinning for the treatment of conditions associated with improper blood clotting. Patients considered to be at a high risk for deadly blood clots may show international normalized ratio levels of between 2.5 to 3.5. Based on these readings, a doctor can adjust a patient’s dosage of warfarin.

Using the international normalized ratio, patients and their doctors can monitor a patient’s prothrombin time and evaluate whether continued use of anticoagulant medications, such as warfarin, is appropriate. Anticoagulants are prescribed for patients who have:

  • Undergone replacement or heart valve surgery
  • Irregular heartbeats or arrhythmias
  • Had a heart attacks or myocardial infarction
  • Are trying to prevent DVT (deep vein thrombosis—blood clots found deep within the body) and pulmonary embolisms (blood clots found in the lungs)

The Alere INRatio Monitoring System (including INRatio2 and INRatio Test Strips) was meant to help patients and medical professionals monitor a patient’s prothrombin time and international normalized ratio levels without the need for constant laboratory testing. However, there are a number of medical issues associated with using Alere INRatio, INRatio2 PT/INR Monitor System, or INRatio Test Strips.

Baum, Hedlund, Aristei & Goldman gave exceptional attention to all aspects of the case, detailed inquiry and tenacious overview of all the information submitted. The paralegals are efficient and diligent. I was completely surprised to find an empathic personal message to take care of my own health during the challenging time of being a full time caretaker.
Mary Flores   Read more from our clients

The Problem with Alere Home Monitoring

The Alere INRatio Monitoring System is not sufficiently accurate to replace laboratory testing and Alere, the manufacturer, allegedly knew this information but failed to warn the public. The use of Alere INRatio Monitoring can result in significantly lower international normalized ratio readings than those correctly analyzed through a laboratory plasma INR test (the “gold standard”).

Alere studies show that INR readings from Alere home INR monitoring can be between 3.1 to 12.2 units lower than laboratory results when tested within one hour to one day of each other. These inaccurate readings, according to the FDA’s safety alert, can cause severe medical complications, as patients and doctors are misled into believing that a patient’s international normalized ratio levels are in the therapeutic range when, in truth, the patient is at serious risk of suffering from bleeding events, including subdural hematoma (subdural hemorrhage) or stroke.

Alere, Inc. has received 18,924 reports of incidents where the INRatio Monitoring System malfunctioned. The company has even documented incidence of death.

Alere INRatio Lawsuit: coagulation test

Alere INRatio Injury

When the Alere INRatio Monitoring System is used, patients may be at risk of serious injuries stemming from false readings. These INRatio injuries include:

  • Subdural Hematoma – Also referred to as subdural hemorrhage or bleeding in the brain, a subdural hematoma is often caused by a head injury significant enough to burst blood vessels. Blood-thinning drugs can increase the risk of subdural hematoma.
  • Hematoma Death – When a collection of blood fills outside the brain, the pressure can be life-threatening.
  • Mini Stroke – A “ministroke,” also called a “warning stroke” or “transient ischemic attack” (TIA), is a temporary interruption of blood flow to the part of the brain, spinal cord, or retina which has the same symptoms as a stroke but does not cause brain damage or permanent disability.
  • Stroke – A stroke is caused by an interruption of blood flow to the brain, resulting in brain damage and permanent disability. An Alere INRatio false reading could lead a patient to receive an improper dosage of blood-thinning medication, which could increase the risk of a blocked blood vessel.
  • Other Bleeding Events – Minor injuries can also be a serious problem with an Alere INRatio false reading. If a patient receives an improper dosage of blood-thinning medication, they can bleed to death.

Alere INRatio Recall

On April 16, 2014, Alere recalled several Alere INRatio2 PT/INR Professional Test Strips manufactured from August 22, 2013 through April 2, 2014 because patients were receiving therapeutic INR readings, but had significantly higher international normalized ratio levels when performed by a laboratory. Alere specifically noted “nine serious adverse event reports, three of which described bleeding associated with patient deaths.”

On December 8, 2014, Alere Inc. issued an additional recall involving the Alere INRatio Monitor System. Due to inaccuracies of the system, Alere said patients with any of the following conditions should not use Alere INRatio or Alere INRatio Test Strips:

  • Anemia of any type with hematocrit less than 30 percent
  • Any conditions associated with elevated fibrinogen levels including:
    • Acute inflammatory conditions (examples may include acute viral or bacterial infections such as pneumonia or influenza)
    • Chronic inflammatory conditions (examples may include rheumatoid arthritis, Crohn’s disease, ulcerative colitis, infectious liver diseases such as hepatitis, or inflammatory kidney diseases such as diabetic nephropathy and glomerulonephritis)
    • Severe infection (e.g., sepsis)
    • Chronically elevated fibrinogen for any reason
    • Hospitalized or advanced stage cancer or end stage renal disease patients requiring hemodialysis
  • Any bleeding or unusual bruising, clinically observed or reported by the patient

According to the manufacturer, “[p]atients with any of the conditions listed above should immediately be transitioned to a laboratory INR method for monitoring their INR and warfarin therapy.”

