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.
Mark DuVal, JD, FRAPS
Mark DuVal, JD, FRAPS, is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical and nutritional supplement industries.
Howard Root is the Chief Executive Officer of Vascular Solutions, Inc., a company he founded in 1997 to develop a single medical device, took public in 2000, and subsequently transformed into a clinically-based multiple product medical device company.
Tom Salemi: Hi, everyone, Tom Salemi here. Welcome back to the Medtech Talk Podcast. We are one week away from the Medtech Conference, and if you’re joining us here on this Podcast, you should be joining us at the Medtech Conference. It’s in Minneapolis at the Loews Hotel. Still time to register and if you use the Medtech Talk code, you’ll save yourself a little bit of money. So go to medtechconference.com, check out the jam-packed agenda. It’s really been great working with our co-chairs, Kevin Hykes and Justin Klein to put together this program. I think you’ll really find the whole day to be fascinating. But if not, there’ll certainly be something for everyone on the main stage, including a robotics panel that I’m going to have the pleasure of moderating. I just did the pre-panel call today, just to go over some talking points, and it was a fascinating discussion, even just in a warm up conversation. So I can’t wait to get on the stage and talk to those leaders in the robotics space. I want to focus on the breakout sessions that’ll be happening in the morning and the afternoon at the Medtech Conference. We’ve got five great sessions. We’ve got partners like Fox Rothschild, PWC, Silicon Valley Bank, McDermott Will and Emory. They’re all presenting great topics that will help medtech executives and entrepreneurs find successful paths going forward. This Podcast, though, I want to focus on one in particular. It’s being put on by Mark DuVal of DuVal and Associates. Mark is focusing on the off-label promotion prosecution that’s being pursued quite vigorously by the Department of Justice, and specifically he’s focusing on the case, or at least building his presentation around the case that the government had brought against Vascular Solutions and Howard Root. We’re very happy to have Howard Root joining us next week at the Medtech Conference. He’ll be joining Mark in the presentation. They’ll share Vascular Solutions’ experiences, his own experiences, and he’ll offer the advice or the lessons he’s learned from the last 5 years that have cost the company $25 million to defend against the case that essentially collapsed against – upon its own weight. Vascular Solutions’ defense team didn’t even have to present a case for the jury to find in the company’s favor. So this really is an important thing, and it’s something all medtech folks should be aware of and to make sure they’re protected against. And this conversation in today’s Podcast will sort of set the stage for next week’s conversation between Howard Root and Mark DuVal at the Medtech Conference. Let’s have a listen.
TS: Howard Root and Mark DuVal, welcome to the Podcast.
Mark DuVal: Thank you.
Howard Root: Thanks, thanks.
TS: Very happy to have you both at our Medtech Conference next week, and you’ll of course be leading a breakout session. Mark, maybe you can just give the title and sort of what you’d be hoped to deliver in that breakout session. And then Howard, we can get into the back story as to what is going on with the DOJ and with the government, and really how they’re going after a number of medtech companies. But we can focus on your experience with Vascular solutions, which fortunately had a happy ending a few months ago when the jury found very quickly in your favor. But Mark, give us a quick overview of the session next week.
Mark DuVal: Well, the session is really about taking stock of the Howard Root Vascular Solutions acquittal, which of course started with the prosecution and indictment and the prosecution. And we want to just take stock of what that case was all about, and what does it mean for executives today who are faced with being in the same position as Howard was with his board of directors and his investors, and understanding the courage it took to make some of the decisions that they made, and how that all turned out well and good, but we want to sort of look at the landscape today and where the government’s approaching this from a legal perspective, and what does it practically mean for a management team as they face these issues day in and day out as they promote products as any company commercializing medical devices promotes their products.
TS: That’s obviously an important issue, and let’s just get into the history. I mean this has been a 5-year battle for you, right, Howard?
Howard Root: Right, yeah. It started back in 2011, and it just ended with a not guilty verdict at the end of February. So almost 5 years start to finish. And $25 million, and 121 lawyers later we had a successful end, but the damage of the money and all the lost opportunities is always gone.
