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Theranos Faces Class Action Lawsuit Over Inaccurate Blood Test

Theranos Faces Class Action Lawsuit Over Inaccurate Blood Test

By: Sarah Massey, M.Sc.

Posted on: in News | Medical Device News

Earlier this week, a class action lawsuit was filed in a federal court against controversial laboratory services company, Theranos. The lawsuit alleges that the company used deceptive advertising to mislead customers into believing that their blood testing methods were accurate.

The lawsuit comes just weeks after Theranos announced that two years’ worth of testing results would be voided, and tens of thousands of corrected and revised results would be delivered to patients. The Centers of Medicare and Medicaid Services (CMS), are also considering banning Theranos’ co-founder, Elizabeth Holmes, from the blood testing industry for a two year period.

The Arizona man who filed the lawsuit is seeking damages and an order that the company stop engaging in false advertising. The man purchased a Theranos finger-prick blood test in December of 2015. According to the legal proceedings, the man would not have purchased the test had known that the Edison device did not work as advertised by the company.

The lawsuit claims that both the voided test results and the report filed after the CMS inspected Theranos’ Newark lab, suggest the company presented misleading information to consumers in regard to the accuracy of its testing methods. “As a result, tens of thousands of patients may have been given incorrect blood-test results, been subject to unnecessary or potentially harmful treatments, and/or been denied the opportunity to seek treatment for a treatable condition.”

According to Brooke Buchanan, a spokeswoman for Theranos, the lawsuit is “without merit” and the company plans to “vigorously defend itself against these claims.” Theranos made claims that the blood testing technology would allow for speedier, less-costly, point-of-care analysis.

Theranos formed a partnership with US pharmacy giant Walgreens in 2013, to allow for distribution of its tests. According to an article published in The Wall Street Journal, Walgreens failed to thoroughly asses the technology, as they were eager to quickly sign a deal with Theranos.

According to the lawsuit, the Walgreens deal legitimized Theranos’ testing claims, allowing the company to market their product to thousands of customers. While Theranos claimed their devices were compliant with regulations, Walgreens failed to do their due diligence to confirm those claims, before making a deal.


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