QUEEN'S BENCH DIVISION
Strand, London, WC2A 2LL |
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B e f o r e :
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MR JOHN LU |
Claimant |
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- and - |
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NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST |
Defendant |
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Damian Brown and Ming-Yee Shiu (instructed by Mills & Reeve) for the Defendant
Hearing dates: 24th, 25th, 26th 27th 28th February & 3rd March 2014
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Crown Copyright ©
Mr Justice Lewis:
INTRODUCTION
THE FACTS
The Centre and Its Work
The Outbreak
The Serious Untoward Incident Inquiry
"Despite extensive investigation, neither the mechanism nor the time of transmission has been firmly established. There is however compelling microbiological evidence that the infection was acquired in the operating theatre."
"18.6.1 Surgeon D's technical abilities have not been called into doubt his outcome statistics prior to this outbreak were entirely satisfactory, and his cardiac revascularisation outcomes are good, with not infective complications.
18.6.2 Surgeon D's practice differs somewhat from his colleagues, but is, if anything, more consultant-delivered and more thorough, almost to the point of single-handed practice, with limited input by junior staff.
18.6.3 While Surgeon D's practice differs in some elements from that of his colleagues, each element is well within the range of acceptable and 'standard' UK cardiac surgery practice.
18.6.4 The Panel neither heard nor found evidence of shortcomings in Surgeon D's infection, prevention and control techniques and practices. Indeed there is much evidence that these were robust.
18.6.5 Surgeon D's approach to clinical care is exemplary, but even if his reputation is unharmed, his confidence is damaged and his clinical skills are unused at a time when he is still gaining experience and confidence for more complicated cases.
18.6.6 Surgeon D has dissected his own practice, sought assurance from other units, co-operated fully with the investigation, and subjected himself to detailed microbiological scrutiny, occupational health assessment and attempts at decolonisation.
18.6.7 At some point Surgeon D became colonised by the antibiotic-resistant, outbreak Staphylococcus epidermidis.
18.6.8 Surgeon D remains colonised with this organism, despite attempts to eradicate it from him. While such eradication may be achieved, he might be recolonisation with this organism (or other flora). For this reason physical and microbiological barriers to the transmission of infection will remain the mainstay of measures to prevent this and similar infections in future."
The Period Following the SUI Report
The Finch Report
"Consider whether Mr Lu can continue to practise invasive cardiac surgery without risk to patients. The investigation will involve the participation of the Trust's Occupational Health Service and an independent microbiological report to determine the level of that risk and the Trust will, with advice from National Clinical Assessment Service (NCAS), then determine whether that risk is acceptable and decide upon the position going forward."
"John Lu acquired the outbreak strain between his appointment in October 2007 and recognition of the first cases of prosthetic valve endocarditis (PVE) in July 2009. The organism had been present in the Trust, notably the TCC and CICU for some time before his appointment. Strains similar to the outbreak strain have also been isolated from patients since the outbreak was recognised.
In conclusion the evidence suggests that John Lu became colonised with the outbreak strain following his appointment. At the time of the outbreak there was clearly something unique about the biology of the organism, John Lu and his insertion of prosthetic heart valve material that conspired to cause infection in so many patients. The exact nature of this biological interaction between John Lu and the host valve material remains uncertain."
"Despite the exemplary thoroughness of the investigation the exact mechanism whereby the outbreak strain contaminated the inserted cardiac valve remains uncertain. However, the most likely route of transmission would be from John Lu's hands, which were shown to be colonised with the outbreak strain, to the operative site as a result of unrecognised perforation of the thinner (Biogel ® Super-Sensitive TM) gloves occurring during an operation which takes some 3-4 hours."
"1. John Lu should return to full operative practice including prosthetic valve surgery. This should be managed as a staged process that will need to be planned and supervised by the cardiac surgical team and a mutually agreed mentor to allow John Lu to retrain and re-skill after a significant absence from operative practice. This process should be agreed and supported by Trust management and NCAS and proceed in accordance with recommended practice and with all necessary support. Allied to this will be the need to develop an appropriate communications and publicity management strategy to support this return to work.
