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Federal Criminal Trialtrial-daytrial-dayJohn C. BosticLance A. WadeAdam RosendorffdirectcrossDay 12 - September 28, 2021Adam Rosendorff completed direct examination on testing accuracy, proficiency testing, inspection preparation, and his departure from Theranos. Cross-examination addressed his government interviews, prior testimony, CLIA responsibilities, assay validation, and the timing of the Walgreens rollout.
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Day 12 - September 28, 2021

Rosendorff Raises Testing Concerns; Defense Tests His Account and Responsibility

Judge Edward J. Davila
2Proceedings
2Pages
1Witnesses
2,790Lines
Day 12 of 51
Appearing:

Adam Rosendorff completed direct examination on testing accuracy, proficiency testing, inspection preparation, and his departure from Theranos. Cross-examination addressed his government interviews, prior testimony, CLIA responsibilities, assay validation, and the timing of the Walgreens rollout.

Full day summary

Adam Rosendorff completed direct examination by describing recurring physician complaints, quality-control failures, anomalous results, and discrepancies between Theranos and predicate testing. He testified that Theranos lacked a formal proficiency-testing program despite his warnings, that management rejected a proposed disclosure about the sensitivity of a TSH assay, and that preparations for a California inspection included restrictions on discussing or visiting the downstairs laboratory. He also recounted disputes over results he considered inaccurate and said the accumulated concerns led him to ask Holmes to remove him as CLIA laboratory director. After leaving Theranos, he spoke with an attorney and then, off the record, with Wall Street Journal reporter John Carreyrou because he believed he had a moral and ethical obligation to alert the public. On cross-examination, the defense examined Rosendorff's repeated government interviews, limited-immunity agreements, and earlier sworn testimony. Counsel contrasted his four stated trial reasons for leaving Theranos with a 2019 deposition identifying proficiency testing as his principal concern. Rosendorff accepted that the CLIA laboratory director bore ultimate responsibility for validation, reliable results, personnel, quality control, and other laboratory functions, while maintaining that management constraints and pushback impeded his work. Evidence concerning the rollout showed that the September 2013 launch was restricted to friends and family and that a spreadsheet listed the first Edison-based test on October 17. Rosendorff agreed that signed validation resolved pre-validation concerns but distinguished those from reliability problems arising later. Before testimony, the court questioned Alternate Juror No. 3 about a new job and directed the juror to explore a deferred start, scheduling accommodations, or remote work; no change in juror status was announced. After the jury left, the court directed the parties to confer about particular documents proposed for post-Theranos cross-examination and deferred further discussion until the next morning.

2. Adam Rosendorff — Direct/Cross (Continued)

Adam Rosendorff completed direct examination and began cross-examination about testing reliability, laboratory oversight, prior statements, and Theranos's launch. After the jury left, the court addressed proposed questioning about his post-Theranos employment.

Direct
Adam RosendorffJohn C. Bostic
637 lines

Adam Rosendorff testified that unresolved assay discrepancies, inadequate proficiency testing, constrained patient transparency, inspection practices, and management responses led him to seek removal as Theranos's laboratory director and later speak with a journalist.

Cross
Adam RosendorffLance A. Wade
2008 lines

Defense counsel challenged Adam Rosendorff with his government-interview history, prior testimony, and laboratory records while examining his CLIA responsibility, management constraints, the restricted September 2013 launch, assay validation, and Theranos's quality and reporting systems.

Procedural
Discussion of Post-Theranos Cross-Examination Topics

The parties disputed notice and handling of protected documents for Adam Rosendorff's post-Theranos cross-examination, while the court deferred further discussion and addressed the next day's witness schedule.

