The side panel of this website has the relevant representatives. Please use this before reading our report. These quotes in the GMC's hearing are designed to give the audience a flavour of the true incompence of the General Medical Council. Mr Forde who represents Mr Spencer was superb in his attention to detail and robust defence based on the law as it stands.
Drs Samuel and Spencer decided to fight for their human rights. It started on Day 2 of the hearing. The GMC had taken an unusual break to read the new statistics report they had commissioned. Following that report after 18 years, they dropped the charges and the panel claimed there was no prejudice to the doctors. We disagree with the panel's decision.
The Chairman stated "Before I ask the Panel Secretary to read out the charges as they currently are, I should formally ask each of the doctors to confirm their name and registration number. Dr Spencer, could I ask you to stand and confirm your name and registration number?
DR SPENCER: Dr Stephen Andrew Spencer, 2305893
DR SOUTHALL: Dr David Patrick Southall, registration number 1491739
DR SAMUELS: Dr Martin Philip Samuels, GMC registration number 2732178.
Ms Sullivan then stated
I can indicate that since last Thursday I have been able to take instructions in relation to the charge and can say that in the light of Professor Hutton’s evidence – you will recall that Professor Hutton is a medical statistician – on behalf of the complainants and the GMC we will not be pursuing the following heads of charge. The numbers are the same in relation to Drs Spencer and Southall and the heads of charge that are not being pursued are 3(b), 4, 10, 12(a), (c) and (e) and 13 in its entirety”
In relation to Dr Samuels the heads of charge that are no longer being pursued in relation to him are head 4(a), (c) and (e) and head 5 in its entirety. All my learned friends are aware of this because I was able to notify them of this shortly after midday on Friday.
In addition there are a couple of typographical errors to correct. You may have noticed in head 14 of the charge faced by Dr Spencer “caesarean” is incorrectly spelt and I proposed to amend that so that it is spelt correctly. There should in fact be an “s” on the reference to “Ethics Committee” and it should be “Ethics Committees” in head of charge 6 as it relates to Drs Spencer and Southall.
The General Medical Council can be seen to be making typographical errors everywhere.
The doctor’s barrister told us all
“It may be a forlorn hope, but it may be of assistance to those who sit at the back of the room to indicate what the impact of these changes is upon that which these doctors face”
Mary O Rouke known to the legal profession as the “irish terrier” due to her ability not to represent her clients to a high standard. She told the GMC
“All I say on behalf of Dr Southall is that it is extremely regrettable that we have these charges dropped on what would have been Day 4 of the hearing, in a case where a complaint was first made to the General Medical Council in 1997 and it has been under consideration with the doctors since 2001. For a period of seven years Dr Southall has had aimed at him a number of charges which the GMC now admits it has no evidence to support. He has suffered injustice as a result of those charges remaining against him until now, not least in recent weeks because we have been putting our preparation towards preparing to meet charges that we now effectively have accepted are of no substance and no merit. Yes, sir, you should allow those amendments because to leave them on the Notice of Inquiry in circumstances where there is no evidence, would serve no purpose. The injustice is passed and it would be justice now to remove them”
The amendments to the charges were made after a decade. The Panel stated “That being the case, the Panel is happy that no injustice would be caused within the terms of the rules and therefore determined that the requested amendments should be made”
Mary O Rouke made further submissions “In respect of the applications about to be made, Dr Southall is not supporting them, not because he does not think there is any merit in them, but he believes, as it is going to be asserted in due course, that there has been inordinate and inexcusable delay on the part of the General Medical Council in bringing these matters to a hearing now in 2008 when they relate to events going back to 1989 and terminating in 1992 and 1993.
Dr Southall believes this delay cannot be explained and justified and most of it lies at the door of the GMC itself and, indeed, the complainants. But for his part, in order to make objections as a matter of law, he would be happy to assert that there is no prejudice to him that would not guarantee him a fair trial. He believes that with the allegations as now worded he can have a fair trial and can defeat the allegations one by one on their merits. That is what he wishes. He wishes to defeat it by my cross‑examination, on his behalf, of the witnesses who attempt to support these charges if we get there.
After a number of submissions and discussions Dr Southall withdrew while the others in the legal teams continued to fight the issues.
Mr Forde then stated
“to indicate that the Henshalls first contacted the General Medical Council in April 1997. My original bundle went up to 2004. I have now found the documents that take us right up to date in 2006, so we will paginate those consecutively. Mr Foster has a section in his skeleton argument about legitimate expectation, and we have available for you as well, but I will probably ask that it be distributed a little later, another bundle that comprises various representations made by officers of the General Medical Council, including the Chief Executive, expressing regret that the matter has taken so long and placing the blame very fairly and squarely on the shoulders of the General Medical Council.
Then perhaps we can have copies made of that bundle. If I can just explain what the bundle comprises, it is really all the interaction between Dr Spencer and officers of the General Medical Council since about the year 2000 or 2001, as well as the document that appears to us – and we do not know whether there is any earlier document – to indicate that the Henshalls first contacted the General Medical Council in April 1997. My original bundle went up to 2004. I have now found the documents that take us right up to date in 2006, so we will paginate those consecutively. Mr Foster has a section in his skeleton argument about legitimate expectation, and we have available for you as well, but I will probably ask that it be distributed a little later, another bundle that comprises various representations made by officers of the General Medical Council, including the Chief Executive, expressing regret that the matter has taken so long and placing the blame very fairly and squarely on the shoulders of the General Medical Council.
Sir, if I can deal with the skeleton, the Notice of Inquiry that we received in its final form was on 8 April 2008, lamentably close, in my submission, to the proposed date of the hearing of 8 May 2008. We still find ourselves being supplied with material not denoted as used or unused as recently as the end of last week, which has made preparation for this case a little difficult, but you will see from the second paragraph of my skeleton that you are being asked to deal with events that took place between nearly 18 and a half and 15 and a half years ago, and that causes obvious difficulties for the doctor.
Perhaps the best example that I can give, whilst you have the Notice of Inquiry in front of you, relates to your new charge 16, which, as you can see from the stem, requires my client to justify clinical care between three minutes past midnight and 12.30 in the afternoon of 15 December 1992. All I can tell you about his involvement on that date is that it was a Tuesday and that my client was probably asleep for more than half the period of time, but there are obviously very real difficulties in reconstructing his movements on that date – hospital rotas, the timing of clinics and matters of that sort. That is just a stark example of the sort of difficulty that we face.
I have described the delay in dealing with this matter as unconscionable and I stand by that submission. None of it is the responsibility of this doctor. Neither have we ever had, as I will be submitting the law requires, a sensible explanation for the considerable delay. It is possible to discern reasons as a result of the slow progress of the administration of this case, but we have never had a constructive and still await a constructive explanation of the delay.
We have the advantage over you in having read the witness statements, but I do not think it is contentious that recollections have faded dramatically. Some of the witness statements with which we have been served seem to have been signed this January and ask patients to recall events in the late 80s and early 90s, and their recollections have faded. In our submission, it is well known within medicine that it is often very difficult to get patients to recall matters such as informed consent even a very few years after the event. So there is a very real issue in this case as to whether or not there can be a fair trial of the issues in relation to fading recollections.
This is probably as old a case as any panel has had to deal with. It is interesting to note that obviously your rules changed in 2004; many of you will have been trained, I suspect, in relation to those rules; some of you may even during the process of consultation in relation to the standard of proof have been trained in relation to the sliding scale, and you will have to remove from your consideration the new regime.
Documentation may well have been lost, including likely contemporaneous correspondence between relevant medical staff and investigators. My client believes that there may have been some documentation emanating from him dealing with matters such as scoring with the other doctors. We are aware, thanks to the assistance of Miss O’Rourke, that it appears that there were meetings, which were minuted, and that the minutes have gone missing. The GMC apparently propose to call in relation to the 1989 application (your charge 2 so far as my client is concerned) and its approval (charge 5) a witness who purports to tell us that she is quite satisfied that nothing is missing as a result of matters being archived for an inquiry that took place in 2000, but she did start working at the hospital until 1994, five years after the events in question.
We also lack any contemporaneous documentation in relation to any changes to trial protocols. Again my client is struggling to recall whether in fact he spoke to the chairman of the local Ethics Committee, either in passing in corridors or more formally, in 1989 or 1990, but believes that there may be in or have been in existence minutes that have now been lost. He also believes that he commented on drafts of the medical paper, but that is not an allegation that is now being pursued, so I can move swiftly on from that
There are concerns about scans, particularly ultrasound scans; they form the latter part of the charges.
We have not seen the originals of those scans. We have seen reports of the scans which are quoted in the charges but I have absolutely no way of demonstrating on this doctor’s behalf whether or not those reports found their way into the notes on any date when he was responsible for the clinical care of Patient 6 or not. He may have had other clinical duties. That information may have been gained by radiology departments, junior doctors and appropriately delegated, so we are struggling in relation to the charges that you have set out at paragraphs 18 and 19 in particular.
Witnesses will have to attempt not only to reconstruct events, and this is a very real concern on our part, but to recall, as I have set out, the subtleties, nuances and prevailing medical culture at the time of the matters the subject of these proceedings. That is a concern because after acquired knowledge and current standards are likely to taint the views, both of experts and witnesses.
A lot of people are going to be extremely defensive and a number of practitioners that the General Medical Council is going to call about their role back in 1989/1990. You will see from the document that is being copied at the moment that there are a number of doctors against whom the Henshalls initially made complaints – eight or nine in all – and some of them will feature as General Medical Council witnesses, perhaps surprisingly. We are going to have to suggest to some of them that these clinical responsibilities may well have been theirs because that is what the notes appear to indicate. It will be difficult for them in the knowledge that they were once the subject of criticism and in the knowledge that standards may be very different now not to allow that to colour their evidence.
These matters have already been in terms of the central facts twice investigated. There was an inquiry which we do not regard as being a well thought out inquiry by Griffiths in 2000 and Professor Hull, commissioned by the North Staffordshire Health Authority also provided a report which certainly in relation to consent suggested that something in excess of 90 per cent of the patients recalled being adequately consented. The General Medical Council’s proposal, as I understand it, is only to call those patients who do not have a good recollection of the consenting process or who say adamantly that they were not able to give informed consent.
I deal with the outline facts in paragraph 2 and they are important because of both the timescale and what I say about the prevailing culture. I deal with my client’s acceptance he was a consultant paediatrician at the Neonatal Unit of the North Staffordshire Hospital. He qualified in 1976 and he had been a consultant since 1985, so these events took place three or four years after he became a consultant.
He came to this trial in the sense that it is believed the randomised study of what we will all become familiar with as “CNEP” commenced in 1984 and it would appear that in 1989 Dr Southall sought to recruit other centres to the trial and two centres expressed a particular interest – Queen Charlottes Hospital, whose investigators were Drs Modi and Harvey, and I say in passing they were the subject of allegations made by the Henshalls and represented by the Medical Protection Society but no longer pursued, and Drs Brookfield and Spencer were the responsible investigators at North Staffordshire and the relevant nurses were Wright and Lockyer, who were specifically trained to deal with CNEP. It is also important to recognise at this time the neonatal departments were staffed by highly skilled, highly qualified nursing staff. They are an entirely different calibre, in my submission, to those that operate within other areas of the hospital and they are usually assiduous in their duties as we shall see from the nursing care plan in due course.
We applied, on 29 November 1989, to our Local Research Ethics Committee. The whole process at this time, it seems to be accepted by all, was a fairly fledgling one in terms of medical ethics. Standards were extremely variable between district health authorities. Again, it will be difficult for us to reconstruct the prevailing culture at the time. The General Medical Council experts attempted to do so through various papers but it is quite clear that standards were extremely variable and there is a very real concern on this side of the room that we may be judged not by 1989/1990 standards, but by the standards of 2008.
I then set out further matters of history on that page but it is important for you to be aware of the fact that the Staffordshire Hospital recruited infants between April 1990 and October 1993 and there is complaint about the fact that they continued the trial for longer than some other centres. The aim of the study was to determine the benefit or otherwise of CNEP in babies with respiratory failure in an attempt to determine whether CNEP reduced 10 markers of disease in the newborn infant. Those were markers that Dr Southall had determined.
Again, of importance when one is dealing with issues of informed consent and recollection is the fact that the entry criteria required suitable infants who had developed a need for oxygen within four hours of birth. Again, the subtleties and nuances of the late 1980s, early 1990s, are unlikely to be capable of being demonstrated. There was identifiably a more paternalistic approach to neonatology than there is now, a real concern not to worry patients. We now know with various patient groups and agitation that the whole process of informed consent has changed dramatically in the last four or five years, but at this stage the intention of these doctors at all material times was to try and benefit these children.
