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Read the Full Zantac Town Hall Transcript
Hi, everyone, I’m Attorney Dennis VanDerGinst, President and CEO of VanDerGinst Law. I’d like to welcome you all to our VanDerGinst Law Virtual Town Hall. We’ll be discussing the legal and consumer related topics with some of the best experts in the country. We have asked for questions from online followers in advance, and this content may be used in one of our podcasts.
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Today, I’m happy and proud to announce that our guests are Barbara Capasso and John Ray. They’re the founders of Mass Tort Nexis, an incredible educational resource on the practice of mass torts, specifically pharmaceutical and medical device litigation. Essentially, what they do is teach, consult, and provide in-depth knowledge and research to plaintiff law firms across the country.
And I’m happy to say that VanDerGinst Law is one of those those plaintiff law firms. We consult with them on a weekly basis. We’re happy to have them here to provide their expert insights into the Zantac litigation. We’re also going to hear from Kitka Galvin, who is the lead paralegal and mass tort coordinator for VanDerGinst Law.
What is Zantac and Ranitidine?
So, John and Barb, thank you for being here. I’d like to begin by having you explain what Zantac and ranitidine are, and what they’re designed to address.
OK. First I’ll start with explaining acidity in general. Everyone probably realizes a fruit like a lime is acidic. If you put it on your skin, if you put it on a cut, it’ll burn. It’s acidic. And then the battery in your car is also full of acid. If you put that same acid in your battery on your hand, it’ll eat a hole through it.
So not all acids are created equal. The battery acid in your car is far more acidic than the acid in a lime. Now your stomach is basically a vat of acid that digests food. Your body produces this acid. Drugs like Tums and Alka Seltzer and so forth are just used to enter that acid and react to the acid that’s there and make it less acidic. Make it closer to lime, further from battery.
Where drugs like Zantac operate differently, they don’t affect the acid that’s already in your stomach, they affect the pumps called H2 pumps. H2 receptors, you don’t need to understand what that is. But what makes the acid the part of your body that makes the acid, they stop it, interfere with it, making the acid in your stomach, to reduce the acid in your stomach. They’re called acid reducers not antacids like Tums or Alka Seltzer.
Alleged Issues and Dangers of Zantac
Now, the problem with Zantac and ranitidine is that they were already known to be nitrosatable drugs. And I know that’s a big word. All that means is it’s a drug, that because of its chemical structure, it can convert, in other words break apart the molecule that the drug is, can break apart. And part of it can become something else. And that something else that a nitrosatable drug can become is called a N-Nitros compound. And I know that, again, I’m using words, but I’m going to simplify it.
The particular compound that has been discovered that Zantac and ranitidine brake down into Is called NDMA. NDMA is known to be highly carcinogenic. It’s mutagenic. It actually mutates the cells in your body. All cancer is, is a mutated cell that then replicates itself again and again. Because it’s mutagenic, it mutates cells, NDMA can also cause birth defects as well as organ damage, kidney damage, liver damage and other organ damage. Now, as I said, the makers of these drugs have known for a long time that this was possible that these drugs would convert in your stomach acid.
The very first thing that struck me about this litigation, what I started looking at the science behind it was that of the other nitrosatable drugs, drugs that could convert to NDMA, none of them were created specifically for people who had very acidic, closer to battery acid, stomach acid. Well, why is that relevant? Because acid, the more acidic your stomach is, the more breakdown of the drug into the carcinogenic NDMA occurs.
But that’s not what started this litigation. Ultimately two outside laboratories that study drugs, took samples of Zantac and ranitidine that had been in people’s shelves, have been in different places. And they tested them just to see how much… see if it was converting to NDMA before you swallowed it and it went into your stomach, and found massive amounts of NDMA in many of the products. The allowable amount in drinking water of NDMA is .096 nanograms. That’s one drop of water in an Olympic-sized swimming pool.
But what they found in these products was thousands and thousands of times that. So essentially, not only was the drug turning into this carcinogenic mutagenic substance when you swallowed it, when it was sitting at room temperature in your home, on a truck, anywhere else, it was already beginning to convert. So the longer it sat, the more it was no longer what it started out as, but nothing but a cancer pill. And and women who took it during pregnancy, which many women have stomach problems obviously during pregnancy, it meant it could cause birth defects and stillbirths. The child to be born dead.
So this was a very dangerous drug that’s been on the market that sold billions and billions and billions of dollars. One of the best selling drugs of all time, and also sold over the counter. And had the makers of these products cared to do what they obviously needed to do is far as adequately testing them. The people who’ve been harmed, people who have cancer, children have been born with birth defects, people who suffered organ damage in children who apparently have suffered their child being born dead, all that could have been avoided.
