Week-end update: Breaking–Theranos lab director suing Hulu, Disney for defamation; ‘green shoots’ for SonderMind, Cognito, Vital, MedArrive; 3 in Asia; Telstra Australia’s new CTO

Key Theranos prosecution witness suing Disney and Hulu for misrepresentation and defamation. It’s not only the FTC but also Adam Rosendorff, MD, the former lab director for Theranos who quit in late 2014, who is fighting against misrepresentation, in this case a fictionalized portrayal of the lab director character. l’affaire Theranos was lightly fictionalized in the docudrama ‘The Dropout” that ran on Hulu in 2022. Dr. Rosendorff is suing both Hulu, its corporate parent, Disney, plus other listed producers, in a New York State Supreme Court lawsuit (link and PDF) for defamation. The summons was filed in New York County (Manhattan) Thursday.

While his name was not used, the lab director named ‘Mark Roessler’ in “The Dropout” was portrayed, according to the summons, as unethical and unfit. He was “shown as covering up Theranos’ fraudulent scheme, thereby endangering patients’ lives … and as otherwise unfit to practice medicine,” “falsely portrayed as a perjurer, a criminal, and of being completely unfit to practice his profession.” In the docudrama, Roessler orders the destruction of damaging lab results, falsifies records, and engages in dishonest behavior. The reality was that Dr. Rosendorff testified against both Elizabeth Holmes and Sunny Balwani in their trials as an invaluable prosecution witness, detailing the failures of the lab tests in his testimony and affidavits [TTA 1 Oct and 6 Oct 2021]. He quit Theranos on these issues and more after 18 months when Holmes and Balwani refused to correct them. “Both the media and defendants’ reckless disregard is sufficient evidence of the malice which a public figure must show to establish claims for defamation.”

Being a whistleblower ain’t for sissies. Being tagged as part of Theranos’ demise and years in endless legal proceedings broke him professionally and fractured him mentally, as revealed after Holmes’ conviction. It became grist for yet more defense appeals that failed [TTA 20 Oct, 26 Oct 2022]. Reuters, New York Post

A (remainder) sale, partnership, and funding roundup–a few green shoots of spring

SonderMind buys out the remains of Mindstrong. The deal is for the remainder of Mindstrong’s tech assets and about 20 related staff. Price was not disclosed. Mindstrong ceased operations as of 10 March and announced they would lay off 100+ employees including the CEO and CFO no later than 15 April according to their filed WARN notice. It raised over $160 million since 2014 including a $100 million Series C in 2020. SonderMind is also in virtual mental health, assessing potential patients, matching them with a therapist in their state, who will see the patient virtually or in-person. According to SonderMind, Mindstrong’s tech will add to personalized care journeys, clinical notes templates, and improved measurement-based services.  SonderMind has had its own series of layoffs, with a 15% cut late in 2022. The deflation of telemental health continues. Mobihealthnews, Digital Health Business & Technology

Neurotech company Cognito Therapeutics raised $73 million in a Series B. It was led by FoundersX Ventures, adding new investors Starbloom Capital, Alzheimer’s Drug Discovery Foundation, WS Investment Company, and IAG Capital. Total funding is now $93 million. Cognito has developed an external neuromodulation device for neurologically degenerative diseases. It uses sensory stimulation to evoke gamma oscillations, which are believed to play a part in memory operations. It is concentrating on improving cognition and memory in Alzheimer’s Disease early-to-mid-stage patients. Cognito is being investigated as part of the HOPE study for Alzheimer’s Disease.  It received FDA Breakthrough Device Designation in 2021 and has completed a Phase 2 trial. Mobihealthnews, Business Wire release

Vital, a patient experience software developer, raised $24.7 million in a Series B. The funding was led by Transformation Capital, with support from Threshold Ventures, strategic health system investors and Vital CEO/Mint.com creator Aaron Patzer. Total funding is now over $40 million. Vital provides real-time patient updates and messaging services for patients and families admitted to hospitals and EDs, as well as follow-ups such as appointments. Business Wire release