TS: How did this start, like literally? What was the first sign that you got that they would be coming at you like they did?
HR: Well, virtually, all these incidents start the exact same way. Some former employee decides that he wants to make some money. And the way the whistleblower system works, the qui tam lawsuits, he goes to a lawyer, talks to him about things, creates claims. In this case, he created a bunch of false allegations of what had gone on at Vascular Solutions about just one of our 100 medical devices that we sell, a product that made up 0.1% of our sales. But he created this idea that this was being promoted off-label, that he has some crazy theories of what the regulatory situation was around the product, created a complaint, filed it. He filed it with the US Attorneys, they get time to decide whether to intervene. They do intervene, and then they start their investigation, and their investigation starts by talking to that disgruntled employee, former employee, who gets 20% of whatever they recover – at least 20% of whatever they recover. So he makes the claim for $20 million. If the government shakes out money from Vascular Solutions, he gets 20% of that, or $4 million. So there’s a strong incentive for him to actually create really false stories about what went on begin. And then from there, the government, after deciding whether this is something to investigate, starts sending a subpoena to us for all our records. At the same time as this qui tam lawsuit goes on, there’s a criminal investigation on the same facts, the same office down in San Antonio starts. And then from there, they decide to call witness down to grand juries, they invest their money and their time. We settled the qui tam lawsuit for an insignificant amount of money, no admission. But the criminal investigation continues to go on. And then it’s just a cascade of issues when the government gets their hands on something, invests their what they call blood, sweat and tears. Because in the end, the only way that they’ll settle it is if someone pleads guilty, people get fired, people get excluded from healthcare. Because we weren’t willing to do that, the government finally had to go trial and the jury decided that there’s nothing there and came off with a not guilty verdict on all charges. That’s kind of a quick thumbnail of what went on.
TS: And what was the nut of the charge? Involved one of your devices and whether or not it was being used to market it for the use of perforator veins? Is that right?
HR: Right, yeah. So it’s the Veri-Lase product, which is an endovenous laser product. It’s the treatment for varicose veins. We had the general indication for use in varicose veins, all varicose veins. We had 8 separate 510Ks. The reason why we had 7 more is to try and get specific indications for the lesser saphenous, for the tributary, for the perforator veins. We had all those except for the one around the perforator veins, and we still had the general indication, but didn’t have the specific indication. And this employee claimed, and the US attorneys went down this theory, is that because we didn’t have the specific indication, and because some sales reps, a few of them talked about perforator veins, they thought that was a crime. And at trial, what we finally proved, but the government never believed or never heard or never even asked us to explain is that because we had the general indication, that was sufficient legally to be talking about perforator veins. It was covered. So in essence, this was an off-label prosecution for an on-label use of a medical device. And it was only at trial we could prove that and be judged not guilty.
TS: And what transpired over those 5 years? What were you required to do? Did you submit to many interviews with the government? Were there a lot of testimony? Were they at your offices, going through, I don’t know, your servers and emails and such?
HR: Well, this is my first criminal investigation.
TS: Good for you, congratulations.
HR: So that’s a good thing, you know? Hopefully my last criminal investigation as well. I was a lawyer by training, but I was a corporate lawyer, and I always wanted to do criminal trials. But I wanted to be the lawyer, not the defendant in the criminal trial. But be careful what you wish for sometimes. But the criminal process is a little bit different because it’s not a back and forth between two equal parties. The government’s got all the power. First, they have the grand jury subpoena. So they go and say we want these 20 witnesses, 20 employees to come down here and answer questions. And when they pull them into the grand jury session, there’s no lawyer from our side allowed in there. There’s no judge in there. It’s the prosecutor, it’s the witness, and it’s the grand jurors. And they just beat these people up. I mean they just outright, I would say, lie about what the law and the facts are and ask them to agree, and then they claim Aha, we have all this evidence about what went on. And in this case, it was even worse. These prosecutors read secret grand jury testimony to other witnesses and asked them to agree, threatened them with perjury charges if they didn’t change their testimony. Really did anything they could to try to create the case that we were doing something wrong. I offered to go down and talk to the prosecutors. That meeting was set up. Two days before the meeting, they canceled it. They never talked to me. So they indicted me without ever talking to me about what the facts were. Instead, they just used the grand jury process to kind of beat us up. They also did subpoenas. They got 2 million pages of our documents. They went through all of them trying to find what words the sales reps said in a trip report about a talk with a doctor. They were just mining through an entire 7-years’ worth of records to try to find something that bolsters their case.
