#ElizabethHolmes trial day 34:
Crowds out bright & early to see Elizabeth Holmes testify for her fourth day. She is still on direct examination.
I am #24 in line (showed up at 4:23 a.m. for a 10:30 a.m. start.) Only 34 "main" courtroom seats.
Crowds out bright & early to see Elizabeth Holmes testify for her fourth day. She is still on direct examination.
I am #24 in line (showed up at 4:23 a.m. for a 10:30 a.m. start.) Only 34 "main" courtroom seats.
update...
#ElizabethHolmes arrives to court
"The jury monitors are not operational," judge Edward J. Davila is hearing.
Attorneys are now arguing a defense motion to admit prior testimony by Sunny Balwani.
Two new attorneys — who have sat in the court but have not litigated — are up to discuss the motion.
Kelly Volkar for the U.S. and Jean Ralph Fleurmont for Holmes
Kelly Volkar for the U.S. and Jean Ralph Fleurmont for Holmes
Fleurmont first.
Holmes and Balwani's cases were charged as co-defendants but their cases were severed.
"Mr. Balwani if called would exercise his right not to answer any relevant questions," Balwani's counsel told the defense, in regards to his unavailability
Holmes and Balwani's cases were charged as co-defendants but their cases were severed.
"Mr. Balwani if called would exercise his right not to answer any relevant questions," Balwani's counsel told the defense, in regards to his unavailability
Fleurmont is citing Federal Rule of Evidence 804b3 in his argument -- a hearsay exception for when the declarant — in this case Balwani — is unavailable to testify and makes a "statement against interest"
In this case the statements have to do with four categories, including Balwani's responsibility for the CLIA lab, and responsibility for financial projections / model, Fleurmont said.
law.cornell.edu/rules/fre/rule…
law.cornell.edu/rules/fre/rule…
Volkar brings up the timeline.
Aug. and Sept. 2017 were the dates of Balwani's testimony, before he was facing any criminal or enforcement charges, she said.
Aug. and Sept. 2017 were the dates of Balwani's testimony, before he was facing any criminal or enforcement charges, she said.
Holmes is supposed to return to the stand around 10:30 a.m.
The defense wants to admit these portions (attached below) of Balwani's SEC testimony which they say show Holmes' lack of involvement w/ financial models
Volkar pointed to 11/2013 texts between Holmes and Balwani, where he advises Holmes to get comfortable with the model
Volkar pointed to 11/2013 texts between Holmes and Balwani, where he advises Holmes to get comfortable with the model
"Should we hail Mr. Coopersmith forward?" Davila pondered, about Balwani's lawyer who is sitting in the court audience, to confirm what Fleurmont put forward about Balwani taking the 5th if called.
Both lawyers disagreed.
We are breaking while court staff attempt to fix tech problems (jurors screens.)
“I expect that Ms. Holmes direct examination will conclude today,” Downey told Judge Edward. J. Davila.
Sounds like Robert Leach will be crossing Holmes, and may finish tomorrow, Downey said.
Possible redirect next Tuesday when we return after the long weekend
Sounds like Robert Leach will be crossing Holmes, and may finish tomorrow, Downey said.
Possible redirect next Tuesday when we return after the long weekend
We have a jury.
Holmes retook the stand.
"We wanted to help people who were scared of needles," Holmes testified, citing children and cancer patients among others.
We looked at a testimonial from an apparent CEO, forwarded by Dr. Jay Rosan of Walgreens to Holmes and Balwani.
"Dr. J wanted to let you know I did some recent blood work at Theranos and I’m a believer!" Lisa Maki wrote, who Holmes testified she didn't know.
"Dr. J wanted to let you know I did some recent blood work at Theranos and I’m a believer!" Lisa Maki wrote, who Holmes testified she didn't know.
Downey's took Holmes through some positive customer reports.
"Very positive guest experience" was the subject of one Oct 7, 2015 email, sent by a phlebotomist in one of Theranos' wellness centers.
