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
		18th June 2004

The Honourable Mr Justice Holland:

Introduction

1. By way of this claim Miss P, now aged 38, sues for damages alleging clinical negligence on the part of the Defendants, their servants or agents in providing her with antenatal care for her fourth pregnancy. As will come apparent, the issue at the heart of her claim is relatively easy to define -- the exercise of judgment with a view to resolution has proved to be exceptionally difficult.
2. The background is uncontroversial. The Claimant was born on the 28^th April 1965. By way of an earlier relationship she had undergone three pregnancies each successful, each serving to provide her with a healthy daughter. In 1997 she formed a fresh relationship, this time with Mr. Nigel Wright. In the result, she fell pregnant again -- it is with events occurring in the course of this pregnancy that I am concerned. Before leaving the background, I record that her relationship with Mr. Wright has ended: happily, they remain at one with respect to all matters material to this action.

Exomphalos and Cloacal Exstrophy

3. It is necessary to describe these two conditions in order to make sense of the chronology. Both conditions can affect the fetus. An exomphalos (or omphalocele) is a defect of the anterior abdominal wall -- it is in the midline at the point at which the umbilical cord inserts into the wall. The defect presents as a sac protruding from the wall which may contain abdominal contents, particularly bowel and liver. Statiscally it is encountered once in every 5,300 births and following birth the problem can be rectified by an early operation. Cloacal exstrophy is rarer and much more serious. Encountered once in 200,000 births (there is a range: 200,000 to 400,000), it is a condition that includes an exomphalos with, additional to such, a whole congerie of congenital defects including extrusion of bladder and bowel and deformity of the male genitalia. Whereas some alleviation following birth is feasible through operative treatment, the prospects cannot be put higher. The baby faces repetitive operative procedures without any prospect of anything like full correction.
4. Turning to that which is at the heart of this litigation, ultrasound examinations of the pregnant abdomen, the following became common ground. First, a competent, careful ultrasound examiner should be able to discern an exomphalos. Second, whereas visualisation of a cloacal exstrophy is such a rare experience that there can be no expectations, it is to be expected that once an exomphalos is discerned then the bladder will be sought. Absent a discernible bladder, the visualisation of an exomphalos raises the potential for cloacal exstrophy; if a bladder can be discerned then the prospect is simply for an exomphalos.

Chronology

Not included

The Issues

5. The Claimant contends that the first two ultrasound examinations undertaken at Leeds were conducted other than with reasonable care and skill; that had there been the exercise of appropriate care and skill the absence of a bladder would have been noted in conjunction with the exomphalos so as to raise the probability of a cloacal exstrophy; and that, given such diagnosis, she would have been entitled to, and would have opted for a termination of pregnancy. The Defendants admit that the reports engendered by the first two ultrasound examinations were wrong inasmuch as they respectively reported visualisation of a bladder (for such was not in truth there to be visualised) so that the diagnosis as advised to the Claimant was wrong. They further admit that had cloacal exstrophy been diagnosed on the basis of an exomphalos unaccompanied by a bladder then termination of pregnancy would have been an option for consideration by the Claimant. That said, they strongly deny that the erroneous visualisation of the bladder could or did betoken any failure to exercise due care and skill; they further put the Claimant to proof that a correct diagnosis would have led her to opt for a termination.

Termination

6. It is convenient to deal immediately with the issue as to the impact of a diagnosis of cloacal exstrophy. The Claimant's case as pleaded is that had the condition of the fetus been correctly diagnosed then she would have opted for termination of the pregnancy. The Defendants effectively put her to proof. Understandably her evidence on this issue whilst to the same effect could be said to be diffident in tone -- and the same comment could be applied to like evidence forthcoming from Mr. Wright. This was hardly surprising: since the period material to this issue, that is since January 1999, X has come on to the scene so as to win parental love and devotion and present diffidence on this sensitive issue necessarily arises. For my part, I am readily satisfied on balance of probability that had the correct diagnosis been communicated to the Claimant then she would have opted for a termination. I accept that there would have been pressure to continue with a pregnancy that promised Mr. Wright's first child and her first boy but every other factor pointed towards termination. I am quite satisfied that the advice that she would then have received had to have included predictions as to the potential for a physically and psychologically harrowing life for the child, and as to the potential for barely acceptable strains upon the family life currently enjoyed not just by the Claimant and Mr. Wright but, very importantly, the three young daughters. Granted that the decision would have been hers, the advice had to point to termination.

