England and Wales High Court (Queen's Bench Division) Decisions

IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION

		Royal Courts of Justice Strand, London, WC2A 2LL
		08/06/2016

Mr Justice Turner:

INTRODUCTION

1. The first claimant is the mother of the second claimant. I will refer to them in this judgment (for reasons of convenience and confidentiality but with no disrespect) as M and J respectively.
2. M gave birth to J on 13 February 2010 at Birmingham Women's Hospital. J was born with cerebral palsy caused by oxygen deprivation during labour. M suffered a dangerous loss of blood and had to undergo an emergency hysterectomy to save her life.
3. They claim that the injuries which they sustained are attributable to substandard advice and care at the hospital and seek damages against the defendant trust which is responsible for its safe running.
4. The defendant denies that the advice and care provided fell below the requisite standard and contends that, even if it did, the injuries would have happened in any event.

THE BACKGROUND

5. M is an English teacher. She became pregnant at the age of 40 with what was to be her first and only baby. The pregnancy had gone well. The due date was 10 February 2010.
6. On 11 February 2010, when M was one day overdue, she attended the hospital on the advice of her community midwife who had some concerns about M's blood pressure and swollen legs. She was admitted to the antenatal ward, Ward 1.
7. On the following day, Mr Qureshi, the consultant on call, decided that it would be medically appropriate to induce labour because M was showing signs of developing pre-eclampsia. Mr Qureshi delegated the job of talking to M about this to a junior doctor, Dr Crosse. There is an issue about what Dr Crosse then said to M.
8. Induction of labour was initiated by insertion of a pessary of Prostin at 16.00 by Midwife Bates.^[1] Midwife Smith came on duty at 20.00 (the night shift) and she found things to be extremely busy, the ward having been one midwife down for the majority of the previous shift. Soon after she arrived on the ward, she introduced herself to M as a friend of her aunt. She saw her again a little after 23.00 and found her to be having "tightenings" at the rate of about 3 every 10 minutes. She started a cardiotocography ("CTG") scan to record the fetal heart rate and maternal contractions. It was found to be reassuring and was disconnected by another midwife. M then stood up and felt a gush of water caused by a spontaneous rupture of the membranes. Midwife Smith reviewed the CTG scan print out at 00.22. She then carried out a vaginal examination and recorded the cervix to be 1-2 cm dilated.
9. Midwife Smith's next note is at 02.05 at which time M was recorded as "not coping" and wanting pethidine which was duly administered at about 02.15. Midwife Smith also noted that she rang M's sister and birthing partner, B, at 02.20 asking her to attend. B gave evidence that she was asked to attend earlier than this but I do not need to resolve this issue.
10. By 04.20, Midwife Smith was noting that M was "becoming distraught again..." She recognised the need to make a reassessment but M was in such pain that she did not want to be touched. Eventually and after some persuasion, Midwife Smith was able to carry out a vaginal examination shortly after 05.00. By this time, M's cervix was 9cm dilated. She was clearly well advanced into labour and Midwife Smith recognised that M needed to be taken straight down to the delivery suite.
11. M was transferred to the delivery suite under the care of Midwife Ames and further CTG monitoring was commenced at 05:35. The trace was, at best, not reassuring from the start. Attempts to site a fetal scalp electrode were unsuccessful. Medical assistance was called and Dr Elgasim, the Registrar, was in the room at 05.44. He delivered J using the Kiwi Ventouse at 06.03. In the 15 to 20 minutes before delivery, there was a fetal bradycardia and J was born in a severely asphyxiated condition. It is common ground that he sustained brain damage in the last few minutes leading up to his birth. It is agreed that, had J been delivered and resuscitated by 05.59, all brain damage would have been avoided. To make matters even worse, M went on to suffer a very severe post-partum haemorrhage from which she very nearly died. It is further agreed that, had earlier delivery by caesarean section taken place, M's post-partum haemorrhage would have been avoided.
12. The hospital carried out an internal investigation (or root cause analysis) which concluded that the level of activity and bed occupancy both on Ward 1 and on the delivery suite was high and it is "possible" that if these areas had been quieter or there had been three midwives on the ward, "as per establishment", then M's care would have been different "in that she may have been transferred to delivery suite earlier for analgesia, in which case monitoring may have been commenced and the outcome may have been different." The report recorded that the delivery suite shift leader had spoken to the ward midwife earlier in the shift to say that the delivery suite was not going to be available to accept women for ongoing induction but that M was not mentioned individually at this time because there was then no indication for her transfer.

THE ISSUES

13. Issues have arisen on very many disputed areas both of primary fact and secondary inference. It has not been necessary for me to resolve each and every one of them. As Schiemann LJ observed in Customs and Excise Comrs v A [2003] Fam 55:

"82. A judge's task is not easy. One does often have to spend time absorbing arguments advanced by the parties which in the event turn out not to be central to the decision-making process.

83. However, judges should bear in mind that the primary function of a first instance judgment is to find facts and identify the crucial legal points and to advance reasons for deciding them in a particular way. The longer a judgment is and the more issues with which it deals the greater the likelihood that: (i) the losing party, the Court of Appeal and any future readers of the judgment will not be able to identify the crucial matters which swayed the judge; (ii) the judgment will contain something with which the unsuccessful party can legitimately take issue and attempt to launch an appeal; (iii) citation of the judgment in future cases will lengthen the hearing of those future cases because time will be taken sorting out the precise status of the judicial observation in question; (iv) reading the judgment will occupy a considerable amount of the time of legal advisers to other parties in future cases who again will have to sort out the status of the judicial observation in question. All this adds to the cost of obtaining legal advice."

