2 hours in the past
Erin Woo
4/2/12 electronic mail from Sung to Daniel Edlin, with Holmes and Younger copied. “We thought it could be nice to maintain her within the loop and conscious of ongoing actions,” Sung mentioned. The e-mail says Celgene “had determined to easily wait till your next-gen machines are prepared after which deploy them”
2 hours in the past
Erin Woo
In additional unhealthy information for Theranos, imply focus profiles weren’t constant between Theranos and QPS, and focus variability was larger with Theranos than with QPS technique. As soon as once more, Sung confirms that focus variability is undesirable.
2 hours in the past
Erin Woo
We’re a scatter plot exhibiting the vary the place Theranos checks ought to fall. Most of them … don’t fall inside this vary. 67% of samples had >25% distinction in serum focus between Theranos and QPS technique. “It’s not excellent news” for Theranos, Sung mentioned.
2 hours in the past
Erin Woo
Theranos entire blood knowledge confirmed extra fluctuations, which Sung mentioned was undesirable.
2 hours in the past
Erin Woo
Theranos additionally had larger variability. Authorities requested if that was good or unhealthy. Sung chuckled and replied: “Dangerous.”
2 hours in the past
Erin Woo
14.1% of Theranos samples didn’t have usable outcomes, in comparison with lower than 2% for QPS.
2 hours in the past
Erin Woo
We will see a comparability between Theranos and QPS assays. Theranos solely used .25mL of blood in comparison with 2mL for QPS. Theranos additionally used entire blood fairly than serum, which Sung mentioned was “very good.”
2 hours in the past
Erin Woo
7/20/10 electronic mail from Sung to Holmes saying they weren’t capable of validate Theranos’s checks. The outcomes have been “shut” in some circumstances however not adequate.
2 hours in the past
Erin Woo
She had visited Theranos and thinks she met Holmes whereas she was there. She noticed a Theranos system whereas she was there and mentioned it regarded like an oven. The thought you can do one thing so small and environment friendly on web site was a “nice thought,” she thought on the time.
2 hours in the past
Erin Woo
Celgene entered into an association with Theranos. Her understanding was that Theranos was growing a platform to investigate the endpoints. She thought they may do it effectively with a really small quantity of blood, which might be a “enormous benefit.”
2 hours in the past
Erin Woo
We’re beginning her testimony in 2009, when she labored on a drug known as ACE-011 being developed for remedy of anemia and bone loss. Her function was to recommend proteins within the blood to measure that will recommend whether or not the drug was working (e.g., hormones).
3 hours in the past
Erin Woo
Dr. Sung obtained a Ph.D at Georgetown after which did a postdoc at Stanford earlier than going into trade. She labored in varied biotech companies, together with Celgene, which was later purchased by Bristol Myers Squibb. She’ll be testifying about her work at Celgene.
3 hours in the past
Erin Woo
We’re again in session. The federal government is looking Dr. Victoria Sung. (Rosendorff will choose up on Friday.)
3 hours in the past
Erin Woo
After a protracted dialogue of an electronic mail chain about proficiency testing, Rosendorff is finished with testimony for at this time. (He has a battle this afternoon.) We’re going to take a 20 minute break after which choose up with a distinct witness for the remainder of the afternoon.
4 hours in the past
Erin Woo
Now a doc from the American Proficiency Institute that provides “Acceptable” scores to the entire proficiency checks.
4 hours in the past
Erin Woo
Trying now at an electronic mail from Rosendorff: “We’re regularly doing proficiency testing.” Rosendorff testifies to make clear that this was predicate testing.
4 hours in the past
Erin Woo
After his 2016 testimony (within the binders!), Rosendorff says he nonetheless doesn’t bear in mind telling the federal government that. “I assume the document is appropriate,” he says.
4 hours in the past
Erin Woo
We’re now again to the place we began yesterday, discussing Rosendorff’s contact with the federal government. Wade asks Rosendorff if he remembers telling the federal government that Theranos machines used various evaluation proficiency to measure accuracy. Rosendorff says no.
4 hours in the past
Erin Woo
Rosendorff beforehand testified there was no formal proficiency testing processes in place. After Wade challenges him, Rosendorff clarifies: There was proficiency testing for predicate testing (business checks), however not for Theranos checks
4 hours in the past
Erin Woo
Taking a look at a high quality techniques presentation for 2014 from Langly Gee, Theranos’s high quality management supervisor. Wade is exhibiting failure charges for Edison high quality management checks. “One thing’s not squaring up,” Rosendorff says — these failure charges are decrease than he thought they have been.
5 hours in the past
Erin Woo
Wade is continuous on this line of questioning, noting that Rosendorff testified about issues in June 2014 however signed validation reviews in Aug. and Sept. 2014.
5 hours in the past
Erin Woo
Rosendorff testifies that he wouldn’t have continued signing validation reviews for Theranos’s blood testing system, the Edison, if he thought it was unreliable.
5 hours in the past
Erin Woo
We’re again from break! And on to a different Edison validation report.
6 hours in the past
Erin Woo
We’re going by way of a Sept. 2013 validation report on the Edison for TSH, a thyroid take a look at. This doc, with Rosendorff’s signature, validates the take a look at for affected person use. Wade is strolling Rosendorff web page by web page by way of the report.
6 hours in the past
Erin Woo
Rosendorff testifies that he by no means informed the CLIA staff to cease utilizing the Edison take a look at altogether, however did on some particular checks.
