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||Neutral Citation Number:  EWHC 1330 (QB)
||Case No: 6CH01151
IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
CHESTER DISTRICT REGISTRY
||Royal Courts of Justice
Strand, London, WC2A 2LL
||10 June 2010
B e f o r e :
THE HON MR JUSTICE HICKINBOTTOM
|| (1) Ruby Baxter
(2) Rowan Baxter
(children suing by their Grandmother and
Litigation Friend Judith Munt)
(3) Joyce Baxter
(suing as Executrix of Katherine Judith Moores deceased)
||Dr Kirsty McCann
Clare Price (instructed by Walker Smith Wray) for the Claimants
Michael J Mylonas (instructed by Radcliffes Le Brasseur) for the Defendant
Hearing dates: 24-27 May 2010
HTML VERSION OF JUDGMENT
Crown Copyright ©
Mr Justice Hickinbottom :
- Katherine Judith Moores ("Katherine") tragically died on 16 March 2003, as a result of an ovarian clear cell adenocarcinoma. In these proceedings, her children and her estate allege that her death was caused by the negligence of her general practitioner (the Defendant, Dr Kirsty McCann) in failing to carry out a proper physical examination of Katherine at an appointment on 21 March 2001 which would, it is alleged, have recognised the tumour at a stage at which it could and probably would have been successfully treated.
- I heard the trial of issues of liability at the Castle, Chester between 24 and 27 May 2010. This is the reserved judgment from that hearing. Subject to liability, quantum is not in dispute.
- Katherine did not prepare any statement before she died, but I heard evidence from her mother, Mrs Judith Munt, as well as from Dr McCann. In addition, the following experts gave oral evidence:
Dr Ian Isaac, General Practice (instructed on behalf of the Claimants)
Dr Frances Cranfield, General Practice (Defendant)
Professor Sir Nicholas Alcwyn Wright, Histopathology (Claimants)
Dr James Brenton, Medical Oncology (Defendant)
Mr Victor Lewis, Obstetrics and Gynaecology (Claimants)
Mr John Latimer, Gynaecology and Gynaecological Oncology (Defendant).
I also had a written report from Dr John Wingate, a consultant radiologist instructed on behalf of the Claimants. There were two joint memoranda: the first prepared by all of the experts except the general practice experts dated June/July 2009 ("the Joint Memorandum"), and the second by the general practice experts dated August 2009 ("the GP Joint Memorandum").
The Relevant Medical Background
- Before I come to the issues in the case, it may be helpful briefly to refer to a number of general medical matters that underlie those issues, namely (i) uterovaginal prolapse, (ii) ovarian cancers and (iii) relevant medical/gynaecological examinations.
- At the relevant time, following the birth of her second child in 2000, Katherine was suffering from a prolapse, i.e. the descent of the uterus or vaginal wall consequential upon the failure of the structures supporting those organs in the midpelvis. Such a failure often results from the structures being stretched during childbirth. For example, the levator ani muscle supports the front of the vagina and, when the fibres of that muscle are stretched, that can lead to the weakened anterior vaginal wall bulging into the vagina (an anterior vaginal prolapse, or cystocele). As the vagina itself supports the uterus, such a prolapse may be accompanied by descent of the uterus to a greater or lesser degree. A complete uterine descent is known as a procidentia.
- Prolapses can often be cured by the strengthening of the relevant muscles through exercise; although, in more serious cases, the introduction of a ring pessary into the vagina or surgical intervention may be required.
- The ovaries are a pair of almond-shaped organs, covered in surface epithelium and embedded in a membranous sheet within the pelvis, each side of the uterus. They are fairly loosely connected, and are able to move in relation to their surroundings. Any mass growing on or in the ovary tends to cause that ovary to move towards the centre line of the body, almost invariably across behind the uterus where, in an area between the vagina/uterus and the rectum known as the pouch of Douglas, it has space into which it can expand. A mass may eventually adhere to a contiguous organ, restricting mobility.
- There are a wide variety of ovarian epithelial masses or tumours. Most (80-85%) are benign. Clear cell tumours are one of several malignant types. Clear cell tumours are relatively slow-growing cancers, but they have a tendency to (i) be asymptomatic, at least in their early course, (ii) metastasise (i.e. spread via the blood or lymphatic system) relatively early, and (iii) implicate other contiguous organs. Generally, the survival rate amongst those who contract such a tumour (to which I return below) is relatively poor.
- Although this type of tumour tends to be asymptomatic during its earlier stages, symptoms can arise later particularly from (i) cancerous spread to other continguous organs, and (ii) the size of the tumour causing pressure on (e.g.) the bladder or rectum. I was referred to the paper Hamilton W, Peters TJ, Sharpe D. Risk of ovarian cancer in women with symptoms in primary care: population based case-control study. British Medical Journal (2009) 339-346, which suggests that abdominal extension, abdominal pain and urinary frequency are particularly associated with a diagnosis of ovarian cancer. Mr Latimer said that, as the size and pressure from the tumour increases, bowel as well as urinary problems are also often encountered.
- Ovarian cancer is relatively uncommon, accounting for under 5% of all female cancers. Malignant ovarian tumours in younger women are especially rare. In 2006, there were 6,600 new cases of ovarian cancer reported in the United Kingdom as a whole, of which less than 75 (i.e. less than 1.2%) occurred within the 31-35 years age group. The figure for Wales alone was 350 for all age groups: taking the same age group proportion, there would have been less than 5 new cases of all types of ovarian cancer in Wales. Clear cell cancer accounts for 5-10% of all ovarian cancers. Therefore, in 2006, there would have been less than 7 new cases in the 31-35 year age group in the whole of the United Kingdom: and an annual rate of less than one in Wales. To put those figures into context, a general practitioner will on average see a case of ovarian cancer once every five years (Mr Latimer Report 6 September 2008, pages 4-5): most general practitioners will never come across ovarian cancer in a patient of under 35 years old: and very few indeed will ever come across a patient in that age range with ovarian clear cell carcinoma.
- Primary ovarian carcinomas are staged by reference to the extent of cancerous growth, the most used criteria being those of the Cancer Committee of the International Federation of Gynaecology and Obstetrics (1985), as follows:
Stage I: Growth limited to the ovaries.
Stage II: Growth involving one or both ovaries with pelvic extensions.
Stage III: Tumour involving one or both ovaries with peritoneal implants outside the pelvis and/or positive retroperitoneal or inguinal nodes; superficial liver metastasis equals stage III; tumour limited to the true pelvis but with histologically proven malignant extension to small bowel and omentum.
Stage IV: Growth involving one or both ovaries with distant metastases; if pleural effusion present, there must be positive cytology to allot a case to stage IV; parenchymal liver metastases equals stage IV.
Some stages are subdivided, the highest substage within stage III being IIIC, namely: "Abdominal implants greater than 2cm in diameter and/or positive retroperitoneal or inguinal nodes".
- Staging is based upon clinical findings and, crucially, surgical exploration. Findings made on surgery (e.g. in relation to the extent to which other organs, including the lymph glands, have been implicated) may require the staging as assessed on clinical findings to be revisited. Staging is a clinical tool that assists in ascertaining the appropriate clinical treatment of a patient, particularly post-surgery. Historical staging (i.e. the stages that the tumour has gone through, and the timing of those stages) is of no clinical interest. Clinicians are interested only in a patient's current stage, for the purposes of prognosis and the future plan of treatment.
- Returning briefly to survival rates, clear cell cancer has the highest hazard ratio of all ovarian cancers, the survival rate being particularly low once the cancer metastasises and implicates the lymph nodes. Hence, the overall 5 year survival rate of women diagnosed when the cancer is at stage III is about 33%, compared with 70% if diagnosed at stage II. The experts were agreed that a patient who is diagnosed at stage II has more than double the chances of surviving for at least 5 years compared with someone who is not diagnosed until stage III.
Relevant Medical/Gynaecological Examinations
- Before me, reference was made to four relevant physical examinations, all conducted with the patient lying down and undressed, namely:
(i) an abdominal examination conducted externally, by pressing the patient's abdomen with the hand;
(ii) a visual examination of the vagina, with or without a full or half speculum (which enables the doctor to look inside the vagina);
(iii) a bimanual vaginal examination, which requires the examining doctor to insert the fingers of one hand into the vagina, palm upwards, with which he presses the cervix upwards: whilst placing the other hand externally flat on the abdomen above the pubic symphysis, pressing downwards. That enables the doctor - to an extent that is in issue - to feel around the uterus, and to identify the characteristics of the size, shape, position etc of the uterus, as well as any tenderness or abnormalities of the uterus, ovaries and fallopian tubes; and
(iv) a vagino-rectal examination, which requires the examining doctor to insert the fingers of one hand (palm downwards) into the vagina, and the fingers of the other hand (palm upwards) into the rectum. For the patient, this is a highly intrusive and unpleasant examination: but, as the vagina and rectum are contiguous, it is a test particularly sensitive to any mass between them, for example a mass behind the uterus in the pouch of Douglas. Although this examination also requires two hands, "bimanual examination" is usually used to connote a vaginal examination ((iii) above), and I shall use it in that sense unless the context indicates otherwise.
