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personpersonLynette SawyerLynette SawyerPhysician who served as a temporary, off-site co-director of a Theranos clinical laboratory.← All People
WitnessTheranos

Lynette Sawyer

Physician who served as a temporary, off-site co-director of a Theranos clinical laboratory.

501 lines·15 proceedings·9 mentions

About

Lynette Sawyer testified for the prosecution about her temporary service as Theranos's part-time California clinical-laboratory co-director from late 2014 through June 2015. She worked off site, principally reviewing and approving standard operating procedures and assay validation or verification documents electronically.

Sawyer said she never entered the laboratory, received quality-control information, communicated with laboratory supervisors, or saw data from a Theranos-manufactured analyzer. She described the procedures she reviewed as involving ordinary FDA-approved assays. She also testified that she had not known about proprietary-device testing listed in an exhibit and had not been consulted about the listed decisions to stop testing.

On cross-examination, defense counsel used the consulting agreement, licensing records, procedures, and departure correspondence to examine the limited scope of her assignment. Sawyer estimated that she reviewed roughly a couple hundred procedures and acknowledged that she did not follow up after a requested personnel roster was not provided. She nevertheless distinguished document approval from practical knowledge of Theranos's laboratory information system, nanotainers, proprietary analyzers, modified third-party machines, or laboratory operations. After consulting her notes, she corrected her description of the only delegation she recalled, identifying the person as a quality-assurance and quality-control manager rather than a technical supervisor, while allowing that other delegations or documents might have existed.

On redirect, Sawyer identified a personnel list in evidence as information she had sought for months. She linked her wish to end the engagement to dissatisfaction with the information she was receiving, explained that signed DocuSign records remained available to Theranos, and reiterated the limits of her technical and operational knowledge. Although she chose not to renew her contract, she agreed to remain through June 30 and continued reviewing documents through the end of the engagement.

Trial Record (15)

FederalFederal Criminal TrialAug 31, 2021 – Jan 3, 2022Called by prosecution

Lynette Sawyer testified for the prosecution about her temporary, part-time, off-site service as Theranos's California clinical-laboratory co-director. Her examination focused on her electronic document review, limited access to laboratory operations, efforts to obtain personnel information, and decision not to renew the engagement.

Day 19

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Day 28

DirectLynette Sawyer β€” DirectLynette SawyerRobert S. Leach6highlights113lines spoken

Summary

Lynette Sawyer said that although she was a Theranos laboratory co-director, she never entered the lab or received information about proprietary-device testing and resigned after failing to obtain sufficient laboratory and personnel information.

Highlights (6)

testimony highlightSawyer testified that she accepted a position described as a two-to-three-month temporary co-directorship but remained through approximately June 2015 and became increasingly uncomfortable with how she was treated as a director.Open in transcript →
testimony highlightSawyer said she was never invited into the laboratory, never saw a Theranos-manufactured analyzer, and never reviewed data she understood to have been produced by one. The SOPs she received concerned ordinary FDA-approved assays.Open in transcript →
Quoteβ€œNO. ALL OF THE SOP'S I SAW PERTAINED TO ORDINARY FDA APPROVED ASSAYS.”— Lynette SawyerSawyer said the documents given to her as co-director did not disclose work involving Theranos-manufactured analyzers.Open in transcript →
evidence eventExhibit 4533 displayed twelve assays described as having been run on Theranos Sample Processing Units. Sawyer testified that she did not know Theranos had used its device for those assays and was not consulted about the listed testing stoppages.Open in transcript →
Show all 6 highlights
testimony highlightSawyer said she resigned after failing to obtain personnel information or sufficient clarity about the laboratory and lacking a person with whom she could address SOP concerns. She recalled Balwani encouraging her to stay and being somewhat pushy.Open in transcript →
Quoteβ€œI ELECTED TO RESIGN BECAUSE I WAS VERY UNCOMFORTABLE WITH THE LACK OF CLARITY THAT I WAS GETTING ABOUT THE LAB, ABOUT PERSONNEL, THE INABILITY TO GET THAT -- IT'S ACTUALLY A FORM THAT LISTS EVERYBODY AND THEIR POSITIONS, AND THE FACT THAT I COULDN'T REALLY TALK -- DIDN'T HAVE A PERSON THAT I COULD ACTUALLY TALK TO ABOUT ISSUES THAT I HAD WITH SOME OF THE SOP'S.”— Lynette SawyerSawyer directly connected her resignation to missing laboratory and personnel information and her inability to address concerns about SOPs.Open in transcript →

