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Cite as: [2016] EWHC 3347 (QB)

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Neutral Citation Number: [2016] EWHC 3347 (QB)
Case No: HQ14X01779

IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION

Royal Courts of Justice
Strand, London, WC2A 2LL
21/12/2016

B e f o r e :

HIS HONOUR JUDGE FREEDMAN
(Sitting as a Deputy Judge of the High Court)

____________________

Between:
TRACY HOLDSWORTH
Claimant
- and -

LUTON AND DUNSTABLE UNIVERSITY HOSPITAL NHS FOUNDATION TRUST
Defendant

____________________

Ms Patricia Leonard (instructed by Osborne Morris Morgan) for the Claimant
Ms Erica Power (instructed by Capsticks Solicitors LLP) for the Defendant

Hearing dates: 8-10 November 2016

____________________

HTML VERSION OF JUDGMENT APPROVED
____________________

Crown Copyright ©

    His Honour Judge Freedman :

  1. On 22nd July 2010, the claimant who was born on 18th August 1957 and is now aged 59 underwent a right unicompartment knee replacement ("UKR") at the Luton and Dunstable Hospital. On 5th May 2011, she underwent a right total knee replacement ("TKR") at the same hospital. Further revisionary surgery was carried out in April 2013.
  2. Sadly, none of these operations achieved the desired outcome. To the contrary, the pain in her knee has increased over time and its function has deteriorated. She has chronic pain syndrome. She is heavily reliant on a wheelchair and needs crutches even to walk short distances. She is no longer able to work and she requires assistance with many activities of daily living.
  3. The claimant claims damages on the basis that the defendant's treatment of her knee problem was negligent. There are three separate strands to the claim:
  4. i) It was negligent per se to carry out a UKR ("the first issue").

    ii) In any event, the claimant did not give informed consent for the UKR ("the second issue").

    iii) The femoral component used in the TKR was too large ("the third issue").

    I shall consider the evidence in relation to each of the three issues in turn.

  5. In accordance with the direction of Master Yoxall, this hearing has been concerned solely with the issues of liability and causation.
  6. The Law