7 hours in the past
Erin Woo
Wade is now noting that Rosendorff was among the many highest-paid workers at Theranos. Rosendorff says that he thought he ought to have been paid extra, given Theranos’s issues, however that is stricken from the document.
7 hours in the past
Erin Woo
Rosendorff says he had issues about QC. Wade says he was paid to have issues. “That’s why you receives a commission the large bucks.” Rosendorff replies: “Not as huge bucks as you receives a commission.” Cue the largest snicker of the trial to this point.
7 hours in the past
Erin Woo
Wade is making some extent he’s made earlier than, that high quality management samples aren’t affected person samples — noting that “nothing unhealthy occurs” to sufferers if a QC take a look at fails.
7 hours in the past
Erin Woo
We are actually on to a mid-Jan 2014 electronic mail from Rosendorff to the CLIA lab staff asking them to seek advice from very detailed quality-control insurance policies.
7 hours in the past
Erin Woo
Balwani’s response: “I spoke with the groups at this time and they’re all going to place in lengthy hours and do no matter it takes to get this accomplished tomorrow.” Rosendorff testifies: “I had many many battles with Sunny about what was wanted versus what he was ready to permit.”
7 hours in the past
Erin Woo
Rosendorff added: “I do really feel that it was very tough to get solutions from Daniel’s staff.” In a later electronic mail, Rosendorff doubles down on needing the specificity research: “No they’re required. Crucial in truth.”
7 hours in the past
Erin Woo
From the e-mail chain. Balwani: “As we all know, we take these points with seriousness. Why didn’t you elevate these earlier than to me once I was asking for any points for months?” Rosendorff: “My apologies for the late suggestions relating to our readiness …”
7 hours in the past
Erin Woo
Notable frustration from Rosendorff after he tries to make some extent and Wade cuts him off: “I’m simply studying emails and saying, sure, that’s what’s occurring right here.”
7 hours in the past
Erin Woo
We’re now onto dialogue of the Walgreens launch. In a 11/10/13 electronic mail to Balwani, Rosendorff flagged points that wanted to be addressed earlier than the Walgreens launch. Wade is strolling him by way of the e-mail chain with Balwani, level by level.
7 hours in the past
Erin Woo
After many questions establishing that Rosendorff didn’t disguise Normandy lab from the inspectors, Wade notes that the inspection discovered “minor deficiencies.” Rosendorff says that Holmes and Balwani have been upset that there have been deficiencies and {that a} clear report would have been “excellent.”
7 hours in the past
Erin Woo
Wade is making an attempt to make the purpose that this was to protect commerce secrets and techniques. Rosendorff says this doesn’t make sense, asking who would pin commerce secrets and techniques to a bulletin board.
7 hours in the past
Erin Woo
We’re trying once more on the electronic mail from Elizabeth Holmes about strolling the auditors by way of the lab. We’re now seeing the response: “The entire bulletin boards from the foyer to HR have been lined with paper so the inspector couldn’t view any of the drawings or objects on the boards.”
8 hours in the past
Erin Woo
Wade is beginning by asking questions in regards to the Dec. 2013 CA Dept. of Public Well being audit that we mentioned yesterday. Wade’s going by way of a doc itemizing preparations for the audit as he tries to determine that Rosendorff had accountability right here.
8 hours in the past
Erin Woo
Courtroom is in session for an additional day of the Elizabeth Holmes trial! We’re persevering with with the cross-examination of former Theranos lab director Adam Rosendorff, which protection legal professional Lance Wade expects to take all day.
1 day in the past
Erin Woo
Rosendorff requested for a loo break, and we’re as a substitute ending for the day! Will choose again up at 9 a.m. Pacific Time tomorrow.
1 day in the past
Erin Woo
Essential content material: The custom-built laboratory data system was named Tremendous Mario. (Different enjoyable names: Jurassic Park = the lab with the entire commonplace machines, Normandy = the lab with Theranos machines.)
1 day in the past
Erin Woo
Cross examination has been a lot slower and calmer now that we’re again from break. Much less urgent Rosendorff to reply particular questions and extra jokes.
1 day in the past
Erin Woo
Wade is holding up a replica of the e-book and speaking in regards to the significance of its PR and advertising efforts, in addition to its secrecy.
1 day in the past
Erin Woo
Rosendorff learn Walter Isaacson’s Steve Jobs biography and preferred the joy of Silicon Valley, which helped lead him to Theranos. (That Steve Jobs biography was a favourite of Holmes’s, too.)
1 day in the past
Erin Woo
We’re again from break! And we’ve taken an enormous step again in time — now trying on the resume Rosendorff despatched Theranos when he utilized in 2013.
1 day in the past
Erin Woo
We’re now going forwards and backwards on who was concerned within the R&D course of. Rosendorff says he was not conscious on the time if Holmes was concerned with R&D. Per the grasp validation plan, Rosendorff needed to log off on every assay earlier than it may well go into validation.
1 day in the past
Erin Woo
We’re going by way of what checks have been provided in the course of the family and friends launch. The one checks run by way of 9/28/13 have been two that didn’t run on the Edison, Rosendorff confirms. The primary Edison-based take a look at, TSH, a measure of thyroid operate, was run 10/17/2013.
1 day in the past
Erin Woo
Wade additionally retains having Rosendorff learn his personal testimony, silently, to himself. That’s occurring once more now.
