The emergence of medical guidelines to shape clinical treatment has been driven by the medical profession’s desire to improve standards in care.

The emergence of medical guidelines to shape clinical treatment has been driven by the medical profession’s desire to improve standards in care. Examples of this thinking can be seen in all areas of medicine. There is a belief that a consensus statement based on available evidence can be used to direct practice and standardise care and thereby keep treatment at a uniformly high level[1].

Can such guidelines be used to evaluate the actions of doctors when their standard of care is brought into question?

In the realm of medical malpractice, to succeed in an action in negligence a claimant must show that the defendant owed her a duty of care. Also that the defendant breached this duty of care by failing to exercise reasonable care and that the breach of duty caused the claimant’s injuries[2]. Prof. Jackson describes that for a Doctor there will usually be no difficulty in establishing that there was a duty of care. However how should the standard of a doctor’s care be assessed? I have mentioned that the medical profession strives to produce a uniformly high standard of care. Similarly patients themselves will wish to receive the highest possible care from their doctors at all times. Many factors may result in treatment delivered falling below the high standards the medical profession has set for itself, such as the individual skill of the medical practitioner or the availability of resources. Care falling below the standards set in guidelines may not be due to faults of the doctor. Guidelines may therefore direct to the highest possible care, but should be considered too high a benchmark with which to assess a doctor’s fitness to practice or for use in negligence cases. The General Medical Council gives guidance for panels assessing a doctor’s fitness to practice. The GMC regards a practitioner failing to provide adequate level of care; which falls well below expected professional standards is not fit to practice. Similarly in medical negligence cases the standard of care which can be expected of a doctor is that of a reasonable doctor, skilled in the particular speciality[3]. Guidelines themselves may not apply to all situations and discretion must be used when interpreting them. Thus to follow guidelines to the letter may not be possible or appropriate for all situations.

In this paper I shall look at how the law assesses the standard of care, with some historical references. I shall then look at why guidelines have been considered as a way to examine a practitioner’s standard of care. With references to cases and opinion I will endeavour to show why these guidelines can inform decisions regarding standards of care, but should not be used as the only judge of them.

How does the law seek to asses the standard of care? In non-medical negligence actions, the courts using the device of the reasonable man settle decisions. Such a reasonable man is not expected to exhibit the skill of an expert[4]. In medical negligence actions the courts have deferred to the opinions of medical experts, the defendant would be considered to have breached the duty of care if his practices did not conform to current medical practice. Opinions of reasonable medical doctors will often differ, how then can the courts decide? The land mark case of Bolam v Friern Hospital Management committee provided the solution for this[5]. In this case McNair J in his direction to the jury said that a doctor’s actions cannot be considered negligent if it is accordance with a body of responsible medical men skilled in that particular art. This view would not be reversed simply because there existed another body of opinion which disagreed with the doctor’s actions. This would become known as the Bolam Test. In essence Mr Bolam a man suffering from severe depression was advised to have electroconvulsive therapy(ECT), he was not warned of the small risk of fracture. The hospital also did not use procedures which would have minimised this fracture risk. Mr Bolam would suffer bilateral pelvic fractures and be confined to a wheelchair in much pain. The Hospital defended it’s practice of not telling the patient about the risks as this may have dissuaded Mr Bolam from having ECT. Also a body of opinion supported the view that routine use of muscle relaxants or physical restraints to prevent fracture were not needed in all cases. Despite the presence of a counter opinion regarding the use of drugs and restraints, the court found the defendant not guilty of negligence. This desire to defer to medical opinion appears to reflect the courts’ high regard it holds members of the medical profession, and possibly the complexity of the cases themselves. This response has been repeated in many subsequent cases, such as Maynard v West Midlands RHA[6]. Here the claimant suffered damage to the vocal cords following a procedure recommended by a doctor in an attempt to diagnose Hodgkin’s disease. It would later be claimed that there had only been a remote chance of Mrs Maynard having a lymphoma and that the procedure should not have been attempted, as the risks were too great. The trial judge in the original case accepted this view that the defendant had exposed her to an unreasonable risk. This judgement was overturned by the court of appeal, and dismissed in the House of Lords. Here it is important to look closely at the comments of Lord Scarman in reaching his decision. He stated that “…Differences of opinion exist, and will always exist, in the medical as in other professions….A judges preference for one body of distinguished professional opinion to another also distinguished is not sufficient to establish negligence in a practitioner whose actions have received the seal of approval of those whose opinions, truthfully expressed, honestly held, were not preferred…” Lord Scarman’s comments supported the Bolam Test and deferred to the medical profession and also implied that the court’s only duty was to examine the credibility of the expert witnesses.

This reluctance of the courts to examine the substance of the expert witness statements has led to claims of excessive deference to the medical profession. Some have suggested that “the Bolam Test became no more than a requirement to find some expert(s) who would declare that they would have done as the defendant did”, Professor Brazier also felt that Bolam hindered the development of any doctrine of informed consent[7].

