FDA Calls for "Spying" Case to be Thrown Out

In July, the Wall Street Journal reported that documents had leaked revealing to the public an apparent case of the U.S. Food and Drug Administration (FDA) sanctioning spying on employees it found to be dissident. Now, the agency has asked a federal judge to dismiss the case brought against it by six current and former employees who claim they were targeted due to pointing out problems with FDA practices. These employees told lawmakers the FDA was improperly approving cancer screening medical devices.

Termed “whistle-blowers,” the employees must first make claims of “alleged whistle-blower retaliation,” FDA’s counsel said in a filing with the United States District Court of the District of Columbia. Those claims then must be reviewed through an administrative process before the plaintiffs seek judicial action. The agency said five of the plaintiffs have complaints pending before the U.S. Office of Special Counsel, which handles government whistle-blower allegations.

The FDA’s complaint, according to the filing, is that there are simply too many people making a complaint at once, and it is not being handled correctly:

“Unlike most such cases . . . this action involves not a single federal employee (or former employee) complaining of personnel actions taken against him or her because of alleged whistleblowing, but rather six individuals complaining of various personnel actions. This unwieldy, hydra-headed action illustrates why a claim of whistleblower retaliation is supposed to be brought by ‘an employee.’”

The agency also claims that the plaintiffs are incorrectly bypassing the congressionally mandated procedure for bringing claims to court of the Civil Service Reform Act of 1978. “Plaintiffs are seeking both administrative and judicial relief simultaneously. Plaintiffs’ attempt at a procedural shotgun blast must fail,” W. Scott Simpson, a lawyer for the U.S. Department of Justice, said in the filing.

According to the filing, the monitoring began more than three years ago, after nine FDA employees signed a letter to President Barack Obama’s transition team alleging government misconduct in the approval of medical devices including an imaging device used to diagnose breast cancer. The “spying” allegedly was 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 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 FDA employees, R. Lakshmi Vishnuvajjala and Nancy Wersto.

The case is Hardy v. Shuren, 11-01739, U.S. District Court, District of Columbia (Washington).