  7. In order to understand the issues which arise in this case and the parties' respective positions, it is necessary to look briefly at certain legal principles, as they emerge from case law.
  8. The starting point in any clinical negligence claim is, of course, what is commonly known as the "Bolam" test which derives from a direction given to a jury by McNair J in the case of Bolam v Friern Hospital Management Committee [1957] 1 WLR 583 at 587, where the judge stated:
  9. "I myself prefer to put it this way: that he is not guilty of negligence if he has acted in accordance with practice accepted as proper by a responsible body of medical men skilled in this particular art… putting it the other way round, a man is not negligent, if he is acting in accordance with such a practice, mainly because there is a body of opinion that would take a contrary view."
  10. In the present case, in relation to the first issue, applying the Bolam test, the question is whether no reasonably competent orthopaedic surgeon would have carried out a UKR. There are obviously different considerations in relation to the second issue. In relation to the third issue, applying the Bolam test, the question is whether no reasonably competent orthopaedic surgeon would have opted to use this particular femoral component.
  11. It is trite law but nevertheless needs to be stated that it is insufficient for a claimant to demonstrate merely that there exists a body of competent expert opinion which disagrees with the judgment which was reached on the facts of a particular case. This is an implicit recognition of the fact that in areas of medical expertise there is likely to be a range of opinion which is both legitimate and justifiable. It follows that if there exists a body of competent professional expert opinion which supports a particular decision as being reasonable, it matters not that other experts might disagree. Lord Scarman in Maynard v West Midlands RHA [1984] 1 WLR 634-638E stated:
  12. "Differences of opinion and practice exist and will always exist in the medical and other professions. There is seldom only one answer exclusive of all others to problems of professional judgment. A Court may prefer one body of opinion to the other, but that is no basis for a conclusion of negligence."
  13. However, and of particular application in the present case, the Bolam test was analysed in the well known case of Bolitho v City and Hackney Health Authority [1997] UKHL 46. The issue which arose was whether a Court was bound to accept the views of one truthful body of expert professional opinion even though the Court was unpersuaded that it was a logical approach. It was submitted that to do so could not be legally correct because it was ultimately for the Court, not for medical opinion, to decide what was the standard of care required of a professional in the circumstances of a particular case. Lord Browne-Wilkinson said this:
  14. "I agree with the submission to the extent that, in my view, the Court is not bound to hold that the attendant doctor escapes liability for negligent treatment or diagnosis just because he leads evidence from a number of medical experts who are genuinely of opinion that the defendant's treatment or diagnosis accorded with sound medical practice…
    The use of these adjectives – responsible, reasonable and respectable – all show that the Court has to be satisfied that the exponents of the body of opinion relied upon can demonstrate that such opinion has a logical basis. In particular, in cases involving, as they so often do, the weighing of risks against benefits, the Judge before accepting a body of opinion as being responsible, reasonable and respectable, will need to be satisfied that, in forming their views, the experts have directed their minds to questions of comparative risks and benefits and have reached a defensible conclusion on the matter."
  15. After discussing various authorities, Lord Browne-Wilkinson went to say:
  16. "These decisions demonstrate that in cases of diagnosis and treatment there are cases where, despite a body of professional opinion sanctioning the defendant's conduct, the defendant unfortunately could be held liable for negligence… In my judgment that is because, in some cases, it cannot be demonstrated to the judge's satisfaction that the body of opinion relied upon is reasonable or responsible. In the vast majority of cases the fact that distinguished experts in the field are of a particular opinion will demonstrate the reasonableness of that opinion. In particular where there are questions of the assessment of the relevant risks and benefits of adopting a particular medical practice, a reasonable view pre-supposes that the relative risks and benefits have been weighed by the experts in forming their opinions but if, in a rare case, it can be demonstrated that professional opinion is not capable of withstanding logical analysis, the judge is entitled to hold that the body of opinion is not reasonable or responsible.
    I emphasise that in my view it will seldom be right for a judge to reach the conclusion that views genuinely held by a competent medical expert are unreasonable. The assessment of medical risks and benefits is a matter of clinical judgment which a judge would not normally be able to make without expert evidence. As a quotation from Lord Scarman (see above) makes clear, it would be wrong to allow such assessment to deteriorate into seeking to persuade the judge to prefer one of two views both of which are capable of being logically supported. It is only where a judge can be satisfied that the body of expert opinion cannot be logically supported at all that such opinion will not provide a benchmark by reference to which the defendant's conduct falls to be assessed."
  17. In the present case, the refinement of the Bolam test as articulated in Bolitho only arises in relation to the first issue. Both experts, Professor Fairclough, instructed on behalf of the claimant, and Mr Sweetnam, instructed on behalf of the defendant, agree that a body of orthopaedic surgeons would have offered a UKR to the claimant. Where they differ is that whilst Professor Fairclough says that it would have been illogical to have done so, Mr Sweetnam maintains that it was reasonable to undertake such a procedure and that it stood a good prospect of success, the latter obviously being highly relevant as to whether it was a logical decision to make.
  18. The second issue self-evidently requires somewhat different considerations. There are many authorities which have focused on the issue of informed consent. For present purposes, it is sufficient to make reference to the Supreme Court decision in Montgomery v Lanarkshire Health Board (General Medical Council intervening) [2015] UKSC 11. The facts in that case are wholly different to the facts in the present case and do not need to be expounded. In their combined judgment, Lords Kerr and Reed, at paragraph 87 stated:
  19. "… An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. The doctor is therefore under a duty to take reasonable care to ensure the patient is aware of any material risks involved, any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient's position would be likely to attach significance to the risks, or the doctor is or should reasonably be aware that the patient would be likely to attach significance to it."
  20. Later, at paragraph 90, they said this:
  21. "… The doctor's role involved dialogue, the aim of which is to ensure the patient understands the seriousness of her condition, and the anticipated benefits and risks of the proposed treatment and any reasonable alternatives, so she is then in a position to make an informed decision. This role will only be performed effectively if the information provided is comprehensible. The doctor's duty is not therefore fulfilled by bombarding the patient with technical information which she cannot reasonably be expected to grasp, let alone by routinely demanding her signature on a consent form."
  22. Having set out a very brief précis of the law, in the particular circumstances of this case, resolution of the second issue falls to be determined essentially on the basis of my factual findings. In short, if I accept the evidence of the treating surgeon, Mr Kalairajah, the conclusion is likely to be that the claimant gave informed consent. If, on the other hand, I prefer the evidence of the claimant herself, then it would follow that the risks of the procedure were not adequately spelt out so that she was not in a position to give informed consent.
  23. Background

