Medsider: Learn from Medtech and Healthtech Founders and CEOs - Is Off-Label Promotion Now Legal? What the Recent Criminal Case Against Vascular Solutions Means for Medtech

Episode Date: June 8, 2016

For as long as I can remember, at every company meeting I’ve ever been to, the topic of off-label promotion is always covered.  Whether it was new-hire orientation, a national sales meeting, or some other large commercial event, the dissemination of off-label information was always presented as not only a fireable offense, but something that could get you...[read more]Related StoriesHow Will These 2 Major Healthcare Changes Affect Medical Device Companies?Substantial and Sustainable – 2 Words That Medtech Companies Should Get Used ToSocial Media Best Practices for Marketing Medical Devices 

Welcome to Medsider, where you can learn from experienced medical device and med tech experts through uncut and unedited interviews. Now, here's your host, Scott Nelson. Hey there, ladies and jens, it's Scott, and welcome to another edition of Medsider. Before we get started with this interview with Mark DeVall, just a few quick messages. First, if you've enjoyed these interviews over the past several years, maybe it's been four or five for some of you. Please head on over to iTunes

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Medsider.com and subscribe to the newsletter. It's completely free, and that way you'll be notified whenever these interviews go live. All right. So on to the interview with Mark DeValle. We are going to learn about the recent First Amendment cases or free speech cases that the government has lost and what the outcomes mean for MedTech companies moving forward. We're going to discuss the criminal cases or the recent. recent criminal case, I should say, against vascular solutions, and why everyone in MedTech

should pay attention, why the government's focus on speech versus conduct is so important. The government's recent recognition that off-label promotion is legal, as long as it's wholly truthful and not misleading. Yes, you heard that right. Off-label promotion is legal, as noted in this recent vascular solutions case. And then Mark's advice for Med-Tech leaders in light of the government's losses to these aforementioned First Amendment cases. and how they should respond moving forward. So Mark is a fantastic interviewee. Not only is he very intelligent, but also very, very personal and presents in a, in a fantastic way.

And before we get down to the actual interview, I'll give you a little bit more of a background in regards to Mark himself. He's the president of Duval and Associates, a law firm dedicated to counseling companies in the medical device, pharmaceutical biotech food, and nutritional supplement industries. And prior to founding the firm, Mark was General Counsel for 3M Pharmaceuticals and Drug Delivery Systems, working both domestically and internationally. Mark is a frequent national speaker and writer on issues related to product approvals, clearances, combination products, product advertising and promotion, anti-kickback, and false claims matters. So without further ado, here's the interview with Mark.

Mark, welcome to the program. Thank you, Scott. I'm looking forward to it. All right, let's dive in. Talk all things off-label promotion and where we stand today with the FDA. So we'll start with one of your recent client alert newsletters, which I highly recommend. Anyone subscribe to if they're interested in keeping up to date with some of this stuff. But in one of those newsletters, you loosely compared Howard Root, who's the CEO of Vascular Solutions. You compared him to Louis Zamperini, who as many know is the main character from the movie Unbrose.

broken. And I think actually in that same piece, you quoted Howard Root as, as, let me pull up the quote here. It's, I think Howard stated, this is the most decisive victory since Operation Desert Storm at only slightly greater expense, which I thought was an interesting quote. So, with that said, or I guess with those two points in mind, let's dig into this recent vascular solutions case. And for those of, for those that aren't aware of it, can you kind of, kind of to provide a high-level overview first, and then we'll kind of dig into some of the key takeaways? You bet, yeah. Well, the vascular solution case involved the verilase product. And if I were to summarize, I think, you know, it's basically the bright tip and its

counsel was indicated for the treatment of varicose veins and varicocities that are associated with the great sapineous vein and for the treatment of incompetence and reflux of superficial veins in the lower extremity. And the government, was basically had said that they were promoting outside the cleared indication. And as you know, when you get a general intended use statement cleared from the agency, it's like an umbrella, if you will. And under that umbrella, there's a collection or a bundle of specific indications for use to which the product could be put.

