I remind everyone who has a mobile telephone, including those in the public Gallery, that they must be switched off rather than set in silent mode. I welcome to this public meeting representatives of Patient Focus, the Medical Injuries Alliance and the Irish Medicines Board as part of the first session. In the second session, representatives of the Health Service Executive will appear before the joint committee. The subject of this morning's meeting is the DePuy hip replacement recall. I welcome all the witnesses, as well as everyone in the Public Gallery. I invite Ms Cathriona Molloy to make the opening statement for Patient Focus.
DePuy Hip Replacement Recall: Discussion
Ms Cathriona Molloy
I welcome this opportunity to address the joint committee on behalf of the 150 DePuy patients we represent. I also thank Deputy Catherine Byrne for bringing this issue to the attention of the joint committee. A number of patients are present with us today and I am accompanied by Ms Audrey Hennebry, one of the affected patients, who will address members later about how she has suffered with the DePuy product in question. As we have only a limited time, I will try to cover as much as possible.
Patient Focus is a registered charity and an independent national patient advocacy organisation. We provide a point of contact and other supports free of charge to patients who have been damaged by the health care system. As for the background, on 26 August 2010 the HSE announced the recall of the DePuy ASR, concerning approximately 3,500 Irish patients. A small number of people contacted us about their DePuy hip implants around this time of the recall. Following this, the HSE put in place an incident management team to deal with the recall. We believed the situation was being handled by the HSE incident management team effectively because no one had contacted us. However, in May 2011 a new client, who was not happy with the management of the recall, got in touch with Patient Focus in respect of a number of issues. She was unhappy with a surgeon in the private clinic and wanted to have her recall handled through the public system. She was unable to do so although her surgery was performed in a public hospital. She had issues in respect of delays in getting MRI scans and the results of blood tests. Another issue concerned the waiting time before seeing an orthopaedic surgeon. We contacted Greg Price of the HSE national advocacy unit, who liaised with the incident management team to try to address the issues raised through us by concerned patients. It came to our attention that more than a third of the recalled patients were from the south or south-east areas. This was a major contributory factor in the backlog of patients getting treated.
Consequently, we held a meeting in Waterford on 4 July 2011 for the patients and Greg Price attended, although no one from the incident management team would do so. At this meeting, several issues again were raised, including delays for MRI scan appointments and results and delays for blood test results, as they had to be sent to the United Kingdom to be tested. There was a lack of consistency for private and public patients and a lack of information being given to private patients because, ultimately, the HSE could not contact private patients but could only contact patients in the public system. There were issues with private health care insurers not wanting to cover costs for surgery, worries and great uncertainty over high levels of cobalt and chromium in the bloodstream, as well as problems with accessing medical records from private clinics. We continued to work with Greg Price and the patients in an attempt to resolve the problems and concerns. More patients continued to get in touch with the same problems and worries. Most of the problems were in counties Waterford and Kilkenny, due to the cluster of patients. We were advised that more than 1,000 of the original surgeries were carried out by one particular surgeon between a public orthopaedic hospital and a private clinic. A number of patients had travelled from counties Kerry, Cork, Tipperary and Kildare to be treated in a private clinic.
On 26 October 2011, we held a second meeting in Clonmel at which, once again, the same issues came up. As Patient Focus considered there were a lot more people in similar positions who had not yet come forward, we contacted "Prime Time" journalist, Paul Maguire, to raise awareness on this topic and inform people of our advocacy services. Ultimately, the programme was not made by Paul Maguire but by another journalist, Barry Cummins. The programme was broadcast in 2011, after which we received more than 100 new contacts. We provided a listening ear to worried patients, as well as providing them with the HSE information leaflet, information on claiming out-of-pocket expenses and associated costs, how to get access to the medical records, information on obtaining a second opinion, contact information for Greg Price of the HSE national advocacy unit and a list of solicitors, who were dealing with the DePuy recall, to protect their legal rights and entitlements. Providing information and support empowered people to seek second opinions. Some people travelled to England for a second opinion and had their surgery carried out there.
As for 2012, at present we have 150 DePuy patients with whom we deal on an individual basis if any issue arises for them. As members can imagine, the story we are telling concerns the impact on patients and how they have felt. Prior to the recall, patients who presented with problems were being dismissed and I note some people had been presenting for three years. As some people's surgery took place in 2004, this issue extended from 2004 to 2010 and people were at different stages all the time. There was a vindication of people's worries when the product recall took place. One lady told us she had been referred to a psychiatrist because everyone said it was in her head. People went through severe pain with the faulty product and some people even had two DePuy implants. I refer to the pain and discomfort of having to undergo further surgery, which is not as straightforward as was the first surgery because of damage to muscles, soft tissue and bones through leakage of cobalt and chromium, as well as the effect of having metal on metal. A number of people had infections after surgery, resulting in a longer stay in hospital. There was longer rehabilitation due to damage caused by the faulty product. Moreover, a number of people told us about pseudo-tumours. People remain very worried over toxicity in the bloodstream and not knowing the long-term effects for them. I refer to psychological damage for patients, including those patients who are well at present and who have no symptoms but who do not know what the future holds for them. As for long-term damage to patients that cannot be repaired, some people will never return to the way they were.
All of the aforementioned features affected patients nationally and we could see that some patients were treated much better than others. It depended on the consultant and the hospital or clinic attended. There was a lot more protection for patients in the public sector than in the private. One point we realised quickly was the public sector offered greater protection but the private sector was much better at recouping its costs from DePuy. Unfortunately, many unanswered questions remain for patients, including who knew what and when? On foot of the high-level clustering, was no evidence of a problem picked up before the recall in August 2010? When did the usage actually drop off and why? Why did HSE hospitals destock the ASR device in 2009, that is, long before the recall? When did the HSE destock the ASR in each location it was used? Why the high rate of usage in Ireland? Moreover, although 30 orthopaedic hospitals in Ireland used ASR, two nearby hospitals in the south east had the highest usage of the ASR, while another surgeon in Galway used 10% of the total.
In the future, more protection must be put in place in the event of a similar situation arising again. It highlights the need for the following measures to be undertaken. First, there should be a national register for all of the patients who have received this product. There should be an annual review for the lifetime of the DePuy ASR. There should be a full audit of all the patients who have been recalled to ascertain whether they have been reviewed thoroughly and have received the services they required. There should be legislation for regulation of private health care because this issue demonstrated the lack of power the HSE has to hold accountable any private clinic or private consultant. In addition, it highlights the poor protection for people within private health care and, in respect of the potential for conflict of interest when an orthopaedic consultant initially was on the design team for the DePuy ASR, raises the issue of whether the disclosure of any vested interest should be made to patients prior to any form of surgery. It also highlights the importance of advocacy for damaged patients in raising these issues. Unfortunately, it is the patients who again have to bring this to the fore.
I would like to hand over to Ms Audrey Hennebry who will talk about her experience and what she went through.
Ms Audrey Hennebry
Public speaking is not my forte but I will try to do my best. I will give a quick timeline. I had my two hips resurfaced in the summer of 2006. The operations were 12 weeks apart. The surgeon who fitted these hips described them as "the Rolls Royce". I was not made aware that there was no track record with these hips. I was told they were suited for young, sporty people; I was 46 at the time. I played tennis three to four times a week, walked my dog and swam a lot. It seemed a very good option for me as opposed to the traditional total hip replacement.
Three years later in 2009, the symptoms started. I had pain and was unable to sleep. It progressed very quickly into clunking and clicking in both my hips when I was walking. At times they locked when I got up from a seated position. I work as a nurse in Waterford, but it was very difficult for me to work.
In early 2009, things got a lot worse. I developed a severe burning pain in my right leg. It radiated from my groin all down along the shaft of my femur, right down into my foot, which was subsequently greatly swollen. Reluctantly, I was reviewed by the surgeon who had fitted the hips. He offered surgery for my right hip and refused me an MRI. Being a nurse, I questioned this.
I then attempted to contact the HSE to see if I could get on a review list for Kilcreene Hospital because that was the hospital where I had originally had the surgery. On 2 February 2011, I entered an ASR recall programme within their clinic in Kilcreene. My understanding was that the HSE put an incident management team in place. At a public meeting, I was told by a representative of the HSE that I was not allowed to use my private health insurance. I was not allowed to choose a hospital or a particular surgeon for the operations I would need. I have paid for private health insurance since the time I was 18, since I started to train as a nurse. I requested that the incident management team would meet with us, the patients. They refused that request.
I was subsequently informed by a second surgeon, independent of the first surgery, who reviewed me in Kilcreene on 2 February, that both my hips needed to be replaced - two total hip replacements - which I would have associated with an older person's solution. They checked my bloods for chromium and cobalt at the time. Funnily enough, they told me I would need an MRI before I could progress to surgery. Because of my private health insurance, I could have had that done and read, within two days to two weeks. Unfortunately, that did not happen. When I questioned the consultant about moving the process forward, he said the resources were not available to him, that they were very limited.
Eventually, at 9.30 a.m. on 30 May of the same year, I had an MRI in Waterford Regional Hospital. My next clinic review was not within a month or six weeks, it was on 20 July. The cover note on the MRI of my right hip said it was grossly abnormal at that stage. I had a very large pseudo-tumour, which was lying on my femoral nerve. I would need a separate operation to have this removed.
I was subsequently booked for surgery for the first week in September. I initially presented on 2 February but I felt the resources were not there - that was confirmed by the surgeon - to bring me to surgery earlier. On the first week in September, I had two operations done. I had a traditional hip replacement and also had major surgery to my groin - I think the incision was ten inches long - to remove this.
