Federal officials took steps last week to reinstate a recently fired reviewer in FDA's diagnostics office, claiming that agency actions may have violated the Whistleblower Protection Act.

Paul T. Hardy, a biomedical engineer who was working at FDA as a member of the U.S. Public Health Service, lost his job Oct. 9 after resisting the approval of a mammography device that he believes is ineffective and exposes patients to unnecessary radiation, according to documents released by Hardy’s lawyers Oct. 19.

According to his attorneys, Hardy is part of a well-known group of 11 current and former FDA scientists who have raised concerns about agency approval processes to members of Congress and the press.

Former reviewer Paul Hardy raised concerns about computer-aided devices for breast and colon cancer screening.

Nine of the scientists made headlines in 2008 with allegations that CDRH managers intimidated and coerced them into modifying their review decisions to allow products onto the market that they did not believe were safe or effective. (See “‘ Also see "“Ordered, Intimidated And Coerced”? CDRH Targeted In Misconduct Probe" - Medtech Insight, 24 November, 2008. ” – “The Gray Sheet” Nov. 24, 2008.)

Aside from Hardy, the identities of only two of the other whistleblowers are known: Robert Smith and Julian Nicholas, both former reviewers in the agency’s radiological devices branch. (See “ Also see "Device Center Detractor Speaks Out At FDA Radiation Meeting" - Medtech Insight, 5 April, 2010. ” – “The Gray Sheet” April 5, 2010.)

Hardy Opposed CT Imaging Devices

While working as a reviewer for FDA’s diagnostics office, Hardy raised concerns about computed tomography and other medical imaging devices, according to an Oct. 7 request from the U.S. Office of Special Counsel to stay, or suspend, a negative December 2010 performance evaluation that resulted in Hardy’s termination.

According to the filing, Hardy and other FDA scientists reported concerns about computer-aided diagnostic devices for breast and colon cancer screening to FDA management, including Office of In Vitro Diagnostic Device Evaluation Director Alberto Gutierrez, Deputy Director Don St. Pierre and others.

In particular, Hardy led a team of scientists that refused to recommend approval of Carestream Health’s DirectView computed radiography mammography device.

“He was fired for raising these concerns,” Stephen Kohn, executive director of the National Whistleblowers Center and one of Hardy’s attorneys, told "The Gray Sheet."

CareStream was not answering questions on the matter and HHS could not produce a comment by press time. The DirectView system ultimately gained approval around November 2010.

After three successful performance reviews, Kohn says, Hardy received a negative review only after he raised concerns about the Carestream and other devices with not only his managers, but also members of Congress and the press.

“He raised very specific concerns and he was ordered essentially, at threat of insubordination, to approve it and do the label,” Kohn told “The Gray Sheet.” “He was told he was being insubordinate for not going along with the program.”

The U.S. Office of Special Counsel, an independent federal agency charged with protecting federal employees from prohibited personnel practices, especially reprisal for whistleblowing, is seeking to overturn the negative performance review and thus reinstate Hardy.

“They reviewed the case and moved for the stay,” Kohn explained. “The documentation is compelling. There’s nothing on him except his opposition to a device.”

The attorney adds: “He had a right and a duty to raise these issues.”

The 45-day stay, granted by the U.S. Merit Systems Protection Board Oct. 14, will last through Nov. 28 while the Office of Special Counsel conducts a full investigation into the matter.

“OSC has reasonable grounds to believe that the annual negative performance evaluation given to Mr. Hardy was a prohibited personnel practice, a violation of the Whistleblower Protection Act,” the office wrote Oct. 7.

Going forward, the office can request an extension of the stay, file a charge against HHS on behalf of Hardy, or drop the case.

Kohn, who is representing six of the other 11 whistleblower scientists, is gunning for an overhaul at the device center to overturn what he calls a culture of retaliation against whistleblowers. All the whistleblowers that have been let go should be reinstated, he added.

“The retaliatory conduct has to stop,” he said. “They need a whole new program there in terms of whistleblowing.”

In 2010, CDRH Director Jeffrey Shuren said the agency was taking steps to fix internal personnel management problems at the device center.

While the HHS Office of Inspector General cleared FDA device center officials of any wrongdoing in the case of the whistleblowers, Shuren said the center was hiring an independent contractor to investigate the allegations further. (See “ Also see "Regulatory News In Brief" - Medtech Insight, 29 November, 2010. ” – “The Gray Sheet” Nov. 29, 2010.)

Kohn, however, has little faith that those steps have done much to improve things at the agency.

By Jessica Bylander

FDA's Device Center Faces New Charge Of Whistleblower Retaliation

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