- Mr Latimer said that he would not expect a general practitioner (rather than a consultant or other specialist gynaecologist) ever to conduct a vagino-rectal examination: and none of the experts suggested that Dr McCann was at fault in not conducting such an examination in Katherine's case. The other three examinations are often performed together in sequence, and are effectively, said Dr McCann, all part of a single coordinated pelvic examination which she, as a general practitioner, would conduct if she had any concerns about a patient's abdominal condition. I shall return to that examination in due course.
- It is common ground between the parties that, in all the circumstances, given Katherine's medical history and presentation at the 21 March 2001 appointment, Dr McCann ought to have conducted a full pelvic examination, including a bimanual vaginal examination.
- It is also agreed between the parties that, as at 21 March 2001, Katherine had a tumour, irregular in shape, but of 5-10cm in diameter, situated in the pelvis and probably behind the uterus. The tumour was not in the event detected until October 2001 or removed until December 2001, by when it was over 11cm in diameter and had infiltrated the bowel, liver and abdomen and nodes in the lymphatic system. It was, by then, a stage IIIC tumour which removal and subsequent chemotherapy failed to arrest, with the result that Katherine died in early 2003.
- The issues that arise on liability are therefore two-fold:
(i) Breach of Duty: Did Dr McCann perform a reasonably competent bimanual examination of Katherine on 21 March 2001?
The experts in general practice agreed that, on the basis of Dr McCann's evidence as to Katherine's presentation on 21 March 2001, Dr McCann ought to have carried out an abdominal examination followed by a bimanual examination at that consultation (GP Joint Statement, Paragraph 2). The Claimants contend that no bimanual examination was conducted: but, if Dr McCann conducted any such examination, it was not performed with reasonable competence. A reasonably competent examination would have identified the tumour. Dr McCann says that she did perform a reasonably competent bimanual examination on Katherine on 21 March 2001, although that examination unfortunately did not recognise any tumour.
(ii) Causation: If Dr McCann did not perform a reasonably competent bimanual examination - and if, as a result, diagnosis of the carcinoma was delayed - did that delay make any difference to Katherine's outcome?
The Claimants submit that, on a reasonably competent examination, Dr McCann ought to have palpated and hence identified the ovarian mass, and sent Katherine promptly for appropriate diagnostic tests, that would have diagnosed the cancer and resulted in a operation shortly after March 2001. It is common ground that, had the ovarian mass been identified on 21 March 2001, that would have resulted in an operation to remove it and consequent therapy shortly thereafter.
The Claimants contend that, as at 21 March 2001, the tumour was probably at stage II and, but for the failure to diagnose the tumour then, Katherine would more likely than not have survived for at least 5 years. However, for Dr McCann, it is submitted that it is likely that the tumour was at stage III even by March 2001 and thus any failure to diagnose it then did not have any material effect on the outcome for Katherine.
- Before I turn to those issues, I shall deal with the factual background (Paragraphs 20-51), and Katherine's signs and symptoms (Paragraphs 52-72).
The Factual Background
- Dr Kirsty McCann has been a doctor since 1992, and a Member of the Royal College of General Practitioners since 1997. Between 1994 and 1997, she undertook the Chester General Practitioner Training Scheme during which she was employed for 6 months as Senior House Officer ("SHO") in Obstetrics and Gynaecology involving Genitourinary Medicine at the Countess of Chester Hospital. In 1995, she gained her Diploma of the Royal College of Obstetrics and Gynaecology, and in 1996 her Diploma of the Faculty of Family Planning and Reproductive Health.
- Following various locum jobs, in 2000 she became a principal in the Menai Bridge Surgery, Anglesey, with three partners. She said that, as all of her partners were male, most of the practice's obstetrics and gynaecology work tended to fall upon her.
- Katherine was born on 22 November 1968. On 13 September 1998, she gave birth to her daughter Ruby (the First Claimant), following an uneventful pregnancy. Following a termination in early 1999, she became pregnant again towards the end of that year.
- At the dating scan on 16 December 1999, a small 2cm diameter cyst was noted on her left ovary: but the experts agree that, on the balance of probabilities, that was a benign corpus luteum cyst rather than a tumour, and it has no relevance to the development of cancer later or to any issue in this claim (Joint Memorandum, Paragraph 5). As at December 1999, it can be said with confidence (and certainly on the balance of probabilities) that Katherine had no ovarian cancer.
- Katherine's son Rowan (the Second Claimant) was born on 1 July 2000. The following day (2 July), the midwife referred Katherine to a physiotherapist, noting the following presenting problems:
"Stress incontinence since ND [normal delivery] in 1998 and painful to have sexual intercourse."
- During this last pregnancy, Katherine had complained to her mother of abdominal pain and discomfort: and, after the birth, she continued to suffer abdominal pain. She attended the surgery on 6 July 2000, when she saw Dr Graham. According to the medical notes, she complained of "crampy abdo[minal] pain + abdominal rash": on examination, it is noted, "Abdo[men] tender above uterus": and she was prescribed analgesics and antibiotics.
- On 11 July, she was due to have her first physiotherapy session, but did not attend. The physiotherapist's note reads:
"DNA [i.e. did not attend]. Mrs Moores left message to say her condition had changed & she now has a prolapse. I phoned her as requested. She forgot about her appt on the 11th. She is going back to her GP to get a diagnosis & referral back if necessary. She asked if she could have an appt next week. I explained I had given her an urgent appt because of her condition & had a 6/12 w/l [i.e. a 6 month waiting list]. Will await referral."
- In fact, Katherine did not go back to her general practitioner's surgery until 2 August, when she saw Dr McCann for the first time.
- Dr McCann's contemporaneous record (taken, Dr McCann said, whilst Katherine was with her at the appointment) notes Katherine's age (31 years), and that she had two children and had had one termination. It then says:
Postnatal 4/52 (2nd child)
Noted "vaginal prolapse". PUing ... O.B. ...
... Noted lump 'golf ball' size out of vagina
- intermittent, assoc discomfort, urinary frequency, worse after doing 'exertion' etc
O/E Abdo soft
Speculum - ant vag wall prolapse
+?? Uterine descent
Plan Advise pelvic floor exercises + - discussed ...
See physiotherapy (referred (()
TCI if prolapse reoccurs - ? for ring if nec
Refer O&G - ?? as only 4/52 post natal. Surgery not appropriate.
- Dr McCann explained this note, as supplemented by her recollection of the appointment. She said that she had looked back at the records and noted the last entry on 6 July. Katherine told her that she was suffering from a "vaginal prolapse" (hence that was in inverted commas in the record), and had noted that a "golf ball size" lump protruded out of the vagina intermittently, especially after exercise or other exertion; and, when that occurred, she had discomfort and increased urinary frequency. Dr McCann recollected Katherine telling her that she had a "dragging feeling down below", but only discomfort rather than pain. Dr McCann said that she would always record pain, if reported to her as a historical symptom or if a patient complained of pain during a consultation, e.g. on examination. That would be clinically important. In response to a battery of questions about any problems with her "waterworks" and bowels (questions concerning dysuria, pain, bleeding, urgency, frequency, poor stream, change in bowel habit), Katherine told her that she was passing urine ("PUing") and opening her bowels ("OB") without any problems ("("). Katherine told her that the symptoms of which she complained in July had gone.
- Dr McCann considered that, on the basis of what Katherine had told her, a pelvic examination was required, and she asked Katherine to move to an adjacent room and undress, which she did. Dr McCann said she then carried out a full pelvic examination, with an external abdominal examination, a vaginal examination using a speculum, and a bimanual vaginal examination. Dr McCann said that she would not diagnose a prolapse without performing a bimanual examination, to see whether (and the extent to which) the uterus had descended: and, she said, in any event she always performed a bimanual examination as part of a full pelvic examination. She could not recall ever having done a pelvic examination of this type without seeking to perform a bimanual examination and, if there was some reason for not conducting that part of the examination, she would record it. Similarly, if there was pain or other symptoms on conducting that examination, she said she would always note that in the records, as it would be clinically relevant. On this occasion, she conducted a bimanual examination, and there was no pain or tenderness on that examination. From the speculum examination, she could see that Katherine was suffering from an anterior prolapse (a cystocele): and, from the bimanual examination, that there was some slight uterine descent, but no procidentia. She said that by "?? Uterine descent" in the records, she meant to convey that there was some slight descent, rather than she suspected there was the possibility of descent.
