Deep Dive Episode 8 – Cardiac Arrest: A Cautionary Tale

Howard Root started Vascular Solutions, a medical device company, from scratch. Fifteen years later, his Minnesota company had created over 500 American jobs and developed more than 50 new medical devices that saved and improved lives.

But in 2011, the federal government accused Howard of marketing medical devices for unapproved uses – a practice prohibited by the FDA. Howard professed his innocence from the beginning but, when prosecutors set their sights on Howard and his company, there was no guarantee that he would save his company from closing or himself from prison.

5 years, 121 attorneys, and $25 million in legal fees later, his life’s work and freedom rested in the hands of 12 strangers in a San Antonio jury room. Would Howard and his company be vindicated by the verdict, or had he made the biggest mistake of his life by challenging the federal government?

Howard Root

Former CEO

Vascular Solutions, Inc.


Enforcement & Agency Coercion

The Federalist Society and Regulatory Transparency Project take no position on particular legal or public policy matters. All expressions of opinion are those of the speaker(s). To join the debate, please email us at [email protected].

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