The standard of medical care required by law is one of reasonableness in all clinical circumstances. This is decided on the basis of an assessment, by a judge, of evidence emerging from the testimony of medical experts in the relevant area of practice.
The standard of care advocated in clinical guidelines cannot, at present, simply be transcribed into a court setting and used as the legal 'gold standard'. In a 1967 case, the Privy Council, in its judicial role, reiterated that the test of medical negligence is:
'…the standard of the ordinary competent practitioner exercising ordinary professional skill, so that evidence from witnesses of the highest professional standing or reference to writings of distinguished medical authorities was not necessary.' 1
The mere fact that a protocol exists for the care of a particular condition does not of itself establish that compliance with it in the circumstances will be held to be reasonable, or that non-compliance would be judged negligent. Although protocols or guidelines can be introduced to a court by an expert witness as evidence of accepted and customary standards of care, they cannot be introduced as a substitute for expert testimony.
The Privy Council judgment emphasised that the appropriate standard of medical care is neither best practice, nor the practices of 'super specialists' (unless that is the type of care that is under scrutiny). There is probably little legal basis, therefore, to the claim that clinical guidelines might cause one group of doctors to be judged in court by inappropriate standards of care laid down by an entirely different group.2
The Privy Council judgment stated that the standard of care required from one sort of practitioner can be different from that required from another.
An instance in which the highest UK court found that guidelines drawn up by a responsible body of opinion can offer a degree of protection to clinicians in the eyes of the law can be found in the case of Tony Bland (1993), a victim of the Hillsborough football stadium disaster.3
The guidelines in question were developed by the Medical Ethics Committee of the British Medical Association, and suggested safeguards to be observed before discontinuing artificial nutrition and hydration to patients in the persistent vegetative state (PVS).4 Lord Goff, in one of the leading judgments, stated that:
'Study of this document left me in no doubt that, if a doctorØtreating a PVS patient acts in accordance with the medical practice now being evolved by the Medical Ethics Committee of the BMA, he will be acting with the benefit of guidance from a responsible and competent body of professional opinion, as required by the Bolam test.' 3
Although the Bland case was not a legal action in negligence, according to this judgment, the BMA guidelines met the requirements of the Bolam test in these clinical circumstances, because they amounted to 'guidance from a responsible body of professional opinion'.
Since this is the standard of care required by law, compliance with these guidelines was also compliance with the law.
However, the judgment also recognised that guidance was 'being evolved', implying an appreciation by the courts that the required standard of care is likely to change over time.
The legal significance of deviation from standard practice was enunciated in a key judgment by Lord Clyde, in Hunter v Hanley (1955):
'...in regard to allegations of deviation from ordinary professional practice such a deviation is not necessarily evidence of negligence. Indeed, it would be disastrous if this were so, for all inducement to progress in medical science would be destroyed. Even a substantial deviation from normal practice may be warranted by the particular circumstances.' 5
Three facts need to be proven in order to establish liability in the case of a doctor accused of negligence as a result of deviating from normal practice:
'It must be proved that there is a normal practice; secondly, it must be proved that the defendant has not adopted that practice; and thirdly (and this is of crucial importance) it must be established that the course the doctor has adopted is one which no professional man of ordinary skill would have taken if he had been acting with ordinary care.' 5
Summarising the case of Loveday v Renton and Wellcome Foundation Ltd 1990, the editor of Medical Law Reports explained that the court held obiter* that failure to observe particular contraindication guidelines when administering whooping cough vaccination:
'…would not in itself constitute negligence because there was a respectable and responsible body of medical opinion that some contraindications should not be observed because the risk of disease outweighed any actual or possible risk from the vaccine'. 6
The case concerned a baby girl who suffered brain damage after receiving pertussis vaccination, despite coming within the then current contraindications issued by the DoH.
Even if it had been possible to establish in the Loveday case that pertussis vaccine could cause brain damage (which the case left unproved), the judge clearly believed that the third and crucial condition set out in the earlier case of Hunter v Hanley could not be established, despite the breach of official DoH guidelines, namely that the course the doctor adopted was one that 'no professional man of ordinary skill would have taken if he had been acting with ordinary care'.5
So long as customary care sets the legal standard of care, deviation from a guideline would be unlikely to be accepted as evidence of negligence by a UK court, as long as the particular deviation accorded with approved practice recognised by a responsible body of doctors. But a finding of negligence cannot be excluded where deviation from an accepted guideline does not accord with approved responsible clinical practice.
