Departing from Guidelines and Balancing of Risks in Different Medical Settings

Mrs Marion O’Brien (Administratrix of the Estate of Mr John Berry (Deceased)) v Guy’s & St Thomas’ NHS Trust [2022] EWHC 2735 (KB)

At [99] HHJ Tindal (sitting as a Judge of the High Court) summarises aptly that “this case turns not on debates about causation – or indeed the definition of Sepsis – but on a simple question, albeit with a complex answer: Was the decision to prescribe Mr Berry 400mg on 4^th March 2017 Bolam-negligent?”

This article will focus on the issue relating to guidelines, which is likely to be the central take-away point for practitioners.  Mr Berry was administered 400mg of Gentamicin on 4 March by Dr Meyer. The parties were agreed that the dosage caused the Claimant ototoxicity side effects.

The Court summarised the issues as:

1. Was the 400mg dose ‘excessively high’ because Dr Meyer simply applied the ICU Gentamicin guideline that was itself Bolam-negligent in failing to adequately take into account the extent of a patient’s renal impairment, ototoxicity risks, and in departing from other national and in-house guidelines for no good reason?
2. Irrespective of the ICU Gentamicin guideline, was the prescription ‘excessively high’ and Bolam-negligent in all circumstances (including the extent of renal impairment, risk of ototoxicity, and the departure from the guidelines)?
3. Even if prescription at 12:30 was not Bolam-negligent, was the decision to administer at around 20:30 Bolam-negligent?

Factual background

At the relevant time, Mr Berry was in end-stage renal failure. On 3 March 2017, Dr Thom (Renal Registrar) prescribed 80mg of Gentamicin and 1.2 of Vancomycin. These antibiotics were to deal with the queried overlying infective process, indicated by fluctuating NEWS infection scores, consistently high heart rate, low blood pressure, and high CRP. It is accepted that Mr Berry did not meet the clinical criteria for sepsis, but did have a significant infection, which may have progressed into sepsis if not treated with antibiotics. Mr Berry was soon after moved to ICU, due to concerns around his clinical presentation, infection, and risk of sepsis.

Gentamicin is a strong aminoglycoside antibiotic that disrupts the ability of Gram-positive and Gram-negative bacteria to make proteins. In high concentrations, it has a bacteriocidal effect (ie: it kills that bacteria). The peak level within the bloodstream takes place within 30-60 minutes of the dose, after which it is gradually absorbed by the kidneys. Follow up doses take place when the Gentamicin in the blood drops below the ‘trough’ level of less than 1 mg/L. Re-prescribing Gentamicin any earlier could create a ‘twin peak’ response but with a weaker bacteriocidal effect, and it raises the risk of ototoxicity. In renal patients with minimised kidney function, the absorption process is slower and more damaging.

The next morning, Mr Berry showed some clinical improvements, but his inflammatory markers significantly increased. Dr Meyer reviewed Mr Berry with this background of knowledge. He prescribed a 400mg Gentamicin dosage, to be administered once the trough level was reached (which it did that evening). After some delay, the dosage was administered. By then, Mr Berry’s NEWS score had dropped, and he was clinically improving, but his inflammatory markers were still high. He was moved to a normal ward later on.

The Court found that, on balance, Mr Berry’s infection and risk of sepsis worsened across the day and if not for the Gentamicin dose administered 4 March, he would have developed sepsis.

Dialysis restarted on 6 March and the Gentamicin levels did not reach trough level until 10 March. Months later, he was diagnosed with Gentamicin-associated vestibular ototoxicity, by June he had mobility limitations, and by July he was using a wheelchair. Unfortunately, in 2018, he suffered unrelated problems and died in hospital in January 2019.

The Guidelines

There were various guidelines on Gentamicin at the time. These are set out in fuller detail at [11] – [14]. In summary, the guidelines were:

1. NICE/BNF guideline for Gentamicin;
2. Renal Handbook 2014;
3. General Renal Impairment Guideline: this was the Defendant’s general ward guideline on antibiotics use for patients with renal impairment;
4. The Antibiotic Use in Adult Patients with Renal Impairment Guideline;
5. ICU Guideline on Gentamicin: this was the Defendant’s guideline on the use of Gentamicin, but only in the critical care areas of the hospital.

Law on Guidelines

This is explored by HHJ Tindal in detail from [75] – [87] and pithily summarised at [88]:

1. Even ‘national’ clinical guidelines are not a substitute for clinical judgment in individual cases;
2. Nor are they a substitute for expert evidence, but may inform expert evidence;
3. Departure from national guidelines is not necessarily prima facie evidence of negligence, but is likely to call for explanations;
4. Compliance with national guidelines may be inconsistent with negligence, if the guideline constitutes a Bolam-compliant body of opinion/practice. Where the guidelines are unsatisfactory, it may still militate against negligence;
5. Defendants cannot in principle set their own Bolam standard of care;
6. Guidelines are not a substitute or shortcut to the Bolam/Bolitho approach on considering standard of care.