I asked to have the second hip removed quickly because I was afraid of another pseudo-tumour presenting. I had my second hip operation in November 2011. I was out of work for eight months. I actually had to go sick two months before the surgery because I could not drive my car. I am a community nurse but I could not drive with the pain from this femoral nerve.
I returned to work six months after my surgeries, probably early, but I had little choice. It had caused me many financial difficulties. I have three grown kids, two of whom are still financially dependent on me. One is in second level and one is in third-level education. I have a mortgage which needs to be paid, so going on half pay would not afford me that.
I have been left with ongoing health problems. I have continuous pain walking, standing, sitting and lying down. I am very worried about the metal ions and the possible long-term damage which may occur to my vital organs, including liver, kidneys, spleen and heart. They tried to sift this product out of my body.
I wish to thank the two surgeons who operated on me in Kilcreene Hospital. I also want to thank the entire nursing staff for the specialist care they delivered with very limited resources. I will not name the surgeons, but they know how grateful I am to them.
The British Medical Journal has published an article entitled “Out of Joint”. Members of the joint committee might like to look it up. According to the article, in some NHS centres in the UK, primary hip procedures were being put back to accommodate ASR revisions because the ASR was an unknown entity. This is only an emerging science. In four or five years’ time, we will know what damage has been done to us.
An article in the Journal of Bone and Joint Surgery dated October 2010, states “In excess, cobalt block cellular metabolism can damage multiple organs”. It also says that “High cobalt levels found in some patients with metal-on-metal hips may cause neurological or cardiac damage that is, in part, reversible with timely revision”. I did not have a timely revision.
That was my experience. I have networked with several people along the east coast, mainly in the south-east. There are horrendous stories to be told out there.
I wish to thank Ms Cathriona Molloy and, in particular, Ms Audrey Hennebry for her very moving testimony. What happened to her should not have happened, which is part of why we are here today. I want to apologise to her for that because it is really unacceptable. I thank her for being here and sharing her story with us.
I will call Mr. Pat O'Mahony, chief executive of the Irish Medicines Board.
Mr. Pat O’Mahony
I would like to introduce my colleague, Ms Andrea Hanson, who is a product manager involved in the monitoring of medical devices safety at the IMB. As members of the joint committee will know, the role of the IMB is to protect and enhance public and animal health through the regulation of medicines, medical devices and health care products. As the regulator in this area, the IMB is the competent authority for medical devices.
As I outlined to this committee in March, when I spoke about the PIP breast implant issue, the IMB has a post-market role. Therefore we are not involved in the original pre-marketing assessment of products, which I will explain in a second. The IMB is responsible for monitoring and vigilance of these devices after they come to the market. Our task is to detect, monitor, assess and act when required on safety issues that are identified. In addition, we also designate and monitor the one notified body for medical devices based in Ireland, which is the NSAI.
There are many thousands of products classified as medical devices, including breast implants, as we discussed before, and hip implants that we are dealing with today. Medical devices are widely used in health care, and individual devices make a major contribution to the health and well-being of patients.
Our role is to monitor the safety of these devices on the market and in patient use. We ensure that any safety issue that is identified, be it through national incident reports or from international data, is acted upon. The IMB has no direct role in approving or certifying medical devices that are marketed in Ireland or any other country.
I would like to say a few words about the pre-market approval of medical devices. To place a medical device such as a hip implant on the market, the manufacturer must be authorised to do so following an assessment conducted by a notified body for medical devices. Orthopaedic implants, such as the DePuy hips, are regulated under directive 93/427 EEC, which specifies the requirements that must be met before a device can be placed on the market. These requirements include safety, performance, specification, design, manufacture and packaging of devices and the need for the device to have a CE mark.
The DePuy hips which we are talking about - both of the systems - were manufactured at the DePuy Orthopaedics UK facility in Leeds. The products were assessed by the notified body - the British Standards Institute - in the UK, prior to the initial launch in 2003.
As mentioned earlier, once a manufacturer has received the CE mark from a notified body, in this case the BSI, it is free to market the product throughout Europe without further national assessment. The products were also licensed and widely used internationally, including in the US, Australia and Canada.
Hip replacement is most commonly used to treat joint failure or chronic pain and, in general, is effective in providing pain relief and improving hip function. Members will know people who have had successful transplants which have transformed their lives. Hip prostheses have been going for 50 years and during that time the products have been developing.
I refer members to the illustrations attached to our presentation. The first shows the traditional hip replacement. The femoral component consists of a metal stem that is placed into the centre of the femur and a metal or ceramic ball that is placed on the upper part of the femoral stem, replacing the damaged bone that has been removed. The acetabulum or hip socket is replaced with a metal cup which may be lined with a plastic, ceramic or metal insert-liner between the head and socket.
The other diagram shows the alternative hip resurfacing products. The design has a different femoral component that requires replacement of only the upper surface of the head of the femur. In this surgery, less bone is removed from the femur as compared with traditional total hip replacement surgery. Resurfacing requires stronger bone, so is usually reserved for younger adults who are more active. Only a small number of hip procedures are resurfacing. We know, for example, from the UK national joint registry data in 2009 and 2010 that only 6% and 3% of hip replacement procedures were resurfacing.
Every hip implant system has a unique set of benefits and risks. The orthopaedic surgeon treating the individual patient determines which hip implant will offer the most benefit and least risk for that individual. When making this decision, the surgeon will consider several factors such as age, weight, height, activity level and the cause of pain. The recommended surgery may involve total hip replacement or hip resurfacing.
DePuy announced a worldwide recall of both its articular surface replacement, ASR, and its acetabular system products on 26 August 2010. A variety of information on the recall is included in our submission. The decision was based on new, unpublished data from the National Joint Registry of England and Wales. The data showed the five year revision rate for these systems was approximately 12% and 13%, respectively. DePuy confirmed on 27 August 2010 the total number of hip implants supplied to the Irish market was approximately 3,500. By that stage, the Irish Medicines Board, IMB, had received 12 reports of revision surgeries. In the immediate aftermath of the recall announcement, DePuy confirmed to the IMB that all unused product had been removed from Irish hospitals. The IMB issued a safety notice to stakeholders, including the Health Service Executive, HSE, private hospitals and the orthopaedic community, as well as circulating and publishing a press release on our website.
The IMB worked with the HSE and Irish orthopaedic surgeons regarding the recommendations for patient follow-up. We understand the HSE and private hospitals continue to manage the review and follow-up of patients who have received ASR hip implants. Further to the 12 revision surgeries reported to the IMB at the time of the recall, an additional 357 patients have undergone revision surgery with a further 166 revisions scheduled.
In line with our post-market surveillance remit, the IMB had been monitoring the performance of the ASR hip systems since their introduction to the market. We also had ongoing discussions with the manufacturer and our European and international medical device colleagues. There was regular communication with the Medicines and Healthcare products Regulatory Agency, MRHA, in the UK as both the manufacturer and the notified body were located in the UK. The higher than expected revision rates associated with this system highlighted in the DePuy field safety notice issued in March 2010 was a particular focus of discussion. This revision rate data concurred with observations emerging from market surveillance from the national joint registries in the UK, Sweden and Australia. At this point, it is worth noting there is no national joint registry in Ireland.
The IMB ensured the March 2010 field safety notice was circulated to orthopaedic surgeons, along with advice on surgical technique and patient selection to achieve optimal implant performance. In the communication, users were reminded of several key factors, including optimal implant positioning, in particular insertion angle, patient selection and consideration of their bone quality. The importance of appropriate post-operative care was also highlighted.
The IMB has remained in close contact with DePuy, the HSE and orthopaedic surgeons in monitoring the implementation of the recommended patient follow-up. The IMB continues to assess the reported incidents it receives relating to revision procedures. The IMB is monitoring the investigation that continues to be conducted by DePuy. The matter is also under regular ongoing consideration at European medical devices experts' meetings.
DePuy continues to investigate the matter through the analysis of data generated from complaints received, from various joint registry data, from its clinical studies and from re-examination of the failure analysis data. Also, independent analysis of explanted devices continues with the aim of identifying the causes of the higher than expected revision rates. This analysis is being conducted at the London Implant Retrieval Centre where returned explanted devices are inspected, including those from Ireland.
To date, the root cause of the problem has not yet been clearly identified. Many complex factors can influence a successful outcome for a hip replacement surgery, including a patient's clinical condition and general health, the component or device selection, implantation technique, and the post-operative recovery and rehabilitation regime. The data from this product recall have provided important input to the wider discussions regarding metal-on-metal implants on an international basis. There is emerging evidence of increased revision rates associated with large head metal-on-metal hip replacements, but the clinical evidence available to date is mixed. Accordingly, it does not support their removal from the market.
Device wear is experienced with all types of hip replacement implants over time as the femoral head and acetabular cup components articulate. With a metal-on-metal hip system, this can lead to the production and accumulation of metal ions, for example cobalt and chromium, within the area around the implant. The size of the released wear debris is in the range of nanometres. Most patients with conventional metal-on-metal prostheses exhibit higher chromium and cobalt ion concentrations in blood, which are however, only rarely related with pathologies. Individuals react differently to the metal ions. Many patients have no significant reaction to these materials while for some others there may be an inflammatory response which, in time, can lead to local bone and tissue reaction. The effects of long-term low level exposure to such metal ions are under detailed ongoing review by scientists and regulators worldwide.
The IMB continues to work with our European and international colleagues to better understand the complexities of the performance of these medical devices. In this regard, we welcome the recent news that a national register for orthopaedic surgery will be established in Ireland. This will allow in the future for more comprehensive data specific to Ireland, which will be added to that available elsewhere, allowing for timely comparison of trends emerging in Ireland with the experiences elsewhere on an implant by implant basis. The IMB will continue to take appropriate regulatory action as required.
