Medsider: Learn from MedTech and HealthTech Experts

Is Off-Label Promotion Now Legal? What the Recent Criminal Case Against Vascular Solutions Means for Medtech

June 08, 2016 Scott Nelson
Medsider: Learn from MedTech and HealthTech Experts
Is Off-Label Promotion Now Legal? What the Recent Criminal Case Against Vascular Solutions Means for Medtech
Medsider: Learn from MedTech and HealthTech Experts
Is Off-Label Promotion Now Legal? What the Recent Criminal Case Against Vascular Solutions Means for Medtech
Jun 08, 2016
Scott Nelson

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]

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Show Notes Transcript

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]

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Scott Nelson:   0:08
Welcome to Med Cider, 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 gents, It's Scott and welcome to another edition of med cider before we get started with this interview with Mark DeVol. Just a few quick messages. First, if you've enjoyed these interviews over the past several years, maybe it's been 45 for some of you. Please head on over to iTunes and rate the podcast. It's relatively simple to d'oh. Once you're in iTunes, you should see a little blue button. Uh, that's labeled rates or review next to the Met cider podcast on. Then just get just just read us a review us. It really helps out in terms of increasing the visibility for med side of radio. So either you can do it now Or maybe after this interview, head on over to iTunes and do us a favor. Second messages in regards to our email newsletter. Now, if you want to be notified when these interviews go live, just head on over to med cider dot com. That's any D s I. D E. R insider dot com and subscribe to the newsletter. It's completely free, and that way you'll be notified whenever these interviews go live. Alright. So onto the interview with Mark Devolved, we're gonna learn about the recent First Amendment cases or free speech Case is that the government has lost and what the outcome's mean for med tech companies moving forward. We're gonna discuss the criminal cases or the recent criminal case, I should say against vascular solutions and why everyone in med techs should pay attention. Why the government's focus on speech versus conduct is so important the government's recent record recognition that off label promotion is legal as long as it's wholly truthful and not misleading. Yes, you heard that right off little potion is legal, a CZ noted in this recent vascular solutions case on Denmark's advice for med tech leaders in light of the government's losses to these four mentioned First Amendment cases on and how they should respond Moving forward. Eso Mark is a fantastic interviewee. Very not only is he very intelligent but also very, very personal on and presents in a fantastic way on. 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, AH law firm, dedicated to counseling companies in the medical device, pharmaceutical, biotech, food and nutritional supplement industries and pride of founding the firm. Mark was general counsel for three in 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

Mark DuVal:   3:10
you, Scott. I'm looking forward to it.

Scott Nelson:   3:12
All right, let's let's dive in talk all things off label promotion and where we stand today with the with the FDA. So Ah, we'll start with one of your recent client alert newsletters, which I ah, highly recommend anyone subscribe to if they're if they're interested in keeping up to date with some of this stuff. But in one of those new leathers, you, uh, loosely compared Howard Route, whose thesis CEO of Vascular Solutions, you compared him to Louis Zamparini, who was Menino, is the main character from the movie unbroken. And I think actually, in that same piece Ah, you Ah, you quoted Howard route as, Ah, let me pull up the quote here. It's Ah, I think Howard stated this is the most decisive victory since Operation Desert Storm at only slightly slightly greater expense, Which that was an interesting quote. So, uh, with that said or I guess, with those two points in mind, let's dig into this this recent vascular solutions case. Um, And for those for those that aren't aware of it, can you kind of provide a high level overview first and then we'll kind of dig into some of the key takeaways.

