The blood testing company Theranos set out three years ago to revolutionize the industry and make testing easier for millions of patients, but now the company is being accused of fraud and of causing more harm than help to patients.
The controversy stems from the company's Edison machines, a blood-testing device that was supposed to be able to run over 200 tests using just a couple drops of blood from finger-prick devices.
Last October, the Wall Street Journal published an exposé of the company's new device, revealing that past employees of the company had serious doubts about the accuracy of the devices and that the technology the company heralded as innovative was not even being used to on most of the blood tests.
Two years into the company's operations, it was discovered that federal officials had not yet approved the device for use, though the company was telling customers that they were received blood test results based on the exclusive technology. The company had used loopholes to hide the devices from inspection.
The article also alleged that the company was aware of inaccuracies in the tests and that the New York State Department of Health had received a formal complaint about the testing practices at Theranos.
Theranos was inspected by federal organizations and was found to be breaching safety and health codes. The company has been heavily fined, and its CEO was banned from running a lab for two years.
The company runs 45 wellness centers across Arizona and California. After the allegations were confirmed true, patients began to sue the company for false results that caused injury. Two class-action lawsuits were filed in May.
This month, another class-action lawsuit was filed in the U.S. District Court in Arizona. The plaintiff, identified only as R.C., is suing the company for its faulty test results. R.C. underwent regular blood tests that were completed by the company. R.C.'s doctor used the tests to monitor R.C.'s lipid and blood sugar levels to create a treatment plan. R.C.'s tests results routinely came back as clear, leading his doctor to recommend that R.C. maintain his current medication routine.
A few weeks later, R.C. suffered a heart attack and had surgery to implant two stents into his arteries. Blood tests by the hospital confirmed that R.C.'s previous results were inaccurate. Their suspicion was confirmed in May when Theranos voided two years worth of blood tests, either nullifying or changing the results.
R.C.'s lawsuit notes:
“Blood tests are a critical component of a patient's healthcare. Patients, as well as their doctors, rely on blood tests to detect conditions and use those results to help determine which course of treatment is or isn't needed. Inaccurate blood test results can contribute to serious conditions going undetected, to treatable conditions growing worse unnoticed, to patients forgoing medications they should take or taking medications they shouldn't. Inaccurate tests can cost patients time and money, change their lives, cause them emotional distress, lead to unnecessary and improper medical care, and endanger their health and even their lives.”
The plaintiff is filing on behalf of the 6.1 million blood tests that Theranos has completed since opening.