I emphasise the fact that many of them were extremely ill and extremely premature and it is not suggested by the General Medical Council through these charges that any active harm was caused to anybody within North Staffordshire. There is a concern about one child with neck trauma and how that was dealt with but it is certainly our case that that was not an adverse event. Remarkably, despite the reporting, this case, as I indicated, is not about, as the Henshalls have been at pains to establish as you will see through the documentation, the death of their daughter in 1992 and the unfortunate brain damage sustained by Patient 6. That is the case that the Henshalls are anxious to bring before you. It is not the case that is pursued by the General Medical Council.
I have indicated that the explanation of the practicalities is to be found in the Parents’ Information Leaflet and there is an issue as to whether that was handed to each and every patient. Again, the burden that the GMC seek to place upon Dr Spencer is onerous and unrealistic. In charge 11(d) it is said that this doctor should have ensured that every parent had a copy of the parental information leaflet. That was a task sensibly delegated to junior doctors and trained nurses and in certain of the notes we have a note that the Parents’ Information Leaflet was given and a tick, but it cannot be the case, in my submission, that a consultant in this position with more duties than CNEP had a duty to ensure that every single parent had received the relevant form, particularly as you will be aware that children are born at all hours. Many of these children were born in the early hours of the morning when my client was not on duty and they had to be in the trial within four hours of birth. That is another example, in my submission, of the difficulties of this case.
I have set out what was said in lay terms – I hope it is useful – about CNEP. Some of you will be aware that the conventional way of ventilating children with respiratory difficulties was to do so through intermittent positive pressure. That of itself can damage the lungs because the oxygen is forced into the lungs under pressure. The theory behind CNEP was that if you placed a chamber rather like an iron lung, and you will see photographs of the baby’s head just poking through and it being in a chamber, and created a situation of negative pressure, that that might assist the respiration of the child and reduce the length of time the child was in respiratory distress. That was the theory. You will see in due course photographs. There is hardly anything one can imagine more dramatic than seeing a child who is encased in the chamber and it makes it all the more remarkable that some of the parents are likely to say we understand that they did not know that their infants had been entered into a trial, but visually it would have been of tremendous impact.
The approval was given on 11 January 1990 and on 22 March the Medical Research Council gave the study an alpha rating, one of the highest possible. Far from being a poorly-conducted trial, or one that was administratively deficient, it was seen by those dealing with it at the time as a first-class trial. That is something which should weigh heavily with you in the exercise of your discretion. You see Patient 6’s mother referred to. She was known by a different name at the time, then aged 28, an experienced mother who had had 11 previous pregnancies and had delivered seven children between 28 and 40 weeks gestation and had a previous child in CNEP who unfortunately died at the age of 10 months due to extreme prematurity, possibly associated with intrauterine infection, not a product of CNEP, although it would appear as recently as last Friday I have seen a newspaper report where the Henshalls hold to the view that there is a causative relationship between the use of CNEP and the unfortunate demise of one child and the brain damaging events suffered by another.
We know from witness statements and the lengthy letters that have been written on my client’s behalf that a Dr Clare Newell, then an SHO, entered Patient 6 into the trial. Appropriate consent was taken by her and she has provided a witness statement to that effect. She was concerned about respiratory distress syndrome and the child was in CNEP for 112 hours and then went into air, discharged home aged 24 days on 7 January 1993.
I have made an error. I said that the previous child died after 10 months. It was 10 months before and she died after a couple of days and I apologise for that.
What was happening in the background after 7 January 1993? At 22 months, according to my researches, so nearly at the age of two, Patient 6 was found to have quadriplegia but her mother had been expressing concern about her development from late 1993 and clearly relating her late development to CNEP. The family pursued medico-legal proceedings as far as they could and as far as we are aware sought the advice of many eminent doctors, none of whom were prepared to support the contention which they have always held to that there was a causative relationship between Patient 6’s brain injury and CNEP. We are not sure when they first consulted solicitors but we have seen a report dated November 1995 which is not supportive of any allegation of negligence.
Matters did not rest there. The family appear to have, in conjunction with other parents, sought still to pursue the matter. There were meetings that took place between them and Dr Spencer which I shall come to in a moment. Perhaps of importance dealing with the issue of delay, given my learned friend’s view of whom she represents, is the fact that as we know by late 1995 a report had been commissioned, it is suggested by myself, I think supported by Mr Foster in his skeleton in paragraph 3.2, that they were questioning the use of CNEP in late 1994, early 1995, 13 years ago. The General Medical Council were aware of complaints against a multiplicity of doctors from 1997, 11 years ago.
The General Medical Council for the purposes of this application are saddled with the Henshalls’ delay. It has nothing to do with the doctor. We were busy cooperating and when they attended outpatients, which they did not always do, we consulted with them. North Staffordshire made themselves available in various guises but for some reason they did nothing between 1995 and 1997, it would appear, so that is two years’ delay, which is regrettable.
In March 1997 they attended a meeting with Dr Spencer and others to discuss their concerns regarding CNEP. The documents are not yet available so I will take you back to them in due course. The minutes of that meeting indicates that they were pursuing medic-legal proceedings. In February 1999 a review of research procedures was set up by the Department of Health, now known as the Griffiths Report, and it reported in May 2000. We say it was demonstrably flawed, but putting that to one side much of it really was to try and set up a watershed in relation to research across the board because there had been no real bringing together of the practice of practitioners. That is some 10 to 11 years after the initial application.
As far as we can discern, part of the reason why the GMC did nothing between 1997 and 2000 is because they were waiting to see what was happening with the Griffiths’ report, and certainly recent case law suggests that that is not a justifiable excuse. They should have progressed their own enquiries during that three year period. Henshalls we say two years, GMC another three years, we are up to five years now of unconscionable delay by 1997, and of course we are now 11 years on almost to the day since they were seized of the matter in 1997.
I wonder if those bundles could be distributed now, please?
Mr Forde who was representing in fine form continued
Mr Forde Continued
To the General Medical Council. You can discern that from the second page of the letter. The first full paragraph:
“We feel there has been a serious breach of the protocol...and would like to make this a formal complaint to yourselves the General Medical Council.”
Not a lot seems to have happened with that complaint, again possibly because the General Medical Council were waiting for the May report and from Griffiths. What then appears to have occurred, and we have not burdened you with the affidavit, although if you wish to see it you can, is that on 1 November, the Hens halls both swore lengthy affidavits detailing their concerns in relation to events that are between nine and eleven years old. Quite why it took the General Medical Council four months to get us a copy of that affidavit, I do not know and we have had no explanation; this, in an old case which needed to be got on with.
We gave a detailed response on 16 May 2001, which you will find top right number 3, right the way through to number 7. It was drafted with alacrity within six weeks detailing the allegations, setting out on its second page how the CNEP trial works – that is the third full paragraph – how the consent form was dealt with, accepting at the bottom of that page that Dr Spencer did not take part in either obtaining consents or allocating babies to one or other method of treatment, which we say was the clinical norm at the time.
An awareness then of the problem with the nexials dealt with in the second full paragraph, which forms the subject of a charge, said by the standards of the day and disputed by us, to have been a sufficiently adverse event to have been reported. The General Medical Council know that they are in possession of a report from Professor Hutton that does not support that view. The problem never occurred in North Staffordshire and so query whether a problem occurring in another trial centre needs to be reported to the trial centre that Dr Spencer was operating in. Tremendous care was taken was the neck seal, as is indicated in the letter.
You are not currently being asked to deal with the patient named on the fifth page, although you will discern that that was initially an allegation made against us, dismissed ultimately for the reason that that patient was under the care of a Dr Brookfield, from whom you may be hearing and against whom serious allegations were made.
Patient 6’s progress is then set out. At various times Mr and Mrs Henshall have alleged that the clear signature in relation to the consent form was a forgery, or alternatively that she was too distressed or under the influence of anaesthesia, having had a caesarean section, to give valid consent; not an allegation currently proceeded with by the General Medical Council, but something which may have informed the decision of subsequent preliminary proceedings committees, a very serious allegation indeed.
We then have the suggestion that CNEP compromised the care in relation to the blood gases, but that does not seem to include the situation which existed, that the umbilical artery catheter was doing that constantly. There is then an allegation in relation to the ultrasounds, again possibly with the benefit of hindsight. There is a suggestion of conversation between my client and the Hens halls in the documentation which I will take you to, but he simply cannot remember the precise terms in which he discussed the scan or scans with Mrs Henshall on 22 December 1992 or 29 December 1992. There is then some scurrilous allegations made which we deal with in the conclusion where, effectively, as has long been the case, my doctor is accused of lying.
On 12 December, the Henshalls having raised another thirty new points on 13 July which we did not comment upon, we were told that the matter would be considered by the Preliminary Proceedings Committee, which you will see at page 8 under the old rule 4. On 28 January 2002, we were told, in terms, that the matter could not be going any further. You will see in the third paragraph:
“The Committee carefully considered the allegations against you and concluded that the allegations did not raise an issue of serious professional misconduct. Accordingly the Committee decided not to take any action in relation to this complaint. In reaching that decision the Committee took account of the following...”
No real prospect of allegations being proved; substantial efforts to show the programme should be carried out and parents dealt with; a team of professionals; the protocol was peer reviewed; the fact that the research programme was not completed indicates that those involved had been properly prepared and properly managed – a very sensible approach, which I commend to this Panel. In relation to the taking of consent, it was needed soon after birth. The practice between 1993 and 1995, and we are dealing with practice between 1992 and 1993, 7 January, when the practice on consent was less rigorous than it is today. It noted that statements and affidavits of those patients who alleged that informed consent was never given, most concede that some consent was given but they are not in a position to assess it properly.
“The Committee noted the emotional stress they were under at the time of giving consent. In view of this, it did not consider that there was a real prospect of these allegations being proved to the required standard. It also considered that there was a wider issue involved about the taking of informed consent for the treatment of very young children.”
They then raise some concerns about the information provided. They go on to say, importantly, in 2002, so some six and a half years ago, and I have quoted it in my skeleton argument at page 7:
“That the concerns were with the benefit of hindsight and in the light of how informed consent may be obtained today... but in summary the Committee felt that those criticisms which could be sustained in relation to those issues were sufficient to reach the threshold of serious professional misconduct required for a reference to the Professional Conduct Committee.”
Dr Spencer, Dr Samuels, Dr Southall all written to in similar terms, along with Palmer, Raine, Modi and Harvey et al.
From Dr Spencer’s perspective, back to work with a sigh of relief, but no. On 2 May 2002, the General Medical Council write and say, “We are going to re‑open this case because we have forgotten to consider 1600 pages of documentation”. Again, nothing that can be said to have been influenced by doctor’s actions. We took the view, and still maintain the view, that those documents added absolutely nothing to the serious allegations that the Henshalls were making.
As I have said, four lever arch files were received which did not advance the original allegations follows by another detailed submission dated December 2002 which it took the General Medical Council about five months to supply; no explanation for that.
It is right to say that there was considerable toing and froing then as to whether or not the General Medical Council had jurisdiction to re‑open the case. A lot of jousting in correspondence, with the General Medical Council taking leading counsel’s advice, but the letter of December 2002 should not have been written if they were not sure of their legal ground. It cannot be seen as any fault on the part of the doctor to indicate considerable unhappiness in relation to that matter.
It took the GMC until January 2003, which is document 16 in the bundle, eight months after they said they were going to re‑open matters, to actually do so. We supplied a response on 24 March 2003, which you have at page 19.
Again you will see that the sibling, page 20, was involved, but no longer pursued now. You find that the other issues that you should be concerned with started at page 23, internal page 5 of that letter. We still have the forgery allegation. That was ultimately to be placed very fairly and squarely at the door of a Dr Kate Palmer, whose involvement in this case ended at the time of the judicial review proceedings, to which I shall turn to in a moment, and whose case – and we will supply you with this document – was dismissed in very similar terms to that which this doctor’s case was dismissed, never revisited despite the seriousness of the forgery allegations.
We invite comparison. We rely on the Newell report, which was 1995, and then there is a suggestion, no longer pursued, on page 24 that there was a delay, in appropriate treatment for the benefit of research, a failure to give surfactant at the relevant time, that is no longer pursued. The thoroughly scurrilous allegation was being maintained that these doctors were involved in procuring caesarean sections against the interest of the foetus in order to provide the requisite number of babies for the trial. No longer pursued, but something which had been hanging over these doctors’ heads for many, many years.