And sometimes you're debating with the agency is something, an indication that falls under the protective reach of the umbrella and is outside from the elements, protective from the elements, and it's deemed on-label, or is it outside the protective reach of the umbrella and is deemed off-label. And so that's often the dispute you're getting into. And so let me give you an example.

If you have devices that are cleared for ablating soft tissue, if you say that they're used to ablate cardiac tissue, that's still soft tissue, but is that on or off-label in the FDA's mind? and if you say it's to treat atrial fibrillation, then is that on or off-label. Well, in that case, the FDA would definitely say the tool for ablation has definitely become the treatment for a disease state or condition. And so we're often, that's the conundrum we're often getting in with the agency is when you get a clear and intended use statement, it seems like you're cleared for absolutely everything, but you can promote it for nothing. And so that's the, when we're working with management teams, that's often the dilemma with which we're faced.

And I help them navigate through that, promotionally speaking, and say, what can we talk about for our device and what can't we say? So with Bastier Solutions, that's precisely what they got into. They had a short kit, a shorter version of the Verilase procedure kit to be used in treating short vein segments. And then some representatives were talking about using it in the perforator, which FDA viewed as a shorter segment. that presented more problems than just a regular varicose vein and required another clearance. And so that was sort of the grobom, and that was sort of the core of the dispute. And they basically went to court over that, and the company originally paid a $520,000 settlement, a civil settlement, to sort of get its way out of it and seek peace with the government.

but they kept pursuing it. They decided to make it a criminal matter and indict both Howard Root as well as the company. And that's the genesis for the case. Got it. And this one, I mean, just to, so just kind of in summary, vascular solutions had this product that was indicated for kind of the ablation of varicose vein or soft tissue. And yet, you know, it was oftentimes being used for shorter segments.

And that fell kind of into that gray area of, you know, is this online? label, is this Hoff label, you know, how far, you know, is this outside of the scope of this, you know, the general indications for use for this product? You know, vascular solutions, you know, then proceeded to settle a civil case with the, with the government, but the government then took a step further, basically, and, and decided to pursue, you know, criminal action against Howard Rute, who's the CEO as well as vascular solutions. Is that kind of, have that right? Yeah, exactly right. Yeah, exactly. And I remember, a year before the case, you know, was going, actually going to trial Howard and his public relations expert,

crisis management expert, John Austin, asked me if I would be an outside, unpaid independent spokesperson to whom they could direct, you know, media inquiries to talk about this stuff. And I, and I acquiesce to that. I had never had a financial relationship. Still don't with Hardroot. We just, we've actually become friends through all of this. I'd been a social acquaintance with them at different CEO VC, me, meetings, et cetera, industry-type meetings. But so I got funneled everything in real time so that I could respond to the Wall Street Journal, the Minneapolis Star Tribune or whomever might have questions about the case. And it was just interesting.

I remember saying a year ago or a year before the case, I said, Howard, just, you know, don't, you don't have to concede that this is off-label. You know, this, under FTE's general versus specific use guidance document, I feel very firmly, very firmly that this is an on-label use. And if you interpret that guidance properly. And in fact, that's what they did in defense. And the crazy thing, the crazy thing about the defense was they rested after the prosecution's case. You can imagine that the defense, who had 20 witnesses lined up, actually after the prosecution rested case, they also rest, which just made the judge drop as well as the prosecuting attorneys.

And I presented no cases because they felt they had done a good enough job on cross-examination and case in point. They took Dr. Neil Ogden, who was a branch sheep with whom I work a lot, and he's a very highly respected, honest guy, and he testified honestly. They basically led him through a path of cross-examination that got him to admit that the use in perforator veins could be considered on label. Well, that destroyed the FDA's case right there. But that's the kind of stuff that goes on in these cases, but it was a fascinating case to follow. And, you know, they basically took them to the general versus specific use guidance. and also a modifications guidance that suggested that in interpreting either of those, one could conclude, through FDA's own guidance document, that these use and perforators was on label.

