Anderson v North West Strategic Health Authority [2015] EWHC 3563 (QB)

Case No OCA10003[2015] EWHC 3563 (QB)
IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
CARLISLE DISTRICT REGISTRY
Venue Royal Courts of Justice, Strand, London, WC2A 2LLDate 08/12/2015
Before
MR JUSTICE TURNER
Between
JAMIE-LEE ANDERSONClaimantNORTH WEST STRATEGIC HEALTH AUTHORITYDefendant
Mr Forde QC and Ms Jane Tracy Forster (instructed by Burnetts) for ClaimantMr Watson QC (instructed by Ward Hadaway) for DefendantHearing Hearing dates: 18 th to 25 th November 2015
JudgmentThe Hon Mr Justice Turner:INTRODUCTION
[1]The claimant was born on 24 April 1989 at the City Maternity Hospital, Carlisle. He suffers from cerebral palsy caused by oxygen deprivation in the period leading up to his birth. He is cognitively unimpaired but is afflicted with significant physical disabilities. He alleges that his condition was caused by the negligence of the doctors who managed his mother’s labour and for whom the defendant is legally responsible. His case, in short, is that the accumulation of risk factors before and during labour mandated delivery by urgent caesarean section. If this procedure had been carried out, he would have been born uninjured.

BACKGROUND

[2]The claimant’s mother (to whom in this judgment I will refer for convenience and without disrespect as Andrea) became pregnant for the first time at the age of eighteen. Her expected date of delivery was 21 June 1989. The pregnancy was medically uneventful until 8 April when she attended hospital suffering from backache and voicing concerns that her waters may have broken. She was admitted and remained an inpatient for six days over which period her backache persisted. Some recurrent vaginal blood loss was also recorded.[3]She was discharged home on 14 April but readmitted on the following day with further blood loss. On 17 April, a new episode of fresh blood loss was noted and a possible diagnosis of placental abruption was identified. On the following day, Mr Rangecroft, a consultant obstetrician and gynaecologist, recorded in the progress notes that this should be treated as a case of slight abruption. Andrea continued to lose blood and the records later referred to the possibility of an early labour. The discharge of clear fluid continued to fuel suspicion that there had been a breach of the membranes.[4]It was against this background that weak contractions were first recorded in the late evening of 23 April. At that stage, it was not considered that Andrea was in established labour. However, by 9.30 on the following morning, Mr Brown, a consultant obstetrician and gynaecologist conducting his ward round, recorded that delivery should be expedited. He made a written note at the time referring to the following: i) the fact that the pregnancy had lasted 32 weeks; ii) the ruptured membranes; iii) loss of vaginal blood; and iv) variable accelerations He later explained that this was an error and that he intended to record “decelerations” rather than “accelerations”. I accept his evidence on this. in the CTG readings. He asked for a vaginal examination to be carried out and queried the possible use of oxytocin to induce labour. He considered the risk of the need for a caesarean section. Whether this was explained to Andrea at the time is an issue between the parties but it is not one which needs to be resolved for the purposes of this judgment. In any event, she was thereafter transferred to the labour ward.[5]Mr Brown gave evidence explaining his likely thought processes at this time. He said that his reference to expediting delivery was in the expectation that it would happen in the next few hours and not straight away. I accept that this was what he had in mind. It is consistent with the fact that about two and three quarter hours later he is recorded to have been discussing with the registrar the use of syntocinon to hasten delivery without any suggestion that he was concerned that delivery had not yet been achieved.

THE RUPTURED MEMBRANES

[6]There was concern from a relatively early stage following Andrea’s first admission that her waters may have broken. In any event, it is agreed that this had occurred at least two days prior to her going into labour.[7]Premature rupture of the membranes gives rise, in particular, to an increased risk of infection which calls for clinical vigilance. It is not, however, a development which, without more, calls for the expedition of labour. The advantages of allowing the preterm fetus as much further time in the uterus as can reasonably be achieved is a strongly counterbalancing consideration.[8]Furthermore, I am satisfied that, once a premature labour has commenced, the fact that the membranes have ruptured some two days previously is not a factor which weighs strongly in the balance when assessing the desirability of performing an urgent caesarean section in response to other discrete complications. Indeed, Mr Forde QC on behalf of the claimant realistically conceded that this was the least significant of the factors upon which he relied to support his contention that there should have been an urgent caesarean.