14. Accordingly, my aim has been to give reasoned decisions on those issues of fact which I consider to be central but without dealing with every peripheral issue the resolution of which would not in any event impact on my essential findings or on the outcome of the substantive claims. Similarly, I have not articulated each and every argument of the very many raised by the parties before reaching my conclusions on these central issues. This does not mean that I have failed to absorb such arguments, merely that I have not regarded them to be sufficiently salient to justify express and specific reference.
15. Taking this approach, I identify the central issues to be these:

i) Did M give informed consent to undergo induction?

ii) Was M adequately cared for following induction?

iii) If not, would adequate care have prevented the injuries which M and J sustained?

INFORMED CONSENT

The law

16. The parties are in agreement that the proper approach in law to the issue of informed consent is to be found in the judgment of Lord Kerr in Montgomery v Lanarkshire Health Board [2015] 2 WLR 768:

"87 … An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient's position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.

89 Three further points should be made. First, it follows from this approach that the assessment of whether a risk is material cannot be reduced to percentages. The significance of a given risk is likely to reflect a variety of factors besides its magnitude: for example, the nature of the risk, the effect which its occurrence would have on the life of the patient, the importance to the patient of the benefits sought to be achieved by the treatment, the alternatives available, and the risks involved in those alternatives. The assessment is therefore fact-sensitive, and sensitive also to the characteristics of the patient.

90 Secondly, the doctor's advisory role involves dialogue, the aim of which is to ensure that the patient understands the seriousness of her condition, and the anticipated benefits and risks of the proposed treatment and any reasonable alternatives, so that she is then in a position to make an informed decision. This role will only be performed effectively if the information provided is comprehensible. The doctor's duty is not therefore fulfilled by bombarding the patient with technical information which she cannot reasonably be expected to grasp, let alone by routinely demanding her signature on a consent form.

91 Thirdly, it is important that the therapeutic exception should not be abused. It is a limited exception to the general principle that the patient should make the decision whether to undergo a proposed course of treatment: it is not intended to subvert that principle by enabling the doctor to prevent the patient from making an informed choice where she is liable to make a choice which the doctor considers to be contrary to her best interests."