- In terms of a future plan, she discussed with Katherine the possible courses. They discussed the possibility of a ring or surgical intervention - but she (Dr McCann) considered both premature at that stage, given Katherine's recent birth of Rowan. She offered to send her to a consultant, but, no doubt heeding Dr McCann's advice as to prematurity, Katherine declined. Dr McCann referred Katherine for physiotherapy, having discussed that with her and given her a leaflet about pelvic floor exercises (hence, she said, the two ticks by that in the notes).
- Dr McCann told Katherine to return ("TCI", i.e. to come in) if the prolapse recurred: that note was underlined, because Dr McCann stressed to Katherine that she must come in straightaway if the problem recurred or continued. The final word of the note is unclear, but Dr McCann said it read, "Review". That was (she said) an indication that, even if there were no intermittent acute problems, she told Katherine of the necessity of coming back to see her in any event to tell her how she was getting on, after (Dr McCann said) about 6 weeks.
- In the event, Katherine did not return for any review for over 7 months. On 10 March 2001 (a weekend day), shortly after midday, Katherine telephoned the out of hours surgery service, and spoke to a doctor from another practise who was on call. Katherine thought that her prolapse had descended further, and was advised to attend her own surgery the following week. There is no reference in that note to Katherine complaining of pain, or any suprapubic lump: nor did that call result in Katherine being called into surgery urgently, nor in a house call.
- On 12 March, Katherine telephoned the physiotherapy service to say that she had waited 8 months for a physiotherapy appointment, saying that she had "no recollection" of various appointments that had been made. She was asked to return to the surgery for an appointment, and a further referral.
- That appointment was on 21 March 2001, when she again saw Dr McCann. In the contemporaneous record, Dr McCann again noted Katherine's age (then 32 years), and that she had had two children and one termination, the last child being "NVTD" (i.e. normal vaginal term delivery), without an episiotomy. The records otherwise read:
"Seen 8/00 re post-delivery and vaginal prolapse (see prev note)
- Now ache pelvis PUing ... O.B. ...
- O/E slight uterine descent. Ant vag wall laxity
Pelvic floor exercises sheet
... TCI smear ...
Dr McCann again explained what she had recorded in this note, as supplemented by her own recollection. She accepted that she did not have a clear recollection of all this consultation, but, aided by the clinical record, she said she could remember parts of it.
Dr McCann said that she had looked at the note from the previous appointment in August. Katherine said that the lump in her vagina of which she had complained in August was no longer a problem, but that she had an ache low down in the vaginal area, again described in terms of a "dragging down feeling". Dr McCann recalled that, as in August, the ache was described in intermittent terms, worse on exertion. Katherine told her that she had not attended the physiotherapy appointments to which she had been referred in August and, although Dr McCann could not recall the reason given for that non-attendance, she said it could not have been because of pain because (i) that would have been noted in the records and (ii) Dr McCann re-referred her for physiotherapy which she would not have done if Katherine would not attend because of pain, or if that therapy was going to be otherwise practically impossible or ineffective.
Dr McCann said that she asked Katherine the same battery of questions about symptoms, "waterworks" and bowels, with the response that there were no problems in those areas. Unlike at the last consultation in August, no complaint was made of urinary frequency. Dr McCann would have recorded such a complaint. Nor did Katherine complain of any pain or suprapubic lump, either as a current symptom or as something she had suffered during the intervening period since the August consultation.
Then, as in August, she asked Katherine to go to the adjacent room and prepare for a full pelvic examination, which she performed. Dr McCann said that, during that examination, she was specifically looking for masses, or tenderness, or anything abnormal. However, the examination (which comprised the three elements of abdominal examination, vaginal speculum examination and bimanual examination) did not disclose any suprapubic lump, or any mass or tenderness: nor did Katherine complain of any pain on examination. The examination did disclose some uterine descent and some anterior vaginal wall laxity, for which Dr McCann advised pelvic floor exercises and referred Katherine once more for physiotherapy. As well as a smear test, a review was planned for 3 months.
That smear test was performed by the practice nurse on 13 July 2001. However, in the meantime on 9 July, Katherine attended the surgery complaining of a cough - the medical records show that she did present with a cough from time-to-time - and she saw Dr Jones. The notes indicate a prescription for that cough, but also: "Felt run down for some time. Feels lost (a bit) wt [i.e. weight] = 8st 5' 2" ".
The note of 13 July in relation to the smear test reads as follows:
"Vaginal prolapse - very tense but cervix appears satisfactory. Smear taken."
The test was negative.
There is a further entry in the records dated 19 July, simply "DNA" (i.e. did not attend): but there is no evidence as to what that appointment was made for. There was a further attendance at the surgery in the first week of August 2001, with Katherine complaining of severe sun burn. There is no reference to anything of a gynaecological nature in the notes for that appointment, which was not with Dr McCann.
However, on 4 September, she attended the surgery again, and saw Dr Thomas, complaining of a "prolapse sensation" and associated urinary frequency. It is expressly noted, "No abdo[minal] pain" which appears to be part of the reportage from Katherine herself. Other than the specific symptoms she complained of, she is noted, "Otherwise well". The notes are supplemented by a referral letter to Dr Kumar, in which Dr Thomas reports that Katherine had:
"… been complaining for quite some time of pelvic pain with associated urinary frequency occurring in the absence of incontinence etc. She complains of lower back pain which is aggravated by lifting her child which may well be related to this problem. There is no sciatica or any alarm features such as sphincter dysfunction related to this…. She is otherwise well."
In the medical notes, Dr Thomas is recorded as having performed an external abdominal examination, with "no mass" palpable, which is confirmed in the referral letter which describes the examination as "unremarkable". Dr Thomas evidently did not perform a bimanual examination but, in both notes and referral letter, he referred to Dr McCann's earlier vaginal examination that had found a "slight uterine descent and anterior wall laxity". Dr Thomas did not perform any intrusive examination that day. However, he referred to the physiotherapist advising that Katherine ought to be referred for an expert opinion - hence the referral to Mr Kumar, a consultant obstetrician and gynaecologist at Gwynedd Hospital, Bangor.
In fact, Katherine did not wait for an appointment with Mr Kumar, but attended the hospital that same morning, where she first saw an Accident and Emergency SHO. According to his note, she complained "lately 1/52 [i.e. in the last week] of sharp pubic pain feels like bearing down like head is engaged": the pain is noted as being "persistent… in her lower abdomen/pelvic area - gradually increasing now with difficulty in sitting down. ... pain when she bends to pick up her children." The SHO conducted an abdominal examination noting, "Tender + suprapubic": and also a "VE" (i.e. vaginal examination), noting, "Difficult as unable to relax. Difficult to confirm prolapse".
The SHO referred Katherine immediately to the Obstetrics and Gynaecology Department, where she was put under the care of a consultant (Mr Tivy-Jones), and saw another SHO. He too noted new pain, and increased urinary frequency and uncomfortable micturation. The discharge summary indicates that the presenting complaint was "sensation of prolapse". In the contemporaneous record, under "O/E" is noted:
Vagina small cystocele
Cervix healthy looking
A cystocele was consequently diagnosed, with a plan of attending the Gynaecology Out Patients Department as apparently already arranged, and also physiotherapy.
Katherine duly attended the physiotherapist on 10 September, when her pelvic floor was noted as being "strong" and, given that an appointment was awaited at the gynaecology department and Katherine was suffering from a third degree prolapse, physiotherapy was not appropriate.
Katherine's appointment with Mr Kumar was on 29 October 2001. She then complained of "constant pelvic pain", and high urinary frequency (15 times during the day, and 2-3 times at night). On abdominal examination, there is noted "Suprapubic firm lump ?uterine": a bimanual examination was "impossible due to pain". An ultrasound scan that day showed a lump of about 11cm in diameter, but it was difficult to make out the origin of this. Mr Kumar ordered a battery of further tests, the results from which were reviewed with Katherine by Dr Blake (Mr Kumar's Specialist Registrar) on 19 November. The ultrasound results showed an irregular mass of up to 11.5cm across, displacing the uterus to the right. Her CA125 level (an indicator of cancerous presence) was noted to be raised, but it was unknown whether the lump was malignant or benign. A magnetic resonance imaging ("MRI") scan was organised.
By 6 December, the MRI test results were available and, with the results of the other tests which had been performed, the lump was considered likely to be malignant. On the basis of presumed cancer, the following day, Katherine underwent a total abdominal hysterectomy, bi-salpingo-oophorectomy and omentectomy.
