MTMP & Tepezza Update with Mark Abramowitz & Ashlie Case Sletvold

By Susan Barfield
September 20, 2023

Susan Barfield:

Hello, everyone. Thank you for joining another episode of The Leverage Report. Super excited and grateful to have our guests here today to talk all things Tepezza and as it relates to their MTMP Panel Discussion. I’ve got Mark Abramowitz here who is a partner at DiCello Levitt. I’ve got Ashlie Case Sletvold who is here as a managing partner from Peiffer Wolf and wanted to just one, take a moment to say thank you for taking time to connect with us and share a little bit about the MTMP Panel Discussion and about Tepezza.

Mark Abramowitz:

Thank you so much for having us.

Ashlie Case Sletvold:

Thank you so much.

Susan Barfield:

Yeah. Yep. Thank you. Okay, well before we dive in and start talking about Tepezza, I’m always interested to hear a little bit about attorneys’ early influences and a little bit about the deeper why that led you to pursue a career in law. So Ashlie, why don’t you start off telling us a little bit about, or Mark, doesn’t matter, but I really want to hear it from either of you just about the deeper why and then why you pursued law.

Ashlie Case Sletvold:

Well, my path to the law came from switching my major from chemical engineering to philosophy when I found out you could get credit just for arguing about stuff. Then I continued on to law school from there and then jumped into big law for about five years and then decided to use my powers for good. So here I am.

Susan Barfield:

Awesome. That’s great. Mark, what about you?

Mark Abramowitz:

I started a little bit younger age wise. I started fighting as the oldest of three boys and decide that I always need to be right whether it’s my parents, the teachers, my siblings, my cousins, and it just stuck with me ever since.

Susan Barfield:

You said you’re the youngest of three boys?

Mark Abramowitz:

Oldest actually.

Susan Barfield:

You’re the oldest.

Mark Abramowitz:

Yeah.

Susan Barfield:

Got it.

Mark Abramowitz:

Oh, yes, a lot of fighting with the younger ones.

Susan Barfield:

Yes. Well, good. Well, thank you both again for joining today. I guess after hearing a little bit about your background, really want to understand Mark from you, can you just give a brief overview of the Tepezza litigation and some of the key allegations?

Mark Abramowitz:

Right. This is a case against Horizon Pharmaceuticals for the drug called Tepezza. It was made for TED, which is thyroid eye disease. What happens in thyroid eye disease when the eyes bulge out of their face a bit, this drug helps deal with that. It’s a disease that affects under 200,000 people a year in the United States, and Horizon brought this drug on to the market as an orphan drug because of that. The problem was, what they should have known when they brought this on to the market in January of 2020 was that it would cause people to have hearing tinnitus and hearing loss. Our allegations are that they knew this, should have known this, and should have warned the consumer as well as telling the government this was what the side effects of their drug was; however, they didn’t.

Susan Barfield:

Well, thank you, Mark, for that. Ashlie, I guess as far as this litigation, what even prompted your interest, and what are some of the challenges that you’ve encountered representing these clients?

Ashlie Case Sletvold:

Well, one of the obvious challenges is that many of them have hearing loss, and so they can be difficult to communicate with to some extent, so we’ve had to work through those challenges. But it’s been thus far an incredible litigation to be a part of because so many of these clients tend to be really great historians of their usage. This is a drug that costs upwards of 200 to $300,000 for one single course of treatment, which is eight infusions about every three weeks apart spaced out. So the clients are fantastic and are very engaged and quite justifiably horrified that they weren’t warned about what could happen, what the decision they were making was.

One of the things that has been particularly promising about this litigation is less than a year into it from the date the first case was filed in August of last year, Horizon changed the warning label in July to say exactly what we said it should say. I couldn’t have drafted it better myself. The warning label was very recently changed to warn of permanent hearing loss, to advise physicians of the need for audiological monitoring before, during, and after the use of Tepezza because it is such a serious risk in relation to this. That just simply wasn’t part of the initial launch of the drug. So we’re glad to see that that change has been made, but that doesn’t make up for the three-and-a-half years of time that Horizon’s been marketing this drug without-

Susan Barfield:

Sure.