The facts

17. It is not disputed that the justification for an induction in M's case was that there were signs that she was at risk of developing pre-eclampsia, a disorder of pregnancy characterised by high blood pressure and a large amount of protein in the urine. It is a condition which increases the risk of poor outcomes for both the mother and the baby.
18. M's evidence was that she thought all along that she was being induced simply because she was overdue and that she was told nothing about pre-eclampsia or the risks associated with it.
19. Having had the opportunity of hearing M give evidence, I consider that hers is not likely to be an accurate account of what happened. She is undoubtedly an intelligent and articulate woman. I find it inherently unlikely that she would have failed to ask why an induction was indicated if no explanation had been volunteered. It is to be observed that M had been provided with "Pregnancy Notes" which, on the first page, are stated to be "a guide to your options during pregnancy…intended to help you make informed choices."
20. One section of the Pregnancy Notes was headed "Preferences for Birth". It listed about thirty topics next to each of which there was a box to be ticked in the event that the topic had been discussed. Two of the topics related respectively to the reasons for inducing labour and the methods used. Each of these two boxes had been ticked on M's form to indicate that the topics had been discussed on 14 January 2010. M had filled in her comments in respect of the proposed topics in detail. Against those relating to induction she wrote "Prefer not to be induced". I am unable to accept that M would have merely submitted herself to a process against which she had previously expressed a written preference without making even the most tentative enquiry as to why it would be justified.
21. The defendant's evidence was that the advice to induce M's labour came from Mr Qureshi, consultant obstetrician, at the behest of Dr Crosse, a junior doctor. Both of them gave evidence. Dr Crosse made a note at 13.50 on 11 February in which she recorded borderline elevated blood pressure, oedema and protein in the urine, all of which are signs of developing pre-eclampsia. She noted a discussion with Mr Qureshi relating to prostaglandin induction of labour. Dr Crosse was a careful and considered witness whose evidence I accept to the effect that she would have explained the implications of the clinical findings to M and would have ensured that in the light of these she was content to proceed.
22. Further, at 15.00 Midwife Bates recorded in the ante-natal progress notes: "Discussed in depth induction of labour process. M consents to being induced." Although the weight of this evidence is reduced on account of the fact that the statement of Midwife Bates was admitted as hearsay and thus not subject to cross-examination, I consider that it lends some further support to the defendant's contention that informed consent was given.
23. A number of fair criticisms were made on M's behalf of respects in which guidelines, including the Hospital's own "Guidelines for Induction of Labour" ("the Local Guidelines"), were not followed. The Local Guidelines provided that the "decision to induce labour should be made by a senior clinician…with the informed consent of the woman and be fully documented in the woman's hand-held and hospital notes, and on the induction pro forma."
24. On a plain application of the Local Guidelines, Mr Qureshi failed to fill out the necessary paperwork. For example, he did not fill out the pro forma at appendix 2 relating to booking induction of labour. I am satisfied, however, that no such lapse, or indeed any other departure from the Guidelines, vitiated the consent which I found M to have given in her discussions with Dr Crosse and Midwife Bates. The obstetric experts were agreed that "the personal discussion by the midwife and doctor is more important in terms of the provision of information."
25. A further criticism was that Mr Qureshi had failed to speak directly to M, and he had made a decision to induce merely relying upon Dr Crosse to communicate it to M as a fait accompli. I do not consider that this criticism was a fair one. The decision that Mr Qureshi made was not that M would be induced come what may but that it would be medically advisable for her to be induced bearing in mind the risk of her developing preeclampsia. It was thereafter sensible for any informed consent to be given in a conversation with a junior doctor who was familiar both with the circumstances of the case and the advantages and disadvantages of induction. I do not criticise Mr Qureshi for leaving this task to Dr Crosse in whom he had personal confidence born of experience. Care should be taken not to treat guidelines as if they were statutes either in strictness of interpretation or enforcement.
26. A point arises as to whether M ought to have been warned before she was induced that the necessary support would not have been available on the ward or that a delivery suite may not have been timeously available.
27. There can be no doubt that the ward was extremely busy on the day in question. The unheralded absence of one midwife meant that on the ward there were two midwives responsible for 25 patients. Undoubtedly, the midwives were working under pressure and the need to prioritise was acute. This much appears from the report of the internal investigation. However, it is not suggested that a ratio of two midwives to 25 or so patients on an antenatal ward is, all other things being equal, unsafe. I am not satisfied on the evidence available that those responsible for recommending and effecting M's induction were negligent in not concluding that it was counter-indicated by the likely busyness of the ward or that they ought to have informed M that it was. Understandably, the Claimants have asserted that Midwife Smith was, in the event, unable to give M the support she needed. To the extent that Midwife Smith would have strongly preferred not to have to balance her priorities on the ward in such a way as to limit the extent of the time she would otherwise have wished to have spent with M this is true. M was, at times, obviously in some considerable distress. I am not, however, satisfied that this compromised the clinical, as opposed to the emotional, support which was provided.
28. The Local Guidelines provide that: "Before administering Prostin to a woman on the ward it is good practice to discuss this with the DS shift leader to ensure the workload allows ward Prostin to be administered." The expert consultant obstetricians, Mr Tuffnell and Dr Kyle, acting for the claimants and defendant respectively addressed this issue in their joint statement of February 2016. Mr Tuffnell concluded that the fact that the delivery suite was not taking elective activity a few hours after induction means that the advice would probably have been to delay the process. Dr Kyle took into account the fact that M was already in the antenatal ward and that it was not known when she might actually go into labour. The workload in the delivery suite would be likely to fluctuate over time.
29. The internal investigation revealed, and Midwife Smith confirmed, that the delivery suite that night was not able to accept ladies who were to continue their induction on the delivery suite. This, of course, would not impact on the acceptance of those ladies who had been found to be in established labour and, indeed, a chart identifying the occupancy levels of the delivery suite during the evening reveals that there was no relevant occasion during the evening when there was not at least one labour room available.
30. My conclusion is that it was reasonable for M to have been advised to undergo induction notwithstanding the potential prospect of very busy delivery suite overnight. It is easy to understand why the Local Guidelines provided that it would be good practice to discuss the induction with the DS shift leader but the practical utility of such advice is ineluctably limited by the somewhat unpredictable effects of Prostin in any event. It was not in dispute that the administration of a single dose of Prostin is effective in inducing labour in only 20% of first pregnancies. In M's case, her cervix was found to have been dilated by less than one cm in the vaginal examination which was performed immediately before Prostin was administered. Mr Tuffnell fairly accepted in cross examination that these factors generated an expectation "that it would take some time." Dr Kyle observed that the interval from induction to the onset of labour may be up to 72 hours.
31. I would stress that, in rejecting M's evidence on the issue of consent, I do not conclude that she has deliberately attempted to mislead the court in any way. The events of the night in question were horrific and the consequences were life changing. It is not unnatural in these circumstances that she should seek to divorce herself from the consequences of consenting to the process which led up to these appalling results. It is easy to understand how, over time, "I should not have consented" can become "I would not have consented."

Consent and causation

32. The parties are agreed that this is a case in which even if M had established that the pros and cons of undergoing induction had not been explained to her she would have to go on to prove that she would have declined her consent if they had. Against this background, I must consider the following factors:

i) No sufficiently detailed evidence was adduced as to what precisely M should have been told about the advantages and disadvantages of being induced so as to allow a useful comparison to be made with what, if anything, this court may have found she was actually told;

ii) There was no evidence from M either in her witness statement or in her oral evidence about what she would have decided if she had been given an account of the relevant pros and cons.

33. On this basis, I am not satisfied that the claimants have come anywhere near to establishing causation on the "but for" test. Accordingly, they must fail on this basis too.

CARE FOLLOWING INDUCTION

The law

34. In Sardar v NHS Commissioning Board [2014] EWHC 38 at para 25 the court observed:

"The legal principles applicable to claims for clinical negligence against doctors, nurses and midwives can be summarised in the following propositions:

(1) The test to be applied is the standard of the ordinary skilled man or woman exercising and professing to have that special skill.

(2) It is sufficient if he or she exercises the ordinary skill of an ordinary competent person exercising that particular art.