So they did a masterful job of that, in that case, the King and Spalding lawyers as well as the Frederson and Byron lawyers. Got it. That's interesting. And just to clarify at one point that you mentioned, the prosecution went through, so the government in this situation, the prosecution went through their entire. their entire list of witnesses to basically testify. And the defense had their series of witnesses as well that they had said, but they didn't have to bring any, any to the stand. They just solely relied on their cross-examination of the prosecution's witnesses, and they won decisively.

So, I mean, that's pretty amazing. Yeah. And, you know, it's gutsy. It's risky to do that. because wouldn't you be tempted to say, gee, I don't know, have we done it? Have we done a good enough judge? Should we put on our witnesses? We're all prepped and ready to do that. But I said, no, it might be better to leave well off alone and just go with what's been presented. And, boy, they called it right. And, you know, the guy's unanimous 12 to zero verdict. So it was pretty spectacular when you think about it. But it also shows the great deficiency and arrogance of the government's position to not to be so blind.

hindsighted that, you know, that they, the defense didn't even have to put on a defense in order to win the case. Right, right, no doubt. So let's, I mean, certainly an interesting case on a lot of different fronts. But in that client alert newsletter that I mentioned earlier, you kind of laid out three different key takeaways, or three different, you know, major implications for med tech companies. And the first one was the government's focus on speech versus conduct. So can you kind of outline that key point? Then we'll get to the other two here in a second. Yeah, this is, so the government, you have to recognize that there's cases that have

gone before the Howard Rout vascular Solutions case, and that'd be the IMS versus Sorrel case and the Coronia case and Amer and Psyria cases. So this is in a lineage of cases and losses for the federal government. They have sort of segued over the time. They've been trying to prosecute this speech, and basically, the government, or the judiciary has basically said, look, you know, if you're admitting government that it's truthful and not misleading speech, that cannot be the basis for a misbranding and adulteration case. Okay? And so they've disabused the government of that idea that they can

use speech. So what the government has fancifully turned to is that, well, we're not going to prosecute speech anymore, but the conduct underlying that speech. So in the case of Howard Rout and Vascular solutions. These are the kinds of conduct that they tried to prosecute. They did try to prosecute six different things. The defendant's decision to launch a special kit designed specifically for perforator veins, which was in response to a competitive threat. Their manufacturer of that kit with perforator specific modifications. Number three, their application to the FDA for clearance in and of itself with conduct. Number four, the, the, and by the way, when they sought clearance for the use in the perforator veins and didn't get it because they didn't like their clinical trial.

I didn't even think, by the way, the company needed to submit for an additional 510K to get that clearance, and indeed the courts agreed. Number four, their investment in a clinical trial for the purpose of gaining that clearance. Number five, their decision to launch the product without clearance while adding new deficient directions for perforator use to the labeling. And finally, their efforts, what the FDA says, or the government, the U.S. attorneys actually said their efforts to defraud the United States by concealing and lying about their perforator sales activity. They said these points of conduct are what we're really prosecuting, not the speech. Well, the courts in this case and in uniformly have pretty said, has pretty basically said, look, the interesting about the theory is that none of the conduct really becomes actionable, of course,

until there's a speech or communication that's made to the outside world, a world outside the company to effectuate the conduct. So basically what Judge Lambert has said in the past is that the regulation of marketing and promotional activities and the regulation of conduct, you can only relate conduct to the extent that moving one's lips is conduct or to the extent that affixing a stamp and distributing information to the mails is conduct. You know, it's ridiculous to think you can get indirectly at something we're telling you you can't do directly. The conduct is really synonymous with the speech.

