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FDA Asks Judge to Dismiss Spying Suit Filed by Employees – Businessweek.
Bloomberg News
FDA Asks Judge to Dismiss Spying Suit Filed by Employees
The U.S. Food and Drug Administration asked a federal judge to dismiss spying claims brought by six current and former employees who told lawmakers the agency was improperly approving medical devices used to screen for cancer.
The FDA, in a filing today in Washington, said the employees must first have what the government calls claims of “alleged whistle-blower retaliation” reviewed through an administrative process before seeking judicial action. The agency said five of the plaintiffs have complaints pending before the U.S. Office of Special Counsel, which handles government whistle-blower allegations.
“Plaintiffs’ attempt at a procedural shot-gun blast must fail,” W. Scott Simpson, a Justice Department lawyer, said in the filing.
The employees, in an amended civil rights lawsuit filed in January, said the agency monitored their communications using spyware to capture screen shots and learn the workers’ identities, as well as “the tactics and strategy” they were planning to use in “blowing the whistle to Congress, the inspector general, among other proper authorities.”
The monitoring began more than three years ago, after nine FDA employees signed a letter to President Barack Obama’s transition team alleging government misconduct in the approval of medical devices, including an imaging device used to diagnose breast cancer, according to the filing. It was expanded in 2010 after the New York Times published an article in which FDA scientists criticized the device-approval process.
The lead plaintiff in the case is Paul Hardy, a former officer of the U.S. Public Health Service Commissioned Corps. The other plaintiffs are three former FDA scientists — Ewa Czerska, Robert Smith and Julian Nicholas — and two current FDA employees — R. Lakshmi Vishnuvajjala and Nancy Wersto.
The case is Hardy v. Shuren, 11-01739, U.S. District Court, District of Columbia (Washington).
To contact the reporter on this story: Tom Schoenberg in Washington at tschoenberg@bloomberg.net
To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net
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Dear readers,
Great post Earl, there has long been suspicion of ‘issues’ around the approval of medical devices, Howard has certainly writte of the issues in the USA and Bob here in Australia has been a vocal critic and achieved our senate enquiry through his actions. I implore all of you that if you come across any evidence around this or hear of any evidence of employees (former or current) of medical device manufacturers who have attempted to become ‘whistleblowers’ please share this with us! I have heard in the De Puy case that they have ‘deposed’ (taken statements for us normal people) from a number of current and former employees that are ‘damning’ of what the company was aware of around the ASR. So if you hear or even know of anyone who is involved in any of these processes (government-manufacturer/distributor-surgeon) please encourage them to speak out or at least pass the information on to someone who can use it! Have a great day all.
Stuart Cain