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The Government Goes Off-Target on Off-Label

INDUSTRY

Lessons Learned from Vascular Solutions

By Scott Nelson, Group Director, WCG; Founder, Medsider

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This article is edited from an interview by Scott Nelson with Mark Duval, President of Duval & Associates, P.A.

Everyone considers the ban on dissemination of off-label information to be an extremely important topic. And rightfully so.

But doctors use medical devices off-label all the time. At conferences, they present off-label uses for medical devices on a regular basis. In fact, talk to any KOL, and they think it’s almost humorous that medical device companies take off-label promotion so seriously.

Because I’ve spent the majority of my medical device career in a sales or marketing capacity, I’ve always found this to be an interesting dynamic. Our physician customers discuss and use our products off-label all the time. But we can’t say anything? “Sorry Dr. Smith. I can’t answer that question. No information. Nada. Zilch.”

However, the times are certainly changing. In a recent landmark criminal case against Vascular Solutions, the actual instructions to the jury included this statement: “It is 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! That’s the first time something like that has ever been uttered by the government!

In my interview with Mark Duval, I discussed recent First Amendment cases and what the outcomes mean for medtech companies moving forward. Here are some other insights we covered as well:

• The 3 key takeaways from the recent criminal case against Vascular Solutions

• Why the government’s focus on speech vs. conduct is so important

The defense didn’t bring any witnesses. They just relied on their cross-examination of the prosecution’s witnesses, and they won decisively.

• The government’s recognition that off-label promotion is legal as long as it’s “wholly truthful and not misleading”.

• Mark’s advice for medtech leaders in light of the government’s losses in so many First Amendment cases. Mark told us that the Bright Tip Vari-Lase product was indicated for the treatment of varicose veins and varicosities associated with the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins in the lower extremities. The government basically said that Vascular Solutions was promoting outside the cleared indication. When you get a general intended use statement cleared from the agency, it’s like an umbrella. Under that umbrella, there’s a bundle of specific indications for use to which the product could be put. Sometimes you’re debating with the agency, is something an indication that falls under the protective reach of the umbrella and is therefore protected from the elements and deemed on-label? Or is it outside the protective reach of the umbrella and is deemed off-label?

As an example, he said “If you have devices that are cleared for ablating soft tissue, and 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? If you say it’s to treat atrial fibrillation, then is that on- or off-label? In that case, the FDA would definitely say the tool for ablation has definitely become the treatment for a disease, state, or condition and is off-label. That’s the conundrum we’re often getting in with the agency. When you get a cleared intended use statement, it seems like you’re cleared for absolutely everything, but you can promote it for nothing.

For Vascular Solutions, that’s precisely what they got into. They had a shorter version of the Vari-Lase procedure kit to be used in treating short vein segments, and some representatives would talk about using it in the perforator, which the FDA viewed as a shorter segment that presented more problems than just a regular varicose vein, and required another clearance. The FDA went to court over that, and the company originally paid a $520,000 civil settlement to seek peace with the government, but the government kept pursuing it. They decided to make it a criminal matter and indict the CEO, Howard Root, as well as the company.

A year before the case was actually going to trial, Howard and his public relations expert, Jon Austin, asked Mark if he would be an outside, unpaid, independent spokesperson to whom they could direct media inquiries to talk about this stuff. He agreed, and has never had a financial relationship with Howard Root.

The defense didn’t bring any witnesses. They just relied on their cross-examination of the prosecution’s witnesses, and they won decisively.

Mark remembers saying a year before the case, “Howard, you don’t have to concede that this is off-label. Under FDA’s General versus Specific Use Guidance document, I feel very firmly that this is an on-label use if you interpret that guidance properly.”

That’s what they did in defense. And then the defense rested after the prosecution’s case. “Can you imagine that?,” asks Mark. “The defense, which had 20 witnesses lined up, actually rested after the prosecution rested their case, which just made the jaw of the judge drop as well as the prosecuting attorneys. They presented no cases, because they felt they had done a good enough job on cross-examination. Case in point: they took Dr. Neil Ogden, who is a very highly respected, honest guy. The defense attorneys basically led him through a path of cross-examination that got him to admit that the use in perforators could be considered on-label. Well, that destroyed the FDA’s case right there.”