  24. I do no more than summarise the background facts and only insofar as they touch on the three issues.
  25. The claimant has had longstanding problems with her right knee, dating back to 1998 following a fall at home. In January 2002, she slipped and again injured her knee. Five years later, in April 2007, she had another fall which caused pain and swelling in her right knee. Over the years, she has consulted her GP on a number of occasions in relation to problems with her right knee.
  26. In July 2009, following a referral by her GP, she was seen by a Registrar in Trauma and Orthopaedics. He arranged for an MRI scan. This was reported on 26th July 2009. There was seen to be "linear high signal within the posterior horn of the medial meniscus consistent with degenerative change." All of the other ligaments including the lateral meniscus were found to be normal.
  27. On 25th August 2009, for the first time, the claimant was seen by Mr Kalairajah. He noted, as set out in a letter sent to the claimant's GP dated 28th August 2009 that the claimant still had "marked problems with her knee with swelling despite large doses of anti-inflammatories and exercises." On examination he found there to be "grade I/II effusion with pain particularly round all three compartments." He noted that the MRI scan showed the meniscus to be degenerate. He advised an arthroscopy.
  28. The arthroscopy was carried out by Mr Kalairajah's associate specialist, Mr Saed. As well as providing a detailed operation note, he took photographs of the knee joint. The findings at arthroscopy were osteoarthritis grade II at the patellofemoral joint, osteoarthritis of the medial femoral joint, grade III, and there was grade II osteoarthritis of the medial tibial plateau. The medial femoral condyle was shaved and debrided. Otherwise there were no abnormalities.
  29. On 5th October 2009, the claimant was reviewed in clinic by Mr Saed. He noted that her right knee was still painful and he commented that this was to be expected due to the arthritis. He recorded that he had informed the claimant of the results of the arthroscopy and advised her to do exercises on a regular basis.
  30. Following a complaint made by the claimant in relation to the previous consultation with Mr Saed, she was seen by Mr Kalairajah on 4th December 2009. He noted that her pain was worse than it had been previously. She complained of instability, her knee giving way and persistent swelling. On examination, Mr Kalairajah noted swelling and tenderness in the medial and lateral joints and in the patellofemoral joint. He concluded his letter dated 4th December 2009 to the claimant's GP in this way:
  31. "I have gone through the arthroscopic findings carried out at the time of the surgery and these show that there is some chondral flaps that have been debrided on the medial femoral condyle and there is a little bit less changes in the patella-femoral joint region. I have explained to her that the key thing at present is to alleviate her pain and thus I have given her a local steroid injection into the right knee and also referred her for some urgent physiotherapy. Hopefully this will dampen things down. She should maintain her anti-inflammatories and simple analgesia and ice the knee. I will review her in six weeks and if things have improved then a course of Hyalgan injections may be appropriate. If not, we can consider going down the route of a further re-arthroscopy with perhaps a microfracture with however no significant guarantees. She knows that eventually she will most likely require a unicompartmental knee replacement…"
  32. On 19th January 2010, the claimant was seen again by Mr Kalairajah. The steroid injections had provided only temporary relief. Mr Kalairajah noted that she was carrying on with her exercises. His treatment plan was to see her within the next few months and to discuss options including Hyalgan injections, arthroscopy and microfracture. There was apparently no discussion about UKR.
  33. On 6th April 2010, the claimant was seen by Mr Amit Sharma (a trauma surgeon). His clinical letter to the GP contained the following:
  34. "She has been suffering from a lot of pain in her right knee. She had extensive discussions about the treatment with Mr Kalairajah at her last visit. She wanted today to straight away go ahead with a unicondylar knee replacement instead of having any Hyalgan injections or arthroscopy. She is well aware of all the complications of this procedure.
    After a long discussion we decided we would bring her back in three weeks' time when Mr Kalairajah will be back in the clinic and we will make a final decision after involving him."
  35. The claimant's fourth and final consultation with Mr Kalairajah before the surgical procedure took place on 27th April 2010. Mr Kalairajah noted that the claimant was now struggling with day-to-day activities. He recorded that they had had a long discussion about treatment options including repeat arthroscopy with microfracture or joint replacement. In his letter to the GP, Mr Kalairajah said that the claimant was very keen to have a joint replacement and that he had agreed to put her on the list for a UKR. He also noted that "She is aware of the risks of the procedure and the potential benefits…"
  36. The procedure was carried out by Mr Kalairajah on 22nd July 2010. He obtained her written consent before carrying out the surgery. At surgery, he found moderate changes in the medial femoral condyle which reflected the arthroscopic findings.
  37. It is agreed all round that this operation was not successful. Ultimately a decision was taken to carry out a TKR. Mr Kalairajah undertook this revisionary procedure in May 2011. Unhappily, the claimant derived no real benefit from this procedure either. Mr Kalairajah suspected that she had developed chronic regional pain syndrome and such was confirmed by Mr Chatoo who saw her at the Lister Hospital.
  38. Following a number of referrals, it was decided to do a revisionary procedure to insert a smaller femoral implant. This was carried out in April 2013. Again, regrettably, this procedure did not alleviate her symptoms. To the contrary, it was noted that she was "in more pain than ever before." There was also this important observation in the medical note dated 3rd July 2013: "Our pre-operative assumption was that the femoral component was oversized but I am not sure if this could account for all her pain and symptoms."
  39. Evidence re. First Issue

