CA - Elizabeth Holmes (Theranos) Wire Fraud

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Dorothy Atkins@doratki·
40m

And we're back! Lance Wade is up for Elizabeth Holmes. He starts by handing Adam Rosendorff two large binders and notes that they're filled with Rosendorff's prior statements. Rosendorff seems confused: "Statements of my testimony?" Wade doesn't clarify.

Dorothy Atkins@doratki·
38m

Wade gets Rosendorff to concede that he hasn't met at all with defense counsel, but he's met with federal agents and prosecutors multiple times about this case. (This is a pretty common point that defense teams highlight in criminal trials.)

Dorothy Atkins@doratki·
26m

Wade asks Rosendorff if federal agents went over questions they planned to ask him on the stand during 'prep sessions.' Rosendorff replies that they told him to tell the truth. Wade: Did you discuss that answer? Rosendorff again seems confused.

Dorothy Atkins@doratki·
25m

Wade asks Rosendorff again if prosecutors went over the q's they planned to ask him during trial. He replies "Many of those, yes."

Dorothy Atkins@doratki·
23m

Lance Wade is much, much louder during Rosendorff's examination than he was during Erika Cheung's examination. It sounds like he's annoyed and shouting into the mic.

Dorothy Atkins@doratki·
19m

Lance Wade points to an errata sheet that Rosendorff purportedly signed with corrections of his deposition testimony. Rosendorff replies "an err-at-uh what? I'm not familiar with the legal term." Wade somehow seems more annoyed.

Dorothy Atkins@doratki·
14m

Wade says prosecutors "jumped all around in that binder," "from assay to assay," "one year to the next," "They never walked you through one of the tests from start to finish," and didn't show policy docs, validation reports or CLIA lab director regulations. Rosendorff agrees.

Dorothy Atkins@doratki·
12m

Wade gets Rosendorff to acknowledge that federal CLIA regulations made him legally responsible for all the critical functions of Theranos' clinical lab operations.

Dorothy Atkins@doratki·
7m

Rosendorff wants to clarify that "I endeavored earnestly to fulfill the laboratory director obligations," but he "faced restraints from management." Wade objects and moves to strike. The judge overrules the objection, but notes the attorney can "certainly probe" his response.

Dorothy Atkins@doratki·
5m

Wade: Did you faithfully dispatch your legal obligations as Theranos lab director?

Rosendorff: Yes I did

W: Did you offer lab tests that you knew at the time were inaccurate or unreliable?

R: No whenever they were inaccurate/unreliable I stepped in v aggressively to stop them

Dorothy Atkins@doratki·
2m

Rosendorff concedes that ultimately if Theranos' tests failed it was his responsibility as lab director, and it was his responsibility to enforce the company's quality control policies and proficiency tests.
 
Dorothy Atkins@doratki·
13m

Rosendorff acknowledges that Elizabeth Holmes dropped out of Stanford as a 19-year-old undergrad and is not qualified to be a lab director.

Dorothy Atkins@doratki·
9m

Rosendorff acknowledges that he had a staff that "under CLIA law" reported to him, but he clarifies that "Sunny Balwani was heavily involved" and gave his subordinates direction daily.

Dorothy Atkins@doratki·
5m

Wade presses Rosendorff on corporate hierarchy and proposes a hypothetical in which Rosendorff keeps rotten food in his office and his subordinates complain to Balwani about him - but the q confuses Rosendorff (and me too tbh) so Wade moves on.

Dorothy Atkins@doratki·
5m

Rosendorff notes that Balwani fired one of his subordinates on his team without consulting him first. Wade asks the judge to strike his answer as nonresponsive, and the judge grants the request.

Dorothy Atkins@doratki·
4m

Wade brings up Rosendorff's 2013 meeting w/ Holmes in which sked he aher to delay the launch. Wade refers to it as the 'drama' of Holmes trembling and her not being her usual self. Rosendorff replies: "No drama. I was just reporting what I observed." (Sounds like a reporter)

Dorothy Atkins@doratki·
42s

Wade is asking Rosendorff about the 2013 Theranos device launch being a "soft launch."

Rosendorff: Can I just ask you--

Wade doesn't let him go on: I'm asking the questions and you're giving the answers.
 
Dorothy Atkins@doratki·
25m

Wade is focusing on Theranos' Walgreens "soft launch" in late 2013, and various tests that were run on fingersticks. There's an excel spreadsheet pulled up and Wade is walking through the data. Examination is slow, but the point seems to be that the tests had been validated.

Dorothy Atkins@doratki·
17m

Wade gets Rosendorff to concede that Holmes suggested they use venous draws for tests in the 2013 launch after he raised concerns about the accuracy of blood draw with fingersticks, and that was the solution he wanted.

Dorothy Atkins@doratki·
8m
Wade is walking Rosendorff through the master validation assay plans for Theranos devices and the definitions of various terms. This testimony is about as thrilling as watching grass grow.

Dorothy Atkins@doratki·
11m

And we're breaking for 20 minutes. BRB
 
Dorothy Atkins@doratki·
1h

Rosendorff says when he served as Theranos' lab director, he wasn't aware Holmes' brother, Christian Holmes, was approving patient blood redraws. Rosendorff notes that anyone making a clinical decision has to be on CMS roster - a 'form 209' - and Christian wasn't on that roster.

