A Complete Timeline Of The Theranos And Elizabeth Holmes Scandal

At 19 years old, Holmes dropped out of Stanford to found Theranos, called Real-Time Cures at its inception. Holmes cited her grandfather’s medical background as well as her internship at the Genome Institute of Singapore as her inspiration.

Her parents allowed her to use the money they set aside for her college tuition to fund Theranos.

Holmes received her first profile in Inc. magazine’s 2006 “30 Under 30” feature, though she wouldn’t gain widespread notoriety for several years. In 2014, Holmes would be included in Forbes‘s “40 Under 40” and appear on the cover of Fortune magazine – which would catapult her into the limelight.

In a 2010 filing with the US Securities and Exchange Commission, Theranos announced it had raised $45 million in one funding round by selling equity and securities in the company. Since its creation in 2003 to the filing in 2010, Theranos had raised $70 million.

Pharmacy chain Walgreens elected to partner with Theranos in 2013, eventually opening wellness centers in 40 Arizona Walgreens locations. The centers featured the health tech company’s blood-testing equipment, which provided affordable, allegedly tell-all blood tests to customers.

Both Walgreens and Theranos came under scrutiny when the pharmaceutical company installed the Arizona blood-testing centers without properly validating Theranos’s technology.

In 2014, Holmes began receiving coverage from major news and business outlets. Publications like Fortune and The New Yorker wrote profiles pieces on her, and both Fortune and Business Insider placed her on their respective “40 Under 40” lists.

In 2014, Fortune reported Theranos had raised over $400 million in equity sales, and investors valued the company at $9 billion. At the time, Holmes said she still owned 50% of Theranos’s stock.

John P.A. Ioannidis, a professor with the Stanford School of Medicine, published an editorial in The Journal of the American Medical Association excoriating Theranos for its secrecy. Ioannidis noted that, although Theranos received coverage from major publications such as The Wall Street Journal, Business Insider, and Silicon Valley Business Journal, the company hadn’t published any “peer-reviewed biomedical literature.”

Holmes countered the criticism by claiming the company operated privately to protect its technology from competitors.

In 2015, the FDA approved Theranos’s test for the herpes simplex virus 1 infection. Though Theranos had received criticism for its secrecy, the FDA’s approval lent the company legitimacy. A Theranos press release extended the approval of one blood test to an endorsement of the company’s technology in its entirety:

[The FDA’s approval] provides independent validation of Theranos’s patented finger stick and… blood testing technology and the groundbreaking Theranos System upon which the [herpes] test is run.

A 2015 front-page report from The Wall Street Journal accused Theranos of performing only 15 to 20 of their over 200 advertised finger-stick blood tests with the Theranos device – the rest were performed on commonly used machines, such as the Siemens AG. Additionally, the blood placed into the Siemens machines was diluted from a finger stick, which likely provided inaccurate results.

Theranos responded by firmly denying the allegations:

[The story is] factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents… We are disappointed that… this reporter relied only on the views of four “anonymous” disgruntled former employees, competitors, and their allies, instead of reaching out to many of the scientific, health care, and business leaders who have actually seen, tested, used, and examined our breakthrough technologies.

In October 2015, just over ten days after the FDA announced it was investigating Theranos’s nanotainer technology, they released a report in which they referred to the nanotainer as an “uncleared medical device.”

Theranos shipped the nanotainer under Class I, a low-risk class subject to little federal scrutiny. The FDA stated the technology should have been shipped under a class subject to more stringent federal regulations.

Theranos and Safeway – an American supermarket chain – entered into a $350 million agreement, but it dissolved when executives raised concerns about the accuracy of Theranos’s testing. One executive received erroneous results indicating that he had prostate cancer.

Theranos called The Wall Street Journal‘s reporting on the matter inaccurate and defamatory.

Federal regulator Centers for Medicare & Medicaid Services (CMS) released a report announcing Theranos was in violation of multiple clinical standards. The report surfaced after CMS performed an inspection at the company’s labs in Newark, CA.