1 day in the past
Erin Woo
Within the electronic mail, Balwani writes, “We really feel assured we will deal with ~30 samples/day from this location at this level. And it has been 2 months since we’ve got been out in WAG [Walgreens]. It’s time to go reside.” Wade now making an attempt to make the purpose that they’d not beforehand been reside.
1 day in the past
Erin Woo
Discovered it! We are actually an 11/7/13 electronic mail from Balwani to Rosendorff about opening their Palo Alto/Uni Ave location to the general public on the approaching Monday. It had beforehand solely been open to mates/household.
1 day in the past
Erin Woo
We are actually, as soon as once more, looking for the proper pages within the MANY binders the protection gave Rosendorff.
1 day in the past
Erin Woo
Wade is now saying that Rosendorff testified earlier to a grand testimony that it was a “restricted family and friends” however didn’t accomplish that on Friday.
1 day in the past
Erin Woo
We are actually on to the business launch. In an electronic mail that we noticed in direct, Rose Edmonds (a growth scientist) says that not one of the assays are fully via validation testing. Rosendorff had testified that is important as a result of they have been only a week from launch.
1 day in the past
Erin Woo
Wade gave a hypothetical the place Rosendorff had rotten meals in his workplace, and subordinates complain to Balwani. Rosendorff continued to appear confused, and Wade is now transferring on.
1 day in the past
Erin Woo
We are actually … asking about firm hierarchy? (Rosendorff reported on to Balwani, and Younger was additionally above him.) “Are there ever circumstances the place it’s applicable for senior administration to have discussions a couple of subordinate?” Wade asks. Rosendorff appears confused.
1 day in the past
Erin Woo
Rosendorff additionally served as Theranos’s medical advisor. Holmes wouldn’t qualify for this both.
1 day in the past
Erin Woo
Wade is asking about Holmes’s training. Famously, she dropped out of Stanford. “Based mostly in your understanding of her background, would she be certified to be a CLIA supervisor or lab director? Rosendorff: “No, positively not.”
1 day in the past
Erin Woo
Wade says, and Rosendorff concedes, that finally it was Rosendorff’s accountability if the checks failed and his accountability to implement high quality management insurance policies and proficiency checks.
1 day in the past
Erin Woo
Rosendorff is agreeing with Wade’s questioning that Holmes by no means informed him to report an inaccurate consequence, and that Holmes by no means directed him to not pause or discontinue checks he thought have been inaccurate.
1 day in the past
Erin Woo
Wade: “Did you ever use a take a look at on sufferers that you just believed was inaccurate or unreliable?” Rosendorff: “No.” Did he ever present outcomes that he believed to be unreliable? “No.”
1 day in the past
Erin Woo
Wade: “Did you faithfully dispatch your authorized obligations as lab director at Theranos?” Rosendorff: “Sure, I did.” Wade: “Did you provide lab checks that you just knew on the time have been inaccurate or unreliable?” Rosendorff: “No … I ordered the laboratory to stop testing.”
1 day in the past
Erin Woo
Two themes of cross up to now: Wade appears to be making an attempt to show that Rosendorff labored with the federal government in shaping his testimony, and is hammering residence that Rosendorff was legally and ethically accountable for the lab.
1 day in the past
Erin Woo
Rosendorff confirms that he was aware of the rules. Wade is now asking a collection of questions on Rosendorff’s obligations: “You might be required to…?” Rosendorff says these are his obligations, however “I obtained pushback from administration.”
1 day in the past
Erin Woo
Wade is now holding up a stack of papers (possibly an inch thick?) and asking if Rosendorff knew all of these rules, presumably the stack of papers he’s holding. Davila, the choose: “You’re asking to confess everything of this doc? It’s what number of pages? 122?” It’s admitted.
1 day in the past
Erin Woo
We’re into Rosendorff’s time at Theranos! Wade requested him if being the CLIA lab director meant he was legally accountable for what occurred within the lab, and Rosendorff mentioned sure.
1 day in the past
Erin Woo
Wade is continuous to attempt to choose aside the prosecution’s case, noting that they didn’t go in chronological order by way of the paperwork. He nonetheless hasn’t actually requested about Rosendorff’s precise experiences at Theranos.
1 day in the past
Erin Woo
Wade is arguing that Rosendorff’s testimony in direct doesn’t match what he testified in 2019. Earlier, he simply mentioned he wasn’t glad with administration’s response to proficiency testing. His testimony on Friday was extra detailed.
1 day in the past
Erin Woo
We’re now into questioning in regards to the testimony itself. Wade is asking Rosendorff about his causes for leaving Theranos. Wade asks if Rosendorff mentioned that query/reply with the federal government. Rosendorff says sure.
1 day in the past
Erin Woo
Wade presses him on whether or not he informed the federal government what he was going to testify.
Rosendorff says no.
1 day in the past
Erin Woo
Wade is now asking about how Rosendorff was ready to testify by the federal government. Rosendorff: “I used to be all the time instructed by the federal government to be truthful.” Wade requested: “Did they inform you to provide that reply?” Rosendorff: “No.”
1 day in the past
Erin Woo
Wade goes by way of a listing of individuals and asking Rosendorff if he’s met every of them. His tone is way extra aggressive than with earlier witnesses.
1 day in the past
Erin Woo
We’re beginning with cross-examination. Lance Wade, Holmes’s lawyer, is beginning by grilling Rosendorff on what number of occasions he’s met with the federal government.
