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In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Howard Root, former CEO of Vascular Solutions and author of "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed's Hit List," and Mark Duval, President and CEO of DuVal & Associates. The episode delves into the harrowing experiences of navigating severe legal battles over off-label promotions, highlighting crucial insights into maintaining innovation while managing legal risks in the MedTech field. Additionally, Mark DuVal, a noted regulatory attorney, provides his expertise on the responsible corporate officer doctrine and its implications for industry executives.Key Timestamps:[00:00:15] - Introduction by Etienne Nichols.[00:01:30] - Howard Root's background and the origins of Vascular Solutions.[00:05:00] - Mark DuVal introduces Howard Root, detailing his legal battles.[00:10:00] - Howard Root discusses the intricacies of his federal indictment and the subsequent trial.[00:30:00] - Discussion on corporate responsibility and regulatory implications in the MedTech industry.[00:50:00] - Audience Q&A session with Howard Root and Mark DuVal.[01:10:00] - Closing remarks and takeaways.Quotes:Howard Root: "We're not imposing rules at the bare legal minimum...we want to have a gray area. It's why you drive 55 in a 60 zone."Mark DuVal: "Always be truthful, fairly balanced, and not misleading when discussing device applications."Takeaways:Latest MedTech Trends:Increased scrutiny on off-label promotions highlights the need for clear regulatory strategies.Growing legal precedents emphasize the importance of corporate responsibility at all levels of operation.The role of ethical practices in sustaining innovation within the MedTech industry.Practical Tips for MedTech Professionals:Ensure thorough understanding and compliance with FDA guidelines and local regulations.Implement robust training and compliance programs for all staff, particularly in sales and marketing.Engage experienced legal counsel to navigate complex regulatory landscapes.Future Predictions in MedTech:Enhanced regulatory frameworks to better define and manage off-label use.Greater use of AI and data analytics to monitor compliance and ethical practices.Increased advocacy for legislative changes to protect innovators from aggressive legal challenges.References:Howard Root's book, "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed's Hit List"Mark DuVal on LinkedInDuVal & Associates Client AlertsFDA guidelines on off-label promotions
Robbie listens back to an interview Jon had with Howard Root, and Max Rymer joins to round out the hour.
Friend of the show Howard Root penned a piece for the Star Tribune about his departure from the state as we welcomed him into studio for a pair of segments to discuss the article among other items.
The Matt McNeil Show - AM950 The Progressive Voice of Minnesota
Tina Turner dies at 83; Minneapolis and St. Paul each have top-5 park systems; the departure of GOP activist Howard Root; more DFL session victories; Jeff Stein makes his weekly Wednesday visit; woman indicted on money laundering; racism issues at a local Culver’s; Columbia Heights city councillor called on to resign over racist incidents; Duluth…
In this episode, The Mentors Radio host Tom Loarie talks with Howard Root, founder and CEO of Vascular Solutions, and author of the book “Cardiac Arrest: Five heart-stopping years on the Fed's Hit List”. Root shares his harrowing fight—and win—against Federal Department of Justice prosecutors who abused their power beyond all imagination. That was in 2011! The Feds' unsuccessful attempt to put Root behind bars and destroy his company was ruthless. They used the justice system to distort justice and abuse individual liberties guaranteed by the Constitution. Five years later, in 2016, after shelling out $25 million in legal costs, Howard Root won a UNANIMOUS acquittal. Even more disturbing than these five years of unwarranted persecution by the Federal Department of Justice, the jurors expressed shock and outrage that these charges were ever filed against Root in the first place! After the grueling journey and ultimate victory against the Feds, Root knew the Feds could target his company again, repeat their horrific injustices and violations of Constitutional rights and he did not want to jeopardize his company or its employees. He sold the company—which, at that time, was one of the most innovative and prolific medical device companies of its kind, and pursues other interests. He also helps other CEOs unjustly targeted and pursued by the Feds whenever asked for advice. This is a modern day David beats Goliath story, and it could affect you! Now more than ever. Learn what you can do to protect yourself and your company. Find Show Notes below. Never miss an episode; subscribe here to The Mentors Radio podcast. Listen on any platform - Apple, Google, Spotify, TuneIn and more - search for "THE Mentors Radio" SHOW NOTES: HOWARD ROOT: BIO: http://www.howardroot.com/ WEBSITE: HowardRoot.com BOOK: Cardiac Arrest: Five Heart-stopping Years as CEO on the Fed's Hit List , by Howard Root LETTER: HOWARD ROOT: A LETTER TO MY PROSECUTORS - Sent on fifth anniversary (Feb.26, 2021) of Root's court victory and an EXCELLENT read! ARTICLES: "Book Review: Cardiac Arrest — A Warning to Aspiring Entrepreneurs and Society at Large" – Catholic Business Journal “Medtech CEO rails against DOJ at industry conference” – Med City News
Jon is joined by another panel of guests midway through the hour including digital guru Max Rymer, friend of the show Howard Root and former candidate for Minneapolis mayor Laverne Turner. They all spend the hour reaction to the election results in Minnesota and nationwide.
