Oireachtas Joint and Select Committees

Tuesday, 8 May 2018

Joint Oireachtas Committee on Finance, Public Expenditure and Reform, and Taoiseach

State Claims Agency: Discussion

1:30 pm

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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We are now dealing with the State Claims Agency and its handling of claims made against the State. I welcome Mr. Ciarán Breen, director, and Ms Jenny Foley, senior clinical claims manager, from the State Claims Agency.

I wish to advise the witnesses that by virtue of section 17(2)(l) of the Defamation Act 2009, witnesses are protected by absolute privilege in respect of their evidence to the committee. However, if they are directed by it to cease giving evidence on a particular matter and they continue to do so, they are entitled thereafter only to qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against any person or entity by name or in such a way as to make him, her or it identifiable.

Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the Houses or an official, either by name or in such a way as to make him or her identifiable. I ask Mr. Breen to make his opening statement.

Mr. Ciarán Breen:

I welcome the Chairman and members of the committee for giving me the opportunity to set out the State Claims Agency's approach to managing claims against the 146 State bodies that fall within the remit given to it by the Oireachtas. I am joined by my colleague, Jenny Foley, solicitor and clinical claims manager, and we will be happy to answers members' questions shortly.

It is important that I set out the details of the agency's role in the Vicky Phelan case. This is clearly a tragic case that has had dreadful consequences for Ms Phelan and her family. I assure the committee that at every stage of our involvement in this case, we have been acutely aware of the consequences, trauma and pain Ms Phelan and her family have suffered and continue to suffer. In carrying out our statutory role in managing this case, we have been mindful of the need to ensure that, wherever possible, nothing that we did would add to the suffering of Ms Phelan and her family.

In managing personal injury litigation taken by persons against the State, we never forget that our work frequently involves the management of difficult, complex and traumatic cases taken by persons who have suffered injury, sometimes of a catastrophic nature. We have a duty, when managing personal injury claims, to manage any individual claim in a humane, ethical, professional and sensitive manner.

Our role in Ms Phelan's case arose because one of the parties she took a case against was the Health Service Executive, HSE, which is one of our clients. The HSE was not the only party. Ms Phelan's case was also against the United States laboratory that had carried out her smear test. It was called Clinical Pathology Laboratories. In every case with multiple parties, each party conducts its own defence independently of the other parties. We managed the case on behalf of the HSE but the US laboratory had separate legal representation and a separate legal strategy.

The primary legal issue in this case centred on the alleged misreading of Ms Phelan's original smear test. The US laboratory accepted that legal liability for that issue rested with it alone and that the HSE was not legally responsible for the misreading. As part of the US laboratory's defence of this issue, its lawyers sought a confidentiality clause that would have restricted Ms Phelan from disclosing details of the settlement or the case. The State Claims Agency opposed the use of a confidentiality clause in Ms Phelan's case and no such request was made by our agency. The request by the US laboratory was not supported by the agency. Our view is that the US laboratory's insistence on a confidentiality clause was a significant factor in the failure to resolve the claim through mediation. Mediation is our preferred route for resolving cases of this nature as it would have eliminated the need for court hearings or a contested court action. A settlement, consequent upon mediation, would have made it unnecessary for Ms Phelan to go to court, personally give evidence and experience all the stress and anxiety that a court hearing entails.

A total of 98% of all cases managed by our agency are resolved without the need for a contested court hearing. It was not possible to resolve this case through mediation, but that was for reasons outside our control, and I have referred to those reasons.

I would like to make a number of points about the way we manage cases. I am conscious that the committee asked us here today specifically to discuss this issue. In Ms Phelan's case, it has not been reported by the media generally that the presiding judge, Mr. Justice Cross, praised the manner in which the case was managed by the State Claims Agency and the other parties. While some cases can take up to between two to three years to be concluded, Ms Phelan's case was settled within ten weeks of the summons being lodged. The judge said the case was handled in an efficient and humane manner, with all sides pulling out the stops to get the matter ready for hearing quickly.

We have heard commentary from some observers in recent days suggesting that the State was in some way trying to place obstacles in the way of settling this case. The judge's comments, being those of an independent party, demonstrate that the opposite was the case.

I will now update the committee on the current number of cases we are managing which are similar to Ms Phelan's case. In addition to Ms Phelan's now concluded case, we are managing nine other similar cases, and we are aware of one additional case where a formal claim has not yet been made. We have received an indemnity from the independent laboratories in three of the nine cases to date and we have sought indemnities in all others. We will manage all of these cases in the same way we managed Ms Phelan's case, namely, carrying out our statutory role by placing a high priority on treating the people who have made the claims, and their families, with the dignity and compassion they deserve.

We have no intention of mounting a full defence in any case of this nature where responsibility is substantially or completely that of the State. In any such case, we will pursue other options, including mediation or settlement.

We have a statutory duty to act in the best interests of the taxpayer. We also have a duty, however, towards injured persons who have suffered a medical negligence related injury, including following a misdiagnosis, and who take legal actions against the State or State bodies. We never lose sight of the fact that in many cases the injured parties, together with the families, have suffered significant trauma and pain. Recognising this, the agency aims always to act fairly, ethically and with compassion in its dealings with these people and their families as well as in the management of all cases which fall within our remit.

In cases of medical negligence, our policy is to admit liability as soon as the expert medical evidence becomes available to indicate there has been a breach of duty. The agency takes every step it can to ensure that litigation is handled sensitively to ensure no additional distress is caused to the person who has made the claim or to his or her family. The agency is required, however, to operate in accordance with its statutory mandate to investigate claims thoroughly and to manage litigation in a professional manner. I am not suggesting to the committee that it is an easy task to get this balance right when carrying out our statutory role, knowing the often devastating personal consequences for persons who have suffered injury, nor would I suggest that we always get this balance right to the satisfaction of all the parties in the case. However, we make every effort to do so. I hope the facts, such as those put on the court record by Mr. Justice Kevin Cross in Ms Phelan's case and by the same judge in two other cases last week bear this out.

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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I welcome Mr. Breen and Ms Foley to the committee.

Vicky Phelan is a neighbour of mine. I know the type of person she is and what she has gone through. The briefing note given to the Minister for Health, Deputy Harris, on 16 April states the State Claims Agency had advised it believed the issue of non-disclosure would fall or be dismissed and, therefore, there was no exposure for the State. Why did the agency give that advice?

Mr. Ciarán Breen:

We did not state that we felt it would fail. We acknowledged in our defence that there had been a breach of duty by the HSE's cervical screening and the HSE via the consultant in not telling Ms Phelan. The only point that we put into that note for the Minister was an issue of exemplary damages which might accrue to the State in respect of that. We indicated that in the absence of malice, the claim would not be made out. One of the reasons we said that was because, when it was put to Ms Phelan's expert whether he thought there was malice on the part of the State in the delay in notifying Ms Phelan, he said there was not. It was just a legal point.

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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With due respect, this is about life or death. When it became known that there was an incorrect reading of a smear test in 2014 and which was not given to Ms Phelan until 2017, three years later, surely at best it was gross incompetence. Mr. Breen is speaking about the whole issue of intent. Surely, as the officer charged with legally advising the HSE, Mr. Breen should have said on the issue of non-disclosure - that is the key issue here - a wrong was done. At that stage Mr. Breen should have been advising the State to accept liability. Furthermore, he should have ensured the State Claims Agency and the laboratory in America, CPL, Clinical Pathology Laboratories Inc., accepted liability, offered a settlement to the Vicky Phelan and not have dragged her through court for four days. Instead, she was dragged through the court and had to put her condition in the public domain. It was offensive to the public and grossly unfair to Vicky Phelan and her family. As the chief legal officer advising the State, Mr. Breen should have said on non-disclosure that we accepted legal liability. It should not have happened. Instead, it resulted in Vicky Phelan being told at the end of 2017 of the difficulty she has with her health. This would not have arisen if she had been told of the incorrect smear in 2014.

When I read this opening statement, the State Claims Agency still does not appear to be admitting that the issue of non-disclosure was culpability on the part of the HSE. Vicky Phelan is an incredible woman. She came out when she was not well and stood up for women and the truth. We still have the situation, however, whereby Mr. Breen is advising the State, the HSE and the Minister for Health, that the issue of non-disclosure was something for which the State should not accept liability. If the State had accepted liability for it, Vicky Phelan would not have ended up having to go to court. Is that not correct?

Mr. Ciarán Breen:

No. I will take the Senator through the sequence of what happened. I deplore the fact that Vicky Phelan was not told. The Senator is absolutely right that she should have been told.

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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Mr. Breen, that is great. However, actions speak louder than words. Mr. Breen could have advised the State to accept liability. Both the State Claims Agency and CPL could have come together. However, no offer was made to Vicky Phelan prior to the court case.

Mr. Ciarán Breen:

If I could take the Senator through the sequence, he might find where my logic is coming from on this. What happened was we did acknowledge and admit liability in respect of the non-disclosure. That was in our defence. As a matter of record and as a matter of law, we admitted liability. That was wrong and we said so.

The issue in the case was whether that failure to disclose affected Vicky Phelan's clinical outcome. There was a separate issue in the case whereby the US laboratory, during the short period before the case went to trial, had admitted liability, had offered the State an indemnity and would deal with her settlement. What happened in the particular case was the solicitors firm acting on behalf of the US laboratory had some difficulty getting instructions from its insurance company. We were, at all times, pushing towards making sure that Vicky Phelan got a settlement. That is always what we wanted to do.

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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The settlement was based on an incorrect reading of the smear test on day one by the laboratory in the US. It was not about non-disclosure.

Mr. Ciarán Breen:

No.

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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That is the key point I want to make. This needs to come out. When Vicky Phelan brought this court case, there were two defendants, CPL and the HSE. The State Claims Agency was advising the HSE. As the senior officer, Mr. Breen was responsible for this advice. If disclosure had been made back in 2014, Vicky Phelan would be in a different position today. That is the key point here. The smear test reading was a major error. It was realised in 2014 that there was an incorrect reading in 2011. If she had been told at that time, medical action could have been taken and Vicky Phelan would be in a different position today.

If the State Claims Agency had accepted non-disclosure early on and it had discussed the case with Clinical Pathology Laboratories, CPL, it could have made an offer to Vicky Phelan, on the basis of the acceptance of non-disclosure, and she would not have had to be dragged publicly through the courts for four days, having had to reveal parts of her life that no one should be asked to reveal.

Mr. Ciarán Breen:

I agree. Vicky Phelan should never have been before the courts. That should have been prevented. We, the agency, did everything in our power to prevent that.

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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Did the State Claims Agency discuss with CPL about coming up with an offer? Why was no offer made jointly by the HSE and CPL to Vicky Phelan?

Mr. Ciarán Breen:

I would return to the point, and I must make it to the Senator again, that our expert evidence and Vicky Phelan's expert evidence was that the non-disclosure point, albeit a terrible point and I deplore the fact that she was not told, did not change her clinical outcome. That was agreed by her expert and by our expert. I deplore the fact that she was not told. We, as an agency, do not have any control over that. We have for a very long time told all of our agencies and hospitals that they should practice full open disclosure.

If I could return to the issue of why her case went to trial, the only reason it went to trial was because the solicitors for the US laboratory could not get sufficient instructions at a point in time, and then they did and they made the offer in the case. The Senator might recall that this case, which we supported being settled via mediation, which would have prevented Vicky Phelan from giving any evidence, collapsed because of the confidentiality clause provision which was insisted upon by the US laboratory. We went on record at that time to say that this is wrong, this should not be done, and that there should not be a confidentiality clause. We did everything we possibly could to try to get the case settled, but we had a letter of indemnity, a complete indemnity, for everything from the US laboratory.

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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Not for non-disclosure.

Mr. Ciarán Breen:

I keep coming back to that point. I do not mean to be disrespectful when I make the point but I have to make it to the Senator in terms of the legalities of the case. Vicky's expert and our expert agreed that failure to disclose, albeit one that should never have happened, did not change her clinical outcome.