The three primary European directives relating to medical devices are being substantially revised by the European Commission. It is expected new proposals will be published in September 2012. These will then be subject to debate at the European Council and Parliament. Further details on that are set out in the appendix and we can return to it if required.
In February 2012, the Commissioner for Health and Consumer Policy, John Dalli, wrote to each of the national Ministers for health across Europe indicating the need to increase control on medical devices to provide an appropriate level of protection to European citizens and to restore trust and confidence in the regulatory system for devices. Commissioner Dalli recognised that legislative revision would take several years to come into effect and identified the need to act immediately to achieve these objectives. The annex outlines the actions required from regulators.
In recognising the great benefits that hip replacement medical devices and surgery provide to many patients, the IMB fully appreciates the difficulties this issue has caused for individual patients and their families. We will continue to provide updates to patients and the orthopaedic community as new data emerge. It is imperative that the issues involved are fully researched and understood. The IMB contribution to this international effort continues and the new European medical devices regulations and the establishment of the Irish register will assist in this effort not only in respect of hip replacement devices but for medical devices generally.
I thank Mr. O'Mahony for his excellent presentation and welcome Ms Andrea Hanson to the meeting. I now call Mr. Colm MacGeehin of the Medical Injuries Alliance to make his opening statement. Mr. MacGeehin is accompanied by Mr. Neil Kidd and Ms Sara Antoniotti.
Mr. Colm MacGeehin
The Medical Injuries Alliance is a recently formed organisation which seeks to reform our antiquated, unjust and ruinously expensive system of dealing with medical negligence in Ireland. We hope to address the committee on the issue in the autumn and we have already met the Chairman to discuss arrangements.
On the issue before us, which has become a major headache for lawyers, we would like to submit to the committee a synopsis that has been prepared by Mr. Neil Kidd and a general paper on reform of medical negligence law. I thank the Chairman for accepting these documents and saving on postage costs.
All of us want to reduce expenditure.
Mr. Colm MacGeehin
I will confine my remarks because Mr. Neil Kidd and Ms Sara Antoniotti have more in depth knowledge and experience of the issues arising. The recall was initiated in the UK on foot of an increase of 12% or 13% in the rate of revision surgery, compared to rates of between 3% and 6% for the older components. The company holds to the view that the revision rate is 12% to 13% but it would say that, would it not? Based on the submissions already made we calculate a rate of 16% between revisions that have already been done and those still to be carried out. That confirms anecdotal evidence our members have gathered that the rates are probably going to be much higher still. This is a major problem, therefore.
Without further ado, I ask Mr. Neil Kidd, who is a solicitor in a large medical negligence firm and one of the leading individuals in tackling the problems in this area, to make his statement. He will be followed by Ms Sara Antoniotti, a barrister who deals with these issues at the coalface of the Four Courts.
Mr. Neil Kidd
As a solicitor I am dealing with a number of claims arising from the recall of DePuy hip implants. I am also a member of the Medical Injuries Alliance, which seeks to bring substantial reform to the manner in which claims arising out of medical accidents are addressed. The objectives of the alliance include promoting access to justice for injured patients; fair compensation for the injurious effects of medical negligence and error; and candour among health care professionals in revealing the facts and causes of medical injury.
These objectives are particularly relevant in the context of the recall. In the cases arising from the recall we are seeking compensation for the pain and suffering inflicted on patients. In light of the testimony provided by Ms Hennebry, there is little need for me to emphasise the nature and extent of those injuries other than to note that her description is representative of a number of accounts I have heard first-hand. It should also be borne in mind that a significant proportion of the patients affected are vulnerable by virtue of their advanced age and as a result face greater risks and longer recovery periods from revision operations. Given the acknowledgement by DePuy of the harm that has been done through its agreement to compensate patients for out-of-pocket expenses incurred as a result of the injuries, it cannot be denied there is also an entitlement to compensation for the significant pain and suffering inflected on these patients.
A number of difficulties have been encountered from a legal perspective in progressing these cases. The two year window within which these cases must be commenced creates significant time pressure. As the priority for most patients is restoring their health, a significant amount of time can elapse before they seek legal advice on these issues. Significant delays have also been encountered in obtaining release of medical records from hospitals. In my own experience I have faced delays of several months in getting records which were necessary for investigating complaints thoroughly. I know of colleagues who have waited six months to have records released from certain hospitals only to find they were incomplete and missing key X-rays. These delays are making it difficult to properly investigate and submit claims before the time limit expires.
Another problem is gaining access to hip implant devices subsequent to their removal. Under a scheme that has been put in place by DePuy, a UK firm called the London Implant Retrieval Centre has been nominated to transport, examine and store these devices once they have been removed from patients. It is understandable, however, that many patients would prefer to retain control of their devices rather than hand them over to DePuy's representative. In those circumstances it is more difficult to secure the release of devices. In one case with which I was directly involved it took more than five months to persuade the hospital to release a device to the nominated firm, which was prepared to transport and store the device in accordance with the relevant regulations.
Once these hurdles have been overcome and litigation has commenced, one would hope that cases could be dealt with in a practical manner given the undeniable entitlement to compensation among these patients. Initial indications from DePuy's solicitors led us to believe the cases would be dealt with in a practical and forthright manner in order to allow them to proceed efficiently, thereby reducing the time and costs involved and ease the stress and strain on patients who have already suffered enough. To date, however, there is little sign of such a practical approach being taken. It is still early days in a number of cases but in certain cases which have been progressed sufficiently, a full defence has been filed by DePuy. There is an emerging trend of blame being passed from DePuy to the treating doctors or the hospitals where the initial operation was carried out. This is resulting in defendants denying liability and seeking to apportion it to other defendants. The net result is that the innocent patient is hindered in obtaining the compensation to which he or she is entitled. Patients are being dragged through complicated and costly High Court litigation.
There must be a simpler way of dealing with these cases. Just as many of these patients were poor candidates from a medical point of view, they are also poor candidates for a litigation process given the difficulties they have already encountered. On that note I will hand over to Ms Antoniotti to discuss our suggestion as to how these cases should be approached.
Ms Sara Antoniotti
I thank Mr. Kidd. From the legal point of view, if as Mr. Kidd has described, DePuy and-or the doctors and hospitals concerned are going to take a completely defensive approach to the litigation - to date that is the indication although the cases are at an early stage - I want this committee to consider the implications of such a defensive approach. If this is the trend and there is to be a complete denial of responsibility made by both DePuy and hospitals and-or the surgeons, the only result is expensive and complicated tripartite litigation. From the point of view of the Medical Injuries Alliance, as Mr Kidd has said, the patients at the heart of this recall are clearly entitled to compensation. They are entitled to compensation for the pain and suffering that has been outlined in great detail by Ms Molloy, Ms Hennebry and also by Mr. O'Mahony. The pain and suffering endured by these patients can be immense. While DePuy has advised it will pay for the cost of revision surgery and in some cases I believe it will pay for the out-of-pocket expenses, it has not indicated to date-----
It is not our job to adjudicate on compensation - that is not our remit. I just wish to make Ms Antoniotti aware of that.
Ms Sara Antoniotti
Absolutely.
That is not the purpose of today's meeting.
Ms Sara Antoniotti
However, the concern from the Medical Injuries Alliance is that there has been no indication to date from DePuy as to how it will deal with these cases. It has offered to pay for the revision surgery and in some cases paid for out-of-pocket expenses, but it has not indicated what it will do about the financial loss that has been suffered by patients such as Ms Hennebry and the pain and suffering it appears she will continue to suffer into the future. From my experience of dealing with a number of these cases her story is not an isolated story. That is a matter that needs to be addressed at the outset. If it is not addressed, individuals such as Ms Hennebry will need to go to court, as it is the only thing they can do. They are faced with suing a multinational company on the one hand and the State or hospitals and doctors on the other hand. They are stuck in the middle because, as Mr. Kidd has indicated, to date the indications are that complete denials are being put forward by DePuy and the hospitals.
If an organisation accepts it is responsible for paying for revision surgery and out-of-pocket expenses, one might believe it would logically follow that it must also be responsible for the pain and suffering associated with the need for that revision surgery. However, to date that indication is not there. What does that mean? It means that people must go to the High Court. As a plaintiff, a patient such as Ms Hennebry must engage experts such as engineers to go to London to review their hips that are being stored in most cases, I believe, in the London Retrieval Implant Centre. The plaintiff must ask the engineer to prepare a report and make himself available for court, and must also engage the services of an independent consultant orthopaedic surgeon who invariably will be from outside the jurisdiction because a number of consultant orthopaedic surgeons within this jurisdiction are involved in the litigation. He will have to examine the patient and prepare another report. In my experience - Mr. Kidd will support me in this - those reports must be paid for in advance by patients who are already at a financial loss and who have already suffered significantly because of what has occurred. That is a very practical difficulty faced by patients.
From the legal point of view our difficulty is that we are ethically bound to carry out certain investigations before we can advise that such a case can issue in the High Court. We must regrettably advise these vulnerable patients that they must get an expert report and have a consultant orthopaedic surgeon confirm there is a case that he will support in that regard. That is a real difficulty.
When the members of the committee are considering the issues, they should have at the forefront of their deliberations the admitted fact that there was some difficulty with this product. Why else was there a worldwide recall? There has been an admitted high failure rate, as I believe it was described, regarding the need for revision surgery. There is an admitted concern that this product has caused some sort of injury to patients necessitating revision surgery. Ms Hennebry has already described in great detail the difficulties associated with that revision surgery, and the pain and suffering involved. It is interesting that Mr. O'Mahony refers to ongoing research in this area. He has referred to ongoing and continuing review regarding the causes of the failures and the potential difficulties for patients in future with further injuries that may manifest themselves.
