The Synthetic Epidemic: The U.S. vs. Big Pharma - A Conversation with Randy Ramseyer

The [F]law podcast team sits down with Randy Ramseyer to discuss the US government’s litigation efforts against pharmaceutical companies. 

Randy Ramseyer is a AUSA who brought the first case against Purdue Pharma in 2006. This case required Purdue to pay out $600 million for intentionally misleading the public and using fraudulent marketing to promote their prescription opioid, Oxycontin.  Randy Ramseyer has also brought multiple cases against other pharmaceutical companies, one which resulted in a CEO being sent to prison. Ramseyer and his work in the Purdue Pharma case were featured in the popular Hulu mini-series, Dopesick. 

To learn more about the government’s fight against pharmaceutical companies: Purdue Pharma Settlement

Episode credits:

• Hosted and Edited by Hannah Justus
• Music by Sean Healey
• Special Thanks to Liz Turner and Andrew Rossi-Schroeder 

The Flaw Podcast is a publication of The Flaw, an online magazine that shares stories that reveal how corporate law and power create social problems and systemic injustices. The Flaw publishes pieces that identify how corporate power has infiltrated social and political institutions, analyzes how it controls them, and proposes methods for dismantling corporate control & building collective power. The Flaw is the product of the Systemic Justice Project and Harvard Law School students concerned about the harms caused by corporate interests and the law’s role in empowering corporations, with Professor Jon Hanson serving as Editor-in-Chief and Director.

Learn more about The [F]law Podcast on our website. 

Transcript

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Randy Ramseyer [00:00:00] Wealthy corporations that have the ability to hire. A lot of attorneys can make things very difficult. Parts of the government were against us. And certainly the health care industry was against us that they thought we were causing a problem by trying to stop the illegal use of opioids. 

Hannah Justus [00:00:40] Welcome to the Floor podcast, a podcast produced by Harvard Law School students, where we share stories that reveal how corporate law and power create social harms and systemic injustices. I'm Hannah Justus. I'll be the host of today's interview with Ramsey. Ramsey Via. Randy Ram Zara is an attorney who helped prosecute Purdue Pharma in the first case in 2007. This case required Purdue to pay $600 million for intentionally misleading the public and using fraudulent marketing to promote their prescription opioid OxyContin. Randy Ramsey or has also brought multiple other cases against pharmaceutical companies, one which resulted in the CEO being sent to prison. Ramsey earned his work in the Purdue Pharma case, were featured in the popular Hulu mini series Dopesick. Randy Ramsey, thank you so much for being here with us today. 

Randy Ramseyer [00:01:43] Glad to be here. 

Hannah Justus [00:01:45] I want to start a bit by talking about your work in the Purdue Pharma case. Could you share with us what you initially saw learned that caused Purdue Pharma to be investigated? 

Randy Ramseyer [00:01:54] Yes. So in the area that I live, southwestern Virginia, there's always been a problem with abuse of of painkillers. I started back and I started this job in 1992. And back then we were prosecuting people for illegally selling Oxycodone products such as Percocet. So we prosecuted a number of doctors over the years for illegally prescribing narcotics. And we got to the point where we prosecuted doctors and thought we need to go as far up the food chain as we can. So the next logical step was to go after the company that was making the money off of OxyContin. So when OxyContin came on the scene, it quickly took over the market for illegal opioids. And so we we opened a case and investigated the company that makes it Purdue. 

Hannah Justus [00:02:41] What was Purdue doing that caused charges to be brought against them? 