Jon welcomes regular guest and Republican strategist Howard Root on for multiple segments to discuss the latest polls released right before Election Day, plus they get into predictions and what is next for the state of Minnesota.
Jon is joined IN STUDIO by Republican strategist and author Howard Root and the lovely Liz Collin to discuss her latest stories filed for Alpha News and new book coming out about the death of George Floyd.
In this episode of The Mentors Radio, host Tom Loarie and mentor Howard Root, former CEO of Vascular Solutions and author of “Cardiac Arrest: Five heart-stopping years on the Fed's Hit List” , deliver a riveting interview. Hang on to your seat as you learns about Root's harrowing fight—and win—against Federal Department of Justice prosecutors who abused their power beyond all imagining.... and based on, literally, nothing. No evidence. No case based in facts. No nothing! The Feds used bully tactics, threats and more, frustrated and trying to "justify" what became a massive, costly "hunt" for something that did not exist. The Feds trampled over individual liberties guaranteed by the Constitution. Five years after $30 million in legal costs and a UNANIMOUS acquital, jurors said they were concerned that these charges were ever filed. This is a modern day David beats Goliath story, and it could affect you! Learn what you can do to protect yourself and your company. Find Show Notes here. Never miss an episode of THE Mentors Radio --available on EVERY podcast platform -- by subscribing here to podcast (free).
Jon is joined in studio for the hour by independent journalist Rebecca Brannon along with the insightful and intelligent Howard Root to discuss Farmfest, crime in the Cities and more.
Scott Johnson and Howard Root compete against Producer Robbie in the News Quiz!
Drew is joined by Howard Root and Scott Johnson of Powerline for a Friday edition of Justice and Drew. Robbie's Rundown includes Dr. Scott Jensen's plan for state income taxes, Biden's cheat sheet, Target beefing up its security downtown and more,
Howard Root joins the show in studio to recap the GOP convention, and the newly endorsed Dr Scott Jensen joins the show.
Justice and Drew discuss the temp being depressed about the Wild, the sports betting bill, and Howard Root joins to close out the hour.
This weeks round table consists of Howard Root and Max Rymer, and Rep Tom Emmer joins the show.
Elon Musk is moving Tesla headquarters to Texas, and the Friday Roundtable with Scott Johnson and Howard Root join Justice & Drew to discuss that as well as various other issues.
The Friday Roundtable rolls into the studio featuring Howard Root and Rob Doar. They discuss how the Minnesota DFL is handling the situation swirling around Representative John Thompson.
The Friday Roundtable with Howard Root and Jason Flohrs sticks around for the final hour of the show to discuss ballot harvesting and security in elections. Later, Tom Emmer joins the conversation and shares his thoughts on a recent SCOTUS ruling related to election integrity. Finally, they finish up the hour by playing the Friday News Quiz!
Howard Root joins Drew and Rob Doar in-studio to complete the return of the Friday Roundtable.They discuss their thoughts on DeSantis as a presidential contender and drama within the many MNGOP House Caucuses. Plus, Tom Emmer comes on the show to discuss Biden's budget and unemployment.
