Marion O Brien v Guy's & St Thomas' NHS Trust

Clinical guidelines inform, but do not replace, the Bolam/Bolitho assessment of clinical negligence. Compliance with a satisfactory national guideline may support a finding that treatment was reasonable, but departure is not itself negligence. It will usually require an explanation proportionate to the guideline’s strength and completeness. An in-house guideline cannot itself define the objective standard of care, although it may evidence a reasonable practice when supported by expert evidence. The clinician must exercise judgment in the individual circumstances. Here, a high gentamicin dose was justified by a worsening, potentially life-threatening infection in an intensive-care patient, despite severe renal impairment and the risk of ototoxicity.

The claimant, as administratrix of her deceased brother’s estate, alleged that the defendant NHS Trust negligently prescribed and administered 400 mg of gentamicin to a dialysis-dependent intensive-care patient. It was accepted that the dose caused ototoxicity and balance problems, with damages agreed at £45,000 subject to liability.

The issues were whether the dose and its administration breached the Bolam/Bolitho standard, including the significance of conflicting national and in-house clinical guidelines, and whether a lower dose would have avoided the injury.

1. Outcome. The claim was dismissed. The court found that both the prescription of 400 mg at about 12.30 on 4 March 2017 and its administration at about 20.32 were not negligent. Causation would otherwise have been established: the dose caused the claimant’s brother’s ototoxicity, and a 160 mg dose would probably not have caused the same injuries.
2. Applicable standard. Under Bolam, a clinician is not negligent if acting in accordance with a practice accepted as proper by a responsible body of skilled medical opinion. Under Bolitho, the supporting opinion must have a logical basis. The court must decide the issue itself and must examine whether the experts addressed the comparative risks and benefits.
3. Clinical guidelines. National guidelines may evidence, and sometimes constitute, a Bolam-compliant body of practice, depending on their relevance, authority, completeness and satisfactory character. Compliance is not conclusive. Departure is not necessarily negligence, but will generally call for an explanation. Guidelines do not replace clinical judgment or expert evidence. An in-house guideline cannot itself establish the objective standard of care, since a defendant cannot set its own standard, although it may reflect a reasonable practice when supported by wider evidence.
4. Application. The defendant’s ICU guideline was poorly drafted and of limited weight, but it was not itself negligent. The judge found that the clinician had not applied it automatically. He considered the patient’s renal impairment, the failure of the earlier 80 mg dose to control the worsening infection, the delay before a further dose could safely be given, the risk of sepsis, and the competing risk of ototoxicity. The infection risk was life-threatening and justified a bactericidal dose of 400 mg. The decision was logical, reasonable and supported by a responsible body of intensive-care opinion.
5. The same reasoning justified administration later that evening. There was no evidence that the infection had improved; the available evidence indicated that it had worsened. The claim was therefore dismissed. The court nevertheless urged urgent review of the defendant’s replacement ICU guideline.