  40. The claimant, for wholly understandable reasons, has a poor recollection of the specific consultations and examinations. This is due not only to the number of examinations which she has undergone over time but also the lapse of time which will have inevitably dimmed her memory. What, however, is abundantly clear from her own evidence is that by 2009, she was having significant problems with her knee such that she had to move out of her own home because she was unable to manage stairs. On the other hand, she had a physically demanding job doing heavy cleaning which she was determined to preserve, not least because she had a mortgage to pay. In her witness statement, she recalled a discussion with Mr Kalairajah where he told her that it was a process of trying different treatment options to see what might relieve the pain. By April 2010, however, when she saw Mr Sharma (although she has no recollection of the consultation), she accepted that by that time, she was not willing to have a further arthroscopy or injections because they had not alleviated the pain.
  41. Her recollection of the consultation on 27th April 2010 was that Mr Kalairajah was very positive about performing a UKR, saying to her that the procedure would make her a "new woman". It was as a result of that reassurance, she says, that she agreed to have the procedure.
  42. Although, ultimately, it must be for the clinician and not the patient to decide on the appropriate course of treatment, the impression gained from the evidence from Mr Kalairajah and Mr Sharma is that the claimant reached a stage when she was unwilling to contemplate any treatment other than a knee replacement. Mr Sharma's letter following his consultation is unequivocal: the claimant wanted to proceed straightaway with a UKR. The thrust of Mr Kalairajah's evidence is to like effect: "She is keen to go straight down the route of a joint replacement." (Letter dated 29th April 2010).
  43. As to Mr Kalairajah's thought processes in making a decision to perform UKR, it is plain that he was heavily influenced by the results of the arthroscopy. In his evidence, Mr Kalairajah interpreted a grade III change in the medial femoral condyle as being a change extending through the full depth of the hyaline cartilage all the way up to, although not penetrating, the chondral bone with a diameter exceeding 1.5 centimetres. This finding confirmed to him that there were focal degenerative changes in the medial compartment. He said that if the lesion was only at stage 2, he would not have offered surgery.
  44. In addition, as it seems to me, there is no doubt that Mr Kalairajah was influenced by the claimant's desire to have knee replacement surgery, having exhausted most other treatment options. He was also (understandably) influenced by the extent of her pain and the degree to which it was compromising her day-to-day activities.
  45. Whether rightly or wrongly, I am satisfied that Mr Kalairajah genuinely believed that a UKR, in these circumstances, had a good prospect of relieving her pain and restoring good function. Hence, it is not surprising that the claimant recalls at the end of the consultation in April 2010, Mr Kalairajah attempted to give her a degree of reassurance by telling her that the procedure would make her "a new woman".
  46. Expert Evidence re. First Issue

  47. As summarised in Paragraph 11 of this Judgment, both Professor Fairclough and Mr Sweetnam agree that only a minority of orthopaedic surgeons would have performed a UKR in these circumstances. Furthermore, they both say that neither of them would have offered the claimant a UKR. Where they part company is that whilst Mr Sweetnam considers that it was a reasonable step to take, Professor Fairclough believes that it was illogical and, therefore, he does not accept that a responsible body of surgeons would have performed such surgery.
  48. Professor Fairclough's opinion can be summarised as follows:
  49. i) The radiology, in particular the MRI scan, would not of itself justify a UKR (Mr Sweetnam agrees with this).

    ii) The changes viewed at the arthroscopy were minimal and not indicative of osteoarthritis (albeit that he accepted that there was a grade III lesion in the medial compartment).

    iii) The hyaline cartilage has no nerve fibres and, accordingly, the lesion in the cartilage could not have been responsible for the pain suffered by the claimant.

    iv) No purpose was to be served in removing normal bone which was not arthritic.

    v) The cause of her pain was a matter of speculation. As such, and absent any medical or scientific explanation, joint replacement surgery cannot be justified.

