David R. Henderson  

Friday Night Video: Howard Root Fights a Criminal Charge and Wins

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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.


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COMMENTS (4 to date)
ThaomasH writes:

Excellent post. I shows (yet again) failures of federal prosecutors to use judgement based on the costs and benefits of the "crime" in deciding whether to prosecute. It may also demonstrate the need to clarify (and possibly repeal) the law on marketing for off label use.

David R. Henderson writes:

@ThaomasH,
Thanks. I agree on all points. One thing, though: there isn’t a law on marketing for off label use. It’s a regulation, so the only way it could be “repealed” is for Congress to override that regulation and the President to sign. Also, although the FDA has lost some battles over its extreme enforcement (I followed this much more closely 21 years ago when I testified against it before the FDA, but I might not be up to speed), it is difficult for companies to fight back when the same agency that regulates on promotion for off-label uses has life and death power over new drug approval. Yet one more reason to repeal the FDA’s monopoly.

EvgouniK writes:

Unnecessary use of government resources. Rather than focus on markets with more volatile applications, the FDA decided to investigate a company that can literally save lives. I found the whole litigation process humorous. Even the expert FDA witness claimed how off-label applications were not qualified in some instances. Overall, Howard Root's bravery and dedication to his employees is a great example of fine management. It is unfortunate how small cap businesses are subject to bullying by the government.

john hare writes:
EvgouniK writes: Unnecessary use of government resources. Rather than focus on markets with more volatile applications, the FDA decided to investigate a company that can literally save lives. I found the whole litigation process humorous. Even the expert FDA witness claimed how off-label applications were not qualified in some instances. Overall, Howard Root's bravery and dedication to his employees is a great example of fine management. It is unfortunate how small cap businesses are subject to bullying by the government.

I do not find five years, $25M in legal fees, possible jail time and blackballing employees humorous in the slightest.

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