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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-05-09
- Length: 55m
- Episode: 366
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-09-366-cardiac-arrest-five-heart-stopping-years-as-a-ceo-on-the-feds-hit-list
- Listen: https://podcast.greenlight.guru/episode/366-cardiac-arrest-five-heart-stopping-years-as-a-ceo-on-the-feds-hit-list

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-09-366-cardiac-arrest-five-heart-stopping-years-as-a-ceo-on-the-feds-hit-list#t=0) Introduction: Howard Root and Mark DuVal
- [2:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-09-366-cardiac-arrest-five-heart-stopping-years-as-a-ceo-on-the-feds-hit-list#t=154) Vascular Solutions Origins and Product Pivot
- [5:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-09-366-cardiac-arrest-five-heart-stopping-years-as-a-ceo-on-the-feds-hit-list#t=309) The Federal Indictment and Trial Costs
- [14:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-09-366-cardiac-arrest-five-heart-stopping-years-as-a-ceo-on-the-feds-hit-list#t=874) The Perforator Vein Case and Strict Liability
- [19:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-09-366-cardiac-arrest-five-heart-stopping-years-as-a-ceo-on-the-feds-hit-list#t=1156) Responsible Corporate Officer Doctrine Explained
- [24:23](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-09-366-cardiac-arrest-five-heart-stopping-years-as-a-ceo-on-the-feds-hit-list#t=1463) Cross-Examining the FDA and First Amendment
- [28:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-09-366-cardiac-arrest-five-heart-stopping-years-as-a-ceo-on-the-feds-hit-list#t=1687) Compliance Strategies and Hiring Risks
- [33:44](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-09-366-cardiac-arrest-five-heart-stopping-years-as-a-ceo-on-the-feds-hit-list#t=2024) Whistleblower Motivations and DOJ Dynamics
- [42:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-09-366-cardiac-arrest-five-heart-stopping-years-as-a-ceo-on-the-feds-hit-list#t=2568) Truthful Speech vs. Thought Crime
- [49:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-09-366-cardiac-arrest-five-heart-stopping-years-as-a-ceo-on-the-feds-hit-list#t=2976) Regulatory Guidance and Closing Advice

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)

## Most relevant to

early-stage companies

## Mentioned

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

## Related episodes from other shows

- [056 - "Non-Promotional Compliance" with Darshan Kulkarni](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-26-056-non-promotional-compliance-with-darshan-kulkarni) (Let's Combinate)
- [047 - "Truthful Not Misleading" with Darshan Kulkarni](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-24-047-truthful-not-misleading-with-darshan-kulkarni) (Let's Combinate)
- [135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-08-135-combination-products-mindset-mdufa-and-combination-products-fda-hierarchy-su) (Let's Combinate)
- [115 - Bottle of Lies, Generic Drugs Quality, Ranbaxy, Audits, and Inspiring Quality Pros with NYT Best-Selling Author, Katherine Eban](https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-20-115-bottle-of-lies-generic-drugs-quality-ranbaxy-audits-and-inspiring-quality-pr) (Let's Combinate)

## Citing this page

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