Thread by @doratki

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.

Lance Wade is standing at the podium, reading through his notes. Holmes isn't in the courtroom yet. He said yesterday that he plans to bring up Rosendorff's post-Theranos work at other companies that have been investigated by the feds for alleged lab deficiencies.

Judge Davila is on the bench and ex-Theranos lab director Adam Rosendorff is on the stand. Elizabeth Holmes' attorney Lance Wade kicks off the day asking Rosendorff about Theranos' Dec 2013 inspection by Cali Dept of Public Health, which gives its inspection reports to the feds.

Wade asks if Theranos' lab was first CLIA certified in 2011 since it was certified every 2 years (prob just laying foundation here), but Rosendorff won't give away any ground. He says he doesn't know: "That’s an extrapolation. That’s a conclusion that you may want to draw."

Rosendorff interrupts Wade's qs: "You keep saying, 'it's my job, it's my job, but I was part of a large company...Yes I did my job, but I also depended a lot of people around me."

Wade asks if they were qualified. He says yes, but it’s not just them - also HR, management, etc.

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...

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."

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."

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.

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.

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?"

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.

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.”

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."

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."

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.

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."

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.

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.

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.

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.

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."

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!

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.)

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.

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

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."

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."

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.

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."

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).

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.

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.

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

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.

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...

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

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.

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.

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."

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.

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.

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.

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."

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.

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.

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.

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.

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)

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.

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.

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.'

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."

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).

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.

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) law360.com/articles/14099…

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.

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.

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.

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.

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.

Theranos ounce touted Celgene as a major pharma client. But an ex-Celgene scientist testified in Elizabeth Holmes' criminal trial today that the co passed on the tech. Here's my recap of her testimony, freshly copy-edited, w/o all the embarrassing typos. law360.com/articles/14263…