You will see from the top of page 24 that there have even been criminal investigations, as in fact there should be because if any of those children were subjected to caesarean section against their medical interests and subsequently died, there would be very serious charges faced by these doctors; nothing came of that at all.
Then they there are concerns about the monitoring of Mrs Henshall, not pursued. The problem that we have on page 25 regarding the scan, Dr Newell is quoted at the top of the next page:
“Patient 6’s respiratory distress syndrome was satisfactory. He makes no adverse comment on the use of oxygen saturation monitors...”
now pursued:
“...nor does he suggest that arterial blood gas analysis was given too late. He says it was not neglect to fail to do a scan prior to 8 days.”
which was an allegation being made against us:
“Standard of care and note keeping was commendable...no evidence of negligence or care of a poor standard.”
It would appear that the brain damaging event occurred in his view before birth. That, we believe, is the view of all the experts who have been instructed, but it has not deterred the Henshalls from making a causal connection.
The concern we have about the ultrasound scans is reflected under (iv). It is the last paragraph:
“There is no record about Mr and Mrs Henshall being told about the scan results. However it was usual practice to share scan results with parents. In this case Mr and Mrs Henshall would have been told the scan results were encouraging which Dr Newell confirms was appropriate.”
Again I have indicated the difficulties of us locating either that somebody would divulge that information or, more importantly, Dr Spencer recalling, after this length of time, the precise nature of the conversation, which we can demonstrate from other documentation, must have taken place. There is a delay in diagnosis, no longer pursued; exclusion of Patient 6 from the trial because of gestational diabetes, no longer pursued; false claims in relation to the value and safety of CNEP, not pursued in relation to the paper but pursued, it would appear, in relation to the informed consent allegations.
Then you will see under the section headed paragraph 51/35:
“Dr Spencer is accused of ‘lying to us about the nature of the trial and the trial result and about the status of [Patient 6’s] neurological damage’.”
Again it is a constant theme:
“Mr and Mrs Henshall do not specify these alleged lies (ie what Dr Spencer has said and when).”
The next page, page 27, deals with the clinical care aspect. We highlight the fact that the Henshalls tried and failed to make out a case of negligence in Patient 6’s clinical management:
“Since serious professional misconduct means a falling short of the expected standard of care to a serious degree, it follows a fortiori that a disciplinary case against Dr Spencer cannot be made out.”
That comment holds as good today as it did then.
A little more on the CNEP trial and a concern on the last page about the Griffiths report which we do not need to go into because, ultimately, the Court of Appeal were to criticise the DPC for weighing the competing claims of the Hey and Chalmers article against the Griffiths report.
You then have, and we think this must have been about April or so, further allegations from page 29 onwards, made by the Henshalls. Just to give you a flavour of that which this doctor has faced, if you turn to page 36, with a slight change of position it is not that, “I do not recognise my signature, it has been forged”, it is now, “I did not sign it knowingly”, and then, “I would never knowingly have risked my children’s lives for an experiment. I was duped. If I sign the form and the one produced does indeed bear my signature, all I can say is that it means nothing, it does not mean I knew what I was signing for, or that I had made an informed choice”. Of course you recall the first document you have, the complaints that were being made, including number 4. Monitoring of a child while undergoing CNEP was not the same as a previous child of theirs had. These are reasonably well‑informed parents.
There is a suggestion of conspiracy upon conspiracy that Professor Hull has been Dr Spencer’s mentor and he was asked to look into the Beverly Allitt case, they have co‑written papers; allegation of forgery specifically made against somebody. On page 38, a fairly detailed information being given about the placing of umbilical arterial catheters.
We are accused on page 39 at letter 6 of again lying and problems with the temperature of children and so on and so forth. At page 41, the large paragraph at the bottom of the page, we are said to have adopted estate agents’ language.
What we are really here for, in my submission, appears at the end of page 42:
“We trusted twice and it cost us the life of one much wanted and loved little girl and robbed the other of a fair chance of fulfilling a happy and normal life unnecessarily.”
That is what has motivated this complaint.
On page 43, up to page 46, we dealt with matters after the matter was reopened. We believe that that should be 28 January 2004 rather than 2003. We have a number of allegations set out, a lengthy document that deals with that which is to be considered by the Preliminary Proceedings Committee. Again I am not going to burden you with going through all of it, but it bears little or no relation to the charges that the doctor now faces.
On 19 February 2004 we sent another lengthy letter to the General Medical Council, dealing with the allegations as they then stood, and that would appear to have satisfied the General Medical Council to the extent that we received – and this is the document that you will have starting at page 67 – a very lengthy letter from the General Medical Council, considering now, in March 2004, the documentation that the General Medical Council had somehow managed to overlook when they considered the matter in 2003.
This is paragraph 3.15:
“On 27th February 2004 the decision of the PPC not to refer the matter was communicated by a very brief letter…” –
which I have not included in my bundle but I know that Mr Foster has in his –
“… On 12th March 2004, nearly 14½ years after the application for approval, 14 years after MRC alpha rating and more than 11 years after the birth of [Patient 6] the detailed reasons concluded as follows…”
This detailed document was then produced by the General Medical Council, going through all the documentation that had been supplied, and, as was later to be suggested by the Court of Appeal, the weighing of the competing claims was said to have been an inappropriate exercise. On page 70, the rationale that was given, in my submission, holds good, and I have quoted it in paragraph 3.15 of my skeleton argument:
“The Committee carefully considered the information before it. It also took account of the amount of time which had elapsed since the events in question and was conscious that the human memory could be unreliable in stressful situations. The Committee considered the majority of the allegations were unsupported by any evidence before it and had no real prospect of being proved to the required standard. Moreover, the Committee was of the opinion that where there was, or might be in the future, some evidence in support of the allegations, they would not reach the threshold for serious professional misconduct even if proved. Therefore, the Committee determined that the matter should not be referred for public inquiry before the Professional Conduct Committee and it directed that no further action should be taken in relation to these complaints against you.”
What then happened was that the Henshalls applied for judicial review in 2004 and that was refused by the judge at first instance on 15 December 2004, so that is nine months after we had been told for the second time that this was an end of the matter.
The appeal was the directed to the Court of Appeal. That appeal took place on 27 and 28 June 2005. Of the ten matters of complaint put before the court, only three topics are now pursued, and we can identify those if you need to; I do not think there can be any dispute about that. Lord Justice Auld dissented; Lord Justice Sedley gave the leading judgment. The two substantive grounds on which the matter was referred, neither of which dealt with my client’s handling of the matters, were that Dr Southall had withheld his comments on the Henshall allegations, that he had been subjected to some concerning behaviour in the past, I think including a burglary, and was concerned about confidentiality going to the press, and the court was not happy about that and was not happy about the competing claims of the Hey Chalmers report against the Griffiths report. It took the Court of Appeal until 13 December 2005 for the judgment to be handed down, and one possibly discerns problems in deciding how the case should be determined, but again that is not something that is the doctor’s fault.
What then happened was that the Henshalls put in some more observations in September 2006 and the matters were then reconsidered for the third time on 2 November 2006, and that is the point at which we need to take up D1-B. Just to assist you, basically what happened – that first letter should be 28 January 2004 – was that the same potential charges were just sent out again in 2006 and then the Panel invited our comments on 13 October 2006 and we referred them to our previous letters, which you have seen, and then on 2 November 2006 we got the disappointing, but perhaps not entirely surprising, observations from the PPC, indicating that the matter should be referred to you. They were conscious, looking at our page 85, the third full paragraph, of the fact that the events were alleged to have happened 14 to 16 years ago and conscious that it should consider the allegations according to the standards of the time.
Quite how the PPC were able to do that certainly remains a mystery to us. They fall into the very trap, it would appear, that the Court of Appeal were disapproving of in comparing the Raine thesis against the Lancet article, because they are not judges of the evidence. They described the consent form as misleading or disingenuous, which is not something that we accept, rather skate over the fact that the Ethics Committee passed the application, said that it was not made sufficiently clear that premature babies were the primary subject of the study, which frankly is astonishing, given that the supporting documentation made it clear that the babies had to be within four hours of birth. If that is not premature, I ask rhetorically, what is?
They go on to decide on which charges, by reference to the first document that you have, should go forth and which should not. Apparently Mrs Henshall was able to indicate that only one day’s training took place. There was a conflict of evidence that they could not seek to resolve in relation to training. The ultrasound scan was in there, could not be resolved, gestational diabetes they decided should not be referred. Neck trauma: clear that there was a nexial problem with the apparatus – well, there never was – at Stafford, so that has to be referred, and that is effectively why we are here today. As I have said, it took them until November 2006, judgment having been given a year previously.
I am going to deal very briefly, if I may, with the law, and I do so relying only on the passages that I have in my skeleton argument, but can I summarise the position in this way: Ms Sullivan and I had a fruitful conversation this morning and in essence I think our agreed approach, subject to the views of the learned Legal Assessor, is that the two routes that you can go down in deciding that there has been abuse of process by reason of delay are either by way of Article 6 of the European Convention on Human Rights, which effectively suggests that the time runs from the moment that the General Medical Council are seized of matters. So, depending on your views as to the Henshalls’ delay, it would appear that that is only from April 1997. However, under the common law we are able to argue that you can look at the whole of the period, so that is from 1989 to 2008, and therefore under the common law you can express dissatisfaction about the length of time that it took the Henshalls to progress matters. In any event, there is no real explanation for the General Medical Council’s delay between 1997 and 2001, and certainly any delay occasioned by the failure to consider 1,600 pages of notes is not something that can be the subject of any criticism on the part of the doctor, and at the end of the skeleton – I will come to it in a moment – I quote a recent decision that suggests that the GMC cannot hide behind administrative delay under its new five-year rule. That is the basic position.
I have summarised what Article 6 allows. It is a fair and public hearing within a reasonable time before an independent and impartial tribunal. The right to a determination within a reasonable time is a separate guarantee, so, in other words, you do not have to find that it is fair and public, that you are independent, that you are impartial, and therefore, because those are all ticked, the time delay is not an issue. It is a stand-alone right that any doctor has appearing before this tribunal.
I say, I hope fairly, that so far as a breach of Article 6 is concerned, time has been held to run from the time that a practitioner is notified of the allegations made against him and procedural delays thereafter. You know that the initial notification was in 2001, so that would suggest a time period under Article 6 from 2001 to 2008, so it is seven years. However, I remind you of the fact that so much time had passed before then that a fair trial was almost certainly impossible even at the time we were initially notified.
It is right that you are informed of the fact that the case law – and I am sure that Ms Sullivan will rely on this – suggests that a stay can only be imposed on the grounds of unjustifiable delay in exceptional circumstances. We cannot countenance circumstances more exceptional than these, given the unconscionable and considerable delay. No default on the part of the practitioner, and I do not think that anybody is pointing to any.
One matter that you may be invited to consider is the approach of the criminal law. What is often said in the criminal context – and although you approach this applying the criminal rules of evidence, you are not a criminal court – is “Well, the defendant has had a long time awaiting his trial but the judge can sort that out, because if the judge was going to give the defendant nine years, he can say ‘You have waited five, so I will give you four’, or ‘three’ or ‘six’.” In my submission, there is a very real difficulty in importing that approach into disciplinary proceedings. You are aware of the fact that this case has attracted a great deal of publicity and you are aware of the fact that regardless of any decision that you make, whether it is ultimately that this application succeeds or whether it is ultimately that the case is not found proven rather at the end or at half-time, the press will almost certainly report that the General Medical Council is pro-doctor; that is the reality of the situation. Similarly, in my submission, you would be very constrained, if this matter was anything like approaching serious professional misconduct, if in the announcement of your sanction you were to say, “This is a case where we would have erased but, because the doctor has had to wait 18 years, we are going to impose conditions”. There would be outrage, and it would be justifiably asked whether you were acting in the public interest, if this doctor had practised since 1989 without restrictions and you now thought it sufficiently serious to erase. So, in my submission, the criminal cases do not assist because you are unable to tinker with sanction in the way that the criminal courts can. It is interesting to note that in the cases in which that has been alleged it has been prison sentence-lessened rather than, “You would have gone to prison but now I am going to give you community service”. It is not a huge difference in sanction.
I say in paragraph 4.6 that the state of the neonatal art and attitude to trials in the late 1980s, nearly 20 years ago, will have to be considered by any Conduct Committee and that this cannot be done fairly at this distance in time; and everybody, in my submission, will struggle to do that.
