The FDA is trying to make lawsuits accusing it of spying on the personal Gmail accounts of current and former device center employees go away. It's a big, messy case that the plaintiffs claim began after they warned Congress that medical devices were gaining approval even though they had significant risks behind them.
As Bloomberg reports, regulators want a federal judge to dismiss the charges filed by six current and former employees who handled evaluations for FDA medical device regulatory approvals. The employees, who worked in the FDA's Office of Device Evaluation, accuse their bosses of using spyware to find out details about the employees' plans to testify to Congress and other authorities about their device concerns. But the FDA is arguing that their lawsuit basically comes out of turn. According to the story, the U.S. Justice Department says the employees first were required to have their whistleblower retaliation claims handled through administrative review before filing a lawsuit.
All of this became public in January with the employees' initial U.S. District Court lawsuit, which claims that the FDA monitored their private emails for two years after their congressional testimony. The suit remains a risky one, considering that FDA computers post a visible warning telling users that anything passing through or stored on work computers is not protected by privacy. Government officials also tell their employees that they can intercept data for lawful reasons.
The employees flagged their concerns about at least 12 radiological devices that FDA had either approved or was close to approving that they felt had not been proven either safe or effective, The Washington Post has reported.
- here's the Bloomberg story