TS: That’s remarkable that they never actually talked to you.
HR: Right. What good was that going to be? I was going to say that nothing happened. And they never even interviewed the FDA expert, the branch chief that they called as their expert at trial. They never interviewed him before hand to ask him did we have the approval. When we put him on the stand and we had the cross examination, we asked the question. So you could see that this approval covers perforator veins? And he answered, It could. Now, if the approval covered the use in perforator veins, it’s not off-label. And if it’s not off-label, you cannot charge me with a crime. But because these prosecutors said their mission was to prosecute us, not to get to the bottom of the matter, not to get to justice, but to get a conviction, they didn’t even care to ask their expert witness that question. Now it all blew up at trial. And as a result of that, we didn’t call a single witness to testify in our defense. The government called 20 witnesses. At the end of that, after cross examining them, we just rested. Went right to closing arguments, a day of deliberations; the jury comes back unanimously not guilty. So how does that work when the government brings criminal charges, presents all their witnesses, and still can’t win a case? I mean there’s a problem at the Department of Justice on how these people are motivated and act and what their attitude is towards medical device companies. And that’s something I think everyone should be aware of if you’re running a medical device company today.
TS: So it sounds like it’s akin to charging someone with theft without anything really ever being stolen.
HR: Well, there’s an old saying that in Soviet Russia – I don’t want to get too far into it – but they say, You show me the person, I’ll show you the crime. And it’s almost gotten to that way with the Department of Justice in medical device companies. I would say that in the eyes of federal prosecutors, every operating medical device company and every CEO commits at least one felony every year that could cause him to go to prison. That’s in the eyes of the federal prosecutors. And once they get that idea and they have the incentive to continue the prosecution, they’re going to bring more and more of these charges. It’s a profitable operation for them. They make $7 for every dollar they invest. So the incentive is there, the ambiguous regulations are there, the process is there for them to abuse. Everything is there for prosecutors to continue to make us the number two target in America, right after banks. Banks are number one; healthcare individuals are number 2 in the eyes in the Department of Justice for criminal prosecutions today.
TS: Mark, can you just give us sort of a broader sense? You’re knee deep in all of this. Are you hearing many other accounts similar to Howards?
Mark DuVal: Yeah, well, first of all, let me tell you when Howard’s indictment came down as well as Bill Facteau and Acclarent, our firm started getting calls from board members and CEOs all over the company. And we started spending a ton of time doing a couple of things. One is helping them understand what the heck is going on, understanding the landscape, the law as it applies to this area; and secondly, are we violating the law. So a lot of them were asking for compliance assessments, and we dig in, kind of look at what they’re doing promotionally speaking. But seminally, it all flows from, in a macro sense, you’ve got these 2 dysfunctional divisions of government. You have the Food and Drug Administration creating, if you will, this label by virtue of the clearance or the approval they give for a device. And you’ve got the Department of Justice acting upon that if they feel that something is deemed off-label like they did in Howard’s case, and running with it from a criminal perspective. Because it’s all about they tout and they brag, the Department of Justice, that for every $1 they spend, they bring in $8 to the federal coffers. And where does government get to have prosecutorial effort become a revenue raising vehicle? Isn’t it really about a search for the truth? And so when we work with management teams, this decision really requires management in essence to rethink how it wants to approach commercial discussions regarding off-label uses and claims about approved or cleared drugs in medical devices. And so we will work through them with the FDA. And the government lost a lot of cases as of late in the first amendment arena. And we’re talking about the Caronia case, the [Ameren?] case and the Paceria case, which I’m not going to drill down on. And what a lot of people are more familiar with now today, the Howard Root Vascular Solutions case. And there’s others coming. There’s the Acclarent/Bill Facteau case as I was talking about. Pat Fabian is involved