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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One final point, the State Claims Agency has ten cases before it. The Taoiseach, through the Attorney General, has gone directly to Mr. Breen to ask that they would look at dealing with these cases on a more compassionate basis than what happened with Vicky Phelan. Has the agency taken that on board? Of those ten cases, are any of the women deceased? If Mr. Breen had Vicky Phelan's case to deal with again, would he deal with it differently?

Mr. Ciarán Breen:

In regard to the other cases, I have very carefully noted what the Taoiseach said and, obviously, we would take his remarks very seriously and do everything we possibly can to ensure that other families who are involved in these ten cases do not suffer the same trauma. None of these cases should go to trial. That is the reality. In three of the cases, the US laboratory has indemnified the agency.

On the Senator's last point, I understand that some of the women have died between the original smear and now.

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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Of the ten, how many have died?

Mr. Ciarán Breen:

Three.

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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Three of the ten women are deceased. I thank Mr. Breen.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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I thank Mr. Breen and Ms Foley for coming here today. Does Mr. Breen accept that the State has a liability to women who had smears misread and who were not informed of that as soon as the State discovered, following an audit, that those smears were misread?

Mr. Ciarán Breen:

I unconditionally accept that. In respect of any woman where there was a failure in her smear and a failure to disclose that to her, there has to be an acknowledgement of liability on the part of the State not to disclose that fact to her when they became aware of it at a later time.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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Let us be very clear that in the 200 plus cases so far of women who developed cancer, and who had misread smears and were not informed immediately when that was discovered, the State accepts liability for those cases.

Mr. Ciarán Breen:

There is a breach of duty in not telling any of those women about that smear.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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Given that the numbers involved will rise very significantly - the State Claims Agency has ten cases currently and, tragically, three of those women have died - and there will be many more cases of women who develop cancer where their smears were misread and they were not told as soon as that information had become available to the State, how will that be dealt with to avoid a situation where women, their partners or widowers will be dragged through the courts? What will the agency do to avoid that situation, to deal with this issue humanely and compassionately, and to ensure the cases are dealt with quickly?

Mr. Ciarán Breen:

We will have to look at every case as it presents itself because some cases necessarily will be different from others in terms of how they present themselves and consequences for the individuals involved. There is probably a co-defendant in all of these cases, which will be the laboratory. The one thing that we cannot allow ever to happen in the exercise of our statutory remit is to allow off the hook a party who should be substantially or wholly liable if they should be paying the damages to the injured party. That would be part of our approach to these cases in seeking the involvement of the US laboratory.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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What does the indemnification that is in place between the HSE and the independent laboratories cover?

Mr. Ciarán Breen:

I do not have the actual contract in front of me but there is a contract between the HSE and the laboratory whereby the laboratory carries out the smear examinations. Flowing from that, as in normal contracts, there would be indemnity clauses whereby if they had been negligent, they would agree to indemnify the HSE. These would be fairly standard contractual clauses.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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In the Dáil last week, the Taoiseach said: "We will need a scheme of redress for women whose cancer was missed and should have been detected beyond normal error". That does not necessarily mean that every misread smear will result in a liability.

Mr. Ciarán Breen:

When the Deputy says will not result in a liability-----

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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The Taoiseach accepted the need for a scheme of redress where the cancer was missed and should have been detected beyond normal error.

Mr. Ciarán Breen:

That is a separate issue, the issue of redress. If and when we have to engage with the any State parties regarding redress, we will certainly do that.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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Where there is an indemnification in place, how does it work in practice? If a woman takes a case and a sum is agreed, who makes the payment?

Mr. Ciarán Breen:

In practice what happens is that a letter of claim will come in on behalf of the injured woman and that letter will be sent to cervical screening. Cervical screening immediately issues a letter to the relevant laboratory, whether it is one of other of the laboratories, stating: "This letter has arrived and under the contract that you have with us, you are obliged, in the event that this is a misread smear, to provide an indemnity". In some of the cases, the US laboratory has immediately indemnified the HSE on the basis that it is the laboratory's mistake. If that happens and the laboratory takes over the indemnity, then the matter is live only between the injured woman and the laboratory and the lawyers on both sides. The HSE is not involved. If the laboratory, for whatever reason, does not give an indemnity, we will be a co-defendant in the case and we will be looking at why it is that the relevant indemnity has not been given to the State, or whether it should be given to the State or what other issues there are in the case.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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Mr. Breen appears to be saying that where there is an indemnity and it is accepted that a case falls within the indemnity, the working through of the case is a matter between the woman, her legal representatives and the US laboratory.

Mr. Ciarán Breen:

Right now, that is the way it happens.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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Where a sum is agreed or an award is made, the payout is from the US laboratory or the independent laboratory.

Mr. Ciarán Breen:

That is correct.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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I have a big problem with that approach because these are women who had a smear test done in Ireland under the cervical cancer screening programme.

Their samples were examined and misread, be it in Ireland or abroad, and they are being left to their own devices to take on an independent laboratory.

Mr. Ciarán Breen:

Under our statutory remit, we cannot assume a legal liability for the State where that liability is for another party.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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Is that not the whole purpose of indemnification? If the State is indemnified by the independent laboratory, it can make the payout efficiently.

Mr. Ciarán Breen:

No, it is the other way around. The lab took over the conduct of the case because it is the lab's case and the lab's misreading. The laboratory will then deal with all aspects of the compensation as well.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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As such, the HSE being indemnified means it is washing its hands of the entire issue. That is the effect. The State is passing the matter on.

Mr. Ciarán Breen:

I will ask the Deputy to imagine something. For a moment I will put myself - I do not mean me personally - in the shoes of the US insurer. For various reasons, the insurer tell the State Claims Agency that it is not happy for us to deal with this case and settle. It tells us that this is its case, that it should have conduct of the case and that it should pay the compensation.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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Indemnification is of no comfort to the women or their surviving partners or widowers. It is of comfort to the State because the State is protected, but the people who are directly affected are left to their own devices and must take on an international third-party independent laboratory in a legal challenge.

Mr. Ciarán Breen:

Yes. Presumably, they would be successful and recover all of the costs. I agree with the Deputy that, in the context of the tragedy of these matters, it looks unsatisfactory. As a matter of us acting within our statutory remit, though, there is nothing we can do except maintain the State's position that it should not pay out when another party should, particularly in light of the large sums of money involved.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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What Mr. Breen is saying is that, apart from the Vicky Phelan case, there are nine other similar cases confirmed and one additional case. In three of those, indemnification has been agreed.

Mr. Ciarán Breen:

Yes.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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It is a matter for the woman or her representative to battle it out with an independent laboratory in an adversarial legal arena. That is the State's message to these women.

Mr. Ciarán Breen:

That is the case, but can the Deputy understand that, from our point of view, we must always act within our statutory remit? We cannot stray beyond it. If I did and, as director of the agency, I paid out but the lab did not pay out, I would face criticisms for the State paying out when another party that was liable ought to have paid out. That is the dilemma for us.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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Will Mr. Breen confirm whether, as of this point, a plan is in place to provide redress and compensation for the more than 200 women who were diagnosed with cancer and had their smear tests misread? In 17 cases, women have died tragically, leaving behind partners, husbands and children. Is there a plan in place now to deal with that situation?

Mr. Ciarán Breen:

I would not be aware of that plan. The State Claims Agency is separate from any redress. Normally, redress is something that the Government of the day agrees to put in place and it is managed by whoever might be in charge of that redress. I am sure that something of that nature is being considered. Clearly, we would assist any redress scheme in whatever way we could.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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I will ask my final question, which is on the insertion of non-disclosure or confidentiality clauses. This is separate to the non-disclosure agreements with women whose smear tests returned false negatives. Where a sum is agreed and the State Claims Agency is the representative of the State, will Mr. Breen give us a sense of or data on how common it is for the State to insist on confidentiality clauses governing settlements and payouts, particularly in cases of medical negligence and other clinical cases?

Mr. Ciarán Breen:

They rarely arise because they run counter to all open disclosure provisions that we espouse and advocate, but there are occasions when do they arise. I will take the committee through them.

First is mediation, a process to which both parties must agree. Independent of the State Claims Agency and the plaintiff, an intrinsic part of the process is that all that happens at the mediation is confidential so that when the parties of the mediation fail and they must go to court, they will not use anything that happened at the mediation. It is not imposed by us. Rather, it is imposed on us and the other party by the mediator. However, if a settlement is reached at mediation in cases that we are involved in, we never insist on confidentiality regarding the settlement amount or anything like that.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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Never?

Mr. Ciarán Breen:

Never. Where that information has been disclosed, we have never taken any action within the confidentiality provisions. Confidentiality might arise in other circumstances. In some instances where we had a line of similar cases in a class action-type scenario, we were admitting or settling a particular case amidst that group for reasons other than the substantial reasons that gave rise to the cases and we wanted to delineate that case, we might sometimes have requested a confidentiality clause about the settlement. In the overall scheme of the approximately 8,500 cases that we have settled since inception, though, it has rarely occurred, but it has occurred. Sometimes, plaintiffs ask us for a confidentiality clause. Where they do, we always offer it.

Photo of Paul MurphyPaul Murphy (Dublin South West, Solidarity)
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I will start where Mr. Breen left off with confidentiality agreements. There are many shameful aspects to this case but one of the most shameful is the fact that Vicky Phelan was asked to gag herself. We must be thankful for her courage in refusing and continuing to fight in difficult circumstances. It is why we now know about this national scandal. Mr. Breen outlined that the State Claims Agency opposed the use of a confidentiality clause in Ms Phelan's case and that no such request had been made by the agency. Can Mr. Breen explain what the agency did to oppose the request for a confidentiality clause by the US lab?

Mr. Ciarán Breen:

I can because of the fact that mediation did not take place. As the mediation was being set up, the mediator spoke to the parties independently. He indicated that the US laboratory was seeking such a confidentiality clause. In such situations, mediators ask the other defendant for its view on such a proposal. When we replied, we were in no doubt that we did not believe such a clause was right or proper. We indicated separately to our co-defendant that we did not believe that asking Vicky Phelan to abide by such a clause was the right thing to do. I want to be clear about that - we opposed it all the way.

Photo of Paul MurphyPaul Murphy (Dublin South West, Solidarity)
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The agency has written correspondence with its co-defendant outlining its opposition.

Mr. Ciarán Breen:

No. As the Deputy can imagine, these are negotiations that take place. It would be during ordinary meetings between the legal teams that we would say this, that is, within the privileged environment of such negotiations. I want to be clear, though, in that we were adamant that such a clause would not have been correct.

Photo of Paul MurphyPaul Murphy (Dublin South West, Solidarity)
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Is there any documentation of the State Claims Agency's position of opposing a confidentiality agreement?

Mr. Ciarán Breen:

We did not seek anyone to make a statement or to give us a written statement outlining that we had raised these objections. It would have been unusual to do so. When such negotiations take place between parties, they do so in a privileged atmosphere, and people believe what the other party says and note it. That is a matter on the record.

Photo of Paul MurphyPaul Murphy (Dublin South West, Solidarity)
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Is Mr. Breen saying there is no documentation and that the discussions were oral?

Mr. Ciarán Breen:

They were all oral discussions, but they were very clear.

Photo of Paul MurphyPaul Murphy (Dublin South West, Solidarity)
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What was the response to Mr. Breen's requests?

Mr. Ciarán Breen:

What happened then, as I understand it, is that Vicky Phelan quite rightly said she was not going to accept that she would be bound by such a clause. Therefore, the mediation never get off the ground. That is why, when speaking to Senator Kieran O'Donnell, I said it was very tragic that it ended up proceeding to a court hearing over those couple of days. The opportunity had been lost.

Photo of Paul MurphyPaul Murphy (Dublin South West, Solidarity)
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In discussions with the agency, did those concerned try to justify why they were looking for a confidentiality agreement and did not agree with Mr. Breen's argument that there should not be such an agreement?

Mr. Ciarán Breen:

No. We were so unequivocal about our position that we just stated it as it was. They would have had their own reasons for this, of which we are not aware even now. We did not even venture into that space with them.

Photo of Paul MurphyPaul Murphy (Dublin South West, Solidarity)
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To return to the question Deputy Michael McGrath was exploring, I understand the position on the cases in which a complainant may request a confidentiality agreement. It makes sense. Could Mr. Breen explain the circumstances in which the State Claims Agency would seek an agreement? In the past ten or 20 years, for example, how many times has the State Claims Agency sought confidentiality agreements? I refer to the total amounts paid and the circumstances of the cases.

