Kingshuk Das, a former lab director for Theranos, has said he told Holmes that the company's blood-testing equipment was deficient and not reliable. Of all the high-profile witnesses set for Elizabeth Holmes’s criminal trial, Kingshuk Das isn’t exactly a key player in the collapse of Theranos Inc. But Das poses enough of a risk for her defense that her lawyer said his testimony threatens to upend the proceeding. Das, a former lab director for Theranos, has said he told Holmes, who founded the company and was its chief executive officer, that its blood-testing equipment was deficient and not reliable, court filings show. He’s one of the few high-level scientists positioned to explain to jurors how aware Holmes was of problems with the machines even as she continued to promote them. But on Friday, lawyers for Holmes argued in court that Das was added too late to the prosecution’s list of witnesses for a trial that starts in 11 days. The defense said in court filings it wasn’t aware until late last month that the government might rely on his expert opinions about assays, or tests. That didn’t allow enough time to prepare a response at trial, her attorneys said. Prosecutors argued that Das is providing testimony about facts and events in the case, not expert opinion. In response, U.S. District Judge Edward Davila said he’s inclined to let Das testify -- so long as he doesn’t veer into subjects that get too technical for jurors. The judge suggested the subject may be “something we’re going to have to police as the witness testifies.” Lance Wade, a lawyer for Holmes, warned against “kicking this can down the road,” suggesting that dealing with Das’s testimony in the middle of trial poses possible problems of fairness that could derail it. “My concern is if we wait and defer on this we’re not going to draw the lines the way we think is appropriate,” Wade told the judge. Waiting until Das testifies, he added, “is creating the serious risk of a continuance down the road.” Jury selection is scheduled to begin in federal court in San Jose, California, on Aug. 31. Holmes is charged with lying to doctors, patients and investors about the accuracy and capabilities of blood-testing machines made by Theranos. The company was once valued at $9 billion, but crashed and was dissolved after exposes and regulators revealed myriad problems with the tests. Possible witnesses at the trial include former Secretary of State Henry Kissinger and former Secretary of Defense James Mattis - who both served on the board of Theranos - and Holmes herself. According to court filings, Das said he was told by Holmes when he was hired in 2015 that his job would include responding to findings in an audit of the company’s Edison blood-testing machine by the Centers for Medicare & Medicaid Services. Das said he was told the CMS audit had uncovered “a few irregularities,” but that specific details weren’t discussed, according to a court filing. The findings by the CMS were grave enough that the regulator banned Holmes from running a lab company for two years. Theranos also had to retract or correct the results of tens of thousands of medical tests. In his own review of Theranos data, Das “concluded the Edison devices did not perform well, and the accuracy and precision did not meet the level needed for clinical testing,” court records show. Das told the government that “even using a fairly low bar, none of the Edison tests passed an acceptable level,” and that CMS inspectors were “100% correct with their deficiency findings.” He was laid off at Theranos in 2018, the year the company ceased operations. The case is U.S. v. Holmes, 18-cr-00258, U.S. District Court, Northern District of California (San Jose).
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