Ashlie Case Sletvold:

… appropriate warnings.

Susan Barfield:

Right. Well, MTMP is going to be here. It’s right around the corner, and I know you guys have a panel discussion. I believe it’s on the 12th at 11:15 where you’re going to be talking about Tepezza more in depth in providing great updates and insights. Mark, would you share a little bit of some of the topics that the group is going to be discussing?

Mark Abramowitz:

Well, we already heard a bit from Ashlie about the big one, which is the label change that happened in July of this year that really, again, the FDA agreed with us. But more so, I also want to highlight that what is unique about this litigation compared to others is the direct-to-consumer marketing that happened here. It happened at such an early stage, happened so quickly and so aggressively. I know we’ve seen other cases where that’s happened as well, but not like this, and it’s pretty jaw dropping what they did. In fact, there’s a little bit of a spoiler here, but you’ll see some posts online about what their sales reps are saying about how aggressive they were with the direct- to-consumer. They were shocked at what they were spending on a drug like this. So don’t let the orphan drug part of this title scare you off or think differently. They were really pushing this to be much greater than what they were trying to do.

Susan Barfield:

Yeah. Well, that leads me into the… just interested, Ashlie, the name of the panel discussion is From Orphan to Blockbuster. So what made Tepezza a blockbuster drug?

Ashlie Case Sletvold:

Well, Abe is right. The direct-to-consumer marketing was really particularly for an orphan drug or really for any drug, quite incredible. They spent a ton of money raising awareness of the fact that this even is a disease with physicians and with the public that could be treated. Because they were so successful in driving the profits related to the use of this drug or the prescription of this drug, late last year Horizon was… there was a bit of a bidding war and Amgen came out on top. So Amgen is in the process of acquiring Horizon. That was held up for quite a while by an FTC antitrust litigation. There were challenges to that that were pending in the Northern District of Illinois. The FTC has recently withdrawn that challenge. So as of Monday the 18th of September, that transaction can proceed. So by the time of the MTMP panel, we should have a little better understanding and can give an update on where things are with that acquisition, which will potentially, in fact, likely change how the litigation proceeds from there.

Susan Barfield:

Yeah. Well, it sounds like you’re already giving us a little bit of sneak peeks into what you guys are going to be talking about. Anything else, Mark, you think potential folks should know about the panel before coming to MTMP?

Mark Abramowitz:

Nope. I think the bigger thing to remember is to be there on October 12th, but at 11:15 to hear us all speak about that. You’re going to hear from, in addition to Ashlie being here, one of the co-leads of the case. Tim Becker’s going to be there. Trent Miracle’s going to be there as well. We’ll be really getting in depth and sharing some of the insights of a case that maybe wasn’t on your radar before but definitely should be, especially in light of the FDA’s changing of the label this July.

Susan Barfield:

Yeah. Well, let’s talk a little bit about MTMP as a whole for maybe there’s some listeners that are on the fence and they’re like, “Oh, I don’t know if I’m going to go to MTMP.” Let’s talk a little bit to Ashlie if you would. What do you think attendees hope to learn or what should they hope to learn from these sessions?

Ashlie Case Sletvold:

It’s just always great to hear the folks who are really in the thick of it for any particular tour. I glean a lot from how excited the people that are involved in a case seem to be about it and how well they get along with one another, which I think emanates pretty well from these panels. That’s mainly what I enjoy about getting a chance to see the crew at work on any of these MDLs.

Susan Barfield:

Yeah, exactly. No, it’s exciting to watch some of the discussions and hear like you said from the leaders. Mark, I guess one thing, what would you encourage potential attendees to join? What do you get out of attending MTMP?