So that’s what this litigation is about.
The Lawsuit for Prescription and Over-The-Counter
OK, and John, you mentioned ranitidine and that is the generic version? And you mentioned NDMA and the cancer that it has been alleged to create that Zantac and ranitidine. Can we talk a little bit about those types of cancers and other side effects? I know you mentioned birth defects and stillbirths. I believe there’s also kidney and liver problems that are allegedly being caused. Can you talk a bit about those side effects?
Absolutely. Well, first of all, let’s just go back for a minute. I don’t know if we made this clear, but Zantac started out as only a prescription, many, many, many years ago. Then it went, as many drugs do, to a generic form. And from there, it went to many over-the-counter forms. In fact, I’m sure some of you out there just started taking it over the counter. You may have bought the Walgreen’s brand of Zantac. You may have bought the CVS brand, the Wal-Mart brand.
Almost every major retailer in the country had an over-the-counter version of Zantac. It was basically the same product. Recently, very recently, the FDA asked the manufacturers of Zantac to please voluntarily pull it from the shelves. Because as of recent, most of the drugs being sold was over the counter. In fact, the prescription form of the drug, as soon as the generic form was made, they stopped making the brand.
Well the sales dropped. Yes.
So please understand that this has been going on for upward of 25 years or more. You could have started on the prescription, moved to the generic and then move to the over the counter. So I just want you… I want to make a real distinction between prescription, generic, and over-the-counter.
The FDA Recall on Zantac
But regardless, the FDA recently asked the manufacturers to pull all the product off the market, which they did, which then began our litigation, because when something that drastic, the FDA rarely takes an action like that.
So that’s really what started this litigation.
Just so you understand, when the FDA “asks” a drug manufacturer to do something, that’s because in order to force them to do it, they have to sue them. They have to take them to court.
Or they “ask”. So you hear FDA recall, surely the FDA first “asks” because that’s the easier route. And the manufacturers all complied because they knew the gig was up.
So it wasn’t really that the FDA was giving them a choice. The FDA was giving the option “we’re asking you to do this.
If you don’t, we’re going to sue you. We’re going to make you do it.”
Side Effects of Taking Zantac
And I appreciate that historical perspective on what’s occurred and where we’re at right now. You started to address the issue of the other side effects and what it is that we’re looking at, what people should be aware of.
You know, if they’re concerned that, “oh, my gosh, I was taking this for some period of time and I’ve had certain ailments”. Well, what are those elements that they really could potentially have a claim for?
Well, let me start with the three broad categories. And I’m going to let John fill in the details.
First and foremost, cancer in adults. Now, obviously, that can mean many, many different types of cancers. We are specifically looking… and it’s not to say from this list that there may be other cancers that we will accept. But most importantly and in the forefront: esophageal cancer, bladder cancer, liver cancer, stomach cancer, and pancreatic cancer. Now that’s kind of obvious based on the way it’s ingested, but we will also at this time accept prostate cancer, testicular cancer, colorectal cancer.
And obviously, you can tell by the list I’ve just recited, it’s the center of your body and your digestive system, if you will. So that’s our first category, which would be cancer in adults. We also, sadly, have a category of cancer in children.
Now, I just want to say with the adults, you have to have three years of use. And what do we mean by use? Well, generally, it’s a minimum of three hundred milligrams per week. And for children, it’s only one year of ingestion and one hundred and fifty milligrams a week.
So cancer in adults, cancer in children because there are pediatric Zantac products, obviously.
And then lastly, we’re looking at midline birth defects, sadly enough, and stillbirths and mothers who take the product while pregnant. Now, what does that mean by “take it while they’re pregnant”? That means that they have to have taken it for at least six months during their pregnancy.
And again, the minimum is three hundred milligrams per week for an adult. So those are our three baskets of injury. And I’ll let John fill in.
Yeah, one of the things that makes… There going to be a lot of cases filed in this litigation, and part of the reason is, is Zantac and other similar drugs are known to have what’s called a rebound effect. In other words, you take them and they affect the anatomical structure that produces acid. Well, it stops doing what it’s supposed to do and then rebounds. It produces more than it normally would.
So it’s not addiction, like being addicted to an opioid, it’s physical, a physical rebound effect. You need to take it again because it stops your problem, the pain you were having from your stomach acid. But then as soon as the drug was no longer affecting those receptors, they tried to make up for lost time and produced even more.
