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Federal Criminal Trialtrial-daytrial-dayKevin M. DowneyElizabeth A. HolmesdirectDay 37 - November 22, 2021Elizabeth Holmes described the 1 Series cartridge failure, development of the 3 Series, research and pharmaceutical work, and her understanding of the proposed 4 Series. The court limited several exhibits to her state of mind, then heard a dispute over late defense disclosures without announcing a Rule 16 remedy.
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Day 37 - November 22, 2021

Holmes Describes Device Development; Court Limits Exhibits; Parties Debate Disclosures

Judge Edward J. Davila
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Day 37 of 51
Appearing:

Elizabeth Holmes described the 1 Series cartridge failure, development of the 3 Series, research and pharmaceutical work, and her understanding of the proposed 4 Series. The court limited several exhibits to her state of mind, then heard a dispute over late defense disclosures without announcing a Rule 16 remedy.

Full day summary

Following sealed proceedings in chambers, the jury returned and Elizabeth Holmes resumed direct examination. Holmes described a pressure-related failure in the layered cartridges used with Theranos's 1 Series and said the company responded by redesigning its analyzer and cartridge around miniaturized liquid handling, producing the 3 Series. After photographs of a Tecan robot and an early 3 Series device were admitted, she explained the system's automation, small-sample testing, software, multiplexing, sensitivity, and calibration. Holmes also reviewed academic, defense, and pharmaceutical work. She characterized a Stanford study's sepsis-related trends as preliminary, citing the small number of participants and need for further research, and discussed proposed or completed evaluations with numerous organizations. The court admitted several documents only as evidence of Holmes's state of mind or understanding, not for the truth of their assertions. Addressing a proposed 4 Series system, Holmes testified that a 2010 presentation led her to understand that it could perform any blood test. After the jury left, the government raised concerns about six exhibits produced late Saturday and suggested that documents intended for the defense case were being disclosed too slowly. The defense disputed that characterization and attributed the timing to its review after Holmes's late decision to testify. The court announced no Rule 16 remedy, thanked counsel for facilitating an efficient continuation, and separately warned attendees to reduce keyboard noise after renewed jury complaints.

1. Elizabeth A. Holmes — Direct (Continued)

Elizabeth Holmes resumed direct examination about Theranos cartridge redesigns, testing technology, and research projects, followed by an outside-the-jury Rule 16 disclosure dispute and the court's warning about keyboard noise.

Procedural
Court Convening

Court convened at 8:39 a.m. for the November 22 session.

Procedural
Sealed In-Chambers Proceedings

The court conducted sealed proceedings in chambers, with no substantive details available in the target text.

Procedural
Jury Return and Witness Recall

The court confirmed that jurors had not encountered case information over the weekend and recalled Elizabeth Holmes to continue her testimony.

Direct
Elizabeth A. HolmesKevin M. Downey
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Holmes described the 1 Series cartridge failure, development of the 3 Series, research studies, and pharmaceutical validation work. She acknowledged limits and unrealized projects while saying internal presentations led her to believe a proposed 4 Series could run any blood test; several partner communications were admitted only for state-of-mind purposes.

Procedural
Rule 16 Disclosure Dispute

The parties disputed the timing of six defense exhibit disclosures, with no exclusion motion or corrective ruling, before the court warned attendees that keyboard noise was distracting the jury.

Highlights

Elizabeth A. Holmes — Directtestimony highlightHolmes described a pressure-related cartridge-layer problem in the 1 Series, the company's redesign effort, and the resulting 3 Series device, which she said was later used in pharmaceutical partnerships.Elizabeth A. Holmes — Direct“THE WAY WE BUILT THE CARTRIDGES FOR OUR 1 SERIES DEVICE REQUIRED US TO PUT TOGETHER MANY LAYERS OF THE CARTRIDGE. THEY WERE HELD TOGETHER WITH WHAT WAS CALLED AN ADHESIVE, IT'S KIND OF LIKE A GLUE, AND WHEN EXPOSED TO CERTAIN PRESSURE, THOSE LAYERS WOULD LOOSEN, WHICH MEANT THAT IF WE WERE GOING TO BE SHIPPING THESE CARTRIDGES ALL OVER THE PLACE, WE HAD A PROBLEM.”— Elizabeth A. HolmesHolmes acknowledged a concrete engineering failure in the early cartridge design and explained why the company needed a different iteration.Elizabeth A. Holmes — Directevidence eventThe court admitted and permitted publication of side-by-side photographs of a Tecan robot and an early Theranos 3 Series device, after which Holmes explained the device's miniaturized liquid-handling design.Elizabeth A. Holmes — Directtestimony highlightHolmes described the Stanford study and its published results but emphasized that its sepsis-prediction trends were preliminary, involved very few participants, and required further study.Elizabeth A. Holmes — Direct“THE STUDY SHOWED SOME PRELIMINARY TRENDS INDICATING THAT IF YOU COULD TAKE SAMPLES FREQUENTLY, YOU MIGHT ACTUALLY BE ABLE TO PREDICT SEPSIS USING THESE KIND OF MARKERS. BUT THERE WAS A VERY SMALL NUMBER OF PEOPLE IN THE STUDY, AND MORE STUDIES WERE NEEDED.”— Elizabeth A. HolmesHolmes expressly qualified the Stanford study's sepsis-related findings and identified its small sample and need for further research.Elizabeth A. Holmes — DirectrulingDuring discussion of AstraZeneca work, the court admitted Government Exhibit 195 only for Holmes's state of mind about her knowledge of the technology, not for the truth of the document's assertions.Elizabeth A. Holmes — Directtestimony highlightHolmes testified that a 2010 presentation led her to understand that the proposed 4 Series could perform any blood test; the presentation itself described multiple contemplated measurement technologies and increased assay capacity.Elizabeth A. Holmes — Direct“I UNDERSTOOD THAT THE 4 SERIES COULD DO ANY BLOOD TEST.”— Elizabeth A. HolmesThe statement directly identifies Holmes's asserted understanding of the proposed 4 Series technology after the 2010 presentation.Rule 16 Disclosure DisputeconfrontationThe government recorded concerns that six admitted exhibits had first been produced after 9:00 p.m. Saturday and suggested that identified case-in-chief documents were being disclosed too slowly. The defense disputed that characterization and argued that exhibit selection followed the late decision for Holmes to testify and a Saturday review of its files.
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