Below are some of our videos explaining the potential dangers of Valsartan, and especially the connection to the development of liver damage & cancer. To learn more about the types of injuries that have been linked to this medication, and the legal claims that have been filed, click Valsartan.
Drug Companies Faces Lawsuit For Exposing Patients To Cancer Causing Medication Valsartan
Mike Papantonio: Drug companies are being sued by patients who took medications containing Valsartan. Instead of helping to control high blood pressure, the drugs actually cause many of them to develop cancer. Madeline Pendley, attorney Madeline Pendley is here to join me now to talk about this. Maddie, first of all, what is, what’s the underlying problem here?
Madeline Pendley: So the underlying problem is Valsartan, which is a generic drug. It was pulled from the market because it was contaminated with a highly carcinogenic compound known as NDMA
Mike Papantonio: NDMA, people are going to start hearing more and more about NDMA because it’s, now we learned that it’s in so many different medications.
Madeline Pendley: Right.
Mike Papantonio: Tell me a little bit about it.
Madeline Pendley: So NDMA it’s extremely dangerous. So the only reason it’s even used today is in laboratory studies. So they actually inject animals within NDMA in order to see how tumors develop. So there’s no question it’s carcinogenic and it’s actually extremely good at facilitating tumor development. Anywhere it’s injected will develop a tumor.
Mike Papantonio: Okay. So the whole purpose, the only purpose that we use it for on the market in the United States is to cause cancer.
Madeline Pendley: Yes.
Mike Papantonio: In laboratory animals.
Madeline Pendley: Exactly.
Mike Papantonio: And with Valsartan we know that it’s in Valsartan. It’s being created, produced inside the, inside the medication itself. And, and so what went wrong? What happened here? Was it, was it contamination of some kind or what?
Madeline Pendley: It’s basically a manufacturing defect and this happened long story short because these companies cared more about making money than making a drug that was safe. So we have two main groups of defendants to keep it simple. API manufacturers. They make the active pharmaceutical ingredient Valsartan and finished dose manufacturers who bought that product. Basically our main API manufacturer is a Chinese manufacturer called ZHP. ZHP had been making Valsartan for years with no issue at all, and that’s important, but in order to save money, they decided to change the manufacturing process, switch from process one to process two, when they did that, they used cheaper materials. They can make more drugs more quickly, you know, so it was just to make money and that process too is what facilitated NDMA in the drug.
Mike Papantonio: So you’re suing, you’re suing these Chinese companies in the United States?
Madeline Pendley: Yes.
Mike Papantonio: And you, you’re going to be able to hold them here, hold them accountable with that case?
Madeline Pendley: Yes. And we have a ton of internal documents, things they we’re saying to each other when they thought nobody was looking. Test results they had early on that shows that they did know about this issue and just didn’t tell anybody.
Mike Papantonio: Well, what, okay, so, so they, this Chinese company knows they’re shipping tons of this stuff to the United States and all around the world for that matter.
Madeline Pendley: Right.
Mike Papantonio: They already know it’s contaminated.
Madeline Pendley: Yes.
Mike Papantonio: They, there’s, there’s not any question, yeah, we know it’s contaminated. They’re trying to say to the, to the world public, don’t worry about it. It’s not enough. You’re going to be okay.
Madeline Pendley: Right.
Mike Papantonio: That is the biggest lie they could possibly tell, isn’t it?
Madeline Pendley: Right. And they knew it was contaminated and they actually had testing results that show things that they were referring to as ghost peaks. So this is probably grossly oversimplified, over-simplify, but they have chromatography testing. It’s like shows little bumps and so they know where these bumps should be in baseline clean Valsartan.
Mike Papantonio: Yeah.
Madeline Pendley: They did testing after the process to switch and saw these huge peaks.
Mike Papantonio: And you’ve seen them?
