One Company Fought the FDA and Won. What That Victory Means for Medicine.

Vascular Solutions CEO Howard Root faced years of jail time in a legal battle over off-label use that has profound implications for medical innovation in America.


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Howard Root is the CEO and founder of the medical device company Vascular Solutions, which develops life-saving medical technologies, such as freeze-dried blood plasma to help wounded soldiers on the battlefield and catheters that make heart surgery safer and easier for doctors.

But five years ago the Food and Drug Administration filed a criminal lawsuit against Vascular Solutions that might have sent Root to prison for 4 years, while tearing apart the company he's spent decades building. Why? Because of a petty bureaucratic dispute over whether Vascular Solutions encouraged doctors to use one of its devices in a way that helped patients, but that the FDA had refused to sanction.

Ultimately the company prevailed, but Vascular Solutions's 5-year, $25 million nightmare has profound implications for the future of medicine in America.

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Approximately 10 minutes. Produced by Zach Weissmueller. Music by Chris Zabriskie.