Via America’s Lawyer: Mike Papantonio discusses a medical device meant to assist with healing hernias that is notorious for causing severe injuries and speaks with attorney, Robert Price, about the lawsuits being filed against the companies that make these devices.
Transcript of the above video:
Mike Papantonio: Electing to have surgery isn’t a decision that most people take lightly because they understand how risky any procedure can be. Medical errors are one of the leading causes of preventable deaths in the United States, and most of those occur on the surgical side. On top of that, there are complications that can arise from anesthesia, the possibility of infections, and the amount of pain that patients understand is going to come with any surgical procedure.
But in some cases surgery is the only option, and that’s the case with hernia surgery. Each year hundreds of thousands of hernia surgeries are performed in the United States. There are numerous types of hernias, but the two most common are hernias, the ventral hernia and the inguinal hernia. The ventral hernia is a bulge that occurs in the abdominal wall muscle and the inguinal hernia is a hernia near the groin.
Many years ago though a product came out to market called the Kugel mesh patch. That hernia patch was a horrific product that was made of a plastic chemical polymer and had a ring around the patch that would break and it would just lodge in the patient’s skin, their abdomen, their intestines. People suffered debilitating injuries and even died from this product. It turns out that it was only the tip of the iceberg. Since the Kugel mesh days, medical device companies have continued to produce devices that supposedly have innovative technologies that are nothing more than marketing ploys, that involve little to no science, and a whole lot of experimental medicine.
Thanks to the FDA’s medical device clearance process, which is totally dysfunctional, these devices don’t have to be independently verified about safety. For example, a company called Atrium released a product called Secure Mesh. The Secure Mesh was a mesh product that was coated with something called Omega 3 acids, basically fish oil goo. That’s the best way to describe it. This goo caused severe reactions inside the human body and leads to infections, adhesions, and can even cause a person to die. On top of that, not only does the product employ a bogus design, but the company itself has been in trouble with the FDA for contamination issues surrounding the way it handles these products.
Then Ethicon, a subsidiary of Johnson and Johnson, who are always in the news for defective products these days, they make a product called Physiomesh, which is used to … It’s a chemical coating on top of its mesh. This chemical coating was touted to doctors as something that would help surgical wounds heal better. It turns out that it did just the opposite. It caused healing problems instead. The problems got so bad that they issued an urgent field safety notice voluntary recall in May of 2016.
The reason that the company issued this recall is because their mesh products were causing an array of problems. They included the mesh beginning to bind with other internal organs or the mesh was falling apart, causing the hernia to reopen and the patient being forced to have corrective surgery. In fact, these negative side effects became so severe that a clinical study on the product was actually terminated early because the product was so dangerous.
Joining me now to talk about the dangers of these mesh products is attorney Robert Price. Robert, tell us the purpose of these hernia mesh products. We think of hernia surgery as kind of a minor process, but these cases are anything but minor. What’s happening? What is the need for this mesh design to begin with.
Robert Price: Yeah, Mike, thanks for having me on the show. To answer your question, what we’re seeing here is we’re seeing these generations of these new innovative basically marketing ploys by these hernia mesh companies. Now when a patient has a hernia and they go in, most hernias require a surgical repair. They have sheet meshes or just uretal mesh that’s been used in the surgeon community since the 1950s, but since mesh is such a big profit driver for so many companies, there’s a huge amount of competition among companies to gain a competitive edge over one another, and that’s what we’re seeing here. We’re seeing these companies just take these-
Mike Papantonio: Robert, let me make a point. The reason it’s such a competitive product is because what it enables is doctors to use … Doctors who may not ordinarily be able to do a particular kind of surgery, now they have this mesh product that allows them to do that. Did I get that right, or … There’s another reason for mesh being on the market, isn’t there?
Robert Price: Right. Right. There’s two reasons. One reason is just as you said. They want to present it to doctors as something that’s easier than what it is to do. There’s sheet mesh that’s been on the market forever, and more advanced surgeons know how to use these basic mesh products, but then it’s a marketing technique. You can convince any doctor that it’s a quick, easy, low risk, easy recovery type surgery with these special innovative procedures.
The second reason is the mark-up on meshes … I mean think about it. It’s basically a plastic sheet of mesh. It costs the company a couple of bucks to make and then they can sell it in a package for $1,000, $2,000. They can bill insurance … I mean the margins on these meshes are just … They’re insane, so they’re a huge profit machine for the company. So you got big profit machine plus trying to gain a competitive advantage equals big disaster.