Day 30

CrossLynette Sawyer β€” CrossLynette SawyerLance A. Wade4highlights261lines spoken

Summary

Lynette Sawyer agreed that her Theranos co-director role was limited and off-site, while emphasizing gaps in her knowledge of the company's LIS, nanotainers, and proprietary testing. Admitted emails documented her decision not to renew, her extension through June, and her formal departure.

Highlights (4)

testimony highlightSawyer agreed that her consulting agreement made her a co-laboratory director, limited additional services to those requested by the company, and contemplated regular review of SOPs.Open in transcript →
Quoteβ€œYES. BUT THAT WOULD NOT HAVE NECESSARILY HAD ANYTHING TO DO WITH DEFICIENCIES BECAUSE A NEW LAB DIRECTOR MUST SIGN DOCUMENT -- MUST SIGN SOP'S WITHIN A REASONABLE TIME.”— Lynette SawyerSawyer rejected the suggestion that the volume of policy review necessarily reflected earlier deficiencies and supplied an alternative regulatory explanation.Open in transcript →
testimony highlightSawyer clarified after reviewing her notes that the one delegation she recalled went to QA/QC manager Langly Gee, not a technical supervisor, and concerned quality-control review and analysis.Open in transcript →
Quoteβ€œI LOOKED AT MY NOTES AND MY INFORMATION OVER THE WEEKEND. THERE WAS, YES, ONE DELEGATION, BUT IT WAS NOT THE TECHNICAL SUPERVISOR. IT WAS THE QA/QC MANAGER.”— Lynette SawyerSawyer corrected her earlier description of the employee who received a delegation after consulting her notes.Open in transcript →
RedirectLynette Sawyer β€” RedirectLynette SawyerRobert S. Leach4highlights38lines spoken

Summary

Lynette Sawyer clarified that she sought to leave after receiving inadequate information, that Theranos had access to documents she signed, and that she lacked operational knowledge of the LIS, proprietary testing, and modified-device fingerstick testing.

Highlights (4)

admissionUsing Exhibit 13047, the prosecution established that by April 5, 2015, Sawyer wanted to terminate her co-laboratory director services because she was dissatisfied with the information she was receiving.Open in transcript →
Quoteβ€œYES. WELL, I WAS SIGNING THEM VIA DOCUSIGN, SO THEN DOCUSIGN GAVE COPIES TO -- WENT TO THERANOS, AND USUALLY I GOT A COPY ALSO.”— Lynette SawyerThe answer distinguished Sawyer's possession of reviewed documents from Theranos's own access to the signed copies.Open in transcript →
testimony highlightSawyer reaffirmed that she never saw or used the LIS, did not understand Theranos to be testing fingerstick blood on its own or modified third-party devices, and described the LDT validations she signed as involving stool bacteria or antibiotic susceptibility rather than an Edison.Open in transcript →
Quoteβ€œNO, NO. I DID SIGN A COUPLE OF VALIDATIONS RELATING TO LDT'S.”— Lynette SawyerSawyer corrected the premise that she signed LDT SOPs or verification reports and narrowed her involvement to a couple of validations.Open in transcript →

Day 31

ProceduralLIS Evidence and Door-Opening HearingMentioned

Summary

The parties debated whether a possible missing-LIS argument would open the door to evidence about the system's unavailability, and the defense agreed to provide limited notice by the next afternoon. The government also announced a limited recall of Danise Yam concerning an email.

Mentioned in this proceeding.

Day 36

ProceduralRule 29 Motion and Evidentiary Record MattersMentioned

Summary

The defense renewed challenges to the CMS report, Erin Tompkins's HIV-result evidence, and evidence affected by the unavailable LIS database. Holmes also made a Rule 29 motion, which the court took under submission, and the court limited the defense's patent summary to applications filed through 2016 before the defense called Trent Middleton.

Mentioned in this proceeding.

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Day 47