BLEEDING

[9]A common and concerning cause of vaginal bleeding is abruption of the placenta. It often accompanied by abdominal pain. The placenta becomes partly detached from the uterus. The immediate impact on the fetus depends upon the extent of the abruption. Where the extent of the detachment reaches 30% the results may be fatal. Bearing in mind the signs of vaginal bleeding and the symptoms of abdominal pain, the differential diagnosis of placental abruption was, by common consent, a reasonable one. However, it is also agreed that this diagnosis, all other things being equal, did not mandate labour. Andrea was significantly preterm and the priority of “keeping the baby in” for as long as possible was a perfectly proper one.[10]However, the extent, if any, to which the suspicion of placental abruption should have impacted on the treatment and level of supervision which Andrea received once she was in labour is a controversial issue to which I will return later in this judgment.

CARDIOTOCOGRAPHY

[11]Of central significance in this case is the evidence of cardiotocography (CTG). The purpose of CTG is to measure and chart fetal heart rate and uterine contractions. Those with the responsibility of monitoring the print out must be astute to recognise signs of fetal distress which may be indicative of hypoxia. The presence of significant decelerations of the fetal heart rate can be indicative of the risk of harm the importance of which is assessed, in part, with reference to the timing of uterine contractions.[12]It is not unusual for the fetal heartbeat decelerate in conjunction with contractions. When the uterus contracts, the fetus may respond with a decelerated heartbeat.[13]Where such deceleration takes place as the contraction starts and before it reaches its peak and the fetal heart rate is restored close to the baseline shortly thereafter an early deceleration is said to have taken place. This is, in the absence of other features of concern, generally regarded as a physiological as opposed to a pathological response. Each contraction gives rise to a decrease in gas exchange with which a healthy fetus undergoing an uneventful labour is usually well equipped to cope with.[14]A late deceleration occurs when the fetal heartbeat slows down after the contraction reaches its peak. Inevitably, the extent, duration and persistence of such decelerations are important factors in the determination of their significance. In particular, a slow recovery to the baseline is not regarded as a good sign.[15]These categories of trace pattern (and more) were illustrated and analysed in “Fetal Heart Patterns and their Clinical Interpretation”, a text by Professor Beard published in 1974. However, in the following decade concern was expressed from more than one source that the interpretation of CTG patterns had hitherto been lacking in quantitative specificity and attempts were made, more formally, to categorise the appearance of CTG traces as a tool to inform, but not dictate, the choice of clinical response. FIGO[16]One such attempt was made by the International Federation of Gynaecology and Obstetrics (FIGO) and published in the International Journal of Gynaecology and Obstetrics in 1987.[17]The authors of this paper were quick to point out the particular challenges of interpretation of the record of fetal heart rates:
“1.4. Certain patterns of electronically monitored FHR recordings are strongly associated with specific changes in fetal condition. However, not infrequently uncertainty exists in respect to interpretation. Unnecessary operative interventions might be the result of incorrect interpretation and overestimation of the diagnostic potential of electronic FHR monitoring. Therefore it cannot be emphasized enough that understanding and interpretation of a FHR record is not an easy matter and that formal training in the underlying physiology and the practise of FHR monitoring is indispensable for all those supposed to make decisions on FHR records. Furthermore it needs to be stressed that whereas certain FHR patterns are sensitive indicators of fetal hypoxia, the specificity is low. It is rarely possible to quantitate hypoxia on the basis of FHR records alone and information derived from FHR records only represents one piece of information which always has to be interpreted in the context of the clinical situation.”
[18]Having acknowledged the limitations of interpretation of FHR records, the report goes on to define the relevant terminology:
“Baseline fetal heart rate is the mean level of the fetal heart rate when this is stable, accelerations and decelerations being absent. It is determined over a time period of 5 or 10 min and expressed in beats/min (bpm). Variability. …in clinical practice variability means long term variability. .. Long term variability is characterized by the frequency and the amplitude of the oscillations. Although the frequency may be important, it is difficult to assess correctly. Therefore variability is usually only quantitated by description of the amplitude of the oscillations around the baseline heart rate. Accelerations. Transient increase in heart rate of 15 beats/min or more and lasting 15 s or more. Decelerations. Transient episodes of slowing of fetal heart rate below the baseline level of more than 15 beats/min and lasting 10 s or more.”
[19]With these definitions in mind, the authors set about categorising the proper interpretation of CTG results as(a) normal,(b) suspicious or(c) pathological. With respect to intra partum monitoring the following was noted: Definition of intrapartum fetal cardiotocogram Normal pattern Baseline heart rate between 110 and 150 beats/min. Amplitude of heart rate variability between 5 and 25 beats/min. Suspicious pattern Baseline heart rate between 170 and 150 beats/min or between 110 and 100 beats/min. Amplitude of variability between 5 and 10 beats/min for more than 40 min. Increased variability above 25 beats/min. Variable decelerations. Pathological pattern Baseline heart rate below 100 or above 170 beats/min. Persistence of heart rate variability of less than 5 beats/min for more than 40 min. Severe variable decelerations or severe repetitive early decelerations. Prolonged decelerations. Late decelerations: the most ominous trace is a steady baseline without baseline variability and with small decelerations after each contraction.[20]It is to be noted that the FIGO paper does not attempt to mandate what clinical response is appropriate to the appearance of each of the categories of pattern which it defines. Indeed, it makes specific reference (in paragraph 13.1) to circumstances in which suspicious or pathological heart rate patterns are noted but where the clinical situation does not necessitate immediate delivery. There thus remains a very substantial role for clinical judgment as to what steps are to be taken in any individual case.