Vascular Solution’s attorneys took Dr. Ogden 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 documents, that this use in perforators was on-label. The government went through their entire list of witnesses. And the defense had their series of witnesses to call as well, but they didn’t have to bring any to the stand. They just relied on their cross-examination of the prosecution’s witnesses, and they won decisively. Mark says it’s risky to do that, but they decided to leave it alone and just go with what’s been presented. And they got a unanimous 12 to 0 verdict. It also shows the great deficiency and arrogance of the government’s position, to be so blindsided that the company didn’t even have to put on a defense to win.

WHAT CAN WE LEARN FROM THIS CASE? A LOT

Mark has laid out three key takeaways for medtech companies. The first one was the government’s focus on speech versus conduct. There are previous cases – the IMS v. Sorrell case, the Caronia case, the Amarin and Viscera cases – that follow a similar pattern of losses for the government. The government had basically been trying to prosecute speech in all of these cases, and the judiciary had said, “Look, if you’re admitting that it’s truthful and not misleading speech, that cannot be the basis for a misbranding and adulteration case.” So they’ve disabused the government of that idea that they can use speech.

The government’s response has been, “Well, we’re not going to prosecute speech anymore, but the conduct underlying that speech.” In the case of Vascular Solutions, they tried to prosecute six different things:

The court uttered these words for the first time ever: “It is…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.”

1. The defendant’s decision to launch a special kit designed specifically for perforator veins, which was in response to a competitor’s threat.

2. Their manufacture of that kit with perforator-specific modifications.

3. Their application to the FDA for clearance in and of itself.

4. Their investment in a clinical trial for the purpose of gaining that clearance.

5. Their decision to launch the product without clearance while adding new deficient directions for perforator use to the labeling.

6. Finally, the government attorneys said their effort is to defraud the United States by concealing and lying about their perforator sales activity.

They said these points of conduct are what they were really prosecuting, not the speech.

The court uttered these words for the first time ever: “It is…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.”

In essence, what Judge Lamberth has said in the past is that in the regulation of marketing and promotional activities, you can only regulate conduct to the extent that moving one’s lips is conduct, or to the extent that affixing a stamp and distributing information through the mail is conduct. In other words, because Vascular Solutions really didn’t ever promote or market based on some of these things, their actions weren’t deemed as “conduct.” It doesn’t become actionable until there’s communication to the outside world. And once there’s communication to the outside world, that’s effectuated through speech, it’s not prosecutable as long as the speech is truthful and not misleading. So if you follow that, the judge basically said you can’t prosecute this conduct. You’re trying to indirectly get at what the court has not allowed you to do directly.

Second is the recognition of off-label promotion within the actual jury instructions, which Mark said blew him away, because the court 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,” and then added “This is often for an unapproved or off-label use. This is not illegal… 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… If you find that Vascular Solutions’ promotional speech to doctors was wholly truthful and not misleading, then you must find the defendant not guilty of the misbranding offense.”

An article came out that day in the trade press about the fact that the government just chronicled their position that off-label promotions could be lawful. That’s a really important concept.

The point that the company was making in its defense was “The truth is the truth.”

The third point was specific to the FDA’s General versus Specific Use Guidance document, which often allows for the clearance of a device that can be arguably used anywhere, but can be promoted nowhere.

It’s important to remember that this was not just about Vascular Solutions, but a risk for Howard Root himself. It could have meant jail time for him. But he chose to dig in his heels and pursue it. Mark says the government has an expectation that companies are simply going to roll over when they encounter criminal allegations and indictments. Most companies do that for purposes of preserving the stock price, or getting matters behind them. They’ll agree to a consent decree, and pay a big fine, and maybe some people will be debarred. The CEO would be fired in this case, and maybe some employees. But this board of directors, headed by Chair John Irvine, and this CEO chose a more courageous strategy. Howard Root said they could have settled for money or limited penalties, but they felt the government was going to continue to pursue and try to debar four of their employees. And so they decided to stand behind their people.