Mark DuVal:   4:17
You bet. Yeah, well, the vast your solution case in involved the verily pride. Um, And if I were a summarized, I think it's basically that if the bright tip and counsel was indicated for the treatment of varicose veins and embarrass ka cities that are associated with the great staff in Spain and for the treatment of incompetence and reflux of soup, superficial veins in the lower extremity and the government, um was basically it said that they were promoting outside the the clear indication and as you know when you get a general intended you 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 indication, you indications for U. S fruit 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 is outside from the elements protected on the elements on deemed on label or that 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 ah, a devices that air cleared for a blading soft tissue. If you say that they're used to a blade cardiac tissue, that's still soft tissue. But is that honor off label on the FDA is mind. And if you say it's thio treat cart atrial fib relation, then is that on or off label? In that case, FDA would definitely say the tool for ablation has definitely become the treatment for a diseased state or condition, and so were often that's the conundrum. We're often getting in with the agency is when you get a clear intended you statement, it seems like you're cleared, um, for absolutely everything. But you can pro promoted for nothing. And so that's the one we're working with. Management team. That's often dilemma with which we're faced. And I help them navigate through that, uh, promotional bigness. What can we talk about? Hearing device and what was, Can't we say so with best your solution? That's precisely what they got into. They had a short get a shorter version of the very least procedure kit to be used in treating short, vain segments. And then some representatives were talk about using it in the perforate er, which FDA viewed of the shorter segment that presented more problems than just a regular, a regular varicose vein and recording and another clearance. Um, so that was sort of the grab him. And now it's sort of the core of the dispute. And, uh um, they went, they basically went to court over that, And the company originally paid a $520,000 settlement, a civil settlement to sort of get it by 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. Well, Howard wrote as well, the company

Scott Nelson:   7:13
got it. And this this will I mean, just so just kind of, in summary vascular solutions had this product that was indicated for ah, for kind of the the oblation of varicose vein or soft tissue, and and yet, you know, there it was oftentimes being used for shorter segments. And that felt kind of into that. That gray area of you know, is this on label? Is this off 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, basketball, you know, basket with solutions, you know, then proceeded to to settle a civil case with the with the government. But the government that took a step further, basically, and and, ah, and decided to pursue criminal action against about Howard route. Who's the CEO as well as vascular solutions. That kind of I have not rightly,

Mark DuVal:   8:01
right? Yeah, exactly. And I remember a year before the case, uh, you know, going, going, actually going to trial Howard in his public relations expert, Crisis management expert John often asked me if I would be an outside, unpaid, independent spokesperson to whom they could direct, you know, media increase to talk about this stuff. And I and I acquiesced to that. I had never had a financial relationship. Still, don't with harder. We just We vote. We actually become friends through all of this. I've been a social appoints with them a different CEO. VC meetings, etcetera, industry, take meetings. But so I got funneled everything in real time so that I could respond to the Wall Street Journal. This committee at Minneapolis Star treatment or whomever might have questions about the case, and it was just interesting. I remember saying a year ago, a year before the cases, said Howard, Just you know, don't you don't have to concede that this is off label. You know this under FDA General versus specific use guidance document. I feel very firmly, very firmly that this is a non 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 with 20 witnesses lined up, actually at the prosecution rested case. They also rest, which just made the

Scott Nelson:   9:21

Mark DuVal:   9:22
The judge dropped as well as the prosecutor prosecuting attorneys

Scott Nelson:   9:27
and presented

Mark DuVal:   9:28
no cases because they felt they had done a good enough job on cross examination. In a case in point, they took Dr Neil Ogden. It was a brand cheap with whom I work a lot, and he's a very highly respected, honest guy. And he testified, Honestly, they basically let him through a path of cross examination that got him to admit that the use and perpetrator veins could be considered on label. Well, that destroyed the FDA case right there. But that's the kind of stuff that go down in these cases. But it was a fascinating case. Follow and, you know, they basically took him to the General versus specific use guidance and also a modifications guidance that suggested betting in interpreting either of those you could. One could conclude through FT. Zone guidance document that these pert Houston perpetrators was on label,

Scott Nelson:   10:14

Mark DuVal:   10:15
they didn't think they did a masterful job of that in that case could the King and Spalding lawyers as well as, uh, Fredriksen and Byron lawyers.

Scott Nelson:   10:23
God, that's interesting. And just to clarify at one point that you mentioned the prosecution went through. So the government in the situation that the prosecution went through their entire you know, the entire list of of, ah of witnesses t to basically testify and the, uh, the defense, you know, had their their Siri's of, of of witnesses as well that that that's it. But they didn't have to bring any any to the, uh, to the stand. They just solely relied on their craft. You know, the cross examination of the prosecution's witnesses and ah, and they want decisively so that, I mean, that's that's pretty amazing.