Madeline Pendley: I’ve seen them and the emails discussing them, like what is in this drug? This is so strange. And instead of looking into it and doing the testing they’re supposed to do, they chalked it up to ghost peaks. It’s a weird testing error and continued to sell it.
Mike Papantonio: Well, okay. They’re, yeah, the FDA of course, to me is one of the laziest institutions we have in the United States.
Madeline Pendley: Right.
Mike Papantonio: They’re either owned by corporate America, corporate America, time and time again, the drug companies just do whatever they want to do with the FDA. The FDA didn’t do much here, did they?
Madeline Pendley: No, they didn’t.
Mike Papantonio: Yeah.
Madeline Pendley: They actually approved this process switch for ZHP because ZHP told them it was a minor change, you know, so that they didn’t have to go through the more stringent regulatory requirements and the FDA just kind of took them at their word and let them do it.
Mike Papantonio: Okay. Tell, tell us how this NDMA operate. I mean, first of all, it’s a carcinogen by itself.
Madeline Pendley: Right.
Mike Papantonio: But then when a, when a person takes this Valsartan, the NDMA is moving through their system. But they’re also doing things like eating bacon, which is huge.
Madeline Pendley: Right.
Mike Papantonio: Eating smoked fish. Explain that a little bit.
Madeline Pendley: So NDMA, you know, it was in this drug anyway, like you said, but if people are on a high nitrate diet, if the drug is exposed to heat and humidity, whether it’s inside the body or out, all of those things can lead to higher levels of NDMA in the drug.
Mike Papantonio: Any question that this Chinese company knew that, in your mind?
Madeline Pendley: No. I mean, to be fair at the beginning, they didn’t know it was NDMA because they didn’t want to know it wasn’t NDMA.
Mike Papantonio: Yeah. They were hiding from it.
Madeline Pendley: But as soon as somebody raised the flag, they knew and kept their mouth shut.
Mike Papantonio: Yeah. Thank you for joining me. Good luck on this case. It’s an important one.
Madeline Pendley: Thank you.
Valsartan Lawsuits Imminent As Heart Medication Found To Contain Toxic Chemical
Mike Papantonio: A major heart medication has been recalled because batches of the drugs been contaminated with cancer-causing chemicals. That medication, valsartan, has now sparked major lawsuits. I have attorney Daniel Nigh with me to talk about this. Daniel, there's been a run on heart ... It's blood pressure medicine. You discovered the Benicar case.
Daniel Nigh: That's right.
Mike Papantonio: The Benicar case was a disaster. It causes gastro problems on people that were ... The equivalent of Crohn's disease. Now we have another blood pressure medicine that's even worse. If you really follow where the story goes, we're talking about the chemical that's being generated by the medicine itself as it operates inside the body. Talk about it.
Daniel Nigh: That's right. What we've now found out, The FDA's come out and they've found that this generic manufacturing company in China, their name is Huahai, they've actually found out that while they're producing the active ingredient in valsartan that millions of people take that a byproduct is NDMA, which is dimethylnitrosamine and it's very toxic.
Mike Papantonio: Toxic nowadays when you're dealing with the pharmaceutical industry could mean anything. It's going to close down the heart, it's going to close down the kidneys, this seems to be focusing on the liver. Is that kind of where the first signs of the cancer is?
Daniel Nigh: That's right. For a lot of people, they develop liver cancer. But for a lot of people, they may also develop colorectal cancers, and that's where we're seeing a lot of cancers. They might also be getting kidney cancer, maybe stomach cancer, bladder cancer, pancreatic cancer. Those are the areas of the body that seem to be affected because when you digest the valsartan into your body, that's where the valsartan, the contaminant, the NDMA breaks down.
Mike Papantonio: When you first looked into this case and you actually ... you're the guy that found a lot of this stuff. When you first looked at it, what you saw is relationship of where the product was being manufactured in China, and it appeared that jet fuel, they were manufacturing jet fuel next to that, was contaminating the blood pressure medicine, right? That's where it started. And then from there it grew to what?