Randy Ramseyer [00:02:45] Purdue was lying about the addict potential addictive effects of the drug of it being less subject to abuse and diversion. Very, very different ways like that. Basically, their strategy was try to get doctors more comfortable prescribing more opioids. That was an overall strategy of making doctors right opiates for things that hadn't been written in the past. Opioids largely were prescribed for people with severe pain, post-operative pain. As you'd go get a surgery, you'd take your opioid for three or four days, your body would heal. You wouldn't be on it anymore. And Purdue really pushed to get people on it on a long term basis. So basically, for chronic use over time, the company marketed and promoted OxyContin as less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications. And then in the charging document, we gave certain examples of how they did that. So they trained produce sales representatives and told some health care providers that it was more difficult to extract the oxycodone from an OxyContin tablet for the purpose of I.V. use. Even though Purdue's own studies showed that a drug abuser could extract approximately 68% of the oxycodone from a oxycodone cotton tablet just by crushing the tablets. Turn it in water and draw in the solution through cotton and into a syringe. So in other words, showing that it's very easy to do. Also, they told Purdue sales representatives that they could tell health care providers that OxyContin potentially creates less chance for addiction. Immediate release opioids. They also sponsored training that taught Purdue Purdue sales supervisors that OxyContin had fewer, quote, peak and trough end quote, blood level effects an immediate release opioids and that this would result in less euphoria and less potential for abuse than short acting opioids. And they told health care providers that patients could stop therapy of drop abruptly without experiencing withdrawal symptoms and that patients who took oxycodone would not develop tolerance to the drug. And also that they told health care providers that OxyContin did not cause a, quote, buzz and quote or euphoria, that it had less addiction potential had less abuse, potential was less likely to be averted than other types of opioids and could be used to, quote, weed out addicts and drug seekers. So, in essence, they were telling doctors, if you think somebody might be abusing drugs, give them OxyContin. If they come back the next visit, that means they're not a drug addict, which of course, we all know how ridiculous that is. But I have to say, at the time, there were a lot of people in the industry pushing that view that there just weren't enough opioids out there. And so we really as we were doing that case, which was, you know, the company pled guilty six years ago. Back then, much of the parts of the government were against us and certainly the health care industry was against us, that they thought we were causing a problem by trying to stop the illegal use of opioids. 

Hannah Justus [00:05:55] You mentioned that they pled guilty. Do you remember exactly what charges they pled guilty to? 

Randy Ramseyer [00:06:01] Yes, they pled guilty to a charge of misbranding with the intent to defraud and mislead. And misbranding basically means that they were saying things in this context, means they were saying things about the drug to promote the drug and providing written materials about the drug that were false and misleading. The package insert for the drug, which of course I didn't know any of this stuff before I started doing these kind of cases. But the package insert is what the FDA approves. It's the it's the piece of paper that's supposed to go along with the drug when it's prescribed the it says a whole bunch of things about the drug. So when a manufacturer markets a drug, they can only market the drug in accordance with that package insert. So if it's not in the package insert, the sales reps can't go out there and talk about it. A doctor can prescribe for a reason other than what's on the package insert. That's legal, but it's not legal for the company to promote anything that's not in the package insert. And so the FDA had approved a package insert that had words to the effect that I won't get it exactly right, but delayed absorption is provided by OxyContin tablets is believed to reduce the abuse liability of a drug, which is a little problematic that that was approved because what does it mean for it's too believed to be either as evidence of it or not, but any event that was approved so Purdue could go out and tell doctors that. But our investigation showed that they went beyond that and went further to say to minimize the abuse liability of OxyContin and and to try to get doctors to to write more of OxyContin. 

Hannah Justus [00:07:41] So after Purdue Pharma pled guilty, they also paid out around $600 million. Did you see the problems in southwest Virginia with the opioid epidemic stop or diminish at all after that guilty plea? 

Randy Ramseyer [00:07:54] No, no. To the contrary, that the rise continued to go. And again, part of it was because the the health care industry and parts of government were still on this idea that we needed to have more opioids out there. And so there were encouraging doctors to write more, more prescriptions for OxyContin and other drugs produced. Sales went up after the guilty plea. So that was frustrating. But that's just how it works, I guess. 

Hannah Justus [00:08:23] And across the past couple of decades, how have you seen the epidemic worsen in Appalachia in general? 