Dorothy Atkins@doratki·
1h

Rosendorff says during the CLIA inspection in November 2013, Sunny Balwani said no one was allowed to go into or out of the Normandy lab (where the Edison devices were) even though the SOP is "to show inspectors what they asked for."

Dorothy Atkins@doratki·
1h

Rosendorff testifies that Young said they shouldn't mention Theranos' other lab with modified Siemens blood testing devices unless inspectors "bring it up."

Dorothy Atkins@doratki·
1h

Rosendorff said in October 2014, Theranos was receiving many doctor complaints and the number of issues "reached a crescendo for me," and so he quit the next month.

Dorothy Atkins@doratki·
1h

Before quitting in Nov 2014, Rosendorff told Christian Holmes he's "going to pass" on defending Theranos' test results when a clinician asked to speak to Theranos' lab director.

Dorothy Atkins@doratki·
1h

Christian Holmes replied to Rosendorff that "passing" on talking to a clinician re interpreting results "is not an option." Elizabeth wrote her bro privately "You handled this excellently."

Dorothy Atkins@doratki·
1h

Rosendorff says he was concerned Theranos was not disclosing to patients the method used to run tests or whether the tests were drawn venously or via fingerprick, while management "made it very clear what the messaging should be" - that he should defend the tests' accuracy.

Dorothy Atkins@doratki·
1h

In Nov 2014, Rosendorff emailed Elizabeth Holmes asking her to remove him as Theranos' CLIA lab director. He wrote "I feel really uncomfortable ...I am feeling pressured to vouch for results that I cannot be confident in..."

Dorothy Atkins@doratki·
1h

Holmes replied: How sad and disappointing... Outside the fact you’ve never emailed me any concerns you allude to...you know from every convos we’ve ever had ..how fundamental it is to all of us for you or any other employee never to do anything you're not completely confident in.

Dorothy Atkins@doratki·
1h

Prosecutor points to a Nov 27 2014 text exchange in which Elizabeth Holmes told Balwani they raised $150M from Walmart heiress Alice Walton and "Rupert [Murdoch] over $100M"

Balwani replied "awesome" and "they are not investing in our company they are investing in our destiny."

Dorothy Atkins@doratki·
1h

Before Rosendorff left, he said Balwani emailed him criticizing him. He forwarded the email to Elizabeth Holmes and wrote "I find Sunnys response offensive and disingenuous. He should apologize.” She sent his email to Balwani and said they need to respond and "cut him Monday."

Dorothy Atkins@doratki·
1h

Rosendorff said he didn't make the decision to quit lightly and when he left he refused to shake Balwani's hand.

Dorothy Atkins@doratki·
1h

Prosector shows the jury Elizabeth Holmes' Dec. 26 2014 text message to Balwani writing that "This year is our year. We can never forget this tiger." Balwani replied "We will execute this year," and Holmes responded that "and for our kids never forget who we are."

Dorothy Atkins@doratki·
1h

The feds wrapped direct examination of Rosendorff. We're taking a 30 minute break, and we'll be back w/ his cross examination.
The pattern of coverup is so clear and consistent from one witness to the next-between Holmes and Balwani. It's always to deny and blame others for their defective devices rather than to learn what's actually wrong and see if it could be fixed.
 
Dorothy Atkins@doratki·
1h

We're back! Wade says he wants to "back up" and shows Rosendorff his resume that he used to apply to Theranos in 2013.

Dorothy Atkins@doratki·
1h

Wade asks Rosendorff why he applied to Theranos. Rosendorff says he got excided about innovation & Silicon Valley after he read a bio on Steve Jobs, although he can't remember the author. Wade holds up @WalterIsaacson's book and asks if that's the book. He agrees that it is.

Dorothy Atkins@doratki
1h

Wade asks Rosendorff if he recalls from Isaacson's book Apple's "branding strategies," the importance of marketing and Apple's Big Brother commercial. He says he does remember those details.

Dorothy Atkins@doratki
1h

Wade asks Rosendorff if he recalls from the book Apple's "intense secrecy" surrounding its technology and that Steve Jobs would review tech in a password protected room. Rosendorff doesn't remember all of those details, but says "that's interesting."

Dorothy Atkins@doratki
1h

The gov't objects to the line of q, arguing it's not relevant. Wade says "he read the book." The judge replies, "he did read the book," and overrules the objection.

Dorothy Atkins@doratki
1h

Wade compares Theranos' secrecy to Apple's and notes that Apple is valued at $2 trillion now. Rosendorff acknowledges that he thought a lot of info on Theranos wasn't available publicly when he applied b/c he thought the company must have great tech.

Dorothy Atkins@doratki
1h

Rosendorff said he watched a talk given by Elizabeth Holmes before he applied at Theranos, but notes "she was a brunette back then." "So was I," the grey-haired Lance Wade replies.

Dorothy Atkins@doratki
1h

Rosendorff acknowledges that when he was hired at Theranos as its lab director, it had at least one "high-complexity" CLIA certified lab and he was comfortable with most of the lab procedures in place when he "took over" in 2013.