in that as well. In addition, you have the Warner Chilcott case that’s coming up. So there’s a lot of stuff and the government is being challenged. And when they get challenged, it’s one thing for them to settle civilly and extract funds, because companies often just don’t want to take the stock hit, they don’t want the specter of what Howard had to face, and that is pursuit of a criminal case. And there’s just a variety of reasons to extract yourself from the governmental allegations early on. There’s no incentive to carry on because you’re exposed. But when companies do challenge the government, the government has uniformly lost. And Howard’s an example of that, but at $25 million of expense. So the case itself was very interesting to me and intriguing on a number of fronts. One was first of all, I teach all the time about general versus specific use. It’s an FDA guidance document, and companies are all the time trying to understand OK, we’ve gotten this umbrella claim from the government. But I have a specific use to which my device can be put. Is that under the umbrella and deemed on-label? It’s protected from the elements and being considered off-label? Or is it so far afield it’s outside the protective region of the umbrella, exposed to the elements, and therefore deemed off-label? And it’s therefore subject to criminal and civil prosecution? So we’re helping management teams all the time trying to understand that. And there’s invariably risk because sometimes you clearly know that a use is on-label; then there’s those that you think are clearly on-label, but you think the FDA may disagree with you. And there’s a third category where you believe the FDA thinks that that use is off-label, but you believe it’s on-label, so what are you going to do in the face of that kind of opposition? So we put companies through that exercise to figure out what is it they can do and categorize each of these things, and then decide how they want to promote their product. But in Howard’s case specifically, I found it remarkable that the prosecution rested their case after presenting their full case against the defense, Howard and the company, and then Howard and the company rested their case much – I mean it had to shock the judge –
TS: You read my mind.
MD: – it had to shock –
TS: That’s what I wanted to get into.
MD: Yeah. Absolutely. It’s crazy. And that took a lot of guts to do that. You had to feel pretty secure that in your cross examination efforts you did such an extensive and good job that you actually presented your defense through the prosecution’s witnesses and other evidence. And they did that. And that’s remarkable.
HR: I mean that exactly – when you get into trial, there’s 2 parts for a jury’s decision. It’s the law and it’s the emotion. It’s the facts and the emotion. Some people are thinkers; some people are feelers, right? The thinking side, we had done enough on the cross examination to give every thinker the understanding that this government was just wrong, just flat out wrong. Their own experts said this thing is covered. That’s enough. We’re not going to get any better than that. On the feeling side, we got into evidence all of the abuse that the government did to my employees. The threats. They said to one guy, You have to sign on the dotted line and come to San Antonio and testify against Vascular Solutions and me, or else you could face 30 years in prison.
HR: So if you don’t sign what we put in front of you, you’re going to – now if you do sign that, you’re free and clear. Nothing’s going to happen to you. I mean that kind of stuff, when juries hear it, they think, What is this going on here? This is not the government; this is a shakedown operation. And we already had that as well. So when you have the feelings and the thinking, and it wasn’t going to get any better, we said that’s it. But it is amazing that the government’s case itself proved our innocence. So the government couldn’t win with just us tying our hands behind our back and calling our own witnesses. And yet what happens to the prosecutors? I mean it’s not like they suffer any damages. They don’t have to pay any money for this. They don’t get censored. I mean in case after case where the Department of Justice has made mistakes, outright misconduct, they still don’t punish their own. They still don’t go after their own prosecutors. And that’s a bigger problem in the entire Department of Justice, but it also applies really to us in medical device land.
TS: HI, everyone, Tom here. Sorry for the interruption, but did want to remind you that we’ll be following this story even further at the Medtech Conference. So go to medtechconference.com, use Medtech Talk Code to register, and you’ll be able to meet with Mark and Howard either in the breakout session or in the hallways at the Loews Minneapolis Hotel.
