Reason TV’s excellent video tells the story of Howard Root’s fight against a federal government charge that, if successful, could have put him in prison. His “crime?” Telling doctors that a medical device that could be used for an FDA-approved use could also be used for “off-label” uses. Root maintains that he never instructed his sales people to market the device for that use, even though, by the way, it seemed to work in the off-label use. The “smoking gun” was an email from an enthusiastic member of his sales staff crowing about a doctor’s excitement about an off-label use. That’s not a smoking gun. There’s no law that says you can’t get excited when doctors, completely legally, successfully engage in off-label uses.

Off-label uses, by the way, are very common for many drugs and medical devices and, indeed, are often encouraged by the federal government, as Charley Hooper and I write about here.

The Reason video does not name the prosecuting attorneys, but the video’s producer, Zach Weissmueller, told me their names: Bud Paulissen and Tim Finely.

Watch the recounting told by two of the firm’s employees about how the government badgered and threatened them, starting at 4:48.

Also watch, at the 7:50 point, the role of the federal government’s expert witness.

Also watch, at the 8:30 point, the victory for off-label uses. By fighting this, Howard Root created a huge public good.

Also, at 8:42, read the letter he got from a juror who learned what many of us have learned about the federal government. The two employees then follow with a similar lesson that they learned.

HT2 Charley Hooper and thanks for permission to Zach Weissmueller.