Randy Ramseyer [00:08:30] Well, it worsened for a number of years. I'm not sure that it's worse now. I think maybe it peaked at some point, you know, being from this part of the country. OxyContin and just opioids in general, pills in general have been a big problem. So I actually started in this job in 1992. And at that point, opioids were a big problem in Appalachia. Back then was Percocet primarily was the big drug of choice that was sold on the street. And so then when OxyContin came on the market, the big thing about OxyContin is it's it's got a lot more of the active ingredient in it, the typical Percocet. Back when I started was five milligrams of oxycodone and then a portion of acetaminophen, Tylenol and OxyContin is just pure oxycodone. And it came in, I think, ten, 20, 1480s and then 160 at one point. So just a huge amount of oxycodone that you get quickly. So it pretty quickly widely spread throughout Appalachia as a drug of choice. And because of the the quantities that they we tended to have more overdoses that were coming about from that. And I think about four or five years ago, the government actually came out with stricter guidelines and encouraged doctors to to realize that overprescribing of opioids is causing a societal problem. Unfortunately, I think it was a year or two years ago, they they loosened up those restrictions. Again, it's like so many things. It seems like we we just don't study our history very well. We continue to repeat mistakes of the past. 

Hannah Justus [00:10:09] Can you talk more about what restrictions they have loosened up? 

Randy Ramseyer [00:10:13] It's more of kind of the tone, I guess, than anything it was. There were some pretty strict instruction that, look, opioid abuse is a big problem. You know, if people are on opioids for long terms, that that's not necessarily a good thing. I'm pretty confident that there's no study, you know, a scientific study that shows long term use of opioids increases a person's quality of life, which to me is kind of that's that should be the guide. I mean, if it's not making the person's life better, why are we doing it? And so it's just been kind of a pull back from that and more of a there's a constant lobby that is pushing the government, saying things like Purdue did back in the time period that we prosecuted them, that there's this epidemic of untreated pain and that people that have a legitimate need to be on opioids for a long term are having trouble getting the drug. I just I don't I just disagree with that. I don't think that's true. I think if somebody really needs opioids, they're getting them. 

Hannah Justus [00:11:12] I know you've made comparisons in the past between the tactics of Purdue Pharma and the ones you saw in the individual case. Can you tell us a bit more about the charges that you brought against INTERVIEWER. 

Randy Ramseyer [00:11:23] So interviewers, a company that manufactures a drug called Suboxone, which is actually indicated for substance use disorder. So basically people that are have been abusing OxyContin can take Suboxone as a treatment. And so. Suboxone became a very widely abused drug. It contains buprenorphine, which is an opioid. There's a morphine milligram equivalency that people use to kind of equate potency of different drugs and buprenorphine as a it's 20 times more powerful than then oxycodone on a milligram, four milligram basis. So there's a lot of powerful drug in it. It there's a little difference between it and oxycodone in that it's a it has sort of a selling effect. So it's harder to kill yourself with Suboxone than oxycodone. But in any event, what Indivior did was they basically told doctors that their drug was less likely to be abused or diverted than other forms of buprenorphine, that it was safer for children. You wouldn't give the drug to children, but that the way it was package would keep children from being inadvertently exposed to it. And beyond that, saying that if you want to reduce the risk of child pediatric exposure, that their drug was a better pick. So it is a common thing that basically these pharmaceutical companies will will take something about their drug that really is of no significance and try to make it sound like it's a huge, big deal and and make comparisons with other drugs that just are founded in in fact. And so so we prosecuted Indivior as we did with Purdue and as in Purdue. The CEO of Indivior pled guilty. The one difference was the C of it CEO of Indivior actually went to jail for four, six months, which is a rare thing for a CEO of a publicly traded company to go to jail. So I think I personally think that probably did have a deterrent effect on others in the industry. The thing we always want to do in these prosecutions, our view is when you prosecute the CEO of a company, what that does is it empowers the the compliance people and other companies that those compliance people in the other companies can say to the CEO, look, your marketing people want to do this. If they do that, you're potentially going to go to jail. Look at what happened in Virginia with Indivior or do you really want that to be you? And so it gives them those compliance people the ability to really try to push back against the marketing efforts to ensure that things will be done truthfully and legally. So I think I think that has a big impact. 

