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In March 2018, Balwani and Holmes were charged by the SEC with securities fraud, "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". Holmes settled the case out of court without admitting or denying wrongdoing, but Balwani is still in litigation as of 2019. He says he is innocent of the charges.

On June 15, 2018, following an investigation by the U.S. Attorney's Office in San Francisco that lasted more than two years, a federal grand jury indicted president Ramesh "Sunny" Balwani and Elizabeth Holmes on nine counts of wire fraud and two counts of conspiracy to commit wire fraud. Prosecutors allege that Holmes and Balwani engaged in two criminal schemes, one to defraud investors, the other to defraud doctors and patients. In June 2019 a U.S. District Court judge ordered Balwani and Holmes to stand trial beginning in July 2020. In March of 2020, a U.S. District Court Judge ordered that Balwani will stand trial separately from Holmes. Holmes's trial is scheduled to start in October 2020. Balwani's trial will begin after the conclusion of Holmes's. Balwani's attorneys were expected to argue that he never made any money for his work at Theranos.

In January 2016, the CMS sent a warning letter to Theranos after inspecting its Newark, California, laboratory. CMS regulators proposed a two-year ban on Balwani from owning or operating a blood lab after the company had not fixed problems within its California lab in March 2016.

The Wall Street Journal reported in October 2015 that the Edison blood testing device by Theranos produced inaccurate medical diagnoses and results. Edison machines frequently failed quality-control checks and produced widely varying results, results that were corroborated in a report released in March 2016 by the federal Centers for Medicare and Medicaid Services (CMS). In April 2016, Theranos told regulators it had voided all test results from Edison machines for 2014 and 2015, as well as some other tests it ran on conventional machines.

Another false claim included claiming a $100 million revenue stream in 2014 that was actually $100,000.

Ramesh "Sunny" Balwani (born March–June 1965) is the former president and chief operating officer of Theranos, which was a privately held health technology company founded by his then-girlfriend Elizabeth Holmes. Theranos is known for its allegedly false claims to have devised revolutionary blood tests that used very small amounts of blood such as that which can be extracted from a fingerstick. Starting in 2015–2016, Theranos came under criticism in the media due to its questionable claims and practices. The company was eventually forced into bankruptcy. Balwani was charged by federal authorities for operating the business as a multi-million-dollar scheme to defraud investors, doctors, and patients. He maintained his innocence and is fighting the charges in court.

Balwani joined Theranos in 2009. He ran the company's day-to-day operations as its president. He had no training in biological sciences or medical devices, which became an issue due to the absence of medical experts on the company's board of directors and Balwani's behavior. He was described by former Theranos employees as overbearing, uncompromising and so concerned about industrial espionage that he verged on paranoia.

Balwani was in a romantic relationship with Elizabeth Holmes during his tenure at Theranos. Holmes met him in 2002 at age 18, while still in school. He was 19 years older than Holmes and married at the time. Their relationship was not disclosed to their Theranos investors.

He was previously married to Japanese artist Keiko Fujimoto. Fujimoto and Balwani lived in San Francisco before their divorce in December 2002.

Ramesh Balwani was born in Pakistan to a Hindu family. The family later moved to India. The family then immigrated to the United States, and in 1986 Balwani began undergraduate studies at the University of Texas at Austin where he was a member of the Pakistani Students Association. He received an undergraduate degree in information systems. Balwani worked for Lotus Software and Microsoft before 1998, when he helped to create CommerceBid, a software development company that helped businesses buy and sell items over the burgeoning Internet. In 1999, the company was purchased by Commerce One, another business development software company with a high valuation stock. The buyout was done entirely with stock and Balwani joined the board of the new company. In July 2000, Balwani sold his shares in Commerce One, netting nearly $40 million shortly before the company went out of business, just before the dot com bubble burst. He later went back to school and received a Master of Business Administration from the University of California, Berkeley in 2003. He spent another four years in a computer science graduate program at Stanford University, but dropped out in 2008.