SOMETHING NEW AND UNEXPECTED SEEMS TO POP UP EACH DAY in testimony taken during the federal criminal trial of Elizabeth Holmes, founder and ex-CEO of Theranos, the defunct and discredited clinical laboratory company.
Last Thursday, a third individual who served as CLIA laboratory director at Theranos was called to the witness stand. It was Lynette Sawyer. The Wall Street Journal reported, “Dr. Sawyer’s name was added to Theranos’ lab license, as its co-director, in late 2014. Dr. Sawyer testified that she has a doctorate degree in public health and experience working in public health, including on HIV research, and was the lab director at a number of biotechnology companies.”
According to testimony, Sawyer was placed at Theranos by Laboratory Consulting Services and her name was added to the CLIA license (which already listed the the name of Sunil Dhawan, MD, who earlier testified that he was Ramesh “Sunny” Balwani’s dermatologist). Balwani is the ex-COO of Theranos who was also Holmes’ boyfriend at the time. He is charged with nine counts of wire fraud and two counts of conspiracy to commit wire fraud. He will be tried separately.
Sawyer testified that this CLIA lab directorship was to be a temporary job lasting about three months. From testimony given by Sawyer and Dhawan, neither seemed to be aware that the other had been hired by Theranos for the same position and was serving at the same time.
In its coverage of her testimony, Ars Technica wrote, “Sawyer said she was sent documents via Docusign that covered standard operating procedures on ‘ordinary, FDA-approved assays’ performed on standard lab equipment. She never visited the lab, wasn’t invited to, and didn’t review data from Theranos’ proprietary devices. In fact, Sawyer said she didn’t even know that Theranos was using its own devices in the government-regulated lab. Despite being hired for only a few months, Theranos kept her on until she left of her own accord after about six months. ‘As that time wore on and on, I grew increasingly uncomfortable in the way things were done,’ she said. ‘I was very uncomfortable with the lack of clarity about the lab.’”
Two CLIA Lab Directors
As the court record shows, following the resignation of Adam Rosendorff, MD, a board-certified clinical pathologist who had been the Theranos lab director from April 2013 through December 2014, Theranos hired two individuals as CLIA lab directors who seldom or never visited the lab and testified that their primary activities were to sign documents.
In the story that follows, The Dark Report presents an interview with an attorney experienced in advising CLIA lab directors. Using questions asked by the prosecution and the defense of Rosendorff’s actions, he analyzes different situations that can put CLIA lab directors at risk of non-compliance.