On July 11, 2016, Alere finally issued a recall notice withdrawing INRatio products from the market. The recall notice stated that the FDA “advised” (i.e. required) Alere to remove the INRatio products from the market.

According to Alere INRatio lawsuit allegations, prior to the July 11, 2016 recall notice, the company “never disclosed to healthcare providers or consumers that INRatio products contained specific defects, including but not limited to defective software and other specific defects which could be remedied with enhancements to software.” Alere also “never previously disclosed that these defects were the cause of INRatio products’ propensity for producing false and erroneous results…”

Alere INRatio Lawsuit Filed in San Diego, California

Several plaintiffs from across the U.S. have filed a lawsuit against Alere, alleging the company’s defective INRatio blood monitoring system used by patients taking a blood thinner like warfarin (also known as Coumadin) produces erroneous results, which can lead to serious injury or death. Filed on March 2, 2017 in San Diego Superior Court, the Alere INRatio lawsuit seeks punitive damages for the plaintiffs who suffered serious injuries and wrongful death after relying on erroneous results produced by the INRatio blood monitoring system.

The INRatio Monitoring Devices Affected by Alere Recall

According to the FDA, the following Alere INRatio devices have been recalled:

INRatio Test Strips

  • 0100071 Alere INRatio PT/INR Test Strips, Box of 12
  • 0100139 Alere INRatio PT/INR Test Strips, Box of 48

INRatio Monitor

  • 0100004 Alere INRatio PR/INR System Professional
  • 0100007 INRatio Prothrombin Time (PT) Monitoring System

INRatio2 Monitor

  • 0200431 Alere INRatio2 PT/INR Professional Testing System
  • 0200432 Alere INRatio PT/INR Home Monitoring System
  • 55128A Alere INRatio PR/INR Professional Monitoring System
  • 55130 Alere INRatio PT/INR Monitor

All of the affected devices were manufactured and distributed between April 1, 2008 and December 4, 2014

Alere INRatio News

Alere Inc. Used Fast Tracking to Get FDA Approval

There is a gaping loophole in the FDA medical device approval process—Section 510(k) of the Federal Food, Drug, and Cosmetic Act. It essentially allows fast tracking for approval of a medical device provided the manufacturer is able to demonstrate that the device is “substantially equivalent” to another device that has already received FDA approval and is currently on the market. Using this loophole, medical device manufacturers are allowed to bypass the usual rigorous testing and clinical trials that should be a basic requirement before a device is available to the public.

The FDA considers a device as substantially equivalent if it has the same intended use as a device that came before it, and shares the same technological characteristics. But even if the device’s technology is in some way different than the predecessor, it can still be approved if it does not raise new questions of safety and effectiveness and is demonstrated to be at least as safe and effective as its predecessor.

In Alere’s 510(k) application, the company used the substantially equivalent loophole for the INRatio2 PT/NR Monitoring System, saying that the only difference between the new product and its predecessor was the use of test strips. We now have seen that the “new and improved” Alere device was poorly tested, resulting in inaccurate readings, which put patients in serious danger.

A 2011 study published in the Archives of Internal Medicine found that a majority of medical devices that were subject to a Class I recall over the previous five-year period had been cleared through the FDA’s 510(k) process.

What is Warfarin?

Warfarin is a blood thinner marketed under the brand names, Coumadin and Jantoven. Warfarin helps the body prevent new blood clots from forming and keeps already existing blood clots from getting worse. Common conditions that can produce life-threatening blood clots include atrial fibrillation, deep vein thrombosis and pulmonary embolism.

When a patient is taking warfarin, it is important to monitor their PT/INR levels in order to manage a balance between blood clot prevention and severe bleeding events. In the event that a patient’s PT/INR levels are higher than therapeutic levels, severe bruising or bleeding are possible. When this happens, an antidote must be given to reverse warfarin’s effects and stop the bleeding.

