Former FDA Employees Sue, Claim Retaliation for Opposing Approval of Some Diagnostic Imaging Devices

Posted: January 31, 2012 by David Rosenfeld

Six former Food and Drug Administration doctors and scientists allege FDA officials spied in their personal email accounts in order to build a case for their dismissal. The spying started, they say, after they and three other FDA employees contacted Congress with concerns about the FDA’s approval of some diagnostic imaging devices they did not believe were safe or reliable enough for use on U.S. patients.

The six former employees filed a lawsuit against the FDA this week detailing through memos and emails how FDA officials accessed their personal email accounts, reports The Washington Post and CBS News.

The diagnostic imaging devices whose approval the group questioned include “at least a dozen devices whose effectiveness was not proven and that posed risks to millions of patients,” the article states.

The devices in question, the allegations say, missed diagnosing breast cancer and osteoporosis. There was an ultrasound machine that dangerously malfunctioned and colon cancer screening devices that gave off overly high doses of radiation. In each of the cases, senior managers at the FDA overruled recommendations to deny FDA approval, the six former employees say in their lawsuit.

FDA officials did not comment on the story. Three of the nine employees who were allegedly improperly spied on did not join the lawsuit.

For the full story in The Washington Post click here.

Posted in safety

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