Daniel Nigh: The idea is we thought they were producing jet fuel or something like that, but it appears that when they changed their manufacturing, the way in which to do it, they were trying to save some costs, and so when they're making the active ingredient of valsartan they're combining two products and as a result, what happens, the byproduct, when it gets too acidic, we get this offshoot of NDMA and other nitrosamines that are bad for you.
Mike Papantonio: Let me ask you. Of course, the viewers see the list up on the screen of the potential companies that make this. It's amazing that this many companies are in this business making the same thing, these competitors. What I'm wondering is, there are other alternatives, there's so many alternatives for blood pressure medicine. Was this some class that was just particularly important or can people go and get another kind of blood pressure medicine that works?
Daniel Nigh: Oh no, there's many other types of blood pressure medication. There's other types of blood pressure medications just in the class that might not have this contamination, although we're not sure about that yet. The FDA says they're not looking into the rest of the angio retention blockers like olmesartan and other ones like that, but they have other options. ACE inhibitors, or take one ... they could even take valsartan that didn't come from a contaminated manufacturing plant. So they have other options, no doubt.
Mike Papantonio: Every time we see this type of thing develop, the first thing the industry says is don't stop taking it. I get that, you don't want to stop taking blood pressure medicine. But it's easy enough to go to the doctor and say, "We've read about this problem we think it's a real problem." And it is a real problem. If this is something that if somebody's been taking it for a long time, has the potential to cause liver cancer, it's a latent development from the cancer. Is it just liver ... have they found out enough information on what types of cancer people should be worrying about here?
Daniel Nigh: It's not just liver. It's those other types of cancers that I listed earlier, colorectal. In fact, we actually know that there is the population in Finland that was studied that had a high amount of NDMA in their diet. Nowhere what you would expect from ingesting this pill every day with this level of concentration, but the ones that had the high level of NDMA in their diet, they were two times more likely to have colorectal cancer. And here, these people who have been subjected to this heavy dose of valsartan contaminated NDMA, They're getting so much more NDMA than that population.
Mike Papantonio: Tell me about NDMA. What do we know about it generally? If you were just to say, here's what we know, here's why this was startling to you when you found it. Here's what you did next. What is it about this chemical that it's causing such a problem here? How's it working physiologically? Do you know?
Daniel Nigh: What we know is when we want to study cancer in rats, oftentimes the toxin of choice is to induce them with NDMA. It's that toxic, it's that chemical causing issue inside of animals. So it's very clear and now that we have human exposure studies where we can see the Finland study, where they're two times more likely to have colorectal cancer ...
Mike Papantonio: This isn't guesswork. This is now we have studies. They're connecting it up. What is the FDA doing about it? Typically the FDA does nothing about it. The FDA says ... the drug companies are in control of the FDA. I think if you watch this program long enough, you understand the FDA is absolutely dysfunctional. Are they doing anything remarkable here to try to help them ...
Daniel Nigh: I think the FDA is sort of freaking out here. Because what were seeing here, this is the largest Class I recall in the history of any recall. We know that 3 million people are taking valsartan or some combination of valsartan in their medication and now the FDA has come out and said that more than half they've identified are on this recall list and they're still finding new ones every day. They've taken this response to tell the users out there and they've notified 1.5 million people are going to be on this recall list, letting them know that they have contaminated NDMA.
Mike Papantonio: I've got less than a minute. Tell me in less than a minute, 30 seconds, tell me, what do you tell people that are on this right now?
Daniel Nigh: Go to your pharmacy immediately, even if you haven't gotten the recall notice yet, go to the pharmacy if you're taking valsartan to see if there is another option.
Mike Papantonio: If it's on the list that is showing on the screen.
Daniel Nigh: Even if it's not on the list, go take a look, ask the pharmacy. See if it's recalled.
