Deep Dive Episode 8 – Cardiac Arrest: A Cautionary Tale

Regulatory Transparency Project Teleforum

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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?


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