This all comes back to the duty of candour that Mr. Kidd discussed. In the circumstances outlined by everybody addressing this committee one might believe there could not be any argument about liability and one might even ask why these matters are even before the court. One might believe that liability would be admitted and that somebody would say, "We accept that an error was made and that we are responsible." In the absence of that we, as lawyers, have no option but to continue with what will invariably be an expensive exercise for the State.
What is the remedy? The Medical Injuries Alliance suggests that some form of pressure be brought to bear on DePuy, the State, the HSE, the surgeons or a representative body of the surgeons in order that they ensure that the patients are left out of this process and are fairly compensated in an expeditious manner. If, as Mr Kidd has outlined, there is an issue as between the hospitals, the surgeons and DePuy as the various defendants to this litigation, they should sort that out themselves by means of some sort of dispute resolution mechanism. Whether that be through mediation or the courts is a matter for them. However, they should leave the patients out of it because we can see no defence to these cases from the patients' point of view. In the absence of some sort of practical approach which we hope the committee will be able to reach, the only people who will suffer in the short term are the patients and in the long term the State and the taxpayers who will ultimately need to pick up the cost.
I thank the witnesses for their presentation this morning and remind them that we are an Oireachtas committee and not a court of law. There is a very clear distinction between us as Members of the Oireachtas and the Judiciary. Our purpose today is to ascertain the facts and be patient focused with regard to the events outlined to us by Ms Hennebry this morning.
I apologise for missing the original address and I thank Deputy Catherine Byrne for bringing the matter to the committee's attention. The presentations have made quite clear what is at play. While I appreciate, as the Chairman has said, that the committee is not a court of law, there is responsibility on the Oireachtas to play an active role in pursuing a solution to it. The indications are that it has been kicked from Billy to Jack and the buck has been passed from one to another in terms of communications between the hospitals, the HSE and DePuy. While I appreciate there is a resource issue from the State's perspective, the State has a responsibility to ensure due process is followed quickly and in the interest of the patient.
Somebody has a mobile phone switched on.
It is not mine on this occasion.
It is someone near Senator.
It often is mine, but it is not on this occasion.
Perhaps the committee might agree to make direct contact with the office of the Minister. Considering the reform of the HSE, which, as we have heard in recent days, is planned take sole control of the health services-----
Representatives from the HSE will appear next.
I appreciate that. It might be best for us to ask the Minister's office to take a personal interest in pursuing a solution to this matter and to ensure that DePuy, the HSE, the hospitals involved and the consultants are brought together and that a solution is pursued under the direction of the office of the Minister. I again thank the representatives from Patient Focus, Medical Injuries Alliance and Irish Medicines Board for attending.
I thank the witnesses for the presentations made to date. My first set of questions is for Mr. O'Mahony of the Irish Medicines Board. There are issues of a failure of regulation here. This is not the first time representatives of the IMB have appeared before the committee. We previously had a meeting to discuss the PIP breast implants. There are questions regarding the regulation of these products, traceability, accountability, and basic quality procedures and processes which we believe were not followed. How often did the IMB inspect the manufacturing site quality system? Was it once or more than that? Who regulates the designated notified bodies? It would seem there are questions to be asked about the role of the Irish Medicines Board, IMB, in premarketing evaluation, monitoring and auditing and about the relevance of the IMB in this instance, given that the product was manufactured and certified in the United Kingdom and that the information on the data that led to its recall came from the UK, Sweden and Australia. The IMB's only role appears to have been to communicate notification of the problem. That is insufficient and we need to look at the regulation of this area. We must make sure we can prevent such situations happening again.
What criteria were used to decide whether or not to undergo revision surgery? Is Mr. O'Mahony aware of a report published in the British Medical Journal and written by its investigations editor, Deborah Cohen, which raises serious questions about the company? The report claims the company knew about some of the problems relating to the products but continued to manufacture them and allowed them to be used. That is a serious report which I did not see mentioned in Mr. O’Mahony’s presentation. Has the IMB seen the report and can Mr. O’Mahony advise on that?
The company has questions to answer, but its representatives are not here. Mr. McGeehin has already referred to rates of revision surgery. Is this the normal expected revision rate for five years? We are told 12% or 13% is the normal revision rate but IMB are saying 6% or 7% is normal. Was the rate of revision surgery twice the normal rate? That raises questions. Perhaps the IMB can answer them.
When will the national register for orthopaedic surgery be established? An Irish national orthopaedic register was promised for 2012. We are now in July and still waiting for it. We have questions for the HSE but we will have to wait to have those answered. There are still 166 patients waiting for surgery. How long have they been waiting and when will they be treated?
My final set of questions are for the Medical Injuries Alliance and Patient Focus. Most of them were answered in the presentations. What sort of replacements and supports, financial and medical, have been provided? Are they adequate? What more needs to be done by the company? I thank the witnesses for their presentations. They have answered some of my questions.
I support the right of people to due process and to take a case if necessary. It would be helpful, however, if the company would work constructively with the victims. That would be the best way to deal with this issue. It would be unfortunate if victims were forced to go down the litigation route, with all the issues that would raise.
My final question relates to the retention of the ex-plants, if that is the correct term. A retrieval centre in the United Kingdom was mentioned. It makes sense that an individual would want to have control of the ex-plant because it may be required for a future court case. It would be better if they were in this country and under the control of patients. Proper de-contamination and storage would be required, which should be paid for by the company. The current situation is not satisfactory for many patients.
We want redress for victims, but the issue of regulation also needs to be addressed. This committee might look at that in the future.
I welcome the witnesses and thank them for their presentations. I particularly empathise with Ms Audrey Hennebry's presentation. It reminds me of a similar experience undergone by a near relative of mine. Early symptoms were dismissed for more than 12 months and followed by hospitalisation for six months, much of which was in isolation. Eventually, the hip was removed but could not be replaced. General reconstruction surgery was done on the area and the person now has a short leg, walks with a cane and has various other difficulties. The experience was horrendous for himself and his family. That is the type of individual experience we are talking about. The rate of occurrence is high. It is twice the normal rate, if not higher. Time will tell what the peak figure will be.
The questions raised by Patient Focus must be addressed, both by the committee and by the Department. The question of clustering must be examined. The case I referred to occurred in the south east. When did usage drop off? Health Service Executive hospitals de-stocked in 2009, long before the recall. Why was that? Were there early indications that should have been acted upon? When did each hospital in each location de-stock? The question of conflict of interest must be considered. The regulation of the private health care industry must be examined.
There are two questions which the Minister and the Department must deal with. The first is the issue of prevention. The IMB has questions to answer in this regard. However, the nub of today's presentations was reached by the final speaker. How are we to deal with patients who have been injured by this experience? DePuy has admitted there was a problem and that patients have been injured, some very seriously, but has not yet indicated whether it will compensate them. There must be compensation.
A non-judicial, short, simple, easily accessed resolution to the process would be preferable. That is what we should aim to achieve, and very soon.
We are all in agreement with your last point, Deputy Healy. I now call Deputy Catherine Byrne. I thank Deputy Byrne for highlighting this issue to the committee and for requesting that today's meeting take place.
Many of my questions are for the HSE. I will keep them for later.
I thank the Irish Medical Injuries Alliance for its presentation and for its concern. I agree with the Chairman that we are not here to judge the question of compensation or anything else. We are here to listen to the stories of people who have been affected and to the agencies that have participated in that.
I am not an expert on this issue, but I have been reading up on it. In a study done in Britain it is claimed that up to 50% of patients will have problems with this replacement hip.
I thank Mr. Pat O'Mahony of the IMB for his presentation. I have only one question for him. What is his job? I have read his presentation in which he refers, on a number of occasions, to safety. Problems were detected in the period 2003-08 in the United States and in 2009 in the United Kingdom. Why did the Irish Medicines Board not take action then? What is the role of the Irish Medicines Board if not to protect people? The board's opening statement to the committee referred to safety a number of times, stating that safety is paramount. From what I have read and from what I have heard this morning, the lack of safety procedures cries out. I identify with Ms Molloy and Ms Hennebry and I thank Ms Molloy for making her presentation. I say to Ms Hennebry it is difficult to speak in public and even as a public representative I still find it difficult but this morning she has expressed better than anyone the trauma and the upset and she has told us a harrowing story. As a public representative I have received telephone calls and e-mails and letters from people over the years detailing their need for a hip replacement and the long waiting time. We seemed to have finally got our act together and then this mess is thrown at us. Lives have been changed completely by this situation. Many of my relatives have had hip replacements and I know that the procedure has changed their lives for the better in most cases. The surgeons are miracle workers because they change people's lives, people who may have been in chronic pain but they wake up two days after the operation and realise they no longer have that pain.
We are here this morning to listen to what the witnesses have to say. I agree with the other speakers, with Senator MacSharry and Deputy Seamus Healy and others, that this needs to go to the top, that the Minister needs to intervene. Regulation is essential. I will raise some of the questions raised by Patient Focus with the HSE later. What has happened to these witnesses and to many others should never have happened. No words of mine nor of any member of the committee can do justice to the torment and torture they have endured. They have had perhaps two hip replacements and then they have to face the whole horror of a procedure to remove them. I am very disappointed that the Harley Medical Group is not represented at this meeting. They did not turn up for the meeting.
This is a different meeting.
The people who suffered have to be compensated for what has happened to them and which has changed their lives so dramatically. I am not a medical expert but I believe that others have to be made accountable for their negligence and the hurt caused to many people throughout the country.
