Mrs Marion O'Brien (Administratrix of the Estate of Mr John Berry (Deceased)) v Guy's & St Thomas' NHS Trust
| Jurisdiction | England & Wales |
| Judge | Tindal |
| Judgment Date | 31 October 2022 |
| Neutral Citation | [2022] EWHC 2735 (KB) |
| Docket Number | Case No: QB-2020-004078 |
| Court | King's Bench Division |
| Year | 2022 |
[2022] EWHC 2735 (KB)
HIS HONOUR JUDGE Tindal
(Sitting as a Judge of the High Court)
Case No: QB-2020-004078
IN THE HIGH COURT OF JUSTICE
KING'S BENCH DIVISION
Royal Courts of Justice
Strand, London, WC2A 2LL
Mr Jim Duffy (instructed by Slater & Gordon) for the Claimant
Mr Liam Duffy (instructed by Bevan Brittan) for the Defendant
Hearing dates: 3 rd–5 th October and 31 st October 2022
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
HIS HONOUR JUDGE Tindal
Introduction
This case relates to the treatment by the Defendant hospital in March 2017 of the Claimant's brother, John Berry (‘Mr Berry’), who sadly passed away on 23 rd January 2019. It is not suggested the Defendant's treatment played any part in Mr Berry's death. However, it is the Claimant's case that the administration of 400mg of the antibiotic Gentamicin on 4 th March 2017, when Mr Berry was in the Defendant's Intensive Care Unit (‘ICU’) under the care of Dr Meyer, was a negligently excessive dose given that he had no effective renal function and was dependent on dialysis. It is agreed the Gentamicin dose caused Mr Berry ‘ototoxicity’ side-effects leading to balance problems requiring care from the Claimant (but disputed whether it also caused him the hearing loss he experienced). Subject to liability, damages are agreed at £45,000.
The Claimant was represented by Mr Jim Duffy; the Defendant by Mr Liam Duffy. Both were excellent, although to avoid confusion, I shall refer to them as Claimant's Counsel and Defence Counsel. Claimant's Counsel accepted the claim stood or fell on whether Dr Meyer's prescription at lunchtime on 4 th March 2017 of 400mg of Gentamicin and its administration that evening were negligent and that a non-negligent lower dose would not have caused the ototoxicity. Boiled down, he presented the claim in three ways. Firstly, he argued that Dr Meyer had ignored Mr Berry's renal impairment and simply applied the Defendant's in-house ICU Gentamicin dosage guideline which was inconsistent with national and other ‘in-house’ guidelines. Secondly, he argued that even if Dr Meyer had calibrated the 400mg dose to Mr Berry's circumstances, he and the Defence ICU Expert Dr Danbury failed to justify a departure from the national guidelines. Thirdly, he argued in any event, the opinion of the Claimant's ICU Expert Dr Bell showed Dr Meyer's choice of dose, even though supported by Dr Danbury, was illogical and unreasonable. Defence Counsel's response was firstly that Dr Meyer's decision was justified given Mr Berry's worsening infection and supported by the in-house ICU guidelines and Dr Danbury's opinion which were both reasonable. Secondly, he argued irrespective of the in-house guidelines, departure from other guidelines was justified. Thirdly, he argued Dr Meyer's dosage was supported by Dr Danbury and not negligent despite Dr Bell's opinion. He added in any event the Claimant had not proved a lower dose would not have had the same effect.
Liability for clinical negligence is judged according to the famous test of McNair J in Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 at pg. 587: that a clinician “ is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art”, and not “ merely because there is a body of opinion which would take a contrary view.” Bolam was clarified and it was also held the burden of proof on the balance of probabilities is on the Claimant in Bolitho v Hackney Health Authority [1998] AC 232 at pg.239. I return to Bolitho and Bolam, but merely as shorthand I refer to a decision or practice complying with the Bolam/ Bolitho standard as ‘ Bolam-compliant’ and a decision or practice not complying with that standard as ‘ Bolam-negligent’.
I return to the familiar principles later, but they raise three issues for me to decide here:
(a) What were the circumstances leading to and following from Dr Meyer's decision to prescribe Mr Berry 400mg on 4 th March 2017?
(b) Having regard to the answer to (a), was Dr Meyer's prescription of 400 mg of Gentamicin and/or its later administration Bolam-negligent?