BOYLAN

[21]Also in 1987 was published in Bailliere’s Clinical Obstetrics and Gynaecology “Intrapartum fetal monitoring” a paper by Peter Boylan of the National Maternity Hospital in Dublin. The author refers to the classification of fetal heart pattern which had previously been deployed in a monitoring trial of 1985 in which he had participated. Variable decelerations were categorised as: mild, moderate or severe. Fetal heart traces were categorised as: ominous, suspicious, reassuring and non-reassuring.[22]As in the FIGO paper, however, Boylan’s analysis is not narrowly prescriptive as to the appropriate response to the development of an abnormal fetal heart pattern. He observes:
“If conservative measures do not succeed in correcting the fetal heart rate abnormality, then delivery or scalp pH and blood gas measurement In the present case, it is agreed between the parties that taking a fetal blood sample was not an option which fell to be considered by the clinicians. should be undertaken, the course of action determined by the severity of the abnormality and the likely proximity of delivery.”
[23]He also concludes from earlier studies that:
“There is good evidence…that abnormal patterns in the preterm fetus are correlated, to a greater extent than term fetuses, with abnormal outcome.”

GIBB AND ARULKUMARAN

[24]In “Fetal Monitoring in Practice”, published in 1992 Although this publication post dates the events with which this court is concerned, it is not suggested that the views of the authors fell outside the scope of reasonable medical opinion in 1989. , Gibb and Arulkumaran expounded the following proposition:
“The most critical feature, however, is the evolution of the trace with time. A change in the baseline rate and change in the baseline variability are the key signs of developing hypoxia and acidosis… Much time is wasted in discussion over whether decelerations are early, late or variable and whether they can be pigeon-holed into “good”, “bad” and “possibly good”
. Such discussion is fruitless. It is not each contraction itself that is critical but it is the evolution of the trace with time. The baseline rate between contractions, baseline variability and presence or absence of accelerations is critical.”[25]For the sake of convenience, I will refer to this approach as the “Gibb proposition”.