MedArrive, an in-home care provider, is partnering with Ouma Health, for maternal-fetal care of women on Medicaid coverage. MedArrive deploys a field provider network for in-home care including testing, assessments, SDOH, and extension of provider services. The technology includes a fully integrated care management platform. Ouma Health is a maternal-fetal telehealth service including behavioral health. Release

And some Asia-Pacific updates…

In Vietnam, online pharmacy Medigo received $2 million in Series A funding, led by East Ventures, with participation from Pavilion Capital and Touchstone Partners. Intellect, a telemental health startup based out of Singapore, received undisclosed funding from global healthcare provider IHH Healthcare for its regional expansion. In India, EHR startup DocPlix raised Rs 5 crore ($600,000) in a pre-series A funding round led by Eris Lifesciences. Mobihealthnews

In Australia, Telstra Health’s new CTO is Farhoud Salimi. He joins in April from eHealth NSW where he held the position of Executive Director, Service Delivery (CTO) among others in a 15-year tenure. Mr. Salimi replaces Russel Duncan, who retired at the end of last year. Telstra release, Mobihealthnews

10 reasons for a new trial? Elizabeth Holmes’ legal team files appeal, delay in prison start (updated)

Elizabeth Holmes and her legal team continue their campaign to keep her out of Federal prison. On 2 December, on the deadline from two weeks of sentencing but just made public, her three-page appeal was filed with the US Court of Appeals for the Ninth Circuit.  She has until 3 March to file legal briefs in the 9th Circuit Court of Appeals in California. In addition, her legal team has requested from Judge Edward Davila that she remain free until her appeal is concluded due to not being a flight risk, citing close family ties and pregnancy. Holmes was scheduled to report to Federal prison (still to be determined by the US Bureau of Prisons) on 27 April 2023.

The 10 reasons for a new trial are not fully enumerated in the SiliconValley.com article, but include purported errors by Judge Davila during the trial. These include allowing the jury to hear about regulatory action against Theranos and the company’s voiding of all test results from its Edison lab machines. The filing argues that those events took place after she made any “relevant” statements to investors. Another reason was the sudden visit by former lab director and key prosecution witness Dr. Adam Rosendorff to her home [TTA 26 Oct, 20 Oct]. Dr. Rosendorff reaffirmed in the court hearing that he testified truthfully and honestly, the visit took place during a moment of distress, and that he continued to believe that Holmes needed to pay her debt to society. 

Legal experts mostly agree that Holmes presents little to no flight risk, as she is known everywhere, and is no threat to her community. Where they are split on whether she will remain free during the full process of the appeal, which could be a year or even more. Appeals have low rates of success at the Federal level. To these observers, Judge Davila has been scrupulous–‘bent over backwards’–to be fair to both prosecution and defense during the trial. He has already heard and rejected defense arguments for new trials and acquittals. He did not permit the prosecution to run wild or overcharge either. The decision of another jury on COO Sunny Balwani on all 12 counts, the same as Holmes, also conducted by Judge Davila, may very well factor into an appeal to the judges, unfavorably for the defense. One wild card factor is that the jury convicted her on but four out of 11 counts (acquitting or deadlocking on the rest; Count 9 was dropped due to a prosecution error). The jury for her trial proved 1) difficult to select and 2) difficult to retain, going through three alternates of the five.

Still pending are monetary damages. Updated: checking Judge Davila’s calendar, this will take place after January as his calendar is filled.

It does look like Holmes may enjoy freedom through 2023–but her chances of reversing her conviction and going free are as small as that nanotainer she is modeling. FoxNews, Ars Technica

News updates: Theranos’ Holmes goes ‘mental’ in last ditch defense; troubled Cerebral telemental health fires another 400

Blood out of a rock? The Holmes’ defense goes ‘mental’ with Dr. Adam Rosendorff. Reduced to a limited hearing before Judge Edward Davila and the US District Court in San Jose, where Rosendorff not only reaffirmed his testimony but also explained the circumstances around his visit to the home, the Holmes defense filed a motion on Monday, citing an obscure interview published in September by the South African Jewish Report to cast doubt about the veracity and credibility of his testimony. Rosendorff, who was born in South Africa, recounted to the interviewer that the stress from blowing the whistle on Theranos led to a “breakdown, medication, hospitalization, and health problems.”