Mr. Ciarán Breen:

The clinical indemnity scheme was established in 2002 and our agency was established in 2001. As has been the case with many defendants over the years, up to when we started to espouse open disclosure as the proper thing to do, there were probably occasions where confidentiality clauses were put into settlements. Without going back over individual cases, I am guessing that, of the 8,500 clinical cases we have resolved, no more than a dozen and a half or perhaps two dozen were in that category over all those years.

Photo of Paul MurphyPaul Murphy (Dublin South West, Solidarity)
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How many years?

Mr. Ciarán Breen:

Since 2002. The circumstances might been such that the plaintiff sought the clause. They would not have been cases where we unilaterally sought the clauses. Normally, when we seek such a clause, it is to protect something that we are not admitting in similar cases. We would not want the view to be going out that we had admitted liability in other similar cases that might be coming along, if we had a strong view on liability.

Photo of Paul MurphyPaul Murphy (Dublin South West, Solidarity)
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I find that hard to understand. The State Claims Agency's role is to represent the interests of the State in these cases. However, the State is not just concerned with pounds, shillings and pence; it should also be concerned with what kind of society we have. It is obvious in this case, and the State Claims Agency agrees, that if there had been a confidentiality agreement, it would have been to the detriment of the State, or society as a whole or the public. In similar cases, it is in the interest of the public and State to know where something has gone wrong, or is at least perceived to have gone wrong, and the State Claims Agency either admits liability or offers some sort of redress or payment.

Mr. Ciarán Breen:

As Deputy Paul Murphy knows, we sometimes make a payment without admission of liability.

Photo of Paul MurphyPaul Murphy (Dublin South West, Solidarity)
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Yes.

Mr. Ciarán Breen:

I must emphasise that the number of cases in which we had confidentiality clauses, particularly in recent times since open disclosure and since we initiated the open disclosure project, has been virtually nil.

Photo of Paul MurphyPaul Murphy (Dublin South West, Solidarity)
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I want to deal with the issue of mandatory open disclosure. The State Claims Agency made submissions to the Joint Committee on Health whenever it was considering this issue. Mr. Breen argued that a discretionary approach was the optimal approach in striking a balance between protecting patients and protecting medical practitioners. He argued against mandatory open disclosure. Why did he do that? We could be in different circumstances here if mandatory disclosure had been in place.

Mr. Ciarán Breen:

Yes. I appeared before the joint committee at the time. My recollection is that I said I was not indifferent about whether there should be voluntary disclosure or mandatory disclosure. I said that if I were asked to choose, I would definitely prefer voluntary disclosure. My worry was - my advices were entirely guided by this - that I did not want it to become a box-ticking exercise by people making disclosures. I believed that a voluntary system would have much greater buy-in and that people would proceed in an atmosphere in which they did not simply feel compelled to disclose. My thinking was that it would result in a better system.

Photo of Paul MurphyPaul Murphy (Dublin South West, Solidarity)
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Is it really too much to ask that medical professionals should be legally required to come clean with people where mistakes have been made?

Mr. Ciarán Breen:

Absolutely not. I have been so clear about this all through the years. I will make my point again to this committee: where a practitioner, of whatever sort, in our hospitals is involved in a medical negligence event, there should be full disclosure. There is no reason there should not be.

Photo of Paul MurphyPaul Murphy (Dublin South West, Solidarity)
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Yes, but that has not worked. It did not happen in this case. For example, we do not know whether, if open disclosure had been mandatory, it would have happened.

Mr. Ciarán Breen:

Yes.

Photo of Paul MurphyPaul Murphy (Dublin South West, Solidarity)
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It might not have but there would have been a more easy route to remedy from Vicky Phelan's point of view.

Mr. Ciarán Breen:

Yes.

Photo of Paul MurphyPaul Murphy (Dublin South West, Solidarity)
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In such circumstances, has Mr. Breen changed his opinion on the issue of mandatory disclosure? Has the State Claims Agency changed its position on it?

Mr. Ciarán Breen:

Going back to what was said to the committee, to us the important point is that there should be disclosure. I outlined the only reason I advocated a voluntary arrangement. Yes, we support mandatory disclosure as well.

Photo of Paul MurphyPaul Murphy (Dublin South West, Solidarity)
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I thank Mr. Breen.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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I welcome the witnesses. Whose responsibility was it to have informed Vicky Phelan?

Mr. Ciarán Breen:

That became a very interesting point. We questioned towards the very end of the case whether it was the responsibility of HSE cervical screening or Ms Phelan's treating oncologist at the time? We found out, during the trial, that there was at least some discussion about that over a long period between HSE cervical screening and the particular doctor involved. Ultimately, in July 2016, I believe, the oncologist or treating clinician told Ms Phelan.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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So the responsibility lies with the HSE.?

Mr. Ciarán Breen:

The Senator is asking me where it lies. I would have believed that Ms Phelan and all the other women should have been told immediately when the results of the audit came back. Therefore, given that CervicalCheck knew about it at the time, it was either a matter for it to do it immediately or, by agreement between it and a treating physician, a matter for the treating physician. It certainly should have occurred at that time.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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In all the other cases the State Claims Agency is dealing with, the HSE should have come back.

Mr. Ciarán Breen:

That should have happened, yes.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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To return to Deputy Michael McGrath's point, there is surely responsibility on the HSE to have put its hands up early on.

Mr. Ciarán Breen:

Absolutely, I agree that any woman who received an audit result to indicate there were doubts about the first smear should have been told, and should have been told immediately.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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How does mediation work? When does the HSE notify the State Claims Agency that there is a case or that it might have a case in respect of which the agency might help with mediation? Does the client have to initiate legal proceedings against the HSE before the State Claims Agency is notified? How does the whole thing operate?

Mr. Ciarán Breen:

Let me outline what normally happens in a medical negligence case.

If a woman has been injured as a result of a medical negligence event, the first thing that normally happens is she will seek her records from the hospital, probably under freedom of information. If, having done that, she feels strongly there may have been a problem, she takes the records to her lawyer, who will send them to medical experts to ask them their advice and to provide expert guidance on whether they feel something went wrong. After that, the lawyers send out a letter of claim and a summons. It is at that point we enter the process to examine the claim. We receive the claim and we begin to examine it.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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Did Vicky Phelan issue proceedings against the HSE and the laboratory at the same time?

Mr. Ciarán Breen:

Yes.

Mr. Ciarán Breen:

She did.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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Did she contact the HSE prior to that looking for her medical records? When did the HSE find out about the case? Was it at the exact same time as the medical laboratory?

Mr. Ciarán Breen:

The HSE cervical screening programme knew the results of the audit of Vicky Phelan's case in 2014 and it was not disclosed, we now know, to Vicky Phelan until July 2016.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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When did the alarm bells start ringing with the State Claims Agency?

Mr. Ciarán Breen:

We got the letter of claim and the personal injuries summons on 12 February this year, and we began to deal with the claim and pick up on the issues. Then, as I said earlier, we got a letter of indemnity immediately from the US laboratory.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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Mr. Breen has put a lot of emphasis on mediation. Did the State Claims Agency go down the route of mediation in the Vicky Phelan case?

Mr. Ciarán Breen:

Yes. Normally what happens is either the plaintiff or we - or, in this case, the US laboratory - suggests the better way of handling it would be by mediation. This is what we think also. We think most medical negligence cases should be resolved through a mediation process. Any of the parties could ask for this.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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When the State Claims Agency was going through the mediation was it also in consultation with the HSE? Was it in consultation with the HSE regarding the fact there was mediation? Was it tick-tacking with the Department or the HSE?

Mr. Ciarán Breen:

Not with the Department. We were in contact with the HSE. This was its case. We seek documentation from the HSE on a reasonably regular basis for examination so we can better understand what is happening on a claim.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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How far back does that go in Vicky Phelan's case? Does it go back to 2014?

Mr. Ciarán Breen:

No, it goes back to 12 February 2018 when the claim was made and the personal injuries summons was received by us.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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So the State Claims Agency did not know anything about it until February 2018.

Mr. Ciarán Breen:

Yes, that is when it came to our notice.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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Was it the case that people were in contact with the HSE before this?

Mr. Ciarán Breen:

We know for a fact that it knew when it got the results of the audit in 2014 that there was a problem with the original smear so it knew from that point. The issue then was that Vicky Phelan did not hear about it until 2017.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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Is the way the State Claims Agency handled this case the same way it handles all cases with the HSE? Must proceedings be issued against the HSE before the State Claims Agency knows about it?

Mr. Ciarán Breen:

No, a letter of claim could be made. Once a letter of claim is made it is normally sent to us. Sometimes it is sent directly to us, and this is when we become involved as the State Claims Agency.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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Is this the same where a person who is an employee has a grievance, perhaps someone who was dismissed from work? Is this also the case? Judge Peter Kelly said today one has to be either very rich or very poor to have redress in the courts. Must people take a case before the State Claims Agency knows anything about it? Mr. Breen has put a lot of emphasis on mediation.

Mr. Ciarán Breen:

I recall one case in particular where a woman had a diagnosis of cancer and where her lawyers informed us and would not have been able to get the proceedings out in time because she had an extremely bad diagnosis. This is going back a number of years. We immediately offered mediation because the pleadings would have gone on too long. We offered mediation in that case and settled it at the earliest possible time so as to avoid legal proceedings.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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What Mr. Breen is saying is that people can go straight to the State Claims Agency rather than going to the HSE to settle a case. Is this what he is saying? Is he saying that a person with a grievance with the HSE can go straight to the State Claims Agency rather than going through the HSE?

Mr. Ciarán Breen:

In many cases a letter might come to us in the first instance stating the lawyer sending it notes we act on behalf of whatever hospital is involved and that his or her client maintains a claim against us arising out of the circumstances presented in the letter. If we can, if it is possible, if we know the position on liability and if we have the expert evidence, our preference is to go to mediation before legal proceedings are issued.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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Many questions have been asked. We have discussed Vicky Phelan's case at length, and Mr. Breen has told us there are nine more cases in the system and he is expecting one more to arrive into the system.

Mr. Ciarán Breen:

Yes.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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The State Claims Agency has an indemnity for three of these and in the case of six others it has sought indemnity but has not yet received it. What is the position with these nine cases? Where are they in the system at this stage?

Mr. Ciarán Breen:

The three that have been indemnified are now, obviously, with the indemnifier, whether it is a US insurance company or whoever it might be. They are between the woman and the laboratory's insurers.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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What is the timeline for this?

Mr. Ciarán Breen:

We do not know.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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Effectively the State Claims Agency is out of the loop.

Mr. Ciarán Breen:

We are out, yes. We have no visibility of where those claims are and how they are being conducted because they are being conducted by another party.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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Does the State Claims Agency ever hear a settlement figure or anything at all afterwards? Is it just that the State Claims Agency has an indemnity and the State stands back and says it is nothing to with it any more and, in this case, the buck is passed to the laboratory, its insurance company and solicitors? Does the State Claims Agency every hear back as to what happens?

Mr. Ciarán Breen:

Very rarely would we ever hear back. We might just hear it anecdotally from the Law Library that a case settled for an amount.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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What is the indemnity actually for? Is it that the laboratory's insurance company states it will take all of the hit and will absolve-----

Mr. Ciarán Breen:

Yes.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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-----others of any claim?

Mr. Ciarán Breen:

Yes.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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That is all it does.

Mr. Ciarán Breen:

Yes.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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With regard to non-disclosure, how does that work?

Mr. Ciarán Breen:

In this case we have a US insurer and the woman who is the injured party and there is a discussion between her lawyers and the lawyers of the insurance company. We are out. We are gone and we have no visibility.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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In the Vicky Phelan case was indemnity obtained?

Mr. Ciarán Breen:

Yes, we got an indemnity in that case.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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The reason she went to court was because she refused to deal with the laboratory in terms of the confidentiality clause.

