Elizabeth Holmes Theranos Trial: Lab Director Testimony Helps Defense Case

Elizabeth Holmes is currently on trial in federal district court in San Jose California. She is charged, as alleged, on 8 counts of wire fraud and 2 counts of conspiracy to commit wire fraud while she was CEO of Theranos, a revolutionary blood testing company. Each count of fraud carries a potential sentence of up to 20 years in prison.

Although prior witnesses in the Theranos trial have testified to the inaccuracy and unreliability of the Theranos testing technology, including former Theranos Lab Director Dr. Adam Rosendorff, the cross examination of Dr. Rosendorff has shed some doubt on the Government’s fraud case against Elizabeth Holmes.

Specifically, the below testimony could be argued to show Holmes’ lack of knowledge of the fraud and/or provide evidence to support a good faith defense, either of which, could support a not guilty or hung jury verdict.  

Here are some of the highlights I noted as I watched Dr. Rosendorff’s testimony: (I’m providing legal analysis on the case)

1              Accuracy tests (proficiency testing) were done on the Theranos Edison testing device.

2.            Dr. Rosendorff developed SOPs for proficiency testing and he signed off on the proficiency testing reports which tested the accuracy of the Edison and other testing devices.

3.            Proficiency testing was done weekly and separate quality control testing was done daily.

4.            4 out of 5 Theranos proficiency tests met CLIA regulations.

5.            Dr. Rosendorff admitted he had “ultimate responsibility” for accuracy of tests and responsibility for labs. (Per emails presented, discussions were mostly with co-defendant Balwani with no cc to Holmes. 2 emails shown where Holmes responded within minutes to follow up).

6.            Theranos Edison samples when compared to gold standard assays met acceptable criteria to pass CLIA regs.

7.            Sample accuracy testing done by witness Cheung resulted in “confusion” due to inappropriate testing procedures.

8.            Confusion in accuracy testing led to a SOP proficiency testing presentation to lab employees to address any testing procedure “confusion and misconceptions”.

9.            Balwani asked for more accuracy testing beyond the regulation requirements to include other assays beyond Vit D.

10.          Dr. Rosendorff kept Balwani posted on accuracy of Vit D tests (not Holmes?).

11.          Dr. Rosendorff failed to call several doctors back who had questions on results even though obligated to do so under CLIA regs.

12.          When Dr. Rosendorff had concerns that proficiency testing SOPs were not being implemented properly, the entire leadership team was willing to meet next day, but, Rosendorff delayed meeting.

13.          Holmes asked Dr. Rosendorff if he wanted meeting and if he “had other points to discuss”. Rosendorff didn’t request a meeting.

14.          Although prior testimony showed concerns regarding Theranos HCG tests, Dr. Rosenberg validated HCG tests for use. When he expressed concerns regarding HCG test result and accuracy, Holmes responded within minutes, “how did that happen”. He does not recall if he had meeting with Holmes to discuss.

15.          Although Dr. Rosendorff was opposed to deleting data points, he approved of the 6-tip practice at Theranos and testified that standard guidelines allowed for averaging 5 readings Theranos averaged 4 readings.

16.          In response to a doctor’s inquiry regarding test results and accuracy, Dr. Rosendorff empathetically assured the doctor that Theranos tests had “rigorous accuracy” and he was “confident on lipid panel results’ as he “checked the QC results”.

While Dr. Rosendorff’s testimony may have shed some doubt as to whether Holmes had the requisite knowledge of the inaccuracy or unreliability of the technology amounting to fraud, or lack thereof, the jury will be instructed that the doubt required is reasonable doubt, not just any doubt or a doubt as to the defendant’s guilt or innocence. And…it is up to the jury to determine what the facts are, weigh the credibility of each witness and determine whether a doubt is reasonable.

The Defense is scheduled to continue their cross examination of Dr. Rosendorff on Tuesday.

Simply my opinion, what say you?      

Watch my legal analysis of the Holmes trial on KRON4, KPIX5 CBS, FOX KTVU. KPIX5 CBS.