FDA Sued By Employees Over Email Privacy

FDA Sued By Employees Over Email Privacy

January 31st, 2012 // 1:52 pm @ marquee

In one of the more troubling episodes to place the FDA in an unflattering light, the agency has been accused by a group of current and former employees that their personal e-mails after they warned Congress the agency was forcing employees to approve medical devices they maintained posed unacceptable risks, according to a lawsuit filed last week.

The agency monitoring took place over a two-year period during which the FDA employees accessed their personal e-mail accounts from government computers. They claim they were harassed and eventually dismissed from their positions in the Center for Devices and Radiological Health, according to The Washington Post, which first reported the lawsuit.

There were all sort of alleged problems with devices that prompted their complaints. The employees, who are all scientists and doctors, charged three devices could have missed signs of detecting breast cancer, according to the paper. Other examples: one device risked falsely diagnosing osteoporosis and an ultrasound device could malfunction while monitoring pregnant women in labor. As the Post points out, the Government Accountability Office warned the process resulted in inappropriate approvals.

The employees charge that the snooping began in January 2009, when they sent this letter to the Obama administration to complain that they were under investigation by the FDA Office of Criminal Investigation over a November 2008 letter sent to by the chairman of the House Energy and Commerce Committee to FDA officials about allegations that the process for approving devices was coercive and intimidating.

The agency began intercepting emails sent to congressional staffers and draft versions of whistleblower complaints complete with editing notes in the margins, the Post writes (see emails here). The agency also took electronic snapshots of the employees’ FDA computers and reviewed documents saved on hard drives of their agency computers (look here and here).

Here is a key point: FDA computers post a warning that a user should have “no reasonable expectation of privacy” concerning any information passing through or stored on its system, and that the government may intercept any such data at any time for any lawful government purpose, the Post writes. But the former FDA employees charge their constitutional privacy rights were violated when the FDA looked at personal e-mail accounts in order to monitor activity they argue was lawful.

“Who would have thought that they would have the nerve to be monitoring my communications to Congress?” Robert Smith, who worked as a device reviewer at the FDA until his contract was not renewed in July 2010, tells the Post. “How dare they?”

At issue, according to the FDA, was the agency contention that the employees had illegally released confidential business information by writing Congress, and the FDA sought an investigation. One device maker, in fact, complained about this. However, the Department of Health and Human Services denied the request, saying there was no criminal conduct and the employees were within their rights to disclose concerns.

But the FDA came back with another request. “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,” wrote Jeffrey Shuren, the director of the CDRH in June 2010. “We are particularly concerned that the continued release of confidential information has compromised or will compromise the integrity of the ongoing premarket review of the subject device applications”

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