The thing about prostate-specific antibody is that you don't expect to see it in most women's blood tests. Most women don't have a prostate. Kingshuk Das, Theranos' former laboratory director, noticed that Theranos devices reported that women had detected PSA levels. He assumed that this meant that something was wrong with the devices.
Elizabeth Holmes, Theranos CEO, had an "alternative explanation", he stated. These women were diagnosed with a rare form of breast cancer. He testified that this explanation seemed "implausible" in US v. Elizabeth Holmes today. Das was just one of many experts that we have heard from during this trial. It seems they were hired mainly to be ignored.
Holmes' defense argued that the central question in the case was whether Holmes knew she was misleading people, or if she was just a naif who accidentally showed investors documents with Schering-Plough logos, even though they were written by Theranos staff. It is important to ask the question of her mental state: Did she intend to deceive?
After Das was appointed lab director, many other lab directors were becoming uncomfortable with Theranos.
Lynette Sawyer, a temporary director of the co-lab, was actually testifying in front of Das. She never went to the physical laboratory and seems to have signed documents in Docusign. Her co-lab director, Sunny Balwani's dermatologist, testified that he did not know she was signing documents. Balwani is currently being tried separately. Sawyer said she didn't want to continue after her six-month contract expired because she was uncomfortable with Thearnos lab procedures.
Both lab directors suggested that a clownshoes operation be conducted.
Sawyer told the court this morning that she didn't know what a Nanotainer was. (A Nanotainer was Theranos proprietary technology for storing fingerstick sample. It was also not known that Theranos had modified third party devices to run fingerstick sample runs. Theranos also messed up her paperwork. She had to send Theranos a certificate to prove she was able to serve as lab director.
Both lab directors testified that there was a clownshoes operation. However, Sawyer did not have direct contact to Holmes. Das is certain that he did. The defense used a strategy throughout the trial to claim that Holmes was heavily dependent on Balwani, her codefendant. Any possible fraud must have originated from him and not her. Balwani left Theranos soon after Das joined. He only dealt with Holmes.
Das was notified by the Center for Medicare and Medicaid Services that the lab had become deficient shortly after he joined the company. The letter contained a 121-page document detailing all of the issues. Das stated that he was responsible for the laboratory's shortcomings.
Holmes was his first reporting partner. While repairing the lab, he consulted her often. He flew with her to Washington, DC to meet with CMS regulators.
"I found these instruments unsuitable to be used in clinical settings."
Das depicted a woman in her testimony who refused to believe that there was any problem with Theranos devices. Holmes was also skeptical about Holmes' assertion that "these instruments weren't performing from the beginning" because of rare breast cancers. Das reached this conclusion after thoroughly reviewing Edison data.
Holmes, however, tried to blame quality control problems and not the machines.
In response to CMS, Das canceled years of patient data on Theranos devices and sent results to doctors and patients that stated the test result was not real. He stated that he found the instruments unsuitable for clinical usage. After reviewing a lot of documentation from CMS regarding the Edison failures, which supported earlier testimony by Rosendorff, the prosecution handed the witness over.
When Das was cross-examined, he testified that many people were hired in order to fix Theranos' lab conditions. These people were hardworking, serious, and diligent. Das was, in the words of Holmes' lawyer Lance Wade the "quarterback" of that team. However, Holmes was unable to accept multiple lab directors telling Holmes that the Theranos machines weren't working. I don't think it matters how many experts were brought into the lab to fix the problem.