A former lab director testified in the criminal fraud trial of Theranos founder and CEO Elizabeth Holmes on Tuesday that he decided to void two years' worth of patient blood tests run on Theranos's "Edison" devices after concluding that he machines had not worked from the beginning.
Holmes is charged with defrauding investors, doctors and patients by making false and misleading statements about the now-defunct company's blood-testing technology. If convicted, she faces up to 20 years in prison and $3 million in fines.
Dr. Kingshuk Das, who joined the company in late 2015, told the jury that he spent the first several months of his job responding to a Statement of Deficiencies from the Centers for Medicare & Medicaid Services (CMS) finding that conditions in the Theranos lab "pose[d] immediate jeopardy to patient health and safety." After looking at volumes of patient results and quality control data, Dr. Das concluded that the Edisons, supposedly able to run multiple blood tests based on a single fingerstick, were prone to error, that there had been a "global and long-term failure of the quality control program," and that there was a "possible patient impact for every test."
Dr. Das said that when he talked with Holmes about the CMS response, she suggested "alternative" explanations for the data. In one conversation, Dr. Das said he used a Theranos test for prostate cancer that found detectible results in a large number of women as an example of the Edisons' "error propensity."
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Dr. Das testified that Holmes suggested instead, based on a study she had read, that the women might have a rare form of breast cancer. Dr. Das said that he "did not think that [explanation] was plausible."
According to Dr. Das, he also told Holmes that his review of the data validating the use of the Edisons to run blood tests in the first place showed that the machines had been "malperforming from the very beginning." In response, he said, Holmes suggested that the problem was not instrument-related but instead restricted to the quality control program. Dr. Das testified that he did not find this to be "a complete explanation."
Dr. Das testified that he believed federal and state regulations compelled him to void patient test results run on the Edisons in 2014 and 2015 and that he informed CMS of the decision to do so in the spring of 2016.
Although Dr. Das stayed at the company until 2018, he did not try to re-start any blood tests on the Edisons, having "found these instruments to be unsuitable for clinical use."
Lynette Sawyer, who briefly served as a part-time co-director of the Theranos lab from November 2014 to June 2015, also wrapped up her testimony on Tuesday.
Dr. Sawyer testified last week that she never met Holmes and never actually set foot in the lab. She did not work on anything related to Theranos fingerstick blood tests analyzed on the Edisons or on third-party devices modified by the company. Her main task was to use DocuSign to sign off on standard operating procedures for FDA-approved tests on traditional blood analyzers, without any ability to edit what she was signing.
Dr. Sawyer decided to leave the company at the end of her initial contract term because there was "a lack of clarity about the lab" and she was frustrated by her inability to get information about issues she had with the documents or to edit anything she was sent.
The trial, now in its tenth week, got a late start on Tuesday, as the scheduled start time of 9:30 was delayed for nearly two hours in an effort to re-boot the video system used to display documents around the courtroom and to jurors on individual screens.
Eventually the court and parties agreed to use an old-school projector to project the images on a wall on the side of the courtroom, turn down the courtroom lights when documents were displayed, and put a lamp in the witness box to allow the witness to see the documents in a notebook.
Judge Edward Davila, who apologized to the jurors, parties and public about the technical "issues with our court that I'm not proud of," has scheduled trial proceedings for every day next week.
The trial will continue on Wednesday, followed by a break until Monday, November 15.