We say that the delay of itself, regardless of prejudice, which I shall demonstrate probably after lunch now, is sufficient for you to be satisfied that for these proceedings to continue would be an abuse or process, and I come back to the question: what were you doing on Tuesday, 15 December 1992, doctor? Surely you can tell us”. It just is not something that is necessarily going to be capable of proof one way or another.
I suggest an approach to be adopted by you, and I have quoted the passage from Dyer v Watson. Again this is, of course, subject to not only the views of your learned Legal Assessor but you will no doubt be addressed by Mr Foster possibly briefly, but Ms Sullivan at greater length, about whether this is an appropriate approach, but in my submission the first step is to consider the period of time that has elapsed, and if on its face that gives ground for real concern, as I suggest it should here, it is almost certainly unnecessary to go further. I accept that the threshold is a high one and not easily crossed, but it goes on to say:
“But if the period which has elapsed is one which, on its face and without more, gives ground for real concern, two consequences follow. First, it is not necessary for the courts to look into the detailed facts and circumstances of the particular case … Secondly, it is necessary … to explain and justify any lapse of time which appears to be excessive.”
We are still awaiting explanation, as I say in paragraph 5.2, and I come back to the period of time that I say should give you cause for concern.
It is right that you are informed, as I set out in paragraph 5.3, that the burden of establishing unjustifiable delay lies on the practitioner, but it is only upon a balance of probabilities, so is it more probable than not that the delay will prejudice the defence of this doctor many years after the event? The answer is “yes”. In my submission, that is the only answer that you can sensibly reach.
We do not concede that we need to demonstrate prejudice, but we can clearly do so, as I say in paragraph 5.4, and I give a further reason why you cannot regard yourselves as operating as a criminal tribunal. A judge, of course, cannot really influence how quickly a matter progresses to court, but you are embodying the General Medical Council, who certainly since 1997 were part of the investigatory process as well as prosecuting this action, so they are able to fulfil every aspect of the investigation and prosecution. A judge cannot ring up the local constabulary and say, “I had a bail application three years ago in this case. Can you tell me what is going on?” That is not what happens, but the GMC, through its offices, are well able to do that.
Can I then just deal with prejudice? I am thankfully going a little faster than I thought I might. We are able to demonstrate prejudice in this case in numerous respects, and I set them out on pages 14 and 15. I will add in an additional matter of prejudice that my client has informed me of this morning and I understand that Dr Samuels has similarly been affected. The first is obvious - the overall delay. 16 to 18 years makes, we say, a fair trial well nigh impossible, even in a case which may be said to be document heavy, you are dealing with attitudes of some years ago.
The evolving science and difficulties of recollection on the part of both the practitioner’s witnesses and any experts as to the state of neonatal art and the approach to trials in the late Eighties and early Nineties. The only General Medical Council guidance in 1989 that I can find effectively said if you are conducting a trial can you please make sure you are not getting a backhander from the pharmaceutical company. Your current guidance is far more detailed in relation to ethics and ethical trials and those of you who were practising at this time will know that there has been a sea-change in attitude in terms of ethics and ethical trials. There is no suggestion here upon the charges that any child came to harm as a result of this trial, whatever the Henshalls may believe. Nowhere will you find a charge that their child was damaged or adversely affected by CNEP.
We have a problem with the communication of the ultrasound scans which I have already flagged up to you. We do not know when the scan report was entered into the notes and, if so, by whom. We have a problem reconstructing Dr Spencer’s likely working pattern and whether any junior doctor can now be identified as having communicated the results of the scan so that after the event we suspect that is likely to have happened.
There are very real problems around this time period – 22 to 29 December – with the doctor recollecting what his duties were. He instructs me that in keeping with many in the profession he is unlikely to have worked both Christmas and New Year. He remembers that his son’s birthday is 28 December, as one would hope any father would, but that is about as far as he is able to go. It, in my submission, beggars belief that a failure of communication, non-causative as it demonstrably is in any event, could found a finding of serious professional misconduct 16 years ago. You forgot to tell a patient about a scan which was probably non-sinister.
The training allegation is another one that causes us difficulties. The difficulties of the recollection of systems relating to training, in particular communication of oral notification of changes to protocols which may well have occurred because that is the way things operated at that time, we certainly cannot identify potential witnesses very easily. We delegated quite properly training to senior nurses. The training offered to doctors at the time was very much on the job. Now we are in the world of 360 degree appraisals, clinical governance and that just was not in operation at this time, so it is difficult for us to demonstrate in a documentary way precisely what was going on.
My client tells me that he cannot find, but knows that they were in existence, the relevant clinical protocols that were there on the ward in the late Eighties, early Nineties. He has been able to find a 1994 protocol which we may be able to put to somebody such as Dr Brookfield, but he cannot find the ones extant in 1992. There is a very real prejudice there because these protocols would have been drafted by clinicians and nursing staff and should have been adhered to and that may be a particular importance when one comes to look at the allegations in relation to the taking of blood pressures at this time delegated to highly trained, highly competent nursing staff. As I have indicated, the majority of the time he was probably asleep in relation to one of the allegations and I can take you, as I know Mr Foster would like you to have the Panel bundles to the nursing care plan which indicates that the taking of blood pressures and the observation of vital signs was something which the nurses undertook in that care plan to do.
The stress of the proceedings is not to be underestimated. Ironically we have had several letters from officers of the General Medical Council regretting the delays in this case which we shall place before you after lunch. This is not to be underestimated, particularly if assurances had been given that matters were not being pursued. On two occasions these doctors had thought they could resume their careers unblemished and beyond criticism. I also complain, as you will have seen as a recurrent them with me, about the usual attendant unbalanced publicity and potentially remediable damage to professional reputation. You are not going to get a “Doctor not guilty” headline in this case. The reporting will be unbalanced and inflammatory. It is interesting that the moment I rose to my feet the press disappeared because all they were interested in was the appearance of the Henshalls. They are not interested in the justice or injustice of the situation of dealing with events that happened two decades ago.
The unavailability of witness – this is extremely prejudicial, particularly due to the lack of particularity that still exists in the charges. We have asked about this. Mr Foster, I know, has developed his skeleton argument to suggest that this is a further abuse of process. Dealing with the charges that we now face, we in particular have been concerned about charge 11. That suggests that we failed to ensure that appropriate procedures were in place to obtain informed parental consent to the patient’s participation in the CNEP trial.
The initial application had a Parental Information form which we are instructed was exemplary by the standards of the time. What we have never been told is exactly what it was that we should have done in order not to have to face this charge. In what material respects are our procedures deficient and what should they have been? We still await confirmation of what that should be because it is not something which appears to be supported by the paediatrician instructed by the General Medical Council, but by an ethicist who, as far as we are aware, never conducted a clinical trial in a clinical setting.
What training is it said would have been adequate for the time? Is there anything more than the technique being shown to be safe which is said to be a misrepresentation? Again, one is looking at the standards of the time. You will recall that Dr Spencer came to this in 1989/1990 and certainly papers published by his colleagues, Dr Samuels and Dr Southall, in 1986 indicated that it was a safe procedure. It is our submission that he was entitled to rely upon their research up to that point. I have dealt with 11(d). A clinician in Dr Spencer’s position simply cannot ensure that every parent has a copy of the Parental Information sheet and the likelihood is that those that said they did not get it have simply forgotten.
Allocation of scores – we are still debating that and we understand a little more of the General Medical Council’s position but, simply put, clinicians involving statisticians, to what extent would that ever found SPM?
I have dealt with charge 16, the difficulties that we have in recalling where we were and what we did but you can rest assured that it is unlikely this doctor was in the hospital before about 8.30/9 o’clock on Tuesday 15 December if he was there at all. The period of time from 003 to let’s say 9.30, because it seems to us is not a fair period to allege against this doctor if he was at home asleep. We may be able to reconstruct from the notes that Dr Brookfield was on duty at the relevant time. He is no longer the source of your inquiry.
We require to have identified to us, even at this late stage as far as paragraph 17 is concerned, every single period between this child’s birth on 14 December 1992 and 7 January 1993 when she was discharged when it is alleged that there was a failure, whether by us or nursing staff, to ensure that appropriate and regular blood pressure checks were undertaken and/or recorded in the notes. We have never been given that and there are real difficulties in this area. Some of you will be aware that it was not uncommon at this time for nursing staff to record notes on a private document or notebook and then complete the formal record at the end of the shift because they are busy looking after some of the sickest children in the hospital. Note-taking whilst important is not as much of a priority as dealing with saturation levels plummeting, alarms going off, arrests, concerns about shunts and hydrocephalous. It has a priority but how high? We cannot identify from the notes who might have been on duty. We can certainly look at the nursing care plan and see that the nursing staff appeared to have taken responsibility for that role.
We are still awaiting finalisation of the General Medical Council’s witness list and we are still getting as recently as last Friday more material though it would appear to be a completion of material rather than entirely new material, so I would not want you to think that it is entirely new, but it will still take a bit of looking at. We understand that somebody is going to be called to deal with the ethical position who did not work within the trust at the relevant time and we have certainly seen documentation which suggests that the views held by that witness may not be adverse to our position.
I then deal finally on the question of prejudice in the skeleton at least with the lack of availability of notes, training materials and the scans, documentary evidence of written communications regarding alleged adverse events, scoring systems and modifications to protocols. My doctor believes that he would have had some contact with Queen Charlottes but he cannot recall now and we know that, apart from minutes of the Local Ethics Committee dealing with the application in 1989, there is nothing else and we are certainly of the view, my client ironically having been involved in medical ethics shortly after this incident from 1992, there would have been more minutes. There may have been communicated amendments to protocols which were criticised for not having undertaken, either in writing or verbally or recorded somewhere, not a chance of finding them now. As I have said,
“This is a considerable handicap to practitioners and experts trying to reconstruct at this distance in time, treatment modalities, thought processes and the exercise of clinical judgment in an evidential vacuum.”
It also causes us, as representatives, some difficulties. I conclude by saying:
“Such prejudice is so severe it cannot be remedied by the burden and standard of proof.”
Sir, would you be prepared to adjourn a little early. It is ten to one. I just want to ensure that the next slim bundle that we have is ready to be handed out. I want to have a discussion with Ms Sullivan about whether she is happy for you to have the Panel bundles in advance of her opening because there are four or five pages I would like to take you to, but in fairness to her I have not raised the issue.
The chairman then stated “Would you think, however, that the matters which you have just been talking to us about at section 6 under the heading “prejudice” would be the sorts of considerations which the Lord Chief Justice had in mind in Dyer v Watson when saying that it is necessary for the courts to look into the detailed facts and circumstances and the outcome is closely dependent on the facts of each case. Mr Forde then submitted “My primary position is that you ought to be able to go back into your room and say this is so old we do not really need to find prejudice, but if you do need to find it, then we have it in spades”
If the primary decision is that you cannot have a fair trial, then that is the end of the matter. Just to give you a couple of examples, it was somewhat ironic to those of us practising in crime at the time the police officers were accused of perjury in the Guildford Four and Birmingham Six cases were able to say because our alleged perjury was undiscovered as a result of our nefarious actions for 20 years we cannot have a fair trial and the court agreed and then abuse of process started to be looked at a little more closely.
There is a case in Archbold which is 56 years old and, in my submission, although the High Court have always suggested there is a discretion open to a judge if there has been delay, again it is extremely rarely exercised. If you think about the sex abuse cases, particularly arising out of children’s homes, some of which are 30 years plus old, no suggestion that a judge says I am going to reduce your life sentence, even though you are a danger to children, because of the delay. It is a discretion which, in my submission, is sparingly used but not one which is, in reality, open to you because of the way in which this body is perceived by the public. If you were to conclude that a doctor should be erased it would be difficult, in my submission, to justify a lessening of sanction, but you will understand that Mr Foster, Ms O’Rourke and myself are reasonably confident that that is not a decision you will have to make ultimately.
Clearly, Mr Forde had his three shredded wheat and continued to work in defending the doctors. This is what he said
I have been made aware I have been going rather quickly, so I will try and slow down a little.
Before I return to the skeleton argument in relation to prejudice, I think it may be of assistance to the Panel if I take you through the charges, so you are able to consider them separately, as I am sure you will be advised, and indicate the prejudice that I suggest this doctor has suffered from, or will suffer from, if the matter proceeds.
Might I deal with first matter, which is charge 3(a). You have not seen the application, but we apprehend that the fact that it also referred to an infra red trial at the time of application, is criticised because not all babies who were subject to CNEP, at least initially, were also subject to the other trial, which is known as NIRS.