Rosendorff also stated in the interview that by the time the trials (Holmes and Balwani) were scheduled in early 2020, he was off medication. The trials finally took place in 2021 (Holmes) and this year. When questioned last week by defense lawyer Lance Wade about his mental state, his response was that “I’m finding this line of questioning to be invasive.” and that his “mental state was solid” when he drove to Holmes’ home wanting to speak with her. The prosecution objected to the questioning and Judge Davila upheld it.

The prosecution’s response to the defense filing is that the court record “contains no indication whatsoever that Dr. Rosendorff suffered from a mental health issue that affected his ability to serve as a reliable witness,” and that “newly raised and uncorroborated insinuations about Dr. Rosendorff’s mental health do not justify discounting his testimony or granting a new trial.”

The Mercury News’ money quote from New York defense lawyer Jennifer Kennedy Park: “I think the judge already made the decision that this is not relevant.” Another lawyer quoted, former Santa Clara County prosecutor Steven Clark, said that the stress can be difficult but that it apparently didn’t affect Rosendorff’s capacity to testify–and that he was consistent across two trials.

Unless Judge Davila decides to delay–not likely given the above and the pending sentencing for both Holmes and Balwani–or there are additional magic ‘rabbits out of hats’, Holmes’ sentencing remains scheduled for 18 November, Balwani’s later this year.

And speaking of mental health, beleaguered telemental health provider Cerebral let go of 400 more staff, or another 20% of their remaining workforce. This follows a layoff of ‘hundreds’ of contractors, including nurse practitioners who did counseling and support staff, at end of May. Cerebral is ‘restructuring’ under a new CEO, David Mou, who replaced CEO and co-founder Kyle Robertson  forced out by the Cerebral board after the first round of investigations by the Department of Justice (DOJ) on over-prescribing of controlled substances and the subsequent defection of CVS Health and Walmart, as well as Truepill on mail fulfillment. Their statement cites “operational efficiencies while prioritizing clinical quality and safety across the organization.” Cerebral had at its peak in the spring 4,500 employees.

In addition to the DOJ investigation, the FTC is investigating Cerebral for deceptive advertising [TTA 1 June] and a former VP of product and engineering, Matthew Truebe, is suing for wrongful dismissal, further exposing the inner workings of the company [TTA 16 June]. Employees have gone public with tales of pushing prescriptions to 95% of patients, disregarding state regulations, and generally Running Wild over any semblance of clinical probity [TTA 29 June]. Certainly Softbank cannot be delighted at the rolling crackup of their once-valued $4.8 billion baby for which they’ve led funding of over $426 million. TechCrunch, Healthcare Dive.

Theranos’ Holmes sentencing now 18 November, defense wants to expand hearing scope; Balwani can’t join in

Elizabeth Holmes will be receiving a limited hearing concerning The Mysterious Visit of Dr. Adam Rosendorff and her defense is attempting to expand the hearing. But Sunny Balwani won’t be joining in. The highlights of their recent District Court activities under Judge Edward Davila:

