The FDA and CMS have until Dec. 31 to provide the documents, including correspondence with Wall Street Journal reporter John Carreyrou, who broke the Theranos story. Judge Edward Davila of U.S. District Court for Northern California granted the motion made by Holmes and former Theranos president Sunny Balwani following a hearing on Monday. The agencies have missed two deadlines to submit the documents.
At that hearing, Holmes defense attorney Lance Wade claimed that evidence had been destroyed, according to reports from CNBC and SiliconValley.com. A lawyer for the FDA responded that documents were corrupted computer files in a faulty email storage system. The government produced more than 1,000 of those emails, from a single witness, that omit portions such as the “to,” or “from,” or the body fields. Attorneys for Holmes and Balwani contend that this fragmentation could indicate that the emails have been deleted and subsequently restored.
Holmes and Theranos were once Silicon Valley darlings, with Holmes claiming that her company was set to revolutionize blood testing with technology that could analyze tiny amounts of blood. Forbes in 2015 even recognized Holmes as America’s richest self-made woman based on Theranos’ multibillion-dollar valuation at the time.
Investigative reporting, though, soon dismantled the claims Holmes was making about Theranos’ technology, raising questions about whether she and others had misled investors. The downward spiral culminated in the 2018 shutdown of the company, with the SEC criminally charging Holmes and Balwani over what it described as a “massive fraud.”
The story of Holmes and Theranos has become part of popular culture. A book by Carreyrou, who investigated the company while at The Wall Street Journal, is set to become a movie. There’s also the HBO documentary “The Inventor: Out for Blood in Silicon Valley.”