Here we go. #ElizabethHolmes Trial Day 7. Looks like former Theranos Lab Director Dr. Adam Rosendorff will be the government's next witness. #TheDropout @RebeccaJarvis @VicThompsonABC @TheOrdonezTimes @TheDunnDunn
On Tuesday the defense asked former Theranos scientist Surekha Gangakhedkar if she recalled, "coming to the view that [Dr. Rosendorff] was not concerned about the patient launch?”
"That was my understanding,” she replied. #ElizabethHolmes #Theranos
"That was my understanding,” she replied. #ElizabethHolmes #Theranos
Dr. Adam Rosendorff is in the witness box #ElizabethHolmes
Prosecutor John Bostick begins by asking Rosendorff why he left #Theranos.
"The unwillingness of management to perform proficiency testing," he said. "I came to believe the company cared more about PR and fundraising than patient care."
#ElizabethHolmes
"The unwillingness of management to perform proficiency testing," he said. "I came to believe the company cared more about PR and fundraising than patient care."
#ElizabethHolmes
Bostick asks Rosendorff why it is critical to be accurate in the lab.
"Physicians depend on the accuracy of the tests to make medical decisions. Sometimes life and death medical decisions." #ElizabethHolmes
"Physicians depend on the accuracy of the tests to make medical decisions. Sometimes life and death medical decisions." #ElizabethHolmes
Rosendorff flew out to San Francisco in 2013 to interview with Sunny Balwani, #ElizabethHolmes and Daniel Young, then a Theranos vice president
Rosendorff met w/ each #Theranos boss individually
“I believed that Theranos had advanced technology. I was impressed by the earnestness and dedication that I sensed in the interviewers," Rosendorff testified.
"I thought it was going to be the next apple."
#ElizabethHolmes
“I believed that Theranos had advanced technology. I was impressed by the earnestness and dedication that I sensed in the interviewers," Rosendorff testified.
"I thought it was going to be the next apple."
#ElizabethHolmes
Rosendorff testifies he reported directly to Sunny Balwani.
"Who was above Balwani," asked Bostick
"#ElizabethHolmes," he said.
"Who was above Balwani," asked Bostick
"#ElizabethHolmes," he said.
Bostick asks him to explain what the Edison machine was.
"A small black box designed to run 1 test at a time," Rosendorff said.
#ElizabethHolmes
"A small black box designed to run 1 test at a time," Rosendorff said.
#ElizabethHolmes
"Did Theranos conduct all of their tests on the Edison device?"
"No just a handful of immunoassays. They [ran] general chemistry tests on the Siemens ADVIA using lab developed tests."
#ElizabethHolmes
"No just a handful of immunoassays. They [ran] general chemistry tests on the Siemens ADVIA using lab developed tests."
#ElizabethHolmes
Bostick asks why they didn't do all patient testing on the Edison.
"Because the Edison wasn’t designed or intended to detect general chemistry substances such as glucose or sodium," Rosendorff said.
"Because the Edison wasn’t designed or intended to detect general chemistry substances such as glucose or sodium," Rosendorff said.
Instead #Theranos added a "teacup" modification on the Siemens ADVIA machine, Rosendorff testified.
Rosendorff said it was Daniel Young's idea to add the teacup modification.
Gov. asks if Balwani had any part in this. He doesn't recall, but said he does remember talking to #ElizabethHolmes about different "dilution schemes"
Gov. asks if Balwani had any part in this. He doesn't recall, but said he does remember talking to #ElizabethHolmes about different "dilution schemes"
There were two labs, Rosendorff testified. One upstairs and one downstairs. The lab upstairs with conventional devices, and the lab in the basement with Theranos tech.
Bostick asked their nicknames.
Bostick asked their nicknames.
The upstairs lab: "Jurassic park, because [Sunny Balwani] believed conventional devices were dinosaurs."
The basement lab: "Normandy."
#ElizabethHolmes #Theranos
The basement lab: "Normandy."
#ElizabethHolmes #Theranos
Clarifying! The prosecutor's name is John Bostic, not John bostick. Apologies for the typo.
Dr. Rosendorff sent an email to #ElizabethHolmes and Daniel Young on Aug. 29, 2013 titled "Concerns about the launch.”
"I have some medical and operational concerns about our readiness for 9/9," he wrote, referring to the upcoming Walgreens rollout.