Mr. Ciarán Breen:

Yes. It is important to clarify for the committee that none of our other cases where an indemnity has been granted by the laboratory is there an allegation of a failure to disclose.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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That was a question I did have. Is the indemnity for the false negative or does it also include the HSE not informing people of the false negative?

Mr. Ciarán Breen:

It is about the smear test, but there are no allegations over and above that in relation to non-disclosure in those cases.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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The people taking the cases are just taking the cases for the false negative and they are not taking any case on the fact they were never told.

Mr. Ciarán Breen:

Exactly. That is not in the particular case.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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But could they?

Mr. Ciarán Breen:

If we take the one among that group which is a potential claim because we know it to be an incident we believe is likely to give rise to a claim, we do not know a lot about it at this stage but there is a possibility that such an allegation could be made.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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If the Health Service Executive, HSE, was aware, therefore, a person who was not told by it could be in a position to make a claim against the State for non-disclosure. Is Mr. Breen aware whether the HSE knew Clinical Pathology Laboratories, CPL, or whatever laboratories were involved knew at some point that the results were false negatives? When did they tell the HSE, or did they ever tell the HSE? Apparently, Vicky Phelan discovered it because she read her chart. If it was on her chart, the HSE must have known about it.

Mr. Ciarán Breen:

Because an audit was carried out of the second smear in regard to the first smear, it would be known that there had been a problem with the first smear.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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So the HSE knew but failed to tell patients.

Mr. Ciarán Breen:

We do not know the extent of that. That is the problem. We simply do not know.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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As manager of the State Claims Agency, is Mr. Breen aware whether the indemnity does or does not cover the non-disclosure? Clearly, anyone who got a false result and then became aware that they were not told about it would be entitled to make a claim against the State for not being told about it when the HSE was aware of it.

Mr. Ciarán Breen:

If there was an allegation that that failure to disclose changed the clinical outcome for the particular party, it is clear there would be a liability on the part of the State regarding the clinical outcome as well as on the laboratory. However, one would have to look at the individual case to establish whether, even if there was non-disclosure, which is clearly a breach of duty, that had an effect on the clinical outcome. That can only be got by looking at the evidence in the particular cases.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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In the case of Vicky Phelan, Mr. Breen mentioned earlier that the argument is that the clinical outcome was not affected by not knowing about it but what is the position regarding the other nine cases?

Mr. Ciarán Breen:

I might ask my colleague, Jenny Foley, to respond. As far as I know, we are not aware of any allegations.

Ms Jenny Foley:

In terms of the allegations in those cases, it is not pleaded by the patients' solicitors that the failure to disclose affected the clinical outcome.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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Other than not knowing about it, the mental anxiety and so on.

Mr. Ciarán Breen:

Yes.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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These women thought they were in the clear when they were not in the clear. In terms of the clinical outcome in terms of the path of the disease and so on-----

Mr. Ciarán Breen:

Exactly.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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-----they are not claiming that. However, if a woman gets a result back from the HSE CervicalCheck stating that she is fine and she is not fine, I believe most people would feel that they were hard done by in terms of being told something that was not the case. Even if the clinical outcome in the end was not different, perhaps it could have managed everything differently.

Mr. Ciarán Breen:

It is that distinction between that non-disclosure being related to the clinical outcome or not. It is up to the experts to tell us whether that material non-disclosure affected the clinical outcome and if it did not, it is a breach of duty but all of the liability would fall on the laboratory.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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Even when the HSE became aware of the results of these tests, put them on their files and in at least some cases in the patient records, the State Claims Agency, on behalf of the HSE and the State, is saying the State can walk away and that it has no liability to these people for failing to tell them the false results of a test when they became aware of those false results. I appreciate the agency has a task to do-----

Mr. Ciarán Breen:

Yes, and we can only ever pay out where there is an acknowledgement that the breach of duty on the part of the State led to the particular clinical outcome and the compensation for that. I am sorry for emphasising this so often but, as a matter of law, that is the way it works. We cannot stray outside the law in regard to our response.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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We have at least teased out that point.

I have a couple of brief questions. Mr. Breen said 98% of the agency's cases do not go to court but clearly some of those are dismissed or rejected at an early point in time. Of the total number, do we have a breakdown of how many go to mediation?

Mr. Ciarán Breen:

We do not record mediations but we will be doing that for the future. However, in 2017, we handled 663 cases, 329 or 49.62% of which were settled by us; 25% were discontinued-----

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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Is that the same as withdrawn?

Mr. Ciarán Breen:

Yes. The figure for cases intimated but not pursued is a little over 15%. Where we got an indemnity from another party the figure is 5%. The figure for some outside our remit is 3%. In 0.75% of cases a lodgement or a tender into court was accepted, and in a tiny number that were settled it was a section 17 offer.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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Is 2017 a typical year?

Mr. Ciarán Breen:

It is.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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There are similar statistics for every year.

Mr. Ciarán Breen:

There is nothing remarkable about it. It would follow a similar pattern. Some years we might be lucky in that we might get a higher percentage of an indemnity from another party.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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I am sorry, Chairman, but I have been asked to ask one question. I was on a health forum as a local authority member before I became a Member and I recall hearing all about Pandemrix and narcolepsy. I am told that approximately 80 or 90 cases are still in the system. They have been dragged through the system for a long time. What is the position with those cases?

Mr. Ciarán Breen:

The position is that a wide-ranging discovery was made against the HSE and the Department of Health. The HSE has made its discovery and the Department of Health, assisted by approximately 13 documentary counsel, is working to make its discovery. That discovery is being case managed by a judge of the High Court.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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When will that be resolved to the satisfaction or otherwise of people who are in the system?

Mr. Ciarán Breen:

Does the Senator mean ultimately for the affected parties?

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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This has been going on for a number of years and the people involved believe they have a grievance. I am sure they do. When will they get some justice?

Mr. Ciarán Breen:

The first case probably will not come up until late this year or early next year.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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Was this discovered in 2010?

Mr. Ciarán Breen:

Around then, yes.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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Nine years later there is still no resolution.

Mr. Ciarán Breen:

I can tell the Senator that these are very complex cases. I was at a conference a while ago at which all the world's experts were together, and they are struggling to understand that issue.

Photo of Gerry HorkanGerry Horkan (Fianna Fail)
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I thank Mr. Breen, and the Chairman.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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I thank Mr. Breen for his presentation. I want to return to the Vicky Phelan case and the State Claims Agency's relationship with the HSE. The HSE was the agency's client in that case and in other medical negligence cases.

Mr. Ciarán Breen:

Yes.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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It will contact the agency and have discussions with it on the best approach to this case. Who gives the agency that client briefing from the HSE?

Mr. Ciarán Breen:

To assist the Senator in understanding this relationship, we have what is called a delegated authority. That delegated authority means that Ministers and others delegate the management of their cases and the litigation in those cases to the State Claims Agency. For example, all the decisions on liability and whether we should go to mediation or to court are absolutely for us to decide.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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That is amazing.

Mr. Ciarán Breen:

To qualify that further for the Senator, notwithstanding that that is the process of delegation, there is a very close relationship between us and all of our clients such as the HSE.

In any individual case we deal with a number of HSE personnel. We get medical records, discuss cases, meet doctors and take statements from the doctors involved in the cases, etc. There is quite a bit of interaction between the State Claims Agency and the HSE. That is true of all 146 State authorities.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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Is it the case that there is no level within the HSE that acts as the State Claims Agency's point of contact in terms of medical negligence claims?

Mr. Ciarán Breen:

There are other processes which lie above that. For example, we have quarterly meetings with the HSE executive, where senior parties from the State Claims Agency and the HSE get together to discuss a whole range of issues, from trends, what we are seeing in terms of claims and claims that we are worried about. The HSE is furnished with quarterly reports which indicate any trends in claims and outline any adverse event notifications. There is quite a bit of activity.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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I am trying to quantify that. Does the director general of the HSE attend those quarterly meetings?

Mr. Ciarán Breen:

No, he does not, but the team immediately under him attend.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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Has the witness met with the director general? Do they meet regularly?

Mr. Ciarán Breen:

I do not meet the director general as a matter of course. I meet with the team of senior national directors from every area of the HSE, including mental health, acute hospitals and right across the board.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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Is it the case that the State Claims Agency has never met with the director general of the HSE?

Mr. Ciarán Breen:

I have met with Mr. O'Brien, but as a matter of course I do not have regular meetings with him. I have regular meetings with his very senior officials, those who brief him.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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Who gave the witness the client briefing for the Vicky Phelan case?

Mr. Ciarán Breen:

That came from HSE cervical screening. We relied on it to give us the relevant papers and to discuss what happened in that particular case.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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Did the witness meet with the clinical director of the HSE to discuss that case?

Mr. Ciarán Breen:

Various parties were involved, including the programme manager. There were some discussions with the clinical director and others.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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Does the witness believe it would be advisable for the State Claims Agency to have one point of contact within the HSE for medical negligence claims, given the amount of contact the agency has with it?

Mr. Ciarán Breen:

That would be very difficult. We are dealing with a great number of hospitals, including voluntary and HSE hospitals. The hospitals have appointed people who liaise with us on behalf of particular hospitals.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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I am thinking of the aggregate of it, and how the State Claims Agency does its planning and actuarial work, in terms of its reporting duties and analysing trends. Is there a key figure within the HSE with whom the State Claims Agency works on those tasks?

Mr. Ciarán Breen:

We have an independent firm of actuaries who calculate the liabilities of the clinical indemnity scheme, for example. That involves the HSE and the voluntary hospital group. All of that information is passed to a particular persons in the HSE who deals with the whole area of budgets and allocation of financial resources for claims.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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Who is that person?

Mr. Ciarán Breen:

It is Mr. Stephen Mulvany

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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Does the witness pass that information to the Attorney General in order to flag up issues?

Mr. Ciarán Breen:

The Office of the Attorney General is separate and does not get involved in clinical negligence or personal injury work. We have a reporting relationship with the Attorney General and we have meetings with his office to alert it to matters we might feel are sensitive, or where we might want to discuss a particular legal strategy in cases where we believe such a strategy is necessary.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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Was the Attorney General alerted in the case of Vicky Phelan? Did the witness believe that was a significant case? Did the State Claims Agency look at this as an isolated incident, or did it consider the precedent that might be set?

Mr. Ciarán Breen:

We had no idea about the added complexities when we received the original case. We got the case in February and it was settled in April. Many things unfolded as the case went on. The facts were bad at the beginning of the case, and of grave consequence for Ms Phelan, but it was not until later that we understood the significance of that case in terms of its sensitivity for other women in particular. I want the committee to understand that while the State Claims Agency was conducting Ms Phelan's case, its understanding was that all the women affected by the audit had been told. We had no other impression but that they had been told.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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The witness was not dealing with cases similar to that of Ms Phelan.

Mr. Ciarán Breen:

Not at that time. There were other cases, as we now know. There were 11 cases; ten plus one potential case. However, Ms Phelan's case was very advanced and was very much based on its particular facts, including the issue of non-disclosure which was set out in her pleadings. We did not know until a very late point in that case that there were women who were similarly affected. In fact, we found that out through the media.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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Did the witness say that the first briefing was done on 12 February 2018?

Mr. Ciarán Breen:

Yes.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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Did the witness ask whether there were other similar cases at that point? Did he check the reporting between the HSE and the State Claims Agency? There seems to have been a huge amount of under-reporting in that respect.

Mr. Ciarán Breen:

No. I can explain why questions were not asked at that point. This case was presented on it own facts. The US laboratory had written to us and given us an indemnity. The only issue, therefore, was the resolution of that case. We did not understand the wider implications; we only learned of those later.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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Part of the witness's duty is to put interventions in place when something is spotted. In all the examination of this case the witness did not cite any issues. Did Mr. Breen, at any point, have contact with the Government about this case or any other medical negligence cases?

Mr. Ciarán Breen:

No. We issue a list of sensitive cases to Government, which I believe is in the public domain, via the Minister for Finance. It is presented along with the sensitive case list of the Attorney General. It was agreed in 2007 that that list would not include medical negligence cases because almost all medical negligence cases are sensitive, involving particular trauma. We had to consider how many such cases should appear on such a sensitive list. Sometimes we do not know when a case involves the kind of sensitivity that Ms Phelan's case had. It is not always immediately apparent to us.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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Does the witness believe that the agreement that exists to keep those sensitive cases closed needs to be revised?

