FDA faces legal attack over alleged spying on whistleblowers

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.

Kohn said the center had learned about the surveillance through a Freedom of Information Act lawsuit, personnel actions and responses from the Inspector General to two unsuccessful requests by the FDA to investigate the whistleblowers. “I have never seen this level of monitoring. I was never even aware that they could go in and to do the Gmail-to-Gmail,” he said, noting the FDA could also “figure out who’s giving information … therefore any employee who associates with a whistleblower could find themselves the target of a surveillance.”

A government report found the FDA required extensive testing for less than one-10th of about 13,500 devices it cleared from 2003 to 2007. The 2009 Government Accountability Office examination of the device-review process called on the agency to bolster scrutiny of products that pose the greatest risk. The FDA lets most devices reach the market through a less stringent approval process that doesn’t require human testing. After the 2009 report, the agency granted expedited reviews to at least 67 “high-risk” devices, including pacemakers and artificial hips, according to testimony to Congress in April by the GAO. The Institute of Medicine, the scientific advisers to the nation, suggested in July that the FDA scrap expedited review for devices that pose greater risk. The agency disagreed.

The FDA said Monday it would not comment on ongoing litigation. FDA spokeswoman Erica Jefferson said the agency does not comment on ongoing or pending litigation. The FDA has 60 days to respond to the lawsuit.

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.

Dr. Ananya Mandal

Written by

Dr. Ananya Mandal

Dr. Ananya Mandal is a doctor by profession, lecturer by vocation and a medical writer by passion. She specialized in Clinical Pharmacology after her bachelor's (MBBS). For her, health communication is not just writing complicated reviews for professionals but making medical knowledge understandable and available to the general public as well.


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