"Very positive guest experience" was the subject of one Oct 7, 2015 email, sent by a phlebotomist in one of Theranos' wellness centers.
2/8/2015
"here are the details of an amazing visit with a special needs guest that happened," read part of the body of another email sent to Holmes by a customer service rep at Theranos.
"here are the details of an amazing visit with a special needs guest that happened," read part of the body of another email sent to Holmes by a customer service rep at Theranos.
Did Theranos work with the U.S. Central Command?
Yes
...Did #Theranos enter into an agreement with CENTCOM?
We did, yes.
Yes
...Did #Theranos enter into an agreement with CENTCOM?
We did, yes.
The agreement occurred on Dec. 3, 2012 after a year and a half of discussions, started by Gen. Mattis, Holmes testified.
In the agreement we see:
"Study Facilities - Combined Joint Theater Hospital, Bagram Air Force Base, Afghanistan."
Holmes brought up IRB approval, "which is one of the approvals we needed to be able to do a study in which we were testing human studies," she said.
"Study Facilities - Combined Joint Theater Hospital, Bagram Air Force Base, Afghanistan."
Holmes brought up IRB approval, "which is one of the approvals we needed to be able to do a study in which we were testing human studies," she said.
"We invested in building a custom device that could meet these goals of being used in very remote areas or ultimately on a medevac," Holmes said, in response to what Theranos did after reaching the agreement w/ the DoD
Theranos invested 10s of millions of dollars to develop the device, holmes said.
They worked on it for much of 2013 and some of 2014, holmes said.
"We weren’t able to finish the work in time, based on the timelines in the contract," Holmes testified.
They worked on it for much of 2013 and some of 2014, holmes said.
"We weren’t able to finish the work in time, based on the timelines in the contract," Holmes testified.
Holmes testified her device was never used for clinical care on medevacs.
"I don't think I did," she said about whether she told anyone that.
"I don't think I did," she said about whether she told anyone that.
Holmes did however admit she talked about it.
"I was trying to convey that we were doing a lot for work for developing this device for use on medevacs…," she began.
She said she was "incredibly proud" of the work they were doing and "incredibly excited" about the prospect
"I was trying to convey that we were doing a lot for work for developing this device for use on medevacs…," she began.
She said she was "incredibly proud" of the work they were doing and "incredibly excited" about the prospect
Downey shifts to demos -- Holmes said those responsible for the demos were the scientists and engineers form the various tech teams, and product managers including Dan Edlin who testified, among others including Dr. Daniel young the Theranos VP
Did you have any concern at the time that this method of demonstration was misleading? Downey asked of the null protocol.
Not at all
Not at all
"The demos were generally to show technology or otherwise new things the company was working on," Holmes testified.
"Theranos Test Report Technology Demonstration - read the title of one report
"Why were results changed or modified from a test run during demos?" Downey asked.
"My understanding is there is a process for the people overseeing the results to make sure the results are correct...Dr. Young had rules for how to do that properly," Holmes testified.
"My understanding is there is a process for the people overseeing the results to make sure the results are correct...Dr. Young had rules for how to do that properly," Holmes testified.
Did you ever overrule any member of the R&D team or …as to what the results of a demo should be?
No.
...ever any instance in which you directed the scientific team to enter results contrary to what they thought the result was?
No.
No.
...ever any instance in which you directed the scientific team to enter results contrary to what they thought the result was?
No.
From 2011-2016 Theranos operated a clinical lab, Holmes testified.
Did #Theranos make efforts to become certified by CMS?
We did.
Did #Theranos make efforts to become certified by CMS?
We did.
"We sought certification in 2011," she said
"We understood we needed to do that as part of the regulatory process. We also understood there was going to be some tests that were not ordered frequently that we would need a traditional lab to conduct to run," Holmes said.
"We understood we needed to do that as part of the regulatory process. We also understood there was going to be some tests that were not ordered frequently that we would need a traditional lab to conduct to run," Holmes said.
