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Regulatory Focus™ > News Articles > FDA Scores Legal Victory Against Whistleblowing Case as Lawsuit Continues

FDA Scores Legal Victory Against Whistleblowing Case as Lawsuit Continues

Posted 12 November 2012 | By Alexander Gaffney, RAC

US medical device regulators scored a minor legal victory on 9 November 2012, prevailing at least temporarily against the National Whistleblower Center (NWC), which is representing several current and former employees of the US Food and Drug Administration (FDA) in a lawsuit alleging the agency violated their rights to privacy by engaging in surreptitious surveillance against them.

NWC has been fighting FDA in the court system to obtain documents about the case, and has challenged the withholding of hundreds of records by FDA on the grounds that normal exemptions against the release of sensitive information are not applicable "when there is evidence of government misconduct."

Judge James Boasberg of the DC District Court agreed with the NWC's argument on this point, noting the organization had, "Provided the requisite factual basis of such misconduct," and ordered a private (in camera) review of the documents.

Boasberg's review of the documents-about 1,500 in all-found them to be "properly withheld or redacted" based on the absence of information within them reflecting "governmental impropriety."

"Having now reviewed all of the challenged documents in camera, the Court finds that they, "Do not reflect any governmental impropriety, but rather are 'part of the legitimate governmental process intended to be protected by [The Freedom of Information Act (FOIA)],'" wrote Boasberg. The withheld documents, he added, "Do not approach the level of misconduct contemplated by these cases with respect to either improper approval of medical devices or retaliation against FDA employees."

FDA had withheld those documents largely because of three exemptions granted under FOIA: the release of company trade secrets, attorney-client privileged documents and personal identifying information constituting an unwarranted violation of privacy.

Documents falling under all three categories may be withheld, but only if there is no evidence of misconduct on the part of the government.

The litigation is likely to continue for quite some time, albeit through different legal vehicles. Despite the Department of Justice's attempts to get the litigation dismissed, Boasberg's statements seem to reflect a judicial view that FDA has engaged in activities that could at least be construed as "misconduct." NWC has meanwhile already succeeded in obtaining tens of thousands of documents related to the case, including some which were released inadvertently by an FDA contractor.

The flagship legal vehicle for NWC, Hardy et al v. Shuren et al, is now in its 14th month of litigation and is awaiting a 14 December due date for NWC to respond to the Department of Justice's motion to dismiss the case for lack of jurisdiction.

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