Hannah Justus [00:14:04] Yeah, absolutely. And I know you've stated before that in comparison to large corporations, the government is often outgunned in these cases. Can you expand a bit more on what you mean by that? 

Randy Ramseyer [00:14:16] Sure the pharmaceutical companies have a lot of money, obviously. And when I say this, I'm talking about the pharmaceutical companies that are engaged in criminal conduct. There's obviously a lot of pharmaceutical companies that have done things right. I just don't deal with them. But they've got a lot of money, so they hire a lot of attorneys. I've said this previously and it was a sentencing hearing for another another company that we prosecuted that these cases are extremely, extremely difficult to bring. And so it's really important when they are brought that the court takes it seriously and imposes a good sentence. There was another pharmaceutical company where the CEO had pled guilty and we were asking for jail time and was trying to make the point about we really need jail time because these cases are extremely rare and this is a chance to hold somebody accountable and maybe it will have effect in deterring others. So I think any time you take on a major corporation, you're going to be outgunned. And so they're extremely difficult to bring. There's you know, they're going to have 40, 50 attorneys on the other side working the case. And it just takes an incredible team. And you don't have a lot of people on the government side working the case. And you got to work through a lot of issues, a lot of legal issues, factual issues to put together the case. So obviously, you know, wealthy corporations that have the ability to hire a lot of attorneys can make things very difficult. And the law is difficult. Criminal law is difficult. And so these they're going to create all kinds of impediments to your investigation with you serve subpoenas on the company. They're going to fight the subpoenas. They're they're going to do is going to fight you at every step. And then the big thing with pharmaceutical companies, that's not true with other cases we prosecute necessarily is they're going to get an audience at the Department of Justice. So, you know, we make our case. We've got our case. We put it together. They're going to be able to go to the highest level of Department of Justice and try to stop our case. You know, that doesn't happen if I'm prosecuting somebody that, you know, sold 50 grams of crack on the street. They don't get to go to the Department of Justice and get an audience. But but these large pharmaceutical companies do. And there may be legitimate reasons for that. There's obviously big policy implications when you go after a large corporation, there's it's going to affect a lot of people. There's people that work at the company that weren't engaged in wrongdoing that could be affected. And then there's obviously stockholders that could be affected by it. So that I'm not saying it's necessarily a bad thing. It's just it does happen. And and that's going to create a lot of impediments to your case moving forward. And at a minimum, it's going to delay the prosecution. And every every year that we delay a prosecution, that's just more money than the company was able to make in the meantime. We've been fortunate in that it hasn't prevented us from doing our job in our cases. And we've been able to, you know, in some way hold them accountable. So it's doable, but it's difficult. There's not very many cases you'll see there's not very many cases against large pharmaceutical companies on the criminal side or corporations in general because of of the complexities and the difficulties. The other thing doesn't really apply to Purdue because it was a privately traded company. But but if you're dealing with a publicly traded company, you have the other difficult issues in that, you know, there are stockholders that potentially don't really know about the scope of the company's criminal conduct. And so you'll ill you'll deal with arguments that you're really punishing, you know, pension funds and other people that hold stock in those corporations. So in a in a nutshell, corporations have a lot of power and it's difficult to prosecute them. 

Hannah Justus [00:18:20] What other kind of tactics have you seen corporate lawyers in general use to help pharmaceutical companies evade accountability? 

Randy Ramseyer [00:18:28] I think the main thing is lobbying at the highest levels of the government to try to show that this prosecution would be detrimental to the country, that, you know, that they've got this great, valuable drug and that, you know, the government should not pursue a prosecution against them, that, you know, a lot of times the people are making those pitches to are not career prosecutors. Those are you know, people have been appointed to that position. They have been there a long time necessarily. They may be totally, well, well intentioned, but they're just not going to be as knowledgeable about what it takes to prosecute a case. And, you know, the defense counsel can have pretty powerful presentations that they present to those people as to why their case should be. The case shouldn't be prosecuted. 

Hannah Justus [00:19:13] I know you've also said before that cases like this are kind of hard to bring. What makes them difficult to bring and why do you think Purdue and individual were exceptions? 