Dorothy Atkins@doratki
1h

Wade has brought up the Theranos' Laboratory Information System, or LIS, database, which contained millions of data points and patient test results. (reminder - in a pretrial fight, the judge said WilmerHale attys helped lose Theranos' database)

WilmerHale Attys Helped Lose Theranos Data, Judge Says - Law360

Dorothy Atkins@doratki
1h

Wade asks Rosendorff if he has data from the LIS database. Rosendorff says no. "The LIS was rendered inaccessible," he says, adding. "That happened after I left."

Dorothy Atkins@doratki
1h

Rosendorff acknowledges that he never had an interaction with Elizabeth Holmes that would lead him to believe she had access to the LIS database. He adds that "I don’t remember what the full capabilities were" of the LIS, but he never had concerns about it.

Dorothy Atkins@doratki
1h

Rosendorff needs to go to the bathroom, so the judge decided to end trial for the day. The judge excused the jury and asked defense if they plan to raise q's about Rosendorff's post-Theranos employment. Wade says yes, but they'd rather discuss any objections in a side-bar.

Dorothy Atkins@doratki
1h

Wade says he thinks Rosendorff's cross-examination will likely go "all day" tomorrow, but Rosendorff has a time conflict in the afternoon, so the DOJ may call another witness in the meantime.

Dorothy Atkins@doratki
1h

With that, trial is breaking for the day. We'll be back here tomorrow morning for more of Rosendorff's cross and a surprise witness in the afternoon!
 
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I fail to see how the defense is scoring points. Rosendorff was another honest person sucked in by Holmes. He left when he saw how unethical Theranos was. Apple's secrecy didn't endanger people's lives like fake blood test results do.
 
Wednesday, Sept. 29th:
*Trial continues (Day 9) (@ 9am PT) - CA – for *Elizabeth A. Holmes (34/now 37) (CEO of Theranos) charged (March, 2018) & indicted (6/14/18) & arraigned (6/15/18) with 9 counts of wire fraud & 2 counts of conspiracy to commit wire fraud and charged & indicted (4/11/20) with fraud relating to a patient's blood test. Another count of wire fraud was added in 2020, bringing the total number of felony charges to 12. Plead not guilty. No bond. Faces a maximum sentence of 20 years in prison & up to $2.75 million in fines, plus restitution, & $250K for each individual count of wire fraud & conspiracy.
Defrauding investors out of $700 million in funding for their blood-testing startup Theranos.
Trial began on 8/31/21 with jury selection. 12 jurors of 7 men & 5 women (6 Caucasians, 4 Hispanics & 2 Asians) with five alternates (2 men & 3 women). Juror #7 excused & replaced with alternate #1. Now jurors are 8 men & 4 women. Alternates 1 man & 3 women.
Trial began on 9/8/21.
The Court trial days will be Tuesday, Wednesday & Friday, possibly other half days. The Court may modify the trial time & set either 8:30am-2pm or 9am-2pm & possibly 30-minute breaks in between. Judge Edward J. Davila presiding. Jury selection was on 8/31 & 9/1 completed; trial dates 9/29, 10/1, 10/5, 10/6, 10/8, 10/12, 10/13, 10/15, 10/19, 10/20, 10/22, 10/26, 10/27, 10/29, 11/2, 11/3, 11/5, 11/9 so far. Motions hearing on 9/30.

Indictment & court info from 4/11/20 thru 8/26/21 & jury selection (Day 1-3) 8/31/21 to 9/2/21 & trial (Day 1-7) 9/8/21 to 9/24/21 reference post #577 here:
CA - Elizabeth Holmes (Theranos) Wire Fraud

9/28/21 Tuesday, Trial Day 8: Government witness: Dr. Adam Rosendorff, ex Theranos lab director on still on direct.
for more info see posts #579 & 580 here:
CA - Elizabeth Holmes (Theranos) Wire Fraud
Dr. Adam Rosendorff on cross-exam.
for more info see posts #581 to 583, 586 here:
CA - Elizabeth Holmes (Theranos) Wire Fraud
The judge excused the jury & asked defense if they plan to raise questions about Rosendorff's post-Theranos employment. Wade says yes, but they'd rather discuss any objections in a side-bar. Wade says he thinks Rosendorff's cross-examination will likely go "all day" tomorrow, but Rosendorff has a time conflict in the afternoon, so the DOJ may call another witness in the meantime.
Motions hearing 9/30/21. Trial continues on Friday, 10/1/21 for Day 10.

*Ramesh “Sunny” Balwani (53/now 56) (CFO & President of Theranos) – Motion hearing on 9/30/21 & trial set to begin on 1/11/22 with jury selection & trial starts on 1/18/22.
 
Dorothy Atkins@doratki
7h

Good morning from San Jose! I took a gamble and caught the late train this a.m. based on a hunch that not a lot of folks would show up for Adam Rosendorff's 2nd day of cross in US v Elizabeth Holmes. The gamble paid off - there was no line to get inside the courthouse.

Dorothy Atkins@doratki
6h

Wade brings up Theranos' Laboratory Information System - which the company called "Super Mario." Wade says, "We talked about Super Mario, it’s a great name." Rosendorff: "I have no comment."