Negligence

7. The issue 'negligence or no' is alas, infinitely more challenging. To resolve it, I first received evidence from those directly involved. Dr. Emma Farriman is now a Consultant in Feto Medicine: at the material time she had had some 18 months experience as a trainee. Understandably she now has no recollection of the examination of the 7^th January 1999 but surmises that the scanning would have been done by her with Dr. Griffin beside her, engaged in entering her findings into the computer data base. Whilst she had never before encountered cloacal exstrophy, she was aware of the condition and appreciated that the finding of an exomphalos put a premium upon the finding of a bladder as a diagnostic tool. She surmises that she was confident that what she saw was a bladder -- had she not been confident she would have activated the colour flow doppler so as to identify the two umbilical arteries, believing that their siting (one on each side of the bladder) would help confirm identification of this organ. Seemingly she did not activate the doppler on this occasion. As to what she did visualise as the bladder, she surmises a piece of bowel or a cyst. She strongly maintains that she was not negligent.
8. Her colleague, Dr. Griffin, similarly rejects negligence. Now a Consultant in Feto Maternal Medicine, he has some recollection of the scan of the 7^th January 1999, albeit no recollection of the scan of the 4^th February. Like Dr. Ferriman he was aware of the diagnostic significance of this visualised presence of a bladder and is confident that reasonable care and skill were exercised in pursuit of such on both occasions. He opines that on each occasion a fluid filled structure with the appearance of the bladder and occupying a place appropriate to such must have been seen. Having regard to the increase of knowledge and experience he would now be readier to support visualisation by checking on volume changes reflecting the bladder filling and emptying and by activating the doppler so as to check upon the relationship between the apparent bladder and the umbilical arteries.
9. Finally, Mr. Mason has now no recollection of the scan of the 4^th February 1999. He too acknowledges the diagnostic significance of the visualisation of a bladder. His approach to visualisation as in 1999, and now, matched that of Dr. Griffin. Notwithstanding the terms of his letter of the 6^th May 1999 he did not attempt by way of evidence to explain or justify the undoubted error in visualisation on the basis of a spine uppermost fetus.
10. The Claimant relied upon the expertise of, respectively, Dr. Pam Loughna, Senior Lecturer and Consultant Obstetrician at Nottingham City Hospital, and Dr. Peter Twining, Consultant Radiologist at the Queen's Medical Centre, Nottingham. The Defendants countered with the aid of Dr. David Howe, Consultant in Feto Maternal Medicine, Princess Anne Hospital, Southampton, and Dr. Hylton Meire, a retired Consultant Radiologist (Ultrasound). Rather than recite and review their respective opinions (all of which are readily apparent from their respective reports), I think it feasible to go straight to the respective cases as supported by expertise. The balance poses a challenge to me as will be apparent and I am then poised to declare my judgment.
11. The Claimant can invoke the following:

a. Her referral to Leeds invited a high standard of care. The Whitby sonographer had (correctly) visualised an exomphalos but had not (again correctly) visualised a bladder: all reasonable care and skill had accordingly to be directed to the issue 'cloacal exstrophy or not'.

b. At Leeds there was or should have been the care and skill equal to meeting that high standard.

c. Granted that visualising cloacal exstrophy is a rare, potentially unique professional experience as to which there may be no 'norms', visualising a bladder is an integral part of a standard anomaly scan.

d. In the event the purported visualisation of a bladder by those at Leeds was mistaken, not just once but twice. It may not be coincidental that the contemporaneously recorded images are (as I accept, on the evidence of Dr. Twining) of indifferent efficacy and do not include an image of that which was believed to be the bladder.

e. The original explanation (that in the letter of the 6^th May), namely that the fetus was spine uppermost and thus scanning was impeded and potentially confused for visualisation purposes by shadows, may or may not have validity (it is indeed favoured by Dr. Twining as the explanation for the mistake) but it cannot be reconciled with the exercise of all reasonable care and skill.

f. Finally, as urged by Drs. Loughna and Twining (and not, as I think, seriously in dispute) it was always possible effectively to establish ' yea or nay' whether that which was visualised as a bladder was such -- by ensuring through sustained and repeated visualisations that it did fill and empty and by activating the doppler.

