Thread by @doratki

It’s 7:30 a.m. and I’m outside the San Jose courthouse for day 7 of US v Elizabeth Holmes. To my great frustration, there’s a line to get inside today. Maybe they all think Mattis will testify again today or something. (He won’t.)

A couple of folks in business attire who look like law associates just said hi to a defense attorney. One of them told the defense attorney that they’re here to watch, and “break a leg.”

Judge Davila is on the bench to talk with the attorneys about an issue that came up with ex-Theranos lab director Dr. Adam Rosendorff. The DOJ says since Rosendorff left Theranos, a new lab he manages was the subject of a CMS probe and the CMS found deficiencies in that lab.

Judge Davila says he doesn't know if Rosendorff's post-Theranos work will be relevant yet, but "let's see where we go." Holmes' atty says they won't go into the topic today on cross but may next week. Sounds like Rosendorff's exam will take up most of trial today.

Prosecutor John Bostic says Adam Rosendorff also worked for another company after Theranos that was the subject of another unrelated DOJ investigation. Defense counsel says they will probably go into that during cross.

Here's a list of where Adam Rosendorff has worked according to his LinkedIn. (Notably, Theranos is referred to merely as a "privately held biotechnology company.")

The judge said he'll hold a hearing on going into Rosendorff's post-Theranos employment Monday, since Rosendorff's examination will likely go into Tuesday. ITMT, the parties will ask him q's about his time at Theranos.

The jury is back in the courtroom (on time today!) and the judge reminds everyone that you can't audio record or photograph anything going on in the courtroom or you'll be subject to sanctions. The gov't calls Adam Rosendorff to the stand.

Rosendorff says he quit Theranos as lab director in Nov 2014 b/c of the "unwillingness of management" to perform tests as required by law. He says he felt pressured to vouch for tests he didn’t believe in and the co "believed more about PR and funding than about patient care."

Rosendorff explains his background. He's from South Africa, and has an MD in Icahn School of Medicine at Mount Sinai. He's qualified to be a CLIA lab director b/c of his MD degree and he had at least a year of practical experience. He said he learned about Theranos from LinkedIn.

Rosendorff interviewed w/ Balwani, Holmes and Daniel Young in a "small room, locked off" from the lab. "I really bought into the idea of laboratory testing being done with a small blood sample... I believed that Theranos had advanced technology that allowed them to do this."

Rosendorff says he was impressed w/ the "earnestness" of the people he met. "I thought it was going to be the next Apple." He says he read some of the patent applications and "I honestly did not know very much about what kind of technology the company was developing or running."

Rosendorff says when he was hired, he didn't initially know who his direct report would be, but he eventually reported to Sunny Balwani.

Rosendorff says Theranos used Siemens devices to test blood. Gov't points to an Aug 2013 email Holmes wrote before a Siemens rep visit telling Rosendorff "you’ll obviously need to make sure our micro-cups & protocols/modifications are not in any way visible to any Siemens rep."

Rosendorff says Theranos cut a deal w/ Safeway but it out was "extremely rushed and hurried." "The general mood of the co was optimistic," he says but "there was a lot of anxiety in the CLIA group" regarding the appropriateness of using modified devices for patient care.

Feds show an Aug 2013 email in which R&D tells Rosendorff none of the assays are "completely through validation" w/ fingerstick. Rosendorff says he was concerned b/c it was 9 days before launch & under CLIA law you must validate a test fully before using it for patient care.

Days later, Rosendorff says he emailed Holmes and Daniel Young Aug 29, 2013 "raising the alarm bells" about the tests which he thought weren't ready for the launch and his email also raised his concerns about staffing and training.

Rosendorff said he emailed Holmes asking her to delay the launch and he didn't make the request lightly. He met w/ her in her office but "she was very nervous. She was not her usual normal self." "She was clearly upset." and her knee was tapping and she was "trembling."

Rosendorff says he asked Holmes to delay the launch and not Balwani b/c "I felt it would have more impact going to Elizabeth directly. I felt many of the concerns raised to Sunny, he would either dismiss them attempt to explain them away or tell me to talk to Daniel Young."

Rosendorff says he didn't realize Theranos was showing patients a Theranos device, but then using non-Theranos devices to test blood until his interviews with the government prosecuting this case.

