Device reviewers sue FDA over personal email monitoring

Six scientists and doctors who handled evaluations for FDA medical device approvals are suing their former employer. They accuse the regulatory agency of spying on their personal Gmail accounts for two years after the employees told Congress about medical devices with "unacceptable risks" that gained approval anyway.

"Who would have thought they would have the nerve to be monitoring my communications to Congress?" Robert C. Smith, one of the plaintiffs and a former device reviewer, told The Washington Post, which broke the story.

The suit is filed in U.S. District Court in Washington. Post journalists contacted the FDA, but regulators declined to comment.

This case will be pretty fascinating to watch. On the one hand, as the Post notes, FDA computers post a visible warning that users shouldn't expect privacy over anything that passes through or is stored on their work computers, and that government officials can intercept that data "for any lawful government purposes." But the former FDA employees, who reviewed cancer screening and other devices before, they say, they were harassed or dismissed, cried foul. They claim, according to the story, that the government violated their privacy rights because their action--talking to Congress--was legal. Therefore, they argue, their personal email accounts should have been off limits.

The folks, who worked in the FDA's Office of Device Evaluation, first complained internally about the device approvals in 2007. They balked at the notion that the FDA had either approved or was close to approving at least 12 radiological devices that hadn't been proven effective or safe, according to the Post's depiction of the lawsuit. In trying to get the word out, the group conveyed concerns to the inspector general for the Department of Health and Human Services, and in 2009, sent a letter to the White House and spoke to members of Congress, and news of their concerns made it to a number of news organizations, the Post writes.

Among their specific worries: three of the devices allegedly missed breast cancer signs and a number of colon cancer screening devices were alleged to have used radiation at levels that could cause cancer in healthy people. (The Government Accountability Office issued similar, more general concerns about device safety approvals in 2009 and 2011, according to the article.)

FDA officials were quoted in some of those stories as stating that the agency said it was addressing those concerns, the Post writes.

The suit, based on FDA internal documents the plaintiffs obtained under the Freedom of Information Act, claims that the monitoring began in 2009, after a device company alleged that the employee complaints led to the leaking of confidential business information. The employees said they were either fired, did not have their contracts renewed or were harassed or passed over for promotions.

- read The Washington Post story
- here's the Post's link to select, related FDA docs, as compiled by the plaintiffs

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