Right here’s the factor about prostate-specific antigen: you don’t look forward to finding it in blood check 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 ladies had detectable PSA ranges, he assumed that meant there was one thing fallacious with the gadgets.
Theranos CEO Elizabeth Holmes had an “various clarification,” he stated. It was that these ladies had a uncommon form of breast most cancers. That clarification “appeared implausible,” he testified at present 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 have 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 folks or whether or not she was merely a naif who someway by accident confirmed traders paperwork with Pfizer and Schering-Plough logos on them, despite being written by Theranos staff. 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 develop into uncomfortable with Theranos and give up, most notably Adam Rosendorff, who was a serious supply for John Carreyrou’s 2015 exposé about the company 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 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 advised the courtroom that she didn’t know what a Nanotainer was. (A Nanotainer was Theranos’ proprietary expertise 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 mandatory to point out she might function a lab director, which Theranos must produce for an audit.
Each lab administrators’ testimony recommended a clownshoes operation, however Sawyer didn’t have direct contact with Holmes. Das positive 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 should 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 Heart 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 along with her continuously whereas attempting to repair the lab. He even flew to Washington, DC along with her to fulfill with CMS regulators.
All through his testimony, Das painted a portrait of a girl who willfully refused to consider there was something fallacious with the Theranos gadgets themselves. In addition to 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 accountable 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 check outcome basically wasn’t actual. “I discovered these devices to be unsuitable for medical use,” he stated. After going by means of a substantial amount of documentation from CMS concerning the varied Edison failures — which underscored earlier testimony from Rosendorff about Edison’s issues — the prosecution turned the witness over to the protection.
Now, a terrific many individuals have been employed to repair the Theranos lab situations, Das testified when he was cross-examined. These folks have been critical and diligent, and so they labored arduous, 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 undecided it mattered what number of specialists have been introduced in to attempt to repair the lab.