Alere INRatio Lawsuit Settlement

As of November of 2015, there haven’t been significant group settlements stemming from any Alere INRatio lawsuit. Alere lawsuits have only begun to be filed recently, so discovery is active and ongoing. Until a number of Alere lawsuits have gone to trial or settlements have been reached, Alere Inc. may be unwilling to settle an Alere INRatio lawsuit.

It is worth noting that cases like these usually take years to resolve, as Alere INRatio attorneys have to find out precisely why patients were injured or died using the Alere INRatio PT/INR Monitor System and if these injuries and deaths could have been prevented. This doesn’t mean you should wait to hire an attorney and file an Alere INRatio lawsuit—quite the opposite. Waiting carries risk, as it is possible for you to permanently lose your rights, even in the event that a settlement is agreed to.

Each state has what is called a statute of limitations, which governs the maximum time limit on when a personal injury lawsuit must be filed. If a claim isn’t filed before the statute of limitation date expires, the injured parties cannot bring claims against those who may be liable for their injuries.

Injured Using Alere INRatio Home Monitoring?

If you or someone you know received a false PT/INR reading from an Alere INRatio Monitoring device and was injured after going through a bleeding event, you deserve monetary compensation. The list of dangers people face after receiving a false reading includes subdural hematoma (or subdural hemorrhage), brain bleeding, ministroke, stroke, or other bleeding events. In some cases, false readings can result in hematoma death.

Patients injured after a false PT/INR reading from an Alere home monitor may be able to recover damages such as lost wages, medical bills, and pain and suffering.

Alere INRatio Class Action

Our firm is not litigating a class action against Alere. A class action lawsuit is effective in the event that thousands of people share a legal claim. A small party (one person or several people) are chosen as class representatives for “the class,” a significantly larger party of others who opt to join the case. The class is bound by the same legal resolution. Any monetary award is divided between all the members of the class. Class actions usually do not apply to personal or physical injury claims since each plaintiff will have sustained different and unique injuries, rather, class actions usually apply when plaintiffs are only seeking compensation for economic losses,  such as for example, individuals who are only seeking a refund of the purchase price of the monitor or test strips.

We are only handling individual cases where someone has been injured as a result of a false reading from one of the Alere INRatio medical devices that has been recalled. An individual Alere INRatio lawsuit is based on your injuries and your damages alone. We would be seeking compensation for the physical injuries (i.e., strokes, hematoma, excessive bleeding, etc.) you have sustained as a result of the  false readings caused by a defective Alere INRatio medical device. Any money obtained from an individual case is not divided amongst other people injured by an Alere product misreading, it belongs to the individual.

Some patients might think their injury is from their blood thinner medication, when in fact it may be related to an inaccurate reading caused by a defective Alere product.

Why Baum Hedlund?

Companies that make medical devices like heart valves and stents, bone graft material, heart defibrillators and pacemakers, orthopedic joint prosthetics, surgical mesh, and medical infusion devices bring in a combined total of over $200 billion in revenue worldwide.

The medical device industry is one of the most profitable enterprises in health care, which is why companies work tirelessly to either invent the next groundbreaking medical device or make advancements to existing medical devices. But this race to be the first to bring a new device to market can put patients in danger if steps are not taken to ensure quality and safety first.

Baum, Hedlund, Aristei & Goldman has represented thousands of clients in defective medical device and pharmaceutical cases throughout the country, including cases involving the illegal and off-label use of drugs and devices. Since the late 1980’s our firm has handled cases against some of the largest pharmaceutical medical device companies in the world, including:

  • Alpha Therapeutic
  • Armour Pharmaceutical Co.
  • Baxter Healthcare Corporation
  • Bayer Corporation
  • Covidien
  • Cutter Biologicals
  • Eli Lilly
  • Forest Labs
  • GlaxoSmithKline/SmithKline Beecham
  • Marion Merrell Dow/Richardson-Merrell
  • Merck
  • Oclassen
  • Pfizer
  • Schering-Plough
  • Sigma Aldrich
  • Solvay Pharmaceuticals
  • Takeda Pharmaceuticals
  • Wyeth Pharmaceuticals

We have developed unique and very effective techniques to uncover evidence that device makers would prefer remains hidden from consumers and even physicians.

Related Articles

Alere to Initiate Voluntary Withdrawal of Alere INRatio and INRatio2 PT/INR Monitoring System –

Alere Test Strips, Monitor System Recalled by FDA – Headlines & Global News

Urgent Product Recall for Patients on Blood Thinners – Forbes

Alere Starts Urgent Recall of Some Blood Clot Test Strips – Reuters