I thank all those who made comprehensive presentations this morning. I have a legal background and I have worked in litigation for more than 25 years so I have some idea of the situation. I am not involved in any of these matters but I know that my office paid out €3,288 for one medical report. This illustrates the kind of costs incurred in obtaining comprehensive medical reports. I imagine the average medical report if coming from the UK will cost between €2,000 and €3,000. This is an initial cost in the total when dealing with these cases and engineering costs will be substantial.
The Personal Injuries Assessment Board was established in 2004 and it dealt in the main with road traffic accidents. There is a need for a constructive system for dealing with claims of medical negligence. It is not so long ago when it was common to have three defending solicitors in cases of medical negligence, one solicitor for the consultant, one for the junior doctors and one for the hospital. Some progress has been made and now one legal team acts for the defence. I am always amazed at the lengths to which plaintiff solicitors are pushed to get discovery of documents and medical records. In many cases application for orders for discovery are required in order to get the full picture. I ask why it still takes five to six years to settle an average medical negligence claim. This should not be the case in this day and age. The other problem is that if a case goes for a full hearing in the High Court, an appeal to the Supreme Court could result and this will add another three to four years. I raised with the Minister for Justice and Equality the need for a separate appeals court similar to what is available for criminal cases. Every civil appeal must be heard by the Supreme Court and this needs to change. I am delighted the Minister has announced some changes in this regard.
I ask if any cases have been decided in other jurisdictions against the manufacturers or medical providers. In many cases, court proceedings are issued. When can the first case be expected to come to a hearing? Medical negligence cases can take four to five years. Often on the day of the court hearing, everyone suddenly sits down around a table to try to agree percentages of liability. In the opinion of the witnesses, who should be responsible for trying to get agreement among the parties? This would be a fast-track solution. Litigation costs are very high and I suggest significant savings could be made if all the parties - the consultants, hospitals, manufacturers, suppliers - sat down around a table to settle the case. What will be the total number of these cases which will go to litigation?
Mr. Pat O’Mahony
I thank the Chairman and the members of the committee for their very interesting questions. I will explain how devices are regulated and I will address Deputy Byrne's comments about safety. Deputy Byrne also referred to the life-changing effect of a hip replacement. I made some reference to this in my statement. I know people who had hip replacement surgery 25 years ago and are doing very well. These technologies significantly improve the quality of life of the recipients. However, there needs to be a regulatory framework for these procedures. Our job in the Irish Medicines Board is to do the best we can for the protection of the public. I will address the broader questions raised and I refer to Senator Cullinane's question about the medical devices regime. The Irish Medicines Board regulates a range of technologies including medicines but devices are regulated differently. The big difference is that the pre-market assessment is not done by the regulator.
Where a company is bringing a medicine to market, the medicines regulator is involved in the pre-market assessment and thereafter issues the authorisation. In the case of medical devices that process is done in Europe by way of the notified body structure. The revision of the legislation is being brought forward because we all recognise that the current regime is not adequately protecting patients and must be amended. There are more than 80 of these notified bodies - generally private commercial companies - operating in Europe, which are monitored and audited by our equivalents in the various countries. The scope of the work they are allowed to do is determined by the regulator.
Are the audits effective or merely for show?
Mr. Pat O’Mahony
In terms of what we do and what we know goes on generally, we cannot be absolutely assured that in every one of the 80 notified bodies throughout the whole of Europe, the quality of the audit is exactly as we would want it. In this country, the National Standards Authority of Ireland is the only notified body and we are responsible for auditing it and ensuring staff have the correct skillset and so on. Under the new legislation, instead of undertaking that work on our own, we will be assisted by a colleague from another authority in Europe and a colleague from the European Commission. This is a clear statement that the current system is not adequate and must be revised. However, in the specific case of the hip implants we are discussing, BSI is a reputable notified body in the United Kingdom and the Medicines and Healthcare Products Regulatory Agency, MHRA, is one of the leading agencies. I am confident that the MHRA would have done a very thorough job with BSI.
I have dealt with the auditing by the regulator of the notified bodies. In regard to the second aspect to the process, whereby the notified bodies then audit the companies, substantial changes are also proposed. For example, instead of audits typically being announced, there will be provision for unannounced audits of the companies by the notified bodies. It will be a significant regime change.
Under the existing legislation, the Irish Medicines Board also has a role to play after products come to market. Specifically, after a product is approved and granted the CE mark, our job is to monitor its use in the marketplace. We have already referred to the situation with the PIP implants and the issues arising from our small population. An important part of what we do is linking with international counterparts. In the United Kingdom, for instance, there are 35,000 entries every year on the hip register, whereas we do not have a hip register. Even when such a register is put in place, as is proposed, we will have 3,000 or 4,000 entries per year at most.
When will that register come into effect?
Mr. Pat O’Mahony
Our colleagues from the Health Service Executive might be able to give a definitive answer on that. My understanding is that it is intended to be up and running by the end of the year. The work is under way to put it in place.
I asked a question about who regulates the notified bodies. Mr. O'Mahony has indicated that these bodies also audit the companies. How does that happen in terms of site visits to the manufacturing plant, for example, and in terms of quality control? There were obviously quality control issues in this case. What level of auditing is done?
Mr. Pat O’Mahony
The regulator in each country is responsible for auditing the notified bodies. It gives approval to the bodies, assigns them their designation, sets out the scope of the products they are allowed to work with and so on. All of that is done by the regulator. We can undertake audits of sites, as can the notified body. In fact, the latter is obliged to do audits of sites and to examine the quality system. This would normally involve an annual visit, but the CE mark is assigned to a particular product for five years and there would be a major review at the end of that five-year period.
There is some confusion in regard to the revision rates. The net issue with this particular ASR implant is that the revision rates are substantially higher than what one would expect for equivalent products. Of course, comparing revision rates is only valid if one compares like with like, that is the one-year, two-year, three-year, five-year or ten-year rates for two products. There is no point in comparing the revision rate at nine years for one product versus the five-year rate for another. Having said that, in the case of these ASR implants the figures clearly show the revision rate running at double or more the rates for equivalent products.
While it is not our role to defend innovation, we accept that it is a fundamental component of efforts to improve health care. As we have said, medical devices can have a life-changing impact on the patients who receive them. The whole raison d’être of those involved in developing these products is to find the next innovation that will improve people’s quality of life. That was the impetus behind the development of this hip resurfacing product. If a patient undergoes a conventional hip replacement, which requires the removal of a sufficient amount of bone to put the implant in place and allow the stem to pass down through the femur, it will have to be redone in 25 years. The revision rate at 25 years might well be 100% for that traditional procedure, which is accepted as normal. The ASR device was targeted at younger people with a damaged hip who require surgery as soon as possible. As Ms Hennebry told us, she was offered the procedure in her 40s. Innovation inevitably means that products are brought to market which are pushing the boundaries. The requirement for us as regulators is to ensure patient safety is respected in so far as it can be in that process. It is a very complex area.
When will the revision of the medical devices legislation be completed?
Mr. Pat O’Mahony
Realistically, we are looking at a five-year timeframe before the new requirements will be up and running. The regulations will be published in September, after which a whole process must be gone through in the European Parliament and so on. It will be four to five years before they are effective. That is why the Commissioner for health and consumer policy, Mr. John Dalli, has written specifically to Ministers for health across Europe with a list of initiatives that national authorities are requested to take without delay. We are about to send our response to the Commission. Thankfully, we are in a position to do all that the Commissioner has asked of us. The question is whether all of the other agencies across Europe have sufficient resources and expertise to do the same. We are depending on a CE mark that can be applied anywhere and which allows the designated product into our market. It is a complicated position.
Page 5 of Mr. O'Mahony's presentation includes the following sentence: "To date, the root cause of the problem has not been fully or clearly identified." Mr. O'Mahony did not read that sentence but instead said that the cause of the problem is "not fully understood". Do we know the root cause? Can we have an assurance, in so far as it is possible, that what has happened will not recur? Mr. O'Mahony spoke about innovation and technology, but the bottom line is that we must ensure nothing like this ever happens again. Ms Hennebry's testimony told the story of a person who was formerly healthy, lived a regular lifestyle and did the normal things we all take for granted. Everyone undergoing elective or non-elective surgery should have confidence and trust in the care they receive. In this case, unfortunately, that trust was breached.
Mr. Pat O’Mahony
In the case of any routine surgery, a very small proportion of people will have an adverse event. It might be an infection or something else, but the reality is that a small group of patients will have a bad experience. In the case we are discussing, the design of the product in some way contributed to at least a doubling of cases where the patient outcome was poor. When I say that the causes of the problem are not fully resolved or fully understood, I mean that there is an ongoing examination of the issue. The design people are involved in that and all of the revised surgeries are delivering up devices that are being carefully examined. There is a range of issues to consider, including the technique of the surgeon, the design of the head of the implant, whether the use of metal-on-metal was a substantial issue, the precise angle at which the device was implanted and so on. If we had the definitive answer today, we would present it. If it was concluded, for instance, that the use of metal on metal was the issue, then we would say it should be banned. However, right across the world, including in the United States and Canada, metal-on-metal implants are still in use. The question is whether they will still be in use in five years. I cannot provide assurance in respect of that matter because it is an emerging science.
The emerging science of regulation also means that there must be proactivity and a hands-on approach.
Mr. Pat O’Mahony
Ireland's population is 1% of the total population of Europe. As a regulator in the sphere of medical devices, however, we are one of the leading agencies in terms of influence and reach within Europe. We are very active in this space and I am personally active in respect of the reform of the legislation, etc., because it is extremely important for patients. I wish to assure the committee that this is the case.