Howard Root joins Justice & Drew to discuss the Department of Justice launching an investigation into the Minneapolis Police Department. Later, they're joined by Jason Flohrs and he explains why a public option in healthcare is not the answer for Minnesotans.
Scott Johnson from Powerline and Howard Root join Justice & Drew to share insight on the trial of Derek Chauvin. Later, they're joined by Art Del Cueto from the National Border Patrol Council to discuss the crisis on the border from his perspective working it.
Interview with Howard RootSupport the show (http://www.parkerdk.com/victory-hour)
Howard Root joins Justice & Drew to explain shorting stocks and meme stocks. Later, they discuss Minneapolis setting records for carjackings and car thefts.
Justice & Drew discuss the COVID-19 spike in cases that never happened, and how the media has handled the pandemic and election. Later, they're joined by Howard Root.
Justice & Drew are joined by Howard Root to discuss a judge ruling that Minneapolis must answer for the lack of police. Later, Pete Hegseth joins the conversation to chat about COVID-19 restrictions.
Justice & Drew discuss Biden being the least scrutinized presidential frontrunner *ever.* Plus, COVID-19 fear mongering is abound in Minnesota and Osterholm is out here stoking the flames. Howard Root joins the conversation as well to share his thoughts on a lawsuit by Minneapolis residents against the City Council for their lack of police in the city.
D.C. Correspondant Andrew Langer kicks off the second hour of the show with Drew and Brian McDaniel to discuss the DNC and all of Joe's plagiarism. Later, Howard Root comes on the show to discuss the Bannon indictment.
Howard Root joins Justice & Drew to discuss residents suing the Minneapolis City Council and Mayor Jacob Frey to take action to secure the safety of citizens amid an exodus of MPD officers. Later, they chat with Pete Hegseth about the DNC.
Howard Root joins Justice & Drew to discuss the lack of business owners and CEOs calling out bad policy in Minnesota. Later, Pete Hegseth discusses several topics including Minneapolis wanting to give the boot to their police department.
Justice & Drew discuss the high rate of COVID-19 deaths in long term care facilities and why the blame is on Governor Tim Walz. Later, they chat with Howard Root about the handling of the Michael Flynn case.
Justice & Drew discuss Amy Klobuchar being a hypocrite before they're joined by Howard Root to hash out details about a judge rejecting Roger Stone's previously secret request for a new criminal trial and Trump claiming that he was treated "very badly" by prosecutors.
On this show guest mentor Howard Root, healthcare founder and CEO of Vascular Solutions and author of “Cardiac Arrest: Five heart-stopping years on the Fed's Hit List” , shares with host Tom Loarie an insider's view of his harrowing fight—and win—against Federal Department of Justice prosecutors. Root faced Department of Justice prosecutors who abused their power in their unsuccessful attempt to put him behind bars and destroy his company. They used the justice system to distort justice and abuse individual liberties guaranteed by the Constitution. Five years after $30 million in legal costs and a UNANIMOUS acquital, jurors said they were concerned that these charges were ever filed. This is a modern day David beats Goliath story, and it could affect you! Learn what you can do to protect yourself and your company. Find Show Notes here. Episode link will be posted after its airing Saturday morning. Never miss an episode by subscribing here to podcast (free).
Howard Root joins The Cheri Hill Show via telephone. Howard discusses his experiences of false accusations against his original company, and encounters with The Department of Justice. Cheri also shares a similar experience that happened to her and her father. https://www.cherihillshow.com/ http://www.howardroot.com/about-howard/
We are excited to have Howard Root, founder of Vascular Solutions and author of Cardiac Arrest on our show. Howard’s story is incredible. He founded Vascular Solutions in 1997, took it public in 2000, and then sold it for $1 billion to Teleflex in 2017. Howard Root is most known for his recent five-year battle with the Department of Justice. After a lying whistleblower went to the DOJ with a false story about Vascular Solution, Howard ended up spending $25 million on 121 lawyers to stay out of prison. More Notes: Read Howard Root’s book, Cardiac Arrest Some advice: No matter your innocence, ask to speak to your lawyer before dealing with prosecutors. 40:35 – Quick fire questions. THIS WEEK: Work on the way you speak. Find videos online to provide guidance; complete some speaking exercises.
