Via America’s Lawyer: A Chinese pharmaceutical company faces a wave of lawsuits after an ingredient in their blood pressure drug Valsartan was found to cause cancer. Attorney Madeline Pendley joins Mike Papantonio to explain the case against the Zhejiang Huahai Pharmaceutical (ZHP), who knowingly manufactured and distributed the tainted medication while cutting corners in its production.
Transcript:
*This transcript was generated by a third-party transcription software company, so please excuse any typos.
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.