Dorothy Atkins@doratki
6h

Rosendorff: "I alone fulfilled my duties as lab director but it is just not reasonable that I could guarantee the quality for services coming out of the lab." Wade notes that under CLIA regulations, he as lab director was responsible if those jobs were not done properly...

Dorothy Atkins@doratki
6h

Rosendorff replies "yes." But then tries to add "But there are a lot of --" Wade interrupts him: "I don’t have a question pending, your honor."

Judge: "Then ask one."

Dorothy Atkins@doratki
6h

Wade asks Rosendorff: You didn’t hide any information from these inspectors in 2013, you would never do that? That would be a big problem if you did that?

Rosendorff: Yes, I would never do that.

Dorothy Atkins@doratki
6h

Rosendorff says Sunny Balwani gave the "verbal instruction" not to enter or leave the Normandy lab during the inspection. Wade downplays Balwani's order, asking: So that employees would not be "running in and out" of the lab in the middle of it? "Correct," Rosendorff replies.

Dorothy Atkins@doratki
6h

Lol, Wade points to an email from Rosendorff's colleague who told Holmes they covered up bulletin boards with papers to prepare for the inspection. Rosendorff is not impressed by the former colleague: "We would not pin up trade secrets on a bulletin board, who would do that?"

Dorothy Atkins@doratki
6h

Rosendorff says he "did not" tell inspectors about Theranos' R&D lab, but Wade impeaches Rosendorff and points to his prior testimony in which Rosendorff said he "must have told" the inspectors about the lab. Rosendorff concedes that he didn't hide the lab from them.

Dorothy Atkins@doratki
5h

Wade is going through a series of emails from Nov 2013 about getting Theranos into compliance before the inspection, and Rosendorff seems annoyed with the examination: "You’re just showing me emails and asking if I read them and I’m saying yes, and that’s what’s going on.”

Dorothy Atkins@doratki
5h

Balwani replied to Rosendorff's list of things to be done before the inspection: "As you know we take these issues with seriousness. Why didn’t you raise these before to me when I was asking for any issues for months? It was only a month+ ago when you signed off on these assays."

Dorothy Atkins@doratki
5h

Rosendorff: "I had many many battles with Sunny about what was needed and what he would allow..."

Wade notes that Balwani's name wasn't the lab director and responsible for the lab tests under CLIA regs.

Rosendorff: "That’s why I had battles with him."

Dorothy Atkins@doratki
5h

Wade makes a point he and others have made many times before during this trial, particularly during Erika Cheung's testimony. Theranos' quality control tests don't involve patients, and "nothing bad happens" to a patient if a QC test fails, he says. Rosendorff agrees.

Dorothy Atkins@doratki
5h

Lance Wade points out ex-Theranos lab director Adam Rosendorff's job was important and had a lot of responsibility and "that's why you get paid the big bucks."

Rosendorff: "Not the big bucks that you get paid."

Dorothy Atkins@doratki
5h

Rosendorff's response seemed to catch Wade off guard momentarily. He quickly points out that Rosendorff was one of the highest paid employees at Theranos and earned over $200k annually.

Dorothy Atkins@doratki
5h

Rosendorff says he didn't know he was one of the highest paid, but he thinks he should be paid "much much more" for the problems he had to deal with while at Theranos and for the legal expenses he incurred after. Wade asks the judge to strike his answer, and the judge agrees.

Dorothy Atkins@doratki
5h

Rosendorff concedes that he never haulted the use of Theranos' Edison devices outright while he was the lab director, but he did stop it for certain assays like hCG.

Dorothy Atkins@doratki
5h

Wade is going through Theranos' assay validation reports. Rosendorff says "reliability" is not defined in regulations. He seems to be getting more impatient. At one point, Rosendorff tells Wade he already explained certain data to him.

Dorothy Atkins@doratki
4h

After some more questions about the validation report terminology, Rosendorff says, "I’d like to point out something. But I’ll shut up, because I’m not being asked a question."

Dorothy Atkins@doratki
4h

Wade points to a long list of citations related to validation testing procedures and says if he were to print them all out and give them to him it would take up a lot of space. "Yes, please don't," Rosendorff replies. With that, we're breaking for 45 min. We'll be back at noon!
 
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Dorothy Atkins@doratki
7h

Good morning from San Jose! I took a gamble and caught the late train this a.m. based on a hunch that not a lot of folks would show up for Adam Rosendorff's 2nd day of cross in US v Elizabeth Holmes. The gamble paid off - there was no line to get inside the courthouse.

Dorothy Atkins@doratki
6h

Wade brings up Theranos' Laboratory Information System - which the company called "Super Mario." Wade says, "We talked about Super Mario, it’s a great name." Rosendorff: "I have no comment."

Dorothy Atkins@doratki
6h

Rosendorff: "I alone fulfilled my duties as lab director but it is just not reasonable that I could guarantee the quality for services coming out of the lab." Wade notes that under CLIA regulations, he as lab director was responsible if those jobs were not done properly...

Dorothy Atkins@doratki
6h

Rosendorff replies "yes." But then tries to add "But there are a lot of --" Wade interrupts him: "I don’t have a question pending, your honor."

Judge: "Then ask one."

Dorothy Atkins@doratki
6h

Wade asks Rosendorff: You didn’t hide any information from these inspectors in 2013, you would never do that? That would be a big problem if you did that?