The mass was found to be irregular in shape but with a maximum of nearly 12cm across, densely adhered to the sigmoid colon, rectum and posterior surface of the uterus. A small nodule was also noted on the surface of the liver, and the two abdominal lymph nodes were palpated. A clot from the peritoneum was also positive for metastatic clear cell cancer. The clinical and histopathological diagnosis was a stage IIIC clear cell adenocarcinoma of the ovary. That diagnosis as at December 2001 and the surgical findings are not in issue.
Despite chemotherapy and palliative radiotherapy, following the operation, the cancer returned and progressed. On 16 March 2003, Katherine died of complications associated with that cancer.
Signs and Symptoms
The Particulars of Claim (at Paragraph 5) allege that, prior to 21 March 2001, Katherine complained of severe pelvic pain and a suprapubic lump which was visible at times. The implication of the pleading is that, at the 21 March 2001 consultation with Dr McCann, (i) Katherine would have referred Dr McCann to both the pain and the lump, and (ii) the lump would have been apparent, if not obvious, on a proper abdominal examination and/or Katherine's pain would have been apparent on such an examination. Such pain and lump would have been clinically significant, and were potentially important diagnostically.
The basis for these allegations was evidence given by Mrs Munt, Katherine's mother and a lymphoedema specialist nurse. Her evidence is worthy of particular consideration.
In her statement of 29 June 2007, Mrs Munt recalled that Katherine was in a lot of pain following the birth of Rowan, and "felt too unwell to go to the [11 July 2000 physiotherapist] appointment". She continued thereafter to suffer from abdominal pain, and also pain in her lower back. She (Katherine) found her prolapse lump, and wondered whether that was related to the pain from which she was suffering. She was also concerned about urinary incontinence from which she was suffering. Those were the matters which Katherine told her mother she was concerned about when she first saw Dr McCann on 2 August 2000. When she returned from the doctor's, Mrs Munt said that Katherine told her that the doctor had tried to do an internal examination, but that it was too painful for her to perform it.
Following that consultation, the abdominal pain continued and Katherine told her mother that the lump was getting bigger. She showed Mrs Munt the lump about which she was talking, that was above the pubic bone: and Mrs Munt (Statement, Paragraph 8) remembered that:
"… this was visible when she was sitting and was bulging over her trousers. Kathy felt it was more obvious before she went to the toilet to pass urine. With hindsight, I think that this lump was completely different to the lump that Kathy could feel, which was diagnosed as the vaginal prolapse. Kathy however seemed to be under the impression that the two were connected, and that the lump she could feel when she was examined internally, was the same as the lump that was becoming visible when she looked at her pubic area."
Following the 21 March 2001 consultation with Dr McCann, Mrs Munt said (Statement, Paragraphs 9-10) that Katherine told her that:
"9. … she had told the doctor about the continuing pain and the increase in the size of the lump. She however kept on being reassured that it was nothing more than a prolapse and that physiotherapy would sort it out. I believe that there was another attempt at an examination at this appointment, and that this was very painful for Kathy. I understand that Kathy did miss some physiotherapy appointments which led to the need to be re-referred. My understanding however is that Kathy was in such severe pain that she was unable to get to some of these appointments. The amount of pain that she was in is one of the reasons why she was not reassessed by a physiotherapist until September 2001.
10. Her condition continued to get worse with continuing abdominal pain, and she was worried that the lump was getting bigger. She was continually tired, and felt that she was a bad mother. She therefore went back to her GP again in July 2001. I understand that on this occasion, she saw Dr Jones, and it was arranged for her to have some blood tests and a smear. Kathy later told me that it was not possible for the smear to be performed in July as it was too painful for her and the instruments could not even be inserted, due to the painful obstruction. Kathy was then seen by Dr Thomas on 4 September 2001 and requested physiotherapy. I understand that the GP records refer to no abdominal pain on this occasion but do not believe that this is the case…."
Mrs Munt's evidence was that, prior to the 21 March 2001 consultation, not only did Katherine tell her of the severe pain and the suprapubic lump, but that she herself saw the lump. She said (Paragraph 26):
"I can remember that Kathy visibly had a mass growing. My recollection is that by the spring of 2001 it was possible to see the mass when she was sitting down. It was not a question of post-pregnancy loose skin as the area was much harder than this. Kathy would sit in my house on occasions and say, "What is this". The mass would protrude over her trousers, and her zip was often open as it was painful to close it."
Mrs Munt therefore recollected Katherine complaining to her, prior to 21 March 2001, of severe abdominal pain and a suprapubic lump which was visible to Mrs Munt particularly when Katherine was sitting: and, following the consultation, that Katherine told her that she had informed Dr McCann of both. The pain and lump continued after 21 March 2001, until she saw Dr Thomas and visited the hospital on 4 September 2001.
I do not doubt for a moment that Mrs Munt was sincere and genuinely attempting to recollect matters, with a view to assisting me. There is no question of her being dissembling, nor did Mr Mylonas for the Defendant suggest that she was. However, I consider that Mrs Munt's recollection is incorrect in a number of important respects - particularly as to the timing when her daughter, Katherine, suffered the pain and suprapubic lump to which she referred. Given the time that has elapsed since, and the traumatic and tragic circumstances of this case, those lapses of memory, which Mrs Munt acknowledged with frankness and good grace when her memory was shown to be at fault by other evidence, are understandable.
Mrs Munt said (and I accept) that, if Katherine had been in severe pain, then she was the sort of person who would tell her doctor and other healthcare professional (such as physiotherapist) whom she might see. The clinical records support that being the case.
Examples of where Mrs Munt's memory was, in my judgment, at fault are as follows.
Statement, Paragraph 5: Mrs Munt recalled that Katherine was unable to attend the physiotherapist on 11 July 2000 because she was in so much pain. Mrs Munt said that she would have expected the reasons for non-attendance to be elicited by the physiotherapist, as would I. However, the clinical notes indicate that Katherine told the physiotherapist that she had simply forgotten about the appointment (see Paragraph 26 above), with no mention of pain at all. In cross-examination, Mrs Munt frankly accepted that Katherine could simply have forgotten about this appointment, as suggested by the notes.
Statement, Paragraph 6: Mrs Munt said that Katherine also had pain in her lower back. When first asked about when that was, Mrs Munt said that she thought it was late 2000 or early 2001: but, when she had been taken to the entries for 2 August 2000 and 21 March 2001, she accepted that she was not sure about when Katherine complained of back pain. She recollected that Katherine was in back pain for some time - and there is mention of back pain in the records in mid-1999, obviously unrelated to the tumour - but the first mention of back pain in the medical records after the birth of Rowan was in Dr Thomas' referral letter to Mr Kumar on 4 September 2001.
Statement, Paragraph 7: Mrs Munt said that Katherine told her that the doctor (Dr McCann) had tried to perform an internal examination on 2 August 2000, but it was too painful. In her oral evidence, she said that Katherine only told her that an examination had been too painful to conduct on one occasion, and on one other occasion that it had been difficult to perform an internal examination because of pain. When taken to the clinical notes for the consultation with Mr Kumar on 29 October 2001 ("VE imposs due to pain") and with the Accident and Emergency SHO on 4 September 2001 ("VE difficult as unable to relax"), she accepted that those could have been the occasions she recollected.
Statement, Paragraph 8: Mrs Munt was firm in her recollection that Katherine complained of a suprapubic lump (and such a lump was visible) prior to the 21 March 2001 consultation with Dr McCann. However, as Dr McCann's note records " º lump pv" (i.e. no lump per vaginam), she accepted that, if Katherine had been suffering from a lump elsewhere, it is likely that she would have informed Dr McCann of it and it would have been recorded.
Statement, Paragraph 9: Mrs Munt said that Katherine did not attend physiotherapy appointments because of abdominal pain. However, when it was pointed out to her that the records do not suggest that pain caused any such non-attendance, she accepted that there were a variety of other reasons why the appointments were not met, including distress over her relationship problems, and problems with transport to get to the appointments. She said that, because of her depression, Katherine did not always remember to go to appointments. Dr McCann said, compellingly, that, had pain been a reason for Katherine attending previous physiotherapy appointments, and if that pain was still a complaint, there would have been little point in re-referring her on 21 March 2001. Dr McCann said - and I accept - that she would not have made the 21 March referral in those circumstances.
Statement, Paragraph 9: Mrs Munt referred to the out of hours call made by Katherine on 10 March 2001. That was at a time when, according to Mrs Munt, Katherine was in considerable abdominal pain. However, if she had reported severe (or, indeed, any) pain, then she should and in my judgment would have been required to attend the surgery immediately, or would have had a house visit. It is almost inconceivable that the locum doctor would not have even noted pain, or taken some steps to deal with it. In fact, Katherine's appointment with Dr McCann was not until 21 March 2001, 11 days later. That contraindicates that Katherine either reported pain to the doctor over the telephone, or indeed was actually in abdominal pain at that time.
