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Home/Legal & Regulatory and Reimbursement/“FDA 9” Whistleblower Lawsuit Tossed Out
Legal & Regulatory and Reimbursement

“FDA 9” Whistleblower Lawsuit Tossed Out

October 13, 2014 2 min read Premium comments

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“FDA 9” Whistleblower Lawsuit Tossed Out
Source: Wikimedia Commons
Secondary

The “FDA 9” whistleblowers who accused the FDA of spying on them have had their lawsuit tossed out by a federal judge in Washington because they did not exhausted all other administrative avenues of redress within the FDA.

According to an October 3, 2014 story in Mass Device, Judge Reggie Walton ruled on September 23, 2014 that although the plaintiffs “alleged no shortage of facts establishing that the defendants took, or threatened to take, a variety of prohibited personnel actions against them for their whistleblower activities, ” his court lacked jurisdiction.

On January 25, 2012, FDA “whistleblower” scientists filed a suit in federal court, accusing FDA Commissioner Margaret Hamburg, M.D., Jeff Shuren, M.D., the head of the Center for Devices and Radiological Health (CDRH) and Kathleen Sebelius, the then-head of the Department of Health and Human Services of illegally spying on them and using the ill-gotten evidence to retaliate against them.

The scientists said the government violated their constitutional rights and protections against reporting government corruption. And most importantly, claimed the illegal spying activity would chill future federal employees from reporting official misconduct.

According the lawsuit, on January 29, 2009, the FDA “commenced a covert and secret search and seizure operation” on the “FDA 9” to intercept private communications sent by the scientists to Congressional representatives created on government issued computers, sent through government networks, or remotely connected to government networks.

The agency allegedly set up a secret file on its database labelled “FDA 9” to collect the surveillance data. The agency, according to their suit, took screenshots of their computers as they accessed their private Gmail accounts. “Although the government has the right to surveil any activity on the computers it issues, it’s unclear whether it’s legal to secretly gain access to private email accounts used on government-issued devices, ” wrote Brad Perriello of Mass Device.

Judge Walton wrote that “If the administrative and remedial scheme set forth under the [Civil Service Reform Act] can resolve the claims that the plaintiffs have alleged in their complaint before this court, then the plaintiffs must use that scheme to seek redress and the court is precluded from exercising jurisdiction over the plaintiffs’ claims.”

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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