Hardware Podcasts

#366: Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List

Global Medical Device Podcast · 9 May 2024 · 55m · Episode 366

What this episode covers

Howard Root, former CEO of Vascular Solutions, and Mark DuVal, President of DuVal & Associates, discuss Root's five-year federal criminal trial for alleged off-label promotion of a vascular device. Root details how a disgruntled whistleblower triggered a DOJ investigation into a product representing only 0.1% of sales, leading to a $25 million legal battle and the application of the Responsible Corporate Officer doctrine. DuVal explains the legal precedents, including the First Amendment protections for truthful speech, that ultimately led to Root's acquittal and shifted industry regulatory strategies. The episode highlights the critical importance of robust compliance programs, careful hiring practices, and maintaining a 'gray area' in corporate policy to avoid becoming a target for aggressive prosecutors.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vascular Solutions, DuVal & Associates, Teleflex, St. Jude Medical, Medtronic, Dorsey Whitney, Pure Watercraft, GM
Also
Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed’s Hit List, FDA, Department of Justice

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