So it was a fanciful theory. The government keeps trying, and it has lost on that grounds now. And that's a very important basis for their prosecution. So, Mark, just to be clear, you laid out kind of six different points or six different kind of points of conduct at the prosecution addressed in the trial. And you're saying because vascular solutions, really didn't ever, you know, present that or market based on some of these things, it really wasn't conduct, right? Or I should sorry, it really wasn't ever speech versus, you know, conduct.

Am I kind of understanding that correctly? Well, it doesn't become actionable. None of the conduct becomes actionable until there's communication to the outside world. And once there's communication to the outside world, that's effectuated through speech, and speech is not prosecutable, if it's true. and not misleading. So if you follow that philogism, that's how the judge basically said, you can't prosecute this conduct. You're getting at, you're getting at this, trying to get at it indirectly, well, I've not allowed you to do directly. Conduct will eventually be speech.

Sure. Okay. That makes sense. All right. So the second point I think that you call out, if we, if we can move on to that one, was the recognition of off-label promotion within the actual jury instructions in this particular case. So can you kind of provide us with some background on that point as well? Yeah, well, this really rocked my world. And I think a lot of insiders who really are counseling companies like I am. And just before the case, there have been some motions to dismiss. And the King and Spalding team did a brilliant job as sort of forcing the government's hand at declaring what their position was. But at the very end, because they had so hammered them that you can't use truthful and not misleading speech as a basis for prosecution,

they ended up agreeing to a jury instruction that blew me away. Because we've always heard about off-label dissemination, but we've never heard about a theory or a concept of off-label promotion. And so if you'll permit me, I'm just going to read, it's very short, I'm going to read this jury instruction because it's going to blow you away too when you appreciate it. Sure. So these were the instructions to the actual jury in the trial on this particular trial. This is what was acquiesced to by the prosecution, the U.S. government. So they uttered these words for the first time ever. Doctors may use medical devices that have been approved or cleared for one use or for a different use that has not been cleared or approved by the FDA.

We all know that. It goes on to say this is often for an approved or off-label use. This is not illegal. Now listen to this. It is also not. a crime for a device company or its representative to give doctors wholly truthful and non-misleading information about the unapproved use of a device. Wow, I can't believe that. If you find that Vascular's promotional speech to doctors was solely truthful and not misleading, then you must find the defendants not guilty of the misbranding offense. That rocked my world in a lot of experts who were following. In fact, I know an article came out that day in the trade press about it saying, wow, the government just chronicled their position that off-label promotion could be lawful.

And so it stands for that proposition today. That's the first time it's ever been uttered by the government. And now it's in the context of a jury instruction. And it's a really, it's a really important concept that they've just uttered. Right. Yeah. I can definitely see the importance of that particular. point, maybe the most important point of these three that we're covering right now. So the first one was kind of the government's focus on speech versus conduct. The second point that you just covered was this, you know, the way the instructions were addressed to the jury in terms of being able to a medical device company's ability to promote a message that's wholly truthful, right, you know, this concept of off-label promotion. And the third point was specific to, you know,

the FDA's interpretation of general versus specific use. So can you tell us a little bit more about that third point? Yeah, and it's going back to the point I made about, you know, when they cross-examined Neil Ogden, who was the branch chief, and they got him to basically admit that it was not off-label or a non-label use by just the defense counsel just literally took them through, you know, the package insert. And they talked about, so they talked about the the indications for use statement, they said, you know, it refers to the ablation of soft tissue, yes, and you'd agree that the veins are soft tissue, correct, yes. The great saffinous vein is made up of soft tissue, yes, correct.

Correct. The short saffinous vein is made up of soft tissue, correct. The perforator veins are made up of soft tissue, correct. Intributory veins are made up a soft tissue correct. And the second part of the clearance refers to varicose veins, and they took them down that path, but, yes, perforator veins could be varicose veins. And they basically entrapped the branch chief into indirectly admitting that this could be an on-label use. And they also did it with the outside clinician and that the government put on as a witness.

