Right here’s the factor about prostate-specific antigen: you don’t anticipate finding it in blood take a look at outcomes for most ladies, as a result of most ladies 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 incorrect with the gadgets.
Theranos CEO Elizabeth Holmes had an “different rationalization,” he stated. It was that these ladies had a uncommon form of breast most cancers. That rationalization “appeared implausible,” he testified right this moment in US v. Elizabeth Holmes. Das was one in every of a parade of specialists 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 in some way 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 turn into uncomfortable with Theranos and stop, most notably Adam Rosendorff, who was a significant supply for John Carreyrou’s 2015 exposé in regards to the firm after being sidelined by Holmes.
In truth, testifying earlier than Das this morning was Lynette Sawyer, a brief 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 wish to keep on after her six-month contract ended as a result of she was “uncomfortable” with Thearnos’ lab procedures, she stated.
Throughout testimony this morning, Sawyer additionally instructed 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 obligatory 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 counsel that Holmes leaned closely on Balwani, her co-defendant, and any potential 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 obtained a stern letter from the lab’s regulator, the Middle for Medicare and Medicaid Companies, saying the lab was poor and enclosing a 121-page report on all the issues. Coping with the lab’s deficiencies was “practically the only real accountability I had,” Das testified.
He reported to Holmes. He consulted together with her often whereas attempting to repair the lab. He even flew to Washington, DC together with her to fulfill with CMS regulators.
All through his testimony, Das painted a portrait of a girl who willfully refused to imagine there was something incorrect 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 responsible quality-control issues, not the machines themselves.
To reply to CMS, Das voided years’ price of affected person outcomes on the Theranos gadgets, sending outcomes to sufferers and docs that stated the take a look at consequence basically wasn’t actual. “I discovered these devices to be unsuitable for scientific use,” he stated. After going by way of a substantial amount of documentation from CMS in regards to the numerous Edison failures — which underscored earlier testimony from Rosendorff about Edison’s issues — the prosecution turned the witness over to the protection.
Now, a fantastic 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, and so they labored laborious, and he was the “quarterback,” within the terminology of Holmes’ lawyer Lance Wade, of that crew. 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 specialists had been introduced in to attempt to repair the lab.