Via America’s Lawyer: Mike Papantonio is joined by attorney Daniel Nigh to update us on litigation against manufacturers of the popular heartburn relief aid Zantac. The drug has been found to create sky-high doses of the carcinogen NDMA in the human body leading to stomach, bladder, and kidney cancers. Just WHY has it taken the FDA decades to alert the public about the dangers of this chemical, which is specifically used by researchers to foster cancer in lab animals? It appears celebrity attorney Michael Avenatti will be unable to escape the litany of charges against him, including for wire fraud, embezzlement, and extortion against Nike. Mike Papantonio explains more.

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Transcript:

*This transcript was generated by a third-party transcription software company, so please excuse any typos.

Mike Papantonio:             Researchers at Valisure discovered that Zantac, the popular heartburn medication, is loaded with a cancer causing substance known as NDMA. They first notified the FDA about this in June of last year, but just in keeping with the FDA, they did nothing about it. The FDA slept on this issue and now it’s killing Americans. Joining me to talk about this is Daniel Nigh. Daniel, let’s start at the top. What’s the Zantac problem?

Daniel Nigh:                          Well, Zantac breaks down inside of the body. It’s an unstable molecule, it breaks down inside with this toxin called NDMA and NDMA is a radical, terrible toxin. It causes cancer in numerous organs inside of the body. You know, when they’re doing animal studies and they want to induce an animal with cancer, the toxin à la choice is often NDMA just because of how quickly it can induce a cancer and it can induce a cancer at any site.

Mike Papantonio:             Okay, put it in perspective. We’re not talking about small amounts, as you point out, this is a chemical that when a scientist wants to make an animal, induce cancer in an animal, this is their go to chemical.

Daniel Nigh:                          That’s right.

Mike Papantonio:             Now, there’s a number that the, and of course, I trust nothing that the FDA says. This is the most dysfunctional, it’s almost a useless entity. But they say, well it’s 96 nanograms is going to be okay, but tell me how many nanograms we, we’re talking about with this.

Daniel Nigh:                          Well, there’s multiple different options out there, theories that we’re still trying to gather a little bit more information about. You know, the petition from Valisure show that it may break down into as many as 4 million nanograms.

Mike Papantonio:             Four million?

Daniel Nigh:                          Right. There’s another, but that’s with heating the sample, there might be some issues recognizably with that. But the other issue is when it goes inside of the body and it’s, and it’s combined with nitrates, a high nitrate diet, like if you’re eating pizza at the same time as taking your NDMA, they’ve shown also that under a simulated testing that it may be hundreds of thousands of NDMA breaking down there. The FDA has even only tested the pill itself and found nano, you know, high nanograms of NDMA in the pill itself.

Mike Papantonio:             Okay, let’s back up on all that. Okay. First of all, we know we can begin here, that we know GlaxoSmithKline, if I’m betting the farm on it, they phonied up results from clinicals. I see it almost every case that I handle.

Daniel Nigh:                          Well along those lines, Pap, in the 1980s GlaxoSmithKline had a, Glaxo back then because keep in mind, Glaxo rode on the back of Zantac.

Mike Papantonio:             That’s right.

Daniel Nigh:                          That’s their moneymaker. That’s how it became GlaxoSmithKline. They forced the merger because they weren’t in superior position without Zantac, we don’t, I don’t know if they’d even be in the name.

Mike Papantonio:             Right.

Daniel Nigh:                          You know, but they knew back in the 1980s that combined with a high nitrate diet that it would break down the NDMA.

Mike Papantonio:             Let’s talk about, okay, so right now we know we’re way above the acceptable level of 96 nanograms.

Daniel Nigh:                          Right.

Mike Papantonio:             We’re maybe 3000 maybe 4 million.

Daniel Nigh:                          Right.

Mike Papantonio:             The argument is that, that we’re hearing from the other side is, well, oh that’s only when it’s heated up. The point is, we know this, when the Zantac goes into the human body and it can, it combines with nitrates, as you’re saying.

Daniel Nigh:                          That’s right.

Mike Papantonio:             Nitrate is something you can get from smoked sausage. You can get it from any, look, food is packed with nitrates. Bacon has more than you can count. When you combine bacon with the Zantac pill, those numbers can hit three thousand, four thousand, five thousand, that’s what this is showing right now.