Statement, Paragraph 10: Mrs Munt said that, in July 2001, Katherine told her it was impossible for a smear to be taken, because it was too painful to insert the instrument. Leaving aside Mrs Munt's misrecollection that it was Dr Jones who referred Katherine for a smear test in July (Paragraph 10 of her statement, quoted at Paragraph 56 above - it was Dr McCann on 21 March 2001), it is clear from the records that a smear was satisfactorily taken - it was negative (see Paragraph 41 above) - and, although the notes record that she was "very tense", there is no reference to pain or even discomfort on the taking of the smear. Dr McCann said that it was a common feature of the intrusive procedure for patients to be tense, and a nurse taking smears would know the difference between a patient being tense and a patient in pain. Dr Isaac said that, if a patient complained of significant pain during the taking of a smear, then the nurse would stop the procedure. From the clinical notes, it seems clear that, despite Katherine being tense and the procedure being unpleasant, a smear was taken without pain.
As I have said, I am quite satisfied that Mrs Munt was doing her sincere best properly to recall the relevant events and when they occurred - but I am also sure that her memory was significantly defective, particularly with regard to timings. Her memory with regard to when Katherine suffered from and complained of abdominal pain and a suprapubic lump is belied by the other evidence, especially that of the clinical records, which paints an entirely different picture.
There is no note of any complaint of any abdominal pain until September 2001. In his computer entry for his consultation with Katherine on 4 September, Dr Thomas noted, "No abdo[minal] pain" (see Paragraph 43 above): although in his referral letter to Dr Kumar he said that she had been complaining of pelvic pain "for quite some time". That is not reflected elsewhere in the previous notes. More specific is the Accident and Emergency SHO note of the same day, which records Katherine as having reported "sharp pubic pain" "lately 1/52", i.e. over the previous week (Paragraph 45 above): and the Obstetrics and Gynaecology SHO who, that same day, recorded "now increasingly painful" (Paragraph 46 above). However, that reported pain was put down by the SHO as "sensation of prolapse", and his relative lack of concern about the reported symptoms (and examination, to which I shall return) are evidenced by his discharge letter of 7 September 2001, which simply left matters to the gynaecology outpatients appointment which had already been arranged, and which eventually took place some seven weeks later on 29 October.
When Katherine was seen by Mr Kumar on 29 October, matters had worsened. His notes record "constant pelvic pain"; that a bimanual examination was impossible because of pain; and, for the first time, a suprapubic lump was both presented as visible when the bladder was full, and identified from the abdominal examination.
The experts described September 2001 as being a watershed time for Katherine, in that, from the clinical records, it appears that symptoms of what can now be attributed to her tumour (as opposed to her concurrent prolapse) became evident. As I have already indicated, Mrs Munt said that Katherine, if in severe pain, would have reported that to her doctor or other healthcare professional to whom she had access. On all of this evidence, I am not satisfied that Katherine either reported any abdominal pain (as opposed to discomfort or ache) or any suprapubic lump to any medical practitioner (including Dr McCann at the 21 March 2001 consultation), or indeed actually suffered any such pain or lump, prior to about August 2001. The first complaints to a healthcare professional were made in September 2001.
Breach of Duty
The Claimants contend that Dr McCann did not perform any bimanual examination (nor, indeed, any abdominal examination) on 21 March 2001: and, had she done so, she would have palpated the tumour.
Other than the submission that, had she done a competent bimanual examination, she would have found the tumour, the main evidence relied upon for the proposition that Dr McCann did not perform the appropriate examinations at all derived from Mrs Munt, the medical records and Dr McCann herself. I did not find this evidence compelling, for the following reasons.
So far as Mrs Munt is concerned, I have already considered her evidence in some detail. In Paragraph 10 of her statement, she said of the 21 March consultation:
"I believe that there was another attempt at an examination at this appointment, and that this was very painful for Kathy."
It is perhaps noteworthy that Mrs Munt does not suggest that Katherine told her that no examination was attempted. However, for the reasons I have given, I do not accept that Katherine was in abdominal pain at that time: nor, for the reasons given below, do I accept that Dr McCann would have been foiled in her attempt to conduct a bimanual examination and not recorded either that failure or that pain in the records. Certainly, I do not consider that Mrs Munt's evidence in any way undermines the evidence of Dr McCann as to what transpired at the 21 March 2001 consultation.
Turning to the clinical records, Miss Price for the Claimants relied upon the fact that, unlike the appointment of 2 August 2000, there is no specific note in the records that an abdominal examination was performed on 21 March 2001. She submitted that Dr McCann's explanation that it was her practice to record only positive findings was unconvincing, given that she specifically recorded an unremarkable abdominal examination ("abdo[men] soft") in August 2000, and she recorded on each occasion that Katherine was able, without a problem, to pass urine ("PUing (") and open her bowels ("O.B. ("). However, Dr McCann explained that, at the August consultation, the "negative" finding of "abdo[men] soft" was clinically important because it was a confirmatory sign that the infection problems reported in July 2000 had resolved, and that Katherine was no longer in abdominal pain: and the annotation "PUing ... O.B. (" was shorthand for no concerns having been raised by Katherine on either occasion in response to the important battery of questions Dr McCann put to her about her urinary function and bowel movements. Dr McCann did not say that she never recorded a negative examination finding, but rather that she did not consider herself bound to record every negative finding and she would not routinely do so. That is clinically plausible and sensible; and, on the basis of all the evidence, I find it to be Dr McCann's usual noting method in the clinical records.
Miss Price also relied upon the fact that, in August 2000, Dr McCann recorded a diagnosis of a cystocele ("ant vag wall prolapse") and some slight uterine descent ("?? Uterine descent") on, apparently, a speculum (i.e. visual) examination. Although Dr McCann said that, in practice, she would not diagnose a prolapse without performing a bimanual examination (to determine, amongst other things, the extent of any uterine descent), in line with the expert evidence, Miss Price said that a prolapse can be diagnosed by a visual examination alone. She submitted that, on all the evidence, I should be satisfied that (i) Dr McCann did not conduct a bimanual examination on 2 August 2000; (ii) she did not conduct any examination on 21 March 2001 (alternatively, she did not conduct a bimanual examination that day, but at most a speculum visual examination); and (iii) the examination "findings" recorded on 21 March were simply a repetition of the findings made in August, reported again but without any further examination.
Those submissions were forcefully made by Miss Price, but I am unable to accept them. They are, with respect, speculative: they seek to construe the medical records in the manner of a formal document such as a statute or contact, rather than in their proper context of clinical notes for the future assistance of Dr McCann and other medics: and they run counter to the compelling evidence of Dr McCann which, in substance, I accept.
Dr McCann said that she could not well remember everything about the consultations with Katherine in August 2000 and March 2001. Given that she is (and has been at all material times) a doctor in a busy general medical practice, but particularly bearing a heavier load of gynaecological work than most, that is entirely unsurprising. Her evidence would perhaps have raised more concern had she indicated that she could remember every detail. Miss Price suggested that Dr McCann's evidence was the weaker because she could only say what she would have done, not what she did: but that is unfair to the strength of Dr McCann's evidence with regard to pelvic examinations and how she routinely performs them.
Dr McCann holds a Diploma in Obstetrics and Gynaecology. The general practice experts were agreed that that demonstrated that she was competent in obstetrics and gynaecology (GP Joint Memorandum, Paragraph 7). Dr McCann said that, during her 6 month obstetrics and gynaecology stint in the Countess of Chester Hospital, she performed pelvic examinations six days per week, and perhaps as many as fifteen such examinations on a clinic day, all subject to supervision by a consultant. As the sole female general practitioner in her practice, she deals with most of the gynaecological works there, and regularly conducts pelvic examinations. She said that, since her training days, she has had a "systematic routine way of doing things", i.e. on a pelvic examination she would perform each of the three discrete examinations (external abdominal, speculum visual and bimanual), which she regarded as all parts of a single examination, and would note if any part of that examination was not done. She said that, as all parts required the patient to undress, the bimanual examination did not significantly add to the time taken to complete the examination. Given the presenting abdominal symptoms of Katherine on both 2 August 200 and 21 March 2001, the notation in the records "O/E" meant that she performed a pelvic examination. She was confident that she would have performed her routine in each case, and would have noted if she had not performed (e.g.) the bimanual examination because of pain or any other reason. Because of her inevitable practice, she was able to say with confidence that she did perform a bimanual examination of Katherine on both 2 August 2000 and 21 March 2001.