1 day in the past
Erin Woo
And, with that, his direct testimony has wrapped. We’ll choose up with cross-examination after a 30-min. break.
1 day in the past
Erin Woo
In the end, Rosendorff mentioned, he left after “limitless conferences and conversations, very cautious examine of medical literature, late nights … nice efforts on my half to enhance the standard of testing at Theranos.”
1 day in the past
Erin Woo
Rosendorff testified about why he spoke with then-WSJ reporter John Carreyrou: mentioned he felt a “ethical and moral” obligation to alert the general public.
1 day in the past
Erin Woo
Bostic identified the road “We’ll execute this yr.” When did Theranos begin testing? he requested. Rosendorff responds: 2013.
1 day in the past
Erin Woo
Extra texts from Holmes/Balwani! Holmes: “This yr is our yr. We will always remember this tiger.” Balwani: “I do know, I’m centered on it. We’ll execute this yr.” Holmes: “I do know. I’m centered on it too. And for our children always remember who we’re.”
1 day in the past
Erin Woo
On Rosendorff’s final day, he says Balwani provided a handshake, and he declined. Balwani gave him exit paperwork to signal. Balwani mentioned he can be ready to maintain him on, however Rosendorff mentioned it wasn’t well worth the danger to his popularity.
1 day in the past
Erin Woo
Holmes forwarded it to Balwani: “We have to reply to him now and minimize him Monday.” Rosendorff had already accepted a job provide at one other lab and was planning on leaving — interpreted this as them making an attempt to fireplace him proper earlier than he left.
1 day in the past
Erin Woo
Nov. 2014 electronic mail to Rosendorff asking for a redraw. Rosendorff forwarded this to Holmes/Balwani, and Balwani mentioned the rep “jumped the gun” asking for a redraw. Adam forwarded this to Elizabeth: “I discover Sunny’s response offensive and disingenuous. He ought to apologize.”
1 day in the past
Erin Woo
Gov’t making an attempt to make the purpose that Holmes/Balwani are actively courting investments at the same time as Rosendorff raises issues about essential issues within the lab.
1 day in the past
Erin Woo
We’re now Nov. 2014 texts between Balwani and Holmes, speaking about investments from Alice Walton and Rupert Murdoch. Balwani: “They aren’t investing in our firm, they’re investing in our future.”
1 day in the past
Erin Woo
“…how basic it’s to all of us for you or another worker by no means to do something you’re not fully assured in.” Rosendorff says he disagrees with this, and we’ve seen emails exhibiting that he raised issues.
1 day in the past
Erin Woo
Holmes’s response (pt. 1): “How unhappy and disappointing to see this from you. Outdoors of the very fact you’ve by no means emailed me on any issues you allude to there earlier than however now electronic mail this, you recognize from each dialog we’ve ever had collectively …”
1 day in the past
Erin Woo
Now Nov. 14 emails from Rosendorff. “I really feel actually uncomfortable with what is going on proper now on this firm. Is there any means you will get Spencer again on the CLIA [Clinical Laboratory Improvement Amendments] license and take me off? I’m feeling pressured to vouch for outcomes that I can’t be assured in.”
1 day in the past
Erin Woo
Christian forwarded the e-mail to Elizabeth, writing: “His response to this was to do a vacutainer redraw & I ended the dialog at that time.” A vacutainer draw is a non-Theranos retest.
1 day in the past
Erin Woo
He continued: “Additional 100% honesty and transparency to the affected person is important. “My first obligation is to not Theranos, however to the affected person as per my Hippocratic oath “primum non nocere.” “I by no means mentioned I wouldn’t speak to the MD.”
1 day in the past
Erin Woo
In an electronic mail to Christian, Rosendorff doubled down. “This isn’t a query of deciphering outcomes — this can be a query of the reliability and accuracy of the consequence.” “Probably the most constructive factor at this level is to supply dependable and strong assays, to not spin.”
1 day in the past
Erin Woo
Nov. electronic mail from Rosendorff in regards to the affected person name to Christian: “For those who’re asking me to defend these values then the reply is not any.” He was refusing to defend the accuracy of the consequence, Rosendorff testifies.
1 day in the past
Erin Woo
Emails like this contributed to a “crescendo” of points, Rosendorff testifies, resulting in his resignation in Nov. 2014.
1 day in the past
Erin Woo
Taking a look at an electronic mail from a medical assistant involved that HDL and LDL (ldl cholesterol) readings usually are not including up. That raises issues in regards to the accuracy of the take a look at, Rosendorff testifies.
1 day in the past
Erin Woo
In a follow-up electronic mail from Holmes: “Kerry please delineate this primarily based on what we did with the NY inspector lately and ship that out.” Nobody was allowed to enter or exit the Normandy lab in the course of the go to, Rosendorff mentioned. These instructions got here from Balwani.
1 day in the past
Erin Woo
1/26/13 electronic mail from Holmes in regards to the upcoming audit from the California Dept. of Public Well being: “Let me know if the trail for strolling the auditors in and downstairs has been cemented so we keep away from areas that can’t be accessed, and what that path is.”
1 day in the past
Erin Woo
Christian forwarded the message to Daniel Younger and cc’d Elizabeth. In a later electronic mail to Elizabeth and Daniel, Christian wrote that Rosendorff already permitted the redraw. “Want to debate messaging for my name with this doc, with regard to purpose for the redraw,” Christian wrote.