TS: That’s remarkable. And it’s chilling, too, to hear that, and to be an employee who’s given basically a way out, and all you have to do is do this thing that even if you don’t think it’s the right thing to do, the alternative might be 30 years in prison. That’s a difficult place to be in. I mean for them – it must be really remarkable for you as an employer to have employees who didn’t take that offer and didn’t do what was being crammed down their throat.
HR: I mean the guy I mentioned there, he did sign what they wanted him to say, and then he came and he testified. And it sounded bad on direct. And then he gets a cross examination, and our lawyer starts asking him the questions about why did he sign the statement and what did he believe. And you don’t want to get him to admit he committed perjury on the stand, but on the other hand, he pretty quickly backtracks from the words that the government wrote for him to sign, as opposed to the words that really happened in his own mind. And the jurors, I mean people fear juries. In my case, I feared the judge. I feared the prosecutors. I didn’t fear the jurors. The jurors could see through things. They felt things, they understood what was going on. And in this case, a product that was so insignificant, 0.1% of or sales, never harmed a patient, and we’re getting prosecuted based on what a sales rep said. No one could figure out why this was even a criminal case. And that’s the great equalizer. They have to believe beyond a reasonable doubt you committed a crime. But I’ll tell you, there’s no false optimism here. To get to that point, to spend that amount of time and that amount of money and suffer those kind of attacks and have your name plastered on the front page of the local paper as being a criminal, I mean you gotta have a strong stomach to go through that. And then you get exonerated, but only then exonerated. And the allegations probably still live on forever.
TS: That’s amazing. So where do you go – you’re right. You don’t even present your case. You’re vindicated. You probably, obviously, were elated. But you just spent 5 years and $25 million fighting this thing that obviously was baseless to begin with. Where do you go from there? And how are you managing Vascular Solutions going forward? And maybe within that answer you could also say how did you manage it during these 5 years? It must have been a major distraction.
HR: Yeah. So what do you do going forward? Well, the first time we looked at it is can we sue the prosecutors in the government for malicious prosecution, because that’s clearly what this was? We find out that there’s a provision for that, statutory provision. But the problem is if you’re a rich company, you can’t take advantage of that provision, and if you have a net worth over $7 million, you can’t take advantage of that provision. You can’t sue the government for malicious prosecution. So you have to have enough money to survive, to pay $25 million for your legal defense. But if you have over 7 million when you started it, well, the only people who could sue the government is the ones who couldn’t survive a malicious prosecution. So that was completely eliminated. We couldn’t do that. And we’re trying to push the Department of Justice on doing something against these prosecutors and their supervisors, who should have been reviewing this and stopping this before it got there. But it’s all based on a Washington, DC kind of putting pressure on the Department of Justice. What we do internally, well, even though I say that every company is committing a felony every year, that’s not an excuse to say ignore your compliance. If you’re going to be accused of something, it doesn’t matter, just don’t do anything. No, you’ve got to make sure that you’ve got the policies in place, you’ve got the compliance officer in place, you do the audits, you do the follow up, you address things as they go along. You want to minimize that risk as much as possible. We had already done that. I mean I had been doing this since I was a lawyer. I was a compliance officer at my old company back in the 90s. And we put this complete system in place, but you can always do more. And one of my lessons is the first day that a medical device company sells a product in the US, you need to have a full-time compliance officer. I don’t know any other way you can limit the risk unless you have a full-time compliance officer just devoted to this. There’s just too much to do. We have a compliance program that goes 100 pages long of just the tasks that we’re doing every single month in terms of education, in terms of auditing, in terms of record keeping, in terms of record retention. And the record retention policy is as important as anything else in these situations because emails and documents can be the benefit or oftentimes the magic bullet that kills you in these kinds of situations. So all that has to be done. And you can amp it up and amp it up and amp it up. And what does that do? It just takes money away from developing new medical devices and puts it into really the compliance area, which is important, but not to the extent that they’re forcing us to go into insignificant matters like what we went through with the short kit investigation and prosecution.
TS: What was the company like over these 5 years?