I accept the submission of Miss Price (supported as it was by the experts) that it is possible to diagnose a prolapse by a visual examination. Indeed, if the prolapse is severe, the cervix may protrude from the vagina, and be readily visible even without the aid of a speculum. Dr McCann accepted that. However, she said that she would not, in practice, ever diagnose a prolapse without performing a bimanual examination: and that evidence I accept. Although in some circumstances, the fact and degree of prolapse may be apparent from a visual examination, with or without using a speculum, Dr McCann said that she performed a bimanual examination in any case of prolapse to ascertain the degree of prolapse. Dr Cranfield confirmed that it is difficult to assess the degree of uterine descent without a bimanual examination (Report 8 September 2008, Paragraph 7.21) and, given that the anatomy of every woman is unique, one would need to feel the degree where the descent was slight.
The experts were agreed that any competent doctor would have performed a bimanual examination on 21 March 2001. Dr McCann had significant experience in dealing with gynaecological conditions - albeit mainly in general practice - and, throughout her evidence, she came across as a committed and diligent doctor. Her clinical notes were thorough, and certainly equal in quality to others disclosed in Katherine's records. In line with the general practice experts, she readily accepted that, given Katherine's presenting symptoms, a full pelvic examination was both appropriate and required on both 2 August 2000 and 21 March 2001. On all of the evidence, I am quite satisfied that Dr McCann would not have marked the records for both consultations "O/E" if she had not conducted an examination of Katherine that day: and that the examination she performed, in accordance with her invariable routine, included a bimanual examination. Her evidence was compelling.
Further, for the following reasons, I am satisfied that the examination which she performed was, at least, reasonably competent.
I was referred to a number of learned papers produced by Dr Cranfield to support the proposition that it is difficult to palpate masses within the abdomen by bimanual examination.
However, a recurring difficulty in relation to ovarian clear cell carcinomas is that the condition is so rare that there are no statistically significant data and, indeed, little reported anecdotal experience. In relation to both this issue - whether Katherine's tumour would have been palpated by a reasonably competent bimanual examination on 21 March 2001 - and to the staging issue in relation to causation to which I shall come in due course (see Paragraphs 112 and following below), in an attempt to be helpful, the relevant experts sought to draw conclusions or support from data relating to conditions other than clear cell carcinoma, but inevitably the strength that could possibly be drawn from such data was limited. That is not a criticism of the experts, but a reflection on the rarity of the condition, and consequently the absence of research and hence data relating to that particular condition.
The literature to which I was referred on this issue related generally to the accuracy of bimanual examinations in detecting any adnexal mass, i.e. a mass in the one of the areas to the sides of the uterus as affecting the ovaries, fallopian tubes etc. As a summary of the conventional learning, I was referred to the Oxford Textbook of Oncology (eds Peckham M, Pinedo H and Veronesi U) (1995) which, in Chapter 9.1 of Volume 2 (Carcinoma of the ovary), states (at page 62) that:
"The most important sign of ovarian cancer is a pelvic mass on examination, particularly one which is irregular and fixed".
However, that same text also states (at page 63):
"Bimanual pelvic examination has been the most commonly used method for the detection of ovarian cancer, but it is too insensitive and cannot reliably detect early disease."
The two most relevant individual papers to which I was referred both derived from research done by the same team in the United States. The first (Padilla LA, Radosevich DM, Milad MP. Accuracy of the pelvic examination in detecting adnexal masses. Obstetrics & Gynaecology (2000) 96, 593-581) concluded:
"Bimanual pelvic examination has marked limitations for evaluating adnexa, even with ideal circumstances…."
The second (Padilla LA, Radosevich DM, Milad MP. Limitations of the Pelvic examination for evaluation of the female pelvic organs. International Journal of Gynaecology and Obstetrics (2005) 88, 84-88)) concluded:
"The bimanual examination appears to be a limited screening test for the female upper genital tract even under the best possible circumstances. Uterine assessment appears to be more accurate than adnexal assessment."
In a third paper, Rulin MC, Preston AL. Adnexal masses in postmenopausal women. Obstetrics & Gynaecology (1987) 70, 578-581, a retrospective study of adnexal masses in postmenopausal women found that multiple masses equal to or greater than 5cm (and even as large as 10cm) were frequently missed by gynaecologists at an academic centre.
The weakness in these papers, submitted Miss Price, was that they were concerned with the whole gamut of adnexal masses across the entire spectrum of the female population. The Padilla papers give no indication of the pathology of any of the masses involved, and the Rubin paper suggested that only one of the masses involved was "solid". In any event, given the rarity of solid tumours, compared with aqueous adnexal masses, Miss Price said that very few of the masses involved in this research would be solid masses. Further, the vast majority of the subjects would be women older than 32, with a higher BMI than Katherine had. There were insufficient data upon which to found any significant conclusion.
There is obvious force in Miss Price's submissions, and I agree that the assistance that can be derived from this literature is limited. However, despite its limitations, this literature does show that ovarian masses, even of some significant size (5cm or above) can be missed on a bimanual examination. I take the point that the literature does not effectively differentiate between so-called "solid" or firm masses such as clear cell carcinomas on the one hand, and aqueous masses on the other - and firmness is one relevant criterion for the palpability of a mass. However, the general practice experts agreed that firmness was of less importance than other factors (such as location and size of the tumour, and size of the patient) in assessing the ability to locate a tumour on examination (GP Joint Memorandum, Paragraph 5). Mr Latimer too considered that firmness was of less importance, explaining that a "solid" clear cell carcinoma was not hard or "wooden", but "squishy" on palpation, unable to maintain its own weight on removal, although offering resistance to the touch.
Insofar as it goes, therefore, this literature offers some support for the proposition that ovarian masses (including masses such as a clear cell carcinoma) are not always easy to palpate. However, in my judgment, that general proposition is of far less importance than the other available evidence, as to clinicians' experience and the particular circumstances of this case. Dr McCann's bimanual examination on 21 March 2001 has to be looked at in its proper context.
As I have already indicated, Dr McCann was, in her own context as a general practitioner, experienced in gynaecological conditions and in performing bimanual examinations. Furthermore, it was her evidence that, in performing that examination on 21 March, she was looking for masses, tenderness or anything else abnormal.
However, Dr McCann "looking for masses" also has to be seen in its full context. Clear cell ovarian cancer in a woman of 32 is extremely, "vanishingly" rare. Katherine did not present with any of the risk factors for ovarian cancer as set out in the standard textbooks (e.g. Female Genital Cancer (eds Gusberg SB, Shingleton HM, Deppe G) (1988) at page 379). I was referred to Hamilton et al (cited at Paragraph 9 above) which suggests that abdominal extension, abdominal pain and urinary frequency are particularly associated with a diagnosis of ovarian cancer. I have found that, as at 21 March 2001, Katherine was neither complaining of nor suffering from either abdominal extension or pain (see Paragraph 72 above). Although she did complain of urinary frequency at the 2 August 2000 consultation, and also to Dr Thomas on 4 September 2001 (Paragraph 43 above) and thereafter, there is no record of her complaining of urinary frequency on 21 March 2001. Urinary frequency is a symptom of prolapse (which, on the balance of probabilities, explains why the complaint in August 2000), as well as being a symptom arising from the pressure exerted by a tumour on the bladder (which appears to explain the symptom from September 2001). Dr McCann asked a battery of questions on 23 March about the passage of urine that would in my judgment have elicited from Katherine any problem she had with urinary frequency if she had suffered from it: and I am quite satisfied that, if such a problem had been elicited at that consultation, Dr McCann would have recorded it. I am satisfied that no such problem was reported, or indeed was being suffered by Katherine, on 21 March 2001.
Given Katherine's age, and the lack of any symptoms that would mark ovarian cancer, on 21 March 2001 the index of suspicion was very low. The experts were agreed that, where the index of suspicion is low, then a clinician is less likely to find a mass. As Mr Latimer in particular indicated, that is so even if, in general, a doctor is looking for anything abnormal in the abdomen, including masses, as Dr McCann was on that occasion.
The general practice experts agreed that there were a number of variables that would need to be considered when determining whether or not a tumour should have been revealed on a reasonable bimanual examination, including the size and weight of the patient, the size and location of the tumour, and (to a lesser extent) the mobility and firmness of the tumour (GP Joint Memorandum, Paragraph 5).
With regard to Katherine's size and weight, in March 2001, she was just over 8 stone, and her BMI was within (but towards the lower end of) the normal range, being no higher than 21. She was described as slightly built.
Turning to the characteristics of the tumour, its size was, of course, a relevant factor in whether Dr McCann ought to have palpated it.
