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Confidence to Thrive is a podcast built for practitioners and healthcare entrepreneurs who are doing something that matters - building innovative practices in functional medicine, aesthetics, integrative healthcare and mental health, while navigating the regulatory complexity that comes with it.
Confidence To Thrive - a podcast for ambitious healthcare practitioners and entrepreneurs
Episode 23 - Product liability and managing legacy risks in private healthcare with Adrian Richards, Medical Director at iQonic Aesthetics
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Episode 23 - Product liability and managing legacy risks in private healthcare with Adrian Richards, Medical Director at iQonic Aesthetics
In this episode of Confidence to Thrive, Christopher Cloke Browne and Roger Houston, directors at Owlicity, talk to Adrian Richards, medical director at iQonic Aesthetics about the blurred line between product liability and surgeon responsibility when medical devices and implants fail, noting that patients typically hold the surgeon accountable regardless of where fault lies.
They explore examples including hip replacements with manufacturing faults and surgeons mixing components, and a breast implant case involving textured implants later linked to the rare lymphoma ALCL, with current UK guidance favouring monitoring and treatment typically being implant removal.
Their discussion covers reporting requirements, manufacturer compensation schemes that patients may struggle to navigate, and the practical need for surgeons to help patients through processes to reduce anxiety, protect reputation, and avoid escalation amplified by social media.
This is the part 3 of a multi-part series with Adrian Richards. We recommend listening to Parts 1 and 2 - Episodes 21 and 22 - before listening to this episode.
Episode time stamps
- 00:35 The product liability grey zone
- 01:41 Hip implant legal action
- 03:44 Textured implants and ALCL
- 05:16 Compensation and patient support
- 07:20 Legacy risks for healthcare practitioners
- 08:13 Handling social media reputation fallout
- 09:46 The importance of a response plan
- 10:30 Why rapid team decision-making is key
- 10:56 The value of expert advice
- 12:01 Why it’s a surgeon’s responsibility first
- 12:49 The reality of the NHS safety net
- 13:36 Tracking implants and data
- 14:06 Helping patients navigate the claims process
- 14:39 Risk management and the value of good note-taking
- 15:30 The moral duty to patients
- 16:48 Reputation and making amends
- 17:46 What insurance really does
Who are Owlicity?
This podcast was brought to you by Owlicity Insurance Advisors who support your business ambitions. Owlicity advises practitioners, owners, and entrepreneurs of healthcare practises on mitigating risks so your business can thrive.
Learn more about how Owlicity can support here: Owlicity.co.uk
Call us on 0203 988 8090
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You're listening to Confidence to Thrive, the podcast for ambitious healthcare practitioners and entrepreneurs, brought to you by Our City Advisors. Welcome to Confidence to Thrive, the podcast helping growing practitioners and healthy entrepreneurs navigate the challenges and risks of regulation while building brands that matter. Every episode we tackle a different issue facing healthcare practitioners and entrepreneurs, or we interview a guest who is working on the leading edge of private healthcare, building something that matters in their sector or profession. On today's episode, Adrian Richards, Medical Director Iconic Aesthetics, is back for the third part in this series in discussion with Christopher Cloak Brown and Roger Houston, Directors of Tollicity. If you haven't listened to the two previous episodes, we recommend going back to episodes 21 and 22 before listening to this one. In this episode, Christopher Roger and Adrian discuss the challenges for private healthcare businesses when using third-party medical products and how later issues may cause liabilities well into the future, as well as how to handle these issues when they arise. Let's join them now.
SPEAKER_02Welcome to the Confidence to Thrive podcast. Thank you once again, Adrian, for the absolute pleasure. So this time we really want to talk to, as we said, your sort of medical businesses have scanned everything from equipment and devices and implants and everything through to surgery and the whole gambit. And I think one thing in Roger's experience is there is this fine line where you have products between what is ultimately from our insurance perspective a product liability. The product's faulty, but you, the surgeon, and the person who put the faulty product in the patient. And the hospital abort it. So it's all everybody's involved. So rather messy, yes.
SPEAKER_03And everyone like you know, take responsibility for this, everyone takes a step backwards, doesn't it? Yes, yeah.