Feds point to a Nov 2013 email in which Balwani told the lab team developing Theranos' devices to use two Siemens blood test devices. A member of the R&D team replied she was "somewhat concerned" w/ the decision, but they did it anyway. (Holmes was CCed on the emails.)

Rosendorff says in 2014 he emailed Theranos scientist Sharada Sivaraman asking what protocol they use to remove 2 of 6 datapoints in Theranos blood tests. "I was concerned that we didn't have a protocol for it," he says. She responded they were removing the data manually.

Rosendorff says it was common for Theranos assays to fail quality control tests and that would create a backlog and raised accuracy concerns. In March 2014, 26% QC tests failed.

Rosendorff says QC failure rates should be "in the single digits," not the double digits. We're taking a break - back in 30!

We're back. But the judge prefaces the examination by telling folks in the gallery that they can only type on a silent keyboard, and if you don't have a silent keyboard, "You must close your clamshell and not use them."

The judge said if folks don't know if their keyboard is silent, he'll have a U.S. Marshall inform you. (Fortunately we don't have this issue where I'm sitting in the overflow courtroom.)

Rosendorff says in Nov 2013 he emailed Holmes and Balwani telling them he preferred that Theranos tests showed "reference ranges" that were specific to the sample type and whether they used fingerstick or venous draw.

Rosendorff said he escalated the issue and to Holmes and Balwani. He said they should stop using venous blood draws in Theranos tests. Holmes "did not have a clear position" on the issue, but Balwani was "strongly opposed" to stopping the practice, he says.

Balwani replied to Rosendorff's email expressing concerns about QC failures stating "this is not the case." Prosecutor notes that Balwani specialized in software and at one point was enrolled in an MBA, but he doesn't have medical expertise.

Rosendorff said Elizabeth Holmes' brother, Christian Holmes, was "put in the roll as a liaison" between Rosendorff and customers who complained about Theranos test results.

Rosendorff says complaints he received at Theranos were "much more frequent" than the number of complaints he received in his prior job as medical director of the Children's Hospital of Pittsburgh.

(Now all I can think about is how we're all typing on a "clamshell.")

The prosecutor is going through a series of email exchanges from 2013 b/w Sunny Balwani, Sharada Sivaraman that were eventually sent to Holmes about the precision problems Theranos was having with hCG tests.

In May 2014, Rosendorff said he told Holmes he was "freaked out" by the large range of hCG results he was seeing and he thought he should have been included on exchanges about the hCG results. "She said 'don’t be freaked out,' or she didn’t seem alarmed by it," Rosendorff says.

In June 2014, Christian Holmes wrote his sister: “Just fyi-hCG right now causing some serious issues and patient complaints. Been spending all morning talking to docs about just hCG and will continue to do so… it’s a sensitive one obviously b/c of people find out if pregnant."

Christian Holmes sent another email to his sis: "Seems like we also have a capacity issue right now with Edisons at full capacity and venous samples in a serious queue not being run. Went down there and it’s a complete mess." Rosendorff says he wasn't included on the exchanges.

Prosecutor points to more emails from Sept 2014 re HCG issues. It was taking 4 days for patients to get results, and one patient was told she wasn't pregnant when she was. (It's unclear to me if this is the patient Brittany Gould who testified earlier this week.)

Rosendorff says Daniel Young was an exec and wasn't CLIA certified, but he was "very involved in the CLIA lab after the tests were launched. He would often offer his opinion" re. test results. (Just based on his change in tone, it seems like Rosendorff is not a fan of Young.)

Rosendorff says in February 2014, he "suspected" that Theranos' HDL tests weren't working after a spate of low HDL quality control test results.

Rosendorff emailed Balwani and Young, and cc'ed Holmes, telling them he wanted to stop using Theranos' HDL tests, b/c he thought it wasn't good medical practice in light of the problems.

Rosendorff said he included Holmes in on the email exchange, b/c at that point he didn't think Balwani and Young would be receptive to his request and "I thought that Elizabeth had more power within the company to make corrections."

Rosendorff said he "got a lot of push back" when he suggested reverting back to using FDA approved devices. That "didn’t go down well with management." Prosecutor asks who was management? He says "Sunny, Elizabeth and Daniel."