Guest Howard RootSupport the show (http://www.parkerdk.com/victory-hour)
John Gilmore is in for Sue this week...and he's joined by Howard Root. 8th District Candidate Pete Stauber and also Kim Crockett from the American Experiment.
John Gilmore is in for Sue this week...and he's joined by Howard Root. 8th District Candidate Pete Stauber and also Kim Crockett from the American Experiment.
Local pundits Howard Root and John Gilmore join the discussion of Tim Pawlenty's (possible) bid for Minnesota governor. More details are being released on the Florida school shooting, Brian Strawser from the Minnesota Gun Owners Caucus joins in the conversation.
State Senator Warren Limmer weighs in on Melissa Hortman going up against Raheel Raza. Later, they're joined by Howard Root.
When the feds thought Vascular Solutions would be a good target for a fraud investigation, CEO Howard Root thought it was merely a shakedown. He was wrong. Howard Root is author of Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds' Hit-List. See acast.com/privacy for privacy and opt-out information.
The gang (sans plus Howard Root) talks movies coming out this week, DVD/Blu-Ray releases, and more!
Musical comedian Henry Phillips comes in-studio ahead of headlining at Acme Comedy Company to provide some much needed comedic relief after a very long week. Plus, Bryan Miller and Howard Root stick around to hear Eric Dayton's puff piece, the parody song contest, and more!
The Friday Roundtable commences, with comedian Bryan Miller and Howard Root filling in for little Nick Zerwas, and they tackle Franken's speech and announcement of resignation.
It’s a dangerous trend—federal prosecutors have the power and authority to destroy a person’s company and reputation, but are falsely accusing innocent people of crimes they didn’t commit. To discuss growing concerns of “over-criminalization,” prosecutorial misconduct and the overall lack of accountability in the system, we’re joined by Cyril H. Wecht, M.D., J.D., an expert in forensic medicine and practicing forensic pathologist for the past 40 years, and Howard Root, retired CEO of Vascular Solutions, Inc., and author of the book, “Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List.”
Howard Root from the Center of the American Experiment joins Justice & Drew in-studio to talk about GOP Obamacare failures. They also discuss Dayton vs the GOP, opioid solutions, and more.
Howard Root is in for Sue this week. He chats with a conservative college student about what it's really like to be the outsider on campus. Tim Miller joins in the second half to discuss his campaign.
Howard Root is in for Sue this week. He chats with a conservative college student about what it's really like to be the outsider on campus. Tim Miller joins in the second half to discuss his campaign.
Howard Root is in for Sue this week. He talks identity politics. Also Scott Johnson joins the conversation to discuss the MN Supreme Court.
Howard Root is in for Sue this week. He talks identity politics. Also Scott Johnson joins the conversation to discuss the MN Supreme Court.
Howard Root is in for Sue this week. He talks identity politics. Also Scott Johnson joins the conversation to discuss the MN Supreme Court.
Howard Root is in for Sue this week. He talks identity politics. Also Scott Johnson joins the conversation to discuss the MN Supreme Court.
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?Featuring:- Howard Root, Former CEO of Vascular Solutions, Inc.Visit our website – https://RegProject.org – to learn more, view all of our content, and connect with us on social media.
Guest Howard RootSupport the show (http://www.parkerdk.com/victory-hour)
Closing Argument with Walter Hudson - KTLK Twin Cities News Talk AM 1130 - 103.5 FM
Closing Argument with Walter Hudson - KTLK Twin Cities News Talk AM 1130 - 103.5 FM
Closing Argument with Walter Hudson
After five years and $25 million, Vascular Solutions CEO Howard Root watched a jury confirm what he knew all along. His company had done nothing wrong. In this interview, Root and Mark Duval, who is advising companies in this area but didn’t work with Vascular Solutions, explain what all this means for Medtech executives.