It is our case that in 1989 it was not uncommon for applications to go above and beyond that which was the subject matter of initial trial, in other words not all changes to protocols were necessarily notified. We are supported in that view, to some extent, by the General Medical Council’s paediatric expert, Dr Stimmler, and with the agreement of my learned friend I will read into the transcript a record of the conversation which took place with him recently. This is very much a charge which will require all witnesses to try and recreate the culture in 1989 which may be extremely difficult.
Similarly in relation to charge 6, there is no dispute that in February 1990 a patient at another hospital, Queen Charlotte’s Hospital, was found to have experienced neck trauma. As you are aware, our entry point for babies was not until April 1990. Our application had gone in on 29 November and had been approved on 10 January. Our case is, by the standards at the time, that was not an adverse event which mandated a re‑referral to the ethics committee of North Staffordshire Hospital. It did not occur at our hospital.
It is also possible it was discussed by my client with the chairman, but he cannot recall, and there is the possibility of further minutes revealing the reporting of the matter; again, not something which appears to be supported by the General Medical Council’s paediatrician, although I believe commented upon by their ethicist.
As far as changes to the scoring system are concerned, you know that those are dealt with in paragraphs 7(a) and (b). It is our case that eighteen years ago such a change did not mandate going back to the ethics committee. Again, first point, the relevant culture at the time; second point, difficulties of recollection; third point, possibility of missing minutes or notes.
The surfactant point is another criticism. Again, it is our case that this was not a change of the protocol which should have been reported. I make the points I have made in relation to paragraph 6 and 7. There may well be different views as to whether it was or was not something which should have been reported all that time ago. My client may not have reported it but, in any event, you will see from his correspondence in our bundle that it was introduced across the board, and I will take you to some comments made in conversation with Dr Stimmler.
The same point can be made in relation to paragraph 9 and paragraphs (a) and (b). There is no dispute that there was a change to the exclusion criteria from that at the time of the application in 1989. It may or may not have been notified, it did not place any child at risk, it was not sufficiently serious by the standards at the time to be something which needed to be notified to the ethics committee in any event. That is something which you will see reiterated in the correspondence in our D/AB1 and we have denoted it.
The difficulties with charge 11 I have touched upon already, and they only bear very brief repetition. The role of a responsible investigator in 1992, which is really the period we are most concerned with – but perhaps between 1990, 1991 and 1992 – again will require investigation of the responsibility of an investigator, and whether there was appropriate delegation to medical and nursing staff. We have asked for particulars of this as to whether there was a set limit. It seems to encompass both staff at Queen Charlotte’s and North Staffordshire. As far as the charge against my client is concerned, it is not clear. You will see the charge is mirrored in the Southall charges, although he was not working at the North Staffordshire Hospital at the relevant time.
We are still struggling to know what “adequate training” would have been, as set out in 11(b), what the misrepresentation is said to have been in 11(c), because, as I have indicated, the contemporaneous documents, certainly the studies in 1986 by Samuels and Southall, suggested safety. We struggle to, first, demonstrate that every parent had a copy of the parental information leaflet at this distance in time; secondly, to see why that is not a responsibility that could be delegated to an appropriate junior member of staff or appropriately trained nurses; and, thirdly, that allegation is maintained despite the fact that the Hull report seems to suggest 90 per cent plus of parents, again it has been dealt with in correspondence, were happy that they had been given adequate information.
The role of the responsible investigator in paragraph 12, in relation to the statistical evidence, again will require examination of the state of the art between, perhaps 1989 and 1992 in my client’s case, are difficult. There is no dispute but that a statistician, Mr Alexander, was part of the original team and it is really a matter for you as to whether you feel at this distance in time that you are able to assess the responsibility of clinical members of the trial team when they are employing a dedicated statistician.
The remaining charges perhaps cause us the most difficulty in terms of recollection and specific times and the reconstruction of events. I start with paragraph 16. I have made the point that my client believes – but it would be of course joyous from our perspective if we could produce work rotas and clinic times – that he would not have been present until about three hours before the end of that time period. We will have to, and we have struggled to, identify, and probably will never be able to, relevant nursing staff who would have been responsible, we say, for ensuring that vital signs were appropriately monitored.
I have managed to identify – and my learned friend is happy for me to read these into the transcript – the care plans. The first point to make is that with Patient 6’s sibling, born some ten months before, for the benefit of my learned friend it is page 3 behind tab 4 in panel bundle 2, there is an entry which makes it clear that the nursing staff, as part of their care plan, the need is identified as to breath unaided in air, and the care plan is, ventilation, monitor, respirations, oxygen, saturation, and I think that word is apex. That must be the heart. There is an umbilical catheter in situ and the blood pressures to be monitored via a transducer. That was 12/2/1992, so that gives you an indication of the normal standards within the unit and we say the doctor’s reasonable expectation of that which would be undertaken by nursing staff.
Then dealing with Patient 6, behind tab 5 at page 13, the nursing staff on 14 December are indicating that they will explain, something my client cannot decipher, but it looks like “explain IFC to parents”, “encourage parents to participate in care”, and then, more importantly, “inform parents of any changes in treatment or condition”. On the next page, page 14, “To observe respiratory pattern and rate, record oxygen saturations and to record and report any brachycardias or apnoeas”.
On page 16, again recorded as the responsibility of the nurse, “To administer oxygen as necessary, to observe breathing pattern and rate, to record saturations and vital signs, to record pressures and oxygen requirements, oral suction and endotracheal suction as required, to observe perfusion colour of lower limbs”, a whole raft of things properly delegated to experienced nursing staff which appear now to be levelled against us as criticisms. Never mind the time period in paragraph 16, in my submission the suggestion that a clinician was entirely responsible for these failures, if failures they were, is most unfair and difficult to defend at this distance in time. If we had been in a position to call the relevant nurses or identify the handwriting, it may have been possible to call them in rebuttal, but that is not something we seem to be in a position to do at this time.
That is a submission I make only in relation to paragraph 16. If I turn to paragraph 17, we have asked for each time period when it is alleged that during this doctor’s involvement in Patient 6’s care he failed to ensure that appropriate and regular blood pressure checks were undertaken or recorded in the notes. We had taken that possibly to be the same time period between 0.003 on 15 December and 12.30 on 15 December. It is right that this patient was booked in under Dr Spencer’s name and you know was born on 14 December and was discharged on 7 February. If it is the General Medical Council’s case that there were defined periods within that three week period or so, when we failed to ensure that appropriate and regular blood pressure checks were under or recorded, we would have liked them to be identified. At the moment we are struggling with this charge.
It is possible, for instance, or would have been had they been more closely defined, for this doctor to try and reconstruct events. He has, for instance, suggested to me that if the records existed of his outpatient clinic letters on any given day, he might then be able to say, “I know sixteen years ago that I did an outpatient clinic on a Wednesday afternoon”, and if that coincided with the time period when this criticism was being made of my client, we would be able to rebut it. But with the lack of particularity in that allegation, we are struggling to meet it because of the delays in this case.
And having taken a deep breath Mr Forde continued again
We very much doubt that we will ever have it available to us, which is the problem of the delay, but you are right to point out that it is a subtle variation on the delay abuse argument, and in fact has been dealt with I think most adequately by Mr Foster in his skeleton argument, where he is suggesting that lack of particularity is of itself an abuse. He also complains about the difference between matters placed before a PPC and those with which we currently stand charged, because one of our concerns is that if the expert evidence had been available to the PPC in the form that it is now, this matter may not have come to a Professional Conduct Committee, but that is not something that we will ever know.
If I can take 18 and 19 together then and just to give you some indication of the difficulties that we face in this regard, we again have some of the entries in the notes; just bear with me for one moment. There is alleged here a failure to inform parents of an abnormality on two separate occasions, 22 December and 29 December. It is not clear when the ultrasound report found its way into the notes. We have not seen the ultrasound scans and we do not know whether we were on duty at a time when they were available to us. What we do have, however, is some correspondence between the Henshalls and the Directorate of Child Health, Child Development Centre, Stoke-on-Trent, and for the benefit of my learned friend it is proposed Panel bundle 2, behind tab 5, page 209. That is a letter from Dr Heycock, a female practitioner, to Dr Spencer. It was typed on 30 June 1994, dictated on the 29th, and it refers to a clinic on 28 June 1994, therefore nearly 14 years ago.
In essence, the Henshalls during their consultation with this consultant paediatrician apparently initiated a lot of discussion about Patient 6’s management on the neonatal unit and were concerned as to why Patient 6 was ventilated on day 3 rather than day 1, but importantly, in terms of finding of witnesses and recollection, because my client simply cannot remember whether he had a discussion but believes that he is likely to have done or one of his junior staff may well have done, it says this:
“And she was also concerned that although she was present at the time of [Patient 6’s] ultrasound scan of the head, she was told this was normal.”
There have been suggestions that she was never told about the abnormality until such time as Dr Newell reported in November 1995, and again it is the subtleties and the nuances. It may have been that she was told that it was normal. She may also have been told, as my client believes she ought to have been told, that it was virtually or essentially normal, and therefore we are now dealing with an allegation of failure to inform of abnormality. These are shades of grey, I am afraid, which, to mix metaphors, must now be lost in the mists of time.
My client wrote in response to Dr Heycock on 28 July 1994 – and that is our page 211 – saying:
“I have offered to see this mother in my office on two occasions to discuss her concerns re [Patient 6]. The first appointment was cancelled and on the second the parents did not attend.
With regard to conflicting advice about the scan, I would note that [Patient 6] had mild symmetrical dilatation of the lateral ventricles and at one stage there was the possibility of a clot attached to the choroids plexus on the left side.”
You will see that in paragraph 18. He continues:
“The ultrasound changes could be considered virtually normal in a
pre-term infant and would not in any event be associated with increased risk of handicap.”
You will recall what I described as the motivating factor in 1997 for the complaint that a causal connection in the minds of the parents between this scan, although Mr Newell was to say that he thought the brain damage occurred prior to delivery, but they remained convinced that there is a causal link between the scans and their daughter’s current condition.
We have also been supplied with some of the comments that have been made by Dr Stimmler, who is to be called by the General Medical Council if this matter continues. In relation to surfactant, he is recorded as saying that he hopes the surfactant had been evenly distributed between both limbs of the trial, otherwise it could have affected the results. He said that the introduction of surfactant could not have been foreseen at the beginning of the trial and it was not a good enough reason to stop the trial.
In relation to the handing of booklets and information sheets, he thought that two leaflets should have been given, one medical and one nursing. It was most important that they had the medical information sheet. Well, we have a note that says that the parental information sheet was given to the Henshalls and that it had a tick next to it in the clinical notes, and that is the best we can do. In an ideal world there could have been a similar leaflet describing how positive pressure ventilation worked, but you will appreciate that we are not dealing in an ideal world.
He was asked about the neck injury and he is recorded as saying that injuries occur very easily in premature babies. Dr Stimmler was not surprised by the injury seen in the photograph. He did not believe that it could have been foreseen, and you will recall that it did not even happen at our hospital.
Dr Stimmler was asked whether the researchers should have returned to the Ethics Committee at this point and he said “No, it was probably just to proceed with the trial”.
He was then asked about the weaning off of CNEP and he apparently said that it would be the SHOs who would do the weaning and the consultants would rely on them.
In relation to head scans, he thought that one at discharge would have been appropriate, but we have one very close to discharge; and he expressed a personal view that the abnormality shown on one of the scans – it is not clear which but I think it is the first – should be told to the parents. He said that it was a personal view but he thought that it was generally accepted.
Once he had received the draft charges, he appears to have had a further conversation on 25 March 2008. He said in relation to randomisation that he had never come across it before, this specific method, but that it seemed reasonable, and suggested that a statistician should be asked to comment on this. You are aware that Professor Hutton’s views have led to an amendment of the charges.
With regard to the allegations relating to the failure to return to the Ethics Committee, he was not sure that an average person would have returned to the Ethics Committee at such junctures or whether an Ethics Committee would demand constant appraisal.
In relation to the charge that consent had been delegated to too many people, which I think is our charge 11, he said that given that the babies were being born at all times during the day and night, he did not see that it was unreasonable to delegate consent to the staff members on duty, and he did not see how this could be avoided. He commented on how the members of staff had given a reasonable account of how they would have taken consent. In his opinion, the technique had been shown to be safe on older babies and it was the introduction of the technique to younger babies that was new. He thought that generally it was acceptable to extrapolate the findings in older babies. So that gets round the alleged misrepresentation that the technique had been shown to be safe in paragraph 11c.
