Amid concerns about the accuracy of Theranos blood testing, a class action lawsuit has been filed, alleging that tens of thousands of patients may have received inaccurate results.
Theranos is a privately held company that developed a blood-testing device that is designed to use only a few drops of blood obtained from a “finger-stick”, avoiding the need for blood vials or other more inconvenient testng measures. The blood, which was collected in pill-like “nanotainers” were allegedly run through revolutionary Edison blood-testing devices. However, a Theranos scandal has arisen in recent months about the accuracy of the company’s results.
According to allegations raised in a Theranos class action lawsuit filed by a man identified only as M.P.B., which was brought in the U.S. District Court for the Northern District of California on May 25, the company has provided unreliable and possibly inaccurate blood test results to tens of thousands of patients who may have relied on those results to decide whether to undergo harsh or dangerous medical treatments or whether they had potentially life-altering and sometimes life-threatening conditions which need to be treated.
“[T]he Edison machines did not work, and Theranos’s tests were not accurate,” states the the complaint (PDF). “This became evident on May 19, 2016, when Theranos conceded that it had informed regulators that it had voided ‘all’ of the Company’s blood-testing results from its proprietary Edison machines, as well as many tests run on traditional machines from 2014 and 2015. 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 class action indicates that the Edison Device, which the manufacturer has never allowed to be photographed, was only approved for testing of Herpes Simplex HSV-1, but the company implied they were being used for insulin, thyroid and a number of other tests. In actuality, the Edison device was only being used in 15 out of every 205 tests.
FDA approval was not required to perform much of the testing if that testing complied with industry accuracy standards and safeguards, but the lawsuit indicates that they were not.
“In February 2015, an Edison device used for testing certain hormone levels failed 87 percent of quality control checks,” the lawsuit states. “In addition, the FDA observed that there were no quality audits being performed at the Newark lab in contravention of FDA regulations.”
The lawsuit also indicates that in September 2015, the FDA determined that the capsule-like nanotainers as unapproved medical devices.
The class action lawsuit seeks to represent all purchasers of Theranos lab panels and blood testing services. It notes that there were 6.1 million tests conducted by Theranos and that the class may contain thousands of members.
The lawsuit presents claims of false advertising, violating California and Arizona consumer protection laws, unfair business practices, fraud, negligent misrepresentation, and deceit.