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Federal Criminal Trialtrial-daytrial-dayJohn C. BosticKevin M. DowneyDaniel EdlincrossredirectrecrossDay 22 - October 20, 2021Daniel Edlin described Theranos’s military exercises, demonstrations, public-claim review, and limited FDA clearance. Redirect focused on artificial military results, hidden demonstration errors, result selection, and the doubts that preceded his departure, while the court addressed several evidence disputes.
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Day 22 - October 20, 2021

Edlin Addresses Military Tests and Demonstrations; Evidence Disputes Continue

Judge Edward J. Davila
4Proceedings
2Pages
1Witnesses
2,489Lines
Day 22 of 51
Appearing:

Daniel Edlin described Theranos’s military exercises, demonstrations, public-claim review, and limited FDA clearance. Redirect focused on artificial military results, hidden demonstration errors, result selection, and the doubts that preceded his departure, while the court addressed several evidence disputes.

Full day summary

Daniel Edlin’s cross-examination placed Theranos’s military work and technology demonstrations in a development-and-evaluation context. He described devices adapted for transport and heat, an AFRICOM exercise using artificial results, and planned CENTCOM and SOCOM evaluations that did not produce clinical deployments. He distinguished demonstrations from physician-ordered Walgreens testing and denied that the demonstration arrangements were intended to deceive. The defense also introduced communications showing Holmes and others seeking scientific review and revising public materials to qualify turnaround times, venipuncture, test availability, comparisons, and risk disclosures. On redirect, Edlin said the AFRICOM results were predetermined, the proposed Bagram experiment never occurred, and SOCOM apparently did not test the shipped devices. He confirmed that demonstration software shielded errors from viewers and testified that Daniel Young and Holmes had final authority over reported demonstration results. He recalled Theranos’s FDA clearance as limited to the HSV-1 assay and said repeated failures to demonstrate the technology after critical press coverage contributed to his departure in December 2016. On recross, he said he did not consider continued display of the demonstration interface deceptive, relied on technical personnel about which application to use, and identified an assay-team leader as the source of one result-removal suggestion. Outside the jury’s presence, the court admitted a text-message exhibit under its Rule 106 analysis, subject to objections when particular portions were read. It deferred a decision on Dr. Shane Weber’s internal Pfizer report while considering proposed redactions. The court also declined to admit a collective binder of customer-feedback reports at that stage, while allowing the defense to return with relevant portions.

2. Daniel Edlin — Cross/Redirect/Recross (Continued)

Daniel Edlin completed cross, redirect, and recross testimony concerning Theranos’s military projects, demonstrations, external claims, and reported results before the court excused him and recessed the jury.

Cross
Daniel EdlinKevin M. Downey
1000 lines

Defense counsel used Daniel Edlin's resumed cross-examination to characterize Theranos's military projects as customized evaluations and its demonstrations as varied, labeled processes distinct from clinical testing. Edlin denied deceptive intent but maintained limits on his technical knowledge and confirmed that SOCOM never performed its planned experiment.

Procedural
Customer Feedback Reports Admissibility Hearing

The court allowed limited authentication of aggregated customer feedback reports but deferred admission of the binder pending review for relevance. It also ordered monitoring of keyboard noise reported as distracting jurors.

Cross
Daniel EdlinKevin M. Downey
732 lines

Daniel Edlin described Theranos's collaborative process for sourcing, reviewing, tailoring, and revising investor, website, media, and patient-facing claims. The court admitted numerous supporting emails and presentations, excluded a collective of customer-feedback reports on relevance grounds, and admitted an email concerning an external technology advisory board.

Redirect
Daniel EdlinJohn C. Bostic
466 lines

Daniel Edlin distinguished Theranos's military evaluations and artificial scenarios from clinical deployment, confirmed that demonstration software hid errors and that results were selectively reported, and connected Holmes to technology information and final review of external materials. He said repeated failures to demonstrate the technology contributed to his departure.

Recross
Daniel EdlinKevin M. Downey
107 lines

Daniel Edlin's recross addressed operational reasons for artificial data in the AFRICOM experiment, qualified what the device's travel established, and contextualized demonstration software, a specialist-requested result removal, and formation of a technology advisory board.