2. This return of John Lu to surgical practice should initially exclude prosthetic valve surgery in order to monitor skin samples at monthly intervals to check for the possibility of his acquisition of the outbreak strain, recognising that this organism continues to circulate within the Trust. It is recommended that this period of monitoring be for 6 months. This monthly screening might most conveniently be completed during the period of retraining and before he commences valve surgery. He should then be screened at 3 monthly intervals for a further 18 months. It is recognised that screening John Lu at such intervals will provide only partial reassurance hence the importance that all practical and effective barrier precautions be adopted, in conjunction with other sound surgical practices within the theatre suite in order to provide optimal safeguards against post-operative infection.
3. The barrier precautions recommended by the SUI Report should be implemented and adopted by John Lu as far as is practical. In particular this applies to the use of thicker gloves, double gloving and down gloving during glove changing procedures."
The Quality Assurance Sub-Committee and the Trust
"3.1 Of particular concern to the committee, articulated first by Mrs Tabreham, was that none of the reports supplied had given a definitive answer on the risk of Mr Lu infecting patients if he returned to prosthetic valve surgery. It was unclear to committee members whether a definitive answer could be given, but it was felt that the experts should be pushed to quantify the risks as patient safety was of paramount importance.
3.2 The committee acknowledged the uniqueness of the situation that had arisen and the enormity of the decision it was being asked to make, both in relation to Mr Lu's career as a cardiac surgeon and for the safety of patients to which the Trust owed a duty of care. The Committee, through the Chairman, expressed enormous sympathy for Mr Lu and the very difficult situation being faced by a highly skilled surgeon that was not of his making.
3.3 None of the investigations to date had been able to give a concrete answer as to how the outbreak occurred and what mitigating actions would ensure no recurrence in the future. This made it doubly important to have some quantifiable risks to guide the committee's decision making."
"The committee was anxious not to introduce further delay in reaching its decision, but unanimously felt that in order to reach the correct decision for the safety of the patients in the care of NUH, it should seek to have its specific concerns addressed."
"The evidence received by the committee from the three expert microbiologists suggests that the risk to patients of Mr Lu returning to cardiac surgery, including valve surgery, is minimal, provided he agrees to adhere to all practical measures recommended by the expert microbiologists, including the testing regime to ensure he remains free of the outbreak strain of Staphylococcus Epidermidis.
The risk to patients with the control measures in place is estimated to be the same as for all the other cardiac surgeons in the TCC.
The Committee members unanimously agree that based on the expert evidence received, there was no clinical reason why Mr Lu should not be allowed a phased return to cardiac surgery, subject to all practical recommendations being implemented.
Before returning to work, the committee would require Mr Lu to be rescreened, in order to ensure that he currently remains free of the outbreak strain of Staphylococcus Epidermidis. Also, as recommended in Professor Finch's report (para 9.2.2), following return to non-valve surgery, Mr Lu's skin samples should be monitored at monthly intervals to check for the possibility of his acquisition of the outbreak strain and this should continue for a period of six months.
After returning to work, the committee would require a report at the end of six months, and three monthly thereafter for a period of 18 months, of Mr Lu's colonisation status (the screening intervals recommended by Professor Finch). In the remote possibility that Mr Lu becomes recolonised by the outbreak strain, the committee would be urgently reconvened to agree an appropriate course of action to ensure patient safety."
"The Board then formally resolved that Mr Lu should be allowed to undertake a transitional return to full-duties, subject to his agreement to, and compliance with, the prerequisites and on-going requirements advocated by Professor Finch."
"I write to confirm that the Trust Board received at its meeting on 30th August 2012 the view of the special committee convened in March to consider the clinical risk of your returning to valve surgery. You are aware of the rigorous process the committee followed: four meetings were held, advice and assistance was received from counsel, all relevant reports were reviewed and the committee met directly with Professor R Finch, Professor S Eykyn and Dr T Boswell.
