FDA Surveillance of Medical Device Employees Posted Online

July 16, 2012 — Six former employees of the U.S. Food and Drug Administration (FDA) are suing the agency for monitoring their private communications on work computers while they were talking to Congressional officials and journalists about the FDA’s approval of unsafe medical devices. FDA officials have defended their actions by saying that they had to make sure the employees were not sharing confidential trade secrets about the medical devices. Unfortunately, documents collected in the hour-by-hour electronic surveillance were accidentally posted on a public website online, allowing New York Times reported to review the documents.

The dispute began in 2007, when several scientists and doctors voiced their concerns that the FDA had approved 12 radiological devices with serious safety issues, against the employees’ recommendations. The employees claim some of the devices could accidentally deliver high-doses of radiation during mammograms and colonoscopies, which could cause cancer. The devices could also miss signs of cancer, misdiagnose diseases, and more.

FDA officials decided to place electronic surveillance software on 21 employees’ computers. The software logged keystrokes, collected passwords, intercepted email correspondence, took snapshots of the monitor, copied documents on thumb drive

Although military and intelligence agencies uses this type of software to monitor national security threats, it is very unusual for a public government agency to take these measures against its own employees.

The FDA defended itself by saying they had to ensure the employees were not sharing confidential trade secrets about the medical devices they were criticizing.

The surveillance program began in 2010 and the FDA will not confirm or deny whether it continues today, against two people who are still employed at the FDA, or against other employees. At least 80,000 pages of documents have been collected, involving 21 employees, six members of Congress, several journalists, and more.

According to the New York Times,

“The documents captured in the surveillance effort — including confidential letters to at least a half-dozen Congressional offices and oversight committees, drafts of legal filings and grievances, and personal e-mails — were posted on a public Web site, apparently by mistake, by a private document-handling contractor that works for the F.D.A. The New York Times reviewed the records and their day-by-day, sometimes hour-by-hour accounting of the scientists’ communications.”

The employees sued the FDA in January of this year, alleging that the FDA’s actions were illegal because they infringed on privacy rights. Although the legal protection of privacy (especially in the workplace) is very weak, government agencies are not allowed to engage in surveillance that might have a “chilling effect” on whistleblower lawsuits, or attorney-client communications. The White House Office of Management and Budget sent a governmentwide memo regarding this stipulation.

The FDA has faced mounting criticism about the way it approves medical devices. In recent years, there have been numerous high-profile recalls involving defective medical devices. In multiple cases, device manufacturers gained approval without conducting safety studies of the devices. By the time the FDA became aware of safety problems, tens of thousands of people had been severely injured, disabled, or killed. Examples include metal-on-metal hip implants, transvaginal mesh, brain stents, gastric bands, and more.

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