The case of Bolitho v City and Hackney Health Authority[8], appears to cast doubt on the Bolam Test. The defendant was found not guilty of negligence as a body of professional opinion supported her actions. The use of the Bolam Test here was overshadowed by the comments of Lord Browne-Wilkinson who stated that the testimony of a expert witnesses must withstand logical analysis, and that the courts alone are the arbiters of a doctor’s standard of care. He suggested that in rare cases the statements of one or more expert witnesses might be disregarded if the judge did not feel it could withstand logical analysis. Unusually the Bolam Test was used here to determine the question of causation. The defendant had admitted negligence by not attending her patient, and the Judge accepted that if she had attended her patient she would not have intubated him. The question what should happened became the issue to decide causation. Central to the decision in Bolitho was the opinions of the leading experts for the defence and the prosecution. I summing up Lord Browne-Wilkinson rejected the premise that he was obliged to accept the evidence of expert witnesses even if he was not persuaded by it’s logical force. The ultimate decision did not reject Bolam, but placed the onus on the courts to examine the substance of expert witness testimony. An earlier case that of Hucks v Cole[9] the court of appeal rejected the evidence of four expert witnesses, on the grounds that the accepted practice knowingly put patients at risk, and could be easily remedied, their did not have logical force. The Privy Council came to a similar conclusion when a practice universally endorsed by solicitors in Hong Kong was nonetheless found to be negligent[10].

Doctors then should not set their standards “in house”, the courts should be the ultimate arbiter of standard of care. We have already established that it is difficult for a Judge to rule against the opinion of an expert in another field, could evidence based guidelines be used for this purpose. The NHS Litigation Authority runs a Clinical Negligence Scheme for trusts (CNST) which seeks to mitigate risks within their departments. The Royal Colleges of Medicine and also other specialities such as paediatrics regularly produce guidelines on practice. Some of these guidelines are becoming more prescriptive and may be described as protocols or algorithms in which there may be less scope for clinical judgement. The National Institute of Clinical Excellence (NICE) has also been set up by the government to develop guidelines for good practice. These may be read and understood by Judges and in specific cases used to assess standards of clinical care. Guidelines then may be used to inform Judges decisions regarding clinical care, for example a doctor administering the antibiotic gentamycin will be aware that toxic levels may cause deafness or kidney damage, failure to follow the protocol for regular drug levels would be negligent. However in most cases medicine is far more complex than this and guidelines can be used to direct practice but clinical discretion is also needed. Some recent publicity has also highlighted some problems with guideline production. NICE for example has recently come under public scrutiny because their recommendations have apparently been contrary to the beliefs of experts in the field. The case of Barbara Clarke who had early stages of breast cancer was denied the drug Herceptin by her local area health authority. Mrs Clarke’s oncologist apparently wished to prescribe Herceptin for her[11]. The published NICE guidelines limited it’s use to advanced stages of breast cancer. The perception was that NICE had limited the drug’s use because of the excessive cost, and that the primary function of NICE was to ration resources. Courts must be wary then of using guidelines too rigidly and must take into account of funding levels when assessing best practice. Guidelines themselves may give a false impression of a consensus view, and may not represent best practice. They will also become out of date due the rapid changes in knowledge[12]. Nonetheless NICE guidelines are increasingly being used as a type of gold standard by which medical practices are assessed and the courts are likely to use them to indicate the quality and standard of care a patient can expect[13].

Brian Hurwitz also writes that guidelines may be subject to well grounded dissent and this must be considered when assessing their validity. He however concedes that increasingly the need to follow practices which are in the patients’ best interest will mean practitioners have to act within professional boundaries. In many cases this will mean following guidelines.

There are two scenarios which may arise, can the use of guidelines be used to justify a practitioner’s actions, and secondly can the use of guidelines result in reversal of the burden of proof. In the case of Richards v Swansea[14], a mother was brought into one of the defendants hospitals in labour. A heart rate tracing of the baby (CTG) was taken and a doctor decided on the evidence of the trace to perform a caesarean section. The time delay between the decision being made and delivery of the baby was 55 minutes. Baby had suffered brain damage, opposing expert witnesses agreed that if the bay had been delivered within 30 minutes of the decision brain damage would have been avoided. There was a disagreement between the expert witnesses regarding the CTG traces significance. The expert for the prosecution contended that the CTG represented severe foetal distress and baby should have been delivered with haste, the expert witness for the defence took the opposing view, that the trace did not indicate baby needed to be delivered rapidly. It is of interest because the NICE guidelines concerning CTG traces was discussed and both accepted that the trace was not consistent with the NICE definition of a worrying trace. Should the fact that the trace did not fit the NICE guidelines for foetal distress justify the doctors’ lack of haste in performing the caesarean? Other factors such as the duty of care to perform the operation once the decision had been made were taken into account. The judge considered negligence to be proved, and the claimant was successful in her claim for damages. Clearly then the court will not rely solely on guidelines. The alternative scenario of a child born by normal delivery who was then found to have asphyxia leading to brain damage prior to delivery. Could a doctor who had chosen not to have done a caesarean because CTG did not meet NICE guidelines, expect to be protected from an action in negligence? I suspect that a body of professional support for his actions in line with Bolam would also be required.

