The Theranos Trials, ch. 3: Sunny and Elizabeth were in it together, all the way

March 23, 2022 | by

“Partners in everything, including their crimes” was part of the prosecution’s opening statement in today’s start of Ramesh ‘Sunny’ Balwani’s trial. Delayed by a week by a Covid-19 exposure, the former chief operating officer of Theranos is on trial for the same charges as Elizabeth Holmes–10 counts of wire fraud and two counts of conspiracy to commit wire fraud. Their trials were severed when her defense charged him with emotional abuse. The trial is taking place in the same US District Court in San Jose, with Judge Edward Davila and with the same prosecution team, for the next 12 weeks.

Prosecutor Robert Leach brought Holmes into the picture repeatedly with their personal and professional partnership, adding that while Balwani “skewed the medical decisions patients were making and put them at risk”, he laid the financial and technical fakery at both their feet. “The defendant and Holmes knew the rosy falsehoods that they were telling investors were contrary to the reality within Theranos.”  Leach also contended that Balwani had absolutely no background in healthcare technology and was unqualified to lead the company.

His defense, which is led by Stephen Cazares of Orrick–a former Federal prosecutor and enforcement attorney at the SEC–contends that Balwani was not a founder, nor a controlling executive, or had final decision-making authority–Holmes was. If anything, Balwani was blinded by his belief in the technology, to the extent of putting up his own $10 million to guarantee a loan for Theranos before investing another $5 million for a stake in the company. And others, such as Safeway and Walgreens, had reviewed and invested in Theranos. Like Holmes, he never cashed in his stake.

A new piece of the defense is quoted from the very thorough article in tech website Protocol: “…the government was to blame for not doing its due diligence. Theranos handed over a hard drive to the Department of Justice with encrypted test data for more than 9 million Theranos patients back in 2018. The DOJ didn’t analyze that database, and therefore, Cazares argued, the government cannot definitively say how well or not well Theranos’ technology worked.” It’s an interesting limb but given the Holmes convictions, feels to this Editor like one that’s easily sawed off.

The first witness called was Erika Cheung, the Theranos lab associate who became a whistleblower. Court ended before she got to any statements, but in the Holmes trial she stated the Edison lab results were about as accurate as a coin toss, which was devastating. More to come through Thursday. The Guardian, NBC Bay Area, and Mercury News (annoyingly paywalled).

Theranos, The Trial of Elizabeth Holmes, ch. 10: Holmes testifies about the salad days of Theranos, setting up cognitive dissonance

November 23, 2021 | by

Setting up a defense of cognitive dissonance. Today, in a brief appearance in Federal District Court in San Jose, Elizabeth Holmes returned to the stand to testify in her defense after a start last Friday. Her attorney Kevin Downey walked her through Theranos’ salad days, when the labs were numbered 1.0, cartridges stuck together, and the drug company studies were preliminary. Returning to her deep voice according to reports, she recalled Theranos’ Completed Successes, circa 2009, as many, and the performance as “really good.”

But 2009 was before the fraud with investors really got going. The falsifying of reports from Pfizer and Schering-Plough, for instance, was later. But every single drug company approached for the preliminary studies in those early days, including AstraZeneca at London’s Royal Marsden Hospital, never followed through with Theranos for more, such as a clinical trial or advanced study. Whether Holmes knew from an employee that Constance Cullen of Schering-Plough was less than enthusiastic about Theranos and found Holmes ‘cagey’ is beside the point, when the company later forged the Schering-Plough logo on a report to make it look as if Schering found Theranos’ labs acceptable. Downey took some care with Holmes not to introduce the later forgeries. Yet she was nothing if not persistent with other companies. Holmes pursued a partnership with Pfizer as late as 2015, in conjunction with Walgreens’ Theranos locations as clinical trial sites. 

She also testified that the series 4 lab could run any test, despite testimony from her last lab director Kingshun Das, MD that the series 3 could run perhaps a dozen at best and not reliably, leading him to void all tests made in 2014 and 2015. Earlier testimony stated that the series 4 never ran tests on patients.

Holmes’ testimony will continue tomorrow. Then the courts will be in recess for the Thanksgiving holiday until the 29th, which is when the prosecution will have its turn to cross-examine.

“Trying your hardest and coming up short is not a crime,” Lance Wade, another of Holmes’ many attorneys, said during opening arguments. But Holmes has already admitted to a repeated fraudulent claim of legitimacy–having the Department of Defense as a customer where the labs were on medevacs and the battlefield. But if the defense can introduce enough reasonable doubt, also known as cognitive dissonance or plain confusion, about Holmes and her ‘long con’ in the minds of the jury–that she was an entrepreneur with a dream just ‘trying harder’ and she didn’t know or mean to defraud investors as the prosecution claims but caught up in pursuing her noble aims–and add to that mind control by Sunny Balwani, Holmes does not have to be innocent to, as they say downtown, skate. CNBC, The Verge, FT, Mercury News (paywalled)

TTA’s earlier coverage: Chapter 9, Chapter 8, Chapter 7, Chapter 6, Chapter 5, Chapter 4 (w/comment from Malcolm Fisk), Chapter 3, Chapter 2, Chapter 1

