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Elizabeth Holmes- Case Archive
Federal Criminal Trialtrial-daytrial-dayJohn C. BosticRobert S. LeachLance A. WadeErika CheungSurekha GangakhedkarcrossredirectdirectDay 8 - September 17, 2021Erika Cheung completed testimony about validation, quality control, and Edison workflow. Surekha Gangakhedkar then described unresolved device problems and concerns about a planned patient launch, while cross-examination emphasized the limits of her CLIA-laboratory knowledge and favorable earlier assay results.
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Day 8 - September 17, 2021

Cheung Concludes; Gangakhedkar Describes Device Failures and Launch Concerns

Judge Edward J. Davila
4Proceedings
3Pages
2Witnesses
2,130Lines
Day 8 of 51
Appearing:
John C. Bostic Robert S. Leach Lance A. Wade Erika Cheung Surekha Gangakhedkar

Erika Cheung completed testimony about validation, quality control, and Edison workflow. Surekha Gangakhedkar then described unresolved device problems and concerns about a planned patient launch, while cross-examination emphasized the limits of her CLIA-laboratory knowledge and favorable earlier assay results.

Full day summary

Outside the jury's presence, the court addressed evidentiary issues involving Theranos emails and Surekha Gangakhedkar's immunity. It allowed the jury to learn that Gangakhedkar had received immunity but barred the prosecution from using the grant affirmatively to support her credibility unless the defense opened the door. Erika Cheung completed her testimony. On cross-examination, she described separate hardware and clinical-laboratory quality-control functions, maintained that procedures had not been followed during a vitamin D incident, and acknowledged that a hepatitis C sample was tested with OraQuick rather than Edison after she raised reagent-stability concerns. On redirect, she said Theranos compressed validation work to move assays into the clinical laboratory quickly, recurring quality-control failures could delay results, and only four to nine Edison assays could be performed by fingerstick during her employment. She also contrasted Edison's multistep workflow with the more automated Siemens Advia and said lower prices did not reduce the need for accurate results. Gangakhedkar then testified about Theranos's assay-development work and unresolved problems involving Edison devices, cartridges, calibration, data, and reliability. She said Holmes restricted project information to assigned personnel, that no assays had been validated for the 3.0 or 3.5 devices by August 21, and that she learned after returning from vacation that Theranos planned to launch assays on patient samples. Gangakhedkar said she resigned after raising concerns with Holmes and retained records because she feared launch problems and possible blame. On cross-examination, the defense established that she worked in research and development rather than the CLIA laboratory, did not know what occurred with validation after her departure, and had produced two Theranos assays that compared favorably with GSK's established assays in an earlier study. The court recessed for the weekend after beginning her cross-examination.

1. Pretrial Evidence, Witness Immunity, and Juror Inquiry

Before Erika Cheung's cross-examination resumed, the court addressed email admissibility, testimony concerning Ian Gibbons's death, and Gangakhedkar's immunity, then confirmed that jurors had encountered no outside information.

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Procedural
Morning Court Opening and Appearances

The court convened without the jury and recorded appearances for both sides, including Elizabeth Holmes's presence.

Procedural
Pretrial Evidentiary Hearing on Witness Testimony, Hearsay, and Immunity

The court addressed email hearsay foundations and allowed disclosure of Gangakhedkar's immunity while barring affirmative credibility bolstering unless the defense opened the door.

Procedural
Seated-Juror Outside-Information Inquiry

No juror or alternate indicated exposure to outside information, and Erika Cheung's cross-examination resumed.

Highlights

Pretrial Evidentiary Hearing on Witness Testimony, Hearsay, and ImmunityrulingAfter hearing competing positions on Gangakhedkar's immunity, the court permitted the fact of immunity to come before the jury but barred the government from using the grant affirmatively to bolster her credibility unless the defense opened the door.

2. Erika Cheung — Cross/Redirect (Continued)

Erika Cheung completed cross-examination and redirect concerning Edison testing, validation, quality-control failures, and Theranos’s claims about speed and accuracy before the court excused her.

