In October 2019, the U.S. Food and Drug Administration (FDA) initiated a Class 1 recall—its most serious type of recall—of Ethicon surgical staplers. According to the federal agency, the device fails to properly form staples which can increase the risk of surgical complications. There have reportedly been several injuries caused by Ethicon surgical stapler complications and even one death. Ring of Fire’s Farron Cousins discusses this with Scott Hardy, the President of Top Class Actions.
*This transcript was generated by a third-party transcription software company, so please excuse any typos.
Farron Cousins: The approval process for medical devices here in the United States is absolutely pathetic. And because of that, we have seen countless medical devices in just the past few years come onto the market only to have to later be pulled off the market because they’re maiming and sometimes killing American consumers. Joining me now to talk about the latest example of this is Scott Hardy with Top Class Actions. And Scott, today we’re talking about the Ethicon surgical stapler, yet another medical device put out by Ethicon that the FDA had to come back later and say, oh no, horrible things are happening to people because of this product. So take it away. What are these horrible things that we’re seeing in patients?
Scott Hardy: Sure. So this is the Ethicon stapler, which is used for internal staples after surgery. And these could be just minor surgeries, even just going to the pediatrician, the gynecologist, these are, doesn’t have to be major surgery where it happened, but they would use this stapler to go to, to help seal up things inside your body. Now, the problem is, is that the stapler wasn’t actually stapling correctly. So they found a defect and the, the staple once went into place, didn’t actually go to the correct form, which creates major problems that could cause infection. Poor wound healing. The wound reopening. Could even cause allergic reactions. So we already have reports of death connected to the stapler along with people being in the hospital for an extra long amount of time.
People having to go back to the hospital when they’re getting their staples removed because they have these additional infections. And so it’s, it’s, this investigation is looking for people, if you had a surgery in the past two years and those surgeries, you had problems connected to it, you know that a surgical stapler was involved. And you know this because you had to go back in to get the staples removed. They don’t dissolve. And so if you had problems with your surgery that may have been connected to your stapler, you’re going to want to participate in this investigation.
Farron Cousins: You know, I think a great way to describe it too is, you know, imagine trying to staple a stack of papers and the staple doesn’t close and we, we’ve all had that experience and you can feel around the back of the paper and you feel that little bit of staple sticking out. Now imagine that inside your body and it’s poking anything that comes near it. You know, if you get, if you push on that area where the staple is, that little metal prong is going to poke other things inside of your body. It could put holes in them, you know, cause serious infections, sepsis, hemorrhages, all kinds of things. You don’t want sharp objects sticking out inside your body.
It’s absolutely terrifying and can cause these horrible side effects that we’re starting to see. And again, as you pointed out, right now, we’re kind of in the investigative phase. We’re trying to find out what’s happening, how many people are affected, you know, is this a diff, a defect with the product or the doctor’s not using it correctly? You know, does there need to be better instruction? But I think the FDA at this point has pretty much said, listen, the stapler itself is shoddy. There’s something wrong with the stapler. This isn’t doctor error. Ethicon made a mistake.
Scott Hardy: Exactly, the FDA has issued a class one recall for this stapler. So that means the FDA said, just like you said, there’s a problem with this stapler. We need to stop using it on patients. It is harming them and potentially killing them. So if you had that surgery and you know the, the, that a stapler was used and you had problems. Now if you had a surgery and you went out perfect, you know, the surgery went great. You didn’t have any infections, didn’t have any other problems, then wonderful. This is not for you. But if you were sitting there wondering, well, I had a surgery and I had gotten an infection or I had other problems and I couldn’t understand why, this might very well be the issue.
You might have, your doctor might’ve used this Ethicon stapler and as you said, might’ve left that prong kind of pointing out there and poking things. You know, someone actually had a ruptured rectum because of these staples. So there’s lots of different problems you can get to it and you’ll, you know, you’ll want to follow up and get it checked out to see if you do qualify. Because if you do qualify, I think that, that could mean a substantial amount of money for you in the end.
Farron Cousins: And this is something anybody who’s had a surgery and had staples, they can, they should be able to call, I guess the, the doctor or the hospital where they had the procedure done. They should be able to tell them if it was in fact, one of these Ethicon staples. So is, is that something, I guess, that is in the records? Will they be able to find that out just by making the call?
Scott Hardy: The doctors will have that, but if you think you qualify, it’s better to call in and have the attorneys actually make those records requests. Because sometimes if you call in, you know the, the people you talk to go, I dunno, I dunno. But if your attorney calls in, then they know they’re, they’re on the hook and then they’re going to have to actually provide the, the medical records. So they can confirm that. If the attorneys think that you had a qualifying injury for this investigation, then the attorneys will request the medical paperwork to verify exactly which stapler was used.
Farron Cousins: Absolutely, that’s phenomenal advice. And again, anybody, if you have had any surgeries where staples were used, ended up with an infection, pain, whatever it is, after the staple was inserted, follow the link in the description of this video, head on over to Top Class Actions, arm yourself with all of the knowledge about this case and so many others. And of course, make sure you, make sure you subscribe to their weekly newsletter. Scott Hardy with Top Class Actions, always a pleasure talking to you. Thank you.
Scott Hardy: You’re welcome. Thanks for your time, Farron.