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Week in Review: Gagged by the Government

March 3, 2019

Semantics and a quarter of an inch nearly ruined Howard Root’s life and destroyed the billion-dollar medical device company he created. Only a jury saved him.

Root had spent five years under federal investigation, indictment or in trial by the time he and his company, Vascular Solutions Inc. (VSI), were acquitted of all criminal charges by the jury in February 2016.

A conviction would have shuttered the company and sent Root to prison for three years.

By the time of the acquittal, $25 million had been spent on lawyers defending Root, his employees, and VSI’s very existence.

The value of the company’s stock plummeted.

Medical devices that might have saved countless lives went undeveloped.

Company employees were threatened with decades in prison, indictments, and financial ruin if they did not “fix” their testimony to comport with the prosecution’s theory of the case.

All because of the pitches of a few rogue salespeople, which even the government prosecutors acknowledged were, in themselves, legal and protected by the First Amendment.

All over a financially insignificant and FDA-approved product in the company’s inventory that constituted less than 0.1 percent of VSI’s overall sales.

All over the definition of what constitutes a “varicose vein.”And all despite the fact that prosecutors conceded they made no claims that any patients were harmed.

Root is one of several pharmaceutical and medical device company executives who got entangled in the U.S. Food and Drug Administration’s attempts to preserve its power to regulate what they can say about their products and how they are used.

Read the rest of this compelling story in a new report by Goldwater Institute national investigative journalist Mark Flatten, Gagged: Feds Use Criminal Charges, Threats to Silence Drugmakers, and learn about the Goldwater Institute’s solution to this pervasive practice that is already taking hold in states across the country.

 

 

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