Bloomberg News

FDA Ordered to Release Documents Sought by Staff in Spy Suit

July 23, 2012

The U.S. Food and Drug Administration was ordered to turn over documents sought by current and former employees who claim they were illegally spied on after reporting improper device approvals to Congress.

U.S. District Judge James Boasberg told the government to produce 4,000 pages by Aug. 24 and any remaining material by Sept. 10 after he agreed with the employees’ lawyers that documents about the agency’s surveillance of staff who worked on medical devices should be made available quickly.

“What you want to tell the public is why the FDA was doing this and how they were doing this,” Boasberg said to Stephen Kohn, one of the employees’ attorneys, during a hearing today in Washington.

The researchers filed a civil rights lawsuit in September accusing FDA officials of spying on staff members who told lawmakers the agency was improperly approving medical devices used to screen for cancer. Today’s ruling was in a related case seeking internal FDA documents through the Freedom of Information Act.

The allegations include the interception of e-mail from personal accounts sent across agency networks. About 80,000 pages of intercepted communications were inadvertently made public on the internet by a government contractor compiling data for probes into the spying by Congress and the U.S. Office of Special Counsel, Marian Borum, an assistant U.S. Attorney representing the Health and Human Services Department, told Boasberg.

‘How and Why’

“How and why that was done is being investigated,” Borum said.

The information the judge ordered released doesn’t include the documents that already became public.

The monitoring began three years ago after nine FDA employees signed a letter to Barack Obama’s presidential transition team alleging government misconduct in the approval of medical devices, including an imaging device used to diagnose breast cancer, according to the filing. The surveillance expanded in 2010 after the New York Times published an article in which FDA scientists criticized the device-approval process.

The lead plaintiff in the civil rights case is Paul Hardy, a former officer of the U.S. Public Health Service Commissioned Corps. The other plaintiffs are three former FDA scientists -- Ewa Czerska, Robert Smith and Julian Nicholas, and two current employees, R. Lakshmi Vishnuvajjala and Nancy Wersto.

The Freedom of Information Act case is National Whistleblower Center v. Department of Health and Human Services, 10-cv-02120; the civil rights case is Hardy v. Shuren, 11-01739, U.S. District Court, District of Columbia (Washington).

To contact the reporter on this story: Tom Schoenberg in Washington at tschoenberg@bloomberg.net.

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net.


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