FDA Faces Surveillance Lawsuit - Consumer Justice Foundation

FDA Faces Surveillance Lawsuit

Written by Faith Anderson on January 30, 2012
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FDA Employees Claim Agency Approved Dangerous Medical Devices

All six plaintiffs involved in the lawsuit worked for an FDA office charged with reviewing applications to sell medical devices in the United States. Four of the six employees have since left the agency. Among the devices that FDA employees believed to be dangerous was a computer-aided detection device used with mammograms. The FDA approved the medical device for sale despite the fact that staff warned it could cause severe harm to women, documents say.

FDA Allegedly Takes Part in Illegal Surveillance of Employees’ Activities

According to agency reports, FDA computers warn users when they log on that no one accessing the system has a reasonable expectation of privacy, and that the government may intercept any data at any time for any lawful government purpose. After FDA employees voiced their concerns to the Obama administration in January 2009, the agency began intercepting emails that were being sent to congressional staff using government computers, even though the emails were sent using private Yahoo and Google email accounts. The FDA also used spyware to capture electronic snapshots of staff computer screens, which the lawsuit alleges allowed the agency to obtain privately stored reports from whistleblowers, and also allowed the FDA to identify others involved in whistleblower activities.

Lawsuit Claims FDA Retaliated Against Whistleblowers

The six plaintiffs also claim that the FDA retaliated against the whistleblowers by failing to renew employment contracts and by twice trying to allege criminal wrongdoing, which was unsuccessful both times. In one instance, the documents say, the FDA pursued a criminal investigation over a March 2010 New York Times article containing staff allegations that the FDA had tried to approve dangerous and ineffective medical devices. This FDA investigation was based on a letter of complaint the agency received from a law firm representing medical device maker General Electric Co., which complained that the article may have included confidential information. Government investigators rejected the referral, saying it lacked evidence and indicating that the activity cited was protected by law.

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