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Elizabeth Holmes- Case Archive
Federal Criminal Trialtrial-daytrial-dayRobert S. LeachJohn D. ClineLance A. WadeAdam RosendorffVictoria SungcrossdirectDay 13 - September 29, 2021Rosendorff acknowledged signed Edison validations and corrected his broad proficiency-testing testimony while maintaining that later quality and compliance problems persisted. Celgene’s Victoria Sung said comparative testing did not support validation or further use of Theranos assays. After the jury left, the court deferred a dispute over possible evidence concerning destruction of the laboratory information system.
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Day 13 - September 29, 2021

Rosendorff’s Lab Testimony, Celgene Comparisons, and a Deferred Evidence Dispute

Judge Edward J. Davila
3Proceedings
2Pages
2Witnesses
3,584Lines
Day 13 of 51
Appearing:
Robert S. Leach John D. Cline Lance A. Wade Adam Rosendorff Victoria Sung

Rosendorff acknowledged signed Edison validations and corrected his broad proficiency-testing testimony while maintaining that later quality and compliance problems persisted. Celgene’s Victoria Sung said comparative testing did not support validation or further use of Theranos assays. After the jury left, the court deferred a dispute over possible evidence concerning destruction of the laboratory information system.

Full day summary

Defense counsel continued Adam Rosendorff’s cross-examination through the 2013 California laboratory inspection, his regulatory responsibilities, Edison validation reports, quality-control performance, and proficiency testing. Rosendorff acknowledged that Holmes appeared open to showing inspectors the downstairs Normandy laboratory and that he would have shown it if asked, while maintaining that inspectors were not affirmatively told about it. He agreed that he signed validation reports approving multiple Edison assays for patient use and would not have done so had he considered the platform inherently unreliable, but distinguished initial assay validation from later quality-control failures and operational performance. Rosendorff also corrected his earlier unqualified testimony that Theranos lacked proficiency testing, agreeing that testing existed for predicate instruments. He maintained, however, that no formal alternative-assessment process was implemented for Theranos-developed tests despite internal discussion and drafting of such an approach. Victoria Sung testified that Celgene evaluated Theranos assays for an ACE-011 clinical trial by comparing them with established laboratory methods. She said the results did not align closely enough for Celgene to proceed, citing unusable samples, variability, and substantial differences between methods. Celgene did not validate or endorse the technology, stopped further deployment and testing, and ended the work before reaching full validation. On cross-examination, Sung acknowledged relying on specialists to review validation materials, confirmed that Theranos responded in detail to Celgene’s concerns, and discussed contractual milestones while stating that she did not know whether the associated payments were made. After the jury left, the government argued that the defense’s questioning might permit evidence concerning responsibility for destruction of the Theranos laboratory information system and that portions of Rosendorff’s cross-examination exceeded the scope of direct. The defense disputed those positions. The court deferred the information-system issue pending transcript review and further research and discussed scheduling without imposing a time limit on the defense.

1. Adam Rosendorff — Cross (Continued)

The morning session opened with Adam Rosendorff being resworn before the defense resumed cross-examination.

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Procedural
Morning Session Opening and Rosendorff Reswearing

The court checked the jury, reswore Adam Rosendorff, and set a schedule accommodating his childcare obligation.

Cross
Adam RosendorffLance A. Wade
2540 lines

Defense counsel challenged Adam Rosendorff with inspection records, compliance emails, signed Edison validation reports, quality-system data, and proficiency-testing records. Rosendorff acknowledged inspection cooperation, assay approvals, and predicate-device proficiency testing while maintaining that later Edison performance, incident management, and alternative testing remained deficient.

