QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT
Strand, London, WC2A 2LL |
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B e f o r e :
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THE QUEEN (on the application of SHEILA ADAM) |
Claimant |
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- and - |
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GENERAL MEDICAL COUNCIL |
Defendant |
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Catherine Callaghan (instructed by GMC Legal) for the Defendant
Hearing dates: 13 October 2015M
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Crown Copyright ©
Mr Justice Edis :
A Review of the Facts
"What is the story re open access and your involvement? Paed units often offer open access as a matter of course.
"Any light you can throw on this would be appreciated."
"My understanding is that although you advised RBH to establish a review of the care of BL and to share the outcome with the family, they have been reluctant to do this. There has also been no progress on the development of a clinical pathway for Kawasaki Disease. The contact between NHS London and the family is now through solicitors.
"The family continue to believe that there were failings in the care provided for Ben last year and that their concerns have not been properly addressed by RBH. They also consider that RBH has not been held to account.
As I explained [BL's family] approached me using my contact details which were unintentionally released by NHS London. I feel that I now have a duty of care to highlight these concerns, and therefore propose to contact Bruce Keogh, to seek his advice about this complex case."
"I don't think this will be helpful at all.
"Am sure that Bruce will come back to me at some stage and ask for advice on the matter.
"The Trust will claim that they have investigated the complaint to their satisfaction and I have no authority to counteract that. There have been independent external views given on BL's care hence his change of consultant and trust. The next phase in complaints proceedings would be to take it to the ombudsman which BL's father could do and I am sure you could support him if you wished.
"The Trust has agreed to working with others to produce an appropriate pathway for KD patients which it is my responsibility to take forward. I'm not sure where your personal responsibility lies here… are you supporting the family's personal grievance against RBHT or seeking improved care for young people on this pathway throughout London – to which RBHT would be a signatory?"
"Thanks for your email which I have reflected on over the last 24+ hours. To clarify my position: I have been made aware of concerns about the clinical care provided at [the Royal Brompton Hospital] and do not have evidence that these have been properly investigated and, if necessary, action taken. I am therefore acting within the duty of care which any doctor would have in these circumstances."
"Dear Bruce
"I would be grateful for your advice.
"When I was Regional Director of Public Health with NW Thames RHA, I dealt with a complaint about the clinical care of a three year old with Kawasaki's Disease. There was a delay in making the diagnosis and in prescribing IgG, and the child was left with a coronary artery aneurysm. The trust did not handle the complaint well and an independent investigation was commissioned by the RHA. This confirmed the delay and the missed opportunity to provide early treatment.
"Last year, now aged 19 years, the patient had a myocardial infarction which required a graft, and was treated in a second trust. The family are concerned about the delay in making the diagnosis and in instituting effective treatment. They are also unhappy about how the trust provided care, and what they perceive to be an inadequate response to their concerns.
"I attach a draft letter from Professor Michael Levin who looked after the child and family following the initial diagnosis. I should emphasise that this letter was not sent but I think it does provide an excellent summary of the events last year.
"The family made contact with NHS London towards the end of last year. I was contacted a few weeks ago by them…as they remain unhappy with the NHS response to their concerns, and I have now met with them. On the basis of the information which I have, it seems that the Trust has not provided the family with an appropriate response to what are potentially serious concerns. It is possible that there may be wider implications for clinical care.
"It would be very helpful if Michael Levin and I could talk this through with you. Would it be possible to book a slot in your diary?"
"While he has an obvious interest in clinical care, Bruce has indicated that it is not appropriate for him to become involved in an individual case at this time. Apologies."
"I realise that, in your role, you cannot get directly involved in investigating clinical concerns or complaints. However, I believe that, as medical director for the NHS, you do have a locus in ensuring that such concerns are properly investigated. This may be via the complaints process, but as the Mid-Staffordshire inquiries show, this can be a blunt instrument. Moreover if an NHS body is aware of concerns about clinical care, they should take action whether or not there has been a complaint.
"I am putting this on record, as I believe is my responsibility as a doctor registered with the GMC. I remain unhappy with the present position, and, of course, very happy to discuss the case with you."
"Serious concerns have been reported to me, as a medical practitioner. My understanding is that the GMC requires any registered medical practitioner to address concerns about the practice of a colleague."
The relevant regulatory scheme
"35C.— Functions of the Investigation Committee
(1) This section applies where an allegation is made to the General Council against—
(a) a fully registered person; or
(b) a person who is provisionally registered,
that his fitness to practise is impaired.