Mark DuVal:   10:59
Yeah, and you know it. It's got It's risky to do that. Wouldn't you be tempted to say, Gee, I don't know. Have we done it? We've done a good enough judge we put on. Our witnesses were all prepped and ready to do that. They said no. It might be better to leave well off alone and just go What what's been presented? And boy, they call it right in the

Scott Nelson:   11:19

Mark DuVal:   11:20
12 deserve a verdict. So what pretty spectacular when you think about it. But it also shows the great deficiency and in arrogance of the government's position to not to be so blind sighted that

Scott Nelson:   11:34

Mark DuVal:   11:34
know that the defense didn't have to put on a defense in order to win the case.

Scott Nelson:   11:39
Right? Right, no doubt. So let's Let's, uh I mean, certainly an interesting case and a lemon on a lot of different fronts. But in that client alert newsletter that I mentioned earlier you you kind of laid out three different key takeaways. Ah, are three different, you know, major implications for, ah, for med tech companies. And the 1st 1 was that the government's focus on speech versus conduct. So can you kind of outline that that key point that we'll get to the other two here in a second? Yeah,

Mark DuVal:   12:07
this is so the government have to recognize that there's there's cases that have gone before the Howard Route Vascular Solutions case, and that's be the um, the AMs vs Terrell Case in the Caronia case and Amorim sirrah cases. So this isn't a lineage of cases and losses for the federal government. They have sort of said wait 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 miss branding an adulteration case. Okay? And so they disabused the government of that idea that they can use speech. So what the government is fancifully turned to is that well, we're not gonna prosecute speech anymore. But the conduct underlying that speech. So in the case of Howard written vascular solutions, this is the kind of the kind of conduct that they tried to prosecute. They try to prosecute six different things. The defendant's decision to launch a special kit designed specifically for a perpetrator vein, uh, which was in spot response to a competitive threat the minute their manufacturer of that kit with perpetrator specific modifications, uh, number three their applications thio FDA for clearance in and of itself with conduct number four of the, uh ended. By the way, when they made the sought clearance for the use of the perforated rains 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 fighting Kate 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, deficient directions for appropriator used to the labeling and finally, their efforts, What the FDA said or the government. The U. S attorney's actually said their efforts to defraud the United States by concealing a lying about. They're perforated sales activity, they said. These points of conduct what we're really prosecuting, not the speech. Well, the court, in this case and in uniformly Pretty said, It's pretty basically said, Look, it's anything but The theory is that none of the conduct really becomes actionable. Of course, until there's a there's a speech or communication that made to the outside world the world outside the company to effectuate the conduct. So basically what Judge Lambert has said in the passes that the regulation of marketing and promotional activities in the regulation of conduct you can only raise really conduct to the extent that moving one lips is conduct or to the extent that fixing a stamp and distributing information to the male's conduct you know, it's ridiculous to think you can get in directly. It's 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 is lost on that ground now, and that's

Scott Nelson:   15:10
not important. So just to be clear, you laid out kind of six different points are six different kind of points of conduct at the prosecution breast in the trial. And you're saying because vascular solutions really didn't ever you know, uh, you know, present that or market Based on some of these things, it really wasn't conduct right. I should say it was It really wasn't ever speech versus, you know, conduct. Is it my kind understanding that correctly?

Mark DuVal:   15:41
Well, it doesn't become actionable. None of the conduct becomes actionable until there is communication of the outside world. And

Scott Nelson:   15:48
that's the

Mark DuVal:   15:49
communications. The outside world that's effectuated through speech in speech is not prosecutable if it's truthful, not misleading. So if you follow that villages of that So the judge basically said, you can't prosecute this conduct that you're getting it. 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.

Scott Nelson:   16:10
Sure. Okay, that makes that makes sense. All right. So that the second point, I think that you called out if if we could move on to that one was was theon the recognition of off label promotion within the actual jury instructions in this particular case, so can you kind of provide a provide us with some background on that point as well?

Mark DuVal:   16:30
Yeah, well, this really rocked my world. And I think a lot of insiders who really are conflict companies like I am, and it's like just before the case, Um, there have been some motions to dismiss, and, uh, the King and Spalding team did a brilliant job, sort of forcing the government handed, declaring what their position waas. But at the very end, because they had so hammered them that you can't use truthful and not 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 concept of off label promotion. And so what if you'll permit me? I'm just gonna read very short. I'm gonna read this instruction because it's gonna blow you away, too, when you appreciate it.

