In an ongoing dispute between scientists critical of the Food and Drug Administration’s

(FDA’s) medical-device review process, FDA has sought to dismiss claims of adverse employment action allegedly taken in retaliation for whistleblowing. Hardy v. Hamburg, No. 1:11-cv-01739-RBW (U.S. Dist. Ct., D.D.C., motion filed October 1, 2012). Details about allegations that the agency tracked the scientists’ computer keystrokes, captured screen images, intercepted their personal emails, and copied documents on their personal thumb drives appear in the July 19, 2012, issue of this Report.

FDA contends that most of the employment-related claims are already the subject of administrative complaints filed with the Office of Special Counsel, most of which are still pending, and are precluded by the Civil Service Reform Act. The agency also argues that the remaining causes of action “must be dismissed for lack of standing and because the statute cited does not provide a private right of action.” FDA further indicates that the Office of Special Counsel is “currently investigating this matter pursuant to plaintiffs’ administrative complaints, including investigating allegations that the FDA ‘used covert surveillance as a tool to retaliate against whistleblowers.’ Indeed, a recent OSC news release indicated that the Office had ‘broadened’ its investigation into allegations that the FDA ‘monitored the communications of employees who were suspected of blowing the whistle on FDA’s approval of unsafe medical devices.’”