And now, Howard Root is getting invited to speak frequently, as is Mark. They were on ReasonTV, which is an online content provider that did a documentary on this case.

Howard Root took a principled stance. And they won in a decisive fashion.

Mark told me about other healthcare companies who have also preemptively filed suit against the government before facing a risk of civil and criminal penalties. He gives them a lot of credit. In the case of Amarin, the company preemptively filed suit against the agency. It was a prescription version of a fish oil pill which is typically sold as a dietary supplement, and comes with a disclaimer that you would see on dietary supplements. They wanted to use that same disclaimer and make mention of their clinical trial and some of the other data in the literature to talk about the use of EPA and DHA omega-3 fatty acids that are in fish oil pills. The FDA wouldn’t allow it. They said the regulatory regime for dietary supplements is different than prescription drugs.

But the point that the company was making in its defense was, “The truth is the truth. Either this disclaimer provided for dietary supplements is equally applicable to the prescription version or not, and we should be able to use it in our promotions as well.” The government lost that case, too. The judge allowed the company to use that disclaimer and talk about some of the other available data. The judge said also that if other truthful and not misleading information comes to the fore, then they could pursue further refinements to this disclaimer. Essentially, the judge allowed the information to be in the promotion, but with certain disclosures and disclaimers that would render it wholly truthful and not misleading, which was the same standard the judge used in the Howard Root/Vascular Solutions case.

In fact, Amarin wanted a certain disclaimer that they proposed to the judge, and the FDA countered with another disclaimer that they preferred, and then the judge fashioned his own disclaimer and said: “This is what you’re going to use.”Pc0440100

HOWARD ROOT OF VASCULAR SOLUTIONS. CLICK ON IMAGE TO WATCH THE DOCUMENTARY.


We asked Mark to sum up his advice for clients facing these challenges. He said “First, you need to sit down and understand this landscape and that it’s evolving. You can’t let your sales and marketing organization be exposed. You need to 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 don’t feel like they’re ever exposed.

“And sometimes you believe it’s on-label, but the FDA may disagree. So you have to decide, where are we going to draw the line, and how aggressive are we going to be? Fortunately, the lines seem to be blurred now, because we have this [new] concept of off-label promotion, which we never had before. [The courts have said] we can provide information about off-label uses if it’s 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.

“We look at the full breadth of promotional efforts, from sales representatives’ 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. Let’s 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.”

Finally, he expressed his admiration for the CEOs and venture capital firms he works with. I encourage people to go to Mark’s practice’s website, and subscribe to those Client Alert newsletters. It’s not your typical legal, regulatory sort of content; they’re enjoyable to read, and very informational. You can see Mark’s Client Alerts at duvalfdalaw.com.

Mark is inspired by their courage, and actually said he has “fun” at his job. “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.”

Mark DuVal, J.D. President, DuVal & Associates

Prior to founding DuVal & Associates, Mark was general counsel for 3M Pharmaceuticals and 3M Drug Delivery Systems and various medical device divisions working both domestically and internationally. He was on assignment for 3M Health Care Systems, Ltd. in Europe, based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance, covering FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry.

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DuVal & Associates, P.A., is a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries

Scott Nelson, Group Director, WCG Founder, Medsider Scott is a self-described medtech enthusiast and currently serves as Group Director for WCG, a W2O company. Prior to his work with WCG, Scott held sales and marketing leadership positions for some of the largest medical device companies in the world, including Covidien, Boston Scientific, C.R. Bard, and ConMed. In addition, Scott is the Founder of Medsider, which helps ambitious doers learn from proven medtech thought leaders. His work with Medsider has been featured in publications like Forbes, Mass Device, MedCity News, and MD+DI. Scott is also an advisor to the Medical Devices Group, which includes over 300,000 members worldwide.

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