Thread by @doratki

Good morning from San Jose! It’s 7 a.m. and I’m outside waiting for day 5 of US v. Elizabeth Holmes. There’s barely a line to get into the courthouse this morning - all press - and yet some folks still seem to insist on skipping to the front.

To the media's frustration, the feds haven't been publicly filing a list of who they plan to call, so we don't know who will be testifying after Surekha Gangakhedkar's examination today. Stay tuned.

Judge Davila is on the bench. Defense counsel is arguing that the government wants to show the jury select text messages from witness Justin Offen, but they shouldn't be limited. Prosecutors note that the doc w/ the messages is 447-pages and "not all of them are relevant."

It's unclear to me if the text messages are the ones b/w Balwani and Holmes, or b/w Offen and Holmes, (the audio in the overflow courtroom cut out briefly), but the judge told the parties to meet about it during the break. Sounds like Offen will be the last witness of the day.

The judge says he's going to ask the jury to stay until 3 p.m. tomorrow and Friday. We should be going until 2 today, and the parties will finish with Gangakhedkar's exam and then feds plan to call 2 quick witnesses before Offen.

Yeah, correction, the 447-pages worth of texts at issue are b/w Balwani and Holmes. Not Offen. (Off to a great start this morning!) The jury is back in the courtroom and Gangakhedkar is heading back to the stand.

Holmes' counsel Lance Wade kicks off Gangakhedkar's cross examination, asking her about ex-Theranos chief scientist Ian Gibbons, who committed suicide in 2013 (which hasn't been mentioned during trial yet). She says she looked up to him and they worked together on assay tests.

Wade turns to a series of docs Gangakhedkar signed attesting to Theranos' quality assurance & federal compliance related to a 2011 validation report given to Celgene. He also gets her to acknowledge that Theranos' policy removed a max of 2 outliers for 'the combined 3 core runs.'

(The point about the 2 outlier data removal policy seems to be countering Erika Cheung's testimony last week that Theranos didn't have a standard protocol for deleting the outlier data, which Cheung said amounted to "cherry picking.")

Wade gets Gangakhedkar to acknowledge there are 100s of assays and Theranos was focused on developing assays for the most commonly ordered. Gangakhedkar wrote Holmes in March 2011 five assays - including fertility assays - were complete and in Aug 2011, 11 assays were complete.

In June 2012, Gangakhedkar wrote 40 Theranos assays were complete and 18 were in development, and in June 2013, she wrote 93 were complete. She says her assay validation work was a step before sending assays to Theranos' CLIA lab to determine if they can be used w/ patients.

Holmes' counsel Lance Wade points out the amount of work put in to each assay validation report.

Wade: It's a tremendous volume of work, is not?
Gangakhedkar: It is.
Wade: Did you feel proud of your team and all the work they did to accomplish this?
Gangakhedkar: I think so.

Holmes' attorney points to a November 2011 email Elizabeth Holmes sent to Gangakhedkar and others asking for updates on the completed assays, because she was meeting with Department of Defense officials.

Holmes' attorney notes that Gangakhedkar responded that Theranos' Vitamin D assays weren't ready, and Holmes left it at that and never asked for the vitamin D assay info to give to the DoD.

Wade gets Gangakhedkar to acknowledge that despite Theranos' assay development plans, there would occasionally be setbacks and that's to be expected in R&D.

Wade: In research and development, you have to fail before you succeed?

Gangakhedkar: Yes.

Wade has been showing Gangakhedkar pages from Theranos' validation plans for assays on Theranos devices. She acknowledges that the plan's standards came out of federal regulations, which she agrees she was generally familiar with at the time.

Slow-going testimony. Wade is asking Gangakhedkar to explain what various terms in Theranos' validation plan - including "calibration" and "accuracy" - mean.

Gangakhedkar acknowledges that Theranos' master validation plan and CLIA regulations say it's the responsibility of Theranos' lab director to ensure that the company's assays are validated.

And we're taking a break - we'll be back in 45 minutes.

The jury is back, and Holmes' attorney is back to pointing to some more Theranos master verification plan documents -- this batch is specific to Theranos' use of Siemens Advia 1800 blood-testing devices.

Gangakhedkar says in 2013 ex-Theranos lab director Adam Rosendorff "didn’t go into all of the details" of Theranos' device launch or the plan to use Siemens' devices when he met with her.

Wade: He was not concerned with the approach?
Gangakhedkar: That was my understanding.

Holmes' atty asks Gangakhedkar if the plan was to focus on validating a few assays on Theranos' Edison devices and then roll out more in "phases." She replies "I don’t recall the entirety of the plan." He points to an Aug 21 2013 email she wrote mentioning the phased approach.

Holmes' atty brings up Balwani's 2013 email to Gangakhedkar criticizing her team for not working through the night like the software team. Wade says Balwani was "essentially boast[ing] about the oppressive hours his team was working, as though that was a badge of honor."