  50. Mr Sweetnam's opinion can be summarised as follows:
  51. i) A lesion in the cartilage can give rise to pain in the knee joint. He explained that it has a cushioning effect on the bones as they move against one another and loads are transmitted in the vertical plane.

    ii) In support of his contention that damage to the cartilage can give rise to symptoms, he said that he had operated on such patients in the past (albeit that he now adopts a very conservative approach to surgical intervention).

    iii) A grade III lesion was significant (he described it as being approximately the size of a 10p piece).

    iv) Generally, there is a range of legitimate opinion and that it was neither illogical nor irresponsible for Mr Kalairajah to carry out UKR in these circumstances.

  52. In looking at the difference in opinion between the two experts, nowhere is it more strikingly demonstrated than in their assessment of the prospect of the surgery either eliminating or materially diminishing the pain. This was a question which I suggested should be posed to the experts at the commencement of the trial. The response from Professor Fairclough was that the surgery stood zero percent prospect of success whereas Mr Sweetnam considered that there was a 75 percent chance of the pain being eliminated and an 80 percent chance of the pain being materially diminished.
  53. Analysis of First Issue

  54. On this central issue, the claimant's evidence, in the end, adds very little. However, and as I have already observed, and whilst not being in any way determinative, I am satisfied that the claimant made it abundantly clear, as of April 2010, that she was intent upon having knee replacement surgery. This was entirely understandable given that other therapeutic options had not provided any lasting benefit and her symptoms were materially impairing her quality of life. But I stress (and it needs to be stressed) that the mere fact that a patient is insistent about receiving a certain type of treatment does not and cannot, of itself, justify such treatment being provided. The mode of treatment must always be a clinical decision based upon a clinical assessment as well, of course, of taking into account the patient's wishes. As to the latter, I am in little doubt but that if the claimant had told Mr Kalairajah that she did not want to undergo surgery, he would not have proceeded with the operation. That is, however, very different from saying that the reason for her undergoing surgery was her insistence that was what she wanted.
  55. The crucial question is whether Mr Kalairajah's decision to carry out a UKR was legitimate in the sense that a body (even if only small) of responsible orthopaedic surgeons would have done likewise. In accordance with Bolitho, that raises the question as to whether the decision withstands logical scrutiny.
  56. In making that determination, it is helpful first to look at Mr Kalairajah's background and to make some form of assessment of him. He acquired membership of the Royal College of Surgeons in 1998 and became a Fellow of the College (Trauma and Orthopaedics) in 2004. He became a consultant orthopaedic surgeon in 2005. As at the time of making his witness statement in January 2016, he had performed over 500 knee arthroplasty procedures directly as a consultant and supervised, or assisted in, an additional similar number. In short, as at the time when the claimant was his patient, he was highly experienced in treating knee problems and in carrying out surgical procedures.
  57. I am equally satisfied that he was and is both a caring and careful consultant. He made a detailed note (in the form of letters to the claimant's GP) after each of the four consultations leading up to the surgery. Although of no particular significance, I accept his evidence that he dictated the letters in the presence of the claimant. I am satisfied that the content of the letters accurately reflects that which transpired in each of the consultations.
  58. As a witness, he presented as measured, genuine and plausible. I am satisfied that he considered carefully the results of the arthroscopy which suggested to him that there were degenerative changes of some significance in the medial compartment. Equally, I am satisfied that he considered that the source of the pain was very likely to be the focal lesion which would be improved, if not eliminated, by a UKR.
  59. Notwithstanding my positive assessment of Mr Kalairajah, ultimately this first issue must be determined on the basis of which expert opinion is to be preferred.
  60. Manifestly, as it seems to me, if I accept the opinion of Professor Fairclough to the effect that the operation stood no chance of success, then the conclusion must necessarily be that the actions of Mr Kalairajah do not meet the Bolitho test. If, on the other hand, I accept the evidence of Mr Sweetnam, that the operation stood good prospects of success then it is difficult to see how it could be said that it was illogical or irresponsible to do a UKR.
  61. Ms Leonard on behalf of the claimant urges me to accept Professor Fairclough's opinion on the grounds that it is scientifically based. Specifically, she submits that Professor Fairclough must be right in saying that there was no purpose to be served in removing normal bone and tissue which is aneuronal. Ms Leonard also relies upon the fact that Professor Fairclough, in his 40 years' experience of orthopaedic surgery, had never come upon surgery being performed in these circumstances. It is said that absent degenerative change seen radiologically, there can be no logical basis for knee replacement surgery. In this instance, the point is made that the MRI scan showed damage to the posterior horn of the medial meniscus whereas in fact the pain was not at the back of the knee but on the medial joint line. Reliance is also placed upon the fact that the radiology had not changed between 2007 and 2009 suggesting that there was no degenerative process underway. It is also submitted that Professor Fairclough was correct in saying that such changes as were seen at arthroscopy were minimal and unexceptional for a lady of this age.
  62. Other matters relied upon in support of Professor Fairclough's assessment are that the claimant was comparatively young to undergo knee replacement surgery and that, by implication, this should have been a contraindication. Furthermore, when she had undergone surgery in the past, she had suffered an adverse pain reaction: this, again, should have been regarded as a contraindication. Moreover, it is said that far from relieving the pain, there was a substantial risk that the pain and disability would be made worse. Coupled with these matters, and unsurprisingly, Ms Leonard submits that what occurred post-operatively, namely a worsening of the pain, validates entirely the opinion expressed by Professor Fairclough.
  63. My assessment of Professor Fairclough was that he was expressing a genuinely held and sincere opinion which was based on his clinical experience over many years. I bear in mind the justifiable criticisms which are made of Professor Fairclough in the way in which he dealt with revision of the experts' joint statement after he had signed it off. I find his explanation of dyslexia as a reason for attaching his signature to the original joint statement, the contents of which he did not agree, somewhat baffling. I should record that Professor Fairclough was clearly embarrassed about the way in which he had dealt with the joint statement. However, I should equally make it clear that in evaluating the respective merits of the experts' opinion, I do not attach any weight to his somewhat unprofessional approach to the preparation and revision of the joint statement. The reality is that, in the main, the views he expressed in evidence were properly reflected in the original draft of the joint statement.