And so you had to take more. So most people who took it eventually became, I don’t want to use the word addicted, but they developed an ongoing need for it and took it over a longer time.
In other words, the same dosage that they once took was no longer effective. So they started taking more. In fact, we have a personal friend who basically we had to wean him off of it a bit. And I don’t suggest you do this, but it was to the point where he needed so much of it to get the same effect, he was taking it more than prescribed, which I don’t suggest anybody ever do.
And if you did and you had the same effects that we’re talking about here, we just want you to understand that unfortunately that was normal for people who took Zantac or any form of it.
Qualifications for the Zantac Lawsuit
Now, there’s a couple of really important points I want to make about this. If you did have any of the adverse events that we just described, be it the cancer or the birth defects, please understand that your last dose has to be 10 years less or prior to.
So in other words, you could have stopped taking it 10 years before your cancer diagnosis and you’re OK. But if you took it and it was 11 years, then you don’t have a claim. That 10 years is a long time, but I just want you to understand that you have to have had your diagnosis of cancer or any other adverse event in this litigation after 10 years. That can be that’s what we call the latency period. It can only be 10 years. I don’t know if I explain it very well.
But most people what we find when people call law firms, like VanDerGinst Law, is that people were on this drug a really long time for some of the reasons John just described. They needed more and more of it to feel better.
So you’ll find many of you out there were probably on the drug 5 years, 10 years, 15 years and more. And as we spoke about before, you may have started on the on the prescription form and moved to over the counter.
The Defendants In This Case
So let me then move into another important subject you may be asking yourselves: “well, my goodness, there’s going to be so many of these cases”. Well, please understand that as a claimant, we’re suing the manufacturers, all the pharmaceutical companies, of which there are many. We are suing the distributors and we are suing all of the retail outlets that sold this drug. And so we have many, many, many defendants here. So…
Who can afford to pay the claim.
I didn’t want to say that. Yes, there are many defendants. There will be many claims, but there are many, many defendants for whom we will be suing.
And I think that’s a great point to make, because in a lot of these types of litigations, there may be just a couple or a handful of potential defendants. And the concern becomes, if there are a lot of claimants out there, well, is there enough to adequately compensated those people who have been injured?
But as you pointed out here, there are a lot of potential defendants. This has been going on for many, many years, as you’ve also pointed out. So there should and will be ample assets, I guess, with respect to compensation.
How Far Along is the Zantac Litigation?
Now, let’s talk a little bit about where we’re at. What has occurred as a result of discovering these side effects, these potential side effects. I know in other discussions that we’ve had, we talk about distinctions between class actions, mass tort actions, multi-district litigation, et cetera.
So could one or both of you speak to that as far as what we do with these potential claims once they come into our office, for instance.
I’m sure Kitka is going to go over this. But this is what we call an emerging litigation because the FDA just asked the manufacturers to stop selling it a short time ago. So we call this emerging litigation. It just began.
So right now is a great time to call because we will get your claim processed. We will update you as to what’s going on in the litigation. We have yet to have trials, though will be scheduled shortly. Still, again, the chances of your claim being chosen to go to trial are almost zero.
But that’s a good thing. I don’t want you to look at that as negative. It’s actually a very good thing. So what happens is most of the claims will be filed with the court, which is here in Florida. That’s where it’s consolidated. And then VanDerGinst Law will update after your claim is filed and keep you updated on what’s going on in the litigation.
Now, please understand, because it is emerging litigation and they’re going to be a lot of claims, we may not get to the settlement phase for many years.
But during the processing of your claim, please, please work with VanDerGinst Law, answering all of their questions so that they can file your claim and you’ll be on file. So when they do settle the case, you’ll be all set and ready to go.
And a multi-district litigation was granted. So the simpler form of filing does exist. Simpler for the plaintiff, not necessarily for the law firm, but simpler for the plaintiff, has been granted.
And because there are so many defendants and every major retailer in the country decided to make their own version of this drug, there are a lot of defendants. From a legal standpoint, the fact that the FDA drug asked that the drug be recalled is very positive for plaintiffs.
There are a very long list of defendants that have to be dealt with. The litigation is going to be complicated and that may make it take longer than it otherwise would.
And that’s a very, very good litigation. I’m sure most of you are familiar with the term “fraud”. And in the complaint that we’ve made to all of these defendants, there are a lot of fraud charges. So it’s a very, very interesting litigation.