Scott Nelson:   17:21
So these were the instructions to the actual jury in the trial on this trial?

Mark DuVal:   17:25
This is

Scott Nelson:   17:25

Mark DuVal:   17:25
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 a Ford, or for a different use that has not been cleared or approved by the FDA. That that we all know that go down and say this is often too often for now approved for off label use. This is not illegal. Now listen to this. It is also not a crime for a device company writes represented to give doctors wholly truthful and non misleading information about the unapproved use of a device. Wow, I can't believe it. If you find that vascular promotional speech, the doctors was solely truth on that misleading. Then you must find that event defendants not guilty of the misbranding offense that rocked my world in a lot of experts who are following perfect. I know an article came out that day in the trade press about it, saying, while the government just chronicled their position that off label promotion could be lawful and so that it stands for that proposition today. That's the first time it's ever been uttered by the government, and now it's in it. It was in the context of a jury instruction, and it's it's a really it's a really important concept that that just uttered,

Scott Nelson:   18:43
right? Yeah, I could definitely see the importance of of that particular point may be the most important point of these of these three that were covering right now, So So the 1st 1 was it was kind of the government's focus on speech versus conduct. The second point that you just covered was this This, uh, you know that this is the way the instructions were addressed to the jury in terms of being able thio, um, a medical device companies ability to promote a message that's wholly truthful, right? You know, this this concept of off label corrosion and and the third point was specific to the FDA is interpretation of general versus specific use. So can you Can you tell us a little bit more about that third point?

Mark DuVal:   19:25
Yeah. And then going back to the point I made about, you know, when the cross examined, uh, Neil Ogden, who was the branch chief, and they got him to basically admit that I'm not off label are a non label used by just the defense counsel is literally took him through. You know, the package insert and they talked about. So they talked about the the indications for you statement. They said, you know, it refers to the oblation of soft tissue. Yes. And you'd agree that the veins or soft tissue correct? Yes. The great staff in this scene is made up of tough issue. Yes. Correct. Correct of the short, definite vein is made up of tough issue. Correct the perforated Vandermade. A tough issue correct in tribute to re veins are made a tissue correct on the second part of the clearance refused the varicose veins and they took him down that path that yes, up perforated veins could be miracle beans. And they basically entrapped the branch chief into indirectly admitting that this could be a non label use, and they also did it with the outside clinician. And they also that that the government put on is is a witness. And so, through a number of witnesses, they essentially established that this used if it wasn't on labels, certainly could be on label. And the challenge FDA parsing of its general versus specific use guidance document, which is, like I said, it's often allows for the clearance, the device that could be arguably used anywhere but can be promoted nowhere specifically.

Scott Nelson:   20:56

Mark DuVal:   20:57
it was. That was also pretty, pretty fun. Don't tow watch how they masterfully you cross examined the government witnesses

Scott Nelson:   21:07
got it. That's Ah, there's a three really, really important takeaways And so I want I want to get Thio toward the end of this conversation will get t kind of summarize. You know what this all means for medical device companies and how how your you know your firm, you know, we'll be using this particular case moving forward, but just to kind of wrap up and put a bow on this vascular solutions story because I think it's, um, you know, hearing you describe it is that I have heard you presents on this, you know, in the past. And this was no small task for vascular solutions, nor nor Howard route. I mentioned that. That quote, you know, you quoted him earlier, you know, mentioning something about the cost of this. But it wasn't just the hefty cost. It was also the that the personal implications to Howard himself. I mean, this could have potentially meant jail time as well, but he chose toe. He chose to sort of dig his heels in and and, uh, and and pursue this s o. I think I'd like to just get your take on that, you know? And, um and it may be just kind of, you know, summarize. Summarize the case. In general. With that light,

