Lynette Sawyer described the limits of her off-site laboratory-director role and her dissatisfaction with the information she received. Kingshuk Das testified about Theranos's CMS response, the voiding of approximately 50,000 to 60,000 Edison tests, and his conclusion that the instruments were unsuitable for clinical use, while the court restricted selected CMS evidence to Holmes's knowledge and intent.
Full day summary
Outside the jury's presence, the parties disputed how the CMS deficiency report and Kingshuk Das's conclusions could be presented. The court limited Das to percipient-witness testimony, made his conclusions dependent on foundation, and later admitted selected report pages only as evidence of Holmes's knowledge and intent, not for the truth of the report's assertions. The court also barred use of a civil regulatory provision as a basis for criminal conviction and deferred any related instruction until the final charge.
Cross- and redirect examination of Lynette Sawyer focused on the scope of her part-time, off-site co-laboratory-director role. She described reviewing SOPs and other records while lacking experience with Theranos's laboratory information system and never visiting its laboratory. After reviewing her notes, she corrected her earlier account of one delegation, identifying its recipient as QA/QC manager Langly Gee. Emails showed that she sought to end her service because she was dissatisfied with the information she received, then remained through June at Ramesh Balwani's request.
Das testified that responding to CMS became nearly his sole responsibility as laboratory director. He described reviewing quality-control data and patient-result distributions, discussing the deficiencies and response with Holmes, and using PSA results reported for female patients as an example of apparent Edison errors. He said the laboratory concluded that every TPS 3.5 test presented possible patient impact, issued voided corrective reports for approximately 50,000 to 60,000 Edison tests, and never resumed testing because he considered the instruments unsuitable for clinical use.
On cross-examination, Das agreed that Theranos had begun strengthening laboratory practices before the CMS report issued, that the remediation team worked diligently and in good faith, and that Holmes supported his leadership and placed no limits on his review. His cross-examination remained unfinished at adjournment.