"I have some medical and operational concerns about our readiness for 9/9," he wrote, referring to the upcoming Walgreens rollout.
"I felt it was very important for Elizabeth to be aware of these issues as the CEO of the company,” Rosendorff testified.
His concerns surrounded the variance in glucose and sodium measurements.
#ElizabethHolmes
His concerns surrounded the variance in glucose and sodium measurements.
#ElizabethHolmes
“I would like us to be the best we can be. A few more weeks to sort through these medical and logistical issues, and getting the proper level of training and staffing would help us tremendously,” Rosendorff wrote to end end his email.
#ElizabethHolmes
#ElizabethHolmes
Rosendorff also spoke directly with #ElizabethHolmes. He went into her office and saw a number taped to her window that indicated the number of days remaining until the launch.
"[Elizabeth Holmes] was very nervous. She was not her usual composed self," Rosendorff testified. "She was trembling a little bit, her knee was tapping, she was clearly upset."
#ElizabethHolmes #Theranos
#ElizabethHolmes #Theranos
Bostic asks if #ElizabethHolmes was surprised.
"She didnt seem surprised, she just seemed nervous and upset."
"She didnt seem surprised, she just seemed nervous and upset."
Bostic has Rosendorff explain quality control (QC) to the jury:
"Quality control is a method to determine whether your instrument is working correctly before you start testing patient samples."
"It has to be done for every instrument and assay type."
#ElizabethHolmes
"Quality control is a method to determine whether your instrument is working correctly before you start testing patient samples."
"It has to be done for every instrument and assay type."
#ElizabethHolmes
At #Theranos QC was run once a day.
And it was frequently discussed with #ElizabethHolmes, Rosendorff testifies
We are now looking at a Jan. 2014 email sent by Rosendorff to former #Theranos lab associate Ericka Cheung with regard to the Vitamin D assay.
He wrote, the CV%, "is way too high."
#ElizabethHolmes
He wrote, the CV%, "is way too high."
#ElizabethHolmes
Rosendorff testified that tests often performed worse in the clinical lab than they had in validation (the process of getting an assay ready for clinical testing)
#ElizabethHolmes
#ElizabethHolmes
The #Theranos outlier removal process comes up again w/ Rosendorff. Bostic showed a 1/2014 email in which a fellow scientist wrote, "At this time our outlier removal procedure is manual… I chose the cartridges in green for exclusion since they improved conc CVs.”
"I was concerned that we didn't have a protocol for [outlier elimination]. I asked Daniel about it, and he said it was going to be part of an algorithm on the Edison 3.5," Rosendorff testified.
But before the algorithm came out Rosendorff said there were no rules to the process
But before the algorithm came out Rosendorff said there were no rules to the process
(To note, I did not hear Rosendorff clarify how long it took #Theranos to instate the algorithm.)
We just looked at a table of “MARCH ELISA QC FAILURES,” the same table we saw in the government's direct of Cheung.
Rosendorff confirms the failure rates listed (for Vitamin D, tt4, tt3, etc.) were typical.
Rosendorff says no, it wasn't just March that was a bad month.
Rosendorff confirms the failure rates listed (for Vitamin D, tt4, tt3, etc.) were typical.
Rosendorff says no, it wasn't just March that was a bad month.
“This was not acceptable. The QC failure rate should have been lower," he testified. "Theres the concern that high QC failure rates would indicate problems with the accuracy of the tests.”
#ElizabethHolmes
#ElizabethHolmes
Bostic: Did you see superior [QC] performance from non Theranos analyzers?
Rosendorff: Yes.
Rosendorff: Yes.
Bostic shows Rosendorff another QC failure table. He draws attention to the tPSA test — which the lab director explained can be ran to help detect prostate cancer.
1 out of 3 tPSA tests passed QC.
#ElizabethHolmes
1 out of 3 tPSA tests passed QC.
#ElizabethHolmes
Break. back in 30 #ElizabethHolmes
We're back in session. Rosendorff is wearing a speckled orange mask and a navy blue suit. He's got rectangular black Oakley's on.
#elizabethholmes #theranos
#elizabethholmes #theranos
Judge Davila has had enough of the typing sounds. We have been kicked off of our keyboards.
I will be continuing my tweets via Mobile.
#ElizabethHolmes
I will be continuing my tweets via Mobile.
#ElizabethHolmes
We are hearing about one meeting Rosendorff had with shareholders in which the "high failure rate of the edisons" was discussed.