(3) He or she is not negligent if he or she has acted in accordance with a practice accepted as proper by a responsible body of medical people skilled in that particular art.

(4) The standard by which the individual doctor, nurse or midwife is to be judged is the standard of a reasonably competent doctor, nurse or midwife carrying out the functions expected of him or her in the delivery suite of a general district hospital."

35. The applicability of these principles to the facts of this case is not in doubt.

The standard to be applied

36. The starting point for the evaluation of the level of care provided to M after her induction must be to identify the objective standard to be applied, and by which those involved in M's care fall to be adjudged. The issue in this case has been occasionally clouded by the use of the terms "high risk" and "low risk" in different contexts and with different meanings. For example, M's pregnancy was high risk because she had previously undergone a large loop excision of abnormal cells from the cervix. However, by the time of induction the risk arising from this history, namely prematurity, had passed and so the label of high risk in this respect was no longer relevant. Furthermore, as the experts agreed, the fact that M was being induced for reasons other than going over term would justify her induction to be characterised as high risk in that particular sense. However, as will be seen, the relevant guidance, to which I will return, categorises high and low risk inductions by drawing a different line with consequences which have significance in this case. The important consideration must be to exercise care to establish the relevant context in which any given witness is using the terms "high risk" or "low risk".
37. On the issue of the timing of fetal heart rate monitoring, the evidence of Mr Tuffnell was that such monitoring should have been continuous in M's case once contractions became established because she was being induced for a reason other than prolonged pregnancy. It is therefore necessary to establish whether this approach is consistent with the relevant guidance material.
38. NICE Clinical Guideline 70 ("CG70") of July 2008 "Induction of Labour" provided national guidance at the time of M's induction in addition to the Local Guidance to which I have already referred. NICE Clinical Guideline 55 ("CG55") provided guidance on the "care of healthy women and their babies during childbirth." Also contained in the trial bundles was the local "Guideline for Intrapartum Fetal Monitoring, including Fetal Blood Sampling" which I have read but upon which little substantive reliance has been placed by the parties.
39. CG70 provides:

"1.6.1 Monitoring

1.6.1.1 Wherever induction of labour is carried out, facilities should be available for continuous electronic fetal heart rate and uterine contraction monitoring.

1.6.1.2 Before induction of labour is carried out, Bishop score should be assessed and recorded, and a normal fetal heart rate pattern should be confirmed using electronic fetal monitoring.

1.6.1.3 After administration of vaginal PGE₂, when contractions begin, fetal wellbeing should be assessed with continuous electronic fetal monitoring. Once the cardiotocogram is confirmed as normal, intermittent auscultation should be used unless there are clear indications for continuous electronic fetal monitoring as described in 'Intrapartum care' (NICE clinical guideline 55).

1.6.1.4 If the fetal heart rate is abnormal after administration of vaginal PGE₂, recommendations on management of fetal compromise in 'Intrapartum care' (NICE clinical guideline 55) should be followed.

1.6.1.5 Bishop score should be reassessed 6 hours after vaginal PGE₂ tablet or gel insertion, or 24 hours after vaginal PGE₂ controlled-release pessary insertion, to monitor progress (see 1.3.2.1).

1.6.1.6 If a woman returns home after insertion of vaginal PGE₂ or tablet or gel, she should be asked to contact her obstetrician/midwife:

when contractions begin, or

if she has had no contractions after 6 hours.

1.6.1.7 Once active labour is established, maternal and fetal monitoring should be carried out as described in 'Intrapartum care' (NICE clinical guideline 55). [Emphasis added].

40. Mr Tuffnell was asked the following in cross examination:

"So now we have a case where there were contractions after induction. So long as the CTG is normal this guideline is saying intermittent auscultation should be used unless there are clear indications for CEFM in CG55. Is that not right?

To which he responded:

"That is correct, yes."

41. Mr Tuffnell asserted that CG55 established a category of those induced for reasons other than prolonged labour which gave clear indications for CEFM. However, having been given an opportunity to find such a category in CG55 following a short adjournment, Mr Tuffnell was able to locate no such passage. He did refer to a quick reference guide but, upon closer scrutiny, this took his argument no further.
42. The Local Guidelines distinguish between low risk and high risk inductions. Low risk inductions can appropriately be carried out on the antenatal ward and high risk inductions must be done in the delivery suite. Those circumstances which mandate induction to be performed on the delivery suite are listed. They include severe pre-eclampsia but not signs of developing pre-eclampsia. None of the other factors in the list are material to M's case.
43. There is nothing in the Local Guidelines inconsistent with the national guidance to be found in CG70 and CG 50. Further, no other written material in the form of medical texts or studies has been brought to my attention to undermine the aptness of the Local Guidelines.
44. In the circumstances, I prefer the evidence of Dr Kyle to the effect that the Local Guidelines are sound and can be taken as a proper starting point from which the actions of those responsible for M's care can reasonably be judged. Of course, there must always remain a role for the exercise of clinical judgment but I find that Midwife Smith was entitled to exercise this within the parameters of a "low risk induction" as defined within the Local Guidelines.
45. The application of the Local Guidelines is, in part, dependent upon the stage at which established labour is achieved. CG 55 provides:

"1.6.3 For the purposes of this guideline, the following definitions of labour are recommended:

Established first stage of labour – when:

- There are regular painful contractions, and

- There is progressive cervical dilatation from 4 cm"

46. This definition of established labour was adopted in the Amended Statement of Claim and agreed by the midwife experts in their joint statement.
47. Mr Tuffnell purported to contend in the joint statement and in cross examination that this definition of established labour did not apply where the labour was being induced and he sought to apply a lower physiological threshold than that set out in CG 55. He attempted to justify this with reference to guidance prior to 2007. I reject this approach unsupported as it was by any confirmatory contemporaneous guidance, medical materials or expert opinion.