Mr. Ciarán Breen:

That is entirely a matter for Government. If the Government asked us for a list of sensitive cases we would provide whatever it requires.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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I will pick up on a couple of the points raised by my colleague, Senator Conway-Walsh. In response to one of her questions, the witness said that his understanding was that all women were notified of the non-disclosure. This was during a period when the HSE was being taken to court by Ms Phelan because of non-disclosure.

How is Mr. Breen satisfied to make that statement? How was he satisfied that all women were notified?

Mr. Ciarán Breen:

During the conduct of the particular case, given that we became aware - and it was only at a late stage in the case - there were issues about not having disclosed the result of that audit, our understanding, based on discussion with HSE CervicalCheck, was that all of the women had been informed. We did not-----

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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All the 208 women who had been identified.

Mr. Ciarán Breen:

Whatever number. We did not even know the number at the time.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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What position was the person in CervicalCheck who gave Mr. Breen that assurance at that time in?

Mr. Ciarán Breen:

I was not doing the liaising myself so I do not know that. This was based on our contacts with regard to insuring the case where we were getting documentation, etc.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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What we know now is that that information was false.

Mr. Ciarán Breen:

Yes.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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It was way off the mark. I am deeply alarmed that we have the State Claims Agency pursuing a victim, somebody who was let down badly by the State with regard to non-disclosure and CervicalCheck, and some senior person in there was telling Mr. Breen that all the women identified in the audit had actually been informed and that there were no other Vicky Phelans out there in terms of non-disclosure.

Mr. Ciarán Breen:

The Deputy said we pursued Vicky Phelan. We never pursued Vicky Phelan. We were a co-defendant and we were getting our co-defendant to pay in that case and to do the right thing.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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We will come back to that. On the issue of the assurances the State Claims Agency was given, can Mr. Breen provide the committee with the position of the person within CervicalCheck who assured the State Claims Agency that all other women had been notified?

Mr. Ciarán Breen:

I do not have that information right now so I will have to talk to the persons who were actually dealing with-----

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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What is Mr. Breen's view on the fact the State Claims Agency was given inaccurate information during a legal case - information which was clearly inaccurate - that these women were notified?

Mr. Ciarán Breen:

As I said, I will have to find out exactly how we were of the view that all the other women had been informed. Then we heard it in the media.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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Mr. Breen mentioned to Senator Conway-Walsh with regard to the quarterly meetings the State Claims Agency has with the HSE executive and the management team, at which they go through the list of cases the State Claims Agency is handling, that he is satisfied the director general is briefed by these individuals. Can he stand over that claim?

Mr. Ciarán Breen:

Obviously I do not know what they do but the briefings we have with the HSE are at the very highest level just below the director general. Those briefings are very thorough. They are very useful from their point of view and our view point. We also supply them with quarterly reports with regard to claims and incident notifications.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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Do those briefings identify the individuals who are taking claims?

Mr. Ciarán Breen:

No, we do not do that.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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They deal with the substance of the claim or the generality.

Mr. Ciarán Breen:

The generality.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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I will come back to the numbers. In Mr. Breen's opening statement, he talked about nine other similar cases. Tony O'Brien appeared before a committee of this House last Wednesday and he talked about a list he had received from the State Claims Agency and stated there were ten cases on that list. He said:

There are ten on this list that I can see in front of me, but I cannot share it with the committee because it is a State Claims Agency list. Ten cases are listed as active which means, in essence, that they are either in legal proceedings or they are in pre-legal proceedings and there is a further one which is described as "potential".

Were there ten cases last Wednesday and it is down to nine now?

Mr. Ciarán Breen:

I will be very precise about that. If we exclude the potential case, which was the 11th case, the ten included the Vicky Phelan concluded case.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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So when he described this as active and said they are listed as active, one of them was not active.

Mr. Ciarán Breen:

Yes, it had been concluded, in other words.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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There was also discussion about a prior case that did not involve the State Claim's Agency that was settled with a lab in America. Was the State Claims Agency aware of this settlement?

Mr. Ciarán Breen:

No, it was taken over instantaneously by the laboratory. Even though the HSE was named as a co-defendant along with others, the laboratory and its insurance company took over the conduct of the case immediately so the HSE did not have to even enter an appearance to the proceedings. The lab just took it over straight away.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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Was it notified of it?

Mr. Ciarán Breen:

Yes.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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The HSE was aware of the original-----

Mr. Ciarán Breen:

Sorry, I beg the Deputy's pardon. I thought he meant was the lab notified of it. I do not know whether the HSE was aware of that particular case or not.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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But it was a co-defendant originally.

Mr. Ciarán Breen:

In the pleadings that would appear in the central office-----

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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Yes.

Mr. Ciarán Breen:

-----where one has to do it, it will name the defendants, but the defendant laboratory immediately went in, took out all the other defendants and-----

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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Would it not have to serve papers? Would it not have to notify the parties that it is taking a case against them? Would it not have to notify the HSE and the lab that it is taking a case against them and then, as Mr. Breen said, the lab would say it would take it over completely? Would there not have to have been initial notification?

Mr. Ciarán Breen:

Sometimes the solicitor for the party will serve the proceedings on all the parties but in this particular case it obviously issued and then it was taken over quickly by the laboratory. We do not know what happened after that except it indemnified all the parties.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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So it indemnified the HSE.

Mr. Ciarán Breen:

It indemnified every other co-defendant in the case.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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There must have been communication between the HSE and the lab on that case, if that is the case.

Mr. Ciarán Breen:

Not necessarily. Ms Foley has just indicated to me it was never notified to us in the State Claims Agency so we do not know anything about what happened other than that we know that the laboratory concerned took over the conduct of the proceedings.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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Mr. Breen has just stated that the lab indemnified the HSE.

Mr. Ciarán Breen:

Yes. It would have had to have done that.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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How did it do that without notifying the HSE?

Mr. Ciarán Breen:

What it could do is it could enter an appearance on behalf of all the parties, which means it is taking over the case.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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I am obviously not a legal expert but it seems bizarre that a party would indemnify somebody else without telling that party.

Mr. Ciarán Breen:

It is unusual but that is what happened here.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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Mr. Breen is sure there was no contact between-----

Mr. Ciarán Breen:

There was no notification to us and if-----

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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When did the State Claims Agency find out about this case?

Mr. Ciarán Breen:

We only found out about it when we did a courts search ourselves on the laboratory, under the laboratory name, and we found the particular case.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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When was that?

Mr. Ciarán Breen:

When did we do the search? It was some time after the Vicky Phelan case.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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On the nine cases before the State Claims Agency and the one potential case, Mr. Breen mentioned that none of those cases is making the same arguments as the Vicky Phelan case which was the failure to disclose led to an adverse clinical outcome. It is still pursuing the HSE. Is that not the case?

Ms Jenny Foley:

No, three indemnities have been provided in those nine cases and we have requested indemnities in the other six.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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Is the HSE still named as a defendant?

Ms Jenny Foley:

It is still named but the indemnity lets us out of it.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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It lets the State Claims Agency out of it but the lab is going to foot the bill on this but it is still pursuing the HSE. On that issue, when the State Claims Agency says it will not mount a full defence, is it the case that it will defend the cases?

Mr. Ciarán Breen:

Our-----

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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What kind of defence will it mount?

Mr. Ciarán Breen:

We have to look at every case because the particulars of negligence will differ from case-to-case. Our statement said, and we want to be very clear about it, that if the State has any liability in these cases we will clearly be dealing with them in a particular way, which is to ensure that injured parties do not go through the kind of trauma that Vicky Phelan had to go through in terms of, for example, a court trial. That is where we can establish that the State has a liability. If, on the other hand, the liability is that of the laboratory, quite clearly it will be indemnifying us and we will be out of the case.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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Where it does not indemnify the State Claims Agency, will it mount a full defence?

Mr. Ciarán Breen:

If the laboratory does not indemnify us, we would ask. First of all, we would have to look at-----

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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I will read from the earlier statement from the State Claims Agency: "We have no intention of mounting a full defence in any case of this nature where responsibility is substantially or completely that of the State." However, the State Claims Agency is going to mount a defence against these nine individuals. Three of the nine are deceased but their partners are taking the cases against the HSE.

Mr. Ciarán Breen:

No. We will be looking to the laboratory to provide an indemnity. This is on the basis of the contractual agreements between the HSE, CervicalCheck and the individual laboratory. If it is-----

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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Is that not akin to saying to these women that it is not the fault of the HSE but the fault of the laboratory and that they should pursue the laboratory? By operating as Pontius Pilate the agency is ensuring that there will be legal cases because the laboratory in America will pursue this. Is it not the case that these women were let down by the State? They were completely and utterly failed by the State because of misdiagnosis.

The State Claims Agency should be settling with every one of them. Then the agency should sue the laboratory in America. Instead, the agency is asking people who now have a cancer diagnosis to pursue the State. The same applies in certain circumstances involving people who lost loved ones - they are grieving families. The State Claims Agency is washing its hands and suggesting people sort it out with the laboratory in America. Why can the agency not settle with these individuals? Why can the agency not do what the Taoiseach has said? Even if there is no legal responsibility, there is a moral responsibility. The agency should settle with these women. Then, if the laboratory in America failed in its duties - clearly it has - then the agency should sue the laboratory and get the money back. Why make the individual victims go through this arrangement?

Mr. Ciarán Breen:

We are constrained by our statutory remit. We can only do things in a particular way. We must ensure the State does not pay out when another party should pay out. That is the constraint we operate under and we cannot do anything different from that. If the State decides to have a form of redress for the women involved, that is a different matter. That would involve taking the matter entirely out of our hands and into a redress scheme. We are constrained by what we can do.

I understand the point Deputy Doherty is making well. I agree with him that it is terribly tragic that women have to take these cases against the laboratories involved, but the laboratory is the liable party based on-----

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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The women did not go to the laboratory in America. They went for a service operated under the HSE and the HSE has failed them. The HSE should settle this. The State Claims Agency should do it. If the laboratory with which the HSE has a contract has failed the executive, then the executive should sue.

Another question comes from evidence or testimony provided by Mr. John Gleeson, the programme manager of CervicalCheck. He talked about the Vicky Phelan case. It is clear that an approach was made to get Vicky Phelan to drop the case against the HSE. Is that not the case?

Mr. Ciarán Breen:

No. Sorry, from our point of view, we came into the case when the personal injury summons had been served. We were a co-defendant with the State and the HSE along with the laboratory. All that we did was ensure that the laboratory picked up the liability arising from the contractual arrangements.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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Let me read a sentence from Mr. John Gleeson. He stated: "The plaintiff's legal team was asked if it would drop the case and make it just against the co-defendant, and they said "No"." Is that an accurate statement?

Mr. Ciarán Breen:

I do not know. I would have to ask him what he means by that because I do not understand it.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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Let me go on a little bit further. He stated:

The legal team said it had an issue around the delay in informing the affected woman. That element of the case was struck out; it was not that we did not tell the patient, it was noted that the information was late and took a long time. That was the basis. After that, any engagement largely centred on legal teams and we were asked if a settlement was proposed during mediation prior to a court appearance. The State Claims Agency advised that we should be supportive of any such moves. We took the agency's advice and said "Yes".

Was there consideration whereby the State should settle with Vicky Phelan in mediation? Did that conversation between the State Claims Agency and CervicalCheck take place as represented by Mr. John Gleeson?

Mr. Ciarán Breen:

I do not know the exact context for why he says it that way. I am simply reading into what Deputy Doherty has put before me. I would say that was a discussion with the State Claims Agency. When the agency was talking to its co-defendant obviously we would have been supporting the idea that there should be a settlement with Vicky Phelan by the US laboratory.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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At no time was there any suggestion that the State should contribute to a settlement. Is that the case?