He was asked about the 12-hour period of monitoring and the readings that are the subject matter of charge 16. He thought that he had maybe been slightly too harsh in his report and that the period of criticism is really a 12-hour period, which therefore affects the readings that are to be included in the charge. Dr Stimmler mentioned that he was not sure that an FTP Panel would find this to be misconduct, as it is the type of incident that are frequently the subject of compensation claims. So, at best, negligence, which we know is not enough for SPM.
Then Dr Nicholson, whose impartiality I know is questioned by Mr Foster ---
The legal assessor stated "
At the moment, with that last bit, you are in danger of proving that you can defend the case."
Undeterred, Mr Forde continued
No, no, it is not that. What I am suggesting is that if there is a lack of certainty on the part of an expert, he is having a discussion – for instance, “Not sure the average person would have returned to the Ethics Committee; it was probably okay because babies are being born at all times during the day and night” – to then have charges that are critical of this, where there is wavering on the part of the General Medical Council expert possibly as a result of his inability to reconstruct events at the time, puts us in a very difficult position. It is my submission that we are not here dealing with a case which, when you come to exercise your discretion, should concern you because it is overall a strong case in any event, but we do have very real difficulties – and I know that Mr Foster will develop this in his submissions – in dealing with certain aspects of this case that have not been particularly strongly put by the General Medical Council’s experts.
We compare and contrast that, which is another aspect of our complaint as regards abuse, with the strong views expressed by the Preliminary Proceedings Committee, and having had no opportunity to deal with these aspects of the expert evidence until we have a Professional Conduct Committee hearing. That, it seems to us, cannot be a fair position. These comments could have gone back to the Preliminary Proceedings Committee for review. We have not had an opportunity to comment on the stance of these experts until I am doing so now.
I do not labour the point, and it will obviously be a matter for you, sir, as to how you advise the Panel as to whether I have strayed into the merits of the case to too great an extent, but I hope that the Panel can appreciate that when tentative views are being expressed, it could be, and I cannot put it higher than that, because even the GMC experts are struggling to reconstruct the culture at the time.
Bearing in mind your comments, sir, I do not think that I need to trouble you with the Nicholson comments, because on reflection they are probably straying into the arena of what can be proved and disproved.
My client wishes me to make the point – and I cannot find the reference in my bundle so far – but when I was taking you through the initial 75 pages there is a reference – and this is just the point that he wishes me to make despite the views of the Henshalls – to the fact that the Henshalls were consulted during a post-trial study, a long-term follow-up study was conducted comparing the outcomes in CNEP babies with babies on standard care, they were part of the steering group and it did not demonstrate any detriment to the patients in CNEP. I think that reference will be found for me.
Sir, can I just return then to the skeleton argument briefly, if I may. I think I had almost finished the prejudice as set out in paragraph 6. The one additional aspect of prejudice of which I have forewarned my learned friend about, and I think Mr Foster has a similar submission to make, relates to the thwarting to some extent of my client’s career whilst these matters have been hanging over him. He is quite confident that had he not been the subject of these proceedings for so long, he would not only have the qualifications but is likely to have been invited to have been the Medical Director of this Trust. He has been a long-standing consultant, and obviously his attitude to research has been quite severely affected by these allegations.
I am told, sir, that that reference is D1-B at page 83. That is the reference to the outcome. It is quoted in italics. Can I make it clear, both for the benefit of my learned friend and the Panel, that I do not place reliance on that? It is obviously important to Dr Spencer in terms of his view of his scientific credibility, but I would not invite you to necessarily adopt those findings. You have not heard the evidence and you would be falling into the very trap that the Court of Appeal criticised the previous PPC for, namely accepting one version against another. Dr Spencer was just anxious that I make the point that we had replied in that way.
Can I then move to the position under the new rules? I appreciate that this is not necessarily something that the Panel will have had to consider, and I can find no authority dealing with this point, so we are in uncharted waters here and I fully accept that.
The primary submission that I make is that the reason for the amendment to the 1988 rules initially in 2002, which introduced a five-year rule, and to the retention of that in Rule 4(5) of the 2004 rules is because of a very real concern on behalf of the public, practitioners and the GMC that old allegations would or might be unfairly pursued, and we are all concerned here about fading recollection and reconstruction of events.
The only exceptional circumstance that we were given at the time of the reconsideration that led to delay back on 17 January 2003 was that the loss of the documentation of itself amounted to an exceptional circumstance. In my submission, that only has to be stated for it to be quite obvious that there is nothing exceptional about that position at all. The courts have been visiting and revisiting this matter in relation to Rule 4(5), and at the end of my skeleton I quote two recently decided cases, which I am happy to supply to the Legal Assessor if he wishes to see them, but I hope that I have quoted them fairly.
It is my primary submission that you should look at the five-year rule and use it to inform you decision. I cannot pretend that it was in existence in 2001. It came into force between the first decision that this matter would go no further and the second. We were told in no uncertain terms that we could not import the new rule 6.8 into these allegations because they were too old, ironically, and we are really caught between a rock and a hard place. If the allegations had been even further delayed we would have had a run post 2002 on the five-year rule and obviously if they were being brought post 2004 we would be seeking to place an onus upon Ms Sullivan to say what was exceptional about this case. It is not exceptional because the Henshalls want it pursued – all complainants want their complaints pursued. It is not exceptional because they believe, erroneously we say, that there was a causative link between CNEP and the demise of one child and the brain damaging events relating to another. There is in truth and fact nothing exceptional about this case apart from the length of time it has taken the GMC to pursue it.
The case of Gwynn I deal with in paragraph 6.5 which did involve an administrative error on the part of the GMC and the court was unimpressed by the attempt of the GMC to elevate that to a level such that it could be regarded as exceptional. In Peacock, Sullivan J (no relation) repeated the rationale of Gibbs J. I have quoted what I hope is the most relevant passage of the case. There was a concern about the prematurity of the challenge, that there is a debate about what is exceptional and what was said at page 17 of Rule 4(5):
“The rule under consideration provides a distinct and free-standing safeguard which sets a general prohibition against the pursuit of long-delayed complaints. It provides only for very limited – i.e. exceptional – circumstances in which such complaints may proceed. I am not persuaded in the event of a wrong decision under that rule which allows a complaint to proceed further, there would be any satisfactory remedy later in the proceedings.”
He was suggesting also that in terms of serious professional misconduct something beyond “serious misconduct”, which is possibly the highest this case could be put, and not as high as that in my submission, could justify waiving Rule 4(5).
“It is possible the alleged misconduct may be so serious as to amount, of itself, to exceptional circumstances, but if that is the Registrar’s view, it should be clearly stated.”
It has never been suggested this is an exceptionally poor case of unethical research or failures in consent; far from it. As you are aware there have been those consulted by the GMC who regard it as being a good, if not model, trial.
I have quoted the aide memoir but I probably do not need to delay your deliberations by going through that and a requirement to give reasons, which of course under the Old Rules we have not been given and I will come in a moment to the statements that have been made by officers of the GMC in relation to delay.
I therefore say in conclusion that:
“The recent robust view of the High Court in relation to delay, as encapsulated in the interpretation of Rule 4(5) should be regarded as instructive and reflecting the current judicial view in attempting to adjudicate upon the merits of this case proceeding against the background of considerable and unexplained delay.”
I quote Lord Justice Auld in his dissenting judgment saying that, in essence, this is the position that we are still in. No identified advantage to Mr and Mrs Henshall in that the charges drafted barely scratch the surface of the matters that they are truly concerned about and they have led to professional disruption and personal distress on the part of the doctors which we will see in a moment has been acknowledged by the General Medical Council in the past.
It will be apparent to you, and it is again a question of weight for you, that it can be submitted that this is not the hearing the Henshalls want and there will be a considerable degree of cross-examination upon prior inconsistent statements as well. In looking at the public interest, you might want to consider whether it really is in their interests to be subjected to that with such documentation as we do have tending to allow us to dispute quite strenuously some of the claims that they made in the past.
Could I have handed up to you, sir, a final clip of documents. I am conscious that I have not dealt with one aspect of Mr Foster’s skeleton argument which relates to legitimate expectation. I am happy to leave him to deal with the case law, but it is perhaps something which can be suggested on behalf of Dr Spencer as well.
On 25 March 2004, Finlay Scott, the Chief Executive, wrote in relation to the fact that we had been told on 24 March the matter would go no further and he writes in the following terms:
“I am writing to apologise that it took so long to bring the CNEP related complaints to a conclusion. This should not have taken almost seven years. As you know, some of the excessive delay was a consequence of the decision to await the outcome of other inquiries. However, even allowing for this, we were clearly at fault because our handling of the complaints was poor and because the original screening and PPC decisions could not stand. I very much regret the distress that has been caused to you and to the other doctors.
I realise that it will be of scant comfort to you, but I am confident that we have addressed the causes of the evidence handling problems. I am only sorry that we did not do so earlier.”
Once again, I apologise for our failings.”
That was written in excess of four years ago.
My client replied to the letter. This is an unsigned copy but he assures me that this was his response. He acknowledges the apology in the first paragraph and then sets out the difficulties that he has experienced in terms of his career. He says:
“I was severely hampered in obtaining two senior posts, one as head of postgraduate medicine in the new medical school at Keele University, a post to which I was invited to apply. After my case was dismissed the first time, I had a very positive discussion with the Medical Director of the Trust in relation to a newly created post of associate medical director for Research and Development. When my case was re-opened I was told that it would be inappropriate for me to apply. Having previously had both considerable research and management experience I was very well placed to be successful in applying for either of these posts. In addition, both my personal life and my work has been affected in many other ways as you might imagine.”
Then he deals with the area which I am sure you are aware has attracted a deal of controversy recently. Paediatricians are feeling slightly put upon, I think, to say the least at the present time. Then he asks if he can contribute in any positive way to the training of staff and discussions just to address the underlying problems to result in better case management. He does not believe he received a response to that letter.
Dr Samuels meanwhile had written a much lengthier letter and he appears to have got a reply to a letter written at an equivalent time to the unsigned letter I have just taken you to. Ours is 23 April and he wrote on 14 April following a letter of 25 March which was in exactly the same terms as page 1 of D1-C, so both Drs Spencer and Samuels, as you will hear, received letters from Finlay Scott. In this letter, he acknowledges:
“… the delay in your case was excessive and arose from a combination of factors, including serious error on our part.”
He then goes through the pressures that the General Medical Council has been under historically, the increase in claims and what the proposals were on the second page:
“… within four months of receipt of a complaint a decision will be made whether to conclude the case or refer the doctor to the PPC … where referred by the PPC to the PCC, the hearing should take place within 12 months.”
The new Orders of 2000 and 2002, the 2002 Order bringing in the five-year rule under the 1988 Preliminary Proceedings Committee and Professional Conduct Committee Rules. Then he deals with the reviewing of decisions in the penultimate paragraph on page 4 and how they have a duty to process complaints. I think that is all I need to take you to in this letter. The rest of it is really a policy statement.
This is something my client wished you to be made aware of – the last document from Peter Swain, who is the current head of Case Presentation Standards & Fitness to Practise as short a time ago as 24 October 2007, in response to a letter written by my client to Professor Sir Graeme Catto, dealing with the difficult history of this case and the Court of Appeal decision, he indicates that the case is an extremely complex one – this is the fifth paragraph – possibly the nearest we have ever come to an explanation for the delay, but in many ways it has become less complex than it was if you look at the initial assertions being made by the Henshalls back in 2000-200.
“We aim to open cases at hearings not more than nine months after referral but in more complex cases such as this one such a timetable is often not realistic.”
We have concerns and my learned friend has helpfully provided me with a copy of the supplementary judgment in the Court of Appeal matter when the Court of Appeal as long ago as January 2006 were suggesting that the matter be dealt with as swiftly as possible.
“The matter should be remitted with the utmost expedition.”
We say implicit in that is also “and dealt with”. We are now nearly 18 months on from that and certainly the main judgment was in 2005. The nine month time period, ironically as we still find ourselves receiving expert reports, is said at the bottom of page 6 to
“… include a significant element for the defence to prepare its case after all the GMC’s evidence has been obtained and disclosed together with finalised draft charges.”
You may know that we were scheduled to start this case on 6 May. The reason that we started on the 8th was because the General Medical Council served their 8 April Notice of Inquiry within the 28-day period, so we were then asked if we would mind starting on the Thursday rather than the Tuesday, so that gave us under a month to prepare our defence and you are aware of the position with the Hutton Report arriving a week Friday. We were told and assured by Mr Swain in the penultimate paragraph:
“We are committed to seeing this case resolved as quickly as possible while ensuring that we properly and effectively discharge our statutory duty to inquire into the fitness to practise of doctors.”