  • Holmes’ sentencing on her four counts has been reset to 18 November at 10am PT. This is despite the limited hearing on 17 October to determine whether Adam Rosendorff was really regretful about his testimony (as the Holmes defense maintains) and what he said and did. 
  • In a separate order, Judge Davila rejected Balwani’s defense move to join in the hearing. Rosendorff’s statements to Evans “related exclusively to his testimony during Ms. Holmes’ trial, not Mr. Balwani’s trial,” and provide “no basis for Mr. Balwani to examine” Rosendorff at the hearing.
  • In a filing, Rosendorff’s legal team asked Judge Davila to quash a subpoena sent by Holmes’ defense to obtain additional information from Rosendorff to use in next week’s hearing. “(Holmes) has sought to transform that limited inquiry into a free-for-all in which Dr. Rosendorff would be required to search through more than a year’s worth of sensitive emails, text messages, and other communications with family, friends, and others so that (Holmes) can try, yet again, to make him look like a liar.”
  • In that filing, the legal team also provided explanations of Dr. Rosendorff’s actions on that day. Driving around the area, he saw that the Theranos building had been torn down and a residential development complex built in its place, and the Palo Alto Walgreens where the first pilot took place had been replaced by a rug store. He wanted to “forgive her for the pain and suffering her actions have caused in his life” and to express his condolences on the child growing up without a mother. Unfortunately, he didn’t stop there on Memory Lane but took a drive up to the well-known location of her rental house, where recollections do differ and increased his tsuris as a result. 

Mercury News, Palo Alto Online

Catchup News Roundup: UHG-Change buy final; Theranos’ Holmes sentencing delayed, ‘limited hearing’ agreed to

Note: your Editor is on the mend after returning from vacation with a nasty bug that’s laid her low for the better part of a week.

UnitedHealth Group’s Optum unit completed its acquisition of Change Healthcare, after the 10-day agreed waiting period post-decision. As planned, Change will be folded into the OptumInsight unit. The all-cash deal was either $7.8 billion or $13 billion, depending on what source you go with [TTA 20 Sept].

The Department of Justice has a generous quantity of Grade A, Extra Large Egg on its metaphorical face. The District Court decision found that the DOJ did not conclusively prove its allegations of antitrust and loss of competition in services. Statements from UHG’s competitors such as Cigna, Aetna, and Elevance (Anthem) that the acquisition would not lead them to ‘stifle innovation’ also weakened the DOJ’s case. The major conflict, ClaimsXtend, was already in progress of divestiture to TPG.

Challenging acquisitions post-closing is difficult but has happened. Readers may recall the 2019 nine-month long District Court Tunney Act review drama over the final approval of the CVS buy of Aetna, dragging on long after the buy was final and reorganization was underway. If the Tunney Act applies, and this goes to a certain Judge Richard Leon, watch out!  Optum’s release did not disclose reorganization plans or management changes. Healthcare Dive, FierceHealthcare 

Elizabeth Holmes’ sentencing delayed to allow a ‘limited hearing’ on The Mysterious Visit of Adam Rosendorff.  The ‘crafty strategy’ [TTA 16 Sept] scored a win today (3 October). Judge Edward Davila accepted the defense’s request for a limited hearing on whether there was any prosecutorial misconduct in Dr. Rosendorff’s testimony and delayed Holmes’ sentencing originally scheduled for 17 October.

In August, according to Holmes’ partner Billy Evans, in a scene lifted out of TV’s Perry Mason, Dr. Rosendorff arrived at Holmes’ home doorstep disheveled and apologetic, allegedly telling Evans that the prosecution “made things sound worse than they were.” Yet Dr. Rosendorff swore a declaration to the prosecution after the Mysterious Visit that he testified “completely, accurately and truthfully” and stood by his testimony, while expressing “compassion” for her and her family. Rosendorff’s testimony was more about the Theranos labs and how they defrauded patients based on specious PR and inflated claims, not the investor fraud of which she was convicted. 

The limited hearing has been scheduled for 17 October (the original sentencing date). Judge Davila has already stated that the hearing will not last the full day. He also offered to both the prosecution and defense options for new sentencing dates: mid-November, early December, or mid-January. How this will affect Sunny Balwani’s upcoming sentencing on 12 counts is not known. Mercury News 

Elizabeth Holmes’ three swings and a miss in overturning her trial verdict reveal a crafty strategy

Putting off the inevitable? Elizabeth Holmes’ legal team in the past two weeks has filed a flurry of motions in US District Court to have her verdict thrown out prior to sentencing on Monday 17 October.

