Elizabeth Holmes and attorneys from Williams & Connley head into the Northern District on Monday, January 13. (Photo: Jason Doiy/ALM) Elizabeth Holmes and attorneys from Williams & Connolly head into the Northern District on Monday, Jan. 13. (Photo: Jason Doiy/ALM)

The top lawyer at the U.S. Food and Drug Administration told the judge overseeing the criminal case against Theranos founder Elizabeth Holmes that the case is putting "wholly unprecedented" demands on the agency to fulfill a court order to hand over internal agency documents to the defense team.

Stacy Amin, who serves as chief counsel of the FDA and deputy general counsel of the Department of Health and Human Services, appeared by telephone at a hearing before U.S. District Judge Edward Davila of the Northern District of California on Monday where federal prosecutors were asking the judge to extend a court-ordered deadline for the agency to hand over a trove of requested documents to April 30.

Amin said that the agency had multiple employees working at 200% of their normal capacity to try to meet the court's initial Dec. 31, 2019, deadline the judge set in November. But, she said, technological bottlenecks stemming from issues with the agency's software and bandwidth limitations curbing the amount of data the agency could export made completing the task before the new proposed date unlikely. Amin also said that data that had been archived—specifically emails that had been compressed and decoupled from attachments—had to be "rehydrated" before searching for relevant terms. Amin said that the agency's efforts had involved redirecting people and resources that would typically be called on in the FDA's criminal investigation and injunction enforcement efforts.

"Some of that work has taken a backseat to this discovery," Amin said.

Davila, who sounded impressed by the government's efforts and sympathetic to its technological plight, held off ruling on the government's request Monday morning and said that he might request more information from the parties.

Holmes, who is represented in the criminal case by counsel from Williams & Connolly, was present for Monday's hearing, but her co-defendant, the company's former COO and president Ramesh Balwani, was in Washington, D.C., with his lead counsel Jeffrey Coopersmith of Orrick, Herrington & Sutcliffe for depositions in a related civil proceeding brought by the U.S. Securities and Exchange Commission.

The pair were initially indicted in July 2018 on two counts of conspiracy to commit wire fraud and nine counts of wire fraud based on claims they knew that Theranos' blood analyzer could not deliver on the public promises they were making to provide "fast, inexpensive, accurate, and reliable" tests. As part of the charges, the government claimed that Holmes and Balwani misled investors by saying the company's blood analyzer and tests did not require FDA approval when they knew that they did.

One of Holmes' lawyers, Lance Wade of Williams & Connolly, said Monday that the government had turned over roughly 140,000 documents from the FDA thus far in rolling productions, and that the government's search is yielding "highly significant documents … exhibit list-type documents." He warned the judge that the government's proposed new deadline would run up against current deadlines for expert disclosures and other key pretrial deadlines as the August trial date approaches. Orrick's Stephen Cazares, representing Balwani, told the judge that pushing back the FDA's production deadline leaves the defense lawyers "in the position of weighing our need to prepare trial to our desire to get to trial and clear Mr. Balwani's name."

At Monday's hearing, Assistant U.S. Attorney Robert Leach stressed that only a small portion of the government's case deals with the FDA.

"I don't want to minimize the importance of these documents," Leach said. But he added: "This is not a case about the FDA."

Davila said he was amenable to pushing back pretrial deadlines, but didn't seem to entertain the idea of pushing back the Aug. 4 trial date. The judge said the next hearing in the case, a Feb. 10 hearing on defense motions to dismiss the case, will go forward as planned.

 

Read more:

Lawyers for Elizabeth Holmes Make Dismissal Bid in Theranos Criminal Case

Judge to Let Cooley Bow Out of Representing Elizabeth Holmes in Theranos Civil Case

In Theranos Civil Case, Cooley Says Elizabeth Holmes Has Growing Unpaid Legal Bill

Orrick Adds White-Collar Trio, Including Ex-Theranos COO's Lawyer

Judge Nudges Agencies to Hand Over Info to Theranos Defendants