(c) If so, did the 400mg dose cause ototoxicity which a lower dose would not have?
Issue (b) raises an interesting legal question, which arises from time to time and does so centrally in this case: what is the relevance of (non-)compliance with clinical guidelines (both national and ‘in-house’) to Bolam-negligence? However, the question has only been addressed relatively briefly in a few authorities I discussed with Counsel, possibly more rarely than one might expect given the prevalence of clinical guidelines. Perhaps the reason is that ultimately Courts must decide whether claimants have proved Bolam-negligence in the circumstances of the particular case. Guidelines are not a substitute for expert medical evidence on liability in that particular case and so will rarely – if ever – be wholly determinative. Nevertheless, in this case the Defendant deploys its ‘in-house’ ICU guideline as a ‘shield’ and the Claimant deploys the Defendant's other and national guidelines as a ‘sword’, to use the expressions in the 2003 article by Samanta, Samanta and Gunn: 1 “Legal considerations of clinical guidelines: will NICE make a difference?”. Therefore, this appears an appropriate case to consider the question in a little detail. I turn first to the relevant guidelines and their legal and regulatory context.
The Guideline Framework for Gentamicin
The regulatory context of clinical guidelines and their application in clinical negligence litigation is helpfully discussed in the Samanta article. As it explains, ‘NICE’ (The National Institute for Health and Care Excellence) is a non-departmental governmental body founded in April 1999 and ‘One of its main functions is to develop guidelines on best practice and clinical management’. NICE now operates under Part 8 of the Health and Social Care Act 2012, but that comment remains true. As NICE's website states: 2
“ NICE guidelines make evidence-based recommendations on a wide range of topics… Many guideline recommendations are for individual health and social care practitioners, who should use them in their work in conjunction with their own judgement and discussion with people using services.”
As that illustrates (and as is often said in guidelines themselves), NICE itself does not regard its own guidelines as inflexible ‘rules’, but as ‘recommendations’ to clinicians to be used in conjunction with their own clinical judgement and discussion with patients. Now closely related to NICE (although it predates it by almost 50 years) is the British National Formulary (‘BNF’), jointly authored by the British Medical Association and Royal Pharmaceutical Society. The BNF, updated regularly, contains basic information on a wide variety of common drugs with prescription guidance, including pharmacological details, indication, contra-indications, side effects and recommended dosages. It is one of the most familiar books for clinicians and the BNF is now also available to the public on the NICE website. 3
Whilst I return to the relevance of clinical guidelines in clinical negligence cases later, for clinicians their relevance is clear. From a regulatory standpoint, the General Medical Council (‘GMC’) in ‘Good Medical Practice’ (2013) instructs doctors that:
“ You must recognise and work within the limits of your competence and you must keep your knowledge and skills up to date. You must maintain and develop your knowledge and skills that are relevant to your role and practice in: a pharmacology and therapeutics and prescribing and managing medicines.”
Therefore, as at 2017, consideration of NICE and BNF Guidelines was not an explicit regulatory requirement, but may well have been good practice in ‘keeping up to date’.
“ You should follow the advice in the BNF on prescription writing….You should take account of the clinical guidelines published by NICE [and]…Royal Colleges and other authoritative sources of specialty specific clinical guidelines.”
The Defendant appears to be typical for large NHS Trusts in producing its own ‘in-house’ clinical guidelines to share and encourage best practice. Dr Danbury's hospital in Southampton has also done so (to which I return). Indeed, Dr Meyer is Chair of the Defendant Trust's Clinical Guidelines Committee. Whilst he was not involved in the production of the relevant guidelines in this case by the Drug Sub-Committee, he said ‘in-house guidelines’ for the Defendant were often authored by specialists in the field, there would be collective effort and editorial input from several different specialisms.
Before turning to the relevant clinical guidelines in this case, it may be helpful to discuss what Gentamicin is. It is a strong aminoglycoside antibiotic used widely in intensive care medicine for a range of infections and typically comes in ampoules of 80mg/2ml. There is a detailed description in Dr Danbury's report and its appendices. For present purposes it is sufficient to note that Gentamicin works by disrupting the ability of two different types of bacteria (Gram-positive and Gram-negative) to make proteins. Dr Danbury explains that in low plasma concentrations it exhibits bacteriostatic effects (i.e. it holds bacteria in check), but in high plasma...
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