  • The filing on 1 September sought to have the verdict of guilty on four counts [TTA 4 Jan] tossed with no new trial. This was denied in a preliminary ruling by Judge Edward Davila, stating that the verdict by the jury was supported by the evidence. A final ruling is pending arguments by the defense and prosecution.
  • The three filings on Tuesday 6 and Wednesday 7 September seek to have Judge Davila rule, on the basis of new evidence, for a new trial.

According to the Mercury News, the first motion on Wednesday, which states that arguments presented in the Sunny Balwani trial could have acquitted her, has little chance of being successful and in fact may be counterproductive in annoying the judge in that case–also Judge Davila. The second motion filed has a better shot, including on appeal. It centers on the “Brady rule” that requires prosecutors to disclose and turn over information that could be helpful to the defense. This was the database of patient test results that the prosecution failed to preserve. It didn’t factor in the trial, but could in the expected appeal. 

The filing on Tuesday is straight out of an episode of Perry Mason. Holmes’ partner (and father of her one-year old son) Billy Evans declared that former Theranos lab director Dr. Adam Rosendorff showed up at the door of her home in a ‘desperate and disheveled’ state. In the declaration, Evans stated that “He said he wants to help her. He said he feels guilty. He said he felt like he had done something wrong. He tried to answer the questions honestly but that the prosecutors tried to make everybody (in the company) look bad” and that prosecutors “made things sound worse than they were.” Legal experts interviewed by the Mercury News believe it’s not the remorse, but the pressure prosecutors may have put on the witness. A hearing on this would be extensive and involve both prosecution and defense. Of course, this neglects that during the trial, the defense attempted to rip apart Dr. Rosendorff’s testimony as self-serving and essentially incompetent.

Net-net, Elizabeth Holmes has a best-money-can-buy legal strategy designed to delay her serving time, if not negate it, on the four of 12 counts on which she was convicted.  Mercury News 1 Sept, Mercury News 10 Sept  Adam Rosendorff’s testimony during trial summarized in Chapters 1 and 2

Theranos, The Trial of Elizabeth Holmes, ch. 2: the lab director’s contradictions, competence questioned

The grilling of former Theranos lab director Adam Rosendorff continued Tuesday, with the defense hammering Dr. Rosendorff about his activities there prior to his departure in August 2014, catching him on contradictions in his testimony, painting him as self-serving and, through his actions there and with later companies, essentially incompetent.

Lance Wade, the defense attorney handling today’s redirect, returned to Dr. Rosendorff’s testimony about the lower-than-normal HDL levels recorded by the Edison lab machine. Earlier, he had testified about his major issue with it, urging Ms. Holmes and COO Sunny Balwani to discontinue the test but got “pushback”. Using a long trail of emails, Mr. Wade continued what’s proving to be a theme at this trial–that the government is showing only limited information to witnesses and the jury, that Holmes and Balwani addressed problems, and that Dr. Rosendorff often used his own judgment to resolve problems without discussion with Holmes or Balwani. Dr. Rosendorff admitted, contradicting his earlier testimony, that Balwani and others “jumped” on the HDL readings right away, and that the real problem was with a Siemens machine.

Mr. Wade also got Rosendorff to admit that in a civil case, he testified that complaints about Theranos “weren’t more common than what usually sees in … some labs with high volume” and, even more specifically, that “I don’t think I had a greater number of tests that were anomalous that I had to review at Theranos than at other places I’ve been like University of Pittsburgh.”

Dr. Rosendorff, according to reports, kept commenting on his earlier testimony to reinforce that decisions made at Theranos were ‘not good solutions’, no matter what he believed or how he acted at the time. Mr. Wade tried to have these comments struck from the record, but Judge Davila ruled that both should move on.