SPEAKER_02But I guess as you're the surgeon whose name's above the door, ultimately you're probably the first door that people come and knock on.
SPEAKER_03Yep. So I mean it's a fascinating thing, okay. So if you're using any product on somebody, particularly if it is implantable, hip, knee, yeah, implant, don't you?
SPEAKER_02And that's some of the stuff was that's your NHS experience, isn't it? Is the is hip and knee joints, isn't it?
SPEAKER_01Yeah, hip and knee joints. Yeah, so we had a 3M class action, and that ended up as an apportionment between the manufacturer and the orthopedic surgeon because there were issues about the cementation of the prosthetic. The what the C the what the okay, so that's interesting.
SPEAKER_03Okay, so this was a hit replacement that people thought was a great hit replacement at the time. Surgeons and everyone looked at all the data, went to conferences, bet. What and what was the problem with it?
SPEAKER_01So there was a effectively a manufacturing fault. It was the accommodation of the design and the materials agent. So they they failed prematurely and catastrophically.
SPEAKER_03Okay, so that wasn't really the surgeon.
SPEAKER_01I mean No, it that wasn't the surgeon's fault. Now I can tell you where that's evolved to, yeah, and this is where some orthopedic surgeons have gone off script significantly, is where they combined elements of for very sound reasons. They were trying to do it for the for the best for the patient, so they'd have a socket with of one manufacturer and the ball from the other, yeah, and they ended up with an adverse reaction and creating he's and God knows what.
SPEAKER_03Well they thought it was a good idea, it seemed like a good idea. Yeah, yeah, exactly. Yeah, no evidence it wasn't a good idea. No, you've done it, and it turns out 10 years later it wasn't such a great idea.
SPEAKER_01Yes, yeah. So the question is what does so if we segue into your situation with implants, yeah. You were doing perfectly proper revision procedures based on the whole PIP thing at the time. You were pushing another brand in, which 15 years down the line has started to cause problems. There was some research, and you stopped using that implant. Where are we now? What nine years ago? We've got a patient that's come back, they've got problems there under the Marsden. There is a yet a further revision procedure, which is fine. She's come knocking on your door because you were her surgeon. Yeah. So this is an interesting case.
SPEAKER_03So probably can't go into too much, but essentially, Lady had an implant made by a company that was very textured. So at the time, the the most expensive, the best implants were the textured implants, which means they're slightly rough on the outside, you know, Chris. And they were supposed to adhere, reduce capsule or contraction rate. They were the best. All Americans were talking about them. Yeah, they were the most expensive and the best implants. So, what did you do? Everyone was using them in the NHS, so you use them. And it turns out that they are associated with very rare forms of cancer, lymphoma, of the shell around the implant. Because of their texture, they cause more inflammation. So this rare form, this is called ALCL, it doesn't tend to spread around the body. This isn't irregular breast cancer in the breast tissue, it's overlining, and it's normally treated by removal, and it doesn't tend to spread throughout the body. So, number one, it's rare, it's much rarer. And the guidance at the moment from the company and all the UK institutions and the BARPs or whatever are if you have these implants, they advise monitoring rather than taking them out because on analysis the risk is uh of having surgery is more than so that's the consensus, but a lot of women have got these implants, so it's an important issue. Now we recently had a patient who unfortunately did develop ALCL years later. She's been treated at the Martin Hospital. The Martin Hospital is a big centre in the UK. Basically, if a patient has ALCL, it must be reported, it must be reported to Allegan because there are compensation through the company, through the right process. That is compensation, but it's difficult for people to understand and follow. So we can give you guidance on that if that is the way to go. But the patient wrote to me quite rightly saying, you know, you put these implants in all these years ago, always got on well, but I've had all these expenses and yeah.