Who was responsible for the operational management of the lab
Sunny Balwani
Who was responsible for the clinical and scientific decision making …
The lab director and lab leadership
Sunny Balwani
Who was responsible for the clinical and scientific decision making …
The lab director and lab leadership
In late 2011 there was a CMS inspection done of the Theranos CLIA lab.
"I recall that there were no deficiencies identified," Holmes testified.
We are looking at what appears like the report from CMS. The "statement of deficiencies and plan of correction" box is blank.
"I recall that there were no deficiencies identified," Holmes testified.
We are looking at what appears like the report from CMS. The "statement of deficiencies and plan of correction" box is blank.
Holmes on former Theranos Lab Director Dr. Adam Rosendorff
“I was really excited to meet him....[he] seemed to have perfect expertise for what we wanted to do," Holmes testified.
She hired him full time.
“I was really excited to meet him....[he] seemed to have perfect expertise for what we wanted to do," Holmes testified.
She hired him full time.
"That we were performing extremely well,"
Holmes understanding of how Theranos was performing in their proficiency testing.
Holmes understanding of how Theranos was performing in their proficiency testing.
"Congrats to all of you for the NY inspection today. Job well done. I hope you all feel good about this...Our commitment as a company is to raise our own standards even more and have the best lab in the world….”Balwani wrote in April 2013 to #ElizabethHolmes and others.
Holmes explained NY was a "special state" b/c it has "the highest standards," she said.
“We wanted to get that certification,” Holmes said.
“We wanted to get that certification,” Holmes said.
Onto the CMS inspection on Dec. 3, 2013
Daniel Young sent Holmes and Balwani his notes from the audit the next day.
Daniel Young sent Holmes and Balwani his notes from the audit the next day.
5) “Tests”
a. Auditor asked if we have any new tests offered since last audit
i. Adam said yes and spoke about all LDTs (GC, city, ELISA)
1. Mentioned Edison 3.5, Flow Cytometer, Advia, and Normandy lab.
a. Auditor asked if we have any new tests offered since last audit
i. Adam said yes and spoke about all LDTs (GC, city, ELISA)
1. Mentioned Edison 3.5, Flow Cytometer, Advia, and Normandy lab.
"Why was #Theranos comfortable communicating to the auditor that these methods existed" Downey asked
"Again this was a government regulator they had methods in place to protect trade secrets," Holmes replied. "We could make these disclosures and still protect our trade secrets."
"Again this was a government regulator they had methods in place to protect trade secrets," Holmes replied. "We could make these disclosures and still protect our trade secrets."
(last week Holmes testified about disclosing certain proprietary info to FDA)
Holmes testified she learned in 2016 Theranos had done 8-12 million tests
...Times when dr rosendorff decided to stop offering certain tests?
Yes
Did you interfere...?
No..bc he had the expertise to make those decisions
Yes
Did you interfere...?
No..bc he had the expertise to make those decisions
Do you recall ever having any comms with [Erika Cheung - former lab associate who testified] while she was working at theranos?
No
Do you recall ever hearing about any concerns she had prior to the time when she left theranos
No
No
Do you recall ever hearing about any concerns she had prior to the time when she left theranos
No
Recall Ms. Cheung testified about concerns that were communicated to her by an employee named Tyler Shultz?
Yes.
Yes.
Young met with Shultz and sent #ElizabethHolmes his notes on the meeting on Feb, 20, 2014.
"I explained our calc methods and he was slow too understand. I am going to follow up again with him, as he does not understand the reasoning behind running replicates..," he wrote.
"I explained our calc methods and he was slow too understand. I am going to follow up again with him, as he does not understand the reasoning behind running replicates..," he wrote.
"I asked Dr. young and our scientists to look into his concerns," Holmes had testified.
“I had a follow-up discussion with Tyler yesterday. In summary:
-He acknowledged now understanding the calculations so this issue is closed
-...
