FDA staffers sue agency over email surveillance

Whistleblower

Six of the so-called "FDA 9" whistleblowers are suing the federal watchdog agency, alleging that the government violated their constitutional rights with surveillance of their private email accounts.

The staffers allege that the FDA spied on the private email accounts they accessed using their government-issued computers, after they warned Congress and the president that unsafe medical devices were being allowed onto the U.S. market.

The lawsuit, filed in the U.S. District Court for the District of Columbia, levels 12 counts against the agency, its chief Dr. Margaret Hamburg, medical device chief Dr. Jeffrey Shuren, the Dept. of Health & Human Services and its head, Kathleen Sebelius, and other government officials. It accuses them of enacting the secret surveillance after learning of a letter the staffers sent to then-President-elect Barack Obama’s transition team Jan. 7, 2009, and of using the information gleaned from the tapped email accounts to harass and, in some cases, fire the whistleblowers.

After learning of the letter, the FDA set up a secret file on its database labelled "FDA 9" to collect the surveillance data. The agency took screenshots of the staffers’ computers as they accessed their private Gmail accounts, according to the lawsuit. Although the government has the right to surveil any activity on the computers it issues, it’s unclear whether it’s legal to secretly gain access to private email accounts used on government-issued devices.

The staffers later wrote an open letter to Obama asking him to hold former and current officials accountable for their alleged wrongdoing. The Jan. 7 letter to John Podesta, the transition team leader, warned that potentially unsafe radiological devices were being allowed to hit the market.

"For example, in the January 7, 2009 letter to Mr. Podesta, the FDA scientists noted 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. This has led to significant harm to large numbers of women and significant unnecessary costs to the public," according to the lawsuit. "After the defendants learned about the Jan. 7, 2009, letter to Mr. Podesta, FDA officials began to secretly refer to the signatories of the letter from the FDA scientists and including [the plaintiffs] as the ‘FDA Nine’ or ‘FDA 9.’"

The FDA staffers also communicated with aides of Sen. Charles Grassley (R-Iowa), who then warned the FDA not to retaliate against the whistleblowers.

But, "despite Senator Grassley’s warnings," the agency "commenced a covert and secret search and seizure operation on the ‘FDA Nine’ in retaliation for their protected speech, which included, but was not limited to, the interception of private communications sent by or on behalf of plaintiffs to congressional representatives," according to the lawsuit.

"The information secretly obtained by defendants included plaintiffs’ legally protected documents and information that was stored by plaintiffs in folders labeled ‘For Congress’ and other folders that clearly indicated the intent of plaintiffs to raise issues of public concern with appropriate authorities," according to the complaint.

"Defendants have taken and converted private emails without due process or just compensation in violation of the 5th Amendment of the United States Constitution. Defendants have initiated searches and seizures in violation of the 1st and 4th Amendments. Defendants have conducted searches and seizures of a scope that violates the 1st and 4th Amendments. Defendants have violated the 1st Amendment by chilling free speech with searches and seizures. Defendants have violated the 1st Amendment by chilling Plaintiffs’ and the public’s right to associate with whistleblowers. Defendants have violated plaintiffs’ right to representation. Defendants have chilled plaintiffs’ protected 1st Amendment right to free speech."

Documents obtained by the Washington Post show that the FDA twice asked the HHS inspector general’s office to investigate the whistleblowers, accusing them of illegally releasing confidential business information about the devices they believed were unsafe.

"We have obtained new information confirming the existence of information disclosures that undermine the integrity and mission of the FDA and, we believe, may be prohibited by law," Shuren wrote, according to the documents.

But both times the IG’s office declined to intervene.

"Who would have thought that they would have the nerve to be monitoring my communications to Congress?" Robert Smith, one of the plaintiffs in the suit, told the Post. "How dare they?"

Michael Sussmann, a former federal prosecutor who is now a partner at the Perkins Coie law firm, told the newspaper that the FDA has the latitude to conduct extensive monitoring.

"Anything on this agency’s network is fair game by use of this banner, as long as they’re lawfully targeting their employee," Sussman said.

Federal investigators later cleared the FDA managers of criminal acts against the whistleblowers.

“We do have a zero tolerance policy for retaliation,” Shuren said at the time.

"The FDA has a huge responsibility to protect public health and safety," Grassley said in a statement to the Post. "It’s hard to see how managers apparently thought it was a good use of time to shadow agency scientists and monitor their e-mail accounts for legally protected communications with Congress."

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