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Elizabeth Holmes- Case Archive
Federal Criminal Trialtrial-daytrial-dayLance A. WadeAdam RosendorffcrossDay 14 - October 1, 2021Defense counsel tested Adam Rosendorff's recollections and oversight through AAP records, HCG communications, and physician complaints. Rosendorff acknowledged several practices and communications while preserving concerns about assay accuracy, implementation, and laboratory control.
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Day 14 - October 1, 2021

Rosendorff Cross Covers Edison AAP, HCG Controls, and Physician Complaints

Judge Edward J. Davila
2Proceedings
1Pages
1Witnesses
2,301Lines
Day 14 of 51
Appearing:
Lance A. Wade Adam Rosendorff

Defense counsel tested Adam Rosendorff's recollections and oversight through AAP records, HCG communications, and physician complaints. Rosendorff acknowledged several practices and communications while preserving concerns about assay accuracy, implementation, and laboratory control.

Full day summary

Defense counsel cross-examined Adam Rosendorff about Theranos's alternative assessment of proficiency for Edison assays. Rosendorff accepted responsibility for the written AAP policy and agreed that a February spot check did not follow it, but maintained that the check was reasonable and its data remained concerning. Records placed a senior-leadership AAP meeting in October 2014, later than he had recalled, and Rosendorff agreed that he then directed Edison AAP to be used for official compliance purposes while proficiency work continued on larger instruments. He continued to dispute Balwani's qualifications to direct laboratory quality-control work. The examination also addressed physician complaints and HCG testing. Rosendorff acknowledged a delayed callback and explained that he referred a renewed testosterone inquiry to Christian Holmes because he could not explain the discrepant results. He maintained that Holmes did not share his level of alarm about an HCG problem, while calendar and email records challenged his recollection of related meetings and communications. The court limited Exhibit 3526 to Holmes's state of mind and conditionally admitted selected portions of Exhibit 13862 subject to a possible motion to strike for lack of foundation. When cross-examination resumed, Rosendorff confirmed that he had held Edison HCG testing and directed samples to the Immulite. He later acknowledged receiving notice that HCG was back on the Edison, although he said he had assumed his directive was being followed and did not independently check compliance. He also agreed that one HCG backlog arose from an Immulite reagent shortage within his laboratory group. On Edison's six-tip procedure, Rosendorff acknowledged knowing of and approving the practice of discarding two results and averaging four, while describing it as unusual. The court also announced that trial would resume October 12 after a scheduled break.

1. Adam Rosendorff — Cross (Recall)

Court convened with the jury before Adam Rosendorff's cross-examination resumed on proficiency policies, Edison assay practices, HCG testing, and physician complaints. The court conditionally admitted limited calendar information subject to later foundation.

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Procedural
Court Convenes and Jury Returns

Court convened with the jury, counsel, Holmes, and Adam Rosendorff present.

Procedural
Juror Exposure Inquiry and Trial Schedule

No juror reported outside exposure, and the court announced that trial would resume October 12 after a long weekend.

Cross
Adam RosendorffLance A. Wade
1585 lines

Defense counsel challenged Adam Rosendorff with AAP policies, laboratory emails, physician-call records, and meeting calendars. Rosendorff accepted substantial laboratory-director responsibility but maintained that proficiency-testing implementation and data access were incomplete and that management sometimes exceeded its qualifications.

colloquy
Admissibility Colloquy Regarding Defense Exhibit 13862

The court conditionally admitted limited calendar information from Defense Exhibit 13862 while excluding its written material.

Cross
Adam RosendorffLance A. Wade
685 lines

Defense counsel challenged Adam Rosendorff about his HCG hold, later notice of Edison use, an Immulite reagent backlog, the six-tip averaging practice he approved, and his handling of physician complaints.