THE CRUCIAL PERIOD

[26]Following Mr Brown’s entry of 9.30, Andrea was admitted to the labour ward. Criticism has been made of the fact that, at this stage, no continuous CGT readings were taken over a period in excess of an hour before they were resumed at about 10.45. However, since it is now common ground that there is no evidence to suggest that such readings, if taken, would have given rise to any cause for concern, the issue of alleged fault has become causationally irrelevant and it is not necessary for me to resolve it.[27]At 10.15 the result of the vaginal examination requested by Mr Brown was recorded by Dr Dufour, an obstetric registrar of some seniority. The cervix was found to be fully effaced and 4cm dilated. A decision was made to review in two hours.[28]It is agreed that until about 11.30 the CTG readings on the labour ward did not show a pattern which would have given rise to any concern sufficiently serious to mandate an emergency caesarean section. Indeed, for a period of about 25 minutes until shortly before 11.30 the trace is entirely normal.[29]The next entry in the clinical records is timed at 12.15. The registrar notes no change on vaginal examination. He records the CTG “showing variable deceleration – a mild deterioration has taken place.” He notes that he had a discussion with Mr Brown and makes specific reference to the use of syntocinon, a drug used to stimulate contractions and thereby hasten delivery. I am satisfied that Dr Dufour would not have recorded the results of the CTG pattern at this stage without having looked at the trace and having formed his own view of the significance of the patterns it had produced.[30]In the event, Andrea went on to give natural birth at about 13.40. However, from about 12.30 the claimant had begun to suffer the consequences of hypoxia which have given rise to the disabilities which now form the basis of his claim.

THE MANAGEMENT PLAN

[31]The claimant criticises Mr Brown and his colleagues for failing to formulate or document an adequate management plan. The experts disagree on the issue as to whether it was common practice in 1989 for such a plan to be formally set out in writing. Again, however, I am not persuaded that this issue is causally relevant. Even the most meticulously documented and detailed plan would probably have made no difference to the timing of the labour. The record at 12.15 demonstrates that both Mr Brown and Dr Dufour had applied their minds to the developments in Andrea’s condition without concluding that a Caesarean Section was mandated. The history of suspected abruption and membrane rupture was well known and had been specifically noted in writing by Mr Brown less than three hours previously. It follows that whatever plan had been formulated or recorded it is unlikely that the doctors would have acted any differently or would have reached any different assessments at any stage prior to 12.15. There is no indication that the clinicians involved were at all concerned at 12.15 that anything had gone awry through inadequate obstetric involvement, lack of clarity of purpose or misunderstanding over the previous two hours. The central issue must therefore be whether this conservative approach was negligent. If so, then matters of timing and causation arise. If not, then the claim must fail from the outset.

THE CTG TRACES FROM 11.26

[32]The claimant’s case, articulated by his expert Dr Thomas, a consultant obstetrician and gynaecologist, is that from 11.26/7 the CTG traces began to reveal a worrying picture. There was a series of decelerations the timing and contours of which, he contends, mandated a decision to perform an emergency caesarean section. The decision should have been taken shortly before 12.00 and the baby delivered no later than 12.30. If this had been achieved then the parties are agreed that the claimant would not have suffered hypoxic damage.[33]The defendant’s case, advanced on the basis of the approach of Mr Mackenzie, a retired consultant obstetrician and gynaecologist, is that the traces were not so alarming as to necessitate an urgent caesarean section and that the decision to proceed to a natural delivery concluding as it did at about 13.40 was a reasonable one.[34]Understandably, much time was spent in cross examining these experts upon the proper classification of the decelerations seen on the CTG traces against the categorisations to be found in the literature to which I have already referred.