One violation involving testing for blood cell counts raised serious allegations that the company was endangering patient safety. Theranos claimed the California lab CMS investigated had conducted only 10% of the company’s blood tests, while their Arizona lab was responsible for more extensive testing.

A 121-page report released by federal regulators announced quality-control issues that may have endangered the safety of patients who used Theranos’s technology. Among the allegations was the claim that the company stored blood samples at unsafe temperatures and failed to properly train their employees in testing procedures.

The most troubling assertion in the federal report was that Theranos’s test results failed to meet quality-control standards. The company was sending inaccurate test results specifically for the blood thinner Warfarin, which can cause internal bleeding or increased risk of stroke depending on the amount taken.

In a letter to Theranos’s partners in April 2016, the company announced the Justice Department and the Securities and Exchange Commission (SEC) had launched an investigation into their practices. Though Theranos submitted a plan for correcting the violations flagged by CMS in January 2016, federal regulators claimed they didn’t “constitute a credible allegation of compliance and acceptable evidence of correction for the deficiencies cited.”

Holmes said, “I feel devastated that we did not catch and fix these issues faster,” and that she planned to “rebuild [the] entire laboratory from scratch” to avoid such issues in the future.

In May 2016, Ramesh “Sunny” Balwani stepped down as the president of Theranos. Inside sources claimed, however, that Balwani was fired by Holmes. The pair had been involved in a covert relationship since 2002.

The company promised to restructure and form a Technology and Clinical Operations division after they were investigated by federal regulatory committees. Theranos also announced upon Balwani’s departure that they were adding three new members to their board of directors.

In June 2016, after Theranos halted operations as they were being investigated by a number of federal agencies, Forbes lowered Holmes’s estimated worth to $0. The publication had previously valued her at $4.5 billion and placed her on a list of America’s Richest Self-Made Women.

Forbes acknowledged their calculations were based on Holmes’s 50% share in Theranos, which was projected to make $9 billion; by 2016, however, the company was only making $100 million annually.

Walgreens announced in June 2016 that they were ending their relationship with Theranos, closing over 40 blood-testing centers in Arizona. Walgreens had already halted testing conducted by Theranos as they awaited word from federal agencies on whether Holmes would be banned from the biomedical industry for two years; ultimately, Walgreens pulled the plug before regulatory committees made their decision.

Walgreens said of the split:

In light of the voiding of a number of test results, and as the Centers for Medicare and Medicaid Services has rejected Theranos’s plan of correction and considers sanctions, we have carefully considered our relationship with Theranos and believe it is in our customers’ best interests to terminate our partnership.

In July 2016, Theranos announced that regulatory agencies leveraged severe sanctions against the company and Holmes. Theranos’s certificate for their California lab was revoked, and the company could no longer receive Medicare or Medicaid payments.

Holmes was also banned from owning or operating a medical lab.

A man who used Theranos’s testing center at a Walgreens sued the health tech company for giving him positive blood test results just one month before he suffered a heart attack. Other testing centers – as well as the man’s lawsuit – suggested the Theranos results were inaccurate and could have prevented the heart attack had they been correct.

Theranos voided two years of test results after the company received scrutiny from federal regulatory agencies.

Holmes continued to advertise her technologies even after Theranos closed. At a biotech conference, she presented what she called a MiniLab that bore striking similarities to Theranos’s compact blood-testing lab. Holmes claimed the MiniLab could test for the Zika virus with a single drop of blood.

While the audience expected a detailed explanation of the machines, they received much of the same vague information Holmes provided during her tenure at Theranos.

In a damning exposé on Theranos’s company culture, Nick Bilton of Vanity Fair detailed the impact Holmes’s practices had on her employees. Bilton revealed the intense secrecy that dominated Theranos; communication between departments was prohibited, ensuring that Holmes was the only one who truly understood the company’s at-large operations.

Theranos’s negative company culture wrought devastating consequences. Ian Gibbons, an accomplished scientist with multiple Cambridge degrees, was named chief scientist at the company. When Theranos sought to make their technology public long before it was ready, Gibbons vocally opposed the plan. Believing Theranos wanted to fire him, Gibbons attempted to end his life and passed in the hospital one week later.