Highlights

Adam Rosendorff — Crossevidence eventThe defense introduced Rosendorff's signed Edison AAP SOP and established its twice-yearly schedule, five-sample comparison procedure, 80-percent acceptance criterion, and laboratory-director review requirements.Adam Rosendorff — Crosstestimony highlightRosendorff agreed that the February spot check did not follow his AAP policy, while maintaining it was a reasonable quality-control check and that the resulting data still concerned him.Adam Rosendorff — CrossrulingThe court admitted Exhibit 3526 only to show Holmes's state of mind, not for the truth of the email's assertions about internal vitamin D proficiency testing.Adam Rosendorff — Cross“IN GENERAL, I DON'T THINK MR. BALWANI WAS QUALIFIED TO BE DIRECTING A QC STUDY. IT WAS NOT APPROPRIATE FOR HIM TO BE DIRECTING CLIA STAFF OR MAKING ANY KIND OF DECISIONS TO THE VALIDITY OF DATA.”— Adam RosendorffRosendorff maintained that Balwani lacked the qualifications to direct laboratory quality-control work despite management's involvement in the studies.Adam Rosendorff — CrossconfrontationThe defense confronted Rosendorff with delayed physician callbacks and his decision to have Christian Holmes handle a renewed testosterone inquiry; Rosendorff said he was frustrated by his inability to explain discrepant results.Adam Rosendorff — Cross“I WAS BECOMING FRUSTRATED AT MY INABILITY TO EXPLAIN DISCREPANT RESULTS. IT CULMINATED ON ONE OR TWO OCCASIONS WITH MY REFUSAL TO JUSTIFY THE DISCREPANT RESULTS TO PHYSICIANS.”— Adam RosendorffThe statement links Rosendorff's delayed or declined physician communications to his concerns about unexplained laboratory discrepancies.Adam Rosendorff — CrossimpeachmentEmails and calendar records placed the senior-leadership AAP meeting in mid-October 2014 rather than mid-2014, about one month before Rosendorff left Theranos.Adam Rosendorff — CrossadmissionRosendorff agreed that, after the October leadership meeting, he directed that Edison AAP be used for official compliance purposes while proficiency testing continued on larger instruments as a good practice.Adam Rosendorff — Cross“I DID NOT USE THE WORD "INDIFFERENT." SHE SEEMED PRETTY CALM ABOUT THE WHOLE THING. SHE DIDN'T SEEM TO SHARE MY LEVEL OF ALARM.”— Adam RosendorffRosendorff preserved a qualification in his characterization of Holmes's reaction to the HCG issue.Admissibility Colloquy Regarding Defense Exhibit 13862rulingThe court conditionally admitted the limited portions of Exhibit 13862, subject to a motion to strike for lack of foundation, and permitted publication.Adam Rosendorff — Cross Resumed“FOR ME THE URGENCY WAS TO HAVE AN HCG TEST THAT WAS ACCURATE. THE URGENCY WAS NOT TO PUT IT STRAIGHT BACK ON THE EDISON.”— Adam RosendorffRosendorff distinguished his patient-testing priority from the company's efforts to return the assay to the Edison.Adam Rosendorff — Cross ResumedconfrontationAfter reviewing a mid-June email chain, Rosendorff acknowledged that he was being told HCG was back on the Edison, despite his earlier testimony that he had not been aware of its reimplementation.Adam Rosendorff — Cross Resumed“NO, I WASN'T POLICE -- I MADE A DECISION THAT HCG SHOULD BE ON VACUTAINERS. I ASSUMED THAT WAS BEING FOLLOWED ON. I DIDN'T DO ANY POLICING ON MY OWN OF THIS.”— Adam RosendorffHe acknowledged relying on others to implement his HCG decision rather than independently checking compliance.Adam Rosendorff — Cross ResumedadmissionRosendorff agreed that an HCG backlog described in an admitted inventory chain resulted from running out of Immulite reagent, a supply problem within his laboratory group rather than an Edison issue.Adam Rosendorff — Cross ResumedimpeachmentRosendorff acknowledged knowing of and approving the practice of discarding two of six Edison tip results and averaging the remaining four, while describing the practice as unusual. His deposition was then used unsuccessfully to refresh his independent recollection about whether Dr. Pandori also approved it.
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