Elizabeth Holmes, founder and former executive director of Theranos, arrives for a hearing in the U.S. District Court in the Federal Building of Robert F. Peckham in San Jose, California on Monday, November 4, 2019.
Yichuan Cao | NurPhoto | Getty Images
The mystery of what happened to critical evidence proving Theranos’ blood testing technology was not working deepened when Elizabeth Holmes accused the government of what she calls an “investigative failure”.
In a file filed late Tuesday, Holmes lawyers shot back prosecutors to rule out evidence of so-called test results, saying they were to blame for losing a database called the Laboratory Information System (LIS) that contained three years of accuracy and failure rates of Theranos tests.
“Rather than accepting responsibility for this investigation failure and the resulting gaps in evidence in their case, the government has taken a different path,” write Holmes’ attorneys, adding, “The government has assumed that the loss of LIS data reflects the woman . Holmes’ alleged guilt, although it had nothing to do with it. “
“The reason the government lacks this evidence is because prosecutors sat on their hands for years before attempting to acquire them and then sat on their hands again after acquiring them. It is entirely their fault,” the lawyers write from Holmes.
“The reason the government built their case on this fluctuating house of cards of irrelevant evidence is because they lost – or, worse, didn’t want to analyze – the actual evidence of the test results in this case,” argued Holmes’ attorneys.
However, prosecutors claim that Theranos executives destroyed the LIS system, which proved their blood test product was inaccurate.
In a filing last month, the government said that three months after a federal grand jury issued a subpoena for a copy of the database in August 2018, “the LIS was destroyed”. They wrote that “the government was never given the full records in the LIS, nor were they given the tools available in the database to search for evidence as critical as any Theranos blood test with validation errors. The Data disappeared “”
Prosecutors say the failure rate in one of these tests was 51.3%, adding that Theranos’ test results “were so inaccurate that it was essentially a toss of a coin whether the patient got the correct result. The data was devastating.” You want to invite 11 patients and 11 physicians to testify about the accuracy and reliability issues.
Holmes says there is a certain amount of expected errors in all laboratory tests: “Just as the fact of a heart attack does not prove what caused the heart attack, the fact of a wrong blood test does not prove what caused the error.”
Prosecutors point to internal emails that prove Theranos and his lawyer tried to cover up the grand jury’s test results in the database. Theranos provided backup copies of the database for investigators to put together. However, prosecutors claim that the backup required a password that Theranos executives could not remember.
Once a Silicon Valley darling, Theranos attracted the who’s who of venture capitalists and a $ 9 billion private valuation before closing in 2018.
Holmes and her co-defendant Ramesh “Sunny” Balwani each face a dozen fraud charges related to deceiving investors, patients and doctors about Theranos technology.
Holmes will face prosecutors next month for believing that evidence should not be presented to a jury that will determine her fate.
The judge’s verdicts will set the stage for her long-awaited trial, due to begin in July.