Finally, Mr. Wade brought up as confirmation of Dr. Rosendorff’s incompetence his subsequent employment and termination at now out of business uBiome, charged with health fraud (but not fraudulent lab tests) but was not permitted to go beyond basic statements. He was permitted to ask about Dr. Rosendorff’s current employer, PerkinElmer, which has also violated CMS (Centers for Medicare & Medicaid Services) regulations by the same inspectors who audited Theranos, and which may cause the loss of his license for two years. NBCBayArea, CNBC, Ars Technica

(Editor’s note: unfortunately the Mercury News, Bloomberg, and WSJ coverage are heavily paywalled after one or two views. The WSJ focused on text messages between Holmes and Balwani, and the Mercury News added color coverage of Holmes’ lifestyle with Balwani and vegan diet.)

To be continued…

Theranos, The Trial of Elizabeth Holmes: ch. 1

“The company believed more about PR and fundraising than about patient care”, from Tuesday’s testimony by former lab director Adam Rosendorff, could be the prosecution’s strategy in the proverbial nutshell. Mr. Rosendorff, who quit in November 2014 after a long struggle to get Ms. Holmes and Theranos management to address persistent problems in patient lab results and to implement a legally required verification process, was a witness for the prosecution. The defense tried to paint his testimony in cross-examination as inconsistent and self-serving in accounts of Ms. Holmes’ state in hearing concerns about three particular blood tests, the launch date of public blood tests, proficiency tests versus ‘precision tests’, when the California Department of Public Health audited the lab, and exactly why he quit Theranos 18 months after hire. The questioning twice grew so heated that District Circuit Court Judge Edward Davila deemed it inappropriately argumentative. One example from Lance Wade to Mr. Rosendorff was that supervising quality control tests and making sure laws were followed was “why you get the big bucks, right?” “Not as big bucks as you get paid,” Mr. Rosendorff replied. Mr. Rosendorff did get caught up in an email trail and on narrowing the proficiency testing to FDA-approved devices versus the Edison labs. The cross and the bickering went on into Friday and probably will resume on Tuesday next week (@doratki).

Also on Tuesday was brief testimony from Celgene manager Victoria Sung, who drew a picture of more Theranos fabrications around how pharmaceutical companies (Celgene owned by Bristol Myers-Squibb) had not  “comprehensively validated” Theranos technology. 2012 results showed that Theranos labs performed “out of range” versus standard tests, and other tests were not run. Last week, Theranos employee Surekha Gangakhedkar in her testimony stated that she did not think GSK’s report validated Theranos’ tests. Mercury News, The Verge

Today, John Carreyrou, who broke la scandale Theranos in The Wall Street Journal and authored the book Bad Blood, filed a motion to stop being barred from court. Cleverly, La Holmes’ defense put him on the witness list but not subpoenaed him. Being on the witness list, however, means he cannot attend any part of the trial or publicly discuss his testimony, if given, without permission from Judge Davila. “Placing Carreyrou on the witness list was done in bad faith and was designed to harass him,” the motion claimed, calling his placement on the list “a cynical ruse” that violates the First Amendment. Also cited in the motion were the company chant about him and various text messages between Ms. Holmes and Sunny Balwani. Mercury News  Mr. Carreyrou and six years before the Theranos mast, interviewed in The Verge in an interview that diverges fascinatingly into the psychiatric drives of the players….

And earlier in September (Wednesday 22nd), General James Mattis, Ret. testified about how he initially wanted to pilot the Theranos labs on ships and remote locations, where space and swiftness are at a premium. The Verge article does take liberties in the psychology between the two (bachelor general, young female CEO), including his joining the board after retirement, sticking around despite his growing doubts until he was named secretary of defense in 2016. The defense drew out that he was confused about his compensation package ($150,000 per year plus a stock option purchase).

The Mercury News (which has a minimum of free articles before the paywall goes up, the WSJ (paywalled), local TV KRON4, The Verge, and CNBC have been covering the past weeks of the trial. Dorothy Atkins of @Law360 is also tweeting in real time on it (@doratki).

To be continued….