Randy Ramseyer [00:19:26] Well, we've been successful with our cases because we've had U.S. attorneys. That's the top person in the office that I work in that have been supportive of the case and have done what they could to make sure it could go forward. We've been successful in building an investigative and prosecutor team that's dedicated to doing this. It's it takes it takes special people because these these cases last two years and nobody's got years of full time bandwidth to devote to it. So I think what's been successful are those things that we had a U.S. attorney that gave us the permission to go forward and we were able to amass the resources that are necessary so that if this case went to trial, we were going to win. And that's I think that's what you have to do. And I don't think that happens in every case. We basically, when we're negotiating with a company, we're negotiating from strength because we know if they don't make a proposal that's reasonable, we'll go to trial and we'll you know, you never know what's going to happen at trial. So I'm not going to say we would win, but we certainly can present a case that's very winnable. And so I think that's why that the case we have the case is ready. And so that when we're negotiating, we're negotiating from strike. 

Hannah Justus [00:20:42] Do you feel that these corporations have been truly held accountable? 

Randy Ramseyer [00:20:49] You know, I do think the one thing that's that the government doesn't do a good job of and we got to do better at is holding individuals accountable. So I do think what was significant about the prosecution in 2007 as we prosecuted three of their top executives, now they were misdemeanor pleas. So, you know, that is what it is. But but because of those those guilty pleas, they were all excluded from participating in federal health care benefit programs or anybody that dealt with federal health care benefit programs for a number of years. And so those three individuals, I think, you know, if you talk to them, they would say it was not a pleasant experience. They really did not enjoy being prosecuted, even though it was a misdemeanor and even though they didn't go to jail. And there were some real consequences to them. I've you know, I'm a prosecutor. I do all kinds of prosecutions. And I get defendants that get 15, 20, 30 years in prison. And I do have to say that those three individuals were some of the most unhappy defendants I'd ever seen. And so I think there was some accountability for the individuals. And I think that's something that there needs to be more of. You know, the other example I gave of when we prosecuted the company individual were this was more much more recently their CEO went to prison. They only went to prison for six months. But I don't know about you. I don't I don't wanna go to prison for six months. And I think those kind of things will will go a long ways in deterring, you know, companies if you can, if you just prosecute the company. The downside is that the people that did the bad conduct, you know, they still got their bonuses, they still got their raises. And they're not really there's not much deterrence. And sometimes they've left the company. So I think it is important to try to hold the individuals accountable. It's a difficult I mean, it's very, very difficult to do because of the way companies are structured and trying to show that, you know, the individual that you'd want to prosecute. And what I mean by that, people at the highest levels are involved in the conduct or knowledgeable about the conduct, because I think, you know, they're so often so far above the level where the conduct actually taking place, it becomes very difficult. 

Hannah Justus [00:23:12] So where do you think the law, regulatory agencies and politicians maybe have failed in preventing and eliminating the opioid epidemic? 