Shortcomings

48. Mr Qureshi did not prepare a plan for M as the Local Guidelines expected him to do. Appendix 3 to the Local Guidelines requires that "the frequency of subsequent maternal and fetal monitoring should be individualised and determined by medical staff and documented in the case notes." However, in the circumstances of this case I am satisfied that such a plan would have been redundant. I accept the evidence of Ms Fraser, the midwifery expert relied upon by the defendant, on this issue:

"…a woman who is being induced who does not have pathology and the midwife is dealing with standard inductions like this every day. I do not need to be told by the doctor that the blood pressure needs monitoring, whether labour is established and needs monitoring."

49. Midwife Smith, who at the relevant time had had 20 years' experience as a midwife, said:

"There was an absence of plan but I think we are experienced and, like you say, use your own judgement on things."

50. Mr Tuffnell and Dr Kyle were asked in the context of their joint statement whether the failure to fill out the pro forma made any difference to the outcome. Dr Kyle thought it unlikely and Mr Tuffnell expressed doubts only as to the capacity of the unit to cope.
51. I reach the clear conclusion that, with respect to the care given to M on the antenatal ward, any management plan would not have required a more rigorous or different approach from that laid down in the national and local guidelines.

The expert obstetricians

52. I do not doubt the genuineness of Mr Tuffnell's views but his inability to identify any literature or contemporaneous guidelines to support his call for continuous CTG, in circumstances nowhere else recommended, left him exposed to the charge that he was introducing a level of subjectivity which was ill-suited to represent a reliable standard by which to judge the actions of the hospital staff. I note also that if Mr Tuffnell's threshold for continuous monitoring were to be applied then it should have been started after M's waters had broken and contractions were taking place. Nevertheless he accepted in cross examination that M's management at this stage was in keeping with accepted practice. This inconsistency shed further doubt upon the robustness of the standard by which he considered the midwifery staff should have been assessed.
53. Save where otherwise appears in this judgment, I formed the view that the evidence of Dr Kyle was to be preferred on issues where she and Mr Tuffnell disagreed. Her approach was more internally consistent over time and did not, on the central issues, involve the maintenance of a stance unsupported by guidance. Mr Spencer on behalf of the claimants sought to undermine the credibility of Dr Kyle in cross examination with examples of errors and omissions in her reports and her contribution to the joint statement. This was a perfectly legitimate approach but ultimately I was left unpersuaded that the flaws upon which he focused amounted to any more than errors and oversights of the sort not infrequently encountered in relatively complex cases. The central tenets of her evidence remained unshaken and I was satisfied of her independence and objectivity.
54. It follows that I consider that national and Local Guidelines in this case provide a safe and reliable basis upon which to assess the actions of staff on the antenatal ward, and Midwife Smith in particular, in the period leading up to the birth of J.

Applying the guidelines

55. The Local Guidelines provided that following administration of Prostin:

Fetal wellbeing must be established once contractions are detected or reported. Following each dose of Prostin this is done by CTG initially, followed by intermittent auscultation (IA) in low risk women if CTG confirms normality.

Vaginal assessment should only be repeated if labour appears to be established, or following spontaneous rupture of membranes to exclude cord prolapse

Routine care and observations should be carried out as normal – see Appendix 3

56. With respect to follow-up assessment the Local Guidelines provided:

All women should be assessed vaginally 6 hours following administration of the first dose of Prostin…

With ruptured membranes there is no benefit to giving a second dose of Prostin and the woman should be transferred to DS for Syntocinon as soon as possible (workload permitting)…^[2]

57. Finally under the heading "Labour" the Local Guidelines provided:

When labour is established, the woman should be transferred to The Birth Centre if she is suitable or to the Delivery Suite for ongoing care and delivery.

58. By the application of these principles:

i) The point at which transfer to the delivery suite is mandated is when labour is established. This is the point at which continuous CTG monitoring is to be commenced in the context of low risk inductions;

ii) Established labour, as I have found, occurs when there are regular painful contractions and there is progressive cervical dilatation from 4 cm;

iii) The extent of cervical dilatation is assessed by vaginal examination;

iv) Vaginal assessment should only be repeated if labour appears to be established.