Rosendorff: Yes, I would never do that.

Dorothy Atkins@doratki
6h

Rosendorff says Sunny Balwani gave the "verbal instruction" not to enter or leave the Normandy lab during the inspection. Wade downplays Balwani's order, asking: So that employees would not be "running in and out" of the lab in the middle of it? "Correct," Rosendorff replies.

Dorothy Atkins@doratki
6h

Lol, Wade points to an email from Rosendorff's colleague who told Holmes they covered up bulletin boards with papers to prepare for the inspection. Rosendorff is not impressed by the former colleague: "We would not pin up trade secrets on a bulletin board, who would do that?"

Dorothy Atkins@doratki
6h

Rosendorff says he "did not" tell inspectors about Theranos' R&D lab, but Wade impeaches Rosendorff and points to his prior testimony in which Rosendorff said he "must have told" the inspectors about the lab. Rosendorff concedes that he didn't hide the lab from them.

Dorothy Atkins@doratki
5h

Wade is going through a series of emails from Nov 2013 about getting Theranos into compliance before the inspection, and Rosendorff seems annoyed with the examination: "You’re just showing me emails and asking if I read them and I’m saying yes, and that’s what’s going on.”

Dorothy Atkins@doratki
5h

Balwani replied to Rosendorff's list of things to be done before the inspection: "As you know we take these issues with seriousness. Why didn’t you raise these before to me when I was asking for any issues for months? It was only a month+ ago when you signed off on these assays."

Dorothy Atkins@doratki
5h

Rosendorff: "I had many many battles with Sunny about what was needed and what he would allow..."

Wade notes that Balwani's name wasn't the lab director and responsible for the lab tests under CLIA regs.

Rosendorff: "That’s why I had battles with him."

Dorothy Atkins@doratki
5h

Wade makes a point he and others have made many times before during this trial, particularly during Erika Cheung's testimony. Theranos' quality control tests don't involve patients, and "nothing bad happens" to a patient if a QC test fails, he says. Rosendorff agrees.

Dorothy Atkins@doratki
5h

Lance Wade points out ex-Theranos lab director Adam Rosendorff's job was important and had a lot of responsibility and "that's why you get paid the big bucks."

Rosendorff: "Not the big bucks that you get paid."

Dorothy Atkins@doratki
5h

Rosendorff's response seemed to catch Wade off guard momentarily. He quickly points out that Rosendorff was one of the highest paid employees at Theranos and earned over $200k annually.
BBM. Wade is missing the point. Faulty QC tests indicate that actual patient tests aren't reliable, and those DO hurt the patient!
 
Dorothy Atkins@doratki
4h

We're back! Wade begins the session pointing to Rosendorff's signature on multiple Theranos validation reports. (I'm kind of surprised it's taken Wade this long to get to this in cross.)

Dorothy Atkins@doratki
3h

Wade points to "total triiodothyronine" - or T3 - assay validation report that Rosendorff signed, and asks Rosendorff to read the name, b/c "it's a big word" and he can't pronounce it. That gets a laugh out of Rosendorff - the first one in 3 days on the stand.

Dorothy Atkins@doratki
3h

Rosendorff concedes that he would not continue signing validation assay reports if he thought the Edison - Theranos' blood-testing device - was "inherently unreliable."

Dorothy Atkins@doratki
3h

Rosendorff wants to clarify something and tries to ask him a question.

Wade: "I've never been asked a question on cross examination...."

Judge quips: "Maybe you haven't been practicing law long enough."

Dorothy Atkins@doratki
3h

Wade is walking through a quality control report presented to Rosendorff in July 2014. Lotta data, but it shows in the first quarter of that year, 663 patient samples were processed by Theranos at pharmacies and 26 resulted in "redraws."

Dorothy Atkins@doratki
3h

Rosendorff says "something’s not squaring up" w/ quality control data in the 2014 report that Wade is showing him, and the QC data discussed during his direct examination. Wade says there are different starting dates for the data and the QC presentation was made by Langly Gee.

Dorothy Atkins@doratki
3h

Wade points that the 2014 presentation shows that from quarter 2 to quarter 3 the number of complaints Theranos received went up from 2 to 10. The q3 complaints include "no one answered the phone on Sunday and could not leave voicemail" and "testosterone result was wrong."

Dorothy Atkins@doratki
3h

Wade gets Rosendorff to concede that his prior testimony that there wasn't a proficient testing policy at Theranos is inaccurate, because Theranos did have a PT policy for "predicate instruments" (meaning, I think, Siemens blood-testing devices, but I'm not totally sure).

Dorothy Atkins@doratki
2h

Wade is still on Theranos' proficiency testing policies. Testimony has slowed down quite a bit. Neither Wade nor Rosendorff seem annoyed. They both just seem like they're on autopilot now.

Dorothy Atkins@doratki
2h

Wade asks who was responsible for proficiency testing. Rosendorff says it was the lab director, but he adds that it takes a large team effort and "it was not something that I could have achieved on my own." Wade asks to strike the 2nd part of the answer, the judge agrees.

Dorothy Atkins@doratki
2h

Rosendorff keeps correcting Wade who keeps accidentally saying precision testing instead of proficiency testing in his questions. (Who needs coffee?)

