By Farron Cousins
October 1, 2012 10:00am
The FDA has an incredibly lax set of rules for approving medical devices – If a company can prove that their device is “similar” to a device already on the market, they are exempt from testing and can receive immediate approval. This lapse in oversight has allowed countless faulty products to make their way onto the market, putting consumers and patients at unnecessary risk.
The following is a transcript of an interview conducted by Mike Papantonio, president of The National Trial Lawyer Association and host of the nationally syndicated radio program Ring of Fire, with attorney Ben Gordon. This interview originally aired on The Thom Hartmann Program, for which Mike Papantonio was sitting in as a guest host:
Mike Papantonio: Welcome back to the Thom Hartmann Show. I’m Mike Papantonio standing in for Thom Hartmann. I’ll get back to your calls. We’ve got to go to Ben Gordon. He’s going to talk about how medical devices are now, you can buy them. The only problem is the FDA never tests them, things like hips and knees and shoulder joints, they don’t even test them to find out whether they actually work, whether they have the propensity to kill you in the long run.
Ben Gordon, this issue of Metallosis and the fact the FDA never even studied Metallosis just scare the hell out of us, shouldn’t it?
Ben Gordon: Yeah, it’s shocking Mike, and I appreciate you having me on. The reports that are just coming out just today from the Netherlands report that the metal ions breaking down from this hip implants are found in mother’s breast milk. Why? Because they have allowed marketing to control the message, to control clinicals, to control the FDA, to control the government, and to sell these devices to a younger and broader audience including women who are of child bearing age which is just, it should be criminal.
Mike: Women are a greater risk to begin with, aren’t they? Because, first of all we’re talking about, there are hip implants where you have metal-on-metal, the two parts of the hip, they rub against each other and you get Cobalt from that, you get Titanium, you get all types of metal particles, and they have them for knees, they have them for shoulders, they have them for hips, and now we learn or the American public learns that the FDA never did any testing to find out what they would do to human beings.
Ben: It is exactly right, Mike, and what’s so shocking about it is that the companies knew. They knew since the 60’s that metal-on-metal was a bad idea. Why did they go after it? Because it was a $50 billion a year market if they could get younger people, but they had to have a hook. The “marketeers” had to have a hook and the hook was we don’t have to wait till you’re 70 to put one of these in, we can put it in when you’re 30, when you’re 40, you can still play golf with it.
Mike: It was just another industry, pharmaceutical, medical device industry scam. Now we learn, and lie, it’s a huge lie. Now we’re learning that the metal-on-metal is causing something that they described as Metallosis. Does it actually have a diagnosed name now?
Ben: It actually does. Let me tell you what, the newly diagnosed name, and this is the conclusion of a recent study out in June, Peer Review Journal that says, “The introduction of modern metal-on-metal hip arthroplasty has been accompanied by a newly described disease called ALVAL, Aseptic Lymphocytic Vasculitis Associated Lesions.”
Mike: This is what’s so incredible Ben. We think that the FDA is looking out for us. They didn’t even test these damn things and how many thousands of people have these in their bodies?
Ben: Half a million people now as of 2010, over half a million people a year, more than that for the implant get total hips put in, and that’s up more than five times from 2000. So just 10, 12 years ago, they were only putting in a 100,000 of these a year, now it’s going up five times and that’s because of the lie that metal-on-metal will wear twice as well and last twice as long. Let me tell you something that you’ll find entertaining here. Your audience will. You know where they got that slogan that they wear and be more stable and wear twice as long? They got it from an 1800’s advertisement for the Caligraph typewriter. That’s where the marketing department got that slogan.
Mike: It doesn’t surprise me. It doesn’t surprise me. Look, let me just jump back the little bit of… I wasn’t really a chemist, but for what I do I have to understand chemistry a little bit. I mean what are… My memory is that Cobalt alone in the system, too much of it can cause blindness, deafness, peripheral neuropathies, convulsions, God, the list goes on forever, and so it would seem that somebody, some numb brain. You don’t have to be a genius to understand that if you have Cobalt and Titanium moving through your blood or Chromium, it can’t be good for you.
Ben: Metal ions, there are numerous abstracts and papers, Mike that support the notion that metal ions in the human bloodstream are not a good thing. We already have specific cases of blindness, major retinopathies, and eye diseases, several people are studying these. Unfortunately for these poor people, it’s going to take 20 years to figure out how greatly increase their risk of cancer is, but certainly everyone has known for decades that Cobalt and Chromium in your bloodstream is a bad thing.
Mike: Well the reason I want to talk to you about just today this new article comes back. Hell it’s terrifying. I mean if you’ve got this in your body, now do they have to explant the device whether it’s a knee or a hip, would they have to pull it out and put another one in or…
Ben: They do, Mike and then you’ve touched on the most insidious part of this whole thing that the manufacturers are laughing all the way to the bank. They’re laughing at the government, they’re laughing at the doctors, they’re laughing at the patients, and at the FDA because guess what? One of these things fails, they got a solution for you. Guess what it’s called? A hip revision. They get to sell you another one and they get paid twice or three times, every time the product fails they get another one for another metal product or in this case, if they’re… Now that they’ve been found out and have been caught with their hand in the cookie jar, they can’t do metal-on-metal, so they stick a plastic sleeve in between to supposedly protect you when they shouldn’t have ever put the metal on in the first place.
