FDA faces legal attack over alleged spying on whistleblowers

Published on January 31, 2012 at 6:25 PM · No Comments

By Dr Ananya Mandal, MD

A latest lawsuit filed in federal court has accused the Food and Drug Administration (FDA) of electronically spying on whistleblowers who alerted the Obama administration and Congress of alleged misconduct in the agency, particularly relating to what they claim was the push to approve unsafe and ineffective medical devices.

The FDA and several of its employees, the Surgeon General, the Health and Human Services Secretary, among others are named as defendants.

After FDA employees aired their concerns to the incoming Obama administration in January 2009, the agency began intercepting the emails they sent to congressional staff via government computers, using private Google and Yahoo email accounts, the documents allege. The FDA also used spyware to capture electronic snapshots of staff computer screens, which the lawsuit says allowed the agency to obtain privately stored whistleblower reports and identify others involved in whistleblower activities. The doctors and scientists maintain that own their actions were legal but that the FDA surveillance violated their constitutional rights to privacy and had a chilling effect on whistleblowing activities. The alleged surveillance lasted for two years.

Known originally as the “FDA nine,” the employees - some still current, other former - alerted the House and Energy Committee in a letter dated Nov. 17, 2008, that the administration’s Center for Devices and Radiological Health (CDRH) had “ordered, intimidated, and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law,” according to the lawsuit, which was filed in U.S. District Court in Washington, D.C., on Wednesday. In a second letter to the Obama transition team, dated Jan. 7, 2009, the scientists “raised issues of public concern, including, but not limited to, corruption within the FDA device review process, managerial misconduct, dangers to public health, welfare and safety, and retaliation against whistleblowers,” the lawsuit said.

The FDA then embarked upon a “covert and secret search and seizure operation,” including intercepting private communications sent by the plaintiffs to congressional representatives, emails sent from private accounts to other private accounts under “circumstances in which the plaintiffs had a reasonable expectation of privacy,” and secretly “installed or activated spyware on all of the government-owned computers, electronic hardware, and networks used by the plaintiffs,” the lawsuit alleged. “This spyware allowed defendants to secretly conduct additional surveillance of the plaintiffs, including ... real-time pictures or 'screen shots' of the computer screens opened by the plaintiffs,” the complaint read. “These screen shots enabled defendants to secretly view information on each of the plaintiffs’ computer screens, even if the information was not saved by plaintiffs.”

“The heart of it is an injunction prohibiting the government from targeting whistleblowers or anyone who engages in First Amendment protected speech for surveillance. You know, routine monitoring or monitoring done to everybody on an equal basis is fine, but you can’t select people because of their whistleblowing for this type of intrusive, over-the-top surveillance, which is done without a warrant, without any limitations whatsoever," said Stephen Kohn, executive director of the National Whistleblowers Center and lead attorney on the case.

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