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Cross
Erika CheungLance A. Wade
722 lines

Defense counsel used laboratory procedures, email chains, workflow improvements, and a sample-volume patent to emphasize Theranos's monitoring and remediation systems and to narrow Cheung's expertise. Cheung nevertheless maintained that the vitamin D SOP was not followed, confirmed that hepatitis C was not run on Edison after her concerns, and described Edison as a one-patient, one-test device.

Redirect
Erika CheungJohn C. Bostic
165 lines

Cheung testified that Theranos compressed validation, offered few Edison fingerstick assays, and faced frequent QC failures that could delay patient results for days; she also contrasted her experience with Theranos system claims in Exhibit 9925.

Highlights

Erika Cheung — CrossconfrontationCheung maintained that the SOP had not been followed during the vitamin D quality-control episode, expressly disagreeing with Daniel Young and testifying that her group was not retrained afterward.Erika Cheung — Redirecttestimony highlightCheung said ongoing QC was necessary after validation, placed her vitamin D accuracy concerns around November 2013, and described frequent recalibration episodes that could delay expected patient results by two or three days.Erika Cheung — Redirect“YEAH. I MEAN, WE HAD PEOPLE SLEEPING IN THEIR CAR BECAUSE IT WAS JUST TAKING TOO LONG. EVERY THREE DAYS YOU WERE HAVING TO JUST RUN THESE SAMPLES OVER AND OVER AND OVER. SO IT WAS HAPPENING VERY FREQUENTLY.”— Erika CheungCheung gave a memorable description of the frequency and operational burden of recalibration work.

3. Surekha Gangakhedkar — Direct/Cross

Surekha Gangakhedkar completed direct testimony about Theranos device failures and launch concerns, faced cross-examination about her role and favorable GSK results, and was followed by the weekend recess.

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Direct
Surekha GangakhedkarRobert S. Leach
964 lines

Gangakhedkar described unresolved Edison and Nanotainer problems, rushed launch validation, repeated notice to Holmes, and her decision to resign and retain records after raising concerns directly with Holmes.

Cross
Surekha GangakhedkarLance A. Wade
199 lines

Gangakhedkar limited her knowledge to pre-launch R&D and said she did not know the ultimate CLIA validation outcome, while acknowledging extensive assay-development work and favorable results from a two-assay GSK study.

Procedural
Weekend Recess and Jury Admonition

The court issued its weekend jury admonition, recessed until Tuesday, and deferred a prosecution request for longer trial days until jurors could be consulted.

Highlights

Surekha Gangakhedkar — Directevidence eventUsing admitted emails, Gangakhedkar described 4.0 testing problems including failed calibration, no TSH response, seven errors in 20 runs, and unresolved system behavior that could require redeveloping assays for the new platform.Surekha Gangakhedkar — Directtestimony highlightGangakhedkar said she returned from vacation to learn that Theranos planned to launch assays on patient samples, although she believed the 3.0 and 3.5 devices still had unresolved reliability problems; she described increasing pressure from Holmes and a rushed validation effort.Surekha Gangakhedkar — Direct“WELL, BECAUSE I DIDN'T THINK THAT THE 3.0 DEVICES WERE READY TO BE USED FOR PATIENT SAMPLES.”— Surekha GangakhedkarShe stated her central concern about using Edison devices in the patient launch.Surekha Gangakhedkar — Directemotional momentGangakhedkar described resigning because of launch concerns, telling Holmes that Edison problems continued, hearing that Holmes felt compelled to launch after promising delivery to a customer, and retaining records because she feared launch problems and being blamed.Surekha Gangakhedkar — Direct“AND AT THAT TIME SHE MENTIONED SOMETHING ALONG THE LINES THAT WHEN SHE HAS A PROMISE TO DELIVER TO THE CUSTOMER, SHE DOESN'T HAVE MUCH OF A CHOICE BUT TO GO AHEAD WITH THE LAUNCH.”— Surekha GangakhedkarGangakhedkar recounted Holmes's qualified explanation for proceeding with the launch despite the concerns Gangakhedkar raised.Surekha Gangakhedkar — Crossevidence eventUsing Exhibit 112, the defense elicited that GSK reported favorable results from a study involving two Theranos assays. Gangakhedkar acknowledged that she was proud of the work and understood that GSK personnel were pleased with the results.
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