Mike Papantonio: Daniel Nigh, thanks for being out there. You seem to be the guy discovering these things on a pretty regular basis. Thanks for joining us.
Daniel Nigh: Thank you.
Valsartan Heart Medication Tainted With Cancer-Causing Chemicals
Mike Papantonio: A major heart medication has been recalled because batches of the drugs had been contaminated with cancer-causing chemicals. Now, can’t make that up. This, drug that people are … This is an entire class of drugs. The problem is, we know exactly where the contamination is coming from. It’s being contaminated with toxins from jet fuel. Take it from there.
Farron Cousins: This is such an odd story here. Valsartan is this class. It’s used in blood thinners and heart medications. It’s manufactured or final manufactured, I guess you would call it. Part of the manufacturing process is done over in China. While they’re doing that, somehow this chemical called NDMA, it has a very long scientific name, hard to pronounce.
Mike Papantonio: Horribly toxic, horribly carcinogen.
Farron Cousins: Right, it is. This thing will absolutely give you liver cancer, this chemical does.
Mike Papantonio: In very small doses. What’s interesting about the chemical, this is what everybody can’t miss, is what we call a dose response. The dose response is very, very small. This is a critical point.
Farron Cousins: Right, and so they go through this manufacturing process in China. It gets contaminated with this jet fuel NDMA, cancer-causing chemical, shipped not just here to the US, all over the world. That’s any valsartan medication made by A-S Medication Solutions, which is also labeled as Solco Healthcare, Bryant Ranch Prepack, HJ Harkins Company, Northern Pharmaceuticals, and the biggest one is Teva Pharmaceutical Industries. They made a lot of this also labeled as Actavis and Major Pharmaceuticals. Any one of those that contains valsartan has been recalled for containing this cancer causing-chemical.
Mike Papantonio: Here’s the problem though, here’s where it really gets ugly. A company understands what’s happened here. They understand that they’ve put millions of people at risk. And so a person that … If you don’t see this on this story for example, you probably won’t even know about it because corporate media won’t tell stories like this.
The idea of being able to turn on the nightly news and have corporate media say, “Hey look, you might want to know the heart medicine you’re taking, the blood pressure medicine that you’re taking has been contaminated with a drug, with a chemical, a toxic chemical that is so toxic that the dose response that you get in very, very low doses can be projected and can develop cancerous problems in a time period that is actually faster than a normal progression of cancer.” Because it goes to the liver and the liver is so susceptible to cancer.
That’s the unique thing about this. Sometimes you hear about a contaminant, you hear about a toxin that’s a contaminant and it causes cancer and usually it’s a very latent process. It takes a while for it to develop. Here, this NDMA works a little differently. It works right on the liver. The liver is very susceptible to the cancer in this toxin. If you know somebody taking any of the drugs, read the list again, I think it’s important.
Farron Cousins: Oh yeah, let me get that here. It’s important to point out, these are heart medications and people unfortunately cannot just stop immediately taking them. They have to go visit their doctor and they need to do that. If you think you are on one of these medications, you need to do that immediately.
Mike Papantonio: Let’s just post it. We’ll post it on the show because I want everybody to see this. But, here’s what’s really important about it. Every time you hear a drug that’s been a recall or it’s got a problem; it’s causing death, it’s causing disease, the industry always comes out and says to the FDA, “You got to tell people that they can’t just stop taking it suddenly as if there are no other kinds of alternatives.”
There are alternatives to every drug out there. Very unusual where there’s not an alternative. This is a class of drugs that treats blood pressure, it treats heart. There are many classes of drugs that do that. So yes, you want to get an alternative, but the idea of, “Oh my God, I got to be so afraid because I got to keep taking this stuff.” Understand, these people want to continue selling this drug even though they’ve pulled it from the market. The inventory that’s left out in the market is massive.