SPEAKER_02I think that's maybe one of the tensions that uh it really comes out of this, isn't it? Is ultimately it's a product that failed. It is a product fault, but at the end of the day, the patient's relationship is not with the product or the product manufacturer, it's with you as a surgeon. And in fact, there is probably even unbeknown to the patient. Effectively, there is even another step in the chain in the the manufacturer sold the product to the private hospital who sold the product to you, who sold the product to the patient that you insert. And so I suppose really, you know, you are really just on the face of this whole thing, right? It's the same ultimately you are responsible for the patients. So it's really, and I think, and maybe Roger's NHS experience is interesting here. So ultimately the manufacturer has done the right thing, and they've said a compensation fund. Yes. But as a lady who had an operation 15 years ago, you're not going to really be into finding out the details of how to claim against a compensation fund in America.
SPEAKER_03We're actually helping her with it, actually, because she didn't realise because it she didn't realise the process. So we're helping her with the process.
SPEAKER_02So that's the point you're doing, is you're actually helping her through that, which is the right thing to do. Technically speaking, you could wash your hands and say, I'm not liable, you know, as a product saying, Good luck.
SPEAKER_01Uh Rog. It's a good idea, Rog. Yes, which wouldn't be the right thing to be doing.
SPEAKER_03So I don't think that's yeah, yeah. And that's what lawyers have said. You could do that, but you're human beings, and you know, that's not really what we want to do. But if if you've done any fillers, anything you imply to please you have potential legacy issues. You do. So even when you're retired, these things can hop up. And what you don't want really is after you're retired or whatever, you don't you need the stress of this and the potential financial. I've known people lose their houses, lose their careers, lose their marriages, all because of these things. You really want to try and avoid that.
SPEAKER_01Yeah, yeah, and it's this constant tension between you know there's no responsibility, you know you didn't have the opportunity to look at this thing. There's this statutory scheme or this there's this company-driven scheme, it's in a different country. To what extent do you front uh the patient so that there's always this pressure to say I've spent this money, I've now got this diagnosis, which is very anxiety-driven. Of course, why wouldn't it be?
SPEAKER_03Yeah, you're absolutely right.
SPEAKER_01Yeah, and then you've got increasingly now where you didn't have at one point you've got this whole social media thing. Yeah, I'm in a support group, I'm gonna give a bad review, I'm going to crucify you in the court of public opinion, never mind it in the court of legal opinion.
SPEAKER_02And I think that's the other consideration, isn't it?
SPEAKER_03As you're trying to grow your business and your brand, the last thing you need is this wave of no, we could talk a lot about reputation management as well, because I've had a lot of my friends have had difficulties with reviews, uh stalkers, malicious reviews. Yeah, and that's another area you've got you've helped us with, isn't it? Yes, yeah.
SPEAKER_01And we had a long chat with Holly just this morning on on that. There's an approach to that.
SPEAKER_03Some of my friends had horrendous problems, yes, yeah, really, really made their life a misery for a long time.
SPEAKER_01Yeah, yeah. And then it gets very difficult when you need to get into the whole criminal thing, and are you into a restraining order and you need the police involved?
SPEAKER_03And we don't want to get into that. No, no, no, you don't, I don't know.
SPEAKER_01Restraining orders, no, and no, and certainly some of the cases I've seen or we've been involved in with that that's the direction they've gone.
SPEAKER_03You've heard all sorts of things secret recordings, restraining orders. Yeah, there's someone arrested at this show. Do you remember that? The police came and arrested him when he was doing his main tour. There's all sorts of stuff going on. Yes, yeah, and you've got to be honest, there's a lot of bad practice, Rog.
SPEAKER_01Yeah, there is, it's not bad, not no, not the greatest. And certainly from I do think that there's a conversation when you have a products thing, there's a difference between the legal high ground and the commercial reality of having your business crucified on social media, and actually trying to treat people properly, and trying to treat people properly.
SPEAKER_03You're right.
SPEAKER_01And the idea that you would bridge something on the basis that there is this scheme, that's a perfectly sensible thing to think about in terms of managing the reputation.
SPEAKER_03Yeah, you just gotta have a plan. No, they don't. They just there was that there was a gardener who's gonna say in that letter the other day, haven't you checked it with us? I said please, you know, don't please, and checked it, we changed it, it's better. Yeah, we have to work together, yes, yeah.
SPEAKER_01And in the scheme of things, this particular case, the out-of-pocket expenses are gonna be less than two grand.