HR: Well, there is ebbs and flows. And actually, when it got to the trial was one of the more calm times because I could see what was happening as it was happening, and I had confidence in what the result was going to be. But the real tricky time, the real uncertain time is before you get indicted, when you see something and it’s not been exposed, it’s not been disclosed, and you’re sitting there trying to figure out well, what’s going to be the stock market reaction when the company gets indicted? We’re a public company. Are the shareholders going to sell all the stock? Are they going to believe me? Are they going to say the government’s never wrong? And the fortunate thing that I found as we got indicted and the stock went down some, but it bounced back up, and we never had a single shareholder lawsuit. The only reason that was because there wasn’t any lost money in the stock market. I mean for a day or two, but it came back and the plaintiffs’ firms didn’t see anything through their trolling to try to find plaintiffs or to try to create claims that they could go after us on. So that was amazing. But the banks and the financial institutions and the mutual funds, they understand that the government’s not always right. And so they are really on your side. And once the shareholders are on your side for a public company, the employees see the stock price being up, and they’re on your side as well. Until they get pulled down to a grand jury. And I saw employees who are very strong employees leave the office to go down to San Antonio for the grand jury confident and come back just beaten down, and really beaten to the point that they didn’t want to continue to go on. But we kept them together. We didn’t lose a single officer during this process. Our business grew, our sales grew by 17% last year while we were fighting this criminal indictment. And it was our 12th consecutive year of double-digit percentage sales growth. And we still were profitable, even in spite of that. But if it happened to us 10 years ago, we wouldn’t have been big enough to survive. If it happens 20 years from now, we’re probably too big to survive, and the board of directors would have done something different. But we didn’t make a single change to our system in terms of operations and governance through the whole process. We just hunkered down. We went full turtle, as I said, pulled everything into the shell, and withstood the blows from the government, won, and now we’re back out spending all the money on R&D as opposed to lawyers.
TS: And you are not shrinking back. I think a lot of people would be tempted just to duck and keep down after this sort of entanglement. I remember reading the release that you issued the day after the acquittal, and I remember how strong the language was. How did this affect you personally, both just as a professional, but also at home? You clearly are very passionate about this.
HR: Yeah. If you look at it, and you got through something like this, and the government’s done something wrong, and you see them doing it over and over again, not to me over and over again, but to more people and more people, and then I see people who want to just like say nothing and wander away. And that’s just not acceptable. That’s just not the way that things improve. If we don’t say something publicly, it’s going to get worse. And it’s already really, really bad. So I was confident that we were going to win. I put a lot of time into that press release, wrote it myself, edited it myself, did the legal review myself, which I don’t recommend. But in this case, I was going to make sure that I said the things I wanted to say my way. And we’re not out there slandering people, but we’re certainly laying the facts out there. Because there’s got to be pushback. There’s no other answer to this. If there’s not a public pushback against what the government’s doing to us, it’s going to continue. So that’s where I am. And I’m kind of built for that. I mean I was a lawyer by training. I started the company 20 years ago, and you don’t go through that without having a pretty thick skin. Of the things I’ve gone through, this is only the third worst thing that I’ve encountered at Vascular Solutions. I mean our first product failed, commercially failed. Our stock price went from $12 IPO to $26 down to 70 cents. And we had very little chance of survival. And because of the hard work of our employees, we pulled it through. So that was even harder than going through this criminal trial. But once you do all this, you don’t want to just sit there and wait for the next one. You want to go out there and talk about it, and hopefully something changes in the Department of Justice and at the FDA that they don’t continue to try to do this nonsense to companies that are creating jobs and developing lifesaving medical devices.
TS: And you probably go to work every day worrying, or perhaps you don’t. But I would guess anyone listening to this has to wonder what their sales reps are saying, even perhaps being misheard or being misconstrued or uttering accidentally something that could be used against them in a future investigation.