59. It follows that once Midwife Smith had performed a vaginal examination after the spontaneous rupture of M's membranes the point at which a further vaginal examination was to be carried out was when she appeared to be in established labour. The National Guidance CG55 makes it clear that vaginal examinations are not to be conducted as a matter of routine:

"Healthcare professionals who conduct vaginal examinations should

be sure that the vaginal examination is really necessary and will add important information to the decision-making process

be aware that for many women who may already be in pain, highly anxious and in an unfamiliar environment, vaginal examinations can be very distressing…"

60. Indeed, M's own reaction to vaginal examination after her waters had broken confirmed the aptness of the warning in CG55. She was recorded in the progress notes as "Difficult to assess as M so tense? Membranes absent as not tolerating examination…"
61. Of the experts, only Ms Greenway suggested that M should have been transferred to the delivery suite by about 00.30, relatively shortly after the rupture of her membranes. However, here and indeed wherever her evidence is contradicted by that of Ms Fraser, I prefer that of the latter. I note:

i) Ms Greenway was expressly critical of the lack of midwifery records relating to four hourly blood pressure examinations but a perusal of the records revealed that her criticisms were unfounded;

ii) In her responses in the joint expert report Ms Greenway listed a number of features which by 02.05 "were all signs/symptoms commonly associated with established labour. The midwifery decision to prescribe and give narcotic analgesia (Pethidine), a drug which should not be given by midwives unless she considers that a woman in in labour, suggests that M was considered to be in labour by 02.05." Ms Fraser's researches, however, revealed that the local protocol for midwives authorised them to give pethidine to women prior to being in established labour;

iii) In contrast to Ms Greenway, Mr Tuffnell agreed in cross examination that M's management was in keeping with accepted practice in the period immediately following the vaginal examination of 00.30. This disagreement between the claimants' own experts illustrates the uncertainty inevitably generated by seeking to impose a gloss on the relevant Local Guidelines in the absence of any other authoritative resource such as medical literature or conflicting documented national standards.

62. In summary, I reached the conclusion that Ms Greenway had allowed herself to become more of an advocate for the claimants than a purely objective expert. I do not doubt that this was unconscious but it limited the assistance that her evidence afforded to the court.
63. It was at or about 02.05 that Midwife Smith recorded that M was having three contractions every ten minutes. She was suffering from backache and not coping. Midwife Smith administered pethidine and auscultated the fetal heart. She did not perform a vaginal examination.
64. In his report, Mr Tuffnell was critical of Midwife Smith's omission but by the time he discussed the case with Dr Kyle, his opinion had shifted. This shift was explored in cross examination during the course of which he accepted that he was dealing with a "question of judgement where there is room for a difference of view." He went on to say that "in the end I suppose I am suggesting it is a midwifery view because it was a midwife that would have been performing that examination."
65. It follows from my earlier findings that Midwife Smith should have carried out a vaginal examination if M appeared to be in established labour. However, I accept the evidence of Dr Kyle and Ms Fraser that Midwife Smith was entitled to conclude that she was not. The following factors are significant in this regard:

i) No more than about 1 hour and 35 minutes had elapsed since the last vaginal examination had been performed. The Local Guidance expressly cautioned against too frequent examinations;

ii) The results of the earlier examination did not suggest that progress towards labour thereafter was likely to be rapid. The cervix had not yet effaced being still between one to two cm long;

iii) J's position in the womb was in right occipito posterior which is associated with longer labours;

iv) The Local Guidelines recognised that Prostin pains can be regular and painful but not effective at dilating the cervix. It is to be noted in passing that severe pain is often associated with an elevated pulse whereas M's pulse rate curiously remained at the lower end of the normal scale throughout the night.

v) As Mr Tuffnell conceded, this was a matter of midwifery judgement. Midwife Smith enjoyed a very considerable and obvious advantage over this court and the experts because she was there and witnessing M's presentation at first hand. Even the fullest of contemporaneous notes must inevitably fall short of being able to communicate a complete picture.

66. It is properly pointed out on behalf of the claimants that, at this stage, there was a combination of significant presenting features including: the breaking of the waters, the earlier progress of dilatation, the significantly increased level of pain and strong contractions. These were factors which Midwife Smith, for the most part, recognised in her evidence as features that she would be looking out for in her assessment of whether M had entered established labour. Nevertheless, bearing in mind the factors identified in paragraph 65 above and, in particular, the considerable advantage of first hand observation I am satisfied that Midwife Smith reasonably believed that labour had not been established by 02.05.
67. By 03.50, Midwife Smith noted that the pain in M's back was subsiding. She noted a small red area remaining from an allergic reaction to the Pethidine. It is contended on behalf of the claimants that it would be inappropriate simply to divide the passage of time during the course of the night into discrete points at which the judgment as to whether to perform a vaginal examination must be considered and that consideration must be given to the stretches of time in between documented visits by Midwife Smith. I bear this in mind but observe that caution must be exercised in attempting to "fill in the blanks" between events recorded in the notes with speculation. In particular, in the absence of evidence to the contrary I am not willing to assume that there had been any sufficiently salient development in M's condition to suggest that she had given the appearance of being in established labour prior to 04.20.
68. At 04.20, Midwife Smith records that M is "Becoming distraught again…" This clearly indicates that the situation was developing and suggests that her pain which, at least in the back, had recently been described as subsiding was becoming unmanageable. Midwife Smith felt that it was time to attempt a vaginal examination and, for the reasons I have already given, I do not consider that she could fairly be criticised for not making the attempt earlier.
69. Unfortunately, the difficulties of assessment which had first manifested themselves some hours earlier were encountered once again. Midwife Smith recorded: "…doesn't want me to "touch" her (auscultate, rub back, V.E.)" This evidence is corroborated by what M said in cross examination that "At that point I was beyond the point of pain and I wouldn't let anyone touch me, not even my sister."
70. She goes on to record: "Spoke to M, encouraged to breathe deeply, change position. Suggested V.E. to assess if establishing."
71. It would appear that Midwife Smith was beginning to make some progress as M's initial refusals seemed to soften: "…cannot make her mind up."
72. Midwife Smith recorded that she was "Spending as much time as I can with M but high activity on ward. D/S not taking elective work at present, as could have Synto with epidural."
73. At some stage between this visit and 04.40, Midwife Smith absented herself to attend to another patient. M's sister, B, said in evidence:

"Midwife Smith and myself were with M, and when Midwife Smith came to my sister, she said, "Let us see how things are doing, M" and M wouldn't let her go near and I tried to rub my sister's back and calm her down. She wouldn't let me touch her either, she was in such a state of pain, and then between us we decided that I would try and, you know, have a word with her, she said she would come back in a minute, and Midwife Smith went and then I managed to persuade my sister."

74. Midwife Smith noted on her return that "M declined to see other midwife. Very distressed…" Eventually, Midwife Smith's efforts paid off and at 05.05 she noted "Spent time persuading her to let me assess her. Eventually agreed about 05.00 but reluctant." On examination she found M to be 9cm dilated (anterior rim). In other words, she was well into established labour.
75. I cannot conclude that Midwife Smith's actions over the period of forty minutes or so before M gave her consent to a vaginal examination fell short of what was reasonable. I take into account the following:

i) Midwife Smith appears to have concluded that a vaginal examination was called for at an early stage in this process and she promptly set about trying to obtain M's consent;

ii) M was not merely reluctant at first but implacably opposed to an examination;

iii) Not even M's sister could persuade her to let her touch her;

iv) The efforts of Midwife Smith and B were showing signs of paying off when M could not make her mind up;

v) M had begun to place some particular confidence in Midwife Smith and was refusing to see the other midwife;

vi) The efforts of Midwife Smith and B eventually bore fruit.

76. The evidence of M and B was that Midwife Smith was shocked, apologetic and tearful when she discovered the extent to which M was advanced in labour just after 05.00. Midwife Smith said in evidence that if she apologised it was because she had to keep leaving M and coming back. Having had the advantage of seeing Midwife Smith giving evidence I am satisfied that she was a conscientious and empathetic character who would not feel inhibited about expressing concern about not being able to see M as often as she would have preferred to and would have been understandably fretful when she discovered the extent to which M was advanced in establish labour. I do not, however, regard this to be a safe basis upon which to conclude that Midwife Smith's response amounted to an admission of carelessness. What she wished had happened with the benefit of hindsight is not determinative of the issue.
77. It, therefore, follows that I find that the defendant's care of M did not in any material way fall short of that reasonably to be expected.

CAUSATION

What would a vaginal examination at 02.05 have revealed?

78. My findings on the issue of breach of duty are sufficient to determine the outcome of this claim but I nevertheless consider it appropriate to deal with the issues of causation in case I were to be found to have been wrong on breach of duty.
79. The first issue to be considered is what a vaginal examination carried out at 02.05 would have revealed. Ms Greenway accepted in her evidence that what would have been revealed by such an examination would be "a matter of speculation" and that it would be unreliable to draw inferences about how far labour had then progressed by working backwards from the knowledge that the cervix was 9 cm dilated by 05.00.
80. On this topic, Mr Tuffnell volunteered in cross examination:

"... Most biological features tend to have a curve a bit like that, so a sigmoid-type curve. So the labour will start off slowly, the cervix will thin and start to dilate and then it will get into a faster phase of labour around 2 cm to 3 cm. The labour will pick up and then, to be honest, typically nearer the end you sometimes get a bit of slowing down but women who are labouring very quickly will often, kind of, go over that hump and just progress on to a quick birth."

81. I took Mr Tuffnell, who was tracing his finger in a broad sweep through the air when giving this evidence, to be saying no more than that the progress of dilatation would, when reproduced graphically, follow an approximately "S" shaped curve. Mr Westcott QC on behalf of the defendants, however, emboldened by this reply, attempted to illustrate this point in his final written submissions in a graph purporting to show the likely extent of dilatation by reference to the special case of the sigmoid logistic function y= 1/(1+e^-1) thus:

[Diagram or picture not reproduced in HTML version - see original .rtf file to view diagram or picture]

82. I must admit, however, that the well-intentioned effort which must have gone into the formulation of this analysis was disproportionately greater than the assistance which it gave me.
83. Ultimately, it is not a mathematically plausible function which determines this issue but the lack of one. The progress of labour is, by its very nature, unpredictable. Towards one or the other end of any given timeline it may be possible to draw conclusions with some level of confidence but here the position at 02.05 falls well within the murky hinterland of doubt and speculation.
84. Mr Spencer QC on behalf of the claimants seeks to persuade me that even if the extent of dilatation at 02.05 were less than 4cm it would have been sufficiently close to mandate a further vaginal examination earlier than that which eventually followed on from the time when M was found to be becoming distraught again at 04.20. I do not agree. There is simply insufficient evidence of the extent of dilatation which would have been found at 02.05 to support this contention. The claimants fail on this issue through lack of proof on the balance of probabilities.