(2) A person's fitness to practise shall be regarded as "impaired" for the purposes of this Act by reason only of—
(a) misconduct;
(b) deficient professional performance;
……
(4) The Investigation Committee shall investigate the allegation and decide whether it should be considered by a Fitness to Practise Panel."
(1) Misconduct is of two principal kinds. First, it may involve sufficiently serious misconduct in the exercise of professional practice such that it can properly be described as misconduct going to fitness to practise. Second, it can involve conduct of a morally culpable or otherwise disgraceful kind which may, and often will, occur outwith the course of professional practice itself, but which brings disgrace upon the doctor and thereby prejudices the reputation of the profession.
(2) Misconduct falling within the first limb need not arise in the context of a doctor exercising his clinical practice, but it must be in the exercise of the doctor's medical calling. There is no single or simple test for defining when that condition is satisfied.
(3) Conduct can properly be described as linked to the practice of medicine, even though it involves the exercise of administrative or managerial functions, where they are part of the day to day practice of a professional doctor. These functions include the matters identified in Sadler , such as proper record-keeping, adequate patient communication, proper courtesy shown to patients and so forth. Usually a failure adequately to perform these functions will fall within the scope of deficient performance rather than misconduct, but in a sufficiently grave case, where the negligence is gross, there is no reason in principle why a misconduct charge should not be sustained.
(4) Misconduct may also fall within the scope of a medical calling where it has no direct link with clinical practice at all. Meadow provides an example, where the activity in question was acting as an expert witness. It was an unusual case in the sense that Professor Meadow's error was to fail to recognise the limit of his skill and expertise. But he failed to do so in a context where he was being asked for his professional opinion as an expert paediatrician. Other examples may be someone who is involved in medical education or research when their medical skills are directly engaged.
(5) Roylance demonstrates that the obligation to take responsibility for the care of patients does not cease simply because a doctor is exercising managerial or administrative functions one step removed from direct patient care. Depending upon the nature of the duties being exercised, a continuing obligation to focus on patient care may co-exist with a range of distinct administrative duties, even where other doctors with a different specialty have primary responsibility for the patients concerned.
(6) Conduct falls into the second limb if it is dishonourable or disgraceful or attracts some kind of opprobrium; that fact may be sufficient to bring the profession of medicine into disrepute. It matters not whether such conduct is directly related to the exercise of professional skills.
(7) Deficient performance or incompetence, like misconduct falling within the first limb, may in principle arise from the inadequate performance of any function which is part of a medical calling. Which charge is appropriate depends on the gravity of the alleged incompetence. Incompetence falling short of gross negligence but which is still seriously deficient will fall under section 35C(2)(b) rather than (a).
(8) Poor judgment could not of itself constitute gross negligence or negligence of a high degree but it may in an appropriate case, and particularly if exercised over a period of time, constitute seriously deficient performance.
(9) Unlike the concept of misconduct, conduct unrelated to the profession of medicine could not amount to deficient performance putting fitness to practise in question. Even where deficient performance leads to a lack of confidence and trust in the medical profession, as it well might — not least in the eyes of those patients adversely affected by the incompetent doctor's treatment — this will not of itself suffice to justify a finding of gross misconduct. The conduct must be at least disreputable before it can fall into the second misconduct limb.
(10) Accordingly, action taken in good faith and for legitimate reasons, however inefficient or ill-judged, is not capable of constituting misconduct within the meaning of section 35C(2)(a) merely because it might damage the reputation of the profession. Were that not the position then Professor Meadow would have been guilty of misconduct on this basis alone. But that was never how the case was treated.
The Decisions
i) On 26th September 2013 Tracy Fisher who was an Assistant Registrar employed by the defendant was considering the complaint against Sir Bruce Keogh at the rule 4 triage stage. She analysed the allegation against him and decided to seek advice from her senior colleague, Mr. Swain. He was Directorate Manager and Assistant Director of Investigations. Her evidence makes it clear that Assistant Registrars work as a team and that they consult each other about their work. She did this by email saying"I have spoken with Simon who is aware that we will be triaging the matter to him – but I would be grateful if you would please confirm if we are to triage this through the NIT route (due to the high profile/involvement of you and Paul Philip in the matter) or as a "normal" Stream 1 RIT [Regional Investigation Team] investigation with a request that it is allocated to Simon for investigation."ii) This email, it is submitted, means that Ms. Fisher had decided that the complaint should not be rejected at the rule 4 triage stage and was asking for advice only on how it should be progressed thereafter.