Mr. Colm MacGeehin
I wish to confirm to Senator Cullinane that the figure was 3% to 6% prior to the problems relating to DePuy. At present, a figure of 12% to 13% is being touted but we suspect that the actual figure is much higher. However, this is a matter for another day.
Senator Colm Burke referred to the antiquated and ruinously expensive system that we have in place. I have just submitted a document from the Medical Injuries Alliance and I urge members to read it because we hope to address them on reform in this area in the autumn. The document relates to case management and, in particular, the statutory duty of candour, which could dramatically affect the reform of this entire area and expedite the way in which these cases are dealt with. That is also a matter for another day. I will now ask Mr. Kidd to address the remaining points.
Mr. Neill Kidd
Senator Cullinane asked about the retention of the explants which have been removed from patients. Under the scheme which has been set up and if patients consent, their implants will be removed and brought for storage at the London Implant Retrieval Centre by DePuy at its expense. However, as the Senator quite rightly pointed out, it is quite reasonable for a number of patients to want to retain control of the explants, particularly when legal proceedings are contemplated. I am not implying that anything untoward might happen to the devices when released to the retrieval centre but it is obviously a patient's right to retain control of an explanted device. To my knowledge, the companies which provide the service are based in the UK and there is a significant cost involved in arranging for their representatives to come to Ireland to collect devices from the relevant hospitals and decontaminate and store them safely. In addition, an ongoing storage fee is charged. That is another cost relating to the litigation which will have to be borne by the plaintiffs themselves in the first instance. The position in this regard is similar to that relating to medical reports to which Senator Colm Burke referred. It is another burden or obstacle which the patients must overcome in terms of making claims for compensation in respect of what they have endured.
Patients are being obliged to do everything I have outlined as a result of a lack of concession of liability on the part of DePuy. If it was conceded that the implants were defective, there would be no need for this entire process. We are concerned with people who have actually undergone revision surgery in order to have implants removed. They clearly have experienced problems and they are not malign individuals who are chancing their arms by making spurious claims for compensation. Theirs are genuine cases and there should be an acknowledgement that the implants were defective. If the latter is not forthcoming, patients should be given the option of arranging to have their explanted devices stored at facilities of their choice and DePuy should pay for this in the same way it pays for the storage of such devices at the nominated facility in London. Ms Antoniotti will address the other issues.
Ms Sara Antoniotti
I am concerned, from a legal point of view, with regard to the transportation of devices to London. I understand from Mr. O'Mahony's presentation that these devices are the subject of ongoing examination and consideration in London. In the context of the cases that are going to go before the courts, I am concerned by the fact that there might be prejudice to plaintiffs because the devices would have been examined by somebody else in the first instance. If examinations are to proceed, they should be carried out on a joint basis. In other words, they should be joint inspections with patient representatives present in order that they might consider the issues. This is an important matter which must be dealt with immediately. We have tried to obtain some concession on that from DePuy by way of letters and correspondence but this has not been forthcoming.
What has DePuy said in respect of the matter?
Ms Sara Antoniotti
We have not received any responses.
So it did not reply to any correspondence.
Ms Sara Antoniotti
We received no response with regard to what is going to happen to the implants.
Did DePuy ignore communications regarding that specific issue?
Ms Sara Antoniotti
I cannot say whether the communications have been ignored because I did not write the letters. I am a barrister and I advise the solicitor to write the letters. My understanding is that we have not received any assurances one way or the other.
Ms Antoniotti stated that our guests have not received any communications from DePuy.
Ms Sara Antoniotti
We have written to DePuy but I am not sure whether a response has been received. I certainly have not been advised by my solicitor that there has been a response to our request that joint inspection facilities should be provided.
During my presentation I failed to mention the fact that we have also written to DePuy and asked for indemnities in respect of the relevant hospitals and surgeons and the State.
Was a reply received in respect of that communication?
Ms Sara Antoniotti
Those indemnities have not been forthcoming.
When were the letters relating to that matter written?
Ms Sara Antoniotti
We wrote those before the issuing of proceedings. The latter are issuing on a precautionary basis at present. Some of us have been obliged to issue proceedings as a result of the Statute of Limitations and we have named the hospitals and surgeons, as well as DePuy, in these proceedings. That is a major problem for patients because they are now suing their surgeons. I will not go into the reasons for this but they have received legal advice to the effect that this must happen. This is a difficulty because they have built up relationships with their surgeons over the years. We wrote to DePuy and asked it to provide indemnities in order that we would not be obliged to issue proceedings against the hospitals and surgeons. We have not received those indemnities. As a result, we have to sue them. That is why the costs are mounting in these cases. After all, tri-party litigation involves several defendants.
Senator Colm Burke asked four questions. I do not think I can answer all of them. In the context of whether there are any decided cases internationally, I do not believe so. As I understand it, all cases in the United States of America are being case-managed by a judge in Idaho. He is going to hear all of the cases and presumably there will be some determination shortly. In Ireland, there is the case with which Mr. Kidd is involved. This is at the defence stage. I remind the committee that there is no provision in Ireland for test cases. We do not have a provision whereby one case will govern all cases.
It would, however, set a precedent in the context of how the courts would approach other cases.
Ms Sara Antoniotti
It would of course. There is a question as to when that would come on for hearing. That is a big "when".
I apologise for interrupting but a vote has been called in the Dáil and there will be a need to suspend proceedings while members go to the Chamber. Is Ms Antoniotti in a position to conclude before the suspension.
Ms Sara Antoniotti
I only need 30 seconds. I wish to deal with the issue to which Mr. Kidd referred in respect of discovery. Patients are being asked to prove the defect, the negligence and all of the other issues involved. As Mr. O'Mahony stated, the science in this area is emerging and the IMB is having difficulty in identifying the root cause. We need discovery in respect of what patients are being asked to prove and that could take years. DePuy is resisting us on discovery and we have been obliged to obtain court orders in respect of it. This takes time and any judgments we obtain in this regard will probably be appealed. If we did not need to do that, these cases could be on for hearing within six months.
We will suspend proceedings until the vote in the Dáil has concluded.
Sitting suspended at 11.10 a.m. and resumed at 11.30 a.m.
I apologise to our guests for the interruption caused by the vote in the Dáil. Do Ms Molloy and Ms Hennebry have remarks to make in response to the questions from the committee members?
Ms Cathriona Molloy
The cost of going down the legal route is scary and not everyone wants to take that route. Many can claim out-of-pocket expenses or loss of earnings and child care costs. They are entitled to claim them and it should not affect any future claim, although it cannot be duplicated. Much of this was due to poor regulation. With the reconfiguration of the HSE, some legislation must be put in place. Too many people are being damaged in health care in Ireland.
In the interaction between DePuy, the HSE and Patient Focus the comment was made that DePuy would cover reasonable and customary costs. What has been its approach to costs incurred by Patient Focus and its members?
Ms Cathriona Molloy
There is a process whereby people must register with a firm of solicitors, Thornton & Partners. Every DePuy customer has been given a unique identifying number. Customers must prove expenses with receipts to claim their costs. I do not know which individuals have claimed because it is a private arrangement. One professional had incurred a considerable loss of earnings while out of work. He did not have time to go down the legal route to recoup his costs, but they were covered. However, he will still take a case in respect of pain and suffering. He could not wait five or six years. A brave firm of solicitors must push a case to court. They must not all wait for other firms; someone must set a precedent for the patients with the first case.
What is Ms Molloy's experience of dealing with DePuy and its intermediaries?
Ms Cathriona Molloy
I have had no personal dealings with DePuy. We had dealings with Thornton & Partners and Ms Aoife Travers to find out how people could claim. We have had no other dealings with them.
I raised the issue of taking a test case but the difficulty is that, if money is suddenly put on the table on the day of the court hearing, the case may not be heard. It leaves everyone in the terrible predicament of having to move on with their cases.
The second issue raised while we were on a break was that VHI does not cover the costs of medical care once the problem has been identified. It should be taken up by the committee with VHI. I asked the person who raised it with me to send on a copy of the correspondence. There are legal and medical costs issues, which are not covered by the insurers.
Following today's meeting and next week's meeting, we will review today's hearing. We will review the situation of any private health insurer not working with the various parties.
Where the VHI is involved in a road traffic accident, it will cover the medical costs where a person is injured. An undertaking is given by the solicitors and injured parties to refund the moneys once the case has been settled. I do not see why the same issue cannot apply in this case. It is important and it is a drain on people's finances.
Ms Antoniotti was interrupted for the Dáil vote. I invite her to conclude her remarks.
Ms Sara Antoniotti
One issue raised by Senator Colm Burke concerns the total number of individuals involved in legal proceedings. We do not know the number but in all cases of which we are aware, the only ones coming forward for hearing involve patients who have had revision surgery or who have been advised that they will require revision surgery. Figures given by Mr. O'Mahony suggest an estimate of 550. I caution the committee to bear in mind what has been said by Mr. O'Mahony in respect of the future prognosis. It would appear more patients will come forward if it fails in a couple of years time. We must consider what happens to them.
I thank Ms Cathriona Molloy and particularly Ms Audrey Hennebry for her moving testimony. I thank Mr. O'Mahony, Ms. Hanson, Mr. Ward, Ms Antoniotti and Mr. MacGeehin for being here. We will suspend for five minutes before reconvening in public session for our meeting with the HSE.
Sitting suspended at 11.33 a.m. and resumed at 11.35 a.m.
We continue hearings on the DePuy hip replacement recall. Deputy Catherine Byrne intended to refer to DePuy as opposed to Harley Medical Group in her earlier comments. I welcome Dr. Orla Healy and Dr. Joe Devlin from the HSE.