Earlier consent

85. The defendant seeks to show that, even if M had been transferred to the delivery suite at 04.30, the time thereafter to secure consent, set up the CTG, interpret the CTG, secure the attendance of the doctor and for a caesarean section to be performed would have meant that delivery would have been achieved no sooner than it actually was i.e. 06.03.
86. The speculative permutations involved in this approach involve the assessment of no fewer than eight variables any one of which would be susceptible to trimming down here or augmenting there. In the final analysis, I am simply not satisfied that M's consent would have been given any sooner than it actually was, even if she had been transferred to the delivery suite 35 minutes sooner. It follows that I am not convinced that, even in such a hypothetical situation, it could be said that she and J would not have suffered the tragic consequences which befell them in the minutes leading up to 06.03.

When did the relevant abnormality first become detectable?

87. After exploring various unattractive alternatives, the obstetric experts were left with two competing possible causes of the disastrous conclusion to M's labour.
88. Mr Tuffnell's opinion was that the process leading to J's hypoxia was a chronic one caused by a persisting pattern of strong contractions. The cause of the severe bleeding after the birth was the failure of the exhausted uterus to contract. If this analysis were correct then signs of fetal stress could have been picked up well in advance of the delivery if CTG monitoring had been in place earlier in the night.
89. Dr Kyle, in contrast, concluded that the most likely explanation for what went wrong was a sudden and complete abruption of the placenta.
90. Mr Tuffnell, in summary, prayed in aid the following in support of his theory:

i) Strong contractions, even at the rate of three in ten minutes, are capable of causing fetal compromise.

ii) Prostin can cause strong contractions.

iii) The progress of M's labour was consistent with her having strong contractions.

iv) There was no evidence of a clot having formed between the placenta and the uterus which is an expected consequence of an abruption. Mr Tuffnell had not come across a placental abruption without such a clot in his thirty years' experience as an obstetrician.

v) The CTG scan commenced in the delivery ward, in response to which Dr Elgasim was called before bradycardia became evident, was pathological from the outset which is consistent with the final stages of a chronic process not a sudden abruption;

vi) A very late acute abruption would not adequately explain the catastrophic postpartum haemorrhage and would be indistinguishable from the normal separation of the placenta from the uterus which would have occurred naturally in the aftermath of the birth.

vii) The severe haemorrhage is adequately explained by the failure of the tired uterus to contract down and prevent bleeding after the birth.

91. Dr Kyle relied on the following:

i) J was a big (and presumably robust) baby.

ii) The labour was relatively short.

iii) There was no meconium in the amniotic fluid which can be an indicator of fetal stress.

iv) The high pCO² reading in the umbilical cord vein was consistent only with a sudden and complete failure of gas exchange such as may be encountered with an acute abruption but not with chronic fetal distress.

v) The extreme severity of the postpartum haemorrhage is best explained by an abruption. The rate of contractions in M's case was not high enough to cause the uterus to be so exhausted that it failed to contract after labour. The abruption probably caused fetal material to escape in to the maternal circulation resulting in a coagulopathy resulting in massive bleeding.

vi) Although the lack of a retroplacental clot makes it harder to establish that there had been an abruption it is, at least, consistent with any such abruption being acute and of very late onset.

vii) The CTG scan is very indistinct particularly in the early minutes. At the stage before bradycardia becomes indisputably established it is consistent with no more than a suspicious as opposed to a pathological trace and does not therefore preclude a sudden and complete abruption thereafter.

92. The resolution of this issue presents the court with particular problems in the circumstances of this case:

i) Neither expert referred to any medical literature or studies in support of his or her competing claims. In the absence of such material the court is more than usually heavily reliant upon subjective and anecdotal assessments.

ii) The opinions of the experts on this aspect of causation continued to develop up to a very late stage and, in some respects, even during the course of trial itself. For example, Mr Westcott QC conceded that it was not until the evening of the second day of trial that the alleged significance of clotting problems in M's blood were first identified to be potentially relevant to his case on this issue. In the end he realistically abandoned reliance on arguments based on haematology. Mr Tuffnell, in turn, was unprepared for questions relating to the relative rates of O² and CO² perfusion put to him in cross examination. Without seeking to attribute or allocate blame, there was a distinct flavour of improvisation in the way in which these arguments were articulated by both expert obstetricians which did little to strengthen my confidence in the resilience of the hypotheses upon which they were based.

93. Against this background, I come to the conclusion that the claimants have failed to discharge the burden of proof on this issue. I readily acknowledge that in the vast majority of cases in which there is evidence on an issue the judge will rightly be expected to resolve that question one way or another. On this issue, however, the factors which I have identified above preclude me from being able to make a rational or logical choice between the stark alternatives.

CONCLUSION

94. In must follow that the claims of M and J fail on grounds both of breach of duty and causation. In cases like this it is impossible not to have very considerable sympathy for the claimants. It is perfectly understandable that those who suffer such tragically adverse outcomes will tend to assume that the doctors and midwives are to blame. This is particularly so where the unfamiliar context of an extremely busy antenatal ward is apt to give the impression of a lack of appropriate support. Nevertheless, the law is clear. Professionals, doctors and midwives alike, are to be found to be in breach of duty if the decisions they make fall outside the range of reasonable opinion and cause injury and loss. In this case, they did not and the claim must fail.

Note 1   I allowed the defendant (out of time) to rely upon a written statement of Midwife Bates (who has not been in good health) in response to an application to admit her evidence as hearsay.     [Back]

Note 2   The parties were agreed that this reference was to an elective and not a mandatory transfer.    [Back]