Randy Ramseyer [00:23:20] Well, I'm not going to say anybody failed. I mean, you know, I assume most people are working from from their perspective, they're doing what they think is right and they're acting in good faith. I think where problems come up is I think the regulatory agencies sometimes lose sight of the fact that these pharmaceutical companies are profit making enterprises in terms of regulatory agencies, you know, regulatory agencies. Have limits on what they're allowed to do. So, you know, it's easy in hindsight to blame some regulatory agency, but they're working under the constraints that are placed on them. I don't know that I, I wouldn't blame the regulatory agencies. I think the thing that everybody has to realize is we we live in a country where corporations, publicly traded corporations in particular, are have a duty to their shareholders to make money for them. And so you have this profit motive in the pharmaceutical industry that's there. That's real. Regulatory agencies need to be cognizant of that when they're making decisions that, you know, they can't be naive and assume that this company is just altruistic and is just trying to help people. I mean, they may be trying to help people, but they also are trying to make money. And so they do have a motivation to, you know, to increase profits. And so the regulatory agencies need to be mindful of that when they're, you know, agreeing to what goes into package insert when they're and then they have other dealings with the the corporations. And I think the companies will make a pitch about something to try to make it sound like, hey, this is all in the public's interest to do this certain, you know, approve a certain drug or approve a certain indication for a drug. And it may be, but I think we all need to be thinking about the fact that there's a profit profit motive behind all of that. And so we need to be a little skeptical of what's being said and really need to be questioning what's going on. And unfortunately, a lot of the mistakes have been made. The passes keep getting repeated in terms of, you know, we we shouldn't just think a pill is going to be the answer to everything. I think that's a big problem. I mean, pills are helpful. There's pills that have good uses. But the biggest problem comes when we take a medication that has a use or legitimate use, and we decide that a huge quantity of people need to be on it way beyond the people that would really benefit from it. I think that's true for OxyContin and other drugs, that there's a legitimate use for OxyContin, that the drug in of itself is not evil. It's the way it was, its way its use, the way it's marketed, and the idea that a lot of people need to be on it, that don't really need to be on it. And that's just, you know, we've got a we've got a system. It's you know, it's designed to increase profits. That's how our pharmaceutical business is. And so there's always that push to, you know, maybe there's only 20,000 people that need this drug. Well, the pharmaceutical companies are not going to make money if only 20,000 people take that drug. So it's going to be this push to get as many people as possible on the drug. So I think regulatory agencies need to be thinking about that. And I think, you know, if an agency like FDA could could it could benefit from having more empowerment from the legislature to take enforcement actions, it's difficult for them to do things. 

Hannah Justus [00:26:45] Can you speak from your perspective? What direction do you think the law is moving towards? Do you think it's loosening and these pharmaceutical companies and other corporations are going to be able to evade accountability further? Or do you think that the law maybe is moving towards holding these corporations accountable? 

Randy Ramseyer [00:27:02] Yeah. First, let me just say, like everything I'm saying is this is my view is not the Department of Justice view or not. I'm not this is not official policy. Anything like that is just me. But. You know the law. I don't see a dramatic difference one way or the other, I don't think. And it's more the people that are making the decisions, I think, rather than the law. And, you know, that just comes and goes. And it doesn't seem to be it's not a party thing. It's not it's not a Democrat or Republican thing. It's just individual per individual people that are decision makers sometimes, you know, would make decisions that may be different than I would. 

Hannah Justus [00:27:41] So today, Purdue Pharma has paid out over $6 billion and they've declared bankruptcy while the CEO of Indivior did receive prison time. Do you feel like the victims of the prescription opioid epidemic and their families received justice in these cases? 

Randy Ramseyer [00:27:57] You know, I work for the Department of Justice, and our job is to try to seek justice. But, you know, justice is very difficult, and particularly if you've lost a loved one. I mean, what what's going to be justice? I don't think there's anything we can do that's going to give adequate justice to anyone that's in that situation. And then you think about the communities that have been devastated by by opioid abuse where their downtowns are just kind of wastelands now, you know, not totally just from opioid abuse, but it's had a real detrimental impact. You know, they're not going to get justice either. And, you know, you know, I don't think people are going to get justice. No, I don't. We try, but I don't think it's there. I think it's Clarence Darrow, famous attorney that said there is no justice either in or out of court. And, you know, there's something to that. I think what we all have to do is just try to come up with the best justice we can. And I think it's a little naive to assume that we're going to get perfect justice. I don't think that's going to happen. But like I said, you just do small things and hope that those small things have some impact. 

Hannah Justus [00:29:00] Thank you so much for being here today, Randy. 

Randy Ramseyer [00:29:02] Yeah, I'm glad to be with you. Thank you. 

Hannah Justus [00:29:19] Thank you for listening to this episode of The Floor podcast with Original Music by Sean Healey, and special thanks to Liz Turner and Andrew Rossi Schroeder The Flaw podcast is a production of Harvard Law School Systemic Justice Project and the Fkaw Magazine, an online publication that explores how corporate power creates social harms and systemic injustices. A special thanks to Professor Jon Hansen, Director of the Systemic Justice Project and the Flaw's editor in chief. I'm your host, Hannah Justus.