Rather than sending Gibbons’s wife her condolences, Holmes called and requested she immediately return all of Gibbons’s files related to Theranos.

On October 5, 2016, Holmes posted a letter to Theranos’s website announcing that it would close its laboratories and wellness centers and lay off 340 employees. The remaining employees would focus on developing miniature medical testing machines, which Holmes described as “miniaturized, automated laboratories capable of small-volume sample testing.”

In October 2016, Walgreens launched a $140 million lawsuit against Theranos for breaching contract. The suit alleged Theranos misled Walgreens regarding the extent to which their technology had progressed at the time the two companies started doing business.

In an attempt to recoup their losses, Theranos investors filed a class-action lawsuit against both the company and Holmes for misleading them with falsified research. The suit included over 200 investors. A judge ordered that the investors couldn’t sue Theranos with a class-action lawsuit, however, and would need to file individually.

He reasoned that not all of the lawsuit’s members could prove they were convinced to invest in Theranos specifically because of the company’s misrepresented technology – some may have had other reasons.

In January 2017, The Wall Street Journal reported that Theranos had failed their second inspection by US regulatory agencies. The remaining lab was Theranos’s last, and they closed the facility after news of their failed inspection went public.

Theranos did not disclose the status of the inspection to either patients or investors.

Theranos and CMS were embroiled in legal proceedings following Theranos’s failure to comply with regulatory standards. They settled after Theranos promised to cease all involvement with the blood-testing industry for two years. In exchange, CMS reduced the company’s penalties.

Theranos also withdrew its appeal of CMS’s sanctions on their Newark, CA, blood-testing laboratory.

The SEC charged Holmes and former Theranos president Ramesh Balwani with fraud in March 2018. In a press release, the SEC stated:

The Securities and Exchange Commission today charged Silicon Valley-based private company Theranos Inc., its founder and CEO Elizabeth Holmes, and its former President Ramesh “Sunny” Balwani with raising more than $700 million from investors through an elaborate, years-long fraud in which they exaggerated or made false statements about the company’s technology, business, and financial performance.

To settle the case, Holmes returned millions of shares to the company, paid a $50,000 fine, and promised not to serve as an officer or director at a company for at least 10 years. Balwani refused the settlement, prompting the SEC to pursue litigation against him.

John Carreyrou, who first broke the story on Theranos’s deceptions, released a book based on his research, titled Bad Blood: Secrets and Lies in a Silicon Valley Startup. The book delves into the rise of Theranos, as well as the company culture and Holmes’s delusions of grandeur.

Carreyrou boiled down Theranos’s problem succinctly: the company overpromised their technology’s capabilities, and when they couldn’t deliver, they simply fabricated lies to maintain their image of a company revolutionizing the field of biotechnics.

The US Attorney’s Office indicted Holmes and Balwani on charges of fraud in June 2018. The charges accused the pair of misleading investors and deceiving patients. The wealthiest Theranos investors lost hundreds of millions of dollars when the company went under, and patients lives were seriously endangered by Theranos’s unreliable results.

Both Holmes and Balwani pleaded guilty to wire fraud charges.

In September 2018, Theranos announced it was taking steps to close the company completely. Theranos began to turn its efforts toward avoiding bankruptcy rather than salvaging the business. The company defaulted on a line of credit and did not have enough remaining funds to fulfill shareholder distributions.

In October 2018, Holmes and Balwani attempted to prohibit the Justice Department from accessing 200,000 company documents, but their request was denied. In January 2019, a filing by the Justice Department reported that they would comb through nearly 17 million pages of documents, which could result in further charges against Holmes, Balwani, and others.

US Attorney John C. Bostic claimed Theranos’s web of lies was much “bigger than what’s captured in the [original] indictment.”

In March 2019, HBO released the documentary The Inventor: Out for Blood in Silicon Valley, which brought even more publicity to the Theranos case. The film focuses on Holmes but also includes interviews from former employees and journalists, including Carreyrou.

The documentary additionally explores Silicon Valley’s culture-at-large and how it allowed for Theranos, and its deceptive practices, to thrive.