In Paragraph 10 of the Particulars of Claim it is alleged that, in March 2001, the tumour was "probably approximately 9.4cm in diameter and thus it would have been readily palpable in a patient of slim build by abdominal or bimanual examination". That was based upon calculations by Professor Wright (in a letter of 14 July 2006 to the Claimant's solicitors disclosed as part of his evidence) of a "doubling time" (i.e. the time taken for a tumour to double in mass) calculated on the basis that the 2cm ovarian mass identified on the December 1999 dating ultrasound scan (see Paragraph 23 above) grew to nearly 12cms by the time it was removed in December 2001. However, those calculations were based upon an early view of Dr Wingate that the mass disclosed on the December 1999 scan was the relevant tumour rather than an irrelevant cyst, which was his opinion by the time of the experts' joint meeting, recorded in the Joint Memorandum, Paragraph 5(a). As Mr Mylonas for the Defendant pointed out, if the tumour was in fact 5cm across rather than 9.4cm, then its mass would be approximately one-quarter of that calculated by Professor Wright.
Because it is not known when Katherine's tumour first developed, none of the experts at trial suggested there were any means of assessing the size of the tumour by way of calculation. Further, because of the rarity of the condition, there are no data available for doubling times of clear cell cancer, although the evidence suggests that the rate of growth is less than for other ovarian cancers (see Dr Brenton Report 4 July 2008, page 5).
Therefore, the experts had very limited information upon which to base an assessment of the size of the tumour in March 2001, the relevant evidence effectively being restricted to the knowledge that, by October 2001, the tumour was approximately 11-12cm in diameter (Joint Memorandum, Paragraphs 7 and 8), the proposition that such tumours are generally relatively slow-growing, and their own experience of cancers generally and ovarian clear cell carcinomas in particular. On that evidence, they agreed that the estimation of size was in any event "speculative", but agreed the mass was probably in the range 5-10cm in diameter in March 2001 (Joint Memorandum, Paragraph 6(b)). Given that even that range was speculative, it is unsurprising that none would say where, in that range, the tumour was as at 21 March 2001: Professor Wright said that it would be misleading if he tried to be more precise than simply that range and the other experts, in substance, agreed. None of the experts was prepared to say that the tumour was more likely to be over 5cm than not. Given the burden of proof is on the Claimants, I therefore have to work on the basis that the tumour was 5cm in size - but I stress that this case does not simply depend upon the Claimants being unable to show that the tumour was over 5cm in size in March 2001. Even if the tumour had been somewhat bigger, I am satisfied that Dr McCann did not act incompetently or negligently in not palpating it.
With regard to location of the tumour, it was agreed that the tumour was behind the uterus, and there was general agreement between the experts that it would be more difficult to palpate a mass that was behind the uterus than one that was not - although they disagreed as to the additional difficulty involved. All of the experts agreed that the characteristics of the tumour (including its size, location, mobility and firmness) could not be viewed other than in the context of all the circumstances of a specific case.
Dr Isaac considered that a 5cm ovarian clear cell tumour present in a woman of Katherine's build would have been palpated and consequently recognised by a properly performed bimanual examination by a general practitioner.
However, his initial opinion to that effect was very much based upon the reportage of Mrs Munt, specifically that, prior to the 21 March 2001 consultation with Dr McCann, Katherine complained of pain and the tumour stood proud of her abdomen even when she was lying down. That was incorrect, because Mrs Munt had recalled that the lump stood proud when Katherine was sitting (not lying) down - and Dr Isaac accepted that that difference was significant - but, in any event, it was based upon Mrs Munt's pre-March 2001 recollection which I have found to be incorrect. There was no suprapubic lump visible prior to 21 March 2001, nor did Katherine complain of abdominal pain before that consultation. Dr Isaac's original opinion was clearly and starkly based upon Katherine telling Dr McCann on 21 March "about the continuing pain and the increase in size of the [suprapubic] lump" (Dr Isaac Report 5 June 2008, Paragraph 5.8). He refers to them again in (e.g.) Paragraphs 8.1 and 8.15, and importantly in the summary in Paragraphs 10.2 and 10.3 of his report; and in his oral evidence he readily accepted that they were both important features of Katherine's presentation on 21 March 2001 that led him to his initial opinion. Those aspects removed, the basis of Dr Isaac's opinion was substantially undermined. He accepted that, without these signs and symptoms, one would not have been able to palpate the tumour on merely an external examination of the abdomen, given that it was situated behind the uterus: but, based upon his own experience, he considered that the bimanual examination, in the hands of a general practitioner, is a robust and reliable test for ovarian cancer: and, in all the circumstances, Dr McCann ought to have palpated a 5cm firm, irregular and fixed mass, positioned where it was. The robustness and reliability of the bimanual examination as a test for ovarian masses is to an extent brought into question by the literature to which I have referred (see Paragraphs 84 and following above), which Dr Isaac had not considered prior to giving his opinion. Dr Isaac's conclusion based upon his own experience was not shared by other experts, notably Dr Cranfield and Mr Latimer.
Dr Cranfield considered the fact that the tumour was behind the uterus would make it considerably more difficult to palpate. Whilst she agreed in the GP Joint Memorandum (Paragraph 6) that a competent general practitioner would be able to palpate a 10cm diameter clear cell carcinoma behind the uterus, she said even that in stark terms she found uncomfortable - but anything less than 10cm she certainly considered could reasonably be missed. She based that conclusion on her own experience, and the literature to which I refer above (Paragraphs 84 and following). She considered that it was "almost impossible" to feel accurately behind the uterus by way of bimanual examination: she said that, even with maximum pressure from both hands, it is difficult to have the hands only 5cms apart, particularly because of the difficulty in pushing down into the abdomen with the external hand - so that anything of 5cms could quite reasonably be missed.
Turning to the gynaecology experts, Mr Lewis did not significantly assist the Claimants' case on this issue. He said that "An experienced practitioner performing a bimanual examination should be able to detect an ovarian mass, particularly if the mass is solid when it is approximately 5cm or above in diameter" (Report 12 May 2008, Opinion Paragraph (iv)): but, he explained that by "experienced practitioner", he meant a specialist consultant or other gynaecologist, not a general practitioner. He offered no opinion as to whether it ought to have been recognised by a general practitioner, as a matter outside his area of expertise.
Whilst I found all of the experts helpful, I found Mr Latimer's evidence (especially his oral evidence) particularly compelling. Mr Latimer is a consultant gynaecological oncologist at Addenbrooke's Hospital, Cambridge, a post he has held for 10 years. His doctoral research concerned ovarian cancer, and his clinical practice is particularly concerned with ovarian cancer. He has clinical lists and operates on a weekly basis, 10% of the cancers he sees being clear cell tumours.
Like Dr Brenton, Mr Latimer stressed the low index of suspicion in this case, based on Katherine's age and lack of relevant symptoms. That would, he said, have a significant effect on the chances of a bimanual examination identifying a tumour, even if Dr McCann was specifically looking for irregularities including masses. He did not consider a bimanual examination a good test for ovarian masses, saying that a vagino-rectal examination (where the two organs intruded are adjacent and, normally, there is nothing between them in the pouch of Douglas) is far more effective, but highly intrusive and unpleasant, and therefore confined to circumstances in which there is a high level of suspicion of disease. Mr Latimer is of course a consultant, and his patients would be referred on the basis of a raised suspicion of cancer, often after a mass has been identified. However, in all of the circumstances of this case - including Katherine's own size and weight, and the characteristics of the tumour, he was not surprised that Dr McCann did not palpate the tumour, and he said that he may have missed such a tumour even as a consultant gynaecologist to whom the relevant patient had been referred and in whom he was looking for such a mass. That evidence was particularly well-reasoned and compelling. Mr Lewis is also, of course, eminent in his field - but, on the issue of whether a specialist gynaecologist could reasonably miss a 5cm mass behind the uterus of someone with Katherine's characteristics, I prefer the evidence of Mr Latimer.
Mr Brenton supported that evidence. He said that he did not find it surprising that Dr McCann did not palpate the tumour on 21 March 2001, considering the low index of suspicion, based upon Katherine's age and lack of reported symptoms.
Overall, I prefer the expert evidence to the effect that a bimanual examination could have been - and probably was - properly performed on Katherine on 21 March 2001, without identifying the tumour we now know was there.
Dr McCann also gave evidence as to the difficulties in palpating a mass behind the uterus by a bimanual examination. She said that she performed the bimanual examination on Katherine on 21 March 2001 with her usual and proper care, and she did not palpate any mass. In my judgment, for the reasons I have given, the expert evidence strongly supports her case that she conducted a proper bimanual examination on 21 March 2001 but, without any lack of care on her part, she failed to palpate the tumour that was there.