Daniel Nigh:                          Absolutely.

Mike Papantonio:             Okay, so that’s the first part of it. The second part of it is that the company has known about this for a very long time. They, and the FDA has known about it for a very long time and done nothing. How long did it take the American FDA to react after this was already pulled off the market around the world?

Daniel Nigh:                          Well, FDA was the 43rd country to actually take some definitive action.

Mike Papantonio:             Okay.

Daniel Nigh:                          We have countries out there like Guam and Singapore taking definitive action before the FDA. It’s they, they slept on this, like they’ve slept on many other projects, as we know.

Mike Papantonio:             Tell us why in this case, the FDA and they had to save face, that’s what I remember about it. They had to save face. Tell us that story.

Daniel Nigh:                          Well, the FDA tested the pill itself ,so they can see that there are hundreds of nanograms in the pill. And so once we even have hundreds of nanograms, that’s over the threshold level of 96. And the way that it actually started out is even our pharmacies understood what a catastrophic problem this was. They pulled it off the shelves, even the generic medication suppliers and now Sanofi, they all pulled it off the shelf. So really they all acted in the US well before the FDA took definitive action.

Mike Papantonio:             Sloan Kettering, probably one of the most important cancer research hospitals in the world.

Daniel Nigh:                          Right.

Mike Papantonio:             Comes out and says, we did this study. It scares the bejesus out of us. Tell us about that.

Daniel Nigh:                          Well, we know, what we know now is that Sloan Kettering, the lead investigator, they made the, was interviewed by Bloomberg and they had mentioned that as after they saw the study results they polled, using Zantac in their hospital.

Mike Papantonio:             Okay. So the hospital itself pulled the product out of their hospital and they’re the ones that did the study.

Daniel Nigh:                          That’s right. They’re the ones who did the study. So we have pretty, pretty high confidence that there’s going to be some significant results in this study.

Mike Papantonio:             Well, surely it’s going to be in one of the, one of the medical literatures. Surely that study is going to be published so the public can know about that. Tell me, when will it.

Daniel Nigh:                          I think it was supposed to be published in JAMA, and it was supposed to be published a few days ago, and here’s, here’s one of the big stories. Now, you know, in terms of proving this case, we don’t have to have Sloan Kettering study to prove it, but it almost makes it a slam dunk when Sloan Kettering comes out because it’s so clear that if you’re taking Zantac with a study like this, that it increases your risk of cancer.

Mike Papantonio:             Okay. So just to be clear, Sloan Kettering comes out with a report where they completely substantiate everything that you’re alleging. The study shows it, it’s very clear. But nevertheless, even though that study, most of the time would be published in like the JAMA or one of the medical pieces of literature, it’s not showing up yet.

Daniel Nigh:                          That’s right.

Mike Papantonio:             And we, and if I’m guessing, because I’ve seen this before, I’ve seen the FDA get involved and hush a story. I’ve seen the, the lobby, the pharmaceutical lobby work together with the FDA to make a story go away. Is that what’s happening here in your estimation?

Daniel Nigh:                          Well, we’ve seen on numerous of these science blogs online that it’s already leaked, that JAMA pulled the study preemptively. We don’t know why. You know, I hope, Pap, I hope that it’s just to look at it and see if it’s more accurate and just, you know, make, give it a little bit more vetting and make sure that the findings are robust. But we’ve seen this time and time again, we’ve seen this in past projects.

Mike Papantonio:             Oh, I’ve seen it a dozen times.

Daniel Nigh:                          Where the company or the FDA tries to figure out a way to bury a study and I’m concerned that’s what we’ll be seeing here.

Mike Papantonio:             But here, we’re talking about a product that causes cancer. There’s no question. I mean, anybody that says no, there’s no evidence, where do you find a scientist that comes out and says, yeah, this does? That the pill itself generates the chemical NDMA. You understand what I’m saying?

Daniel Nigh:                          Yeah.

Mike Papantonio:             NDMA, it’s not contaminated with NDMA. It goes into the body and synergistically creates the chemical NDMA, which is the chemical that scientists use when they want to promote cancer in a laboratory animal. And this is four, this is thousands of times higher than even the FDA’s number, which is 96, it’s thousands of times higher than that.

