The guidelines of the National Institute for Clinical Excellence (NICE) are designed to facilitate good medical practice. They are not a substitute for professional judgement, or discussions with patients, but provide guideline recommendations. In 2021, the General Medical Council issued specific guidance on 'Keeping up to date and prescribing safely' in which they advised medical practitioners to "take account of the clinical guidelines published by NICE [and]...Royal Colleges and other authoritative sources of speciality specific clinical guidelines".
The NICE Guidelines therefore present a paradox for clinical negligence practitioners. On one level, they are not inflexible rules that clinicians must follow. On another, they represent the consensus views of experts in the field as to proper standards. In Martin O'Brien v Guys' v St. Thomas' NHS Trust [2022] EWHC 2735 (KB) provided an authoritative and comprehensive analysis of the Guidelines, and their relationship with breach of duty in clinical negligence claims. This article deals with the facts of the case, the approach taken by HHJ Tindall and finally provides concluding thoughts on the impact of this judgment in future clinical negligence claims.
The Facts
The Claimant was the administratrix of her brother's estate. Her brother, Mr. Berry, had suffered a cardiac arrest and was admitted to St. Thomas' Hospital. One kidney had been removed and he had end-stage renal failure with the remaining kidney functioning at 50%. His condition deteriorated and he was at risk of sepsis. In light of this, his treating doctor (Dr. Meyer) prescribed a 400mg dose of the antibiotic Gentamacin and started him on dialysis. This was in accordance with the Trust's ICU Guidelines. However, it was a much higher dose than recommended by NICE in cases of renal impairment.
It was agreed that the Gentamacin dose caused Mr. Berry 'ototoxicity' side-effects leading to balance problems. It was the Claimant's case that the administration of Gentamacin was negligently excessive given that he had no effective renal function and was dependent on dialysis. The Claimant deployed the Defendant's non-compliance with the NICE Guidelines to allege negligence. The Defendant relied upon their compliance with the in-house ICU Guidelines to deny liability.
The Judicial Approach to the NICE Guidelines
A clinician must prove that they acted in accordance with practice recognised as proper by a competent reasonable body of opinion to defend a claim of negligence. They are not liable merely because there is a body of opinion which would take a contrary view. Of course, any such body of opinion must be respectable, logical and rendered in good faith. As Mr. Justice Green (as he then was), put it in C v North Cumbria NHS Trust [2014] EWHC 61 at page 25, the report must be:
- Conveyed from a person of real experience.
- Exhibit competence and respectability.
- Consistent with the surrounding evidence.
- Internally logical.
At paragraphs 71 – 87 of O'Brien, HHJ Tindall undertook a magisterial overview on the judicial approach to the NICE Guidelines. He summarised his review of authorities at paragraph 88 in five points:
No substitute for clinical judgement
No guideline can ever be a substitute for clinical judgement in the particular circumstances of the particular patient at a particular time.
No substitute for expert evidence
An expert should not simply recite the NICE Guidelines; nor should such guidelines be relied upon as a substitute for expert evidence about the clinical judgement in question. However, the NICE Guidelines may be good evidence of what is or not a Bolam-compliant body of clinical opinion or practice, rather than an assertion based on their opinion.
Notably, a later guideline which codifies a Bolam-compliant practice may also evidence such a practice at an earlier point. In Jones v Taunton NHS Trust [2019] EWHC 1408, the Claimant alleged that in 1995 her mother was negligently given Nifepidine which was said to have resulted in perventricular leakomalacia. Mr. Justice Swift relied, in part, on NICE Guidelines produced in 2015 to determine that Nifedipine would have been as a safe tocyltic regarded as in 1995.
Non-Compliance with the NICE Guidelines
Mere non-compliance with the NICE Guidelines does not prove negligence. This is because there may be a different reasonable body of clinical opinion which can also be logically supported. Nevertheless, departure from the Guidelines is likely to require an explanation from the clinician. The nature and detail of the explanation will be dependent on a number of factors, including:
- The strength of the guideline's 'steer'. In Price v Cwm Taf University Health Board [2019] PIQR P14, the Claimant alleged that undertaking a second arthoscopy of the knee was contrary to the NICE Guideline. However, the guideline expressly said it did not override the individual responsibility of clinicians. Accordingly, the departure was justified.
- The logic of the Guideline. In Sanderson v Guy's & Thomas NHS [2020] PIQR P9, Mrs. Justice Lambert observed that the 2001 NICE Guidelines on electronic foetal monitoring appeared to advocate two contradictory management options. This contradiction "pulled the rug" from the Claimant's expert's thesis.
The relationship between the Guidelines and negligence
Compliance with a national guideline may be prima facie inconsistent with negligence if the guideline constitutes a Bolam-compliant body of opinion or practice. Even where the guidelines are incomplete or unsatisfactory, it is a factor militating against negligence depending on the circumstances. However, the 'in-house' guidelines of a Trust are not of the same standing. This is because (1) a defendant cannot set their own Bolam standard of care, (2) the resources and data available to an NHS Trust's Clinical Guidelines Committee is not the same as that available to NICE, and (3) they do not carry the same regulatory obligations for an individual clinician.
What matters is whether the conduct fell within a Bolam-compliant practice in the usual way. The guidelines are no substitute for clinical judgement and expert evidence; nor are they a shortcut for the Bolam/Bolitho approach. Practitioners and expert should consider whether any national clinical guidelines were applicable and if any 'in-house' guidelines should be disclosed.
Judgment
HHJ Tindall dismissed the claim. Dr. Meyer had not been negligent for five reasons:
- Dr. Meyer did not simply apply the ICU Guideline, nor did he ignore Mr. Berry's impaired renal function. He chose a higher dose of Gentamacin to stem the worsening systemic infection. He had also noted Mr. Berry's tolerance of Continuing Veno-Venous Haemodialysis (CVVHD) and adjusted his treatment accordingly.
- The Claimant's expert confirmed that he was not saying that the ICU guideline was negligent. In any event, the ICU Guideline distinguished between degrees of renal impairment as it distinguished between renally-normal and renally-impaired patients.
- In any event, there were cogent reasons for adopting a 'one size fits all' approach in intensive care. The ICU required one broad guideline because it was a busy environment with a lot of different staff and very ill patients. A simple, clear guideline was necessary in those circumstances.
- It was appropriate for the ICU guidelines to depart from the NICE Guidelines. The national guidelines constitute a reasonably of general clinical practice. However, on the ICU wards the balance of risk will be different. The different balance for such seriously ill dialysis-dependent ICU patients is not something which other guidelines, include the NICE guideline, factor in at all.
- Departure from the NICE Guideline was justified by good, logical, cogent reasons. A low cautious dose had failed, a higher dose was now required. The risk from the infection outweighed the uncertain risk of ototoxicity.
Concluding Thoughts
There are two points which practitioners should draw on from reading this judgment. First, it is critical that expert evidence engages with the relevant NICE Guideline. The regulatory guidance makes it clear that clinicians must take account of the national guidelines when making clinical judgements. A failure to properly consider the relevant guideline runs the risk of undermining the logic and cogency of the expert evidence in the court's view. Second, departure from the NICE Guideline must be justified. While all will depend on the circumstances, a court will expect an explanation from the clinician. A blanket denial, with no explanation, is unlikely to impress a court.
This article was first published in PI Focus, May 2023.
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