And so through a number of witnesses, they essentially established that this use, if it wasn't on-label, certainly could be on-label. And they challenge FDA's parsing of its general versus specific use guidance documents. which is like I said it's often allows for the clearance of device that can be arguably used anywhere but can be promoted nowhere specifically sure it was that was also pretty pretty fun though to watch how they masterfully you know cross-examined the government's witnesses got it that that's uh those are those are three really really uh important takeaways and so i want i want to get to the towards the end of this conversation we'll get to to kind of summarize, you know, what this all means for medical device companies and how,

how your, you know, your firm, you know, will be using this particular case moving forward. But just to kind of wrap up and put a bow on this vascular solution story, because I think it's, you know, hearing you describe it, because I've heard you present on this, you know, in the past. And this was no small task for vascular solutions nor Howard Rood. I mentioned that, that quote, you know, you quoted them earlier, you know, mentioning something about the cost of this, but it wasn't just the hefty cost. It was also the personal implications to Howard Hood himself. I mean, this could have potentially meant jail time as well, but he chose to sort of dig his heels in and pursue this.

So I think I'd like to just get your take on that, you know, and maybe just kind of summarize the case in general with that in light. I will. First of all, you have to start from the macro. view that the government sort of has this expectation that companies when they encounter allegations like this and criminal allegations and indictment are simply going to roll over. And that, you know, they do that for purposes of preserving the stock price, or at least recouping the stock price, to getting matters behind them. And so the government, the system and the power of the government is in completely,

designed and built through the actual challenge that's being made by the filing of the case and that the company will necessarily fold and they'll agree to a consent decree and they'll pay a big fine and maybe some people will be debarred. You know, the CEO would be fired in this case and maybe some employees. But this board of directors, John Irb, I know, is the chairman and this CEO, were incredibly brave. And one of the things I know that, you know, Howard actually has said, you know, I could have, we could have settled for some money. We could have settled for some limited, you know, maybe pled to a misdemeanor or whatever. But they were going to continue to pursue and try to debar four of their employees. And the government, and they just felt as a company they needed to stand behind their people and that they couldn't let the government run amok. And they finally decided to take a principal stand. And I'll tell you, I told Howard, all the way through this case, I would write them emails. And I just. say, hey, I'm praying for you and your wife. I mean, this has got to be difficult and what they were individually going through because you can't imagine the specter of, you know, actually losing and going to jail.

But, you know, they really felt, but I always also told them those same email, I believe in your case. Just you guys are going to win. And I believe very, you know, I believe in the jury. And the jury did him proud. But, boy, a lot of risk. Yeah, he really faced a lot of personal. Let's face it.

And they stood up, fought, they won. And now he's just gained such notoriety. He's getting invited to speak all over the place. And I'm getting invited to speak with him all over the place. It's been fun. We just were on Reason TV, which is an online content provider that did a documentary on this. So it's been fun. Yeah.

On that note, I'm glad you mentioned that documentary because I think you had forwarded me a link to that. encourage everyone that's listening, go, go check that out. I'm sure it's pretty easy to find. You just do Google Search for Reason TV, you know, Vascular Solutions, documentary of some sort is probably pretty easy, but that's a great piece. And I would definitely highly recommend everyone, everyone to listen to that. And I just, you know, I remember hearing you talk about this case for the first time at a local meeting here in Minneapolis. And I know you were, you could see that you were pretty passionate about it, but I just didn't, I personally didn't understand sort of the, I had heard about it in the news, but really didn't understand kind of

the nuances of the case of what it meant. But just to try to fully grasp, you know, the stance that vascular solutions took, Howard Rout took. And, you know, I don't know, I mean, I know vascular solutions, but certainly I don't know Howard Rout personally. But it's just cool. I mean, from a, you know, if you're in the mid-tech space, it's just, it's just cool to see, you know, a company take, especially a public company, take a, you know, a principled stance,

you know, and, you know, to see that they actually ended up winning in such decisive fashion is, it's, it's cool, cool to see. And, you know, Scott, it's kind of interesting because this company took a reactive stance and fought and defended itself. But there's other companies, you know, recently, particularly in the pharmaceutical arena. And I'm speaking specifically of Amarin and Pesira, who proactively filed or preemptively filed suit against the government to establish their position before it ever really got, you know, rolling into a potential for both civil and criminal penalties. and you give those companies a lot of credit for going out there and staking out their position and winning. So again, there's a high level of inertia going against the government. They keep losing these First Amendment cases.