I also consider that it is supported by the evidence of medical appointments and examinations conducted on Katherine after 21 March 2001. Katherine did not report any symptoms of abdominal pain etc at her appointment with Dr Jones on 9 July, nor at her appointment with the practice nurse for her smear test on 13 July, nor at her appointment with another doctor in August 2001 when she presented with severe sunburn. The first time symptoms were reported was on 4 September 2001, when she visited Dr Thomas. Dr Thomas did not physically examine Katherine that day - he relied upon the previous examination of Dr McCann and her forthcoming appointment at the Gynaecology Outpatients Department - but Katherine visited the hospital later that day, of her own volition. There, as I have described, she saw two SHOs, from the Accident and Emergency Department, and the Obstetrics and Gynaecology department respectively. Whilst I accept that the medical note of the appointment with the latter does not expressly refer to a bimanual examination, given that Katherine was referred to that specialist department by Accident and Emergency with abdominal pain, whatever examination might have been performed by the former, I consider it almost inconceivable that the Obstetrics and Gynaecology SHO did not perform such an examination. On the balance of probabilities, I am satisfied that such an examination was done. That the SHO sent Katherine away to await her outpatients appointment nearly 2 months later is a clear indication that no mass was palpated then, by a specialist (albeit perhaps very junior) doctor under supervision of a consultant (although the records do not indicate what part, if any, that consultant directly played in this case), at a time when abdominal pain was reported and when the tumour would inevitably have been larger than in March 2001. Mr Lewis said he was "astonished" that the SHO did not identify the tumour that day, the only reason Mr Lewis could think of as to why it was missed was that the examination was not done or done properly due to pain. However, I find that extremely unlikely. Such a level of pain would have almost certainly have resulted in the SHO doing more than leaving Katherine to attend her outpatients appointment several weeks hence.
The medical record of the appointment is not as full as it might properly have been, but, on all of the evidence, I am satisfied that the Obstetrics and Gynaecology SHO did perform a bimanual examination on 4 September 2001, and did not palpate a mass then. Although it is of course possible that the tumour may have moved in the meantime - it may, for example, have moved up in the pelvis slightly - that is further supportive evidence that this particular tumour was not unreasonably missed by Dr McCann on 21 March.
For those reasons, the Claimants have failed to satisfy me that Dr McCann was in any way negligent in her performance of her examination of Katherine on 23 March 2001.
The finding that there was no breach of duty by Dr McCann is sufficient to dispose of this claim, and it is consequently unnecessary for me to make any findings in relation to the hypothetical question of whether, had she been negligent, would Katherine's outcome have been different but for that negligence. However, out of respect to the considerable expert evidence and submissions I heard on the causation issue, I should make some comment on the issue of causation.
The causation issue turned upon whether, as at 21 March 2001, the tumour was already at stage III, it being agreed between the experts that, if a tumour is diagnosed at stage II, there is a far better chance of fully excising the cancer and a more than double chance of a patient surviving for at least five years over a patient who is not diagnosed until the cancer has reached stage III (see Paragraph 13 above). Whether Katherine's tumour had reached stage III by March 2001 depends upon whether it had significantly implicated contiguous organs, or whether it had spread by metastasis to implicate the lymph glands, either being sufficient to "up-stage" to stage III.
For the reasons I have given (see particularly Paragraph 72 above), I am not satisfied that Katherine suffered any symptoms at 21 March 2001 that would suggest that the tumour had spread to contiguous organs. Given this absence of symptoms that could reliably be associated with spread to contiguous organs until August 2001, I am not satisfied that there was any significant spread to those organs as at March 2001. None of the experts pressed that, on the balance of probabilities, I could be satisfied that there was.
The position of the experts in relation to metastatic spread was not agreed. Professor Wright and Mr Lewis were of the view that, on the balance of probabilities, that there had been no metastatic spread by March 2001 (i.e. it was, at that time, still stage II): and, if the tumour had been recognised then, it could have been fully surgically removed with a good chance of a different survival time outcome for Katherine. Mr Brenton and Mr Latimer disagreed, considering that, on balance, the tumour was already at stage III by then.
All of the experts agreed that the issue was a particularly difficult one: the disease (particularly in younger women) being so rare that there were few directly relevant available data, and the estimation of the stage a cancer had reached at a particular time being something that would not be done clinically - such historical matters being clinically irrelevant (see Paragraph 12 above) - and the course of each tumour being different. As Mr Latimer indicated, because of the criteria which determine the stage, it is possible for a cancer to move from stage I to stage III. Precisely when a tumour moved stages is extremely difficult to determine.
Again, I was referred to literature - but, again, it was necessarily of limited assistance. The paper considered most relevant by the experts was Takano M et al. Clear cell carcinoma of the ovary: a retrospective multicentre experience of 254 patients with complete surgical staging. British Journal of Cancer (2006) 94, 1369-1374. As its title suggests, this paper does concern clear cell carcinomas - but it evaluated the accuracy of staging cancers by reference to clinical characteristics when compared with surgical findings - the paper finding that a significant number of patients were "under-assessed" on the basis of clinical characteristics, and had to be literally "up-staged" from stage II to stage III following surgery. However, I did not find that paper at all helpful in dealing with the question of whether Katherine, who was at stage IIIC by December 2001, was at stage II or stage III in March 2001, when she was relevantly asymptomatic. The literature does not help on the question as causation in this case, except insofar as it shows that staging is an extremely difficult exercise without the diagnostic benefit of surgery.
However, the experts were agreed on a number of relevant matters. They agreed that, whilst the size of the tumour may affect the implication of contiguous organs, and size was a factor in whether a tumour metastasised, it is not necessarily determinative. They agreed that, relative to other tumours, clear cell adenocarcinomas tend to have early metastatic spread. Further, they appeared to agree that genetic factors bore upon the timing of such spread - there may be a "gene signature" for such spread - but, of course, whether Katherine was prone to early metastasis by her genetic make-up is entirely unknown. Further, the absence of relevant abdominal symptoms until (say) August 2001 is not a marker that the lymph nodes were not involved until then, because lymph node implication by metastasis is asymptomatic in its early stages.
Mr Lewis gave his initial opinion on staging - that the tumour had not reached stage III by March 2001 - upon the doubling of mass time Professor Wright derived from the Dr Wingate December 1999 starting point. That opinion was therefore undermined by the undermining of that calculation (see Paragraph 96 above).
As I have indicated, an exercise in assessing historical staging is one alien to clinicians, because historical staging has no clinical relevance (see Paragraph 12 above). This issue was therefore a novel one for the experts. Further, in relation to it, the evidence upon which the experts had to work was very thin indeed. There were no available data about ovarian clear cell cancer of any statistical significance, nor was there any directly relevant reported anecdotal experience. Mr Latimer said that the only evidence upon which an assessment could be made was (i) the clinical and then surgical findings in relation to the tumour from September to December 2001, (ii) the agreed size of the tumour in March 2001 i.e. in the range 5-10cm, (iii) the agreed proposition that clear cell carcinoma tends to metastasise early; and (iv) the proposition that, generally, Katherine's young age was not good prognostically. None of the experts suggested any other evidence was of any significance.
On the basis of the evidence, Mr Lewis and Professor Wright considered it most likely that the tumour would have been stage II in March 2001: Mr Latimer and Dr Brenton considered it more likely that it had by then already reached stage III. None of the experts had any specific evidential support for the view he took.
It is unnecessary for me to make any finding on causation, and I decline to do so. I have made these comments simply to show that, even if the Claimants had succeeded on the issue of breach of duty, they would not necessarily have succeeded on the issue of causation. That issue was a very difficult one, and the evidence in relation to it was very thin. The opinions of Mr Lewis and Professor Wright appeared to me to be as speculative as the opinions of Mr Latimer and Dr Brenton - and, of course, the burden of proof in relation to causation would rest on the Claimants.
Ovarian clear cell cancer in a woman in her early 30s is extremely rare indeed. That Katherine was struck down by this terrible disease is tragic, the tragedy being compounded by the fact that she left two very young dependent children, Ruby and Rowan. Those children did not deserve to lose their mother so.
However, I can only order compensation to be paid if Katherine's death resulted from negligence. For the reasons I have given, despite Miss Price's able and valiant efforts, I find that, in performing the examinations of Katherine that I have found she did perform, Dr McCann's actions did not fall below the proper standard of care that she owed to Katherine as her patient. Nothing she did on 21 March 2001 was negligent. Tragic as this case is for Katherine's family, I am firmly sure that Dr McCann's examination and care of Katherine was of a proper professional standard.
For those reasons, I shall dismiss the claim.
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