Daniel Young was present. #ElizabethHolmes was present, but not Sunny Balwani.
Bostic emphasizes that fact.
Daniel Young was present. #ElizabethHolmes was present, but not Sunny Balwani.
Bostic emphasizes that fact.
A Nov. 2014 email was published between rosendorff and balwani.
"The rate of qc failure is lower on predicate devices (non-theranos machines) than it is on the Edison, as is the throughput of predicate devices," rosendorff writes.
"Adam. This is not the case...," Balwani says
"The rate of qc failure is lower on predicate devices (non-theranos machines) than it is on the Edison, as is the throughput of predicate devices," rosendorff writes.
"Adam. This is not the case...," Balwani says
Bostic asked Rosendorff if Balwani had any medical or biological background.
"No," the lab director replied.
#ElizabethHolmes
"No," the lab director replied.
#ElizabethHolmes
Rosendorff was put in charge of dealing with customer/physician complaints at #Theranos. The liason between him and the complainants: Christian Holmes, #ElizabethHolmes brother.
"At Theranos I felt pressured to defend the company results to physicians," Rosendorff testified. Though I did not hear him say directly where that pressure was coming from.
#elizabethholmes
#elizabethholmes
Now more discussion of hCG, the assay "most commonly used to detect pregnancy."
hCG was discussed Tuesday when the government called two witnesses to testify to an apparently inaccurate #Theranos result that may have led a patient to believe she had lost her pregnancy
hCG was discussed Tuesday when the government called two witnesses to testify to an apparently inaccurate #Theranos result that may have led a patient to believe she had lost her pregnancy
We just heard about an abnormally low 2014 hCG test result that Rosendorff said a suggested a "possible miscarriage."
He was "freaked out" and brought his concern directly to #ElizabethHolmes.
He said she did not seem alarmed.
He was "freaked out" and brought his concern directly to #ElizabethHolmes.
He said she did not seem alarmed.
(Unclear if this is the same test discussed in Tuesday's testimony)
In June 2014 Christian Holmes wrote #elizabethholmes and Sunny Balwani.
"Just FYI hCG right now causing serious issues and patient complaints. Been spending all morning talking to docs about just hCG and will continue to do so."
"Just FYI hCG right now causing serious issues and patient complaints. Been spending all morning talking to docs about just hCG and will continue to do so."
He followed up.
"Seems like we also have a capacity issue... Went down there and it's a complete mess," he wrote of the basement lab.
#elizabethholmes
"Seems like we also have a capacity issue... Went down there and it's a complete mess," he wrote of the basement lab.
#elizabethholmes
On May 30, 2014 Dr. Rosendorff wrote to his team in all caps.
"ALL FURTHER HCG TESTING (CTN OR VACUTAINER IS TO BE RUN ON THE IMMULITE..." he wrote, referring to the Siemens machine.
#ElizabethHolmes
"ALL FURTHER HCG TESTING (CTN OR VACUTAINER IS TO BE RUN ON THE IMMULITE..." he wrote, referring to the Siemens machine.
#ElizabethHolmes
Bostic just went through another 2014 hCG complaint that Rosendorff was never copied on. Instead, Christian Holmes and Sunny Balwani were on the email. He asked Rosendorff if he believed he should have been on the correspondence.
"Yes absolutely," he said.
#elizabethholmes
"Yes absolutely," he said.
#elizabethholmes
Daniel Young, the VP of #Theranos responded to another "Customer issue."
Bostic asked Rosendorff if Young was a physician, or held any clinical lab title.
Rosendorff said no to both.
#ElizabethHolmes
Bostic asked Rosendorff if Young was a physician, or held any clinical lab title.
Rosendorff said no to both.
#ElizabethHolmes
Again the prosecution shows the correspondence was forwarded to #ElizabethHolmes
Rosendorff is deliberate about every word he utters, often taking several seconds before answering Bostic's questions.
#ElizabethHolmes
#ElizabethHolmes
Back to Feb. the Gov. asks Rosendorff about an email he sent to Balwani and Young about his concerns re the HDL assay, (important for cardiovascular health, he says.)
"I suspected the #theranos HDL test was no longer working," he testified.
"I suspected the #theranos HDL test was no longer working," he testified.
"We have been getting a spate of low HDL values," Rosendorff wrote.