Mr. Ciarán Breen:

The State did contribute to the settlement. It contributed a sum of €25,000. I will explain the only reason we made the contribution. The circumstances were that the US laboratory delayed and was prepared to go into another day's hearing with Vicky Phelan. To prevent that we put up a figure of €25,000 as a contribution.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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I wish to ask one more question, with your indulgence, Chairman.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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Briefly.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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Mr. Breen is arguing that the reason he will defend these cases is that he believes the non-disclosure did not lead to adverse clinical outcomes. We are aware that earlier this year Vicky Phelan was fundraising for treatment. We are aware that if some of the women who are now unfortunately deceased had been aware in 2014 that there was a misdiagnosis and had been informed at the time that they had options for treatment, then the outcomes could have been different. They could have taken part in clinical experiments and so on. Does Mr. Breen not think that has value in itself? If these women knew this information earlier, it would not have changed their diagnosis of cervical cancer but it would have allowed them to look at other types of treatment, drugs or clinical trials. Those options were delayed. In three cases in which proceedings against the State are under way the options were not only delayed but those involved never had the opportunity to take them up in the first place. How can Mr. Breen say that there is no liability on the State?

Mr. Ciarán Breen:

I have to operate within the law of tort. Statutorily, that is what I am told to do: I must operate within that system. If the system said that material non-disclosure affected the clinical outcome, then we would definitely have got involved and would have compensated for it. That is absolutely definite.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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Mr. Breen referred to the humane and sensitive approach of the agency.

Mr. Ciarán Breen:

I cannot-----

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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Mr. Breen should have come in here with a different approach. He applies a strictly legal interpretation with regard to the victims of this scandal.

Mr. Ciarán Breen:

I cannot go beyond that.

Photo of Pearse DohertyPearse Doherty (Donegal, Sinn Fein)
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Mr. Breen should at least spell it out as he is spelling it out. He is applying a strictly legal interpretation. Yet, he came before the committee and said he would deal with the matter in a humane, ethical, professional and sensitive manner. I maintain there is nothing ethical, humane or sensitive in the way the State Claims Agency is approaching this issue.

Mr. Ciarán Breen:

We were praised by the judge for the manner in which we dealt with the case.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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That is fine. Mr. Breen, who are you answerable to?

Mr. Ciarán Breen:

First of all, as the director of the board-----

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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Have you a board?

Mr. Ciarán Breen:

I report in to my chief executive and the board of the National Treasury Management Agency. In addition, there is a strategy committee that contains two board members and some outside persons.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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Who is on that strategy committee?

Mr. Ciarán Breen:

The board members on the strategy committee are: Derek Moran, Secretary General, Department of Finance; Mary Walsh, who is a board member of the NTMA; Donogh Crowley, who is a retired healthcare partner in Arthur Cox; Tom Beegan of Beegan and Associates; Sir Sabaratnam Arulkumaran, who is clinical obstetrician and gynaecologist; and an assistant secretary in the Department of Public Expenditure and Reform, Derek Moloney.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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What strategy do they deal with? Are they familiar with the cases coming up? Did you advise them in the context of the type of cases being run at that particular time?

Mr. Ciarán Breen:

They were not aware of that particular case. Given the particular circumstances of the case we took the view at the time we were handling it that it was not one to bring to their attention because it was a developing case. The implications only arose at a particular point in time. Generally speaking, we talk to them about our strategy in mass action cases.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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How often do you meet this strategy committee?

Mr. Ciarán Breen:

Quarterly.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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At no stage were the committee members aware of what was about to emerge. Is that accurate?

Mr. Ciarán Breen:

No, they were not aware in this particular case.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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So even though the Department of Finance and the Department of Public Expenditure and Reform are on that strategy group, there was still no reason for the agency to explain to them at the point it learned about it. When were they informed?

Mr. Ciarán Breen:

The strategy committee was not informed of this particular case.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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Ever?

Mr. Ciarán Breen:

No, because at that time it was a case where liability had been taken over and there was a letter of indemnity from the US laboratory.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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So they were never informed and the patient in this case was not informed. What is the procedure when an incident of some sort occurs in the HSE? Is the agency informed directly or is the HSE informed and then it, in turn, informs the agency?

Mr. Ciarán Breen:

If there is an incident, which happens regularly in hospitals, it can be notified on the national incident management system or right up along the line.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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Is that the SBAR communication tool?

Mr. Ciarán Breen:

No.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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I refer to what is on the agency's website.

Mr. Ciarán Breen:

No, that is definitely not the means of communication. The national incident management system is the means by which adverse events are notified to the State Claims Agency.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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Which is what this is.

Mr. Ciarán Breen:

I am just guessing that it is just a piece of software.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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The point I am making is that there is, within the HSE, a system by which incidents of this kind are reported.

Mr. Ciarán Breen:

Correct.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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This was never reported anywhere within the HSE either, or was it?

Mr. Ciarán Breen:

We received notification when we got the letter of claim.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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How much would the clinical risk adviser within the HSE who covers the clinical indemnity scheme have known?

Mr. Ciarán Breen:

The clinical risk advisers in the indemnity scheme work on a very general basis with hospitals in relation to providing advice and assistance on risk management matters. In relation to this particular issue they would not have had any visibility on it.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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Why?

Mr. Ciarán Breen:

Quite simply because they were not aware of it.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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Because a hospital or nobody else told them.

Mr. Ciarán Breen:

The HSE's CervicalCheck certainly did not raise it as an issue.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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CervicalCheck did not tell the communications system within the HSE. Mr. Breen did not tell the strategy board, but it did not tell him either. This was a failure of a number of different agencies within the State.

In most of the commentary today there is talk about the 98% of clinical negligence cases that are settled without the necessity for a contested court hearing. That is not all of the work the agency covers, as there are other cases outside of that involving all the various agencies that are represented. I was struck by the figure of 98% because I am aware of a number of cases that went to court outside of the HSE, and cases that were then settled where a gagging order was put in place. I have come across that a lot in the context of my term on the Committee of Public Accounts. The reference to 98% of cases would lead one to believe that there is nothing to worry about given that 98% of the cases are dealt with, but if I were to examine some of the cases, without naming them, that have come before the State Claims Agency, they are reported to the agency through the solicitor that served the summons-----

Mr. Ciarán Breen:

Chairman, are you talking about clinical negligence cases?

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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Yes. The person bringing the claim has to get medical evidence from the UK because no one will do it here as they are minding one another. Then he or she might have to get external legal representation because it is a specialised area and cases drag on for years. Then it is up to the agency to either go to court, settle or mediate. In the course of mediation and settlement, which are two different things, does someone from the HSE sit in on those discussions?

Mr. Ciarán Breen:

No.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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I am not leading Mr. Breen anywhere.

Mr. Ciarán Breen:

The decisions on a particular case in terms of whether it is mediated, settled or the case goes to trial, reside entirely with the State Claims Agency. As to whether there are times when we are accompanied by people from the HSE or a hospital, yes they would be there, but purely in the capacity of, for example, being a medical expert or adviser.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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So senior people within the HSE and within the State Claims Agency are aware of cases but before a case gets to that stage everyone seems to be unaware of what is going on. That is the point. All due attention is given after the summons is served but prior to that, for example in asking for information from the HSE, not all the files are provided. In fact, I heard a solicitor say on the radio the other day that it is only when a legal firm representing the client goes to the HSE that the full disclosure will be made. I find that quite shocking, and it annoys me that it would be the case. In other cases the HSE was asked for the reports and files and it was provided with pages missing and then when it came to the stage leading to the court case the missing pages miraculously appeared on the files of the other side. The impression I get from talking to a number of people who have been through the system with the SCA is that they find it frustrating and hugely costly.

One individual told me he had to put up €100,000 to be able to take part in the game, and to fight for his case, and that it dragged on for years. The messages that are going out from here are mixed. Mr. Breen said the agency shows compassion and humanity, yet people on the other side tell us that the State Claims Agency appoints solicitors to represent it and that they find it difficult to deal with the State Claims Agency and those who take cases find it hugely difficult and the process takes years. In fact, one individual told me that he felt that there was no honesty in the system, that people do not meet face to face and that there is a wall of silence within the HSE, in particular, in relation to these matters.

I am just pointing this out because some of the commentary would lead one to believe that everything is hunky dory but it is far from it. My first question is what Mr. Breen has to say in response to that. My second question is what he says to the HSE, that has failed to report this and whose own system has failed to flag this. Will he stand with those affected who will be going through the courts with the American company? It would seem to me that the original contract was flawed; that it was the case that the Department put it in place to wash its hands of it so that it would not affect it. I believe the HSE and the State Claims Agency have a role to play. What assistance will they give to people affected?

Mr. Ciarán Breen:

In response to what you said, Chairman, about people finding us difficult, the fact of the matter is that tort law, which is the law that applies to personal injury, is just that - it is adversarial. That is why, over the years, we have done different things to try to make that better. One of the things that we did on our own initiative entirely was to bring forward the periodic payment orders, PPO, that we are making for catastrophically injured victims. We are allowing them to be paid for a period of time so that there will be absolute certainty and that families to not have to worry about money running out. That was one of the things we did.

I personally sat on the medical negligence working group in 2010. We advocated PPO legislation. We advocated the pre-action protocol. If we had the pre-action protocol tomorrow my colleague, Ms Foley, and I believe it would transform the behaviour and the way we handle these cases.

It has been in the UK for a very long time and it stops the adversarial element. People do not have to issue proceedings. They simply issue a letter of claim and we would issue a letter in response to that. The idea is that we narrow down the issues to those that are really between the two parties and then mediate them. I have advocated for this position for a very long time and despite the fact that the Legal Services Regulation Act has brought that into play, subject to the making of the regulations, we do not have that even now. It would be of considerable assistance to us if we had that tomorrow.

To come back to the HSE, medical records and the supply of same, when a patient looks for records from a hospital obviously we are not involved. Therefore, the experience of the patient in that context is one that is beyond the State Claims Agency. Clearly, if we were asked to furnish a copy of medical records to a plaintiff we would make sure that we are furnishing all of the relevant records. Plaintiffs' solicitors will say that we are difficult to deal with and I understand that. They will say that we delay but the one thing that they will not say is that very often, when we try to settle cases at pre-defence stage or prior to a trial, the sums of money they are looking for in settlement of their clients' claims are so overstated that we have no choice in many instances but to go to the steps of the court and sometimes, to trial. I am reminded of one example where we were asked in a catastrophic injury case to pay €26 million in damages and we ended up paying €13 million after three days of trial. Clearly we could not pay out €26 million and the plaintiff's solicitor in the circumstances understood that €13 million was the value of the case ultimately. That is what we face. It is not that we want to be in court with medical negligence victims. In fact, as I said previously, if we had the pre-action protocol in place, much of what the Chairman has described in terms of frustrations would be relieved. We share those frustrations because it makes us sound bad when people say things like we are difficult but actually it is the system. It is the system that does not promote good management. I have been saying for a very long time publicly and at previous meetings of various Oireachtas committees that the tort system as it applies to medical negligence cases that we have now is not fit for the management of those cases.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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When did the agency submit that pre-action protocol?

Mr. Ciarán Breen:

We did our first report in 2010 and the pre-action protocol was devised in 2011 or 2012. It was recommended by the group chaired by Ms Justice Irvine.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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It was drawn up in 2011 or 2012 but it still has not been brought into play.

Mr. Ciarán Breen:

That is correct. We are still awaiting it.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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Deputy Boyd Barrett is next.

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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I thank Mr. Breen and Ms Foley for being here today. Do all of the cases of women who had false negative results and who subsequently developed cancer - the nine cases pending and the one which the agency understands has yet to be filed - involve CPL?

Mr. Ciarán Breen:

What is CPL?

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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The American laboratory. The people who demanded a gagging order for Vicky Phelan-----

Mr. Ciarán Breen:

I am sorry, I beg the Deputy's pardon. There are two laboratories involved in those cases.

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Are both of those laboratories American?

Mr. Ciarán Breen:

Yes.

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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All the cases of misreading that have resulted in women learning that abnormalities should have been discovered and who subsequently developed cancer, of which the State Claims Agency has knowledge, involve American laboratories. Is that correct?

Mr. Ciarán Breen:

Yes.

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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There were no other cases settled by the agency other than those nine and Vicky Phelan's case. Is that right?

Mr. Ciarán Breen:

Exactly.

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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That is a very damning fact which should have come out before now and it says it all. There are no cases involving the Coombe Hospital.