  64. Nevertheless, as it seems to me, there are valid criticisms to be made of Professor Fairclough's expert opinion. In the first instance, I find it difficult to reconcile Professor Fairclough's assertion that he has never seen or heard of a UKR being performed in these circumstances with his acceptance that a small body (albeit acting irresponsibly) would perform such an operation. If the former is correct, the question has to be asked as to why he concedes that nevertheless certain orthopaedic surgeons would carry out such an operation.
  65. Further, as identified by Ms Power, there were a number of inconsistencies in the opinions expressed by Professor Fairclough. Specifically, in his evidence, Professor Fairclough was adamant that the changes seen on arthroscopy were not degenerative and, indeed, that was the view which he expressed at paragraph 13(b) of the joint statement. However, in that same document, at paragraphs 2(a) and 9(a), he agreed that the arthroscopy did show degenerative changes, albeit minor.
  66. It is also the case that Professor Fairclough appeared to minimise the findings at arthroscopy. He described them as being trivial and normal for a lady of the claimant's age. However, as Ms Power points out, it is difficult to see how grade III can be described as trivial on a grading system that starts at I and goes up to IV. Ms Power also makes the point that if, as Professor Fairclough said, such changes might often be seen in a younger person, especially if they had had two falls, this would tend to suggest that a grade III lesion is far from being normal. It is also the case that Professor Fairclough accepted that the findings on arthroscopy were markedly different from the MRI findings.
  67. Furthermore, although Professor Fairclough was adamant that change to the hyaline cartilage could not be the source of pain, as Ms Power points out, in his original report he stated, "The MRI scan results also would not confirm there was any significant hyaline change. Therefore, whatever the cause of the pain and discomfort in the knee, it was not going to be resolved by unicondylar replacement." I agree with Ms Power that the proper interpretation of this statement is that the underlying premise is that change in the hyaline cartilage could potentially cause pain and could justify a UKR. If Professor Fairclough had considered that there had to be damage to the underlying bone before a UKR could be considered, it is surprising that in the passage which I have just cited, he makes no reference to the absence of bone damage. I agree too that in paragraph 3 of the joint statement, Professor Fairclough appears to accept that abnormality in the joint alone could give rise to pain which could be alleviated by surgery. I am also somewhat troubled by his bold assertion at paragraph 2(e) of the joint statement to the effect that "the indication for surgery was persistent pain in the absence of any clinical or radiological findings": this seems to me to ignore completely the findings on arthroscopy and also Mr Kalairajah's findings on clinical examination.
  68. I turn then to the expert opinion of Mr Sweetnam. He too is not above criticism in his approach to this case. First, given the views which he ultimately expressed, it is somewhat surprising that he accepted at paragraph 13 of the joint statement that whilst a minority of orthopaedic surgeons may have undertaken the procedure, it would have had no scientific basis. He told me that this was an oversight on his part. I am prepared to accept that it was but it was a significant error.
  69. More particularly, I struggle with the proposition that the surgery, in Mr Sweetnam's view, had an 80 percent chance of reducing the pain and a 75 percent chance of resolving the pain altogether in circumstances where he says that only a very small number of orthopaedic surgeons would have undertaken the operation and he himself would not have done so. It seems to me that if the prospects of success were as high as suggested by Mr Sweetnam, then it would not simply be a small number of orthopaedic surgeons who would have gone down the route of surgery and, furthermore, even allowing for his conservative approach, Mr Sweetnam himself surely would have considered doing a UKR in these circumstances. Furthermore, it is difficult to see how the percentages given by Mr Sweetnam in relation to the outcome of this procedure can be reconciled with a general predicted success rate of 82 percent. A reduction of a mere seven percent in circumstances where, on any view, there were not the clearest indications for UKR strikes me as illogical.
  70. I regret to say that in expressing the view that this procedure stood such high chances of success, Mr Sweetnam became 'an advocate in the cause'. I simply do not accept that the chances of success were as high as he sought to suggest.
  71. That is not to say that I reject Mr Sweetnam's evidence in its entirety. Indeed, to the contrary, as with Professor Fairclough, I am satisfied that, in the main, he was giving his genuinely held opinion to the Court and doing his best to assist the Court. In particular, the Court is bound to be impressed by his candour that he himself would not have carried out a UKR in these circumstances. The proper inference is that he was willing to consider opinions other than his own and, as Ms Power submits, unlike Professor Fairclough, he recognised that there was a range of legitimate opinion. Generally, as it seemed to me, Mr Sweetnam was willing to adopt a more holistic approach as opposed to applying a very rigid, scientific analysis.
  72. On the issue as to whether damage to the hyaline cartilage can itself be the source of pain, it seems to me to be impossible to say that no credence at all should be given to the observations made by Mr Sweetnam. He explained in anatomical terms how it is that loss of cartilage could cause pain in the knee joint. It is also the case that where there is no meniscus, the hyaline cartilage of the femur moves directly against that of the tibia. Moreover, Mr Sweetnam maintained that he had operated on patients in the past who had damage to the cartilage alone without any arthritic change within the bone.
  73. Ultimately, the decision for the court is not whether the defect within the cartilage was or might have been the source of pain but whether it was legitimate to consider that it might be contributing to the claimant's knee problem. If it was legitimate to hold such a view, then it would follow that it was legitimate to proceed to surgery.
  74. I am satisfied on the basis of the evidence of Mr Sweetnam (and on the strength of the evidence from Mr Kalairajah) that a responsible body of orthopaedic surgeons would have legitimately considered that the findings on arthroscopy were or might be the cause of the pain in the claimant's knee. I am equally satisfied that a responsible body of orthopaedic surgeons would, having come to that conclusion, have proceeded to offer a UKR. Further, I am satisfied that a responsible body of orthopaedic surgeons would have considered that such an operation stood reasonable prospects of success but, as I have already observed, not as high as that suggested by Mr Sweetnam. I reject the proposition advanced by Professor Fairclough (for the reason which I have given) that this procedure stood no chance of a successful outcome.
  75. It follows that I consider that the decision to carry out a UKR withstands logical analysis and it was not Bolam negligent so to do.
  76. The Second Issue