Dorothy Atkins@doratki
2h

Wade reads a Feb 2014 email Daniel Young wrote about his concerns w/ using PT samples w/o a peer group and studies. Wade asks a q about predicate devices & Rosendorff's impatience has returned.

"If you could be more specific, that would be helpful to me," Rosendorff tells Wade.

Dorothy Atkins@doratki
2h

The judge let Rosendorff leave because he has a child care commitment, so we're taking a 20 minute break. Prosecutors will be calling another witness, but no word yet on who it will be...
 
Dorothy Atkins@doratki
1h

We're back! Prosecutors called Dr. Victoria Sung to the stand.

Dorothy Atkins@doratki
1h

Dr. Sung is wearing a clear mask. She's worked for a number of startup biotech companies, including Celgene, that were later acquired by larger cos. She now works at Aditum Bio in Oakland.

Dorothy Atkins@doratki
1h

At Celgene, she worked in clinical trial research and helped answer q's about drugs and whether they were working the way they're supposed to. Celgene was working with Theranos while she was at Celgene, she says.

Dorothy Atkins@doratki
1h

Sung recalls meeting with Holmes in 2009 and seeing the Edison device. She says Theranos' device was "a small very efficient looking box, with a cartridge... a little bit like a small toaster oven."

Dorothy Atkins@doratki
1h

Sung says she was interested in Theranos' tech: I thought that the idea of something you could use so efficient and small on site, was a great idea. It was fast and easy requiring very little blood from the patient.

Dorothy Atkins@doratki
1h

Sung recalls that Celgene and Theranos entered a deal to help Celgene test the effectiveness of a drug for treating anemia. Sung said there was a list of assays that Celgene wanted done, like vitamin D tests and hemoglobin tests. She also asked Holmes specifics about the devices.

Dorothy Atkins@doratki
1h

Sung additionally told Theranos that ICON, another blood tester, was Celgene's preferred vendor for assay results, and Celgene wanted to compare ICON's results with Theranos' results.

Dorothy Atkins@doratki
1h

Sung said she and her Celgene colleagues met w/ Theranos employees in the spring of 2010, and she followed up with an email in July saying they were working to hire an bioassay consultant "to understand the finer points of what your team is working hard to achieve."

Dorothy Atkins@doratki
1h

Sung went on: "The work that we put into validating your technology in this exploratory study will directly influence whether we continue to implement the Theranos technology in future trials." But she says Celgene wasn't able to validate Theranos' tests.

Dorothy Atkins@doratki
1h

Sung: "We felt that the results didn’t match up or overlap as much as we would like, so we declined to move forward..." She said in some cases the results were "close," but in others they were "just different" and that wasn't good enough for Celgene.

Dorothy Atkins@doratki
1h

In March 2012, Sung emailed Holmes and other Theranos execs the results of Celgene's test comparing Theranos' PK data to an established testing co's data. The results showed Theranos data showed more variability and unexplained white blood fluctuations than the other co's data.

Dorothy Atkins@doratki
47m

Sung says a month after sending Theranos the results of Celgene's study, Celgene haulted its use of Theranos devices and ended it's deal with Theranos due to the variability in the results.

Dorothy Atkins@doratki
43m

The feds wrap Sung's direct examination pointing to a $5 million entry that Theranos purportedly claimed was made from Celgene, most of it after 2012. She says she isn't aware of any work done with Theranos after April 2012. (she left Celgene in March 2018)
 
Dorothy Atkins@doratki
42m

John Cline is up for Holmes on cross. Cline points out that Sung's Celgene teamed hired an outside consultant because they weren't experts in assay validation.

Dorothy Atkins@doratki
32m

Cline points to Theranos' assay validation reports that Theranos sent to Sung. She says she's not an expert in assay validation, so she likely passed the reports along to others who were experts in the area, but she doesn't recall if she did.

Dorothy Atkins@doratki
17m

Cline brings up a lengthy email from March 2012 that ex-Theranos VP Daniel Young sent to Sung responding to Celgene's comparison study. Sung replied to Young's email that she appreciated the time he spent responding. She acknowledges she didn't respond to him 'point-by-point.'

Dorothy Atkins@doratki
15m

Cline shows Sung Celgene's "statement of work" with Theranos that was effective Nov 18, 2009. Sung says she wasn't aware of the agreement at the time: "This is not in my realm. I don’t really take care of these things."

Dorothy Atkins@doratki
11m

Under the deal, Celgene agreed to pay Theranos $500k "per real time PK assay," with half of that being paid upfront and other amounts based on dif milestones. Sung says she doesn't know if they were paid. "I assumed they were made if they were accepted," she says (confusingly).

Dorothy Atkins@doratki
9m

With that, the parties wrapped the examination of Sung. Gov't has no redirect. The judge excused the jury. The feds have an issue about Rosendorff's cross... oh geez.
 
Dorothy Atkins@doratki
7m

Prosecutor John Bostic says defense counsel "opened the door" to delve into the LIS database during Rosendorff's cross and the gov't wants to go into that during redirect. (Likely to bring up that WilmerHale attys are to blame for losing a decryption key)

WilmerHale Attys Helped Lose Theranos Data, Judge Says - Law360

Dorothy Atkins@doratki
5m

Lance Wade says he doesn't think he opened the door. The judge says "I think what we’ll all do is look at the transcript and see what the transcript says," adding that he thinks defense counsel laid a foundation for his q's about the LIS database.