The Court’s conclusions

The Court found that on 4 March 2017, Mr Berry had a worsening systemic infection, with risk of it developing into sepsis, but that he was also showing considerable improvements in presentation and had good tolerance of dialysis. Far from ignoring or overlooking Mr Berry’s condition, Dr Meyer deliberately decided on a mixed clinical strategy. The 80mg dose of Gentamicin given on 3 March was inadequate to prevent Mr Berry’s inflammatory markers from worsening, and Dr Meyer realistically had “one shot” at a bacteriocidal dose to stem the infection. There were clear and serious risks of the infection developing into sepsis, and underlying vulnerabilities meant the infection could be life-threatening if left untreated – these outweighed the uncertain risk of ototoxicity. Dr Meyer prioritised the worsening systemic infection, yet still considered Mr Berry’s renal function; consequently, he chose a lower than maximum dose available and deferred the administration of the second dose until Mr Berry’s Gentamicin level fell below the trough level.

In considering the Defendant’s ICU Guideline on Gentamicin, the Judge noted it was “surprisingly sloppily-drafted” and “most concerningly, it is internally inconsistent”. He categorised it as not Bolam-compliant, and as it was an in-house guideline, any compliance with it would regardless not militate against negligence. He then went on at [106] to [113] to express why the 400mg Gentamicin dose was not Bolam-negligent. Focusing on the points concerning the guidelines:

1. Dr Meyer neither applied the ICU guideline (still less automatically), nor did he ignore or overlook Mr Berry’s condition or extremely limited renal function. This was shown by Dr Meyer’s mixed clinical strategy and risk/benefit analysis. He independently exercised his clinical judgment, which was logical and, in the court’s view, reasonable.
2. Even if Dr Meyer did apply/adopt, rather than adapt, the ICU Guideline, the Guideline distinguished between renally-normal and renally-impaired patients, leaving room for individual clinical judgment.
3. Even if the ICU guideline was applied/adopted, there are cogent reasons for the ‘one size fits all’ approach in an ICU – amongst other reasons, the court noted the impracticality of undertaking extremely labour-intensive CCR/GFR tests (particularly as patients’ conditions often change rapidly on ICU and some like Mr Berry may not be passing urine to test CCR/GGR for), and the need for simple and clear guidelines applicable to all, “not a confusion of different guidelines where applying the wrong one could lead to someone’s death”.
4. Although the national guidelines constitute a reasonable body of clinical practice generally, there is another reasonable body on ICU wards, where the balance of risk on ICU will often be different than in other setting such as ordinary wards.
5. The different balance for such seriously ill dialysis-dependent ICU patients is factored in by other guidelines – there were therefore good, logical, and cogent reasons to depart from NICE and other general Gentamicin guidelines where the risk from infection outweighs the risk of ototoxicity.

In the round, Dr Meyer departing from the NICE/BNF guideline for Mr Berry was justified. Mr Berry required a high bacteriocidal dose of Gentamicin, there was good reason to give it to him on ICU shortly before he was moved to a ward (where he could only have received a smaller dosage), and it was better to have prescribed and deferred administration, rather than to wait in prescribing altogether. 

The Judge’s response to the remaining challenges were as follows:

1. The decision to administer Gentamicin on 4 March was logical, reasonable, and accorded with a responsible body of clinical opinion, as Mr Berry still presented a mixed clinical picture and was on dialysis.
2. The focus of renal specialists differs from that of ICU specialists – it makes sense that Dr Thom and Dr Meyer struck the balance so differently. Dr Meyer needs to be judged by the standards of his own specialism in Intensive Care, and not that of his non-ICU renal colleagues.
3. The administration of the Gentamicin was also justified, as in the eight hours since prescription, there was no evidence of any significant clinical change, and the risk of infection just as much (or possibly more so) outweighed the risk of ototoxicity.

For the above reasons, the prescription and administration of 400mg of Gentamicin was not negligent.

Comment

This case provides food for thought on clinical guidelines.

Firstly, there is a clear distinction on their value depending on the source – internal hospital guidelines will not carry the same weight as national guidelines, particularly in terms of reflecting a Bolam-compliant body of opinion/practice.

Secondly, it reasserts the importance of practitioner’s own clinical judgment. Not every case will fit the guidelines, and practitioners must be able to adapt – they should not simply adopt or automatically apply guidelines.

Thirdly, it highlights the difference that even the setting of the clinical practice may give rise to variations in what would be reasonable practice. While a 400mg dosage would be excessive from the perspective of a renal registrar on an ordinary ward, an 80mg dosage is inadequate from the ICU perspective where the infection carries greater risk than it ordinarily would. Again, this feeds into the fact that guidelines cannot simply be followed slavishly.

Jim Duffy acted for the Claimant in this case. He did not contribute to this article.