Wade on Balwani: He’s trying to make you feel guilty for the fact you weren't working then wasn’t he?
Gangakhedkar: Yes.
Wade: He’s trying to make your whole team feel guilty?
Gangakhedkar: Yes.
Wade: You were frustrated by that?
Gangakhedkar: Yes.

Wade asks Gangakhedkar if she was deeply offended by Balwani. She replies that his criticism of her team was a "common theme." Wade asks if the witness is aware Balwani criticized Holmes. She replies she was not, but the gov't objects and the judge sustains the objection.

Wade points out that Gangakhedkar was so upset by Balwani's email that she replied to him defending her team's hard work, and resigned 3 days later. He notes that Holmes was surprised and she asked Gangakhedkar if there was anything they could do to keep her, but she said no.

On redirect now. Robert Leach is up for the gov't, asking Gangakhedkar if she conveyed her reliability concerns about Theranos' Edison 3.0 and 3.5 with Holmes when she quit. She says she did.

Leach shows Gangakhedkar an email from a team member responding to Balwani's criticisms re her team not working through the night. The email says "This is so frustrating and insulting when we were all working so hard"..."This is as much as we can take and not the first time."

Gangakhedkar responded to the email "agreed" and she and her team member quit Theranos shortly after. W/ that, the parties wrapped Gangakhedkar's exam. Feds call Arizona nurse practitioner Audra Zachman next.

Zachman says she first heard of Theranos in summer 2014 after a rep pitched its blood-testing devices to her hospital's product committee. They chose to use Theranos b/c they were less costly, less invasive and they thought lab results would be reliable, convenient and accurate.

Zachman says she had her patients use Theranos blood tests, including one patient, who was pregnant in Sept 2014 after previously having a miscarriage and falling into the high-risk pregnancy category.

Zachman says her patient eventually gave birth to a healthy baby, but she ordered Theranos HCG hormone tests that jumped from 1,005 to 12,558 HCG and then dropped 2 days later to 125.58 HCG. The drop "would be very concerning" and suggest a miscarriage.

Zachman says based on Theranos' hormone tests, she told her patient that she likely doesn't have a viable pregnancy, which would have been her patient's fourth miscarriage. Zachman did a 3rd hormone test from another co and learned Theranos tests had been inaccurate.

After, Zachman said she was concerned about the reliability of Theranos' test results and felt uncomfortable as a provider continuing having her patients blood drawn there. "It stood out as such a red flag," she says.

Zachman said after she realized Theranos' test errors she complained to the company, and Holmes' brother, Christian Holmes, responded to her, blaming the mistake on "human error" and a wrong entry into the system.

Zachman said Christian Holmes' explanation wasn't satisfactory, because the values still didn't "fit the clinical picture" and it raised more questions for her.

On cross now, Katie Trefz is up for Holmes. The attorney begins by pointing out there are qualitative and quantitative hCG tests and gets Zachman to acknowledge that there are other ways to test for early pregnancy aside from hCG tests.

Treftz gets Zachman to acknowledge that she advised her patient to continue her prenatal vitamins and hormone treatment despite the two inaccurate Theranos' test results, b/c she didn't show other signs of a miscarriage.

Treftz notes that Christian Holmes apologized for the errors and gave Zachman his cell and email for her to call if she had more concerns, and Theranos offered to do a study and put providers in touch with Holmes directly.

Zachman acknowledges that Theranos did eventually partner with Zachman's hospital to do a study and Zachman "briefly" helped design the study.

Holmes' attorney points out that between October 2015 and October 2016, Theranos performed 300 hCG tests for patients at Zachman's hospital, including Zachman's own patients. Zachman doesn't recall, but after reviewing docs agrees the tests happened.

Holmes' attorney asks Zachman if she knew that her hospital placed 20k assay orders with Theranos. She replies that she isn't aware of that stat.

On redirect, Zachman says the Theranos study w/ her hospital involved ~30 patients, but the incident with her patient was "very impactful to me as a provider" and "as a woman." "There wasn’t much that could restore my faith [in Theranos] at that time," she says.

The parties wrapped with Zachman's examination, and we're going for another 30 mins today before breaking. Zachman's patient, Brittney Gould, is on the stand.

Fun fact: Gould pronounces Theranos the way the judge pronounces Theranos. Ther-Ah-nos.

Gould's exam is quick. She says she got Theranos hCG tests from a Walgreens b/c it was less costly than alternatives and after she received the inaccurate results, she didn't trust it: "You can’t provide accurate patient care w/ inaccurate results." Defense has no cross.

We're adjourned until tomorrow morning. ✌️

Jurors deciding whether ex-Theranos CEO Elizabeth Holmes defrauded investors and patients heard from the first alleged victim today - a mother whose Theranos blood tests wrongly suggested she had a miscarriage. Here's my recap of today's testimony: law360.com/articles/14237…