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Lawsuit says FDA monitored e-mails

Agency workers filed complaints

WASHINGTON - Current and former Food and Drug Administration officials say in a lawsuit that the agency secretly monitored their private e-mail after they raised concerns that approved medical devices might risk public safety.

The doctors and scientists who researched the products approached members of Congress and the incoming Obama administration to express alarm that the devices were approved over their objections.

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Their lawsuit contends that the agency monitored e-mail sent from their personal Gmail and Yahoo accounts from work computers over two years. It says those e-mails included messages to congressional staff and drafts of whistle-blower complaints.

The staffers say they were legally protected whistle-blowers and the monitoring violated their constitutional rights to free speech and against illegal search and seizure, even though a warning on FDA computers said they had no expectation to privacy. The defendants say they were admonished or lost their contracts with the FDA in retaliation.

The FDA said yesterday it would not comment on ongoing litigation. The lawsuit says the plaintiffs were among those who complained in fall 2008 to members of the House Energy and Commerce Committee that senior managers at the Center for Devices and Radiological Health “ordered, intimidated, and coerced FDA experts to modify their scientific reviews, conclusions, and recommendations in violation of the law.’’

Then in January 2009, after President Obama’s election but before he was sworn into office, nine FDA employees sent a letter to the Obama transition team complaining of corruption within the FDA device review process that they said was endangering public health.

For example, the FDA scientists alleged that the agency approved the use of computer-aided detection devices with breast mammograms even though they had been determined not to be safe or effective, harming women and resulting in unnecessary public health costs.

The suit says FDA officials began secretly referring to the letter’s signatories as the “FDA 9’’ and began the secret monitoring. The suit says the agency used spyware on its government-owned computers that allowed it to take pictures of what was on their computer screens without their knowledge.

The scientists’ complaints were the subject of a New York Times article on March 28, 2010, that said the FDA brushed aside its own experts’ warnings about the risks of radiation exposure from routinely using powerful CT scans to screen patients for colon cancer.

The lawsuit says lawyers for General Electric Co., which applied for agency approval of CT scans for colon cancer screenings, complained that confidential information may have been leaked to the Times.

Agency officials used the letter to make a criminal referral to the Office of Inspector General and attempt to have the plaintiffs investigated and potentially charged with serious crimes, the suit says. But the office found no evidence of criminal conduct and noted that disclosures relating to public safety to Congress and the media were protected whistle-blower activity.

The lawyer who filed the suit, Stephen Kohn, National Whistleblowers Center executive director, said spying on employees who raise health concerns stops others from coming forward in the interest of public safety.

“The FDA’s illegal spying program is not just a problem for the six victims in this case,’’ Kohn said in a statement yesterday. “The day we allow the government to spy on employees based on their lawful whistle-blower activities is the day we give up privacy for every honest public servant in America.’’

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