And you probably don't know this, but I want to alert you to this, that just yesterday the government, I think it's the health energy. Let me pull it up here. I got it right in front of me. Sure. The House Committee on Energy and Commerce has just sent a letter to Secretary Sylvia Burwell, Secretary of HHS, essentially asking them why they can't get their act together on, you know, policy positions on this off-label promotion issue.

And they chronicle in the letter, which is written, again, just yesterday, the Coronia case, and they talk about the Howard Rube Vascular Slashire, case and they talk about the IMS case. And at the end of it, if you'll permit me, I'll just as a very short, I'll read it. Sure. They basically say you keep taking the position. You keep every time we tell you, and they're working on new legislation, by the way, that would help define how this information through the 21st century Cures legislation that's

coming up for consideration. They're inviting, they've invited, they've got legislative, draft legislative language that defines intended use and it defines what can be, you know, promoted and disseminated, et cetera. But the HHS and FDA keep fighting that position, and they say the fact that such rhetorical ire is focused on such common sense change is somewhat surprising, particularly given that the provision in question specifically required, quote, a conspicuous and prominent statement describing any material differences between the information to be provided and the

approved labeling." It did, however, confirm our suspicions that HHS has become reflexively opposed to enabling FDA to make even minor policy changes in this space, despite their legal footing continuing to crumble. It also shows why it has becoming increasingly apparent that Congress must act, and it says the committee is basically going to start considering this, and they've asked that they contact John Stone from the committee staff to schedule a brief. briefing so that they can talk to the agency and the secretary about what the heck is going on here.

You keep promising new guidance on this, and yet you keep prosecuting the industry for off-label promotion. And that was signed by Fred Upton, who's the chairman of that committee and Joseph Pitts, who's chairman on the subcommittee on health, with the Democrat on it as well, the Honorable Frank Pallone, who's a ranking member. So that's brand new news, and we're going to see where that takes us. They're basically inviting them to come talk to them, because their suggestion is, if you can't get your act together, we're going to do it for you. Yeah, that's certainly interesting news, especially considering it just came out.

It seems like, I mean, it does seem like if you keep up with med tech at all, it does seem like, you know, this is, we've almost reached a, you know, kind of a snowball, you know, this is like a snowball heading downhill, and we've kind of, you know, got to a point where there's some momentum here for for some significant change. I'm not sure if that's a fair way to say it. That's maybe my own opinion, but it definitely seems like that. And I know just, I don't think we'll have time to kind of get into some of these other

cases that you had mentioned, you know, like Sorrell versus IMS. And I think you mentioned coronia, if I'm pronouncing that correctly. But maybe if, you know, just real quickly just to kind of, you mentioned, you know, Amaran was a recent one. So can you maybe just briefly kind of cover the three, maybe some, key points from the Ameren case, and then we'll kind of just, you know, wrap up this conversation for what it means for med-tech companies moving forward. Yeah, well, this is the case that where the company preemptively filed suit against the agency, and it was basically a prescription

version of a fish oil pill, you know, and for which they are sold as a dietary supplement, and it comes with a disclaimer that you would see on dietary supplements. They simply wanted to use that same disclaimer and make mention of their clinical trial and some of the other clinical trial data that was in the literature to talk about the use of basically EPA and DHA omega-3 fatty acids that are in fish oil pills. And the agency wouldn't allow it, which is ridiculous. They said, well, the regulatory regime for dietary supplements is different than prescription drugs, but the point that the company was making in defense is, look, the truth is the truth. either this disclaimer provided for dietary supplements is equally applicable to the prescription version or not.

