Dorothy Atkins@doratki
12m
We're back, and the government called Kingshuk Das to the stand. Das is a medical doctor and he worked as Theranos' lab director for 2.5 years, starting in March 2016 until 2018, around the time the company dissolved amid regulatory and public scrutiny.
Dorothy Atkins@doratki
6m
Prosecutor Robert Leach points to federal CLIA regulations that say CMS can revoke or suspend a lab owner's CLIA lab certificate if violations are found.
Dorothy Atkins@doratki
18m
Das says that when he started working at Theranos, he thought that Theranos wasn't performing blood tests on its Edison or MiniLab devices, and he didn't think the company was using non-FDA approved machines to test fingerstick blood samples.
Dorothy Atkins@doratki
16m
Das says he had minimal interaction with Sunny Balwani, because Balwani left Theranos soon after Das began working full time at Theranos. He said initially he primarily did paperwork, responding to statements of deficiencies that CMS issued after an audit of Theranos' lab.
Dorothy Atkins@doratki
13m
Das says he reported to Elizabeth Holmes and he responded to CMS's 121-page statement of deficiencies. He says he had many conversations with Holmes and traveled with Holmes to Washington DC to speak to CMS officials about its report.
Dorothy Atkins@doratki
5m
A cover letter came with the CMS report. The letter - dated Jan 25, 2016 - was addressed to Theranos' prior lab director, Sunil Dhawan, and says after a Nov 2015 inspection, CMS concluded Theranos' lab deficiencies "pose immediate jeopardy to patient health and safety."
Dorothy Atkins@doratki
3m
Testimony is slow, b/c they're having technical issues with redactions in the CMS report. Holmes' counsel also has raised multiple objections, but the judge overruled them and noted the evidence can speak to Holmes' state of mind, but not the truth of the matter asserted.
Dorothy Atkins@doratki
24m
Prosecutor points to CMS findings. Das agrees that quality control tests of multiple Theranos assays on the Edison devices violated the "2SD rule," which is a Westgard rule. (Ex-Theranos lab director Adam Rosendorff testified Theranos never adopted Westguard rules into policy.)
Dorothy Atkins@doratki
21m
Das says there was an instance where Theranos tests reported prostate-specific antigens in women who had been tested, but he noted that PSA is only found in men. Holmes told him it may be due to a breast cancer in women, but he says her explanation "seemed implausible."
Dorothy Atkins@doratki
7m
Prosecutor points to Das' response to CMS that Theranos had a "global and long term failure of the quality control program" of its instrument and he had Theranos voided all patient test results "out of an abundance of caution."
Dorothy Atkins@doratki
6m
Das said "these instruments were apparently mal-performing from the very beginning," but Holmes offered an "alternative explanation" that it was not an "instrument failure per se, but a failure of quality control and quality assurance program around it." He disagreed.
Dorothy Atkins@doratki
5m
Das noted that Theranos' validation data "had no bearing on the quality control or quality assurance program," so it couldn't be just a QC problem. "I found these instruments to be unsuitable for clinical use," he said. Trial is taking a 30 minute break. BRB!