What then of the burden of proof , Harvey Teff writes of his concern that a culture of following guidelines may result in a reversal of present practice in negligence. We continue to expect the claimant to prove negligence, causation and damages. Could a reversed situation occur when a doctor may be asked to not only justify non adherence to a guideline but also because he had not followed a guideline be expected to prove he did not cause the claimants’ injuries. One area which may see such a reversal is in emergency medicine. The realm of resuscitation and trauma is very highly protocol driven with almost all practitioners are expected to have an up to date certification of proficiency in resuscitation. A doctor who does not follow to the letter resuscitation guidelines may find himself criticised for example if he were to resuscitate a patient who is subsequently left brain damaged due to lack of oxygen. Prior to these strict new guidelines a doctor would have used his skill and judgement to determine the best treatment to follow, based on his experience and the specific needs of her patient. There is no doubt that evidence based guidelines can minimise risks and improve standards[15]. However there are claims that problems with Acute Paediatric Life Support guidelines led to an increase in admissions to intensive care[16]. It could be argued that by not adhering to guidelines in practice can cause injuries, but in some instances the converse might be true. It is noteworthy that the USA in the case of Lowry v Hendry Mayo Newhall Memorial Hospital[17], the defendant successfully argued that guidelines were not mandatory and deviating from them to tailor care to the individual patient was appropriate. Teff predicted that the adherence to guidelines may produce a new paternalism “guidelines know best”, he also predicted that guidelines may lead restriction in practice[18]. Many find it very difficult to deviate from these guidelines for fear of criticism or worst.

Practising lawyers in the United Kingdom are using guidelines more frequently and predict that their use will increase[19], one of the perceived benefits would be to improve understanding of medical issues. However the use of expert witnesses to interpret guidelines is likely to remain. The evidence base of guidelines is attractive as it represents the result of both study and experience. Care must be taken to prevent consensus views masking differences in opinion on how best to deliver treatment. Guidelines do not represent legal documents and are not in general designed to be adhered to in all circumstances, judges and lawyers must take this into account when considering them in litigation cases. Equally understanding that issues such as lack of resources and manpower may prevent guidelines being adhered to.

The courts will continue to strive to evaluate the standard of care in negligence cases “..the true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of it acting with ordinary care”[20], to do this shall always pose great difficulties.

[1] © copyright 2006 British Society of Gastroenterology

[2] Jackson E, Medical Law Text, Cases, and Materials. Medical Malpractice, p 108, 2006. OUP

[3] Jackson E, Medical Law Text, Cases, and Materials. Medical Malpractice, p 122, 2006. OUP

[4] Phillips v Whiteley Ltd. [1938] 1 All ER 566.

[5] Bolam v Friern Hospital Management Committee. [1957] WLR 582

[6] Maynard v West Midlands RHA. [1985] 1 All ER 635.

[7] Brazier M, Miola J,Bye-Bye Bolam: A Medical Litigation Revolution? Med Law Rev 2000.8(85)

[8] Bolitho (administratrix of the estate of Bolitho (deceased)) v City and Hackney Health Authority. [1997] 4 All ER 771

[9] Hucks v Cole, [1993] 4 Med LR 393

[10] Edward Wong Finance Co. Ltd v Johnson Stokes and Master [1984] A.C. 296, P.C

[11] Does cancer drug decision have impact on NHS resources? LNB News 10/10/2005 1

[12] Hurwitz B, How does evidence based guidance influence determinations of medical negligence? [2004] 329 BMJ 1024-28

[13] National Health Service Rationing: Implications for the Standard of Care in Negligence. OJLS 2001 21 (443)

[14] Richards v Swansea NHS Trust. [2007] All ER (D) 202 (Mar)

[15] Status epilepticus: An evidence based guide, BMJ Sept 2005; 331: 673-677

[16] Chin RFM, Verhulst L, Inappropriate emergency management of status epilepticus in children contributes to need for intensive care. Journal of Neurology, Neurosurgery and Psychiatry 2004; 75:1584-1588

[17] Lowry v Hendry Newhall Memorial Hospital 229 Cal 620 (1986)

[18] Teff H, “Clinical Guidelines, Negligence and Medical Practice”. In M. Freeman and A Lewis, Current Legal Issues: Law and Medicine vol 3 OUP 2000 67-80.

[19] Samanta A. The Role of Clinical Guidelines In Medical Negligence Litigation: A Shift From the Bolam Standard? Med Law Rev 2006 14 (321)

[20] Hunter v Hanley 1955 SC 200