Rosendorf emailed Balwani in Aug 2014 on Theranos' C02 tests that "I am thinking since we void all abnormal bicarbonate results, the test has lost any diagnostic value and probably also reliability when results are reported in the normal range."

In Aug 2014, Max Fosque told Rosendoff "Per Elizabeth’s request, in the short term” don't comment on the result report if CO2 values are voided and instead include the message: "CO2 results were not reported due to temporary unavailability of this test for this sample."

Rosendorff says he thought the message wasn't transparent, b/c the issue "was a permanent problem."
"I thought at the time that a better solution would be not to offer that test. Don’t have it on the order form if we know we can’t perform it," he said.

Rosendorff says in early Nov 2014 he forwarded himself emails and Theranos docs to his personal account in violation of his NDA b/c he wanted to protect himself in case the government began investigating Theranos and he was considering filing a qui tam whistleblower complaint.

Rosendorff: "I also wanted to get the word out about what was going on at Theranos," and the protection he would get by preserving the docs would outweigh the risk of getting sued by Theranos for violating the NDA.

Rosendorff said he was initially enthusiastic about joining Theranos, but he became "very disillusioned" and started looking for other jobs shortly after joining Theranos in 2013. He again says he thinks the company prioritized PR instead of patient results.

Rosendorff says Theranos used venous blood draws for precision tests b/c "I don’t think practically we could have done it any other way." They would've needed to take 20 fingerpricks to draw enough blood for them, and they probably would "have to prick every finger on a patient."

We're taking a 20 minute recess. Trial should go until 3 p.m. PST today, so we're gettin' close to the weekend...

We're back! Rosendorff says he emailed Balwani about problems w/ Theranos' Potassium, Chloride and Sodium tests in May 2014. His email begins, "sorry to bother you" and suggests a potential solution. Young replied Rosendorff's proposed solution was "not a very good one clearly."

Young told Holmes they were going forward with the tests and Holmes replied "Ok."

Rosendorff says the issues w/ the K, Cl- and Na tests were apparent 5 wks after the commercial launch. "I would complain about them, folks would note the problem, Daniel would say he’s working on a fix, ...the problems might stabilize for a while, but then they would come back."

Rosendorff emailed Balwani, cc'ed Holmes, in Oct 2014 that Theranos' Potassium tests were having problems and they had to void tests that report data above and below critical thresholds.

Rosendorff wrote: “I am not sure of the clinical value of a sodium assay in which the only time we can report is when it is not critical, and the very situations that require accurate measurement and reporting of abnormal of sodium results are voided."

Rosendorff says he was "really struggling" and "grasping at straws" to use Theranos' K tests, but when he left he had never seen its devices perform accurate potassium tests.

Prosecutors are going through a string of emails from Christian Holmes to his sister September 2014 regarding a 'customer issue.' He wrote "it's pretty obvious we have issues with calcium potassium and sodium specifically."

Christian Holmes wrote his sister "Sunny is on these emails, but wanted to get your thoughts specifically on considering to stop reporting these tests until we find the reason we are reporting as we are..."

The email goes on it's "a q around the cost/benefit of continuing to send these results to docs when there seem to be issues with their accuracy. I am also bringing this up b/c I haven't heard any reason/root cause for why these tests are off..."

Christian Holmes wrote "I just get a response from Daniel that 'we are aware of the issues and are conducting a study.' Leaves me a bit hands tied with the docs - obviously I can't tell them we are wrong..."

Rosendorff says he was conflicted b/c he had a duty to the company, but also to patients and drs, and at one point he told doctors the tests were inaccurate. "That caused a lot of emotional discomfort for me," he says.

Rosendorff says management was "pushing" him to rationalize or justify the erroneous results. "Anything other than saying our test is inaccurate," he says. W/ that, trial is breaking for the day...

Judge Davila asks how much longer prosecutors have on Rosendorff’s direct. John Bostic says they’re “closer to the end than the beginning.” The judge replies people say that about him “all the time.” And that’s a wrap!

Here's my recap of ex-Theranos lab direct Dr. Adam Rosendorff's direct examination in US v Elizabeth Holmes. There's a lot going on in this one. His cross is Tuesday. law360.com/articles/14249…