Mark Abramowitz:

So first off, I would encourage you to go to any of the ones we have judges on those panels. Anytime you see leadership people on there they are there to share some unbelievable information. I can’t tell you how many times I come in thinking I know about the case, I understand things but walk away going, “Oh, I missed the nuance there.” I can go back directly to my staff and start working with them saying, “Guys and gals, great job so far in the work you’re doing. We got to tweak what we’re doing here.” Those panels and listening from those leaders really helps me and my team really get through that. That’s what I would encourage, get out there. I know it might seem like a trek if you’re on the East Coast and things like that. It’s not cold yet by that point, so we’re not trying to flee from New York or in my case, Cleveland.

Ashlie Case Sletvold:

Me too.

Mark Abramowitz:

Ashlie as well. But get out there because what you can learn out there and just talking to people who are in this practice and really dedicate their practice to it, there’s so much to learn and so many great people to hear from even outside of the panels as well. I’m always blown away with what I come back with.

Susan Barfield:

Yeah. What about for you, Ashlie? What is the value of attending these conferences for you personally?

Ashlie Case Sletvold:

Just the camaraderie that we need to have. You really find out who you get along well with, who you might work well with, who thinks about things the same way you do, who shares your values and that you want to… we’re committing to spending a lot of time together when we get into these MDLs together. I generally tend to prefer when it’s folks that I personally enjoy in addition to it professionally. So I think It’s always very helpful to just get to spend that time together and meet new people. I keep meeting people that become fast friends as I’ve been a recent entrant into this space, but it’s been fantastic for me and MTMP has been a big part of that.

Susan Barfield:

Yeah, what I’m hearing you guys talk about is just all the great networking opportunities, getting to meet other folks, hear what other firms are doing, talk about criteria, listen to what they’ve done well and maybe learn from some of their mistakes. Just thinking about some of the networking opportunities, anything specific that you guys are looking forward to? I know there’s all the parties, of course, which are a lot of fun. But I guess outside of the parties, Ashlie, are there any events, I hear sometimes some of the ladies will say, “Oh, I don’t really want to go to the parties. There’s not a lot to do if you’re not going to want to go to the parties.” Is there anything that you would suggest?

Ashlie Case Sletvold:

Well, I do not understand not wanting to go to the parties. That does not compute for me. But there are also some great golf courses out there. I always haul my clubs out. It’s a great way to when you get everybody together and folks can take a little time off and there’s really no better way to really get to know somebody than four hours in a golf cart with them. So that’s always something that I look forward to on these conference trips. I mean boondoggles, I mean no, conference trips.

Susan Barfield:

Right. Mark, what about you? What would you recommend for people that are going to be attending how to maximize their networking?

Mark Abramowitz:

So one of the things that I think goes under the radar sometimes and it’s a big thank you to vendors like yourself at Case Works and other places is talking to all the different companies that are here to help with mass touring. I know if people are like, “Hey, I hate walking through those, the vendor areas,” don’t be. I cannot tell you how many great relationships I’ve made with vendors who have become instrumental with us being able to practice and practice to the level we practice at. Because there’s enough stress of dealing with statutes and case criteria and all the information we have to do as lawyers to, sometimes have people who come in you can rely on and you meet them at these events and you learn from them is just so important, so important and should not be overlooked because frankly, that’s part of the strength of this as well. Nowhere else do you get to see everybody in one place at one time that you get to talk to.

Susan Barfield:

Yeah, for sure. No, I think That’s key and outside of all the… it’s like a big reunion every six months, people coming together, partying, having a good time, networking and just seeing… and what I see time and time again is people just wanting to support and try to encourage and help each other and help their firms be successful. So again, man, I really appreciate Mark, Ashlie, you guys taking time to connect, talk a little bit about your panel discussion and for just being on the panel, being viewed as leaders and thought leaders and being able to come share what you’re learning for other firms that are interested in this tour. So we really appreciate you taking time to talk to us, and then we will connect after MTMP to learn about all the other things that were discussed.

Mark Abramowitz:

Excellent.

Ashlie Case Sletvold:

Sounds great. Thanks.

Mark Abramowitz:

Thank you so much.

Susan Barfield:

All right. Thank you so much.

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