Mark DuVal:   22:11
I will. First, you have to start from the macro view that the government sort of, um it has it has, uh, expectation. The company's when the encounter of allegations like this and criminal allegations and an indictment are simply going to roll over and then, 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, um so the government did the incentive, the system and the power of the government and completely designed and built through the the actual challenge that's being made by the filing of the case and that the company will up off necessarily fold and they'll agree to a consent decree and that they have a fine and maybe some people be debarred. You know, the CEO would be fired in this case and maybe some employees. Um, but this board of directors, John Irv, I know if that is the chairman and, um and this CEO were incredibly brave and one of the things I know that you know how hard it actually said. You know, I could have We could have settled for some money. We could have settled for some limited, you know, uh, maybe pledge with misdemeanor or whatever, but they were going to continue to pursue and try to de bar four of their employees and the government. They just felt as a company they needed to stand behind their people and that they couldn't let the government run amok, and he finally decided to take a principled stand. And I'll tell you, I told Howard all the way through this case, I would write him e mails. I just say, I'm praying for you and your wife. I mean, it's gotta 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 enough. But I always also told him the same email. I believe in your case.

Scott Nelson:   24:00

Mark DuVal:   24:01
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 exposure, Let's face it.

Scott Nelson:   24:13

Mark DuVal:   24:13
uh, they stood up, but they won, and now he's just got kids gained. You know, 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. Uh, we just were on reason. Uh, TV, which is an online content provider. They did a documentary on this. So it's been fun.

Scott Nelson:   24:37
Yeah, on that note, I'm glad you mentioned that documentary because I think you had afforded me Ah, link to that. But I would encourage everyone that's listening. Go, go check that out. Yeah, I'm sure it's pretty easy to find. Do Google Search for Reason TV Vascular Solutions Documentary of some sort is probably pretty easy, but it's a great piece on and I would definitely highly recommend everyone. Everyone 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 under I personally didn't understand sort of the I'd heard about it in the news but really didn't understand kind of the nuances of the case and what it meant, But just it just kind of fully try to fully grasp, you know, the stance that vascular solutions took Howard route took. And, um, you know, I don't know. I mean, I know vascular solutions, but certainly, I don't know Howard route personally, but it's just it's just cool. I mean, from ah, if you're in the med 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 to see that they actually ended up winning and such decisive fashion is It's cool, cool to see and

Mark DuVal:   25:41
you know it's got It's gonna interesting because, uh, this company took a reactive stance and fought and defended itself. But there's other companies in a recently particular pharmaceutical arena, and I'm speaking specifically of Amour and Empress era, who proactively file their 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. We're going out there and say, taking out their position and winning. So again, if the 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 it just yesterday the government, um, how I think it's a health energy and let me pull it up here. I got it right in front of me.

Scott Nelson:   26:34

Mark DuVal:   26:36
uh, the content The House Committee on Energy and Commerce have just sent a letter to Secretary Sylvia Burwell, Secretary of a J. Jeff, essentially asking that on them, Uh, why they can't get their act together on a, you know, policy positions on this off label promotion issue. And they chronicle in the letter, which is written again just yesterday, uh, the Caronia case and they talk about the Howard Route Vascular Solutions case. They talk about the i. M. S case, and at the end of it, if you'll permit me on this is a very short I'll read it. They basically say you 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 and a lot of defines intended use. And it defines what could be, you know, promoted and disseminated, etcetera. But yet, but the HHS and FDA keep fighting that position, and and they say, the fact that such rhetorical ire was focused on such common sense change is somewhat surprising, particularly given that the provisioning question specifically requires quote a conspicuous and prominent statement describing any material differences between the information to be provided and the approved labeling unquote. 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

Scott Nelson:   28:19
shows why

Mark DuVal:   28:20
it is becoming increasingly apparent that Congress must act. And it says the committee is basically gonna start considering this. And they've asked that the contact John Stone from the committee staff to schedule a 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 so, and that was signed by Fred Upton, who's the chairman of that committee, and Joseph Pitts with chairman of the Subcommittee on Health, with with the Democrats on it as well, the honorable Frank Pallone of the ranking member. So that's brand new news, and we're gonna see where that takes us.

Scott Nelson:   29:06
There, basically

Mark DuVal:   29:07
invited them toe come talk to them because if there's a suggestion is if you can't get your act together. We're going to do it for you.