The Board received and accepted the view reached by the committee that the evidence they received from the three expert microbiologists suggests that the risk to patients of your returning to Cardiac Surgery, including valve surgery, is minimal, provided you adhere to all practical measures recommended by the expert microbiologists, including the testing regime to ensure you remain free of the outbreak strain of Staphylococcus Epidermis. The risk to patients, the Board heard, with the control measures in place, is estimated to be the same for you as for all the other cardiac surgeons in the TCC. Based, therefore, on the expert evidence received, there was no clinical reason why you should not be allowed a phased return to cardiac surgery, subject to all practical recommendations being implemented.
To be clear therefore the Board accepted that you should be able to return to the full range of cardiac surgical practice, subject to the recommendations set out by Professor Finch in his original report – certain of these were stressed by the Board in its conclusion. I recognise that this is an outcome which you have sought for some time but it is one which should, for a short time, be treated as confidential by both the Trust and you. The Board stressed that the planning of your return to practice must proceed with proper care and attention, particularly with regards to the need to carefully communicate the circumstances and way forward to commissioners, other units, fellow clinicians, patients and the public. They also noted the importance of the completion of the agreement of your return to work programme and our discussions regarding informed consent.
It is important therefore that we work together with you to agree the way forward before any wider announcements are made by either you or the Trust. I am meeting your Consultant colleagues on Tuesday 4th September and I would ask that you allow them to be briefed via this forum: the same requirements requiring discretion and confidentiality will be placed upon them.
I have arranged for us to meet on Tuesday 4th September at 3pm in the Trust HQ, City Hospital. Daniel Morimer, Director of Workforce will be present as will Dr K Girling, Clinical Director – DIRC. Mr R Mohammed, MDDUS Advisor has confirmed that he is able to phone in to join the discussion."
Mr Lu's Proposed Re-entry Programme
"would be grateful for any comments from NCAS on the attached, and in particular any advice regarding the effectiveness of the proposals in supporting a return to practice.
We expect a decision on valve surgery by the end of the month."
"Our discussion focused on two particular areas relating to your return to work: consent of patients and your re-entry to surgical practice programme ('re-familiarisation'). These factors were discussed in the context of an acceptance by all parties referred to in this letter of the conclusion were reached by the Trust Board regarding your return to surgical practice.
In relation to the area of consent, we agreed that the Trust would agree an instruction to Mr Michael Mylonas QC, with the input of your advisors (Mr Mitchell provided this on 12th October). This would comment on the approach to consent that you had set down, following discussions with colleagues including Mr Ian Robertson, Chair of the Trust's Consent Committee. Mr Mylonas' response would of course be shared with you.
We discussed the response of your colleagues to your programme of re-familiarisation. I noted that they had welcomed the resolution of matters, particularly for you and your family, at our meeting with them on 4th September. There was however a discussion which pointed out the need for the re-entry programme to withstand any future scrutiny. Concerns were raised by two of your colleagues that Mr Naik was not an accredited trainer; that the mentorship arrangments were the same as the time of the outbreak: and that re-training elsewhere might be desirable. In relation to the last of these points I had explained to your colleagues (an am happy to confirm again to you) that the Trust accepted that it would not only be difficult for you to work elsewhere, but that Professor Finch's recommendations required for you to be working in the Trent Cardiac Centre. We also noted that the involvement of Mr G Cooper from Sheffield Teaching Hospitals FT ensured that there was a different mentorship arrangement than in 2009.
Whilst a number of elements of the concerns raised by your colleagues had been addressed we did agree that it was important for the programme to command their confidence involvement and support. We agreed, therefore, that a meeting of the consultant cardiac surgeons would be convened to discuss the programme and to seek consensus as to the way forward. Mr Cooper would be invited to attend the meeting as would Dr Girling as Head of Service. Mr Mohammed and you supported the step of meeting with your colleagues, and Mr Mohammed reminded us that the MDDUS would vigorously challenge any steps which sought to prevent your return to work.
Subsequently, Mr Mortimer has written to Mr Cooper confirming the Trust's approach to his indemnity (you received a copy of this letter)."
