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Clinical guidelines and the law of negligence: the relationship between protocol and medical judgement in assessing an appropriate standard of care

Posted: 20/02/2023

When investigating a clinical negligence claim, solicitors are always focused on whether the care provided met an acceptable standard of care. The treatment need not have been gold standard, it need not have been what all clinicians would have done but it does need to meet an acceptable standard. In the context of negligence, the question is usually whether a responsible body of clinicians would have acted in the same way in the same circumstances. In ascertaining what is - and is not - acceptable practice, legal and medical experts often look to literature, such as widely used textbooks, NICE guidelines and local trust guidelines, for direction.

Towards the end of last year, HHJ Tindal heard a clinical negligence claim – the case of Marion O’Brien (Administratrix of the Estate of Mr John Berry (Deceased)) v Guy’s & St Thomas’ NHS Trust [2022] EWHC 2735 (KB) - where the relevance of guidelines was one of the key considerations. In this case the issue was the significance of clinicians following local trust guidelines for ICU care specifically which did not accord with wider national clinical guidelines.

The case involved the care of Mr Berry by St Thomas’ Hospital after admission following a cardiac arrest and centred around the administration of the antibiotic gentamicin. Gentamicin is used to treat serious bacterial infections and is commonly used, particularly in cardiac care, but is known to have several serious side effects. As a result, the use of gentamicin is normally carefully monitored in terms of dosage levels and periods. Two of the known consequences of gentamicin when used at high levels or for extended periods are vestibular / balance issues and hearing loss, both of which Mr Berry developed after being administered gentamicin whilst in ICU.

It was not argued that using gentamicin was negligent and the parties were agreed that the balance issues which Mr Berry developed were consequences of the gentamicin. The issue was whether the dose given (400mg) was appropriate. At the trial, various guidelines on the prescription of gentamicin were discussed including those from:

  • the National Institute for Health and Care Excellence (NICE)
  • the British National Formulary (BNF); and
  • the trust’s own in-house clinical guidelines for its ICU team.

In a nutshell, the dose given did not comply with NICE or BNF guidance but was given in accordance with the trust’s internal protocol for ICU patients. The claimant’s case was that the trust’s guidelines were not in line with the NICE guidelines and therefore the doctor who had prescribed the gentamicin was negligent, not for following the trust guidelines, but in failing to follow the NICE guidelines, and the trust was negligent in operating its current guidelines, which all agreed were not well worded. After hearing the evidence, HHJ Tindal concluded that the clinician concerned, although he had not complied with national guidelines, had not been negligent and neither had the trust.

Below is a summary of the key points from his judgment:

  • the clinician had not blindly applied the trust’s own guidelines but had deployed a ‘mixed clinical strategy’ and made a clinical judgment when balancing the need to manage a potentially life-threatening infection with Mr Berry’s renal function – that clinical judgment made in those circumstances would be supported by a responsible body of clinicians;
  • the claimant’s expert, under cross-examination, clarified that he was not saying the ICU guidelines themselves were negligent, but rather that they were poorly phrased;
  • there are good reasons for taking a ‘one size fits all’ approach in ICU with one guideline to follow - it is a busy environment with many different staff and very ill patients. It needs a simple, clear direction which is applicable to everyone, not a range of different guidelines so the care provided needed to be considered in the context of this environment;
  • the national guidelines constitute a reasonable body of clinical practice generally, but there is another reasonable body on ICU wards. The balance of risk in ICU will often be different to other settings;
  • the previous lower dose had failed and the clinician needed to take urgent action to try and control the rising infection – and the risk from that infection outweighed the uncertain risk of ototoxicity from the gentamicin;
  • the clinical decision he made would be supported by a responsible body of ICU clinicians even though it did not follow the broader national guidelines. Ultimately what needed to be looked at was the clinical judgment exercised and whether that was reasonable in all the circumstances – and guidelines would be something used to inform as to ‘usual’ clinical practice;
  • therefore departure from a national guideline was not prima facie evidence of negligence but there needed to be good reason in the particular circumstances – and the judge felt that was the case here; 
  • a trust could not set its own standard of care by creating its own guidelines.

The judge was very clear in his opinion that whilst he did not consider that there had been negligence in this case, even though national guidelines had not been followed, this did not mean that reliance on a local trust guideline or protocol that did not accord with national guidance would be a defence to a claim of negligence. The starting point is that where there is clear national guidance available that should be followed but that non compliance would not automatically mean negligence if there were good reasons to depart from the guidance and that course of action would be supported by other clinicians in a similar scenario.

Philippa Luscombe, partner in the clinical negligence team at Penningtons Manches Cooper, comments: “The issue of the importance of local guidelines / protocols is one that we look at quite often. In this instance, relying on a local guideline at odds with national guidance was not in itself a defence but the guideline was evidence of the need to manage certain circumstances. 

“More often as claimants we look at a failure to adhere to local guidelines. We have taken the view that again a failure to comply with a local guideline would not necessarily be negligent, especially if a national guideline was followed and this case would seem to reiterate that – national guidelines are the starting point for what is an acceptable standard of care. However, where there are specific circumstances that certain clinicians regularly encounter with good reason to depart from national guidelines, this may be regarded as acceptable – and what local or even specific department guidelines say may be a relevant consideration. The key issue remains whether the clinical decision making is such that it would be supported by a responsible body of clinicians.”

Gentamicin toxicity: understanding the risks

As highlighted in Mr Berry’s case, it is imperative that appropriate procedures are put in place to ensure the continuing use of gentamicin is necessary, particularly beyond the BNF guidelines of seven days. Appropriate procedures would include ongoing risk assessments to gauge whether it remains appropriate to prescribe gentamicin and ensuring there is suitable guidance for those administering as well as reviewing the treatment regimen so that they are aware of the potential signs of ototoxicity and the steps to be taken if a patient is experiencing symptoms. 

If it is administered inappropriately, a patient can experience a complication known as gentamicin toxicity which can cause a number of problems including kidney damage / renal failure, ototoxicity (damage to the inner ear), balance problems and oscillopsia (bouncing vision).  

Cases where medical practitioners do not take reasonable measures to prevent gentamicin toxicity could give rise to a claim for negligence. Most commonly, this will involve one of the following issues:

  • failing to undertake assessments as to the continuing need for gentamicin;
  • failing to administer gentamicin safely by relying on serum levels alone as a mark of toxicity;
  • not calculating a suitable dosage;
  • failing to measure gentamicin blood levels appropriately and not adjusting the dose if they exceed 1 to 2mg/l;
  • failing to inform the patient as to the side effects of gentamicin; and
  • failing to recognise and treat gentamicin toxicity in the early stages. 

Amy Milner, a senior associate in the clinical negligence team who specialises in gentamicin toxicity cases, comments: “Unfortunately, we often come across situations where there has been a complete lack of understanding of the risks involved, and a failure to ensure that gentamicin is administered safely. In addition, clinicians can fail to recognise the symptoms of gentamicin toxicity and therefore do not stop the regime. The possible side effects can have a devastating impact on someone’s life, resulting in them requiring further treatment and care as the complications are often permanent.”

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