Scott Nelson:   29:15
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 with MedTech at all, it does seem like, you know, this is we've almost reached out, you know, kind of a snowball. Um, it's like a snowball heading downhill. We kind of got to a point where there's some momentum here for some some, uh, some significant change. I'm not sure if that's a fair, a fair way to say this may be my own my own my own opinion, but 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 like Cyril versus I m. S. And I think you mentioned ah Caronia. I'm pronouncing that correctly. But But maybe, maybe if you just just real quickly just to kind of you mentioned, you know, Amber And was it was a recent one. So can you maybe just briefly kind of cover the three? Um maybe some key points from the Amber in 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 this is

Mark DuVal:   30:12
the case that we're the company preemptively stuff filed suit against the agency. And it was basically a prescription version of a fish oil fill, you know, and, uh, for which they were 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 mentioned 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 e p a and D A J omega three fatty acids that Aaron official appeals and the agency wouldn't allow it, which is ridiculous. He said, Well, the regulatory regime for dietary supplements is different than prescription drugs. But the point that the governor that the company was making a defenses look, the truth is the truth. You know, this disclaimer, uh, 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, they judge allowed them to to, uh, use that that disclaimer and sing and talk about some of the other end of the data that's available on that. And it's funny, because the government Amarin wanted a certain disclaimer that they proposed to the judge than the FDA countered with another disclaimer that they wanted to the judge. And then the judge fashioned his own disclaimer, and this is what you're gonna use. And but he said also that if, uh if there's other other truth on that misleading information comes to the fore, then we would pursue further refinements to this disclaimer. But essentially the judges along information to be in the labeling or in the promotion, I should say, but with certain disclosures and disclaimers that would make render it wholly truthful, not misleading, which was the standard the judge also had in the hard route Vascular Solutions case.

Scott Nelson:   32:06
Got it? Yeah, I know the guy in your client alert newsletter. You kind of went through those those different scenarios. Where in the final sort of Ah, no copier messaging that the that the judge allowed. And it was it was significantly, 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 purely a kind of a patient, a patient's perspective.

Mark DuVal:   32:33
Yeah, he did a good job, you know, again, invite, with anybody out there needs wants to look at our climber than any or all of these topics. Just go to our website Do Ball, uh, FDA law dot com.

Scott Nelson:   32:45
It's d'you Know that note. I'll cover that towards the end, but on that note, it's It's Duval D u V a l. Duval. What was the website again?

Mark DuVal:   32:54
Duval FDA law dot com FDA is and Food and Drug Administration.

Scott Nelson:   33:00
Got it. If you go to the show notes for this for this particular interview, we'll definitely link link to Mark's website as well. Marc's Marc's Practices website. I should say, um, very good. So, you know, just just you'll probably like I said before. We don't have a lot more time to kind of really go into the details of the of the surreal, surreal verses I m s ks for the Caronia case. But when you think about those those cases and, you know, setting the stage for, you know, the vast here solutions Howard root case, you know what What are you You know, how is your firm? Um, you know, when you work with medical device companies, how are you taking all of this information and and what's what? Sort of the, uh, the advice, your advice? Moving forward for most, uh, most device companies.

Mark DuVal:   33:44
Well, um, I say what we were what We try and tell good management teams all the time. It's personal. You need to sit down and understand that this landscape and yet it's evolving, and it's not business as usual, and the government's not gonna stop looking at things, but they are. There is some trepidation. I mean, I had one large client, for example, we decided we were gonna write the FDA proactively. We're gonna tell him we thought our use of this device in this particular indication was on labeling. Here's why. And we stated the reasons for it, set forth a legal analysis, and we said, Look, we'd like to hear back from you. We don't want youto I know the people in the office of Prescription or excuse me, that promotional advertising policy staff, a CD, a rage. And I just said, Look, Tony, the final we'd like to know from you if you disagree with our analysis, but we're gonna be for my client's gonna be promoting this and we'd like not to receive a warning letter if you disagree. So different companies, air dipping, taking different strategies. And by the way, that that has gone on for four months in the company's has been promoting it lawfully off during that time in the FDA, they got back to that Hayward Mark, We're not gonna answer this because it's kind of a one off, and we're trying to reformulate our position generally, and so your request transcends and industry need to define this area. But I tell management teams all the time you're you're gonna be You gotta sit down and not let your sales and marketing organization be exposed. You need thio. You give them some definition of what you believe. The general umbrella and the specific indication Indication statements are that you're going to promote so that they don't feel like they're ever exposed. And you have to figure out sometimes you know that this is on label. Sometimes you believe it 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 line and how aggressive are gonna be. Fortunately, the lines seem to being being blurred now because we have this concept of off label promotion which we never used to have before, and the government to its jury instruction of vascular solutions cases said, You know we can provide information about off label use is if it's set in a kind of put in context. It touched a totally truthful and I'm not misleading what wholly truthful means in the eyes of the government versus industry. Uh, he's gonna 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 fill the establishment and creation of sales collateral materials to your website to your booth panels to your social media and website presents. Uh, etcetera, etcetera, you know, providing grants for a position initiated, uses or grants for CME courses on off label uses. You know, Look, look at every way in which you're communicating or touching interfacing with the marketplace and what can we do? The lawfully be appropriately aggressive yet compliant in all that you say and do