Daniel Nigh:                          Right.

Mike Papantonio:             And so here we are right now, and my supposition here, I’ll bet on this all day long and when we do the discovery on this and take the depositions, what we will show, I promise you, will be that lobbyists for the pharmaceutical industry and the FDA worked together to suppress the Sloan Kettering study. I promise you that’ll happen. Not only the Sloan Kettering study, but other studies. Tell me what scientific, what’s the best support for Zantac and it’s cause to cancer? What do you rely on?

Daniel Nigh:                          Well, we know that Zantac breaks down inside of the, into NDMA. Even the FDA has already known that there are some levels that it’s, that it’s breaking down. So that alone, there’s a mountain of literature in terms of animal studies, in terms of human dietary studies, in terms of occupational exposure studies that show that NDMA causes cancer. But we also even have a few studies that were done back in the day, not understanding that NDMA was breaking down inside of the body, but done back in 2008 showing an increased risk of breast cancer for people who were taking Zantac. And also we’ve seen an increase in the risk of bladder cancer.

Mike Papantonio:             Bladder, colon, stomach, what do people need to be really aware of? If they’ve been popping, look, there’s people that pop Zantac all day long because they have acid reflux, they’ve got ulcers, they’ve got doctor says, yeah, take as many as you want and they pop them like, like candy. What should they be conscious of?

Daniel Nigh:                          Well, I think, I think some of the main cancers we’re going to see is we’re going to see bladder cancer, kidney cancer, colorectal cancer, stomach cancer. But I would say this, when we’ve looked back and we found that it even causes an increase in the rate of bladder cancer in terms of Zantac users. We know from our work in Valsartan where it caused NDMA to break down inside of the body. That breast cancer, you just wouldn’t see that in the animal studies, dietary studies, occupational studies as much. So if it, if it causes that and an increased risk, then I think all cancers are on the table at this point that NDMA from Zantac may cause any type of cancer.

Mike Papantonio:             Now, I can hear it in trial, GlaxoSmithKline says, gee, we voluntarily pulled it off the market. Truth is when should they have known and put this relationship together and not put any more people at risk? As you look at the facts of this case, when should that have been done?

Daniel Nigh:                          Clearly in the 1980s. They were, they were also warned internally that this should at least, at the very least, it should be marketed with a warning to not take Zantac at the same time as eating, especially with a high nitrate diet, but they did the exact opposite. Their campaign was to show that you could take Zantac at the same time as a high nitrate diet so that you wouldn’t have the heartburn and you would be able to eat whatever diet you want it to. Clearly against what their own internal scientists were telling them.

Mike Papantonio:             So, in about 30 seconds, what are their defenses right now? What are they saying? What are the, I mean obviously they know this is a multibillion-dollar problem for them. I mean, because just the call, just the calls that you’re getting from people, they’re staggering numbers, aren’t they?

Daniel Nigh:                          Very staggering numbers. I mean, at this point, you know, we have thousands of clients already internally, but if I look at the scope of this problem, I mean, Zantac was the most popular pill on the, on the market back in the 1990s and still popularly prescribed, even as you know, 2016 had 15 million users at that time.

Mike Papantonio:             Fifteen million.

Daniel Nigh:                          It was very, very popular common drug and what we, what we think is that they’re going to be many people who got cancer as a result of taking Zantac.

Mike Papantonio:             Yeah, and people think it’s like taking aspirin. There’s no problem here, because that’s what their doctors think because the doctors haven’t even been educated really about the NDMA relationship.

Daniel Nigh:                          That’s right.

Mike Papantonio:             Daniel, give them hell. This is, this is an ugly, ugly case. Stay in there and fight them.

Daniel Nigh:                          Absolutely.

Mike Papantonio:             Thanks for joining me. Okay.

Daniel Nigh:                          Thank you.

Mike Papantonio is an American attorney and television and radio talk show host. He is past president of The National Trial Lawyers, the most prestigious trial lawyer association in America; and is one of the few living attorneys inducted into the Trial Lawyer Hall of Fame. He hosts the international television show "America's Lawyer"; and co-hosts Ring of Fire Radio, a nationally syndicated weekly radio program, with Robert F. Kennedy, Jr. and Sam Seder.