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U.S. v. Elizabeth Holmes, et al.

Elizabeth Holmes and Ramesh “Sunny” Balwani are charged with two counts of conspiracy to commit wire fraud and nine counts of wire fraud.  According to the indictment, the charges stem from allegations that Holmes and Balwani engaged in a multi-million-dollar scheme to defraud investors, and a separate scheme to defraud doctors and patients.  Both schemes involved efforts to promote Theranos, a company founded by Holmes and based in Palo Alto, California. Theranos was a private health care and life sciences company with the stated mission to revolutionize medical laboratory testing through allegedly innovative methods for drawing blood, testing blood, and interpreting the resulting patient data.

Holmes and Balwani used advertisements and solicitations to encourage and induce doctors and patients to use Theranos’s blood testing laboratory services, even though, according to the government, the defendants knew Theranos was not capable of consistently producing accurate and reliable results for certain blood tests.  It is further alleged that the tests performed on Theranos technology were likely to contain inaccurate and unreliable results.

The indictment alleges that Holmes and Balwani defrauded doctors and patients (1) by making false claims concerning Theranos’s ability to provide accurate, fast, reliable, and cheap blood tests and test results, and (2) by omitting information concerning the limits of and problems with Theranos’s technologies.  The defendants knew Theranos was not capable of consistently producing accurate and reliable results for certain blood tests, including the tests for calcium, chloride, potassium, bicarbonate, HIV, Hba1C, hCG, and sodium. The defendants nevertheless used interstate electronic wires to purchase advertisements intended to induce individuals to purchase Theranos blood tests at Walgreens stores in California and Arizona.  Through these advertisements, the defendants explicitly represented to individuals that Theranos’s blood tests were cheaper than blood tests from conventional laboratories to induce individuals to purchase Theranos’s blood tests.

According to the indictment, the defendants also allegedly made numerous misrepresentations to potential investors about Theranos’s financial condition and its future prospects.  For example, the defendants represented to investors that Theranos conducted its patients’ tests using Theranos-manufactured analyzers; when, in truth, Holmes and Balwani knew that Theranos purchased and used for patient testing third party, commercially-available analyzers.  The defendants also represented to investors that Theranos would generate over $100 million in revenues and break even in 2014 and that Theranos expected to generate approximately $1 billion in revenues in 2015; when, in truth, the defendants knew Theranos would generate only negligible or modest revues in 2014 and 2015.

The indictment alleges that the defendants used a combination of direct communications, marketing materials, statements to the media, financial statements, models, and other information to defraud potential investors.  Specifically, the defendants claimed that Theranos developed a revolutionary and proprietary analyzer that the defendants referred to by various names, including as the TSPU, Edison, or minilab. The defendants claimed the analyzer was able to perform a full range of clinical tests using small blood samples drawn from a finger stick.   The defendants also represented that the analyzer could produce results that were more accurate and reliable than those yielded by conventional methods – all at a faster speed than previously possible.  The indictment further alleges that Holmes and Balwani knew that many of their representations about the analyzer were false.  For example, it is alleged that Holmes and Balwani knew that the analyzer had accuracy and reliability problems, performed a limited number of tests, was slower than some competing devices, and, in some respects, could not compete with existing, more conventional machines.

The indictment charges each defendant with two counts of conspiracy to commit wire fraud, in violation of 18 U.S.C. § 1349, and nine counts of wire fraud, in violation of 18 U.S.C. § 1343.  If convicted, the defendants face a maximum sentence of twenty (20) years in prison, and a fine of $250,000, plus restitution, for each count of wire fraud and for each conspiracy count.  However, any sentence following conviction would be imposed by the court after consideration of the U.S. Sentencing Guidelines and the federal statute governing the imposition of a sentence, 18 U.S.C. § 3553.  Both defendants are currently out of custody.

Next Court Dates

Notice: Dates are subject to change on short notice. Please check Judge’s calendar before attending.

Pretrial Motions Hearings

08/26/2021 11:30 AM, Videoconference Only for San Jose

Trial Dates

The Court has severed the trials of defendants Elizabeth Holmes and Ramesh “Sunny” Balwani. The trial of Ms. Holmes will begin in 8/31/2021. Mr. Balwani’s trial will begin in January 2022. The Court trial days will be Tuesday, Wednesday and Friday, possibly other half days. The Court may modify the trial time and set either 8:30-2pm or 9-2pm and possibly 30-minute breaks in between. The hearings will take place in San Jose, Courtroom 4, 5th Floor before Judge Edward J. Davila. The dates and times are subject to change.

There will be no live remote public access (e.g., telephone or Zoom) to jury trial proceedings in this case. An overflow room with live audio or video will be available in the San Jose courthouse (Courtroom 7). Public seating in the courtroom and overflow room will be first-come, first-served. The courtroom gallery will have some seating designated for members of the press. All courthouse visitors are required to follow the court’s safety protocols, including wearing a mask in all common areas of the courthouse and in the courtroom if so instructed by the judge, and must review the court’s COVID-19 Pre-Screening Questionnaire prior to arriving at the courthouse.

Due to the level of interest in this case, please see the following webpage for important news and information about access to proceedings and case information:
United States v. Elizabeth A. Holmes, et al. 18-CR-00258-EJD

Resources

Contact Information

For information or assistance with this case, please contact the Mega Victim Case Assistance Program unit at (844) 527-5299 or e-mail USAO.MCAP@USDOJ.GOV.

For information and or questions relating to press inquiries please contact our Public Information officer at 415-436-7264 or email Abraham.Simmons@usdoj.gov.

Updated August 24, 2021

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