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Medical device manufacturer settles over faulty diagnostics

Alere, a company that manufactures various medical devices including diagnostic machines, settled a $33 million dollar claim with the government over claims it sold hospitals unreliable testing devices. As a result, the hospitals ended up submitting fraudulent claims to Medicaid and Medicare.

The devices also adversely affected patient care, but this settlement is the best way for the federal government to hold the company accountable. Filing a false claim with a government-sponsored health care program is a serious crime, because it robs the entire nation of much-needed medical dollars.

According to the claims, the company's "point of care" devices were sold between 2006 and 2012. Using the brand name "Triage," they were designed to diagnose a variety of conditions commonly seen in emergency rooms, such as drug overdoses and heart failures.

Unfortunately, the machines were unreliable. Hospitals and doctors quickly complained that they were producing both false negatives and false positives. That caused doctors who relied on the testing information to make errors in diagnosis and treatment.

Although the company knew there were problems, it did nothing to remedy the situation until the Food and Drug Administration inspected some of the devices and initiated a recall.

The money from the settlement will be divided between the government and the states where the devices were used. The lawsuit was initiated in a somewhat unusual manner. Instead of coming directly from the government, a private individual used the False Claim Act to bring a case against the company.

In this case, one of the company's own quality control analysts set things in motion. For her efforts, she'll receive more than $5 million. The provision in the Act that allowed her to sue is designed exactly for this purposes. It encourages people who know information that companies are keeping hidden to step forward.

Patients who have been injured by such devices or treatment that resulted from their use need to take note. Defective medical devices are a hazard when doctors rely on them to make clinical decisions and order treatment. Some patients may endure unnecessary treatments. Others may suffer delays in care that make their condition worse. If you've fallen victim, make sure that you fully explore your legal options for compensation.

Source: Occupational Health & Safety, "Alere settles case about point-of-care diagnostic devices," March 28, 2018

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