Theranos lab deficiencies posed ‘immediate jeopardy’ to patients, 2016 government audit warned

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  • A former director of Theranos Lab testified that she faced backlash from Elizabeth Holmes over her concerns about the technology being wrong.
  • Kingshuk Das said that he deconstructed every test he had done on the Edison device over the two years and told Holmes that it “wasn’t performing from the start.”
  • Das said her first job at Theranos was responding to an audit by The Centers for Medicare and Medicaid Services, which noted that “laboratory-deficient practices pose an immediate threat to patient health and safety.”

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San Jose, Calif. The company’s laboratory director in Theranos’ final two years, Kingshuk Das, says CEO Elizabeth Holmes ignored his repeated complaints about serious errors with the start-up’s blood-testing technology.

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Das, who joined Theranos in late 2015 and reported directly to Holmes, took the stand on Tuesday in his criminal fraud trial.

He recalled that he tried to explain the issues of inaccuracy to Holmes by using the example of female patients receiving abnormal levels of prostate-specific antigen, or PSA, which is a prostate test.

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Das said, “PSA should usually not be detectable in women,” but recalled that Holmes offered an alternative explanation, citing “one or two articles” which claimed that the rare Breast cancer may cause PSA results in women.

“Was that explanation satisfactory to you?” Robert Leach, an assistant US attorney, asked.

“It seemed impossible,” said Das.

Federal prosecutors allege that Holmes made false and misleading statements about Theranos’ blood testing technology to investors, patients and doctors. Once named the next Steve Jobs, Holmes now faces up to 20 years in prison if convicted. He has pleaded not guilty to all ten counts of wire fraud and two counts of conspiracy.

Das’s testimony may have proved damaging, showing that Holmes knew the tests were not credible, yet continued to promote them. During initial arguments and cross-examining government witnesses, Holmes’ lawyers portrayed him as a young, naive CEO who was not aware of issues of inaccuracy.

Das canceled every test on Edison devices from 2014 and 2015, and explained to Holmes that “these devices weren’t performing from the start.”

“I tried to present it in a more understandable format,” Das said. “I remember [Holmes] Offering an alternative explanation.” Das testified that Holmes told him it was not an equipment failure, but a quality control and quality assurance issue.

As laboratory director, Das testified that his first job was to respond to a finding in an audit by The Centers for Medicare and Medicaid Services.

In January 2016, following an onsite inspection of the Theranos laboratory, CMS sent a deficiency report to Sunil Dhawan, the previous laboratory director. The theme read: “Lack of condition level – immediate danger.”

“The onsite survey was completed on November 20, 2015,” the report said. “As a result of the survey, it was determined that your facility does not comply with all conditions required for certification in the CLIA program.”

The CMS concluded that “defective laboratory practices pose an immediate threat to patient health and safety.”

Holmes’ lawyers are struggling to block the CMS report from appearing on the jury. His objection was rejected by the judge. Das testified that he discussed the issues presented in the regulatory report with Holmes and other employees of his team.

Das was sacked from the company in 2018. His testimony continues on Wednesday.

The trial was delayed by over two hours due to technical issues inside the courtroom. The video system being displayed on the screen for jurors and spectators was down. An old-school projector was mounted in the courtroom and the lights were dimmed to project the performance from the jury box onto a wall.

“I’m so sorry we have these problems in our courtroom,” said US District Court Judge Edward Davila. “I’m sorry, this shouldn’t happen, and we shouldn’t have this disruption. We’ve lost valuable time.”

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