Dorothy Atkins@doratki
4m

Bostic also says defense counsel has told the government they plan to take another full day with Adam Rosendorff's cross-examination, but he's going beyond the scope of the direct examination.

Dorothy Atkins@doratki
2m

Lance Wade responds that Rosendorff is to be blamed in part for the length of cross, because he keeps wanting to clarify his answers, which Wade says he's "let go" even when sometimes his responses are irrelevant or his own defense.

Dorothy Atkins@doratki
2m

Wade also notes that Rosendorff's direct examination was a broad indictment of Elizabeth Holmes and others, and it requires a lot of "unpacking," which takes time.

Dorothy Atkins@doratki
1m

Judge Davila asks Wade if he's close to the end than the beginning of Rosendorff's examination. Wade says "I would suggest I’m at least half time, and sometimes the second half is the more exciting half." And that's game time for today! Trial recessed until Friday.
 
So it sounds like the defense strategy is to try to technically trip up the experts and make them totally reliable for Theranos's errors, when Holmes was out promoting lies that it actually worked and she knew otherwise. These defense attorneys don't sound like they know their stuff.
 
Thursday, Sept. 30th:
*Intervenor’s Motions Hearing-Remote (@ 11:30am PT) - CA – for *Elizabeth A. Holmes (34/now 37) (CEO of Theranos) charged (March, 2018) & indicted (6/14/18) & arraigned (6/15/18) with 9 counts of wire fraud & 2 counts of conspiracy to commit wire fraud and charged & indicted (4/11/20) with fraud relating to a patient's blood test. Another count of wire fraud was added in 2020, bringing the total number of felony charges to 12. Plead not guilty. No bond. Faces a maximum sentence of 20 years in prison & up to $2.75 million in fines, plus restitution, & $250K for each individual count of wire fraud & conspiracy.
Defrauding investors out of $700 million in funding for their blood-testing startup Theranos.
Trial began on 8/31/21 with jury selection. 12 jurors of 7 men & 5 women (6 Caucasians, 4 Hispanics & 2 Asians) with five alternates (2 men & 3 women). Juror #7 excused & replaced with alternate #1. Now jurors are 8 men & 4 women. Alternates 1 man & 3 women.
Trial began on 9/8/21.
The Court trial days will be Tuesday, Wednesday & Friday, possibly other half days. The Court may modify the trial time & set either 8:30am-2pm or 9am-2pm & possibly 30-minute breaks in between. Judge Edward J. Davila presiding. Jury selection was on 8/31 & 9/1 completed; trial dates 10/1, 10/5, 10/6, 10/12, 10/13, 10/15, 10/19, 10/20, 10/22, 10/26, 10/27, 10/29, 11/2, 11/3, 11/5, 11/9, 11/10 so far. Intervenor’s motions hearing on 9/30.

Indictment & court info from 4/11/20 thru 8/26/21 & jury selection (Day 1-3) 8/31/21 to 9/2/21 & trial (Day 1-8) 9/8/21 to 9/28/21 reference post #588 here:
CA - Elizabeth Holmes (Theranos) Wire Fraud

9/29/21 Wednesday, Trial Day 9: State witnesses: Dr. Adam Rosendorff on cross exam.
for more info see posts #590 & 592 here:
CA - Elizabeth Holmes (Theranos) Wire Fraud
Dr. Victoria Sung (worked for a number of startup biotech companies, including Celgene, that were later acquired by larger cos. She now works at Aditum Bio in Oakland).
for more info see posts #593 & 594 here:
CA - Elizabeth Holmes (Theranos) Wire Fraud
Prosecutor John Bostic says defense counsel "opened the door" to delve into the LIS database during Rosendorff's cross and the gov't wants to go into that during redirect.
for more info see post#595 here:
CA - Elizabeth Holmes (Theranos) Wire Fraud
9/30/21 Intervenor: Steven Zansberg. Intervenor's Motion to Unseal Document (Via Zoom Webinar Remotely).
Trial continues on Friday, 10/1/21 for Day 10.

*Ramesh “Sunny” Balwani (53/now 56) (CFO & President of Theranos) – Motion hearing on 9/30/21 which was cancelled & trial set to begin on 1/11/22 with jury selection & trial starts on 1/18/22.
 
