There are as yet no common law cases in the UK in which the courts have had to consider whether authors of clinical advice could be liable for incorrect or misleading statements. But in non-medical spheres, courts have been asked to decide similar questions, where individuals have claimed economic loss by relying upon written statements, e.g. from accountants.
The House of Lords has recently reviewed the law in this area. In the case of Caparo Industries plc v Dickman and others, their Lordships stated that there can be no duty of care between the author of a document or book and its myriad potential readers, unless the authors could reasonably have foreseen that their written advice would be directly communicated to a particular reader who could reasonably be expected to rely upon it.1
The courts recognise the importance of drawing firm boundaries around the sorts of situations in which author liability may arise, and have confined possible liability to situations where a special relationship clearly exists between writer and reader.
A special relationship of this sort can be held to exist between the maker of a statement or the giver of advice (the adviser) and a recipient who acts in reliance upon it (the advisee) only where:
'(1) the advice is required for a purpose...which is made known, either actually or inferentially, to the adviser at the time when the advice is given
(2) the adviser knows, either actually or inferentially, that his advice will be communicated to the advisee, either specifically or as a member of an ascertainable class, in order that it should be used by the advisee for that purpose
(3) it is known, either actually or inferentially, that the advice so communicated is likely to be acted on by the advisee for that purpose without independent inquiry [my emphasis]
(4) it is so acted on by the advisee to his detriment.' 1
For doctors to be expected to follow advice 'without independent inquiry' the authors would require to possess, and to be credited by relevant practitioners as possessing, quite extraordinary authority.
Traditionally, the courts expect medical professionals to act as 'learned intermediaries', interpreting the relevance of 'expert advice' in the context of each clinical problem before them. Doctors are expected to exercise appropriate discretion and judgment, and not to apply advice mechanically, irrespective of relevant individual factors:
'The courts have been very reluctant to make one party liable for the negligent act of another person. It would be exceptional for the failure of a doctor to administer proper care to be made the responsibility of those who promoted the guideline.' 2
Despite this view, it has been suggested that one or two written statements of advice, such as those contained in Martindale's Extra Pharmacopoeia, might indeed possess the status of definitive works of reference such that doctors could safely rely upon their recommendations, without independent enquiry.3 But a court case addressing this question indirectly has suggested otherwise.
In the case of Vernon v Bloomsbury Health Authority (1995), the plaintiff, Barbara Vernon, was treated in 1982 for culture-negative bacterial endocarditis. She received doses of gentamicin higher than those recommended by the Product Data Sheet, the British National Formulary (BNF), the Monthly Index of Medical Specialities (MIMS) and Martindale's Extra Pharmacopoeia, and for a period longer than that recommended by MIMS and Martindale.
She had been given 5.625mg/kg of the drug for 19 days, whereas these reference sources at the time recommended a maximum dose of 5mg/kg for 7 days; as a consequence of this treatment she suffered bilateral vestibular damage.
At the hearing, all but one of the expert witnesses testified that they themselves would have prescribed gentamicin at this dosage for a patient in Barbara Vernon's condition.
Although the plaintiff's expert witness stated that she would not herself have administered such a high dose for this condition, she was unable to say that no reasonably competent microbiologist would have prescribed at this level.
The judge found that:
'... the dosage was a proper one. The doctors were not negligent in prescribing it. I agree with the defendants' experts that the guidelines laid down by the manufacturers and, for example, MIMS are too conservative and that they err on the side of caution. I accept the views expressed by Dr Sowton, Dr Reeves and Dr Cooke, all of whom have great practical experience of prescribing this drug. In particular, I rely on the views of Dr Reeves. He has consistently prescribed higher doses than those recommended by the manufacturers and has advised others to do the same.' 4
The courts do not expect the recommendations of medical reference works with the standing of Martindale's Extra Pharmacopoeia to be automatically translated into clinical practice, and they continue to place the testimony of expert witnesses concerning what constitutes reasonable practice, above that of the recommendations of prestigious works of reference.
The legal status of recommendations could generally be made clearer to doctors by emphasising that they should not be adopted by clinicians 'without independent inquiry'.
A recent UK collection of clinical guidelines adopted this approach, stating:
'Readers are strongly advised to refer to the data sheets when a clinical guideline summary describes a drug therapy or when full details and the clinical significance of the products' contraindications, special precautions, drug interactions, adverse reactions or overdoses are required. While every care has been taken to ensure the accuracy of the clinical guideline summaries, this does not diminish the requirement to exercise clinical judgment and the publishers cannot accept liability for any errors and omissions.' 5
Such a statement clearly places clinical discretion at the heart of appropriate use of guidelines. So also do the 1997 Guidelines for the prevention of malaria in travellers from the United Kingdom, issued by the Public Health Laboratory Service's Communicable Diseases Surveillance Centre, which state that:
'The views expressed in these guidelines reflect experienced professional opinion, since the data are inadequate for unequivocal views to be given on several issues. There is often a range of acceptable options...Decisions on the terms under which different drugs are licensed for use are the responsibility of the Licensing Authority...(not of these guidelines). The guidelines should be read as a supplement to and not as a substitute for the relevant data sheets.' 6
This advice is especially relevant, since these particular guidelines recommend doxycycline for the prophylaxis of falciparum malaria, even though doxycycline is not licensed for this indication.
Guideline developers and authors are unlikely to be held legally liable for faulty or misleading advice. The reason is that there is generally no duty of care recognised in UK law between the author of a document or book and its myriad potential readers.
The law generally places the full responsibility for clinical decisions upon the shoulders of the treating clinician. This means that doctors cannot seek to pass off liability to authors and developers of guidelines for any injury a patient may suffer as a result of compliance with faulty guidelines.
Because it is unrealistic to expect busy clinicians to spot inadequate or invalid guidelines, the Government has recognised that an independent, systematic guideline appraisal service is required, together with a National Institute for Clinical Excellence which will take the lead in developing and disseminating cost-effective, reliable clinical guidelines.
- Caparo Industries plc v Dickman and others. 1 1990 All England Reports 568-608.
- Newdick C. Who Should We Treat? Oxford: Clarendon Press; 1995: 178.
- Brahams D, Wyatt J. Decision aids and the law. Lancet 1989; ii: 632-4.
- Vernon v Bloomsbury Health Authority. 6 1995 Medical Law Reports 297-310.
- Foord-Kelcey G (Ed). Guidelines – summarising clinical guidelines for primary care. Berkhamsted: Medendium 1997;1:4.
- Bradley DJ, Warhurst DC on behalf of an expert group of doctors, nurses, and pharmacists. Guidelines for the prevention of malaria in travellers from the United Kingdom. Commun Dis Rep 1997;7: 10.