Dorothy Atkins@doratki·
5h
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.)
Dorothy Atkins@doratki·
4h
Replying to
@doratki
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.
Dorothy Atkins@doratki·
4h
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.
Dorothy Atkins@doratki·
4h
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.
Dorothy Atkins@doratki·
4h
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.
Dorothy Atkins@doratki·
3h
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.
Dorothy Atkins@doratki·
4h
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."
Dorothy Atkins@doratki·
3h
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."
Dorothy Atkins@doratki·
3h
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."
Dorothy Atkins@doratki·
3h
Rosendorff says when he was hired, he didn't initially know who his direct report would be, but he eventually reported to Sunny Balwani.
Dorothy Atkins@doratki·
3h
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."
Dorothy Atkins@doratki·
3h
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.
Dorothy Atkins@doratki·
3h
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.
Dorothy Atkins@doratki·
3h
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.
Dorothy Atkins@doratki·
3h
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."
Dorothy Atkins@doratki·
3h
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."
Dorothy Atkins@doratki·
3h
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.
Dorothy Atkins@doratki·
3h
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.)
Dorothy Atkins@doratki·
2h
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.
Dorothy Atkins@doratki·
2h
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.
Dorothy Atkins@doratki·
2h
Rosendorff says QC failure rates should be "in the single digits," not the double digits. We're taking a break - back in 30!