THE CLINICAL PICTURE

[35]The claimant points to the combination of the following circumstances as necessitating a caesarean section at or before 12.30 and thus before the deleterious effects of hypoxia would have taken their toll on the fetus: i) the suspected placental abruption; ii) the ruptured membranes; iii) the premature onset of labour; iv) earlier decelerations which can be found within CTG traces commencing at 4.55 and 6.10 respectively; and v) the CTG trace pattern after 11.26/7.[36]I have already considered the impact of the rupture of Andrea’s membranes and have concluded that the risk of infection to which this gave rise or any other material risk would not be so significantly increased by the prolonging of labour from 12.30 to 13.40 as to justify treating this as more than a very modest incentive to expedition.[37]The suspected abruption As it happens, the suspicion of a partial abruption was found after delivery to have been unfounded but this revelation is not material to the consideration of what account should have been taken of the risk at the time the relevant clinical judgements were being made. is a more significant feature the potential consequences of which I have already outlined. This is a risk which still pertained, and at a raised level, during labour.[38]In mitigation of the threat of abruption, the defendants make the following points: i) there had been no record of fresh vaginal bleeding over a period of about 36 hours immediately prior to labour; ii) the liquor produced during labour remained clear of blood; iii) the risk that a significant abruption would occur did not increase as the labour progressed. It is arguable that it, in fact, decreased.[39]Even on the claimant’s case, the background risk of significant abruption was not so high as to necessitate an urgent delivery in the very early stages of labour. It was a steady background risk which it is alleged became decisive only when assessed in conjunction with the later CTG patterns and the other risk factors.[40]Both Mr Brown and Dr Dufour were aware of the earlier CTG trace patterns relating to the period before Andrea was taken to the labour ward. These are not alleged to have been sufficiently concerning to have mandated an emergency caesarean of themselves. The extent to which they ought to have been taken into account later was a matter of clinical judgment. Bearing in mind that they were not particularly easy to interpret and that the CTG pattern had subsequently become somewhat more reassuring I am not satisfied that they represented any more than a very modest factor to be taken into account in the hours following Mr Brown’s ward round. They were not sufficiently salient or important to tip the balance at the material times between an arguably justifiable conservative approach on the on hand and an indisputable need for an emergency section on the other.[41]As observed by Boylan, the fact of prematurity also gave rise to an elevated risk of an adverse outcome in the face of abnormal CTG patterns. However, once again, this is a feature which, even in conjunction with the risk of abruption, is not presented by the claimant as one which mandated an urgent caesarean section from the outset absent sufficiently significant later abnormal CTG patterns.

THE CTG TRACES

[42]The utility of cardiotocography is undeniable but must be approached with the following caveats in mind: i) Although FIGO undoubtedly provided a useful guide to the classification and interpretation of CTG patterns, it did not purport to have a monopoly of wisdom on the appropriate parameters of categorisation; ii) Where interpretation is dependant on the duration of any given deceleration, care must be taken not to adhere too slavishly to a mechanistic stopwatch approach. A line must be drawn somewhere but this does not, for example, justify the clinician treating a deceleration lasting a second or two longer than another as automatically representing a step change in risk terms. Drawing such a line is an inevitable consequence of applying a digital scale to assess an analogue risk. iii) Even with the aid of engineering and mathematical analysis, the categorisation of any individual trace can be controversial. For example, the measurement of deceleration must be made from the baseline level and not from such transient level as may have been reached immediately before the deceleration. Accordingly, for the clinician, there is inevitably an element of judgment by eye leaving some scope for legitimately differing views. iv) The judgements of clinicians are formed in the context of busy obstetric units without the luxury which has been afforded to this court of CTG engineering analysis and hours of time within which to analyse the traces. v) Simply because any given trace may fall into an “abnormal” category does not of itself require an intervention by the clinician. The pattern of traces is important and the assessment of the overall picture involves an exercise in clinical judgment that is incapable of being reduced to a readily defined algorithm. vi) Such guidance as the literature provides puts considerable emphasis on the categorisation of CTG patterns but is understandably more reticent concerning the proper clinical response. Doubtless, this is at least in part because the CTG traces must be seen in the context of all of the information available to the clinician and not in isolation.

THE BALANCING ACT

[43]The experts in this case spent relatively little time addressing the potentially negative consequences of performing a caesarean section. Dr Thomas in his report of 8 July 2014 very properly alluded to the fact that a conservative clinician could have formed the view that Andrea was in her late teens and a caesarean section “might affect her future obstetric career without guaranteeing a successful outcome from this her first pregnancy.” He goes on to conclude that this fear was more than counterbalanced by his own conclusion that a caesarean section was mandated as a matter of urgency by the evidence of deterioration of fetal well-being. He does not, however, say that the fear of the conservative clinician should carry no weight.[44]In addition to the well recognised risks generated by any significant surgical procedure, it is implicit in the approach of both of the obstetric experts in this case that a natural birth is generally to be preferred save where the counterbalancing risks accumulate sufficient weight to shift the default position.