12. The Defendants can invoke the following:

a. Ultrasound scanning necessarily invokes successive judgments as to that which is subjectively visualised on viewing a dynamic situation. It is difficult and potentially unfair to postulate 'norms' in terms of that which is achievable by the exercise of reasonable care and skill.

b. Following on from the above, it is difficult, perhaps impossible to predicate 'norms' for the purpose of visualisation justifying a diagnosis of cloacal exstrophy. So much readily emerged from Dr. Howe's researches and is cogently supported by the literature. Dr. Meire helpfully pointed to Lee and Shim, 'New Sonographic finding for the prenatal diagnosis of bladder exstrophy: a case report', Ultrasound Obstet Gynecol 2003; 21; 498-500. Not only did the authors think that their successful ultrasound diagnosis merited reporting but pointed out that a literature search revealed a total of 17 case reports, in only 3 of which the prenatal diagnosis had been correct.

c. Following on from the above, granted that visualisation of the bladder was crucial and was a common place task here the visualisation was being sought in the context of fetal anatomy that was, ex hypothesi, substantially abnormal in the relevant area with organs misplaced or functioning abnormally so as to give rise to unusual presentations. Arguably, it is this feature of the task posed for the scanner that may serve to offer some explanation for the low incidence of correct diagnoses.

d. Following on from the above, given mistaken visualisations on successive scans with different scanners, does this not point to some real problem referable to the anatomy of this fetus that militated against visualisation of the absence of a bladder?

e. Finally, granted that with repeated and sustained observations, further or alternatively with activation of the doppler in depth checks as to whether a visualised organ is the bladder, a body of professional opinion would be in favour of making an identification as part of an anomaly scan simply on the basis of appearance and position.

Judgment

13. I have to emphasise that I have not found it at all easy to reach a judgment. The circumstances militate against the Judge, not least when there is an embarrassment of riches in terms of expert advice and when those subject to criticism respectively present as normally caring, dedicated and skilled. That said, I have to make a decision and it is my judgment that the Claimant has proved her case. As to this, I emphasise that which was referred to Leeds from Whitby: a visualisation of a fetus with an exomphalos and without a bladder, in essence a possible presentation of a cloacal exstrophy and one calling for tertiary referral. In my judgment, the duty of care subsequently owed at Leeds demanded a high standard of care and skill specifically when focussing in the issue thus raised: 'cloacal exstrophy or not'. The vital importance of the issue is self-evident. Turning to execution to that high standard, I am satisfied that in the prevailing circumstances it was not enough to visualise a bladder simply by reference to shape and position. I accept that no more could necessarily be expected in the course of a standard anomaly scan. I write ' necessarily': the evidence showed that some practitioners would routinely go further, but I cannot find that that which was seemingly done was outwith the range of conduct appropriate for the standard anomaly scan. This, however, was not such a scan, it was a scan with a focus and I am satisfied that with care and skill commensurate to that focus and its importance that which was mistakenly identified as a bladder could have been exposed as something other than that organ. I accept Dr. Loughna's contention (as to which there was really no dispute) that with persistence that which was visualised as a bladder could have been checked for filling and emptying, a test seemingly definitive. Again, with like persistence as demanded by the importance of the issue, the shape could and should have been checked by scanning in different planes and the doppler could have been activated so as to obtain the guidance that can be furnished by visualising the relationship between the organ in question and the umbilical arteries. Granted that no one involved in the Leeds scans has now any real recollection of such, and granted that all now say that they must have been alive to the potential for cloacal exstrophy, it is worrying (whether or not significantly) that there is no reference to this condition in the contemporaneous documentation; that none of the images depicts that which was visualised as a bladder; and that the terms of the letter of the 6^th May are as cited. Finally, the Claimant is entitled to point to the fact of cloacal exstrophy and to visualisations at Whitby correctly consistent with such: there is a heavy burden on Leeds when seeking to reconcile its incorrect visualisations with the exercise of all reasonable care and skill.
14. There must be judgment for the Claimant for damages to be assessed if not agreed.
15. I conclude as follows. First, I do apologise for the delay in drafting this judgment. I had hoped to complete it before Easter but, alas, some ill health forced me to stop work. Second, I am causing this draft to be posted simultaneously to both counsel for immediate onward publication to clients, lay and professional.