iii) Mr. Swain responded
"It's a stream 1 RIT case please."My view is that we don't open a case on Sir Bruce on the Remedy point – i.e. he is too far removed from the point of care to be accountable on this issue in a regulatory sense. If you wanted cover for that view you could seek legal advice. If the legal adviser is to do anything other than close that aspect at triage, let me know before doing anything further."iv) Tracy Fisher in her witness statement says that she did not regard this as a direction to her, merely as advice which she was entitled to consider. She included the advice she had received from Mr. Swain in her record, and recorded her decision as follows:-
"In this case BL appears to be complaining that Professor Sir Bruce Keogh did not investigate concerns to his satisfaction. This is not normally a matter that would call into question his fitness to practise as a doctor or require a GMC investigation."
i) The decision letter is dated 13th October 2014 and is 7 pages long. It declines to review the rule 4 decision. It refers to the decision in Remedy and then says this"The Assistant Registrar is of the view that Professor Keogh could have taken a personal interest in this matter and it might have been better if more detailed explanation had been given why intervention was not within NHS England's remit. However, there is not any provision, of which we are aware, which compels him to do so in his role as Medical Director of NHS England. NHS England is not a complaint body and no concerns were identified at regional level by Dr. Mitchell. It would also not be possible for Professor Keogh to intervene in all situations such as this.Therefore the Assistant Registrar concluded that there were no concerns raised which would call into question Professor Keogh's fitness to practise and as a result there is no material flaw in the decision not to investigate the concerns."
"I have worked in the equivalent role in the Department of Health, and understand the breadth of the responsibilities.
"It was not necessary for Professor Keogh to be personally involved. It would have been sufficient for him to delegate the email to a colleague. He did not do this."
"Finally, I understand the breadth of Bruce Keogh's responsibilities and the volume of work with which his office deals. However, I was concerned that he was not prepared to respond to documented failures to address potentially serious clinical concerns, especially as the email came from a senior and experienced former colleague, and in the context of NHS-wide concerns about failings in the quality of clinical care and failures of medical staff to escalate as necessary."
The Grounds of Challenge
i) Mr. Swain's intervention by his email of 26th September 2013 was unlawful (various other adjectives are also used in the Detailed Grounds). It is said that he took the decision outside the normal procedures of the GMC, and "overturned" a decision which had already been made.ii) It is said that Mr. Swain's intervention was made on incomplete information as he only had an email from Ms. Fisher dated the 26th September 2013 to which he replied.
iii) It is said that the confusion over the identity of the complainant vitiated the decision. The Grounds say that the fact that Dr. Adam had made the complaint was "the single most important aspect of the complaint about Sir Bruce given her seniority and standing within the profession." Part of the material considered by Tracy Fisher was a long statement from Dr. Adam taken by Field Fisher. There is no evidence that Mr. Swain had read this and therefore he was not able to take her views into account.
iv) As to the rule 12 decision, it is submitted that the defendant asked the wrong question in assessing the strength or merits of the allegation rather than simply asking whether, if established, the allegation was capable of supporting a finding of misconduct or deficient professional performance. It is further said that the rule 12 decision was flawed because it failed to acknowledge that the interference of Mr. Swain had rendered the rule 4 decision flawed.
Discussion
i) Was the intervention of Mr. Swain such as to render the rule 4 decision unlawful?ii) Was it rational to conclude that the role of Sir Bruce Keogh as Medical Director of NHS England was so remote from clinical care in the context out which the complaint arose that his failure to intervene was not capable of supporting a finding of misconduct or deficient professional performance? This was the decision on the merits at both the rule 4 and the rule 12 stage.
4.— Initial consideration and referral of allegations
(1) An allegation shall initially be considered by the Registrar.
(2) Subject to paragraphs (3) to (5) and rule 5, where the Registrar considers that the allegation falls within section 35C(2) of the Act, he shall refer the matter to a medical and a lay Case Examiner for consideration under rule 8.
(2A) Where the Registrar considers that an allegation does not fall within section 35C(2) of the Act the Registrar must notify the maker of the allegation (if any) accordingly.
(3) Where–
..
(b) in the case of an allegation falling within paragraph (5), the Registrar does not consider it to be in the public interest for the allegation to proceed; or
(c) the Registrar considers that an allegation should not proceed on grounds that it is vexatious,
he shall notify the practitioner and the maker of the allegation (if any) accordingly.
(4) The Registrar may, before deciding whether to refer an allegation, carry out any investigations as in his opinion are appropriate to the consideration of–
(a) whether or not the allegation falls within section 35C(2) of the Act;
(b) the practitioner's fitness to practise; or
(c) the matters outlined within paragraph (5) below.