Can I see if there is any other matter my client wishes me to deal with and then I should be able to sit down. )
Sir, I end my submissions as I end my skeleton argument. The charges, if proven, can find a founding of serious professional misconduct but that may or may not be something that weighs with you in the exercise of your discretion, but I do maintain that this is a very weak case and it has been made weaker by delay on both sides in terms of the credibility of evidence, but entirely on the General Medical Council’s side in terms of culpability for the length of the delay and against that background and for all the reasons and the submissions that I have addressed you upon, it would be unfair for this matter to continue.
Sir, those are my submissions, although as I have indicated I am happy to answer any questions from the Panel.
Barely taking a breath, Forde continued
“What I have tried to do, and as I have said, we are in somewhat uncharted territory, but the reason we perceive for the five-year rule coming into effect is because of a general concern about old cases. Whilst I cannot point to that rule being in existence at the time that these matters came before the GMC – in other words, 1997 – it is my submission, and again you are to be guided by the learned Legal Assessor as to the weight you attach to this submission, if any, but it is quite instructive to look at current jurisprudence and current thought about old cases as encapsulated in the five-year rule.
If you reach the view that if the case were brought now and was six years old there was nothing exceptional about it therefore you would be constrained in the exercise of your discretion to decide that the hearing should not go ahead, then that might help you in trying to work out where in the scale of gravity this delay lies. We are talking in terms of common law delay in excess of three times that length of delay and in terms of the notification of concerns from November 2000 expressed by the Henshalls a four month delay, we then find out in early 2001 and time at the very least runs from then, I think we are all agreed that that is the case, so we are seven years on.
It may be, and I put it no higher than that, that if you look at some of the rationales expressed in Gwynn and Peacock and you think that really does meet the merits of this case in 2008 that you could not rely upon the five-year rule but look at the approach to the five-year rule as encapsulated by the courts in deciding whether to exercise your discretion in our favour. I am not suggesting that as a stand-alone point that would win the day for us, but it might help you reach your decision.
Finally Mr Forde had chance for a sip of water. Mr Foster took over for Dr Samuels
: I hope a copy of my skeleton argument has reached the Panel. Any objective observer looking at this case will wonder what on earth Dr Samuels is doing here. That incredulity will have been increased this morning when a number of the remaining allegations against him were struck out. His involvement in these allegations is extremely peripheral. He was not at Stoke for most of the material time and he was never a clinician of any of the babies involved in this trial.
Because of the submissions which Mr Forde has made on behalf of Mr Spencer, I can be much shorter. From the chronology under paragraph 1 of my skeleton argument, I would make only these points. Almost all the documents which you need to look at have already been referred to in detail by Mr Forde. There are lots of documents to which he has referred in the context of Dr Spencer which are exactly mirrored in the case of Dr Samuels. The page references to the documents in Dr Samuels’ case are in the skeleton argument. I am not going to repeat them. You will be interested in the documents because of the dates on the letter heads.
Secondly, in relation to the documents which set out the allegations, and the responses to the allegation, the documents in the two bundles which I have just handed up will be mainly of interest to you for what they do not say, by which I mean there are almost no allegations which Dr Samuels was asked to comment on which now appear in the charges against him.
You will be interested in the documents for a third reason. The documents contain copious apologies and acknowledgments of fault on behalf of the GMC. So it will not be possible for Ms Sullivan, on behalf of the GMC, to say with a straight face, “We are not at fault here”, there is no inexcusable contumelious delay. She is stuck with that.
The three documents I particularly invite your attention to are the letter at page 7 of the first bundle, from the General Medical Council to Dr Samuels dated 15 March 2002. It apologises for the delay and says that no further action will be taken. There is then the letter of 25 March 2004 at page 2 in the second bundle. Mr Forde referred to it a moment ago, so I am not going to read it again into the record, but it apologises specifically and abjectly for delay in bringing the matter to a conclusion. In my chronology I have set out the most important section of it.
In the supplemental bundle at page 4, there is letter from the GMC to Dr Samuels dated 3 June 2004, again apologising abjectly for the delay. So far as the delay is concerned, I repeat and adopt the submissions made by Mr Forde. I respectfully agree that the analysis which you should adopt is the Dyer v Watson analysis. It is not necessary to show it is specific prejudice, but there is a good deal of specific prejudice which we can demonstrate in this case.
In a moment I will go through the remaining allegations against Dr Samuels and demonstrate what the prejudice is in relation to each. I make the following general comments. It is notoriously difficult for panels like this, for judges in clinical negligence cases and in lots of other medical contexts, to determine after a lapse of any significant time, let alone such a gargantuan time as this, what the standards appropriate to the material time were. That prejudice almost always redounds against the practitioner, as it does here.
Secondly, in relation to the issue of training, many of the medical witnesses who the GMC, if this case goes any further, would call, would say that they have no recollection of the instruction they were given, have no recollection about the training which they were given. I can exemplify that by reference to some of the witness statements which have been given to us. For example, here is Dr Claire Newell:
“I have very little memory of the trial, it was fifteen years ago, it formed only a very small part of my role as an SHO. Approximately ten years ago I gave a statement about consent to a firm of solicitors whose name I cannot remember. I would expect if I had been asked then I would have been a lot more accurate, I would have had a clearer memory then. I do not now, some fifteen years later, have any recollection of taking consent on this occasion, nor do I remember Mrs Henshall or Patient 6. I can only remember very little about the CNEP trial, although I recall that the aim of the trial was to see if it reduced respiratory problems in premature babies. I cannot remember the information we were given from the consultants about the trial to pass on to parents. I could not say whether it was something you picked up or whether we were given specific training about. It was such a small part of my workload, I just do not remember.
In terms of my usual procedure for taking consent, I can only say what I would do now, which is not the same as recording what I did then. I do not remember if I did things any differently than I did then.”
Asked about a specific patient:
“In relation to the amount of information I gave her, I cannot remember.”
Dr Arya:
“I had not worked with the CNEP before I arrived in Stoke. I do not remember how it was introduced to me. I think I would have been introduced to the CNEP by the doctors and nurses. I do not remember who in particular and I do not remember any formal training sessions. When you start a new job you get so much information thrown at you, it is hard to remember.
I think I was given some instructions, but I do not remember what I was told. I cannot remember what I was told to say, but I do remember what I would have said.”
Dr Wheatley:
“I seem to recall that there was a training session held on CNEP. Dr Spencer was very keen on research so I believed it would have been him who held the session, although I do not remember. I have quite a hazy recollection of the session and I do not recall any of the detail of what we were told.”
Dr Livera:
“I do not remember details of training or who conducted it. I have no reason to believe that any of the staff who worked with CNEP did so unless they had been adequately trained and were confident in its use.
I have been asked if I remember using the term ‘kinder’ and ‘gentler’ to parents. I do not remember using this term, I do not believe it likely. I do not remember if the consultants explored the exclusion criteria during the telephone call. I have been asked if the consultants checked if consent had been given. I do not remember exactly what was discussed.”
So it goes on and on; samples from the evidence which is being led by the GMC upon which they will invite you to say that these charges are made out. If the proceedings had been brought in reasonable time, one would expect a number of these witnesses, who go to crucial issues between Dr Samuels and the GMC, to have clearer recollections. The gist of the statements of the medical witnesses, some of which I have referred to, is entirely exculpatory so far as the adequacy of training is concerned and the standard of training generally.
One would expect, if their memories were as good as they would have been had the proceedings been brought in time, that the overall evidence would have been even more exculpatory than it in fact is. Also potentially available, had these proceedings been brought in time, would have been diary details, schedules and other documentary evidence of the amount of time that Dr Samuels spent at Stoke before he moved there, and of time which the staff from Stoke spent down in London before Dr Samuels moved on to Stoke. We have been deprived of that potentially crucial evidence by the GMC’s culpable delay.
I would invite you to turn to the remaining charges against Dr Samuels. Head 3(a):
“You inappropriately delegated the task of taking consent to too many different medical and nursing staff.”
How has the lapse of time affected our ability to defend that allegation, to whom was it delegated? What, according to the standards at the time, would have been the appropriate number to delegate it to, what was the process by which the delegations happened, are there documents somewhere in existence in a dusty filing cabinet which indicate exactly the terms in which the delegation was done?
Head 3(b):
“You failed to provide adequate training to those taking consent for the trial.”
What training was provided, what training according to the standards of the day should have been provided, what handouts were given to those who were being trained? Did the people who were being trained express any dissatisfaction or feel inadequate in any way with the training which they were given?
3c: “You misrepresented within the parental information leaflet that the technique had been shown to be safe”. What was the process by which that parental information leaflet was generated? Who were the responsible authors? Who had input into its production? What, again, were the standards that would be expected of such a parental information leaflet at the time.
3d: “You failed to ensure that every parent had a copy of the parental information leaflet”. It is difficult to see, of course, how Dr Samuels, being in Stoke and not a treating clinician, could have any impact at all on that. Assuming that this is an allegation that there was an inadequate system in place to ensure that every parent had a copy of the parental information leaflet and that Dr Samuels is in some way responsible for that system, being in London when this was being done at Stoke, questions such as this arise: What should he have done? Who was told what and when about the distribution of this leaflet to the parents? What parents were given copies of this leaflet? By whom were they given it? We have been deprived of potentially crucial evidence.
4b: “You failed to ensure that the scores were allocated correctly”. Whose responsibility was it for the allocation of the scores? What had been decided in the trial protocol about how responsibility for that allocation would be distributed? What, by the standards at the time, is the yardstick by which correct allocation should be judged?
4d: “You failed to ensure that there was an appropriate method of scoring”. The same questions arise as under 4b.
As I have said, Ms Sullivan must begin her submissions on delay in the light of what the GMC has specifically and abjectly said by saying, “Ever so sorry, we made a tremendous mistake here, there is obviously an inexcusable delay, but it does not matter”. For all the reasons that I have just gone through, she cannot begin to do that.
I move on to paragraph 3, legitimate expectations. Just before I do that, I should remind the Panel of other types of prejudice that result from the delay in Dr Samuels’ case: the stress that results from having his hopes raised and dashed on two occasions over a long time; the torpedoing of some of his professional ambitions; these allegations effectively stopped his research career dead for a while; if it had not been for this, he would now have been Professor Samuels; his clinical excellence award was delayed significantly by the delay in processing these allegations.
“Legitimate expectations”. There is a lot of law that I have put down in paragraph 3. The gist of it is this: people have a right to know where they stand. If a promise is made and that promise is later withdrawn, that is regarded by the courts in some circumstances as so unfair that the proceedings should be stopped. In my respectful submission, this is a classic case where that principle applies.
In paragraph 3.1 I deal with R v Bloomfield, Lord Justice Staughton. What had happened here was that the prosecution had said that they would offer no evidence against the defendant at a subsequent hearing and they then went back on that and sought to prosecute him:
“The statement of the prosecution that they would offer no evidence at the next hearing was not merely a statement made to the defendant or to his legal representative. It was made coram judice, in the presence of the judge.”
Pausing there, what we have here, of course, is not an informal comment from a prosecutor to us, saying “We might not be pursuing that allegation”. We have express written documents from the highest level at the GMC not only admitting that there is a failure in the system but also saying expressly that these practitioners will not hear any more about it.
That quotation continues:
“It seems to us that, whether or not there was prejudice, it would bring the administration of justice into disrepute if the Crown Prosecution Service were able to treat the court as if it were at its beck and call, free to tell it one day that it was not going to prosecute and another day that it was.”
In my submission, the public would be appalled if they knew that on two occasions here, over many years, these practitioners were told “Go away, get on with your lives, you are not going to hear any more of this” and then to be told by subsequent letters, “You have to face career-endangering allegations yet again”. That is the sort of change of mind that brings the administration of justice in this jurisdiction into disrepute, and it is one of the reasons why you have this jurisdiction to stop at case at this stage.
In the case of Mulla, the defendant was charged with causing death by dangerous driving. On the first morning of the trial the prosecution said that they would accept a plea of guilty to careless driving, the judge frowned at that and said to the prosecutor, “Go away and have another think”. That afternoon the prosecution came back and said, “We are going on with the original charge”. There was an application by the defendant that this was an abuse of process and the Court of Appeal said “no”, and it is not surprising that they said “no”. This is reported at the bottom of my page 4:
“This was not a case in which the defendant’s hopes were raised, later to be dashed.”