Dr. Joe Devlin
We welcome the opportunity to speak on behalf of the HSE. I am always struck by the testimony of service users and the experiences of Ms Hennebry. It is always a matter of great regret that someone suffers as a consequence of health care, which is supposed to be helping them. I thank the committee for the invitation. I welcome the opportunity to comment on the DePuy ASR recall and I am happy to answer any questions on it. I am here on behalf of Dr. Phillip Crowley, the national director for quality and patient safety, who is unable to attend due to leave. I am joined by Dr. Orla Healy, specialist in public health medicine and co-chair of the ASR recall incident management team. I am co-chair of the national incident management team, of which the ASR recall incident management team is a subgroup.
Dr. Orla Healy
On 24 August 2010, DePuy Orthopaedics announced a global recall of two specific hip replacement implant products. The HSE became aware of the recall on 26 August and on 27 August it convened an emergency management team meeting in response to the recall. Dr. Barry White, who was then director of quality and clinical care at the HSE, provided a commitment on behalf of the health service that the HSE would co-ordinate the recall across the public and private facilities. While this posed a significant burden on HSE resources, it was a significant strength of the process. The unified approach proved successful from the patient and management perspectives. It allowed us to address a number of major issues with DePuy over the course of the recall. In accordance with the serious incident management policy and procedure, an incident management team was immediately established. Membership included the Irish Institute for Trauma and Orthopaedic Surgery, the Independent Hospitals Association of Ireland, representing most private facilities, a patient representative from the Irish Patients Association, the HSE legal services, and finance, communication, ICT and procurement directorates. The group managed the overall response to the recall, providing protocol and guidance on clinical, financial and management issues while surgeons and administrators used the protocols to provide care and information directly to the patients.
Globally, approximately 93,000 components were implanted and this affected 54,000 patients. In the UK, 14,000 products were distributed and in Ireland a total of 4,746 of the components were distributed, affecting 3,317 patients. They are spread equally across public and private facilities, with 16 public hospitals and 14 private hospital sites. The recall process was successful overall with all patients identified and recalled. Some 80% of the patients received a recall appointment within three months of the announcement. In total, some 96% have attended appointments. Over 357 patients have had revision surgery and a further 166 are scheduled. Patients are now attending for year 2 check-up appointments. That is in contrast to other countries where progress has been slower and less co-ordinated.
All recall appointments, tests and surgeries have been provided to each patient free of charge, in both public and private hospitals. DePuy has covered the cost in both public and private facilities. On the interaction between the incident management team, IMT, and DePuy, at the commencement of the recall De Puy stated that it intended to cover "reasonable and customary costs" of monitoring and treatment for services, associated with the recall, including revision surgeries, and to cover non-medical patient expenses, for example, out of pocket expenses. The incident management team managed a protracted engagement and negotiation process with DePuy on behalf of Irish hospitals and patients, via an appointed DePuy liaison person and via DePuy's appointments claims handler, Thornton and Partners. The liaison person attended IMT meetings and there have been multiple other contacts between legal and communication teams. DePuy vice presidents have attended two meetings.
We have worked through a range of issues with DePuy-----
Are the vice presidents senior?
Dr. Orla Healy
Yes, one was from France and the other was from Canada. We have worked through a range of issues with DePuy, including reimbursement, access to patient records, laboratory selection, and management of explanted devices and duration of the recall. Examples of issues that we have worked through include patient consent. De Puy initially sought access to all patients' records and X-rays. That included permission to pass those records to third parties outside the EU, which was contrary to Irish and EU data protection regulations. The IMT advocated that such consent was not required to assess the requirements for payments. After protracted negotiations DePuy waived this requirement and patients remain anonymous, unless they opt to make personal expense claims. De Puy does not have access to their records or X-rays in order to fund the process.
With regard to duration of funding, after much discussion, centred on the potential need for revision surgeries in years to come for some patients with DePuy implants, the company has agreed to fund monitoring and treatment of patients in perpetuity. Reference has been made to legal issues. Early in the process, the IMT, at the encouragement of the patient representative on the team and with the strong agreement of the HSE legal team, sought to establish a mediation scheme to address the inevitable damages claims that would arise from this recall. The clinical indemnity scheme, CIS, which is part of the State Claims Agency, offered to assist with this process, which could have allowed patients to make submissions for personal compensation without recourse to the courts and the associated cost and time burden. DePuy declined the offer to engage in this mediation process, and as a result, the IMT does not have ongoing involvement in legal aspects of the recall as they are now referred to the State Claims Agency and the CIS which act on our behalf.
We contacted the CIS in advance of this meeting and the current estimate of claims intimated or instigated, where the HSE and associated hospitals are named as a defendant, is in the region of 100. None of the cases have been heard. The State is pursuing DePuy for an indemnity in each and every case. The CIS sought overall group indemnity at the outset but this was refused by DePuy.
In terms of patient communication, we appreciate that the recall has generated a high level of concern among patients. We have endeavoured to ensure timely, equitable, appropriate management of all patients, while acknowledging that the caregivers - the patients' own surgeons, were best placed to provide information and advice on the best individual steps to be taken for each patient. Detailed protocols were developed, including template letters and a question and answer document, and distributed to all hospital sites. Media statements and interviews were also employed to keep patients updated, and a dedicated web page was maintained throughout the recall process. We are aware of patients concerns that were ongoing throughout the process, particularly in regard to the lack of certainty on the requirement for revision surgery, and also relating to metal ion levels. It was not appropriate for the IMT to play a role in the clinical management of patients. Patient concerns always have to be addressed with the treating clinician and decisions based on assessment of risks and benefits associated with each treatment option for each patient at individual clinical level.
However, when requested to do so, we have facilitated patients in seeking a second opinion or switching to a new private or public facility or surgeon. Out of 3,317 patients attending, we have handled 18 complaints-queries. Two thirds of those came from the south east. Kilcreene and Whitfield, where almost half, 43%, of all patients had their initial surgery. Half of all contact related to accessing a second clinical opinion, which we facilitated. The HSE director of advocacy liaises with patient representative groups to ensure that queries that arise are resolved promptly on an individual basis, and to ensure a channel of communication between patient representative groups and sites or the incident management team.
A recall of this kind, with potential for further surgery for affected patients, is a very regrettable situation. It can be a huge source of concern for everyone involved, particularly for patients who have had to undergo revision procedures and the associated recovery. Overall, the HSE and the private facilities involved in this recall are satisfied that our approach has been successful in capturing all affected patients, and that our work compares very favourably with progress made in other countries. We have been successful in protecting the privacy of patients, and in securing reimbursement for the State in meeting the cost of this commercial recall. We continue to work hard to support patients involved and are available to address any outstanding issues or concerns as best we can. That concludes my opening statement. If there are any other questions we would be happy to address them.
I thank the witnesses for attending today. We often hear references in the committee to the fact that the mediocrity of other nations is hardly the benchmark against which we should measure any of our performances. While a reaction to dealing with the issue might compare with other countries it is not the benchmark to which we should aspire in the future.
What is the status of the legal pursuit of DePuy for indemnity? Has it been accepted or in what way is it being pursued? Such a case could be lengthy if it is pursued on an international basis. What, if any, interim compensation arrangements is it intended to make available to the people affected?
I apologise for my late arrival as I was delayed in the Chamber. I note in the statement that the number of implants carried out in this country were equally distributed across 16 public hospitals and 14 private hospitals. My understanding is that there is a concentration in the south east – in Kilcreene and Whitfield. The statement seems to contradict that.
Many patients have had difficulty with the interface between private medicine and public hospitals in particular in regard to consultants. Patients have been most concerned about that and felt that there was a certain element of difficulty between the private service and the public service and that the patients were, in effect, falling between two stools. Are there proposals for the regulation of private health care, in particular where it interfaces with the public system?
Regarding the various hospitals where this device was used, it appears it was discontinued in the south east quite some time before the recall. Did an issue arise in that regard? Why did that happen? Were queries or complaints made at that stage? Do the witnesses have any details on when it was recalled in other hospitals?
Many patients have been injured, some seriously, as a result of this situation and they are entitled to compensation. Do the witnesses have a view on that, and can they do anything about it? What is their role in that regard?
I thank the witnesses for their presentation and the manner in which this issue was dealt with by the Health Service Executive. I know it is not possible to tick all the boxes when trying to deal with an issue that arises overnight and that must be responded to but the witnesses have given a comprehensive presentation on what has been done, for which I thank them.
I raise two issues. First, in doing this operation, the servants and agents of the State who are employed by the HSE - namely, consultants - acquired the replacement equipment; therefore, there was a contract to buy these hip replacements from DePuy. The question that arises is whether the HSE and the State have a right of action against DePuy, because the contract was with that company. The contract was not only between the patient and the hospital. The HSE and the State were dealing with this company, which had agreed to provide a device suitable for what was required. It appears to me there is a right of action in that regard. I am aware that DePuy has agreed to cover certain costs but the question of indemnifying the State now arises.
The witnesses said that approximately 100 cases had issued. That involves a legal team for the consultants, a legal team for the hospitals dealing with this issue, and a legal team for DePuy. If DePuy is held fully liable it will have to pick up the costs for the HSE and the consultants and on my rough calculation, at €20,000 per case on each side, that is €4 million. That €4 million could be far more usefully used for the benefit of the people who suffered the problem. I cannot understand why it cannot deal with this in a more comprehensive and humane manner rather than dragging it out.