And I think it’s important to point out, Barb mentioned the litigation being consolidated in Florida. I want everyone to know, well, first of all, VanDerGinst Law is located in Illinois and Iowa. Unfortunately, we’re not in Florida, although I wish I were at this point in time.
But we’re handling cases from all over the country. So the fact that it’s consolidated in Florida is really not important. And of course, we have Mass Tort Nexus right there.
But in any event, it’s also important for everyone to understand that we do this work on a contingent fee basis. So there’s no risk. If you feel that you might have a potential claim, certainly reach out to us. And I’m going to let Kitka talk about that a little bit in a moment.
But reach out to us and know that unless we’re able to get you compensation, there’s no attorney fee. You’re certainly not asked for any kind of retainer for costs or anything along those lines. You’re never going to be out of pocket a dime, unless we get a recovery on your behalf. So that’s important. I know for anyone listening in or watching this to know.
What Happens When I Call VanDerGinst Law?
So along those lines, I guess Kitka I’ll have you speak a little bit about what it is that we are doing with the inquiries that are coming in with respect to this Zantac litigation and how we are vetting those files.
Yeah, Zantac, it’s kind of been in the news. So I know a lot of people have questions. What I want to say is if you took Zantac and you were diagnosed with cancer, or your child was, or your child was born with birth defects, give us a call. We are going to ask you some questions. In order for us to build a case to file your claim with the MDL, we need some facts. So we’re going to have to order medical records.
We’re also going to do some digging to prove that you actually took the product. It’s a little bit different than having a medical device implanted where I’ve got operative reports. We’re going to have to track some things down. It’s not impossible. So don’t feel like, “well, I took the Walgreens brand of Zantac, but I don’t still have the product or I don’t have a prescription for it”. We’ve got some ways to to track down that proof of use.
So we’ll put all that information together. We’ll get your medical records. We’ll determine that proof of use, and then we will put that case together. Build it up and file into the MDL. As Barb and John and you guys have all said, this is a baby tort right now. It’s brand new. So we’re going to be working on this for a few years.
That doesn’t mean that we just leave you high and dry. We try very hard to keep in constant contact with all of our clients. We’ll be in touch about once a month. Sometimes that’ll be to tell you nothing happened this month, but we’re still here and we’re still working on it. And yes, you do have a case, and here’s your case number. And as soon as something happens, we will let you know.
And I’m glad Kitka has mentioned that. That we do reach out to everyone at least once a month, even if there’s not really anything to report, because we know how anxious people can be when involved in these types of situations. And it’s good to know that we’re very communicative.
I think that’s always important whenever we’re dealing with claims and or litigations that are resulting as of, because of, injury or illness caused by products and or situations that arise. So thank you for bringing that up.
Wrapping It Up
As is the case with the other torts that we’ve had the pleasure of discussing with Barb and John. I want to give them the final say here and talk to anything about this litigation that they might like as far as the summary.
The Zantac litigation or…
The Zantac litigation, I would say, the statement made by the FDA on April 20th of 2020 is conclusive of ranitidine (Zantac) converting to NDMA simply by exposure to room temperature (in other words, the temperature in your home) is what made it almost impossible for the defendants to mount a serious defense in this litigation. Because the product was not shipped from overseas, generally, in refrigerated containers. Obviously when you received a prescription or over the counter, you were not told keep this drug in the refrigerator.
Some drugs do, you know it says keep them in refrigerator. This one was not. And because all that needs to occur in order for those tablets to start converting partially into this extremely hazardous substance, that’s an EPA classification, that’s EPA speak for poison, is exposure to room temperature.
And it was always exposed to room temperature from the moment it was made until it was completely used or thrown away. That is kind of hard for the defendant to defend.
They can’t say, no, it didn’t. Not with any honesty. “No, no. Our drug doesn’t convert to this poison, this carcinogen”. And the FDA was slow considering the evidence to take action. But once they took action, the statements made by the FDA were very damning for these defendants.
And I’d just like to say this. Please understand that not all lawyers understand how to file pharmaceutical or pharmaceutical device claims. VanDerGinst Law is very well versed in filing these claims. It’s very important that you understand. Don’t just go to some local lawyer who who really doesn’t handle these cases.
You have to be under the guidance of someone who understands the ins and outs of these cases the way VanDerGinst Law does. So please, if you believe you have a claim against Zantac, call VanDerGinst Law, because they know how to file these claims and they will stay in communication with you and help you along every step of the way.
Well, thank you, Barbara, saying that. And I want to thank both Barb and John for joining us, as well as Kitka. I want to thank you all for joining us.
Thank you again. And everyone, have a good day.
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