Farron Cousins: Right, and my point is that it’s not that they have to keep taking the contaminated drug, it’s that if you’re on heart medication, you have to remain on heart medication. The consequences of skipping it can be deadly. You’ve got to get to your doctor as soon as possible to get a better prescription for a drug that’s not going to oh by the way, give you liver cancer in addition to your heart problems.
Mike Papantonio: And another oh by the way moment, they’ve known about this for a very long time. They’ve sat on it for a very long time. These companies could’ve sent out their doctor letters, they could’ve done a withdrawal. They could’ve got in the newspaper and said, “You need to know about this.” They didn’t do it because every day the drug is on the market, they’re making more money.
What we always see them do, this delay in getting the message to the person, “Don’t take this anymore. It’s been withdrawn.” They understand their inventory out there is massive. As we sit here and talk about it, people are still using this drug. They’re not in a big hurry.
Farron Cousins: Well, here’s the thing to, you know who else wasn’t in a big hurry? It was our own FDA because 22 other countries had already pulled valsartan containing medications off the shelves before our FDA said, “All right, I guess we’ll do a recall. Everybody else did it, we’ll finally do it.”
Mike Papantonio: Like it was a yawn moment. The death toll in Flint, Michigan can be much as 10 times higher than originally reported and the situation is just as bad today as it was a few years ago. Got a couple of minutes. This story is an agonizing story for those folks in Flint, Michigan.
Farron Cousins: It really is because what we’re finding out now, these deaths that were talking about, this actually isn’t the lead. This water the, same lead-contaminated water is also contaminated with Legionella bacteria and that is absolutely one of the most deadly bacterias in the US that you can get inside your body. We’re looking at at least, I think about 116 people dead from this whereas the official death toll that the city gave is was 12.
Mike Papantonio: Well, the Legionella story tells you how contaminated the water is. Legionella thrives in contaminated environments. That’s the notion of Legionella. But it’s not just you’re going to have lead poisoning and your children are going to have mental deficiencies because of it, or you’re going to have systemic organ problems because of this. Now we know the Legionella has the ability to kill you now. So, we’re not talking about delayed. We’re talking about real time, and these numbers where they’re projecting 10 times as high.
Farron Cousins: Look, the people in Flint, Michigan are suffering everyday just like the people in Puerto Rico. But, now it’s okay, well if the Legionella doesn’t kill you, you’re still going to have a horribly deficient life because we poisoned you and your kids with lead and you’re screwed either way.
Mike Papantonio: Sorry, nobody is responsible.
Popular Heart Medication Valsartan Recalled For Containing Cancer-Causing Chemical
A major medicine recall was recently undertaken by the US FDA as well as 22 other countries across the planet. This recall involved a drug called Valsartan. Now Valsartan is a medication used for blood pressure and heart treatments and what has happened is that during the manufacturing process of this over in China, it’s been contaminated with a cancer causing substance that’s called N-Nitrosodimethylamine, NDMA for short. This chemical is a known cancer causing agent. Even our own FDA, with as dysfunctional as they are, said this is a probably human carcinogen … Excuse me, the EPA called it a probably human carcinogen. This is a very real problem. Thousands of people in the United States alone are taking this medication. And this, unfortunately, is a voluntary recall, meaning, if you want to go turn in your contaminated medicine, you can. If you don’t? Okay. It’s not mandatory.
What gets even worse is the fact that our FDA here, when responding to this Valsartan story and recall and the fact that it contained a cancer causing agent that also, by the way, can destroy your liver, other countries, 22 other countries, had already taken action on it. Here is a quick excerpt from a CNN article talking about this.
The FDA action came after 22 other countries issued recalls involving 2,300 Valsartan batches sent to Germany, Norway, Finland, Sweden, Hungary, The Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia, and Hercegovina, [inaudible 00:02:04] and Malta. Now, the US recalls left some patients who take Valsartan containing drugs, scratching their heads over what to do about treatment regimens. Because that’s the other problem. We know they contain this, this cancer causing agent, the Valsartan, but because of what this medication does for patients, blood pressure, heart medication, they can’t stop taking it until they go see their doctor and either get approved to come off it or get a prescription for something else.