The Theranos Story, ch. 40: investor fraud revealed in equipment, fake demos, testing

April 25, 2017 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2017/04/The-big-dig.jpg” thumb_width=”150″ /]Theranos’ ‘Big Dig’ is larger than this German art installation representing a Hole to China. It was as smooth as the turf depicted. Set up some shell companies, buy equipment from Siemens, modify it to take the mini-samples for the Theranos Edison mini-lab–and run their customers’ blood tests on them. Get incentives from a credulous Arizona governor and legislature. Run fake tests for investors on this equipment. Promise $1 bn in 2014 gross profits. Then, when it all comes undone, tell the investors to take additional equity shares and not to sue, or else it’s Chapter 11. Oh yes, and settle with Arizona for nearly $5 million and CMS for $30,000 [Ch. 39].

The latest reveal in the Theranos Saga took place in busy Delaware Chancery Court in a lawsuit brought by investor Partner Fund Management (PFM) LP and two other associated funds, which invested over $96 million in 2014. The unsealed documents, part of the follow-up to a lawsuit originally filed in October 2016 [Ch. 21] and another filed this month to block the equity offer to investors, contain depositions from 22 former employees and (hold the presses) directors. The (paywalled) Wall Street Journal article revealed that Theranos bought commercial blood testing lab equipment from reputable companies including Siemens, modified them to take the miniature samples that Theranos collected, used them to conduct both customer testing and from the filing, “fake ‘demonstrations tests’ for prospective investors and business partners”. Theranos used a shell company, Protegic Procurement Company, to make the purchases. Former director Adm. Gary Roughead, USN (Ret.), was quoted as being unaware of the fact that there were “extensive commercial analyzers in use.”

Now it is not uncommon for competitors’ equipment to be used for reference purposes and testing, especially when the company still is in process for their regulatory approvals. However, the lawsuit claims that customer tests were run on these labs, and not for a limited time as Theranos claims. The demonstration test claims are even more damning as they show fraudulent intent to investors.

The other part of the PFM lawsuit alleges that Theranos investors, including them, were pressured to not sue and take the additional equity deal [Ch. 38] by an attorney representing Theranos, who suggested that the alternative was to seek Chapter 11 bankruptcy protection. “Theranos officials engineered the share offer in a way that would make it impossible for the funds to obtain “any recovery” as part of its bankruptcy filing.” The PFM filing to block was successful. On April 11, Theranos was stopped from going forward with the share-exchange plan, with that hearing scheduled for June 26, not ideal for a company which is buying time before the money runs out. Bloomberg

The ‘cherry on the fraud cake’ is Theranos’ wildly inflated projection of a $1 billion gross profit in 2014. Theranos, of course, states that “The suit is without merit, the assertions are baseless, and the plaintiff is engaging in revisionist history.” Is ‘fake news’ the next claim? Ars Technica, TechCrunch, Fortune, Engadget.

Rest assured that there are many other chapters to come, as the lawsuits continue, including one for $140 million by Walgreens Boots, and the Colman/Taubman-Dye suit in California. Our Theranos and related articles are indexed here.

The Theranos Story, ch. 37: the Object Lessons for future healthcare entrepreneurs

February 22, 2017 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]There’s an interesting take on the Theranos debacle in Entrepreneur by management consultant/author Steve Tobak. He takes a step back from the healthcare technology that didn’t work, the big money lost and the puffery, where most of us have concentrated. Mr Tobak instead sketches a case study of a Startup House of Cards as an Object Lesson in how entrepreneurialism is NOT supposed to work.

Theranos was a Top Ten List of fatal errors. This Editor’s summary:

  1. They generated no revenue. In just over a decade, Theranos blew through hundreds of millions in funding (he says $700 million, the WSJ has estimated $900 million).
  2. They weren’t anywhere near break-even. By the time Theranos was in 40 Walgreens Wellness Centers, it should have been on a road to break-even and scalable.
  3. The company was built as a fraud from the start or near-start, much like Enron and WorldCom
  4. The company was doomed by a culture of utter secrecy (Editor’s note: none of their technology was peer reviewed, tested or published)
  5. The company was doomed by Ms Holmes’ falsity and hubris in not having a backup plan; black turtlenecks aren’t it
  6. The company was doomed by its own hype: a PR machine AND gullible press, who created a Steve Jobs-esque icon sans accomplishments out of Ms Holmes
  7. The company sold a bill of goods to EVERYONE, including multiple Federal regulators, patients and the public (Editor’s note: he doesn’t mention the Board of Directors and Stanford University!)
  8. Investors, swept up in the private equity bubble, didn’t do their due diligence (though some did)
  9. Ms Holmes had no ability to run this business, but she controlled it 100 percent so no one said boo
  10. “This is what happens when people treat ventures so casually and callously that risk becomes immaterial.”–Mr Tobak

Perhaps we should be grateful that the Edison lab didn’t actually work with all these dysfunctions on parade!