SPEAKER_03Yeah, and we've yeah, we've we've we've shown her the way, yeah, and that was a decision that we came up to with together. So we all talked, and everyone made a good point, and we did it to so that was like an MDT on the hoof, wasn't it? It was yeah, we just did it and we had to, yeah. We've got to respond immediately, yeah. Yeah, yeah. So it's just it's a bit lonely. You're doing these procedures, you're ultimately responsible, which is great to have someone who's really good helping you if you do get anything, anything, and you can just talk to these guys literally about anything. We we yeah, they probably talk to you perhaps more than we like, we don't we like to think uh I think Rogers has visions of a little confessional sometimes.
SPEAKER_02You should be able to talk about it.
SPEAKER_01It's maybe theological. We don't talk about the whole thing.
SPEAKER_02But that is the interesting thing about healthcare, is it it is so central to people's lives. You touch everything, yeah, yeah, yeah. And he really touched and it is so emotive some of the stuff. And again, you might say, Oh, it's all cosmetic surgery and but you know, in this case, these ladies are really getting cancer, and cancer is a big deal. And if you don't understand medically, you can understand the difference between normal breast cancer and this encapsulated cancer. But if you're not medical, why worry about the fine lines of you know I've got breast cancer and people die of that. You can see why people get agitated.
SPEAKER_03Of course, and it's not it's not what they were expecting, or you know, so absolutely. So I think so. I think the key thing is try and look after patients, have fun, work together with great people, and that's what we hopefully try and do, really.
SPEAKER_02Yeah, and I think in terms of the product stuff, it's always you know, as as just custom, it's you, you're the surgeon, yeah, you know, the buck stops with you. It's like everything.
SPEAKER_03And I suppose if anything is new, just be really cautious. Just be as cautious as you can about products. Don't if something's new, someone asks you to do it, probably don't do it. If you're doing anything new, you need to let the guys know, don't you? Yes, yes, yeah. So please don't do anything. If you are gonna do anything new, please check it as much as you possibly can, and then if you are you need to let your insurers know.
SPEAKER_01Yeah, and I think for us with some of these large-scale cosmetic aesthetic type in implants, the NHS has been a good safety net there. Had we been having this conversation elsewhere in Europe or America, it would be a totally different conversation. The Marson have picked this woman up, they will go through. Yeah, and so in terms of if you like, the value of the claim is vastly reduced because of that. But there are huge numbers. Yes, we've got lots of millions of women with these implants in, but in terms of likely claims, it's still vanishingly rare. But notwithstanding that, you're still going to have probably thousands of women over time develop this condition. So we will we will get this again, almost certainly.
SPEAKER_03It will happen again in the UK. Yeah, I mean the these implants have been used by a lot of in the NHS. There's a lot of number one thing is no one quite knows who's got these implants. No, uh number two is we haven't really got a clear reply from the company explaining what the process is. So we're with the Marlton group doing a great job. We're really lucky in the UK we've got specialist unit, great surgeons focusing on collecting all the data. That's why it's really important.
SPEAKER_01Anyone does have suspects they also treated at a yeah, but in terms of the process, we haven't run through it, but we know through your support groups that people do. Yeah, I was talking to Holly this morning. We know what the forms are, so there's a certain follow-up, we're gonna have to get a confirmation of the condition from the Marsden air photograph. So we know all about that. So we will get this show on the road. We will get it on the road now. Whether that's for the patient direct or whether that's for us in terms of bridging, in terms of what we pay for the patient, we can talk about that.
SPEAKER_03Yeah, then there's value on both sides, but we probably need a strategy to advise patients on the best way forward. Yeah, there's so many fillers in the face, could be potential problems in the future. They don't would you know from our upstance courses? We see that fillers are still in there many years later.
SPEAKER_01Well, the other thing is just if we think if we think about risk management and the importance of notes. Now, one of the features of this particular implant case was the suggestion that you didn't give a proper consultation in 2019, and yet the notes were brilliant, they were all there. Yeah, I was, yeah, absolutely. Yeah, now yeah, but we were able to re- rebut that legible, exactly. Yeah, as I've consistently said, the kiss of death for a defense for a surgeon is to say, I don't recognise this patient, but my normal procedure is Yeah, that's when you've got nothing else.
