Theranos hit with class action lawsuit over blood testing technology

Elizabeth Holmes, Theranos founder/CEO

Theranos, which has come under fire in recent months for allegations that its proprietary finger-prick blood testing technology is subpar, is now the focus of a class action lawsuit accusing the company of consumer fraud.

An anonymous Arizona plaintiff, identified only as "M.P.B.," filed the lawsuit in California on Wednesday. The lawsuit alleges that that the Edison machine, which Theranos claimed was capable of conducting hundreds of blood tests with only a few drops, did not work, producing results that "were not accurate."

"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," the lawsuit alleges.

[Also: CMS letter to Theranos claims test failed to spot prostate cancer]

The complaint seeks to ban Theranos from engaging in what it calls "deceptive advertisements," as well as reimbursement for the purchase price of the blood testing kit.

On May 19, Theranos conceded that it had informed regulators it had voided the blood testing results from its Edison machines, as well as tests run on traditional machines, from 2014 and 2015, according to the lawsuit.

In April, The Centers for Medicare and Medicaid Services released a "lightly redacted" copy of a letter it sent to Theranos claiming that its proprietary testing devices often failed to meet the company's own accuracy requirements for certain tests -- in one instance, failing to accurately detect prostate cancer.

[Also: Theranos under federal investigation in California, Bloomberg reports]

Earlier that month, CMS had proposed a number of different sanctions, including banning Theranos founder Elizabeth Holmes from the blood-testing business for at least two years. Other recommendations included the revocation of the company's Clinical Laboratory Improvement Amendments of 1988 certificate, or alternatively, a civil monetary penalty of $10,000 per day for each day of non-compliance.

For now, those sanctions are on hold while Theranos is given the chance to take corrective measures, according to published reports.

[Also: Theranos verifies California lab deficiencies saying 'we've made mistakes in the past'.]

"The lawsuit filed today against Theranos is without merit," said Theranos spokesperson Brooke Buchanan. "The company will vigorously defend itself against these claims."

The company's woes, which had been accumulating for some months, became augmented in March, when a study in the Journal of Clinical Investigation found that cholesterol test results obtained through Theranos were found to be an average of 9.3 percent lower than those obtained through clinical laboratories Quest and LabCorp, stoking fears that some patients would inappropriately begin, or fail to begin, important therapeutic treatments. 

Twitter: @JELagasse