Mr. Ciarán Breen:

I am sorry-----

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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The Coombe hospital. We have been informed by the Government-----

Mr. Ciarán Breen:

Sorry, but I do no want to mislead the Deputy in anyway. I thought the Deputy was talking about this group of ten patients to which we have been referring.

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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I am.

Mr. Ciarán Breen:

In this group of ten, they are all US laboratories.

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Is there another group?

Mr. Ciarán Breen:

No, I was just wondering whether the Deputy was referring to something else.

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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I am trying to get clarification on something. This is not the agency's direct concern but one of the big issues at stake here is whether there were differences in the detection rates of the outsourced American laboratories and the Irish laboratories that were testing the samples, as warned about by Sam Coulter Smith and the quality assurance people in the HSE who resigned in 2008. What Mr. Breen has just told us is very informative in that context. He has told us that all of the cases of misreading and failure to detect abnormal or cancerous cells in women who subsequently went on to develop cancer, and who took cases against the State, came from the American outsourced laboratories.

Mr. Ciarán Breen:

Yes, on this list.

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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None of them is from the Coombe.

Mr. Ciarán Breen:

No.

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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That is the big news here and it says it all, frankly. The warnings issued in 2008 have proven to be correct. That is quite stunning but it has taken us until now to get to that truth. We could not get that information last week or in the Dáil today. We have to have scoping exercises and all sorts of hullabaloo but actually, we just needed to know whether the issue was with the American outsourced laboratories. We have just discovered that it was and in that context, there is almost nothing more to say. I cannot understand how those laboratories are still doing our smears.

Mr. Breen is saying that all of the cases involve American companies. He has also said - and I believe him - that the State Claims Agency would never have sought a gagging order and that it was CPL and presumably the other laboratory that were seeking gagging orders.

Mr. Ciarán Breen:

We only know of it in the Vicky Phelan case.

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Does Mr. Breen know of any other cases where gagging orders have been sought?

Mr. Ciarán Breen:

We are not aware of any, no.

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Okay, it was just CPL that was looking for a gagging order. Mr. Breen is asserting that under no circumstances would the State Claims Agency seek a gagging order in a case like this involving medical malpractice or clinical error. Is that correct?

Mr. Ciarán Breen:

Most definitely not and I go back to the point I made to the Chairman about being ethical.

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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If the Coombe had made a mistake - which very tellingly it has not - and was being sued, would that change the likelihood of a gagging order being sought? Would the situation be different if a case involved the Coombe and a domestic laboratory that is part of the health service here?

Mr. Ciarán Breen:

What I can say to the Deputy is that if we were acting for a party, we would most definitely not allow a gagging order to be put in place.

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Let us say, hypothetically, that a case had been taken over a false reading carried out in the laboratory at the Coombe. In those circumstances, Mr. Breen is saying that neither the HSE nor the State Claims Agency would have sought a gagging order. Is that right?

Mr. Ciarán Breen:

Definitely not.

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Whatever about screening quality, there is a difference in how the State treats a victim of a false reading if it involves the Irish health service as against a privatised, outsourced company. One puts the patient through the wringer and the other, that is, the public agency, does not do so.

Mr. Ciarán Breen:

That is correct. We would not do so.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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Deputy MacSharry is next.

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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In a situation where the HSE has subcontracted to a US laboratory, is there a service level agreement in place?

Mr. Ciarán Breen:

Yes, there would be.

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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Would the State Claims Agency, SCA, examine its terms?

Mr. Ciarán Breen:

No. The only reason we might examine that would be if we were involved in a dispute on liability with the laboratory on a co-defendant basis and if there was something we felt was going to the issue of liability we might do it. Otherwise we would rely entirely on a contractual indemnity.

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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As a result of this case, there is a substantial cost to the State, maybe not directly in terms of paying out the claim but this crisis is going to cost the State a lot of money. Is there any recourse within the service level agreements that the SCA has looked at – perhaps it should it look at them – to determine whether the State has recourse for the cost of this meeting, tribunals, scoping exercises and so on?

Mr. Ciarán Breen:

I have not looked at the service level agreement to see if that is the case.

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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Does the SCA have a process in place to always consider that or does it think on reflection that it should have a protocol in place?

Mr. Ciarán Breen:

In the context of litigation between co-defendants and a plaintiff, we tend to consider only the issues that will affect our liability position. If there are extraneous issues beyond that, we do not consider them at the time. That is understandable.

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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Does Mr. Breen think it reasonable that I, as a guest member of this committee, would ask him to reflect between now and the meeting of the Committee of Public Accounts next Thursday, when I will again have the pleasure of talking to him, whether, if the State is about to head into a very expensive line of inquiry, it has any recourse where there is a service level agreement with what might be a section 39 organisation albeit overseas? Could he look into that and determine the practicalities of our recouping the substantial costs of the inquiry and a potential redress scheme?

Mr. Ciarán Breen:

We will make our best endeavours between now and then in preparation for the meeting with Committee of Public Accounts on Thursday. I cannot guarantee that we will be successful.

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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I understand that but with a few days to go between now and then Mr. Breen may be in a position to fully answer why we cannot do that, if that will be his position.

As director of this agency does Mr. Breen sit on the board of the National Treasury Management Agency, NTMA?

Mr. Ciarán Breen:

No.

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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Does the board of the NTMA have a risk register?

Mr. Ciarán Breen:

Yes it does.

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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Does the risk register include the outcome of cases in the remit of the SCA?

Mr. Ciarán Breen:

I have not seen the risk register that the audit and risk committee looks at.

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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Does the SCA highlight cases of concern in terms of damage to the State which it would highlight in reporting to its chief executive officer, CEO, apart from the strategy committee it mentioned to the Chairman?

Mr. Ciarán Breen:

To take the strategy committee for the moment-----

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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We have established what it does with the Chairman. I am more interested in the CEO of the overall agency. Would Mr. Breen sit down with him periodically to say he is concerned about X, Y or Z?

Mr. Ciarán Breen:

Yes, I meet the chief executive with my fellow NTMA directors twice weekly on a formal basis and as often as I would need to get access to him after that.

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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Are those meetings minuted?

Mr. Ciarán Breen:

No, the twice weekly meetings are not minuted. We do have minuted executive meetings of the NTMA, the executive management team which take place approximately once every six weeks.

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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Can Mr. Breen check whether it is possible for him to provide them to this committee confidentially? The committee is in a position to receive such materials and if he can, he might provide them to the secretariat.

Is he in a position to tell us whether at those six weekly meetings any of these cases were highlighted as a concern?

Mr. Ciarán Breen:

I can tell the Deputy emphatically that none of these cases was highlighted to the executive management team because the Vicky Phelan case was the first one of its type which arose. It was only at the point that the case was being settled and afterwards that the implications of non-disclosure in this and other cases arose. Had we been aware-----

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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I am not specifically interested in non-disclosure but in the broader case. Many people have dealt with that issue.

Mr. Breen gave us some dates. The HSE knew about the Vicky Phelan case in 2014. She was not told until 2017. When did the SCA become aware?

Mr. Ciarán Breen:

On 12 February of this year. We got a letter of claim and the personal injury sums.

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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Does the SCA consider or quantify reputational damage to the State in respect of its risk register and responsibilities, and tort, which Mr. Breen said raises difficulties?

Mr. Ciarán Breen:

Most definitely. It is the one thing-----

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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Alright.

Mr. Ciarán Breen:

To respond on that point, the one thing that would cause me as director of the agency anxiety and some stress is when people say to my agency that we are deliberately causing distress to victims of negligence. That is a really important issue because I do not believe that we do or ever set out to do that.

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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Then it is all the more necessary to read the service level agreement to see if we have recourse because there is substantial reputational damage to the HSE, the Government, ourselves and so on.

Mr. Breen mentioned the pre-action protocols. The Bill that brought those into effect or permitted them was the Civil Liability (Amendment) Bill 2017, passed last November.

Mr. Ciarán Breen:

It is actually the Legal Services Regulation Act 2016 which has the enabling provision. That gives the power to the Minister for Justice and Equality to make the regulations bringing them into force.

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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The SCA's website named the other Bill. That was the only reason I said it.

Mr. Ciarán Breen:

That was a mistake.

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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Mr. Breen might check that.

There is a letter on the website, dated 17 October 2017 which states: "...the Health Service Executive (HSE) and the Voluntary Hospitals, are legally obliged to report all adverse events promptly to the State Claims Agency (SCA)." That obviously did not happen-----

Mr. Ciarán Breen:

Yes.

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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-----in this case because it knew in 2014. Was it this case that prompted the SCA to put this up on its website?

Mr. Ciarán Breen:

No. One of the features of the national incident management system and adverse event reporting in healthcare generally is that reporting is never at the level that is wanted. There is always a push for better reporting. We are constantly trying to do that.

Photo of Marc MacSharryMarc MacSharry (Sligo-Leitrim, Fianna Fail)
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Was this the first time the SCA issued such a letter to the hospitals and put it on its website?

Mr. Ciarán Breen:

No. I think we had issued letters in 2015.

Photo of Jonathan O'BrienJonathan O'Brien (Cork North Central, Sinn Fein)
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I will be brief because I think most of the questions have been asked and I will also have the pleasure of meeting Mr. Breen again on Thursday as will several other Deputies.

Mr. Breen said he meets with the CEO of the HSE and informs him of cases but does not go into any details; it is a general discussion. Would the HSE have been aware that there were ten cases relating to this issue? I know Mr. Breen does not name individuals but the HSE might have been aware there were ten similar cases. Is that correct?

Mr. Ciarán Breen:

Correct. HSE cervical screening would have been aware of this, yes.

Photo of Jonathan O'BrienJonathan O'Brien (Cork North Central, Sinn Fein)
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Mr. Breen said that he discusses upcoming cases with the executive of the HSE.

Mr. Ciarán Breen:

We discuss claims in general. The Vicky Phelan case was not discussed at our last meeting of the group. That was a matter of timing. The notification to us of the Vicky Phelan case came only on 12 February 2017. Therefore, the HSE would have been aware of it through CervicalCheck.

Photo of Jonathan O'BrienJonathan O'Brien (Cork North Central, Sinn Fein)
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It would also have been aware of the other cases.

Mr. Ciarán Breen:

Yes, it would have been.

Photo of Jonathan O'BrienJonathan O'Brien (Cork North Central, Sinn Fein)
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Does Mr. Breen think it credible that the director general would not be informed by the executive of the HSE?

Mr. Ciarán Breen:

Honestly, I cannot answer that question. It would be speculation.

Photo of Jonathan O'BrienJonathan O'Brien (Cork North Central, Sinn Fein)
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Given what we now know, thanks to Deputy Boyd Barrett, about all ten cases involving American laboratories, and as the person who deals with legal cases on behalf of the State, does Mr. Breen think it would be a prudent decision that we would cease all testing in American laboratories?

Mr. Ciarán Breen:

It is entirely a matter for the HSE and its CervicalCheck programme to carry out that kind of analysis and to make a decision on that. We manage litigation. We do not make those kinds of policy decisions. That is entirely for the HSE to do, based on an analysis-----

Photo of Jonathan O'BrienJonathan O'Brien (Cork North Central, Sinn Fein)
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Mr. Breen would not give the HSE any advice based on what he now knows, that we have ten cases that all involve American laboratories, that there is obviously an issue here, that it will cost-----

Mr. Ciarán Breen:

Through our clinical risk team, as part of our agency, I think we would give the HSE advices that it needs to look at this.

Photo of Jonathan O'BrienJonathan O'Brien (Cork North Central, Sinn Fein)
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The State Claims Agency has not done that yet but it is something it would do. Is that correct?

Mr. Ciarán Breen:

Yes. It is something we would do in any event.