Mike Papantonio: Okay. Because it’s a medical product it goes from a cost of $2 to $1,000 basically answers that question. But look, Ethicon’s Physiomesh was pulled off the market in 2016, so it was only on the market for about six years. It was approved by the FDA in I think 2010 through a process known as fast tracking, which is an absurd process that the FDA has embraced. Explain this fast tracking phenomenon that’s causing so much harm across … With so many products across the United States.
Robert Price: Yes. So the FDA … Many people don’t know this, even sometimes doctors we talk to don’t know this, but the FDA … If you have a medical device and it’s not what we call a life-sustaining device, like a pacemaker or something like that … You can have a medical device. You can present it to the FDA and instead of studying the device for safety and efficacy, all you have to do is say, “Okay, FDA, I’ve got this mesh and it is what we call substantially similar to another mesh that’s on the market. I’m just like these other guys. Approve me.”
What you see … That’s called fast tracking through the 510(k) process. In that process, on top of that we see what’s called piggybacking, so you see a device over here six years ago that started out as one type of device and then one piggybacks across another, across another, across another. Then you have 10 different devices that have just hit the market in the matter of a year, none of which have been studied for safety, efficacy. The FDA has not questioned hey, what is this goo? What is this coating you’re putting on your mesh? Has this been studied? Has it been tested in humans before you start implanting it in thousands of people? None of that. It’s just … It’s what’s called a clearance process, and sterilely it’s just that easy.
Mike Papantonio: Yeah. So Robert, most people think gee whiz, it’s being sold as a medical device, surely the FDA has tested it? The weird answer is no, they haven’t. With this device, this goo that they put on there, no, it wasn’t tested in humans. The product itself wasn’t tested in humans. It was simply that a product similar to that had been put on the market, so they said gee whiz, we’re going to put our product on the market. We’re going to put this fish oil goo on it and everything is going to be okay. Unfortunately, that’s the way things really work.
Look, Ethicon isn’t the only company facing litigation for their mesh products. What other hernia mesh companies are being looked at for this outrageous thing that’s happening in these surgeries? The results of these surgeries sometimes go really, really bad.
Robert Price: There’s other companies that are being investigated for similar type of coatings on their product. Probably about 80 to 90% of the market share is held by three companies, C. R. Bard, Ethicon, which is the Johnson and Johnson company, and the Atrium company. They’ve got about 80% of the market, and many, many, many of these meshes that have been put out and used by doctors in the past let’s say eight or nine years have been this composite, plastic covering, goo type mesh coating. There’s a lot of them out there, and these three companies hold the largest market share.
Mike Papantonio: So Robert, so we have a surgery that should be fairly minor, a hernia surgery, that all of a sudden has turned into a little bit of a nightmare for a lot of people across the country, but we’ve seen this before. Years ago, there was a litigation called vaginal mesh, where the mesh industry employed bad products in an experimental design used in women. I mean it literally was … They were experimenting on women. Are we seeing the same types of corporate behavior in this case?
Robert Price: Absolutely. Same type of behavior, same type of concept, same type of taking advantage of the FDA’s fast tracking clearance process. We saw a lot of cases with a lot of similar design problems. In fact, there was a case that we had worked on where a lot of these vaginal meshes in women had this coating that they put on the mesh that would make infections and everything else skyrocket through the roof, so same kind of companies, same kind of behavior, same kind of experimental design, and the same kind of situation where, unfortunately, you have doctors and patients being taken advantage of. You’ve got these companies that don’t do the proper research. They don’t study. They don’t do clinical trials. They just put this stuff out on the market, and unfortunately it harms thousands and thousands of people.
Mike Papantonio: If you asked 10 people is that how it works, nine of the 10 people say no, this product is only out there because surely somebody tested this goo that they put on the product. You’ve got to believe that somebody tested this in humans before it was put out there, and unfortunately that is not how this works.
Robert, real quick, we’ve got about 30 seconds, is this a risk benefit analysis where the company says we can make a lot of money doing this, we only have to pay out a little money so we come out ahead? When all the numbers add up we make more money. Do you see that same thing happening with this product?
Robert Price: Absolutely. Absolutely. Let’s put this product out there, and if it doesn’t work out, let’s try to blame the patients and let’s try to blame the doctors, and that’s not right Mike.
Mike Papantonio: So the quick on this is the company looks at the numbers, they say we can harm this many people, we’re making this many billions of dollars. At the end of the game, we may have to pay out one billion, but we’ve made 10 billion, so it is a good profit margin. Unfortunately, we’re seeing more and more companies do that. Robert, thank you for joining me.