Second, the witnesses said that as 14 private hospitals were involved, the vast majority of those people had medical insurance. I understand the VHI has been reluctant to get involved in terms of covering the costs patients will now have to incur. Have the witnesses dealt with that issue with the VHI? Do they propose to deal with it?
I thank Dr. Healy and Dr. Devlin. I agree with Senator MacSharry on the important question of the way the State is pursuing DePuy. I agree with Senator Burke also on the need for this matter to be dealt with in a more humane way for those people who have been seriously affected by it.
I have a number of questions, some of which have been touched on already by Deputy Healy. Why was the rate of usage of the faulty hip implants here much higher than in any other country per head of population? Why were there clusters of cases, as referred to by Dr. Healy, in small areas of the country, particularly Waterford and Kilkenny? Why did it take so long for the announcement about the faulty hip replacements to be made here when the alarm had already been raised prior to 2009?
I am sorry to interrupt the Deputy but Senator MacSharry must leave to attend a vote in the Seanad.
What has been done for those people who have metal-to-metal replacements from manufacturers other than DePuy? Mr. Pat O'Mahony spoke about those this morning.
After the recall, did the HSE continue to use the hip replacements in public hospitals? Do the witnesses have any facts on that? Why was the HSE destocking the ASR at least a year before the official recall was made?
Dr. Joe Devlin
I will give background to some of the questions and perhaps pass others to Dr. Healy. I co-chair the national incident management team for the HSE and our focus from the start has been on looking after patients affected by this problem. We were asked an explicit question on our role in terms of compensation. It is important to be clear that we are discussing here regulation, care provision, and litigation and compensation. Our role is in care provision. Our role is not in compensation. While we had DePuy participate in discussions with us, it is not for us but for the State Claims Agency to compensate. Obviously, that exists within a policy framework and I am cognisant of the discussions the committee had earlier and the suggestions made by some members.
On the specific points made, I agree we should not measure ourselves against international mediocrity but it is a useful benchmark that the incident management side in Ireland is well developed and got at this work quickly. The figures speak for themselves in that regard.
There was a question of falling between two stools in terms of public and private health care. Again, the figures do not speak to that experience. As far as I am aware, the figures indicate that all patients have been seen or offered appointments, that in 80% of cases the first appointments were within three months, and that that occurred in both the public and the private settings.
The presentation earlier made reference to private versus public in terms of access for blood tests and so on. Would that not be the same in this case?
Dr. Orla Healy
The role of the incident management team was to establish protocols for blood testing. The tests had to be done abroad and transported. There had to be a protocol for that in terms of storage and transportation. We had to identify an accredited laboratory and DePuy agreed to fund that process, which was uniform across all of the sites. The point in covering public and private facilities was to ensure there was a standardised, uniform, equitable approach to everything across public and private sites.
Dr. Joe Devlin
I agree entirely with the point made about dealing with all issues in regard to patients and patient care in a humane way, especially in the context of the stress caused by worry about this issue. Those of us in the HSE are open to reform but we have to operate within the rules as they are currently set out for us.
Questions were asked about the procurement of these joints. It could be regarded as a strength or a weakness but there are some countries where the choice of drug or the choice of device is restricted to treating surgeons and doctors. That is not the case here once we are treating within the regulatory rules, as was the case in regard to this product. There is a balance of risks, which Mr. Pat O'Mahony referred to earlier. One could argue for the most conservative approach, namely, wait 25 years until a new product has been tested, which is the length of time it takes to achieve the final failure rate, versus earlier adoption and licensing of the product. There is a balance to be struck in that regard, and that lies with the regulators. Individual surgeons in Ireland have discretion to choose the device they feel is most suited to their patients. As alluded to, the product in question was used disproportionately in younger persons, which reflects a rational approach. Metal-on-metal joints continue to be used and conservative operations for hip replacements continue to be carried out. The rationale is that revision surgery is more straightforward among younger persons. The products in younger patients will wear out in most cases. That is not to say we must have a regulatory framework to guard against premature licensing of products that are unsafe. That balance is the difficult one that regulators must strike. It is not the role of care providers to strike it because it is struck elsewhere. It is the role of the individual surgeon and doctor to choose the specific product that is licensed for their patients.
On the other specific queries, I will pass the members over to Ms Healy.
Dr. Orla Healy
Regarding patients being distributed between public and private facilities, the recent breakdown indicated a ratio of approximately 50:50. The figure for the south east was approximately 43%. The figures, therefore, are not mutually exclusive. All the relevant products were taken off the shelves immediately in the HSE and private hospitals at the time of the recall.
Were they removed completely?
Dr. Orla Healy
Yes.
They have not been used.
Dr. Orla Healy
No. The product has been withdrawn; there is a global recall.
There is a suggestion that there was destocking in hospitals a significant period prior to the recall.
Dr. Orla Healy
I am not aware of individual consultant practices in the run-up to the recall. I can comment only on the time of the recall.
Did the consultants themselves make the decision or did they do so in conjunction with the HSE?
Dr. Orla Healy
As said, once a product is regulated the consultants are at liberty to select what they believe to be the best product for their patients at a given time. The HSE does not have any influence over this decision.
The decision to destock such an item was significant. The HSE would have been paying for such items. If it is correct that there was significant destocking as early as 2009, it is significant.
Dr. Orla Healy
I do not have that evidence.
Dr. Joe Devlin
It is at the discretion of the individual treating surgeon to choose a certain product. Clinical practice will vary depending on the surgeons in practice in the location. At times, there is movement of clinical personnel and issues arise over access to operating theatres and clinics, all of which can influence the overall volume. However, I am not aware of a conscious procurement decision to cease stocking an item on any site prior to the recall. The products were not used in all sites. Therefore, some would not have had a decision to make.
Are there any other questions?
I may be wrong about what I am about to say. Might some surgeons have been using the hip joints after the recall?
Dr. Joe Devlin
No.
Dr. Orla Healy
No.
Definitely not?
Dr. Joe Devlin
No. A very early action of the recall was to ensure that all of the products had been removed from the shelves and were beyond use. That was an immediate action.
Up to a year before the official recall, some hospitals were destocking the products.
Dr. Joe Devlin
The Deputy asked whether the products were used after the recall and the answer is that they were not.
With regard to the continuing use of metal-to-metal joints, it was stated this morning that nobody could predict what will happen with the joints in the future and that there may be problems. Are those who receive metal-to-metal replacements monitored continually, through scanning or blood tests, for example?
Dr. Joe Devlin
Metal-on-metal joints have been used for a very long time and do not comprise a brand new technology. Regarding, the earlier reference to ion measurement, a blood measurement, the significance of ion levels in the blood is uncertain. Although it is being measured in patients, it is very unclear what one should do with the information. It has been known for many years that there are raised ion levels in patients who have metal-on-metal joints. As stated earlier, there is work ongoing, and the data being collected as part of the recall worldwide are informing research in this area. All we can say is that the very long time for which metal-on-metal joints have been in use, and the known widespread presence of raised ion levels, would suggest that if there is an effect specific to the raised ion level, it is quite a small one. However, it is to be taken seriously nonetheless and, therefore, it is the object of further research.
What is the position on ongoing issues regarding patient reviews and the interaction between clinicians and patients?
Dr. Orla Healy
The initial management team was established to oversee the initial recall and to ensure every affected individual was identified and recalled. Once the patients are in the system, they deal with their consultant and his or her facilities at an individual level. Interaction continues at an operational level. As issues arise, we are available to address them. The channel of communication is through the director of advocacy, although we deal directly-----
Is there ongoing interaction between the initial management team and DePuy?
Dr. Orla Healy
We met very regularly at the outset but did not meet as frequently since then. An Irish liaison officer was appointed by the company and he is accessible to us at all times. Our last encounter with DePuy at senior level was in March when we addressed the issue of the long-term funding of the product. At the time of the initial recall, the suggestion was that it might be a five-year recall. Obviously, the lifespan of the hip replacements is much longer so we wanted the recall to be covered indefinitely. We recently secured agreement on that front. That was our most recent encounter with DePuy at senior level. Most of the other interactions are operational and relate to individual issues. We believe we have covered most of the global ones, including consent, decontamination, protocols, funding and reimbursement.
Does Dr. Healy envisage a role for the initial management team, the HSE or the Irish Medicines Board in terms of regulation and the evolution of regulation?
Dr. Orla Healy
It is certainly not a role of my team but it would be the case at a wider level.
Dr. Joe Devlin
We are one of the stakeholders and we are involved in reform. Reference was made to disclosure. It is our policy to disclose harm when it has occurred. Disclosure to affected service users is a prerequisite of our starting to investigate a matter. We engage regularly with the State Claims Agency on the CIS but regulation is necessarily separate from care provision. That is the very point of the rules within which we operate. It is a safeguard.
Has DePuy agreed to fund the monitoring of patients for life?
Dr. Orla Healy
For the life of the hip.
Have the patients been informed about this?
Dr. Orla Healy
We got the document just this week. It states the company will offer funding on a case-by-case basis, regardless of the age of the hip.
Did DePuy make the decision on case-by-case funding or was it the HSE?
Dr. Orla Healy
DePuy is funding it. As far as the HSE is concerned, all costs are to be covered by DePuy.
I thank Dr. Devlin and Dr. Healy for attending and for their presentation, time and commitment.
On behalf of the committee, I pay tribute to and thank Mr. Cathal Magee, who is to resign as chief executive officer of the HSE. I thank him for his courtesy and his having been available to this committee. He has been present before us on a number of occasions in his capacity as chief executive officer. I thank him for his commitment and dedication to public service and wish him well on his retirement.
The joint committee adjourned at 12.10 p.m. until 10 a.m. on Wednesday, 25 July 2012.