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FDA Staffers Sue Agency


Six people who had served on scientific review committees for the US Food and Drug Administration’s Center for Devices and Radiological Health have filed a lawsuit against the government agency, claiming that the FDA used spyware to take screenshots of their personal emails and fired some of the plaintiffs for leaking information on potentially unsafe medical devices to the US Congress and the press.

FDA officials allegedly approved some cancer-screening devices—among them tools for detecting breast and colon cancer—even after members of the review committees advised against doing so. When the plaintiffs, who include doctors, researchers, and a statistician, complained to Congress in 2008, the FDA began “ordering, coercing, and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along,” according to a letter written to then President-elect Barack Obama’s transition team in 2009.

The plaintiffs also allege that the FDA used spyware to capture screenshots of their emails, monitoring that they say continued for 2 years. According to Stephen Kohn, the complainants’ lawyer and director of the National Whistleblowers Center, the lawsuit was triggered when his clients learned of the email monitoring this past December. “It’s the first time we’ve seen heightened surveillance for health and safety issues,” he told ScienceInsider. “And it will have a chilling effect. Maybe the public doesn’t need to know about how many spies we have in Iran, but they do need to know if a device will increase cancer risks.”