1 day in the past
Erin Woo
Now an electronic mail to Christian Holmes to approve a redraw, regardless of his not having a place within the medical lab or a medical/science background. Rosendorff says he wasn’t conscious Christian was concerned in approving redraws.
1 day in the past
Erin Woo
Now onto discussing transparency. “I felt a battle between the messaging that the corporate wished me to offer … and my obligation as a doctor” to precisely report outcomes when speaking with medical doctors, Rosendorff says.
1 day in the past
Erin Woo
In an electronic mail chain in regards to the proficiency testing samples, Balwani wrote that Theranos’s validation has been “wonderful previously” and that “it’s these PT samples which might be off.” Rosendorff testifies that he disagrees.
1 day in the past
Erin Woo
There was no formal proficiency testing course of at Theranos, Rosendorff says. He says he raised these issues at a mid-2014 assembly to individuals together with Holmes, Theranos’s president, Ramesh Balwani, and the VP Daniel Younger. He felt like they gave “lip service” to this challenge, and there was no progress made earlier than he left in November.
1 day in the past
Erin Woo
Rosendorff’s response to conditions like this: “Each time we obtained a doctor criticism, each time our QC would fail, each time we had a spate of anomalous outcomes, it raised nice issues to me in regards to the accuracy of the testing course of.”
1 day in the past
Erin Woo
We’re an electronic mail from somebody who has been on coumadin, a blood thinner treatment, for 13 years. After switching to Theranos testing, her outcomes got here again low, and he or she elevated her dose consequently. “I’ve not felt ‘proper’ for the reason that one elevated dose,” she wrote.
1 day in the past
Erin Woo
I’m again within the courtroom for an additional day of the Elizabeth Holmes trial! We’re beginning with the top of former lab director Adam Rosendorff’s direct testimony.
5 days in the past
Erin Woo
With that, we’re going to interrupt for the weekend. I’ll be within the courthouse Tuesday, Wednesday and Friday subsequent week — see you on Tuesday!
5 days in the past
Erin Woo
For the previous hour, Rosendorff has testified about issues w varied checks, incl. the potassium, chloride and sodium checks. In a ten/27/14 electronic mail, he wrote: “I’m not certain of the medical worth of a sodium assay, during which the one time we will report it’s when it’s not vital”
5 days in the past
Erin Woo
We’re now moving into Rosendorff’s resolution to go away. He forwarded work emails with problems with concern to his Gmail account in 2014, testifying that “I wished to guard myself.” He additionally says he began searching for one other job in mid-2013, shortly after becoming a member of Theranos.
5 days in the past
Erin Woo
Right now’s theme appears to be a) Rosendorff was involved about defective checks, b) Rosendorff beneficial the corporate cease utilizing these checks and c) Holmes/Balwani have been conscious however declined to vary course.
5 days in the past
Erin Woo
We’re now on points with Theranos’s HDL (ldl cholesterol) checks. Rosendorff says he “suspected” Theranos’ HDL was not working as of Feb. 2014 and recommended reverting to FDA-approved gadgets, however obtained pushback from Balwani, Holmes and Theranos VP Daniel Younger.
5 days in the past
Erin Woo
We’ve now seen two electronic mail chains together with Holmes/Balwani about complaints/points that Rosendorff wasn’t included on. Rosendorff says he “completely” ought to have been included on the emails.
5 days in the past
Erin Woo
Rosendorff is testifying about points with the hCG checks, which detect being pregnant. In June 2014, Christian Holmes wrote to Elizabeth: “Simply fyi-hCG proper now inflicting some severe points and affected person complaints.”
5 days in the past
Erin Woo
We’re evaluating Rosendorff’s time on the College of Pittsburgh to his time at Theranos. At Theranos, complaints about take a look at outcomes have been “far more frequent,” and he “felt pressured to defend the corporate’s outcomes to physicians,” he mentioned.
5 days in the past
Erin Woo
Theranos gadgets failed so continuously that it raised questions in regards to the accuracy of the outcomes, Rosendorff testifies. Efficiency of Theranos assays was worse than non-Theranos analyzers.
5 days in the past
Erin Woo
Rosendorff is now discussing high quality management. As we realized in Cheung’s testimony, high quality management occurred as soon as a day, and machines can be recalibrated in the event that they failed. This was a frequent dialogue subject at Theranos, he testifies.
5 days in the past
Erin Woo
Rosendorff had a gathering w Holmes the place he expressed his issues. She was very nervous and was not her regular composed self, he mentioned: She was trembling, knee was shaking, she was very upset.
5 days in the past
Erin Woo
In an electronic mail to Holmes, Rosendorff wrote that “A couple of extra weeks to kind by way of these medical and logistical points, and getting the correct stage of coaching and staffing would assist us tremendously.”nd staffing would assist us tremendously.”
5 days in the past
Erin Woo
An electronic mail from Rose Edmonds from 9 days earlier than the launch says “none of our assays are fully by way of validation together with medical pattern testing with fingerstick.” Underneath CLIA legislation, the checks must be validated correctly earlier than they can be utilized for affected person care.
5 days in the past
Erin Woo
Main as much as Sept 2013 business launch, there was “a variety of nervousness” in regards to the appropriateness of utilizing modified checks for affected person care. The overall temper of the corporate was “very optimistic,” however some have been questioning why Theranos wasn’t utilizing its personal gadgets.