The close to this article is sobering: “Today, there are 186 venture-backed startups valued at $1 billion or more and countless companies valued above $100 million, according to CB Insights. Not too long ago, Theranos was near the top of that unicorn list with a valuation of $9 billion. We still have no idea if it’s a one-off or the beginning of a trend. Remember the Theranos saga as a cautionary tale. Nothing about it is the way business should be. Nothing.” And it will continue, because $900 million makes Theranos a Big Cautionary Tale. Hat tip to our Eye on Theranos, Bill Oravecz of Stone Health Innovations.

See here for the 36 previous TTA chapters in this Continuing, Consistently Amazing Saga

The Theranos Story, ch. 32: 155 employees out in latest layoffs, 220 left to go

January 9, 2017 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/Yak_52__G-CBSS_FLAT_SPIN.jpg” thumb_width=”150″ /]Endlessly, flatly spinning, towards Ground Zero…. As a marketing person made redundant (US=laid off) for various reasons by companies (moving out of area, acquisition, dissolution, etc.), this Editor has zero joy in reporting that 155 Theranos employees will be discharged as it “re-engineers its operations” “towards commercialization of the miniLab testing platform and its related technologies” “aligned to meet product development, regulatory and commercial milestones.” Their Friday press release successfully buried itself on a weekend, aided by a tragic Heaping Helping of Bad News out of Fort Lauderdale. The rationale is that this is justified to better position itself to commercialize the miniLab and “related technologies”. The miniLab reportedly is a compact, microwave-sized lab that automates small volume samples by sending them for analysis to a central server which would do the full analysis, thus driving down cost and time.

Theranos is a company flailing. This Editor notes in its string of releases an endless emphasis on compliance, regulation and operational expertise, the kind of attitude and caution that should have been present years ago. The layoffs follow on last October’s involuntary exits of 340 employees and lab closings (Chapter 21). Run the numbers and there are 220 employees left to go. Will the miniLab, seemingly hastily concocted, be their salvation? Flip back to our Chapter 18 about the October AACC meeting.  Chemical laboratory professionals were distinctly underwhelmed by the miniLab and CEO Elizabeth Holmes’ presentation. Also not boding well was Theranos’ withdrawal of a miniLab Zika test FDA emergency clearance in late August, at the height of the crisis. What may be wafting is the aroma of performing seals on a hot day.

Speaking of leadership, is Ms Holmes among the fired or demoted? Highly unlikely as she controls all $9 of the company’s formerly $9 bn Unicorn Worth. Is she even taking a pay cut? Will you see her out in front of Palo Alto HQ mowing the long grass?

To nearly 500 people now wondering about their livelihood in one of the most expensive areas of the US, how damaged they will be by their association with Theranos? Despite the ‘fail fast’ mantra of Silicon Valley, there’s little tolerance by employers for those at the operational level having a failed company in their past. These people should have our empathy, not ‘guilt by association’, and as appropriate, respect for their skills which were badly used in their last situation.

One also wonders how long it will take before there is another Chapter in The Theranos Story, one that they will file via one of their multitudinous law firms–Chapter 11. Consumerist (Consumer Reports), Yahoo News.

See here for the 31 previous TTA chapters in this Continuing, Consistently Amazing Saga, including the resignation of General Mattis from the BOD (Ch. 31), Theranos’ annus horribilis (Ch. 30) and the law firm feeding frenzy (Ch. 29).

The Theranos Story, ch. 21: the denouement of tears, fears and lawsuits

October 12, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/11/upside-down-duck.jpg” thumb_width=”150″ /]Finally, Theranos sinks its labs, Wellness Centers…and 340 employees. Since founder/CEO/controlling shareholder Elizabeth Holmes has been banned by CMS from running any labs for the next two years, shutting ’em down makes total sense in terms of saving her job. (Of course, if you are one of those fired employees in Arizona, California or Pennsylvania, it doesn’t. But hey, you may be worth more than Ms Holmes!) What she’s betting what is left of the company on is the miniLab, which hasn’t exactly come heartily out of the gate. It was Gimlet Eyed at the AACC annual meeting in Philadelphia, then shortly thereafter she withdrew from FDA review a Zika test using the miniLab due to lack of a patient-safety protocol approved by an institutional review board. (Tsk, tsk–Ed.)

Now the news of a lawsuit by a major investor will, in its process, reveal more of the Bubble That Was Theranos and possibly put the banana peel under the pivot. Investors sank over $800 million into the company, and one of them, Partner Fund Management, wants its $96 million back like Lee Marvin as Walker in Point Blank. According to the Wall Street Journal, which originally wielded the needle, the charges are that they and other funds were lured in by fraudulent claims and various misrepresentations of the Edison technology and its effectiveness–in other words, that they had labs and tests that actually worked. The SEC continues to investigate, including subpoenaing Partner and possibly other investors.  ABC News, Wall Street Journal (search on title ‘Major Investor Sues Theranos’ if you hit the paywall), Gizmodo 30 Aug, 11 Oct (a wonderfully Gimlety take by Eve Peyser), and a series of acid flashbacks in Forbes

See here for the 20 previous TTA chapters.