The 1990 case of Cranley v Medical Board of Western Australia, which involved alleged misconduct by an Australian GP, emphasises the importance that common law usually attaches to the existence of more than one school of thought.
In prescribing injectable diazepam to heroin addicts, Dr Cranley had deviated from the Australian National Methadone Guidelines and, as a consequence, was found guilty of 'infamous and improper conduct'. But the Supreme Court of Western Australia upheld his appeal when it heard of a minority medical opinion in Australia which supported treatment of opiate addicts as Dr Cranley had done, within a harm reduction framework.7
Lord Clyde in Hunter observed that:
'In the realm of diagnosis and treatment there is ample scope for genuine difference of opinion and one man is not negligent merely because his conclusion differs from that of other professional men'. 5
Since clinical guidelines offer doctors, patients and purchasers standards of care for use in specific clinical circumstances, they may be thought to remove the need for expert testimonyÚin a court's quest to define the legal standard of care in a particular case, because the court could have direct access to the appropriate standard from a clinical guideline.
One health lawyer foresees such a possibility:
'Just as clinical guidelines may help to demystify clinical decision-making for managers and purchasers, they may have a similar effect on English judges. If clinical decision-making can be reduced to a series of steps outlined in a published guideline, the argument would go, it must also be susceptible of similar elucidation in court. This of itself could lead to a greater willingness in English judges to assess for themselves the reasonableness of clinical practice rather than simply asking whether the defendant's clinical management as a whole was acceptable to a responsible body at the time.' 8
Yet there are, to date, few clear-cut cases in which this possibility has been translated into legal proceedings in the UK.
One such case is Sutton v Population Family Planning Programme Ltd (1981), in which a nurse who failed to follow the prescribed procedure for referring a patient with a breast lump was on that account found negligent. 9
As clinical guidelines become more pervasively adopted, guideline-informed care may come to be viewed by the courts as some evidence of the standard of care required:
'While it is extremely unlikely that the existence of protocols will lead to the elimination of the Bolam test altogether, there could be a strong argument for reversing the burden of proof in cases where guidelines are not followed. A doctor who had decided not to follow the definitive guidelines produced by experts in his field would be required to justify his decision. He could call upon expert witnesses to assist him, but the burden of proof would be on him and not the patient.' 10
The effects of any such changes in legal emphasis could well be to encourage adherence to clinical guidelines.
The next article in this series will discuss whether the developers and issuers of guidelines can be held legally liable for faulty guidance.
* Obiter here means that this particular reasoning was not central to the main issues which the court had to decide in this case, namely whether whooping cough vacine could cause brain damge, and if so, whether the doctor acted negligently in this particular case
- Chin Keow v Government of Malaysia (PC). 1967 1 Weekly Law Reports 813-17 at 813H.
- Gray DP. Editor's preface. In: Haines A, Hurwitz B, ed. Clinical Guidelines: Report of a Local Initiative. London: Royal College of General Practitioners, Occasional Paper No 58, 1992;vii.
- Airedale NHS Trust v Bland (Guardian ad litem). 1993 1 All ER 821
- British Medical Association. Guidelines on Treatment Decisions for Patients in Persistent Vegetative State. London: British Medical Association, 1993.
- Hunter v Hanley SC 200 (Court of Session) (1955). Quoted in Kennedy I, Grubb A. Medical Law. Text and Materials. London: Butterworths, 1989:420.
- Loveday v Renton and Wellcome Foundation Ltd (QBD). 1990 1 Medical Law Reports 117-204.
- Cranley v Medical Board of Western Australia (Sup Ct WA). 1992 3 Med Law Rep 94-113.
- Stern K. Clinical guidelines and negligence liability. In: Clinical Effectiveness: From Guidelines to Cost Effective Practice. Deighan M, Hitch S (eds). Earlybrave Publications Ltd, UK, 1995:127-35.
- Sutton v Population Family Planning Programme Ltd, unreported 30 October 1981. Cited in: Montgomery J. Health Care Law. Oxford: Oxford University Press, 1997:183.
- Harpwood V. NHS reform, audit, protocols and standards of care. Medical Law International 1994;1:241-259.