  77. The question of informed consent can be considered with much greater brevity. It is not surprising that the claimant now says that she was not warned of the risks of persisting and continuing pain or that she might require further knee surgery. It was also predictable that she would say that had she been so warned, she would not have agreed to have a partial knee replacement. But her evidence about these matters is inevitably coloured by the outcome of the surgery and subsequent events. In any event, I have already indicated that it is difficult to place too much reliance upon what the claimant says about the various consultations.
  78. In contrast, I am able to place reliance upon what both Mr Kalairajah and Mr Sharma said in their respective letters to the claimant's GP. I am satisfied that on 6th April, Mr Sharma did have a long discussion with the claimant and that he pointed out to her the various complications of a UKR. Equally, I am satisfied that there was a long consultation with Mr Kalairajah on 27th April 2010 when he explained to her the various risks of the procedure as well as the potential benefits.
  79. Additionally, it is clear that the claimant signed the consent form prior to the operation and that this form identified the serious or frequently occurring risks. Whilst it is true that there is no specific reference to persistent or worsening pain, I accept Mr Kalairajah's evidence that when advising patients about the risks, he would always make reference to ongoing pain, particularly in the context of infection or neurovascular injury. I reject the suggestion that because the claimant was "gowned up", she was not in a position to give informed consent.
  80. Of course, it is not just a question of being informed about the risks of the intended procedure but also there must be a discussion with a patient about reasonable alternative options: see Montgomery (supra). The discussion of reasonable alternative options must be seen in the context of Mr Kalairajah giving the claimant a steroid injection and advising physiotherapy. He also discussed with her Hyalgan injections but she made it clear to Mr Sharma that she did not want to have Hyalgan injections. She also told Mr Kalairajah that she did not want to have another arthroscopy and microfracture. It seems to me, therefore, on the face of it, the claimant was given reasonable alternative options to surgery.
  81. Overall, I am satisfied that the claimant gave informed consent to this surgical procedure despite what she now says. It should also be noted that Professor Fairclough appeared to agree that if I accepted the evidence of Mr Kalairajah (as I do) then the claimant had been given sufficient warning risks of the procedure.
  82. In any event, and even if I am wrong in finding that she had given informed consent, and even if there were any omissions in relation to warning of risks or in relation to the discussion of alternative options, I am satisfied, on a strong balance of probabilities, that such is of no causal significance. The reality is that the claimant was determined to have surgery and, in my judgment, she would have gone down that route whatever was said to her. Such is abundantly clear from the evidence from both Mr Kalairajah and Mr Sharma.
  83. Third Issue