Mike: Ben, was this one of these situations where they lied to the doctors even, they weren’t even honest with the doctors on clinicals?
Ben: No question, Mike, and we have seen a sea-change in the attitudes of the physicians in the last 18 months. They have come 180 degrees when they now understand that the marketeers crafted the story and tricked people including the medical community and that is the worst kind of marketing sin that could have been fabricated.
Mike: So if you… Every case like this has really outrageous documents. There’s some smoking gun, there’s somebody saying stupid things. If you were to synthesize the culpability here, you were to synthesize the bad act, how would you describe it?
Ben: One word, Mike. Rationalization. The message that they want the American public to swallow is that they rationalize the product, meaning that they took it off the market over a slow period of time because it wasn’t selling well, that it had nothing to do with clinical safety.
Meanwhile, they knew in their own journals, as far back as 2007, that the devices were defective and needed to be revised, needed to be completely redesigned, and instead of recalling it in 2007 when they had this written in their journals, they waited in 2010 so they could do what? So they could rationalize the portfolio which they call a business term, most of it call it, most of it us call rationalizing, making up excuses for bad behavior right? They call it a business commercialization, that’s how they rationalize the product and say that, “Okay, over time we’ll take it off the market because we need that time to get brand loyalty, to keep the doctors happy with our other products.”
Mike: Aren’t we seeing now and whether it’s a pharmaceutical, whether it’s a device like this, we see that marketing decisions, MBAs, people who have no medical background at all make marketing decisions over the safety and science decisions.
Ben: That’s exactly right, and unfortunately our government, our FDA allows it to happen.
Mike: How much did this industry make, selling this garbage that now is just, we’re just seeing the beginning of it aren’t we? This is… We’re just now really as of today with this new… we’re just seeing the beginning of understanding what Metallosis is and how much damage it does to the human body?
Ben: Absolutely. If we allow them to continue, to run amuck, the way they are with marketing new revisions for the old devices that failed, then they will continue to make tens of billions of dollars per year on these hip and knee implants, and there is no end in sight.
Mike: Don’t they just do the economics of it and say, “Well, we made $10 billion in the last two years, we may have to pay out a billion or $2 billion for these people who have lost use of their leg, or have Metallosis that has caused all kinds of illnesses such as peripheral neuropathies and deafness, and blindness so we can just write them a check and we’ll still come out ahead.” Isn’t that kind of how they calculate this?
Ben: That’s exactly right. They still are refusing to take responsibility for it, which is just cowardice.
Mike: What’s the company? Tell me. Tell me the most egregious company that you’ve seen. Now let’s name names.
Ben: Right now it’s Johnson & Johnson. We’ve seen them slapped in so many different fronts lately, and it’s just question that there… There’s no question there’s a corporate culture of greed and dishonesty and they’re the parent company for the DePuy, that’s the worst.
Mike: I mean we’re used to seeing Bayer Corporation, we’re used to seeing Pfizer, we’re used to seeing Merc, it’s all always the same characters time and time again who’d actually sit down. I know you saw this document where they know that once they get a product on the market, they calculate that it’s going to take at least five years, even if it’s killing people, to get it off the market. Then they calculate if they can keep it on for five years, they do a projection of how much they can make by market need and then they figure, “Well it’s going to cost us $2 billion, but we’re going to make $15 billion.”
You’ve seen the documents I guess similar to that on this case because I see them all the time.
Ben: No question, or we can’t talk about some unfortunately for some confidentiality reasons, specific documents in this case, but it’s the same old song and dance, and it’s even worse because in this industry, every time a hip fails, they sell another one and make money again, they continue, it’s self-perpetuating.
Mike: You have clients out there right now, you have people out there that simply been a victim again where the FDA failed to do what they were supposed to do again. Is this one of the stories where we see the FDA, the people who were supposed to, the oversight here, actually having direct ties to the industry that they’re supposed to be overseeing?
Ben: Absolutely, and you know it’s no… they’ve sort of paid lip service to the idea that they’re trying to correct their act and had a hearing, as you probably know, a big orthopedic device hearing for two days, just a month ago, in which they invited all of the various industry… industry whores.
Mike: Call them industry whores. Yeah. I call them industry whores, is what they are.
Ben: Exactly becoming and it’s the same thing we’ve heard in every other product case with these guys come in and try to tell the FDA, tell the American public that it’s not as bad as all that and we’ve got it figured out and we’re actually a responsible company.
Mike: They actually hire scientist, we heard yesterday, they hire scientist to actually write articles that they know are a lie. A matter of fact, sometimes the scientist doesn’t even write the article, they simple sign it after the industry has written it, after the industry has said what they want to say.
Ben Gordon, thanks for joining me. Stay after them man.
Ben: Thanks, Mike.
Contact a DePuy hip replacement attorney to find out if you have a claim.
Farron Cousins is the executive editor of The Trial Lawyer Magazine, a member of American MENSA, and a contributing writer at DeSmogBlog.com.