APPLYING THE BOLAM TEST

[45]There is no dispute in this case that, in order to succeed in establishing a breach of duty, the claimant must prove on a balance of probabilities that the clinicians did some act or failed to act in a way in which no reasonably competent clinician would have acted or failed to act (Bolam v Friern Hospital Management Committee [1957] 1 WLR 582). In this case those clinicians which judgement is called into question are Mr Brown and Dr Dufour.[46]Dr Thomas on behalf of the claimant concludes that the standard of care provided fell below a level of reasonable competence. Mr MacKenzie reaches a contrary conclusion that the care provided was commensurate with obstetric practice at the time.[47]Before analysing the respective substantive merits of the experts’ conclusions, I would make the following preliminary observations: i) Dr Thomas and Mr MacKenzie are both highly distinguished experts in their field as was amply demonstrated by their impressive CVs. ii) Despite relatively mildly articulated suggestions made by each side that the expert instructed by the other had lost objectivity or had otherwise fallen short in discharging his duty to the court, I formed the strong view that each was doing his objective best to assist me to reach the right conclusion.[48]I must now address the central issue in the case. Has the claimant proved that, in failing to arrange for an emergency caesarean section to be performed at or before 12.30, Mr Brown and/or Dr Dufour followed a path which no reasonably competent body of clinicians would have chosen?[49]Taking into account all of the evidence, I conclude that the claimant has not discharged this burden. I rely upon the following particular features of the evidence: i) In his report, Dr Thomas conceded that “There may be those who would contend that the CTG between 11.30 and 12.35 hours was suspicious rather than pathological.” In giving evidence he further conceded that an obstetrician who had formed that view could not be said thereby to have reached a conclusion outside the range of opinion which could be held by a reasonable body of obstetricians. ii) In justifying his view that, despite such potential choice of categorisation, the case for an emergency caesarean was clear cut, he relied upon the additional factors of the suspected placental abruption, the ruptured membranes and the premature onset of labour as being decisive. However, as I have found, the additional risk caused by the breach the membranes was modest. The risk posed by the threat of abruption of the placenta was not insignificant but had not increased as the labour had progressed. The additional vulnerability of the preterm fetus was a relevant factor but one the assessment of which was very much a matter of clinical judgment. Dr Thomas certainly convinced me that a reasonable body of clinicians would have expedited a caesarean section against this background but he failed to persuade me that a conservative approach fell beyond the pale of Bolam reasonableness. The CTG patterns had undoubtedly deteriorated but Dr Dufour had noted this and discussed the way forward with Mr Brown in full knowledge of the complicating factors identified by Dr Thomas. Bearing in mind the caveats I have identified in approaching the categorisation and interpretation of CTG patterns, I reject the contention that the clinicians’ conservative approach was wrong. iii) I may well (and probably would) have reached a different conclusion if the CTG traces had recorded a change in the baseline rate and change in the baseline variability of the fetal heartbeat. These are the key signs of developing hypoxia and acidosis. However, it is to be noted that Dr Thomas, again with scrupulous fairness, endorsed in cross examination the Gibb proposition which advocates the critical importance of the evolution of the trace over time over debates about “whether decelerations are early, late or variable and whether they can be pigeon-holed into “good”, “bad” and “possibly good”. I stress that I am not suggesting that it is only where the CTG pattern reveals a change in the baseline rate and change in the baseline variability of the fetal heartbeat that urgent action may be mandated. I am merely using this hypothetical scenario as an example of circumstances in which, in contrast to the present case, a claimant may be able to surmount the challenge of establishing a breach of duty.

CONCLUSION

[50]In cases like this it is impossible not to have very considerable sympathy for the claimant and for those whose lives have been deeply affected by his condition. It is perfectly understandable that those who suffer adverse outcomes from medical procedures will tend to assume that the doctors are to blame particularly where, as in this case, the exercise of a different clinical judgement would have achieved a dramatically better outcome. Nevertheless, the law is clear. Doctors are to be found to be in breach of duty if the decisions they make fall outside the range of reasonable professional opinion. In this case, they did not and the claim must fail.