5 days in the past
Erin Woo
The downstairs Theranos lab, which contained the Theranos Edison gadgets, was known as Normandy, Rosendorff mentioned. In response to Rosendorff, Balwani known as the upstairs lab with typical gadgets Jurassic Park: Balwani “believed the traditional gadgets have been dinosaurs.”
5 days in the past
Erin Woo
Rosendorff beginning robust with why he stop Theranos, incl. unwillingness of administration to carry out proficiency testing and feeling pressured to vouch for checks he wasn’t assured in. Additionally: “The corporate was extra about PR and fundraising than affected person care.”
5 days in the past
Erin Woo
The federal government is looking former Theranos lab director Adam Rosendorff at this time within the trial of Elizabeth Holmes. Per prosecutor John Bostic, this testimony is prone to take all day.
7 days in the past
Erin Griffith
Mattis is finished and now a prosecutor is studying textual content messages between Holmes and Balwani whereas a forensics man from PWC says “sure” and “appropriate.” I suppose that is how they must current this proof however it’s actually actually weird.
7 days in the past
Erin Griffith
On redirect: Why did Mattis initially help Holmes after the WSJ expose after which change his thoughts? There have been too many surprises, he mentioned. “We have been unable to assist her on the basic points that she was grappling with if we solely noticed them within the rearview mirror.”
7 days in the past
Erin Griffith
We have a look at Mattis’ emailed response to Holmes after the WSJ article. “Be swift in response with unassailable fact,” he wrote. “I’ve full religion in our plan.”
7 days in the past
Erin Griffith
He additionally asks if Mattis knew Theranos was doing blood checks in a central lab.
Mattis: “I assumed the central Theranos lab was the Theranos machine.”
7 days in the past
Erin Griffith
In cross-exam, Holmes lawyer Kevin Downey requested Gen. Mattis about his {qualifications} to guage Theranos’s know-how and be a board director.
7 days in the past
Erin Griffith
Initially Mattis thought the issue was fixable — the corporate merely tousled its messaging and will come clear. Quickly after, he started to query whether or not or not the Edison machine labored. “There simply got here some extent once I didn’t know what to consider about Theranos anymore.”
7 days in the past
Erin Griffith
After WSJ article, board members emailed Holmes in regards to the allegations. Her response: Theranos was transitioning from working below one laboratory framework to a different. Mattis: “I used to be nonetheless confused.” At a minimal, “we had a popularity drawback right here and an integrity drawback.”
7 days in the past
Erin Griffith
Ominous. After Theranos realized a couple of 2015 WSJ article by John Carreyrou that uncovered issues with Theranos’s know-how, there was a board assembly with a slide titled “Responsibility of Loyalty.” We’re proven that slide, besides it’s comically redacted — all content material blacked out — and Mattis doesn’t bear in mind it.
7 days in the past
Erin Griffith
We see an electronic mail from Holmes instructing Mattis that, in an interview with Ken Auletta of The New Yorker, he can’t focus on “how our know-how works (i.e. that there’s a single system that does all checks)”
7 days in the past
Erin Griffith
Fortune printed a protracted correction to that article, which I don’t bear in mind seeing from a variety of different shops that wrote constructive tales. Parloff is listed as a witness and protection is trying to compel him to show over his notes.
7 days in the past
Erin Griffith
Assistant U.S. legal professional John Bostic pulls up Fortune’s 2014 cowl story about Theranos. Mattis spoke to the reporter, Roger Parloff, and mentioned Holmes gave him steering on what he might and couldn’t say.
7 days in the past
Erin Griffith
Nonetheless making an attempt to coach my mind to not hear “amino acid” each time they are saying “immunoassay”
7 days in the past
Erin Griffith
Theranos obtained a variety of mileage out of a 2013 WSJ article! We see an electronic mail the place Holmes sends Mattis the hyperlink, in addition to a slide of it in a Theranos board presentation
7 days in the past
Erin Griffith
We’re going by way of this board presentation, which has a slide claiming Theranos’s tech had been validated by 10 of the 15 largest pharmaceutical corporations, alongside logos of FDA & WHO and a quote from Johns Hopkins.
7 days in the past
Erin Griffith
What have been your sources for details about the corporate? Mattis: “Ms. Holmes.” “Was she the first supply?” “The only real supply.”
7 days in the past
Erin Griffith
Mattis additionally invested $85k into Theranos, which he mentioned was a major sum “for somebody who had been in govt. service for 40 years.”
7 days in the past
Erin Griffith
Did you settle for Ms. Holmes’s invitation to hitch Theranos’s board? “Sure I did, after asking why. I used to be not a medical individual.” She mentioned she wished his mgmt. and organizational expertise.
7 days in the past
Erin Griffith
Mattis testified that he was not conscious of Theranos gadgets ever getting used on battlefields, navy helicopters, clandestine operations…
7 days in the past
Erin Griffith
Mattis testified that Holmes was “very aggressive” at wanting the navy pilot program to get going. “She was very assured that if we obtained it in there, it could show itself.” He knew it was a start-up, however famous that Holmes had been engaged on it for a decade by 2013.
7 days in the past
Erin Griffith
oy, one other electronic mail the place Mattis calls Holmes “younger Elizabeth.”
7 days in the past
Erin Griffith
Holmes was the one telling him in regards to the Theranos system’s capabilities, he mentioned. “I used to be frankly amazed at what was doable.” However he added: “That didn’t take the place of getting the system show itself.”
