Elizabeth Holmes Wins Judge’s Backing in Getting FDA Documents Faster
Elizabeth Holmes Wins Judge’s Backing in Getting FDA Documents Faster
(Bloomberg) -- Theranos Inc. founder Elizabeth Holmes wants millions of documents from regulators to formulate her defense against criminal fraud charges. On Wednesday she got some help from a federal judge cutting through what her lawyer has called the “regulatory haze” in her way.
Holmes and her co-defendant, former Theranos president Ramesh “Sunny” Balwani, won an order requiring regulators to move quickly to turn over troves of documents they say are at the core of their defense. Less than three weeks ago they appeared before U.S. District Judge Edward Davila making the same request, arguing time is of the essence for a trial that’s set to start a year from now.
The Food and Drug Administration has said it may take up to six months to turn over the information Holmes wants, which even prosecutors said in a court filing is “unacceptable.” Government lawyers said if necessary they will subpoena the agency. Holmes and Balwani are also pursuing documents from the Centers for Medicare & Medicaid Services.
“I agree six months is too long,” Davila said at a hearing Wednesday. The judge agreed to order the agencies to produce the documents in 75 days. “If they don’t, they will stand at the lectern you’re at now and tell me why,” Davila told Stephen Cazares, a lawyer for Balwani.
The judge was responding to Cazares’s criticism that the order fails to hold prosecutors responsible for ensuring the agencies turn over all the requested documents. A lawyer for Holmes, Lance A. Wade, argued at a hearing last month that prosecutors have an unfair advantage in their unfettered access to information from agencies. When the defendants seek information, “then suddenly the regulatory haze appears in front of all of these requests,” he told Davila.
Holmes and Balwani say the agency documents are key to rebutting charges that she and Balwani knew Theranos blood tests were inaccurate and unreliable, and misrepresented the capabilities of the company’s testing machines to doctors, patients and investors. Regulators concluded the blood-testing startup’s technology was a threat to patient health and forced the company, once valued at $9 billion, to shut its labs.
The delay in producing documents is in part due to the FDA’s concern that it will be forced to turn over personal and private information, including information that could be used to identify a confidential informant. Holmes, Balwani and the government arrived at a separate agreement, signed by Davila, protecting such information and permitting the agencies to turn it over.
Holmes and Balwani will also be able to get copies of FBI agents’ notes and those of other criminal investigators. The U.S. Attorney’s office had permitted them to look at -- but not copy -- such documents. Defense lawyers had to agree not to disclose the information.
The case is U.S. v. Holmes, 18-cr-00258, U.S. District Court, Northern District of California (San Jose).
To contact the reporter on this story: Joel Rosenblatt in San Francisco at jrosenblatt@bloomberg.net
To contact the editors responsible for this story: David Glovin at dglovin@bloomberg.net, Joe Schneider, Steve Stroth
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