Clinical Guidelines and Birth Injury Claims
By Dr David Sharpe QC, Barrister-at-law
In recent years there has been a proliferation of guidelines issued by the Royal Colleges, Department of Health, NICE, NHS Trusts and other organisations. Their aim is to facilitate best practice in a standardised way, ensuring consistency of care, ultimately leading to improvements in patient safety and in turn driving down the cost of negligence claims against the NHS. In terms of Obstetric practice there are RCOG guidelines on the management of labour including monitoring and interpretation of CTG traces which go back 20 years.
The question is commonly asked as to whether a failure to comply with guidelines represents a breach of duty of care and / or whether it is essential to apply the guidelines in all circumstances. Sir Michael Rawlins, the former chairman of NICE, commented that “No guideline can cover 100 per cent, because people vary. It’s up to the doctor or other health professional to decide when the guideline is no longer applicable and what to do in its place.” The Department of Health, and the British Medical Association have concurred in advising doctors who deviate from guidelines to record treatment decisions in medical records “in ways that show that they have considered the guidelines.” However, clinicians feel uneasy about departing from guidelines and many clinical negligence cases are grounded upon non-compliance with such guidelines.
The applicability of guidelines and the role of clinical judgment was recently considered by the Courts in the case of Sanderson -v- Guy’s and Thomas’s NHS Foundation  All ER (D) 52 Jan,  EWHC] 20 (QB).
The Issues and Judgment in the Case
The Claimant in this birth injury case experienced a period of hypoxia before her birth causing severe cerebral palsy. It was alleged that the obstetric care was negligent in the second stage of labour because (1) a fetal blood sample was performed which involved leaving the room to obtain the sampling kit rather than proceeding to immediate and urgent instrumental delivery in the presence of prolonged decelerations evident on the CTG; and (2) once it was recognised that the Claimant did in fact need to be delivered as soon as possible, the Obstetrician elected to proceed with a trial of an instrumental delivery, this being successful on the second attempt. It was claimed there was delay in commencing the Claimant’s delivery and that but for the alleged breaches of duty, the damaging period of hypoxia would have been shortened or avoided altogether.
The NICE guidelines appeared to promote two contradictory management options in response to a single prolonged deceleration lasting longer than three minutes, namely (1) conservative measures where possible or feasible expressly including fetal blood sampling and (2) urgent delivery with fetal blood sampling being contraindicated. On the critical question for determination, the guidelines pointed in two, entirely different, management directions.
The interpretation of the guidelines by the Claimant’s expert that the presence of a single prolonged deceleration was evidence of acute fetal compromise and that it required urgent delivery was rejected. The Trial Judge held that such an approach was both a highly selective interpretation of the guidelines and one which ignored the apparent contradiction within them. The Claimant’s expert appeared to suggest that NICE Guidelines are intended to provide an inflexible and complete approach to appropriate management. Although no doubt a useful resource, the evidence of the Defendant’s expert that the guidelines were a practical tool to be used in conjunction with clinical judgement was accepted. The Defendant’s expert also made the point that if the NICE Guidelines were interpreted in the strict way advocated by the Claimant’s expert, many unnecessary caesarean sections would be performed in maternity units across the country.
Lambert J also considered that the guidelines were only intelligible and workable if the reasonable Obstetrician also exercised judgment to assess the appropriate response by reference to the CTG trace as a whole, taking into account the depth to which the heart rate had fallen, the presence of any recovery in the heart rate, and the response of the fetal heart during the vaginal examination. Those features would, and should, be taken into account when determining the appropriate management.
The rational interpretation of the trace was of a stressed fetus suffering from chronic rather than acute hypoxia. In those circumstances, the reasonable obstetrician would not have been concerned that the trace had heralded the likelihood of an acute event within the near future. Fetal blood sampling had been appropriate, logical and supported by a reasonable body of obstetric opinion. The CTG trace had not mandated urgent delivery.
Lambert J also concluded that the Obstetrician had acted as quickly as she could have to achieve all that had been required to dismiss the Claimant’s further argument on delay. Accordingly, the Claimant’s case was dismissed.
This case sets out in clear terms the principle that guidelines are just that – a useful tool constructed by a panel of experts to be used in conjunction with common sense and clinical judgment. Whilst any departure from such guidelines is likely to require a cogent and logical basis (and be appropriately documented) it is important to note that a breach of a guideline does not necessarily mean that a Court will automatically conclude there was a breach of duty. Clearly the reverse is also true and departure from a guideline without proper rationale and explanation is likely to represent a prima facie breach of duty.
The standard legal test applies, the Bolam principle with the Bolitho gloss – did the clinician act in accordance with a responsible and logical body of legal opinion? In considering a case in which failure to follow guidelines is alleged as breach of duty it is necessary to consider (a) the role of clinical judgment and its interplay with the guidelines, (b) whether the guideline is clear and unambiguous or does it provide different clinical pathways, (c) whether the guideline is practical and applicable in the real world, (d) the status of the guideline – local or national, authorship etc, (e) whether the Claimant’s approach to the guideline is dogmatic, inflexible and/or too strict; (f) whether there are clear logical grounds for not following the guideline, and (g) whether the reasoning for any departure from the guideline clearly and contemporaneously documented.
About the Author:
Dr David Sharpe QC, FRCP, FRCS is a Barrister specialising in clinical negligence and healthcare law. He is medically qualified and practised to Consultant level in Emergency Medicine prior to admission as a lawyer.
David has extensive experience in birth injury cases involving complex medical evidence and regularly lectures on this topic to both lawyers and doctors. He is a member of Chambers at 12 Kings Bench Walk, London and also admitted in Northern Ireland, Ireland and the Caribbean.
David Sharpe QC can be contacted directly at email@example.com or through his Clerk Graham Johnson at firstname.lastname@example.org