I mean, and we should be able to use it in our promotion as well. And so they lost big time. The government, basically the judge allowed them to use that disclaimer and talk about some of the other infested data that's available on that. And it's funny because the government, Amaran wanted a certain disclaimer, that they proposed to the judge, then the FDA countered with another disclaimer that they wanted to the judge, and then the judge fashioned his own disclaimer and said, this is what you're going to use. But he said also that if there's other truthful and not misleading information comes to the fore,

then we would pursue further refinements to this disclaimer. But essentially the judge is along the information to be in the labeling or in the promotion, I should say, but with certain disclosures and disclaimers that would render it wholly true. not misleading, which was the standard the judge also had in the hard root vascular solutions case. Got it. Yeah, and I know in your client alert newsletter, you kind of went through those different scenarios where in the final sort of, you know, copy or messaging that the judge allowed.

And it was, I thought it was anyway, significantly different than what, you know, what the prosecution or the government initially wanted. So I thought it was a lot more reasonable, to be honest. And easier to understand, you know. from a, you know, purely kind of a patient's perspective. Yeah, they did a good job. You know, again, by the way, if anybody out there needs, wants to look at our claimant on any or all of these topics,

just go to our website at Duvalfdaul.fda law.com. Got it. It's DU. Well, on that note, I'll cover that towards the end, but on that note, it's Duval, D-U-V-A-L. Duval, what was the website again? Yeah, Duval FDA law.com. FDA is in Food and Drug Administration. Got it. And if you go to the show notes for this particular interview,

we'll definitely link to Mark's website as well. Mark's practice's website, I should say. Very good. So, you know, just to, we probably don't, like I said before, we don't have a lot more time to kind of really go into the details of the Sorrel versus the, Sirel versus IMS case or the Kronia case. But when you think about those cases and the, you know, you know, sitting the stage for, you know, the Vascular Solutions, Howard Root Case,

you know, what are you, you know, how is your firm, you know, when you work with medical device companies, how are you taking all of this information and what's sort of the, the advice, your advice moving forward for most device companies? Well, I'd say what we were, what we try and tell good management teams all the time is, First of all, you need to sit down and understand this landscape and that it's evolving. And it's not business as usual. And the government's not going to stop looking at things. But there is some trepidation.

I mean, I had one large client, for example, we decided we were going to write the FDA proactively. And we're going to tell them we thought our use of this device in this particular indication was on label and here's why. And we stated the reasons for and set forth a legal analysis. And we said, look, we'd like to hear back from you. We don't want you to, I know the people in the officer. or excuse me, the promotional and advertising policy staff at CDRH, and I just said, look, to Tony Stefano, we'd like to know from you if you disagree with our analysis, but my client's going to be promoting this, and we'd like not to receive a warning letter if you

disagree. So different companies are taking different strategies. And by the way, that has gone on for four months in the companies, it has been promoting it lawfully. During that time, and the FDA, they got back to us and said, hey, Mark, we're not going to answer this because it's kind of a one-off and we're trying to reformulate our position generally. And so your request transcends an industry need to define this area. But I tell management teams all the time, you're going to be, you've got to sit down and not let your sales and marketing organization be exposed. You need to, you know, give them some definition of what you believe the general umbrella

and the specific indication statements are that you're going to promote so that they feel like they're ever exposed and you have to figure out sometimes you know that this is on label sometimes you believe it's on label but FDA may disagree and sometimes you believe it's on label but you but FDA is disagreeing with you actively and you have to decide where are we going to draw the lines and how aggressive are we going to be fortunately the lines seem to be being blurred now because we have this concept of off-label promotion which we never used to have before and the government through its jury instruction in the Vascular Solutions case has said, you know, we can provide information about off-label uses if it's set in a, put in context such that it's wholly truthful