Friday, October 1st:
*Trial continues (Day 10) (@ 9am PT) - CA – for *Elizabeth A. Holmes (34/now 37) (CEO of Theranos) charged (March, 2018) & indicted (6/14/18) & arraigned (6/15/18) with 9 counts of wire fraud & 2 counts of conspiracy to commit wire fraud and charged & indicted (4/11/20) with fraud relating to a patient's blood test. Another count of wire fraud was added in 2020, bringing the total number of felony charges to 12. Plead not guilty. No bond. Faces a maximum sentence of 20 years in prison & up to $2.75 million in fines, plus restitution, & $250K for each individual count of wire fraud & conspiracy.
Defrauding investors out of $700 million in funding for their blood-testing startup Theranos.
Trial began on 8/31/21 with jury selection. 12 jurors of 7 men & 5 women (6 Caucasians, 4 Hispanics & 2 Asians) with five alternates (2 men & 3 women). Juror #7 excused & replaced with alternate #1. Now jurors are 8 men & 4 women. Alternates 1 man & 3 women.
Trial began on 9/8/21.
The Court trial days will be Tuesday, Wednesday & Friday, possibly other half days. The Court may modify the trial time & set either 8:30am-2pm or 9am-2pm & possibly 30-minute breaks in between. Judge Edward J. Davila presiding. Jury selection was on 8/31 & 9/1 completed; trial dates 10/1, 10/5, 10/6, 10/12, 10/13, 10/15, 10/19, 10/20, 10/22, 10/26, 10/27, 10/29, 11/2, 11/3, 11/5, 11/9, 11/10, 11/12 so far. Intervenor’s motions hearing on 9/30/21.

Indictment & court info from 4/11/20 thru 8/26/21 & jury selection (Day 1-3) 8/31/21 to 9/2/21 & trial (Day 1-9) 9/8/21 to 9/29/21 reference post #597 here:
CA - Elizabeth Holmes (Theranos) Wire Fraud

9/30/21 Intervenor: Steven Zansberg. Intervenor's Motion to Unseal Document (Via Zoom Webinar Remotely).
Trial continues on Friday, 10/1/21 for Day 10.

*Ramesh “Sunny” Balwani (53/now 56) (CFO & President of Theranos) – Motion hearing on 9/30/21 which was cancelled & trial set to begin on 1/11/22 with jury selection & trial starts on 1/18/22.
 
Dorothy Atkins@doratki
4h

Happy Friday from San Jose! I'm waiting for day 10 of Holmes' trial to start. No crowds today, but there's a new filing by @JohnCarreyrou
who's gotten himself an atty. He's a possible witness and wants the judge to assure him he won't be barred from watching/covering the trial.

FAn9yr4VgAYeXY2


FAn99yzUUAkHcgj


Dorothy Atkins@doratki
3h

Wade points to a March 2014 email that Balwani wrote saying Edison's proficiency tests for vitamin D "looks good." Rosendorff takes issue with Balwani's statement. "I do not think Mr. Balwani was qualified" to look at the data and make the assessment it "looks good," he says.

Dorothy Atkins@doratki
3h

Wade points to minutes from a March 2014 meeting that says Theranos execs discussed the "AAP for all 7 Edison assays." Rosendorff says he doesn't have a clear recollection of what was discussed in the meeting, but he doesn't have a reason to doubt the accuracy of the mins.

Dorothy Atkins@doratki
3h

Wade brings up another Balwani email about vitamin d tests. But Rosendorff is not impressed. "In general I don't think Balwani was qualified" to be directing the quality control study or direct CLIA staff or make assessments about the validity of data, he says.

Dorothy Atkins@doratki
3h

In 2014, Balwani suggested Theranos' lab increase vitamin d testing sample size, but Rosendorff says Balwani shouldn't be making that call b/c he wasn't lab director and it would've tied up the devices. In another email, Balwani said make the changes "only if they make sense."

Dorothy Atkins@doratki
3h

In April 2014, Rosendorff reviewed a PowerPoint presentation that was created on proficiency testing and AAP to dispel confusion on the CLIA team about Theranos' PT policy. (Prosecutors never brought this up during Rosendorff's direct exam.)

Dorothy Atkins@doratki
3h

The PowerPoint explains Theranos' PT policy of using "actual clinical specimens" and comparing Edison blood-test results with results on other FDA approved devices.

Dorothy Atkins@doratki
2h

Wade points to an Oct 2014 email from a doc who said his patient got wrong FT4 and TSH results, and wanted to speak with Rosendorff. Rosendorff said he would call, but Wade points out that he waited a week and forgot.

Wade: Everyone makes mistakes.

Rosendorff: Sure.

Dorothy Atkins@doratki
2h

Wade is pointing to another email about a patient's testosterone test. Wade accidentally lets the patient name slip, and Rosendorff calls him out on it. The judge says (repeatedly) that the patient's name is stricken from the record.

Dorothy Atkins@doratki
2h

Wade shows Rosendorff an Oct 2014 email in which Rosendorff wrote "please let Christian [Holmes] handle this," in response to a doctor's request to talk to him about a patient's results.

Dorothy Atkins@doratki
2h

Wade points out Rosendorff's email counters his testimony on direct that he didn't know Christian was responding to doctor complaints and Christian wasn't qualified to talk to them. Rosendorff tries to explain: "I was frustrated by the inability to explain discrepant results."

Dorothy Atkins@doratki
2h

Wade pulls up an email Balwani sent Rosendorff that Wade calls "detailed." Rosendorff: "It's long."

Dorothy Atkins@doratki
2h

Balwani's lengthy Oct 2014 email to Rosendorff tells him "you need to bring up the issues with the right people." But Rosendorff says Theranos staff were not implementing his AAP protocol for 13 assays. "I was not clear what they were doing," Rosendorff says.

Dorothy Atkins@doratki
2h

We're taking a 20 minute break. Brb...
 
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