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FDA whistleblowers sue, alleging electronic spying

The Food and Drug Administration electronically spied 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, according to a complaint filed in federal court.

The complaint, filed on behalf of six former and current employees, alleges that the FDA and a number of others violated a host of the plaintiff's rights, including freedom of speech, association and due process; unreasonable search and seizure; and the right to petition Congress. Named as defendants are the FDA and several of its employees, the Surgeon General, the Health and Human Services Secretary, among others.

“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 instrusive, 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.


The FDA said Monday it would not comment on ongoing litigation.

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."

Kohn said the center had learned about the surveillance through a Freedom of Information Act lawsuit, personnel actions and responses from the Department of Health and Human Services' Inspector General to an unsuccessful request 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 themself the target of a surveillance.”

The plaintiffs had permission to use their government-issued computers for personal purposes, the lawsuit said. Four of the original "FDA nine" chose to pursue the lawsuit.

The number of whistleblowers grew over time, and the FDA, through the alleged spying over two years, learned of the group's strategy to alert the Inspector General, among others.

"These numerous attempts by defendants to have the whistleblowers prosecuted for so-called unauthorized disclosures of confidential or agency information were continuously rejected by appropriate law enforcement officials," the complaint said. "Defendants completely ignored the warnings that the disclosures were authorized and protected by law. Instead, defendants continued to conduct their surveillance activities and continued to try to convince law enforcement agencies to charge one or more of the plaintiffs with a crime."

Eventually, two of the whistleblowers, including one acting as counsel for the group, did not have their contracts renewed by the FDA, creating a "chilling effect on all similarly situated employees/contractors/officers of the defendants," the lawsuit said. Two more of the whistleblowers are no longer with the FDA: one was allegedly fired related to the whistleblowing and another was essentially removed from their post, Kohn said.

The lawsuit highlighted areas that had raised the concerns of the FDA whistleblowers: In the 2009 letter, the group had warned that in the past, "computer-aided detection devices (“CAD”) to be used with breast mammograms were not safe or effective, but the FDA approved the devices anyway in a flawed process that ignored the science" and noted that this "type of behavior had not changed, was ongoing, and that FDA managers were still trying to approve similarly flawed CAD devices."

In another example, a doctor had determined in early 2009 that a CT colonography device was neither safe nor effective for population screening due to a high radiation dose -- thereby raising the risk of induced cancer -- but "FDA managers indicated that they would clear the device anyway," the complaint alleged.

"They’re very upset but they're primarily concerned as physicians to the harm that patients are suffering," Kohn said of the whistleblowers. "They’re looking at ... the dosages of radiation that people get from some of these devices or how some of the devices fail to detect cancers.”

The doctors were being treated like "CIA agents," Kohn added. "They’re acting as if medical information is the same as … classified information on terrorism and it’s not … it’s information that patients need.”

The FDA has 60 days to respond to the lawsuit.