-...
-...
-...
(another email, as downey highlighted parts)
-He acknowledged now understanding the calculations so this issue is closed
-...
-...
-...
-...
(another email, as downey highlighted parts)
"I understood that Mr. Shultz had been confused about certain issues, and that Daniel young had been able to adequately get into those concerns with him and allay his concerns," Holmes testified.
Tyler Shultz wrote Holmes directly on 4/11/2014, in a follow up to his convo w/ Dr young.
Holmes replied:
“Tyler:
These are very very serious comments and allegations you’re making. I am going to have the teams go through this line by line so it will take some Tim before I get back to you on this.”
“Tyler:
These are very very serious comments and allegations you’re making. I am going to have the teams go through this line by line so it will take some Tim before I get back to you on this.”
About an hour later Holmes forwarded Shultz' email to Dr. Young.
"Take a look at this. Let me know where all this data is from/what the data is...," she wrote.
"Take a look at this. Let me know where all this data is from/what the data is...," she wrote.
Young wrote back to Holmes and Balwani (In a long email not projected for long)
Holmes testified she understood that Dr. Young was satisfied that he had addressed the Shultz' concerns had
"Were you satisfied to accept Dr young explanation?" Downey asked
"Yes" Holmes said
Holmes testified she understood that Dr. Young was satisfied that he had addressed the Shultz' concerns had
"Were you satisfied to accept Dr young explanation?" Downey asked
"Yes" Holmes said
Now talking about Rosendorff's departure -- and we're seeing texts between Holmes and Balwani.
"Heading out to Newark Love," Balwani wrote on 11/25/2014
“On my way to Newark. Office is yours," Balwani wrote on 11/28/2014
"Heading out to Newark Love," Balwani wrote on 11/25/2014
“On my way to Newark. Office is yours," Balwani wrote on 11/28/2014
"Normandy lab is a f***king disaster zone. Glad I came here will work on fixing this….in normandy will call when I leave….we built software to remove human error and human judgement. All day I saw these people use their judgements to work around our processes," Balwani wrote
Holmes was told Dr. Suraj Saksena would be the lab director after Rosendorff left in late 2014
"[Balwani] said that Dr Saksena was qualified and he needed paperwork to be able to officially assume the role, but he was already acting officially in that capacity," she recalled
"[Balwani] said that Dr Saksena was qualified and he needed paperwork to be able to officially assume the role, but he was already acting officially in that capacity," she recalled
Before he could get that done however, Balwani brought in Dr. Lynette Sawyer and Dr. Sunil Dhawan, who we heard testify in the government's case.
Holmes played no role in their hiring, and understood they would serve as lab directors for a "very short period of time," she said
Holmes played no role in their hiring, and understood they would serve as lab directors for a "very short period of time," she said
Most in the courtroom are back from lunch break.
Holmes is on the stand and Downey is at the podium. No judge no jury.
What we all are awaiting: Will prosecutors get their shot at asking Holmes questions today?
Holmes is on the stand and Downey is at the podium. No judge no jury.
What we all are awaiting: Will prosecutors get their shot at asking Holmes questions today?
Jury filed in followed by the judge.
"Back on the record," Davila said. "Mr. Downey you would like to continue?"
"Back on the record," Davila said. "Mr. Downey you would like to continue?"
Downey brought up a 2015 CMS audit.
"[Prior to the audit] did mr. balwani communicate to you what he expected the results to be?" Downey asked
"That the lab was in great shape and that the audit should go very well," Holmes said.
"[Prior to the audit] did mr. balwani communicate to you what he expected the results to be?" Downey asked
"That the lab was in great shape and that the audit should go very well," Holmes said.
From reports following the CMS audit Holmes gleaned:
"That it was not as we had expected and that the investigators seemed to be identifying a number of issues that were unexpected," she testified.
"That it was not as we had expected and that the investigators seemed to be identifying a number of issues that were unexpected," she testified.
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