7 days in the past
Erin Griffith
Mattis testified the scale of the Theranos system and its promised capabilities made it so enticing to potential navy use. Accuracy and reliability have been vital given the casualties, he mentioned. “The stakes are very excessive.”
7 days in the past
Erin Griffith
In a single electronic mail, Mattis informed Holmes he desires to discover a pilot challenge to check Theranos machines alongside the military’s present techniques to match. Mattis testified that he was very “taken” by the probabilities of utilizing a drop of blood for diagnostics.
7 days in the past
Erin Griffith
Mattis, a U.S. common and former secretary of protection, was on Theranos’s board between 2013 and 2016.
We begin by 2011 emails between them after assembly. In a single, Mattis writes, “thanks in your notice, younger Elizabeth, and I want you each success.”
7 days in the past
Erin Griffith
On the courthouse for US v. Holmes. James Mattis has taken the stand.
8 days in the past
Erin Griffith
Gould’s testimony lasted round quarter-hour – From behind a transparent masks, she obtained emotional discussing her expertise discovering out by way of Theranos checks that, after three miscarriages, her fourth being pregnant was not viable. The completely happy ending is that it was. She had a child. Adjourned!
8 days in the past
Erin Griffith
Protection wraps up by mentioning that Zachman’s observe had many many take a look at outcomes from Theranos past Ms. Gould that gave the impression to be positive. Choose Davila is raring to maintain going, despite the fact that we’re over on time at this time. Brittany Gould takes the stand.
8 days in the past
Erin Griffith
Protection works to chip away on the testimony by implying that the Theranos take a look at outcomes merely existed on a distinct scale and may have been “rebaselined.” Additionally famous that Holmes’s brother Christian, who responded to Zachman’s criticism in regards to the outcomes, apologized.
8 days in the past
Erin Griffith
Oh my, Theranos provided Zachman a “corrected” model of the outcomes which merely eliminated a decimal level however the she says numbers nonetheless wouldn’t have made sense throughout the context of a viable being pregnant or a lack of one.
8 days in the past
Erin Griffith
“This circumstance was very impactful to me because it stood out as such a pink flag for the being pregnant.”
8 days in the past
Erin Griffith
Gould took 5 blood checks, 3 from a subsidiary of Quest Diagnostics and a couple of from Theranos. She went on a rollercoaster, with the Quest take a look at exhibiting she was pregnant, the 2 Theranos checks exhibiting a miscarriage, and a couple of extra Quest checks exhibiting she was certainly nonetheless pregnant.
8 days in the past
Erin Griffith
Zachman describes the case of a affected person named Brittany Gould (sp?) who had had 3 miscarriages. She got here to see Gould after a constructive at-home being pregnant take a look at “to determine that sure, she is pregnant and have a look at the well being of the being pregnant.”
8 days in the past
Erin Griffith
Zachman was on a committee that evaluated service suppliers and her observe adopted Theranos blood checks round 2014. Theranos even arrange a lab downstairs from one in every of her observe’s places of work, which Zachman mentioned was “very thrilling.”
8 days in the past
Erin Griffith
New witness: Audra Zachman, a nurse practitioner at an OB-GYN observe.
8 days in the past
Erin Griffith
I’ve loved chatting with a few of the trial-heads and and followers of justice who’ve proven as much as watch (supplied they are not moles :). Right now I met a retired paralegal who says he was on the Patty Hearst trial!!
8 days in the past
Erin Griffith
Redirect up. US Legal professional Robert Leach reminds jurors that when Gangakhedkar resigned from Theranos, she had issues in regards to the reliability of Theranos’s checks and mentioned them with Holmes.
8 days in the past
Erin Griffith
Extra unhealthy boss/good boss content material: We see an electronic mail Gangakhedkar despatched to Balwani defending how arduous her staff was working + an electronic mail she despatched to her staff praising their lengthy hours. She then resigned from Theranos and Holmes tried to get her to remain, providing break day.
8 days in the past
Erin Griffith
Protection beforehand confirmed that Holmes let Gangakhedkar go to India to see household, portray her as a sympathetic boss and Balwani because the aggressive one. “[Balwani’s] making an attempt to make you are feeling responsible that you just weren’t working?” “Sure” “You have been annoyed by that?” “Sure.”
8 days in the past
Erin Griffith
We’re nonetheless doing cross-examination of Gangakhedkar.
Wade exhibits an electronic mail from the previous Theranos president, Ramesh Balwani (who goes by Sunny), chastising the lab employees for not working as arduous as his software program staff, portray him because the one pushing unrealistically for overwork.
8 days in the past
Erin Griffith
Zachman will now provide professional testimony on deciphering HCG checks (a hormone used to determine being pregnant standing)
You count on HCG ranges to double each 48 hours or so in early being pregnant.
8 days in the past
Erin Griffith
Wade goes on a run of questions (peppered with “sure” responses by Gangakhedkar) arguing that the purpose of R&D is encountering points and setbacks and fixing them.
“In R&D generally you must fail earlier than you’ll be able to succeed proper?”
“Sure.”
8 days in the past
Erin Griffith
We see an electronic mail the place Holmes requested Gangakhedkar for some testing knowledge forward of a gathering with the DoD. Gangakhedkar emails that Vitamin D knowledge is not prepared and Holmes writes asking for knowledge on different checks. The purpose is, apparently, have a look at this instance of Holmes not doing fraud.