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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I know I only have a few minutes but I thank the witnesses for the honesty with which they have approached the committee. I was watching a lot of the proceedings. The meeting has been very helpful. We will have a debate on health tonight, a meeting of the Committee on Health, on which I sit, tomorrow and a meeting of the Committee of Public Accounts, which I will chair and before which Mr. Breen will appear, on Thursday. Gradually, piece by piece, this jigsaw is coming together, and the information the witnesses have given has been helpful. As some of my colleagues, through questioning, have said, tort law is just not suitable when it comes to these cases. Mr. Breen has been very open about this, which is very useful. In a scenario in which the laboratories do not indemnify, it is almost like the State Claims Agency cannot dislodge itself. Is that fair to say? It is almost like, because of the statutory remit of the State Claims Agency and tort law, to which Mr. Breen has referred, the agency cannot dislodge itself from almost being a party to pursuing these very unfortunate people.

Mr. Ciarán Breen:

Yes. Unfortunately, what happens in law, once they indicate to us that they are indemnifying, is that they take over the entire conduct of the proceedings as they go from that point-----

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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Absolutely.

Mr. Ciarán Breen:

-----including everything else.

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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I think this is important for the witnesses because an awful lot is being said in the media and so on about what the State Claims Agency does. Effectively, there needs to be a change or an alteration, for want of a better to word, to its statutory remit to allow it more flexibility when it comes to these kinds of cases. Whether Mr. Breen likes it or not, if something does not change and if the laboratories do not indemnify, the State Claims Agency is left in a scenario in which it is still party to a case against these other ten women.

Mr. Ciarán Breen:

Yes, exactly. If for whatever reason the laboratories do not indemnify, let us say in these six cases-----

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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Yes, absolutely.

Mr. Ciarán Breen:

-----in respect of which we have not received indemnity, we are in and we are there as a co-defendant with them.

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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Even though the State Claims Agency would obviously rather have all this dealt with quickly through mediation, which would be the right scenario, given the circumstances.

Mr. Ciarán Breen:

Yes.

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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Mr. Breen said he listened quite carefully to the Taoiseach and what he said about how we should behave in these cases, and that is obviously the appropriate thing to do. At governmental level, there will have to be legislative changes to facilitate the State Claims Agency to do this. What would those changes be?

Mr. Ciarán Breen:

I would have to look more broadly at the matter. Deputy Kelly will appreciate-----

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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Obviously, there would have to be changes fairly quickly.

Mr. Ciarán Breen:

Clearly. Our remit and the way in which we do this and manage cases on behalf of the State where we have a duty is such that if there is another party, we ensure it pays up if it has the liability.

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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Does Mr. Breen accept that the State Claims Agency's hands are tied as the agency is currently constituted and that there would have to be significant changes instantaneously for it not to be party to cases involving the remaining six?

Mr. Ciarán Breen:

Yes. The fact is that under current tort law, where we are a co-defendant, if we are named as a co-defendant, and if we are not indemnified, we are there, but if we are indemnified-----

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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I know that.

Mr. Ciarán Breen:

-----we are gone and they are there.

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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Within the State Claims Agency's statutory remit and the rules under which it works, it would not be able, through mediation, to settle with these women and sue the laboratories subsequently.

Mr. Ciarán Breen:

No, because they would feel we had perhaps done things or agreed sums or heads of damage that they might not have-----

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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I just wanted to clarify that. I have a few further quick questions. We are all aware of the famous note that was prepared for the Minister, Deputy Harris, from a couple of weeks ago. There has been commentary on this aside from that of the State Claims Agency. Did Mr. Breen feel it necessary to say there were other cases in that note? Would that have been the right thing to do?

Mr. Ciarán Breen:

At the time, honestly, we were providing detail purely on the case.

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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Did Mr. Breen not feel, as background information, as an escalation issue, that the fact that there were similarities with other cases meant it would have been appropriate to inform the Department? Did the State Claims Agency do so?

Mr. Ciarán Breen:

We did. What happened was that the Department sought from us a note on the case, but it should be remembered that at that time, as I explained earlier, we did not know about all these other cases. We knew there were the ten cases, but I am talking about women who had not been informed. We did not know about that.

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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That is interesting. I was in committee last week with the Department of Health and I was the person who asked the question that revealed that there were not ten cases. I asked the same question of the HSE and the Department of Health. They had two different answers. It was how they categorised them more than anything else. When did the State Claims Agency inform both of those entities last week?

Mr. Ciarán Breen:

Honestly, I would have to go back. I am not avoiding the Deputy's question at all. I would have to go back and look at my notes as to when-----

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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Let us presume the following. I met the Department-----

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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I am anxious to let in Senator O'Donnell so he can wind up.

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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This is a very important point.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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I am sure it is.

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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I met the Department of Health at 3.30 p.m. last Tuesday. The Minister spoke inside-----

Mr. Ciarán Breen:

Sorry, Deputy. I have just been handed a note stating that it was Thursday.

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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Yes. That is what I had presumed. We had to ask the Department of Health and the HSE to ask the State Claims Agency how many cases there were. They did not know, or had not asked, which is quite incredible.

In fairness, through very good questioning, we have now found out that all the cases involve US-based laboratories. There are two laboratories involved: MedLab Pathology and Quest Diagnostics. Will Mr. Breen break down the ten cases for the committee? Is it five and five, six and four and seven and three?

Mr. Ciarán Breen:

We will supply that information to the Chairman, if that is okay.

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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The very last question, and this is important information which Mr. Breen may supply to the Chairman, is with the breakdown of the laboratories. Will Mr. Breen also supply us with the dates on which he was made aware of the ten cases or the dates on which they were lodged?

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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I wish to go back to the agreements. With whom is the contract of CPL, the laboratory in the US, and the other laboratories? Is it with the women who get the smear tests or with the HSE?

Mr. Ciarán Breen:

My understanding is that the contract is between HSE's CervicalCheck and the laboratory to provide the laboratory services.

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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The customer is the HSE, not the individual woman. Going back to the agreement, if the service is being provided, why is the case not taken by the woman against the HSE, which is subcontracting out a service to CPL? Has Mr. Breen had an opportunity to go back and read the contracts between CPL and the HSE and other providers?

Mr. Ciarán Breen:

No, I have not, because I did not deal with the case myself. I was aware of it as the director and was told about it as it unfolded, but I have not personally read the contracts. We would have looked at them from the viewpoint of-----

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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The HSE has subcontracted cervical screening out to a lab in America but the actual agreement is between the woman and CervicalCheck for the smear test. Therefore, why is she not entitled to take her case against the HSE and CervicalCheck?

Mr. Ciarán Breen:

She is allowed to take her case against them.

To go back to the example of the Vicky Phelan case, however, if it was based on a misreading of a smear, what would happen then is that the indemnity provision in the contract between the laboratory and the HSE would have to flow in terms of indemnity from the laboratory to the HSE.

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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As such, it is not really to do with tort law. It is to do with the actual contract that was put in place by CervicalCheck and the HSE with the American laboratory.

Mr. Ciarán Breen:

Certainly that is part of it-----

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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No, it is-----

Mr. Ciarán Breen:

Even in negligence law, if they had been negligent in the carrying out of the smear for some reason, there could be contractual-----

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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No. The HSE, CervicalCheck and the State Claims Agency are saying that they would never take a woman into court. They would not look for a gagging clause. The problem is that it has been subcontracted. I suspect that within the original contract that was signed by the CervicalCheck and the HSE with the American laboratory, they subcontracted the legal responsibility for the smear as well. We now know that the ten cases involved American laboratories. We now have a situation where the women are effectively being told that they are dealing with faceless American laboratories whose employers are the HSE, not the individual women. Based on what has now happened and the fact that there are ten cases, does Mr. Breen believe that settlements will be made out of court? Alternatively, does he believe that they will drag these women into court, or drag their families, three of the women having lost their lives?

The witness mentioned non-disclosure. On reflection, does Mr Breen believe that he is taking a purely legal reading of it rather than looking at it on a moral level? Take the instance of a case of someone like Vicky Phelan. If Vicky Phelan had known in 2014, she may have gone on the drug she is on now. We have to go back to the source. Will Mr. Breen, before he appears before the Joint Committee on Health, look at the contracts that were concluded between the HSE, CervicalCheck and the laboratories themselves?

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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I suggest that we get a reply from Mr. Breen, because Deputy McGrath raised that earlier on, and I think Deputy Doherty raised it. What it boils down to is the role that the HSE can play in suing the laboratory and not putting the women through all of the court cases that will emerge out of this. It is to examine the documentation, the agreements between the HSE and the laboratories, the State Claims Agency's role in all of this, and to try to find a way of protecting the women and getting their rights at the same time rather than have them go to court. I know this may not be Mr. Breen's area, but it is a point that was made, and I think it is worth considering. Every effort must now be made by the State to work with the women and ensure that they get what they are entitled to, and not to have protracted court cases with this American company making life difficult and adding further cost in human terms to the individuals and the families concerned. I would urge the State Claims Agency, the Government and whoever else is involved to take on board, please, what the members are saying.

Mr. Ciarán Breen:

Certainly, Chair.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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I would like to include the actual contracts between HSE, CervicalCheck and the laboratories in the list of items we are requesting. It is a request from the committee that they be provided.

Mr. Ciarán Breen:

Given that they are contracts between CervicalCheck and the laboratories, would it be more proper that they should be sought from HSE and Cervical Check? We received them purely for the purposes of our litigation, but they do not belong to us. We would have to get them.

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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We will, but the context in which we want to see them is to deal with the legal issues and the indemnification around liability which is directly relevant to the State Claims Agency's remit. I know the agency is not a party to the contracts-----

Mr. Ciarán Breen:

No, but does the Deputy take my point-----

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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I do.

Mr. Ciarán Breen:

-----that the documents might be best got from them?

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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We will do that too, but we are asking the witnesses to consider it again.

Mr. Ciarán Breen:

I obviously have to appear before the Committee for Public Accounts on Thursday, so we will do everything we possibly can between now and then to clarify some of these issues.

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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On a point of clarification, the indemnity kicks in or might be sought where the misreading is beyond normal error. Will Mr. Breen clarify whether it is only in those circumstances? A certain number of false negatives are expected. I just want clarification on that. Can anybody who gets a misreading under any circumstances take a case, and would the State Claims Agency seek indemnification, or is it only where it is beyond normal error?

Mr. Ciarán Breen:

We are not cytologists and we do not have any huge knowledge of cytology, so we would rely on expert evidence to tell us whether it was beyond normal error. If it was, then that would kick in. We rely entirely on expert evidence to inform us about the particular smear, whether it was beyond normal or whatever is the particular-----

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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In all those cases, beyond normal, was the-----

Mr. Ciarán Breen:

Yes.

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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One very small point. How many of the ten cases are taken by the women themselves and how many are, unfortunately, being taken by the families of someone deceased?

Mr. Ciarán Breen:

Two cases are taken by families.

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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Two are taken by families?

Mr. Ciarán Breen:

A further potential one would be taken by a family.

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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Two plus one.

Mr. Ciarán Breen:

Yes.

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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Sorry, there was a particular question. Does Mr. Breen believe, given what is happening and the current legal construct, that these women will end up having gagging clauses imposed and will be dragged to a court by these companies?

Mr. Ciarán Breen:

I can only hope that that would not be the case, that the laboratories themselves, who are aware of what has been happening in the past week, would understand public opinion on this and that non-disclosure clauses of the type sought by them are not appropriate to this type of case.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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Essentially it is a matter for the Government,. The Government must understand public opinion as well and understand that we want to see these women protected. It is as simple as that. Whatever steps are necessary, the Government should take them.

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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In the context, I asked because I want to know, based on the current legal situation, what changes need to be made, in Mr. Breen's professional opinion. What needs to be done to ensure that these women will not be dragged into court?

Mr. Ciarán Breen:

If I were advising the laboratories in a situation where they had indemnified the State, my view would be that they should deliver compensation in the shortest period without any gagging clause, making sure that the women are not put through the kind of trauma that Vicky Phelan was put through.

Photo of Kieran O'DonnellKieran O'Donnell (Fine Gael)
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Do changes need to be made through legislation?

Mr. Ciarán Breen:

Not unless the Government was specifically to outlaw such clauses in those kind of situations, and I do not know quite how that could be done.

Photo of John McGuinnessJohn McGuinness (Carlow-Kilkenny, Fianna Fail)
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I thank the committee members and witnesses for attending, and I thank Mr. Breen for being so open with us.

The joint committee adjourned at 4 p.m. until 9.30 a.m. on Thursday, 10 May 2018.