Highlights

Adam Rosendorff — Directtestimony highlightRosendorff used the admitted PT INR email chain to describe conflicting capillary and venous results, an internal list of assay concerns, and his grave concerns about Theranos testing accuracy.Adam Rosendorff — Direct“EVERY TIME WE GOT A PHYSICIAN COMPLAINT OR QUERY, EVERY TIME OUR QC WOULD FAIL, EVERY TIME WE HAD A SPATE OF ANOMALOUS RESULTS OUT OF REFERENCE RANGE, IT RAISED SERIOUS OR GRAVE CONCERNS FOR ME ABOUT THE ACCURACY OF THE TESTING PROCESS.”— Adam RosendorffRosendorff summarized how recurring complaints, quality-control failures, and anomalous results shaped his assessment of Theranos testing.Adam Rosendorff — DirectadmissionRosendorff testified that Theranos lacked a formal proficiency-testing process, that management knew no program was in place, and that he left a management meeting believing the issue was receiving only lip service.Adam Rosendorff — Direct“I FELT A CONFLICT BETWEEN THE MESSAGING THAT THE COMPANY WANTED ME TO PROVIDE AND THEIR DIRECTION TO EXPLORE JUSTIFICATIONS FOR ERRONEOUS RESULTS AND MY DUTY AS A PHYSICIAN TO INFORM THEM OF MY CONCERNS REGARDING THE ACCURACY OF THE TESTING.”— Adam RosendorffThe testimony states the professional conflict Rosendorff perceived between company messaging and his duties to physicians and patients.Adam Rosendorff — Directevidence eventEmails and testimony addressed preparations for a California laboratory inspection, including a prescribed auditor route, restrictions involving the Normandy lab, and Rosendorff's account that the downstairs lab was not to be mentioned unless inspectors requested it.Adam Rosendorff — Directtestimony highlightRosendorff explained that accumulated accuracy and visibility concerns led him to ask Holmes to remove him as the CLIA laboratory director of record; he disputed her response that he had not previously raised such concerns.Adam Rosendorff — Directtestimony highlightRosendorff testified that after leaving Theranos he spoke with attorney Nancy Hersh and, off the record, with Wall Street Journal reporter John Carreyrou because he felt morally and ethically obligated to alert the public.Adam Rosendorff — Direct“EVEN MONTHS AFTER I LEFT THE COMPANY, I FELT OBLIGATED FROM A MORAL AND ETHICAL PERSPECTIVE TO ALERT THE PUBLIC. I DIDN'T QUITE KNOW HOW I SHOULD DO THAT, BUT WHEN THIS OPPORTUNITY PRESENTED ITSELF, I TOOK ADVANTAGE OF IT.”— Adam RosendorffRosendorff explained his motivation for speaking with a journalist after leaving Theranos.Adam Rosendorff — CrossimpeachmentUsing Rosendorff's 2019 deposition and signed certification, the defense contrasted his four stated trial reasons for leaving Theranos with prior testimony identifying proficiency testing as the main concern and denying smaller additional concerns. The certification was admitted as Defendant's Exhibit 11000A.Adam Rosendorff — Crosstestimony highlightThe court admitted the federal CLIA regulations, and Rosendorff agreed that he bore ultimate responsibility for validation, reliable patient results, personnel, quality control, and other laboratory functions. He nevertheless stated that he faced management constraints and pushback; the court overruled the defense request to strike that explanation.Adam Rosendorff — Cross“YES. I ENDEAVORED EARNESTLY TO FULFILL THE LABORATORY DIRECTOR OBLIGATIONS. I FACED CONSTRAINTS AND PUSHBACK FROM MANAGEMENT.”— Adam RosendorffThe answer captured the central tension between Rosendorff's acceptance of regulatory responsibility and his assertion that management impeded his work.Adam Rosendorff — CrossimpeachmentA conditionally admitted Walgreens-visit spreadsheet indicated that fingerstick testing through September 28 listed CBC and HbA1c, with the first Edison-based test shown on October 17. Rosendorff clarified that signed validation resolved pre-validation concerns but did not necessarily answer later reliability questions.
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