So not only do these people now know that they’re taking the medication that could easily give them cancer or severely damage their liver, causing fibrosis or several other liver conditions here, tumors on the lungs, they have to keep taking it until they go see their doctor because the risks of stopping it suddenly are too great.
So, once again, we have a failure from the companies here that are involved, major pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries, major failure on their part to catch the fact that this chemical had contaminated these batches of heart medications but now the people who understand the risks still have to try to get an appointment, go speak with a doctor and make sure it’s okay for them to be switched to a different medication and, in some cases, it may not be. So they would be stuck taking this medication that they know causes cancer or liver damage or tumors all over the body.
This is, yet again, another failure of both our regulatory agencies who, again, ours only jumped on this after 22 other countries came forward and said, “We’re gonna do something about this.” Finally, the USA FDA said, “Okay, we’ll do something too.” But more importantly, it’s another failure from big pharma. They ship production overseas, they let this drug be made over there so they don’t have to worry with it. Maybe not face our regulators. This is a generic drug so there’s far less scrutiny. They bring it back over here, don’t pay attention to the fact that it’s contaminated. They let people get cancer because of the chemicals inside of it and nothing happens to ’em. That’s the worst part. Nothing happens to them. Nothing happens to these pharmaceutical companies. They don’t go to jail. They don’t get pinged. They’ve already made a ton of money off it so whatever happens, fines, lawsuits, they’re still gonna end up making a profit.
The only thing we can do, this point, is make sure that that profit is a lot lower than it should be so that they know destruction of human lives isn’t worth it and the only way we can do that, like so many other things in this country, is through the court system. Because we can’t depend on companies to do the right thing. We can’t depend on the regulatory agencies to catch these things and we can’t depend on the politicians to do anything about the problem. The only group left still fighting for these patients, fighting for the injured people, are the trial lawyers.
Here’s another thing. I gotta circle back to Donald Trump, real quick. ‘Cause this story is just absolutely outrageous. Politico ran an article earlier this week basically commemorating the one year anniversary of General John Kelly becoming Donald Trump’s Chief of Staff. But also, to make a few points about how ineffective John Kelly has been since joining the Trump Administration. And that’s something we all knew. Right? We were promised John Kelly was gonna come in a year ago, he was gonna be the adult in the room, the Tweets were gonna stop or at least cut back a little. The Fox News watching was gonna stop. None of that happened.
And so John Kelly, by every possible measure, has been an abject failure with his role as Donald Trump’s Chief of Staff. But according to this Politico article, talking to staffers inside the White House, not only has Kelly been ineffective, but he’s given up. He doesn’t care anymore. He knows he can’t control Donald Trump. He can’t change his behavior. He can’t even direct him on how to run his White House because there is actually a more powerful advisor speaking to Donald Trump every day. And they’re the ones calling the shot. That advisor happens to be Fox News. And I’m not saying that in hyperbole, I’m saying that is what the staffers at the White House are telling us because Donald Trump, in the evening, speaks to Sean Hannity on the telephone. And Hannity directs what Trump should say or do about any specific issue.
And then, in the morning, again, according to White House staffers, Trump watches Fox and Friends. That show ends, he comes out, he comes down and he dictates what meetings they will have that day on what issues, based on what Fox and Friends talks about that morning. Fox News is officially dictating the agenda for the president of the United States and, therefore, for the entire country of the United States. Fox News is calling the shots. And if that doesn’t terrify you, then you’re not familiar with the history of Fox News. This hate mongering network that spews lies all day long, they’re the ones who have the president’s ears. And if they have a specific agenda they wanna push, which they do, they know that all they have to do is tell Sean Hannity to mention it in his phone call or have those idiots at Fox and Friends talk about it in the morning and soon enough, it’ll be on the president’s official agenda.