Pausing there, the case of Dr Samuels is, of course, precisely one in which the defendant’s hopes were raised not once but twice and then dashed. The quotation continues:
“He knew from the beginning of the proceedings in court, on August 14, that the judge did not approve of the course which the prosecution were proposing to take.”
The judge, in a sense, in this case is analogous to the GMC. The GMC itself is saying, “You will hear no more about it.
“He had not had his hopes raised by anything which counsel had privately said to him. It is true that, in the words of Staughton LJ in Bloomfield, the prosecution indicated to the court what its view was, but that, as it seems to us, is only one of the factors to be considered in a case of this kind. Other factors include what view is expressed by the judge when the prosecution gives its indication…” –
which is not relevant here –
“… the period of time over which the prosecution reconsiders the matter…”
There it was over the morning and the afternoon that they reconsidered the matter; her is it over years.
“… whether or not the defendant’s hopes had been inappropriately raised…”
Here, of course they have, repeatedly.
“…and whether there has been, by reason of the change of course by the prosecution, any prejudice to the defence.”
There is massive prejudice; I have just been through it.
There was a systematic review of the authorities by the Court of Appeal in the case of R v Abu Hamza:
“As the judge held, circumstances can exist where it will be an abuse of process to prosecute a man for conduct in respect of which he has been given an assurance that no prosecution will be brought. It is by no means easy to define a test for those circumstances, other than to say that they must be such as to render the proposed prosecution an affront to justice. The judge expressed reservations as to the extent to which one can apply the common law principle of ‘legitimate expectation’ in this field, and we share those reservations.”
Effectively, they did not like the label.
“That principle usually applies to the expectation generated in respect of the exercise of an administrative discretion by or on behalf of the person whose duty it is to exercise that discretion. The duty to prosecute offenders cannot be treated as an administrative discretion, for it is usually in the public interest that those who are reasonably suspected of criminal conduct should be brought to trial. Only in rare circumstances will it be offensive to justice to give effect to this public interest.”
Pausing there, one can well understand the reluctance of judges in the criminal sphere to let off, because of lapse of time, a terrorist, a rapist or a murderer. That is not the situation that you are dealing with here. You are dealing with practitioners who, as Mr Forde has demonstrated by some of his citations, are not roundly criticised by just the experts who the GMC proposes to call in terms of culpability. Even at the height of the GMC’s own case, this is right at the bottom of the scale. The quotation goes on:
“Such circumstances can arise if police, who are carrying out a criminal investigation, given an unequivocal assurance that a suspect will not be prosecuted and the suspect, in reliance upon that undertaking, acts to his detriment.”
I do not want to weary you too much with my voice, but I pick it up at paragraph 52, which deals with the case of Townsend:
“Rose LJ, giving the judgment of this court, approved the propositions: where a defendant has been induced to believe that he will not be prosecuted this is capable of founding a stay for abuse; where he then co-operates with the prosecution in a manner which results in manifest prejudice to him, it will become inherently unfair to proceed against him.”
That is precisely this case, in my submission.
“He added that a breach of promise not to prosecute does not inevitably give rise to abuse but may do so if it has led to a change of circumstances.”
For the reasons that I have been through in this case, it does.
The summary is at paragraph 54, as follows:
“These authorities suggest that it is not likely to constitute an abuse of process to proceed with a prosecution unless (i) there has been an unequivocal representation by those with the conduct of the investigation or prosecution of a case that the defendant will not be prosecuted…” –
We have two unequivocal representations in this case, not just one –
“… and (ii) that the defendant has acted on that representation to his detriment.”
He has, as I have pointed out.
“Even then, if facts come to light which were not known when the representation was made, these may justify proceeding with the prosecution despite the representation.”
Nobody has suggested that that applies, and in fact, as has been demonstrated by Mr Forde, as this case has evolved facts are coming to light which tend to exculpate. For example, a few minutes ago, just before we came back into this chamber, I was handed an attendance note from Dr Nicholson. It was dated the end of March this year and it indicated that he acknowledged that he was not an appropriate expert to deal with the design or conduct of clinical trials – precisely what in his earlier reports he had said he was able to comment on, and indeed about which he had commented in enormous detail.
My submissions under paragraph 3.4 are self-explanatory and I have made them already in the course of considering the relevant authorities.
I move on to paragraph 4. This is headed “Uncertainty about charge 3a.” Charge 3a reads, “You inappropriately delegated the task of taking consent to too many different medical and nursing staff”. That clearly raises the question: how many is too many? Accordingly, Dr Samuels’ solicitors sought clarification. I have set out there the relevant exchanges of correspondence. We have had no answer, except an assertion by Eversheds on behalf of the General Medical Council that it is a matter for the Panel to consider how many people it would have been appropriate to delegate to; not true. What the General Medical Council is doing by bringing an allegation against a practitioner is saying, “We think that this is the standard that the Council expects, and you have fallen below it”.
In order properly to respond to that allegation, we are entitled to know exactly where the bar is, so that we can determine (a) whether we have fallen beneath it and (b) if so, by how much. We have continued to press them and they have continued to refuse to give us proper particulars. I am not, on Dr Samuels’ behalf, in a position to respond to that allegation and I say that since one of the most fundamental principles of justice is that we should be able to know the case that is brought against us, it is abusive to continue with that allegation without giving particulars. Accordingly, unless and until those particulars are provided, you should stay that charge.
Paragraph 5 is headed, “Failure to give Dr Samuels an opportunity to comment on the allegations”. The 1988 rules say, insofar as material, this:
“Rule 4
Where the Medical Screener refers a case to the Preliminary Proceedings Committee under this rule, he shall direct the Registrar to give written notice to the practitioner:
(a) notifying him of the receipt of a complaint or information and stating the matters which appear to raise a question as to whether the conduct of the practitioner constitutes serious professional misconduct …
(d) inviting the practitioner to submit any explanation which he may have to offer.”
The rationale for the rule is obvious. It would be unfair if a practitioner was referred to the Professional Conduct Committee when either he did not know what the allegation against him was or, if he did know it, he had not had an opportunity to make an explanation which might convince the Preliminary Proceedings Committee not to refer him. It is an important safeguard. The rules have been ignored in this case. Dr Samuels has been deprived of that essential safeguard.
Of the allegations that impute fault that presently face Dr Samuels, he was given an opportunity to comment only about those in head of charge 3c, and that only in 2001 and not subsequently, and those in 3d. I say that in relation to 3c the failure to invite submissions specifically in relation to the 2006 referral is fatal. Effectively what the General Medical Council was doing in 2006 was saying, “We are going to start all over again, we will have your representations please, these are the allegations that you are facing at this stage”. They had not asked anything that can be construed as covering 3c since 2001, and they were obliged to. Therefore, head of charge 3c has not been validly committed.
In relation to 3d, you will see my submissions at paragraph 5.3. There is a very significant discrepancy between the existing form of 3d and the allegation which, it might be argued, covers 3d. The draft allegation is “You did not ensure that parents had adequate information about the CNEP technique to provide properly informed consent for the participation of their children in the CNEP trials, including a patient information leaflet”. It is a very different allegation from the existing one, which is “You failed to ensure that every parent had a copy of the parental information leaflet”, which implies that there was a duty on an absent consultant somehow to ensure that each parent received a copy. Precisely that point about the vagueness of the charges was taken by RadcliffesLeBrasseur on behalf of Dr Samuels. I have set out the terms in which they put the point. We are in a position now of Dr Samuels not having been given an opportunity to reply to the allegation that he now faces.
I now come to paragraph 6. I take entirely the point that the learned Legal Assessor made in response to Mr Forde, namely that I have to be careful to appear to be inviting the Panel at this stage to make any adjudication on the merits; and, of course, I do not invite them to do that.
I have said at paragraph 6.1 that there are two ways in which the prospects of success can be relevant at this stage. First, they go to how you exercise your discretion in deciding this abuse of process application. Even if a case is well out of time or otherwise abusive, a panel is going to be understandably more reluctant to accede to an abuse of process application if the case is obviously a good one. It would be reluctant to give a practitioner a procedural, technical, unmeritorious way out. The second relevance is that consideration of the merits is necessary because the merits indicate something about the motive for bringing these proceedings, by which I mean that if the prospects of success are extremely low, it plainly suggests that something other than an objective assessment of prospects and public benefit is acting.
There are in this case three notionally supportive expert witnesses who, if this case goes further, apparently the Council proposes to call. There is Dr Stimmler, who is a consultant paediatrician, Professor Hutton, a medical statistician and the third is Dr Nicholson. About the first two of those experts I cannot quibble. I cannot say that their credentials are such that they do not have the expertise necessary for their evidence to be validly adduced. I can say that about Dr Nicholson and it rather sounds in light of the memorandum which I have just referred to that Dr Nicholson is beginning to realise that too.
Dr Nicholson is an expert in no discipline which is pertinent to these proceedings. He was involved in paediatrics as a registrar and a clinical medical officer. He gave up medical practice in or around 1986 and he has edited a publication called The Bulletin of Medical Ethics since then. He has not been on the Medical Register for some time. He has never designed or run a clinical trial although he has sat on ethics committees. He has stood shoulder to shoulder with the Henshalls in their campaign against these practitioners over many years.
His inadequacy as an expert appears to be acknowledged now not only by himself in that memo, but also by the General Medical Council, because of course when Ms Sullivan stood up this morning and said that she was not going on with a number of the allegations which were originally pleaded against Dr Samuels, the ones which went were allegations which had originally been supported by Dr Nicholson, entirely out of his specialty.
I am not going to read into the record paragraphs 6.4 through to 6.7. What I do there is to cite long sections from the report of Dr Stimmler. He is the expert who is relevant to all the allegations under charge 3 and the only expert whose evidence is relevant to charge 3. It follows that there is no possibility of succeeding against Dr Samuels in relation to charge 3. My submissions under paragraphs 6.9 through to 6.11 similarly stand alone.
Ms Sullivan is in a very unfortunate position because of the rules. The rules necessarily create a possible conflict of interest. It is difficult to act objectively in the public interest while also acting, as the rules appear to allow one to do, in a partisan way for a complainant who has an agenda of their own.
I do not criticise Ms Sullivan for the way in which she has tried to resolve those two competing interests but it is perfectly plain that an objective look at the evidence in this case forces one to the conclusion, firstly, that there is no serious prospect of success in relation to any of these charges as against Dr Samuels. Even if there were, the charges are charges which comes nowhere near serious professional misconduct. If I had stood up this morning and on Dr Samuels’ behalf admitted everything which stands currently against him, we could have move seamlessly onto the stage of deciding whether these charges amounted to serious professional misconduct and the inevitable answer would be no.
In my respectful submission what we have here is a set of allegations brought effectively by the Henshalls. The General Medical Council in the letter which I have cited at paragraph 6.14 have assured Dr Spencer that they will have the final say over the form of the charges. Dr Spencer and Dr Samuels have a right to expect that that sort of objective assessment would be carried out. If it has not been, and it unfortunately seems that it has not been, it is for you to police your own proceedings and make sure that they are not hijacked abusively by people with their own agendas.
In my respectful submission the only just result in this case in relation to the allegations against Dr Samuels is that the case should be stopped. Sir, those are my submissions. Unless there is anything else I can help you with?
Ms O Rourke summarises her role in some interesting cases
Sir, I did have a case three years ago now in January 2005, the case of Chai Patel, where I made abuse arguments and asked for certain heads of charge to be stayed and the Panel did do that. The case then ended up in the Administrative Court because they did not do quite as much as I wanted them to do and the Administrative Court judge, Mr Justice Collins, gave permission for a full judicial review and stayed any further GMC proceedings. The GMC then collapsed the case by indicating that in respect of the rest of the charges that I had made objection they were conceding that they could not pursue them for the reasons that we had outlined in the judicial review, but the court had approved the fact that the Panel had already – I think there had been five or six applications under the head you are now looking at to stay things – they approved the fact that the Panel had stopped some of them and indeed on the advice of the Legal Assessor. I am sure we can get the transcripts if there is any doubt about it, but that is what had happened. They took a charge by charge approach, although it was one charge of serious professional misconduct and it was an Old Rules case. They took it as each individual one could be looked at in the terms of the prejudice.
I have also recently had a case before the Nursing and Midwifery Council which also ended up in the Administrative Court and they endorsed the same approach and indeed the judge, Mr Justice Beatson, said three months ago that it was appropriate that you looked at each one separately and looked at the prejudice in respect of each one because the test, as Ms Sullivan is going to tell you, she will say involves looking at prejudice and so you do then look at them differently because there may be heads of charge that involve prejudice and others that do not.