Daniel Young wrote in a follow up to his team. "At first glance the HDL QC data looks to be running consistently low... [this data] should have raised alarm several weeks ago." #elizabethholmes
Daniel Young wrote in a follow up to his team. "At first glance the HDL QC data looks to be running consistently low... [this data] should have raised alarm several weeks ago." #elizabethholmes
Bostic showed Rosendorff's speculation (in an email) on the questionable results including preanalytic collection issues ( bad CTN's) and reagents getting old.
Both he tied to #Theranos tech.
Both he tied to #Theranos tech.
On Feb. 20, 2014 Rosendorff emailed Elizabeth and Balwani to recommend the discontinuation of HDL testing on #Theranos devices. He wanted to make management aware.
"Daniel put everyone needed on this project...We can't not refer back to venipuncture for HDL," Sunny replied.
"Daniel put everyone needed on this project...We can't not refer back to venipuncture for HDL," Sunny replied.
Rosendorff forwarded several work emails to his Gmail account in Nov. 2014.
"I wasn’t confident Theranos would preserve these emails in the event of a CMS or government investigation," he said. "I wanted to protect myself.”
#ElizabethHolmes
"I wasn’t confident Theranos would preserve these emails in the event of a CMS or government investigation," he said. "I wanted to protect myself.”
#ElizabethHolmes
This is now the second employee to admit they kept records of #Theranos emails for protection. The first was Surekha Gangakhedkar.
One physician sent Rosendorff a complaint in 11/2014, saying some #Theranos test results "do not appear to be accurate."
Rosendorff told Christian Holmes, "Unfortunately, I do not have a good explanation for the testosterone discrepancy."
#Elizabethholmes
Rosendorff told Christian Holmes, "Unfortunately, I do not have a good explanation for the testosterone discrepancy."
#Elizabethholmes
(Rosendorff wrote to Holmes in an email.)
Back from a short break, Bostic picks up where we left off: bad test results.
"Almost every ISE sample needs a re-run since they are high...," a clinical lab scientist writes to Rosendorff and the CLS group in May 2014.
#ElizabethHolmes
"Almost every ISE sample needs a re-run since they are high...," a clinical lab scientist writes to Rosendorff and the CLS group in May 2014.
#ElizabethHolmes
More bad results in June, 2014, Rosendorff testified. The government asked the lab director to speculate on the possible patient impact of these results.
"Anxiety and a lot of inconvenience for the patient and their family," he said.
#ElizabethHolmes
"Anxiety and a lot of inconvenience for the patient and their family," he said.
#ElizabethHolmes
Exhibit 1953: an email chain that ultimately "culminates in an email from Christian Holmes to #ElizabethHolmes," Bostic said.
The first email of the chain in 9/2014 "appears to be a complaint from a physician assistant," about a calcium test, Rosendorff said.
A customer service rep forwards the email to Christian Holmes. And Holmes sends it directly to #ElizabethHolmes.
A customer service rep forwards the email to Christian Holmes. And Holmes sends it directly to #ElizabethHolmes.
"Hey - wanted to have just a more candid conversation about this with you. I am always confident in our tech, but its pretty obvious we have issues with calcium, potassium and sodium specifically," Christian wrote.
#ElizabethHolmes
#ElizabethHolmes
Rosendorff took issue with the word "specifically," saying it was also other assays that had issue.
Rosendorff said around this time he had thought of leaving the company.
"Was your decision process based partly on your view of the reliability of the assays?" Bostic asked
"Yes," he replied.
#ElizabethHolmes
"Was your decision process based partly on your view of the reliability of the assays?" Bostic asked
"Yes," he replied.
#ElizabethHolmes
"I felt Elizabeth, Sunny, and Daniel were pushing me to rationalize the erroneous results. Dig up patient facts that explained erroneous results — anything other than to explain our test is inaccurate," Rosendorff testified.
That's it for today.
#ElizabethHolmes
That's it for today.
#ElizabethHolmes
Dr. Rosendorff will be back on the stand Tuesday when the trial resumes. The next #Dropout episode also drops Tuesday!
#ElizabethHolmes
#ElizabethHolmes
Bostic says, "We are much closer to the end then the beginning," of Rosendorff's direct examination.
"They say that about me all the time," the 69-year-old judge jokes.
#ElizabethHolmes
"They say that about me all the time," the 69-year-old judge jokes.
#ElizabethHolmes
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