8 days in the past
Erin Griffith
The Protection technique re: Theranos lab issues appears to be: look, actual work was being accomplished; there have been processes in place that certain appeared rigorous; the very individuals mentioning issues additionally signed off on all of it.
8 days in the past
Erin Griffith
Up to now it’s principally a name and response, the place Wade describes work of Gangakhedkar + Theranos’s lab, and Gangakhedkar replies “sure.” “Have been you pleased with that work?” “Sure.” “And others on the firm have been completely happy about that work as properly?” “I feel so.”
8 days in the past
Erin Griffith
Again within the San Jose courtroom at this time for extra US v Holmes. Surekha Gangakhedkar, a scientist at Theranos, is again on the stand being cross-examined by Holmes’s lawyer Lance Wade.
12 days in the past
Erin Woo
With that, Choose Davila is ending Gangakhedkar’s testimony for the day and instructing jurors to not eat media content material in regards to the trial, as all the time. The trial will resume on Tuesday — Erin Griffith can be on the courthouse to deliver you reside updates.
12 days in the past
Erin Woo
We are actually onto cross-examination. Holmes’s lawyer is questioning her about G.S.Ok.’s examine of Theranos’s assays, mentioning that the examine promoted her work. “The Theranos system eliminates the necessity for a lab and supplied high quality knowledge,” the G.S.Ok. memo mentioned.
12 days in the past
Erin Woo
Regardless of having signed an N.D.A., Gangakhedkar printed out some paperwork and took them residence when she left Theranos. “I used to be apprehensive that I’d be blamed,” she testified.
12 days in the past
Erin Woo
Three days after the e-mail from Balwani, Gangakhedkar despatched Holmes her resignation electronic mail. She testified that she was “very careworn and sad and anxious” with the planning of the Walgreens launch.
12 days in the past
Erin Woo
In an electronic mail from Balwani to Gangakhedkar, with Holmes copied, Balwani mentioned the software program staff had been working till 3:07 a.m., however that the Edison blood-testing gadgets Gangakhedkar’s staff labored on have been “all sitting idle.” This was an instance of the strain they have been below, Gangakhedkar mentioned.
12 days in the past
Erin Woo
And, with that, Cheung has been dismissed. The federal government is looking Surekha Gangakhedkar now, a former Theranos staff supervisor.
12 days in the past
Erin Woo
The federal government is now asking questions on a doc that claims, amongst different issues, that Theranos’s gadgets “may be operated with minimal coaching” and that its outcomes have “precision and accuracy equal to conventional medical laboratory analyzers.” Neither is true, Cheung says.
12 days in the past
Erin Woo
Cheung mentioned they have been consistently having to recalibrate the machines, which made outcomes take 2-3 days fairly than the couple hours promised. “We had individuals sleeping within the automobile as a result of it was taking too lengthy,” she mentioned.
12 days in the past
Erin Woo
Cheung simply mentioned she “grew to become involved a couple of month in” with the vitamin D samples, in November of 2013. She was involved in regards to the efficiency of the checks and that they have been getting used on affected person samples.
12 days in the past
Erin Woo
Protection is finished with cross-examination, after exhibiting Cheung Theranos coverage paperwork she mentioned she’d by no means seen. The federal government is now asking questions once more for redirect.
12 days in the past
Erin Woo
Holmes’s lawyer is asking Cheung a variety of questions on high quality management checks that occurred on the Theranos gadgets. “There’s a recognition that some errors would occur and this was the coverage on learn how to take care of these errors,” he mentioned.
12 days in the past
Erin Woo
Erika Cheung is now taking the stand as cross-examination continues.
12 days in the past
Erin Woo
The replace you have all been ready for: The choose is STILL announcing it ther-AH-nos.
12 days in the past
Erin Woo
Within the courthouse now for an additional day of the Elizabeth Holmes trial. We’re anticipating to wrap up testimony at this time from Erika Cheung, one of many key whistleblowers within the case.
14 days in the past
Erin Griffith
That’s it for at this time.🩸💉⚖️
14 days in the past
Erin Griffith
Up to now the theme of the cross-exam of Cheung appears to be utilizing excruciatingly arcane particulars in regards to the processes and procedures of the Theranos lab to point out that its work was very difficult, involving numerous sensible, pedigreed individuals.
14 days in the past
Erin Griffith
Cheung testified that in conferences about high quality management failures, Theranos’s lab administrators ignored the obvious doable purpose for the failures: “The Edison gadgets didn’t work.”
14 days in the past
Erin Griffith
Trial gear alert: A reporter introduced their very own binoculars to see the displays on the TV screens.
14 days in the past
Erin Griffith
Erika Cheung is again on the stand.
She described Theranos’s observe of demoing blood checks for V.I.P.s, the place a few of the outcomes got here from Theranos machines and others from Siemens analyzers.
14 days in the past
Erin Griffith
At this level we’ve got heard legal professionals and witnesses pronounce “Theranos” tons of of occasions, making me begin to wonder if choose is making an attempt to mess with us by sticking to his “ther-AHHHHH-nos” pronunciation.
14 days in the past
Erin Griffith
I ought to notice the girl who clapped and yelled “you’re an excellent mother!” at Holmes yesterday abruptly stormed out of the courtroom after Choose Davila warned everybody that yelling stuff like that in entrance of any jurors might trigger a mistrial. I don’t see her right here at this time!
14 days in the past
Erin Griffith
Elizabeth Holmes’s entourage is down to simply her mother at this time.