"Having reviewed all the information available, it is clear that the recent history in relation to training for the Trent Cardiac Centre has been difficult. Indeed, there was some risk that training accreditation could be withdrawn entirely three to four years ago. This was averted, but recognition of status as a trainer was withdrawn from all consultants apart from Mr Richens. Other consultants have had this position reversed subsequently, but not Mr Naik. To be clear: Mr Naik may have attended the relevant courses but he is not recognised by the regional medical educational system as a trainer.
My primary concern remains to ensure that your re-entry programme is resilient both now, and in any future scenario where it might be reviewed. There are several factors in supporting this resilience:
- The content of the programme: this appears of suitable breadth and depth, and confirmation of this has been given by your professional society and NCAS.
- The availability of external mentorship and review: Mr G Cooper of Sheffield Teaching Hospitals has kindly committed to provide this input to you and the Trust.
- The assessment of your progress: I remain of the view that this must be done by an individual who is recognised as a proficient and competent trainer. Such qualities are evidenced not merely by completion of study but by sustained practical activity over many years and by recognition by external parties.
Accordingly, I confirm that your re-entry programme will commence in the week of 14th January 2013. You will necessarily work alongside all your colleagues – including Mr Naik – during this programme. Your assessor for the various components of the programme must, I am clear, be therefore Mr David Richens, Consultant Cardiac Surgeon. I have asked Mr Richens to contact you to make the necessary arrangements to take this forward."
The September 2012 Proposed Re-Entry Programme
"As a new consultant who has been unable to operate for around 3 years (twice as long as his experience as a practicing consultant surgeon) John will surely now require an exceptional retraining programme which is sensitive to his particular set of circumstances. This will be a very stressful time for him and he will be exposed to unprecedented levels of scrutiny. I would hope therefore that the retraining would require, at the very least, mentoring and training from an experienced, credible and accredited trainer(s). We do have a range of training experience amongst the consultant surgeons here, as in most units. At one end of this training spectrum is a surgeon who is not, and has never been, an accredited trainer and who has a local and national profile as a surgeon who does not train. In my opinion it would not therefore be appropriate to ask this individual to have a role in the retraining programme."
Subsequent Events
"In these circumstances, and given my concerns, I must please ask that my colleagues should not be told tomorrow that David Richens is going to be my mentor and assessor"
"Following an adjournment, when you consulted with Mr Mohammed, you confirmed your agreement as follows (and I quote your words as indicated):
1. The need for a 'robust' re-entry programme
2. Mr Richens would be 'in charge' of all aspects of your re-entry programme
3. Mr Naik would have 'no formal role', and would provide 'help only'
4. An external expert would be identified to address off-pump specific assessments."
The Issue of Patient Consent
"Discussion was had about these issues in some depth. Based on the evidence presented to them and the resulting discussion, the committee felt that Mr L should not have to specifically tell patients about his part in the outbreak as external advisors to the Trust had concluded that the risk to patients undergoing this type of surgery was now estimated to be same for whichever cardiac surgeon was performing the procedure, given that Mr L was no longer carrying the outbreak strain and had agreed to adhere to all the recommendations made by the external advisors."
"It was reasonable for Mr Lu not to identify himself as the surgeon responsible for the PVE outbreak each time that he consented a patient for valve surgery, noting his agreed intention of disclosing this information if asked directly by a patient. "
THE LEGAL FRAMEWORK
The Contract of Employment
"3 General Mutual Obligations
Whilst it is necessary to set out formal employment arrangements in this contract, we also recognise that you are a senior and professional employee who will usually work unsupervised and frequently have the responsibility for making important judgments and decisions. It is essential therefore that you and we work in a spirit of mutual trust and confidence. You and we agree to the following mutual obligations in order to achieve the best for patients and to ensure the efficient running of the service:
- To co-operate with each other;
- To maintain goodwill;
- To carry out our respective obligations and operating a Job Plan;
- To carry out our respective obligations in accordance with appraisal arrangements;
- To carry out our respective obligations in devising, reviewing, revising and following the organisation's policies, objectives, rules, working practices and protocols."
