Slap: Office of Special Counsel Fights for Fired FDA Whistleblower Paul Hardy

For a medical device manufacturer, few joys can be as great as receiving an FDA approval letter. After working untold hours and investing millions into a product, you finally are allowed to put it on the market. These letters are mostly boilerplate, but they often have a backstory.

In the case of the approval of the KODAK DirectView CR Mammography System, the backstory is the retaliation against Paul T. Hardy, a regulatory review officer for the FDA and U.S. Public Health Service (USPHS), who warned the FDA about problems with the device - and was fired for his trouble.

You will find no hint of any problems the device may have had in the FDA approval letter from November 2010. The letter's boilerplate text does include this important caveat:

Manufacturers of medical devices, including in vitro diagnostic devices, are required to report to FDA no later than 30 calendar days after the day they receive or otherwise becomes aware of information, from any source, that reasonably suggests that one of their marketed devices:

1. May have caused or contributed to a death or serious injury; or

2. Has malfunctioned and such device or similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

These would be "adverse events," and, as Antidote detailed in posts earlier this month, the FDA's adverse events system has quite a few problems of its own.

Hardy didn't want the FDA to wait until adverse events hurt patients. As the federal Office of Special Counsel (OSC) puts it, "Hardy led a team of scientists who found serious safety and effectiveness problems" with the device.

The OSC announcement about Hardy's case earlier this month says:

Such devices are used on millions of women every year to detect and diagnose breast cancer. Concerned that FDA managers intended to approve the device over his team's recommendations, Hardy objected and his supervisor accused him of insubordination. Hardy then documented his objections in official FDA records and disclosed his concerns to members of Congress. FDA then launched a criminal investigation of Hardy for "releasing Agency information without authorization."

After having received Exceptional or Fully Successful performance evaluations the prior three years, Hardy was given a negative performance rating in January 2011. In May, he was placed on "Non-Duty with Pay Status" and prohibited from entering an FDA/HS facility. Based upon his negative performance review by FDA managers, the USPHS recommended against his promotion, which automatically resulted in his termination.

Fortunately for Hardy, the Office of Special Counsel, which is supposed to protect whistleblowers, is no longer being headed by Scott Bloch. As The Washington Post describes, Bloch pleaded guilty in April 2010 to criminal contempt of Congress, "admitting that he withheld information from investigators about ordering private technicians to scrub computer files at the Office of Special Counsel." Instead, the office is now being led by Carolyn Lerner, who appears to be taking the job much more seriously. The OSC is now appealing the USPHS decision to get rid of Hardy, which could result in him getting his job back.

Joe Davidson at the Washington Post wrote a great piece last week about the Office of Special Counsel and Hardy's case. Lerner told him, ""Federal workers should know they are not going to be singled out and punished for doing the right thing This is a simple question of fairness."

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