(5) No allegation shall proceed further if, at the time it is first made or first comes to the attention of the General Council, more than five years have elapsed since the most recent events giving rise to the allegation, unless the Registrar considers that it is in the public interest, in the exceptional circumstances of the case, for it to proceed.
8.— Consideration by Case Examiners
(1) An allegation referred by the Registrar under rule 4(2), 5(2), 12(6)(b) or 28(3)(c) shall be considered by the Case Examiners.
(2) Upon consideration of an allegation, the Case Examiners may unanimously decide–
(a) that the allegation should not proceed further;
(b) to issue a warning to the practitioner in accordance with rule 11(2);
(c) to refer the allegation to the Committee under rule 11(3) for determination under rule 11(6); or
(d) to refer the allegation for determination by a FTP Panel.
(3) The Case Examiners may unanimously decide to recommend that the practitioner be invited to comply with undertakings in accordance with rule 10(3) and, where they do so and the practitioner confirms he is prepared to comply with such undertakings in accordance with rule 10(4), they shall make no decision under paragraph (2) accordingly.
(4) As soon as reasonably practicable, the Case Examiners shall inform the Registrar of their decision, together with the reasons for that decision, and the Registrar shall notify the practitioner and the maker of the allegation (if any), in writing, accordingly.
(5) If the Case Examiners fail to agree as to the disposal of an allegation under paragraph (2), or whether to recommend that the practitioner be invited to comply with undertakings under paragraph (3), they shall notify the Registrar accordingly, and the Registrar shall refer the allegation for consideration by the Committee under rule 9.
(6) If, at any stage, one of the Case Examiners is of the opinion that an Interim Orders Panel should consider making an interim order in relation to a practitioner, he shall direct the Registrar accordingly.
12.— Review of decisions
(1) Subject to paragraph (2), the following decisions may be reviewed by the Registrar–
(a) a decision not to refer an allegation to a medical and a lay Case Examiner or, for any other reason, that an allegation should not proceed beyond rule 4;
(b) a decision not to refer an allegation to the Committee or a FTP Panel;
(c) a decision to issue a warning in accordance with rule 11(2), (4) or (6); or
(d) a decision to cease consideration of an allegation upon receipt of undertakings from the practitioner in accordance with rule 10(4).
(2) The Registrar may review all or part of a decision specified in paragraph (1) on his own initiative or on the application of the practitioner, the maker of the allegation (if any) or any other person who, in the opinion of the Registrar, has an interest in the decision when the Registrar has reason to believe that—
(a) the decision may be materially flawed (for any reason) wholly or partly; or
(b) there is new information which may have led, wholly or partly, to a different decision,
but only if one or more of the grounds specified in paragraph (3) are also satisfied.
(3) Those grounds are that, in the opinion of the Registrar, a review is–
(a) necessary for the protection of the public;
(b) necessary for the prevention of injustice to the practitioner; or
(c) otherwise necessary in the public interest.
(4) The Registrar shall not, save in exceptional circumstances, commence a review of all or part of a decision specified in paragraph (1) more than two years after it was made.
(5) Where the Registrar decides to review all or part of a decision specified in paragraph (1), he shall in writing—
(a) notify the practitioner, the maker of the allegation (if any) and any other person who, in the opinion of the Registrar, has an interest in the decision of the decision to review and give reasons for that decision;
(b) notify the practitioner, the maker of the allegation (if any) and any other person who, in the opinion of the Registrar, has an interest in the decision of any new information and, where appropriate, provide them with that information; and
(c) seek representations from the practitioner, the maker of the allegation (if any) and any other person who, in the opinion of the Registrar, has an interest in the decision regarding the review of the decision,
and shall carry out any investigations which, in the opinion of the Registrar, are appropriate to facilitate the making of the decision under paragraph (6).
(6) Where the Registrar, taking account of all relevant material including that obtained under paragraph (5), concludes that all or part of a decision specified in paragraph (1) was materially flawed (for any reason) or that there is new information which would probably have led, wholly or partly, to a different decision and that a fresh decision is necessary on one or more of the grounds specified in paragraph (3), he may decide—
(a) to substitute for all or part of the original decision any decision which he could have made under Part 2 of these Rules; or
(b) that an allegation should be referred for reconsideration by the Case Examiners under rule 8, 10 or 11.
Otherwise, he must decide that the original decision should stand.
(7) Where the Registrar has reviewed all or part of a decision specified in paragraph (1), he shall notify–
(a) the practitioner;
(b) the maker of the allegation (if any); and
(c) any other person who, in the opinion of the Registrar, has an interest in receiving the notification,
in writing, as soon as reasonably practicable, of the decision under paragraph (6) and the reasons for that decision.