And
"17 Disciplinary Matters
Wherever possible, any issues relating to conduct, competence and behaviour should be identified and resolved without recourse to formal procedures. However, should we consider that your conduct or behaviour may be in breach of our code of conduct, or that your professional competence has been called into question, the matter will be resolved through our disciplinary or capability procedures (which will be consistent with the 'Maintaining High Professional Standards in the Modern NHS' Framework), subject to the appeal arrangements set out in those procedures."
"The case manager should decide what further action is necessary, taking into account the findings of the report, any comments that the practitioner has made and the advice of the NCAS. The case manager will need to consider urgently:
- Whether action under part 3 of the procedure is necessary to exclude the practitioner; or
- To place temporary restrictions on their clinical duties.
The case manager will also need to consider with the Medical Director and Director of Human Resources whether the issues of capability can be resolved through local action (such as retraining, counselling, performance review). If this action is not practicable for any reason the matter must be referred to the NCAS for it to consider whether an assessment should be carried out and to provide assistance in drawing up an action plan. The case manager will inform the practitioner concerned of the decision immediately and normally within 10 working days of receiving the practitioner's comments."
"This implied obligation is no more than one particular aspect of the portmanteau general obligation not to engage in conduct likely to undermine the trust and confidence required if the employment relationship is to continue in the manner the employment contract implicitly envisages"
and
"The conduct must, of course, impinge on the relationship in the sense that looked at objectively, it is likely to destroy or seriously damage the degree of trust and confidence the employee is reasonably entitled to have in his employer. That requires one to look at all the circumstances".
"As a general rule it is not appropriate for the courts to intervene to remedy minor irregularities in the course of disciplinary proceedings between employer and employee – its role is not the 'micro-management' of such proceedings: Kulkarni v Milton Keynes Hospital NHS Foundation Trust [2010] ICR 101, para. 22".
Patient Consent
"In a case where it is being alleged that a plaintiff has been deprived of the opportunity to make a proper decision as to what course he or she should take in relation to treatment, it seems to me to be the law, as indicated in the cases to which I have just referred, that if there is a significant risk which would affect the judgment of a reasonable patient, then in the normal course it is the responsibility of the doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him or herself as to what course he or she should adopt."
THE ISSUES
(1) Did the Trust approve Mr Lu's proposed re-entry programme in September 2012 and then, in breach of contract, fail to implement that programme?
(2) Is the Trust acting in breach of express or implied terms of Mr Lu's contract of employment by
(a) proposing a draft re-entry programme in the terms contained in the draft prepared by Mr Richens in September 2013 rather than the draft prepared by Mr Lu in September 2012?
(b) acting in a way which constituted delay either (a) in respect of Mr Lu's return to coronary artery bypass graft surgery after May 2010 or (b) the return to that surgery and heart valve surgery between January 2013 and September 2013?
(c) by failing to consult Mr Lu, or NCAS, or other bodies, or by establishing a task and finish group, including as members Dr Fowlie, Dr Homa and Mr Mortimer?
(d) by acting in the way it did in respect of the proposed communication strategy? and
(e) by requiring (a) surgeons during the re-entry programme period to provide information to the historical association of Mr Lu with the outbreak of PVE in 2008 to 2009 to all cardiac patients in whose treatment he participated and (b) requiring Mr Lu thereafter to provide that information in relation to his patients in respect of heart valve surgery.
THE FIRST ISSUE - MR LU'S SEPTEMBER 2012 PROPOSED PROGRAMME
THE SECOND ISSUE – THE TRUST'S PROPOSED RE-ENTRY PROGRAMME
The Trust's General Approach
The Details
THE FOURTH ISSUE – THE ALLEGED DELAY
THE FIFTH ISSUE – THE PROCEDURES
THE SIXTH ISSUE – THE COMMUNICATION STRATEGY
THE SEVENTH ISSUE – PATIENT CONSENT
OVERVIEW
CONCLUSION