Procedural
End-of-Day Jury Admonition

The court admonished and recessed the jury until Friday, addressed the next witnesses and schedule, and continued measures to limit distracting keyboard noise.

Highlights

Daniel Edlin — Cross“YES. THEY WENT TO THE WALGREENS STORE. I WOULD CONSIDER THAT DIFFERENT FROM A DEMONSTRATION BECAUSE IN WALGREENS IT WAS -- THAT WAS THE CLINICAL LAB TESTING PROCESS VERSUS A DEMONSTRATION, WHICH WAS SEPARATE.”— Daniel EdlinEdlin drew a direct distinction between Walgreens clinical testing and Theranos demonstrations.Daniel Edlin — Cross (Resumed)testimony highlightThe defense used admitted website and brochure communications to show revisions that qualified turnaround-time language, disclosed possible venipuncture, narrowed the range of offered tests, questioned undefined comparisons, and raised possible risk disclosures.Daniel Edlin — Cross (Resumed)rulingThe court sustained a relevance objection to Exhibit 7476 and the listed collective of customer-feedback reports, while permitting the defense to return with particular portions that could be parsed consistently with the court's earlier limitation.Daniel Edlin — Redirecttestimony highlightEdlin explained that the AFRICOM exercise used predetermined, artificial patient results and qualified that he did not know exactly what was done on the device, while maintaining that its returned results were not used.Daniel Edlin — Redirect“THE RESULTS FOR EACH PATIENT WERE PREDETERMINED. LIEUTENANT COLONEL GIVENS SENT TO THERANOS WHAT THE RESULTS FOR EACH PATIENT SHOULD BE, AND THOSE WERE THE RESULTS FOR EACH PATIENT THAT APPEARED ON THE DEVICE.”— Daniel EdlinEdlin described the AFRICOM exercise as displaying predetermined results rather than generating results used for patient care.Daniel Edlin — Redirect“THE DEMO APP, AS DISCUSSED IN THE EARLIER TESTIMONY, IT SHIELDED ERRORS FROM THE VIEWER.”— Daniel EdlinEdlin directly confirmed the feature of the demonstration software that prevented viewers from seeing errors.Daniel Edlin — Redirecttestimony highlightThe prosecution reviewed removed and inconsistently reported demonstration results. Edlin said he did not decide which results to omit and identified Daniel Young and Elizabeth Holmes as having final say over what was reported.Daniel Edlin — Redirecttestimony highlightEdlin said he left in December 2016 after Theranos repeatedly failed to demonstrate that its technology worked, leading him to conclude that the promised proof would never materialize.Daniel Edlin — Redirect“WELL, IN THE YEAR AFTER THE INITIAL "WALL STREET JOURNAL" ARTICLES CAME OUT, THE COMPANY CLAIMED THAT IT WOULD BE ABLE TO PROVE THAT THE TECHNOLOGY WORKED AND PROVE THAT THOSE CLAIMS WERE NOT TRUE, AND THE COMPANY WAS UNABLE TO CONVINCE ANYONE THAT THOSE CLAIMS WERE UNTRUE AND THAT ITS TECHNOLOGY AND SCIENCE WORKED, AND THAT GAVE ME SERIOUS DOUBTS AS TO WHETHER THE COMPANY WAS CAPABLE OF PROVING THAT THE TECHNOLOGY WORKED. AND THERE WERE A NUMBER OF DIFFERENT OPPORTUNITIES THAT THE COMPANY HAD TO PROVE ITSELF, AND THEY ALL WERE UNSUCCESSFUL. AND I ULTIMATELY REACHED THE CONCLUSION THAT THOSE ATTEMPTS WERE UNSUCCESSFUL BECAUSE THEY COULDN'T HAPPEN AND THEY WERE NEVER GOING TO HAPPEN.”— Daniel EdlinEdlin explained the technology-related doubts that contributed to his departure from Theranos in December 2016.Daniel Edlin — Recrosstestimony highlightEdlin agreed that the demonstration application could continue displaying the user interface when an error arose because no blood sample was present, said he did not consider that deceptive, and identified Mr. Craig and Daniel Young as sources of advice about which application to use.
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