In a filing this week, the government said that tens of thousands of patients received “unreliable blood tests,” which deprived them of money and placed their health at risk.
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In May of 2016, Theranos voided two-years-worth of blood test results sent to doctors and customers due to inaccurate results. That sparked numerous lawsuits from patients who made medical decisions based on that voided data.
Theranos eventually folded and its founder Elizabeth Holmes faces fraud charges and a lengthy jail term if found guilty. As Holmes prepares for a trial, her attorneys have sought to block the relevance of those patient claims of fraud filed against her. Holmes and her attorneys argued, according to The Mercury News, that the federal indictment does not “allege that a single patient received an inaccurate result from a Theranos test.”
Federal prosecutors were quick to push back against that claim. In a filing this week, the government said that tens of thousands of patients received “unreliable blood tests,” which deprived them of money and placed their health at risk. Also, the government said, in some cases, the inaccurate tests caused “actual harm” to the patients. The filing goes on to say that many patients “were affected in serious ways by the inaccurate and unreliable tests they received from Theranos,” The Mercury News reported.
As an example, the prosecutors said one patient who took a blood test from Theranos was informed that he was HIV positive. That patient planned to seek a second opinion, but the government said he was discouraged to do so by a Theranos representative who called him and vouched “for the reliability of the Theranos result.” Days later the patient learned that the test from Theranos was inaccurate and that he was not HIV positive, the prosecution said, according to the Mercury News.
There were other examples of how the voided test results affected people. A woman who was pregnant was told by Theranos that the test results she took showed the baby in her womb was not viable. She had been unsuccessful in getting pregnant prior to this and was devastated by the news. However, she sought a second opinion from another lab that showed her pregnancy was normal, the prosecution said.
Another patient was told by the Theranos test that she was not pregnant. However, a test from another lab showed that she was pregnant but that her pregnancy was ectopic. Her life was in danger as a result of the incorrect Theranos result, the government said.
With these patient examples, as well as others, the government is urging the trial judge to reject the claims from Holmes’ legal team. The motion is set to be heard on Feb. 10 and a jury trial is set to begin Aug. 4.
Holmes is facing criminal charges alongside Theranos’ former president and her former boyfriend, Ramesh “Sunny” Balwani. The two have been charged with multiple counts of fraud. From 2013 to 2015 Holmes and Balwani raised more than $700 million from investors through what the U.S. Securities and Exchange Commission called “years-long fraud” in which they exaggerated or lied about the efficacy of the company’s proprietary technology and the state of its finances, according to the complaint. The company also made false claims about its relationship with the Department of Defense and its regulatory status with the U.S. Food and Drug Administration during that time period, the complaint, announced in 2018, said.
