Right here’s the factor about prostate-specific antigen: you don’t anticipate finding it in blood take a look at outcomes for most girls, as a result of most girls don’t have prostates. So when Theranos’ former lab director, Kingshuk Das, discovered that Theranos’ gadgets stored reporting that girls had detectable PSA ranges, he assumed that meant there was one thing flawed with the gadgets.
Theranos CEO Elizabeth Holmes had an “various clarification,” he mentioned. It was that these girls had a uncommon sort of breast most cancers. That clarification “appeared implausible,” he testified right now in US v. Elizabeth Holmes. Das was certainly one of a parade of consultants we’ve heard from on this trial, who it appears had been employed primarily to be ignored.
The central query of the trial, as framed by Holmes’ protection, was whether or not Holmes knew she was deceptive individuals or whether or not she was merely a naif who one way or the other by chance confirmed traders paperwork with Pfizer and Schering-Plough logos on them, regardless of being written by Theranos workers. The query of frame of mind is essential: did she have the intent to deceive?
By the point Das had been introduced aboard as lab director, a number of different lab administrators had change into uncomfortable with Theranos and give up, most notably Adam Rosendorff, who was a significant supply for John Carreyrou’s 2015 exposé concerning the firm after being sidelined by Holmes.
Actually, testifying earlier than Das this morning was Lynette Sawyer, a short lived co-lab director who by no means went to the bodily lab and whose job appears to have been signing paperwork in Docusign. Her co-lab director, who was additionally a dermatologist for Holmes’ co-defendant Sunny Balwani, had testified he didn’t know she was signing paperwork on the time. (Balwani is being tried individually.) Sawyer didn’t need to keep on after her six-month contract ended as a result of she was “uncomfortable” with Thearnos’ lab procedures, she mentioned.
Throughout testimony this morning, Sawyer additionally informed the court docket that she didn’t know what a Nanotainer was. (A Nanotainer was Theranos’ proprietary know-how for storing fingerstick samples.) She additionally didn’t know that Theranos had modified third-party gadgets to run fingerstick samples. And Theranos apparently botched her paperwork; after she left, she needed to ship over a certificates needed to point out she might function a lab director, which Theranos must produce for an audit.
Each lab administrators’ testimony instructed a clownshoes operation, however Sawyer didn’t have direct contact with Holmes. Das certain did, although. One technique the protection has employed all through the trial is to recommend that Holmes leaned closely on Balwani, her co-defendant, and any attainable fraud will need to have originated with him, not her. However Balwani left Theranos shortly after Das joined. He dealt solely with Holmes.
After Das joined the corporate, he acquired a stern letter from the lab’s regulator, the Middle for Medicare and Medicaid Providers, saying the lab was poor and enclosing a 121-page report on all the issues. Coping with the lab’s deficiencies was “almost the only duty I had,” Das testified.
He reported to Holmes. He consulted together with her continuously whereas attempting to repair the lab. He even flew to Washington, DC together with her to satisfy with CMS regulators.
All through his testimony, Das painted a portrait of a girl who willfully refused to imagine there was something flawed with the Theranos gadgets themselves. Moreover the bizarre factor about uncommon breast cancers, Holmes additionally didn’t agree with Das’ evaluation that “these devices weren’t acting from the very starting.” Das got here to this conclusion after extensively reviewing Edison information.
However Holmes tried in charge quality-control issues, not the machines themselves.
To answer CMS, Das voided years’ value of affected person outcomes on the Theranos gadgets, sending outcomes to sufferers and medical doctors that mentioned the take a look at end result primarily wasn’t actual. “I discovered these devices to be unsuitable for medical use,” he mentioned. After going by way of a substantial amount of documentation from CMS concerning the numerous Edison failures — which underscored earlier testimony from Rosendorff about Edison’s issues — the prosecution turned the witness over to the protection.
Now, an important many individuals had been employed to repair the Theranos lab circumstances, Das testified when he was cross-examined. These individuals had been critical and diligent, they usually labored exhausting, and he was the “quarterback,” within the terminology of Holmes’ lawyer Lance Wade, of that workforce. But when Holmes couldn’t settle for a number of lab administrators telling her the Theranos machines didn’t work, I’m unsure it mattered what number of consultants had been introduced in to attempt to repair the lab.
