FDA Must Turn Over 4,000 Documents Due To Whistleblowers

Scientists working for the U.S. Food and Drug Administration claim the agency spied on them illegally. In a court ruling, U.S. District Judge James Boasberg has ordered the FDA to immediately turn over 4,000 pages of material that the scientists requested. This ruling, in essence, speeds up the discovery phase of the trial. Additionally, remaining documents must be produced by September 10. All of these documents are in addition to ones that have already been released to the public.

The case started three years ago when it was discovered by the FDA that some researchers within the agency had contacted Barack Obama, President-elect at the time, with concerns about the process for approving medical devices. These employees criticized the procedures for approval, which they considered to be too lax.

Among the complaints, according the the lead attorney for the whistleblowers, Stephen Kohn, are 20 medical devices that could be exposing patients to dangers. For example, extremely high doses of radiation exuding from CT scanners and ultrasound machines may be exposing individuals to radiation levels that are 800 times higher than a chest X-ray, according to the lawsuit. Breast cancer detection devices were still approved by the FDA, even though the machines are not effective nor safe, per the researchers.

A serious concern arose from the employees when it was discovered that monitoring of their correspondence had begun, as well as monitoring of the interactions with each other on the job. Screenshots of individual computer screens were taken by the FDA. Gmail accounts were also under surveillance. Personal and private information that was stored on defendants’ computers was secretly obtained through these methods, it was learned. In addition, views of documents clearly marked for Congress were illegally obtained by the FDA through such spying, it is alleged.

In an inadvertent move, according to the contractor handling such government documents, much of the documented information was released on a public website earlier this month. It is estimated that there are possibly 80,000 pages of documentation regarding the surveillance activities. The researchers claim that their civil rights, such as unreasonable search and seizure, freedom of speech, and the right to petition Congress, have been violated. Kohn pointed out that monitoring done to every employee on a similar basis is not cause for a lawsuit. When monitoring is selectively done to individuals who are blowing the whistle, however, it is unacceptable.