and not misleading. What wholly truthful means in the eyes of the government versus industry is going to be tested going forward, but we need to consider that. So I just take management teams through that analysis all the time and we figure out how aggressive do we want to be in promotion and we look at the full panoply of promotional efforts from, you know, sales representative work to the establishment and creation of sales collateral materials to your website, to your booth panels, to your social media and website presence, etc., etc., to, you know, providing grants for a position initiated uses or grants for CME courses on off-label uses. You know, look at every way in which you're communicating or

touching, interfacing with the marketplace, and what can we do to lawfully be appropriately aggressive yet compliant in all that you say and do? Got it. Very good. I think that's extremely helpful. And again, for everyone that's, you know, if you're kind of digging this topic and want to know more, I mean, definitely encourage you to go to Mark's practices, their website, Duvalfdaelaw.com and subscribe to those client alert newsletters.

I think it's not your typical kind of like legal regulatory sort of content. They're actually really enjoyable to read and information, you know, very informational at the same time. So definitely encourage everyone to do that. Mark, I know we talked about this a little bit in the pre-interview, but you've got a unique way to be very straightforward, but do it in a kind of a relaxed personal way. You know, so I think I've always been a fan of yours. So let's kind of wrap this up for the sake of time.

And we'll get to kind of the last three rapid fire questions. The rapid fire questions don't necessarily have to be rapid fire answers per se. But we'll get to those now and kind of conclude this conversation. So first, Mark, what's your favorite nonfiction business book? That's kind of funny. I looked at that. I really don't have one. I would say this.

I try to conduct my affairs and my life through the Bible. And, you know, that's probably an odd answer for this interview. But I got to that by way of the seven habits of highly effective. effective people. That book, because it's talked about the servant leadership qualities of Jesus. So I try to conduct myself that way, but the book I'm next getting to is True North by Bill George. And I know I work for Bill. I saw him at a book sign where he made a presentation, and he signed my true north book, and I can't wait to get it because he's a man who approaches life from a faith perspective as well. Got it. Very good. I think a lot of people would appreciate that

take. So second question, is there a business leader that you're following right now or one that that's inspiring to you? You know, that was a great question too. And there's not a singular business leader I follow. I love the clientele. I have. I work with an amazing array. We've had 730 clients over my 13 years. And I work with an amazing array of CEOs and VCs. And I just never ceased to amaze me what I can learn just by working in and around these people. And that's the people that inspire me. And I love my clientele. And I think I learn a lot from them.

And I'd like to think they learn from me as well. Sure. That's cool. And then lastly, when thinking about your career in healthcare, if we had the option to rewind the clock, what's the one piece of advice you tell your 30-year-old self? Yeah, well, first of all, you never, I got here without a predefined path or thought.

It's just like I just worked hard. I was intellectually curious. about everything that I did, and I tried to do everything with excellence and passion. And ultimately, you know, it just seems like, you know, you get led to the place you should be. And I think that's how I got here. I thank God for where I'm at. And my practice is super fun. And I have great people working for me and around me and continue to grow.

And I just enjoy what I'm doing. It's a blast, to be honest. It's a privilege to be in this industry knowing that you're developing devices and drugs and other products that save and help people's lives. Got it. Very good. So Mark, I'll have you hold on the line here in a second as I conclude this. But thanks again for your time. Really appreciate it.

Again, everyone go to Duvalfdaelaw.com and subscribe to those client alert newsletters. You won't be disappointed. They're really good. And then if you get a chance, please rate this show in iTunes. It really helps us out in terms of increasing the visibility for the Medsider podcast. And if you want all of these interviews delivered to your inbox whenever they go live, just go to medsider.com and sign up to the email newsletter. It's totally free.

I don't, I won't kill you with, I won't kill your inbox. I don't send them out too often. But what I do, I try to make sure they're valuable. So with that said, thanks for your listening attention. And it's next episode of Medsider, everyone, take care.