  84. This question in relation to the third issue is whether Mr Kalairajah was Bolam negligent in selecting an over-large prosthesis for the purposes of the TKR. This issue can be addressed with even greater brevity.
  85. Mr Kalairajah's unchallenged evidence was that the components are not custom-built but rather come "off the shelf". He said that there were six different sizes from which to choose. He is careful not to use too small a size because of the risk of the component cutting into the femoral bone. He maintained that he had used the correct size and rejected the notion that it was 3mm too large. He stressed that the important measurement was the anteroposterior size.
  86. There is, however, evidence in the medical records that other clinicians considered that the component may have been too large. In a letter dated 12th December 2012, Mr Odri commented that the x-ray showed that the "femur is really over-sized". Mr Chatoo and Mr Odri came to a similar conclusion. On the other hand, Mr Donaldson who reviewed the claimant on 3rd July 2013 noted, "Our pre-operative assumption was that the femoral component was over-sized, but I am not sure if this could account for all her pain symptoms…"
  87. Professor Fairclough expressed the view that the component was approximately 3mm over-large. Mr Sweetnam, on the other hand, considered that the correct size was selected and he confirmed that, in his view, a reasonable body of orthopaedic surgeons would have used a component of this size.
  88. My conclusion is that the prosthesis did err on the large side. But that is a far cry from saying that Mr Kalairajah was Bolam negligent in selecting a component of this size. It is not clear, but it may well be that the size down would have been too small and carried the risk about which Mr Kalairajah was concerned. Whether or not that is the case, I cannot, and do not overlook, the observations made by Professor Fairclough in the joint statement. At question 21 he said this:
  89. "As these components come off the shelf, if one is to be driven by the measured AP distance the 'apparent' oversizing mediolaterally would not be an issue that he would seek to correct."

    That to my mind implies that Professor Fairclough did not regard the size of the component as a serious problem. Moreover, at question 22(5), Professor Fairclough says this: "He would possibly have used a smaller size." That observation is not consistent with an assertion that no reasonably competent orthopaedic surgeon would have chosen a component of this size.

  90. In the result, I am far from persuaded that the implant chosen by Mr Kalairajah was of the wrong size, far less that it was Bolam negligent to use a component of this size.
  91. Conclusion

  92. Of course the claimant is deserving of the utmost sympathy and I unhesitatingly express my sincere sympathy to her. However, she will appreciate cases such as this cannot be decided on grounds of sympathy but rather they must be subject to rigorous legal analysis.
  93. The consequence of my findings in relation to each of the three issues is that there must be judgment for the defendant.
  94. Finally, I express my gratitude to Counsel for the very real assistance which they gave to the Court.


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URL: http://www.bailii.org/ew/cases/EWHC/QB/2016/3347.html