SPEAKER_02Whereas here, you can say there are the notes. So I think we'll go to Roger to uh for the final word on this. So I think the our learning from this is so where you are using products in your medical surgery, ultimately, if there is a problem with the product, it is an issue for the product manufacturer. Should be. At the end of the day, as the treating surgeon, you are the person they know, you are the person they trusted, you are the person who phone number they've got, to be honest. So you are going to be in the front of this. Yeah. And I think my takeaway is whilst legally it might not be your problem, yeah. Morally, socially, yeah, business-wise, reputation ever for every other reason. And to the patient. It it is your problem. So I think our top advice, which Roger you can comment on, is don't run away from it.
SPEAKER_03No, never, never should you run away from a scary situation.
SPEAKER_02Yes. Yeah.
SPEAKER_03Well, not as far.
SPEAKER_02Yeah, getting you with it. So yeah, toughen up to it. Um look to work out that back end and that process and get the liability in the right place whilst you're in the firing line, you have something to back you up. Is that yeah, would that be the bridge?
SPEAKER_01Yeah, indeed. And on this particular case, there could be the tactic of offering to cover something that they'd not asked for.
SPEAKER_03Yeah. So which is what we've done actually. Exactly. So we have actually researched the exact process.
SPEAKER_01Yeah. That she could actually refund more than reputationally, the ambition is to bring the business back to a position of neutral opinion, thinking that you're terrible. You've got to be realistic, you're not going to be invited to their Christmas party. We're not. We're not. In terms of they did a professional, honourable, proper moral job, and that is spread around because that they're all in these mutual support groups.
SPEAKER_02Yes, it sets a standard at least.
SPEAKER_03Yeah, we need to try and set good standards. Yes. I think, and then you've set good standards.
SPEAKER_01So actually, something went wrong, but it was dealt with professionally.
SPEAKER_03The last thing I said, Robert, so you explained something really interesting to me. You actually explained what insurance was. So basically, I got this wrong. So you said insurance is when something goes wrong, you're like you're going a long way, and not something goes wrong, but something diverts you and you're going in that direction. Insurance is to get you back to where you were. Yes, yes, it's just so your ship goes wrong, yeah, insurance gets you back on track.
SPEAKER_02Yeah, that's that's what insurance is making what's gone wrong.
SPEAKER_03Yeah, I never realized that. So number one, you're gonna help us not go off track, and number two, if we do go off track, you're gonna help us get back on track.
SPEAKER_01Yes, and that's effectively what isn't it, in terms of dealing with complaints.
SPEAKER_03Get us back on track. We'll try and drive the boat. If we hit school, you're gonna get us back on track. And you no bet no, honestly, guys, no better people. Chris is more the front man, you deal with all the people, you need great with people. You obviously know the insurance industry, Roger's more the in the engine room dealing with complaints and claims, complaints and claims, yeah.
SPEAKER_01And to try and feed back, you know, if there's consent wordings and processes that can try and head some of this stuff off before it becomes a problem, then we try and do that as well. But yeah, it's but you're not gonna be able to necessarily foresee everything. And this was a process from 2012, which exploded.
SPEAKER_02Another one, 2026 recently. Yeah, yeah. That was interesting. Yeah, yeah. Adrian, thank you once again. Thanks for having me. To be honest, being candid with yeah, what happens in healthcare. Yeah, Chris, lovely. Thanks for inviting me, Rod.
SPEAKER_03Thanks for being here. Thanks for supporting us all guys. No, lovely. Love working with you. Yeah, thanks.
SPEAKER_00Thank you for listening to Confidence to Thrive. Before you go, please rate, review, and subscribe to Confidence to Thrive on your preferred podcast platform and help us spread our message to others who are making a difference in private healthcare. This podcast was brought to you by Amlicity, insurance advisors who support your business ambitions. Amplicity advises practitioners, owners, and entrepreneurs of healthcare practices on mitigating risks that your business can drive. Learn more about how Amlicity can support you by finding the link in the show notes or visiting amlicity.co.uk