Scott Nelson:   36:55
got it very good. I think that's extremely helpful in again for everyone. That's ah, you know, if you're kind of digging this this topic and wanted no more, I mean definitely encourage you to goto thio Um, the Marks practices there, their website, you know, Duval, FDA law dot com and subscribe to those those client learned newsletters. I think it's not your typical kind of like Legal Regulatory is sort of sort of content you want. They're actually really enjoyable to read and information very informational at the same time, so definitely encourage everyone to do that. Mark and I know we talked about this a little bit in the pre pre interview, but you've got a, ah, unique. A unique way to be very straightforward. But do it in a kind of, ah, relaxed, personal way, you know? So I I think, uh, I think I just have always been a family. You were. So, um, let's just kind of wrap this up for the sake of time, and we'll get to the kind of the last three rapid fire questions. They're the rapid fire questions don't necessarily have to be rapid fire answers per se. Um, we'll get to those known and kind of Ah, and conclude, conclude this conversation. So, first mark, what's your favorite nonfiction business book?

Mark DuVal:   37:59
Yeah, that's kind of funny. Look at that. I really don't have one. I would say this. Um I try to conduct my affairs in my life through the Bible. You know, that's probably not answer for this interview. But I got to that, by the way, um, of the seven habits of highly effective people that

Scott Nelson:   38:16

Mark DuVal:   38:16
it talks about the servant leadership qualities of Jesus Oi, I try to conduct myself that way. But the book I'm next getting too, um is, um, true North by Bill George. And, uh, I know I worked for Bill. I saw him at a book signing and where he made a presentation and he signed my boat, My True North book. And I can't wait to get it because he's a man approaches life from a faith perspective as well. I

Scott Nelson:   38:40
got it very good. I think a lot of people would appreciate that that take the second question. Is there a business leader that you're you're following right now? Or one that that that's inspiring to you?

Mark DuVal:   38:52
You know that that was a great question, too, and that there's not a singular business leader I follow. I love the clientele. I have time. I worked with an amazing array. We've had 730 clients over my 13 years and work with Amazing Ray of CEO NBC's and I just never cease to amaze me what I can learn just by being working in and around these people, and that's the people that inspire me. And I love. I love my clientele, and I think I learned a lot from them, and I collected think they learned from me as well.

Scott Nelson:   39:19
Sure, that's cool. Ah, and then lastly, when thinking about your career in, Ah, health care if we had the option t rewind the clock. What's the one piece of advice you tell your 30 year old self? Yeah.

Mark DuVal:   39:33
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, but 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 a man in my practice is super fund, and I have a great, uh, great people working for me and around me and continued continue to grow on. I just enjoy what I'm doing at the blast. To be honest to be, 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.

Scott Nelson:   40:14
I got it Very good. Ah, So, Marco, have you hold on the line here in a second? As I as I conclude this, But ah, thanks again for your time. Really appreciate it again. everyone go to AA DeVol FDA law dot com and subscribe to those client alert newsletters. You won't be. You won't be disappointed. They're really good. Ah, and then if you if you get a chance, please rate this show in iTunes, it really helps out. Helps us out in terms of increasing. You know, the visibility for the Met cider podcast. And if you want all of these interviews delivered to your inbox whenever they go live, just go to med cider dot com and sign up T email newsletter. It's totally free. I don't I won't kill you with I won't kill your inbox. I don't see too often, but when I do, I try to make sure they're valuable. So with that said, thanks for your listening attention. In the next episode of Med Cider, Everyone take care