Highlights

Adam Rosendorff — Crosstestimony highlightUsing the admitted inspection-path email chain, the defense established that a route to the Normandy laboratory was proposed and that Rosendorff had told the government Holmes appeared open to showing inspectors the downstairs lab; he maintained that inspectors were not affirmatively told about it but would have been shown it upon request.Adam Rosendorff — Cross“ALL THAT I KNEW WAS THAT THE INSTRUMENT WAS NOT PERFORMING ANYWHERE CLOSE TO THE PERFORMANCE THAT WE SAW IN THE VALIDATION STUDIES.”— Adam RosendorffRosendorff distinguished unresolved operational performance problems from the earlier validation results on which approvals had been based.Adam Rosendorff — Crossevidence eventThe parties stipulated to admission of a large collection of validation reports, and the defense walked through reports Rosendorff signed for multiple Edison assays as meeting applicable requirements and being appropriate for patient use at the time.Adam Rosendorff — CrossimpeachmentThe defense confronted Rosendorff with his earlier broad testimony that Theranos lacked a proficiency-testing process. He clarified that proficiency testing existed for predicate instruments, agreed his earlier unqualified answers were inaccurate, and maintained that no formal process was implemented for Theranos-developed tests.Adam Rosendorff — Cross“SO THAT'S NOT CORRECT. THERE WAS PROFICIENCY TESTING FOR THE PREDICATE METHODS.”— Adam RosendorffRosendorff corrected his earlier broad testimony and narrowed the claimed deficiency to proficiency testing for Theranos-developed methods.

2. Victoria Sung — Direct/Cross

Victoria Sung completed direct and cross-examination about Celgene’s evaluation of Theranos assays, followed by an outside-the-jury discussion of evidentiary and scope issues concerning Adam Rosendorff’s cross-examination.

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Direct
Victoria SungRobert S. Leach
538 lines

Victoria Sung testified that Celgene compared Theranos assays with established laboratory methods, found inadequate alignment and greater variability, and halted further deployment without validating or endorsing the technology.

Cross
Victoria SungJohn D. Cline
429 lines

Victoria Sung confirmed that Theranos supplied validation materials reviewed by Celgene specialists, while qualifying her own expertise, memory of later responses, and knowledge of milestone payments.

Procedural
Witness Excusal and End-of-Day Jury Admonition

The court excused the witness, set Friday's session for 9:00 a.m. to 1:00 p.m., and renewed its admonition against outside research or reports.

Procedural
Post-Jury Evidentiary Hearing on Cross-Examination Issues

The parties disputed whether defense questioning opened the door to LIS-destruction evidence and whether Rosendorff's cross-examination exceeded the scope of direct. The court deferred a ruling and addressed the examination schedule.

Highlights

Victoria Sung — Directtestimony highlightSung confirmed that 67 percent of samples differed by more than 25 percent between the Theranos and QPS methods and said the result showed the assay had not performed as hoped.Victoria Sung — DirectadmissionSung testified that Celgene halted further deployment and testing, did no further work with Theranos after April 2012, and never reached the alignment needed to begin a full validation.Victoria Sung — Direct“SO THE FULL VALIDATION WOULD REQUIRE A LOT MORE WORK THAN WE DID, BUT I THINK IT WOULD START WITH BETTER ALIGNMENT OF THE RESULTS FROM THE THERANOS PLATFORM VERSUS THE STANDARD ASSAYS, AND THEN WE WOULD GO FROM THERE TO DO FURTHER WORK IN ORDER TO DEMONSTRATE THAT THE TWO PLATFORMS ARE COMPARABLE, AND THEN THE ADVANTAGES FROM THE THERANOS PLATFORM WOULD THEN COME INTO PLAY WITH LESS BLOOD DRAWN AND SO FORTH. BUT WE NEVER GOT THERE.”— Victoria SungSung directly rejected the premise that Celgene had comprehensively validated the technology and explained where its work stopped.Post-Jury Evidentiary Hearing on Cross-Examination Issuesevidence eventThe government gave notice that it might seek to introduce evidence concerning responsibility for destruction of the Theranos laboratory information system, arguing that defense questioning had opened the door. The defense disputed that position, and the court deferred consideration pending transcript review and further research.
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