HR: Yeah. Everyone who’s got an operational medical device company that’s selling a medical device in the US – and it’s not just the US, and It’s not just off-label. You got the False Claims Act, you got the Foreign Corrupt Practices Act, you got all the general regulations that apply to businesses, not just medical device businesses. So every one of those laws, every one of those regulations creates criminal liability for the CEO as the responsible corporate officer. If you’re not afraid of that, you’re not paying attention. And everyone who’s running a company or has their hand into a medical device company has to pay attention to what’s going on with the Department of Justice in these criminal prosecutions. When it was just money, anyone could just say, Well, we’ll just do a cost/benefit analysis. But if I’d lost, I would have gone to prison for a minimum of 3 years, no parole, 85% had to be time served in a federal penitentiary. I would have been excluded from healthcare for over 5 years. Essentially, my career would have been over. For a product that made up 0.1% of our sales, had 8 separate FDA clearances, and never harmed a single patient. Because supposedly a sales rep said the wrong word. I mean you wouldn’t believe it if it didn’t happen, if it wasn’t something that actually occurred because you wouldn’t think that the system is so out of control that this would occur.
TS: That’s quite a story. And we’d be interested in following up with you further down the line. Will you be telling this story in one form or another? You mentioned off the call that you’re working on a book.
HR: Yeah. One of the young attorneys working on the case decided to leave the legal profession to become a writer. And real fortuitous timing, because he quite right after the trial was over. So I said, Here’s the first project. Let’s write it together. And we’re about two-thirds of the way through it, and by the end of the year, it’s going to be called Cardiac Arrest, which I thought was a good title, and about the whole story of the criminal prosecution of Vascular Solutions and our successful outcome. So that’ll be the whole story. We’ll try to keep it under 300 pages, although he could write a lot, lot more about it. But keep it interesting and keep it small and short. But yeah, between that and just doing talks about it, I think it’s important to get this story out because I don’t think there’s enough people who realize it. Certainly in the medical device community, and even in the legal community as well. And when I talk about it, I get one of two reactions: either they’re appalled at it or they’re apathetic. And people who are apathetic just aren’t paying enough attention to what’s going on, especially if you’re working in this industry. So it’s good to get people aware of what’s going on.
TS: Well, we’re grateful to have you at the Conference next week. And Mark, thank you for putting this breakout session together. I’m sure it’ll be a fascinating study of this – it is an appalling situation. So I’ll go with appalling, not apathetic. Anything to add in this with Mark? What folks can look forward to next week?
MD: Yeah, just to say that I think you can tell it’s going to be an interesting session. They’re going to get the opportunity to sort of hear some general observations about the case and what it means for the management of any company. And they’re going to get an opportunity to hear Howard talk a little bit more. He’s got some bullet points that he’s going to go through that are going to be very interesting takeaways from this case. And we’re going to open it up for dialog, and we just really want people to ask the questions that they have on their minds at this point. And I think with only 35 minutes, it’s not enough time to do justice to this topic, but we’re going to at least try and broach some of the topics at a high level, and let some executives and VCs in attendance just bandy about the questions that they have on their minds that they’re confronting as they sit on boards, as they sit on their management teams. It’ll be fun.
TS: Well, I have a feeling that some people will be pulling you aside before and after those two breakout sessions. So thank you both for your time today, for sharing your story. Congratulations, Howard, on your victory earlier this year. And just sorry it came at such a cost.
HR: Thanks Tom, Thanks.
MD: Thank you, Tom, for your time.
TS: Well, thank you, Howard Root, for joining us on the Podcast and for coming to the Medtech Conference next week. Mark DuVal, thank you for bringing this important conversation to the Medtech Conference. It’s rather chilling to hear the account of a company that has done no harm can be really gone after by federal prosecutors. I’m glad that ordeal is over for vascular solutions. I’m amazed that Howard is taking as strong a stance as he can. I think it takes a lot of courage to do with he’s doing, and I admire that. And it also just reminds us that this continues to go on. There’s other members of the Medtech Conference community who are facing these sorts of investigations and indictments and trials. So something that bears watching going forward. Thank you to our Medtech Talk listeners for joining us today. One more time, this is the last chance to register for the Medtech Conference. Go to medtechconference.com. Use the Medtech Talk code, save a little money, and we will see you in Minneapolis.