Kristen Sparrow • August 02, 2012
I did a previous blog post on the whistleblowers at the FDA and how the FDA then spied on them, fired them etc… This is an article about one of the victims of the surveillance and one of the main whistleblowers. I won’t go detail here, but even though he was trying his best to call attention to dangerous medical imaging devices for the sake of the unsuspecting public, they go out of their way to paint him as some sort of abrasive crank. I think I would be pretty abrasive too if faced with the potential dangers of releasing the devices.
Robert Smith: Caustic Crusader.
…He and eight colleagues accused agency managers of being too closely aligned with the medical manufacturers they
regulated. They became known as “the F.D.A. 9,” and Dr. Smith was clearly their leader.
In the lawsuit he and six of the supporters brought in 2009, which was later unsealed, Dr. Smith’s group essentially
accused the F.D.A. and medical manufacturers of conspiring to approve faulty devices. They brought the multibillion-
dollar suit under the False Claims Act, which allows whistle-blowers to collect up to 30 percent of any damages. They
withdrew it last year after the Justice Department declined to support the case…
When Dr. Smith and other medical reviewers began demanding that manufacturers provide them with more clinical data about
the safety of their products, F.D.A. managers deemed the requests excessive. “Things were getting out of hand,” said
Larry Kessler, a former top F.D.A. official. “The reviewers were setting the bar far too high.”