Clinical Guidelines on the Test for Breach of Duty
This article will consider two recent cases that consider the impact of clinical guidelines on the test for breach of duty.
O’Brien (administratrix of the estate of John Berry (deceased) v Guy’s and St.Thomas’ NHS Trust,  EWHC 2735 (KB)
B died in 2019. There is no suggestion that his death was as a result of any negligent treatment.
B’s sister brought the claim, asserting that B’s treatment in March 2017 had been negligent. B was prescribed 400mg of the antibiotic gentamicin, which she claimed was a negligently excessive dose due to B’s lack of effective renal function.
It was agreed that the gentamicin dose had caused B’s ‘ototoxicity’ side effects, leading to balance problems which had required care from the claimant. It was disputed that the drug had also caused B’s hearing loss.
Subject to liability, damages were agreed at £45,000.
The decision centred around whether the decision to prescribe 400mg of gentamicin had been Bolam negligent.
The claim was dismissed because the prescription of gentamicin (and it’s administration some hours later when the infection had become worse) had not been negligent despite causing B ototoxicity with balance problems and hearing loss.
The Court did not accept the argument that Dr M had simply ‘applied’ the ICU guidelines, nor that he had ‘overlooked B’s condition or extremely limited renal function.’
The Court noted that even if Dr M had applied the ICU guideline without adaptation, the specific circumstances were sufficiently nuanced for him to have done so.
Indeed, the Court concluded that even if the circumstances had been insufficiently nuanced, there were cogent reasons for taking a ‘one size fits all’ approach in ICU.
The Court noted that there were good, logical and indeed cogent reasons for ICU guidelines or practice to depart from national guidelines which turn on creatinine clearance rate/glomerular filtration rate levels.
Dr M departing from the NICE/BNF guideline for B had been justified by good, logical and cogent reasons. His decision to prescribe 400mg of gentamicin to B, despite his improvement in clinical presentation, and the planned step down to Stephen Ward if he had tolerated faster dialysis had been logical, reasonable and in accordance with a responsible body of clinical opinion.
The fact that Dr M had used a flawed guideline did not prove that his decision had been negligent. In adapting the guidelines which were poorly worded (as opposed to blindly applying them) Dr M had made a ‘Bolitho-logical’, Bolam-compliant clinical judgment in accordance with a sound body of practice confirmed by Dr D.
Causation was therefore not proven.
A review of the authorities raised the following points for practitioners:
- Even ‘national’ clinical guidelines were not a substitute for clinical judgment in an individual case.
- It followed that even ‘national’ clinical guidelines were not a substitute for expert evidence about that impugned clinical judgment. However, they might inform expert evidence, e.g. as additional evidence of a Bolam compliant body of practice at a particular time, even if the guideline came later.
- Departure from a national guideline was not necessarily prima facie evidence of negligence, but would be likely to require some explanation, with the nature and detail required being dependant upon the circumstances, including the ‘strength’ of the guideline’s steer. An incomplete or contradictory guideline may require less explanation.
- Compliance with a national guideline might be prima facie inconsistent with negligence if the guideline constituted a Bolam compliant body of opinion. Even if the national guidelines were incomplete or unsatisfactory, compliance with them may still ‘militate against negligence’ depending upon the circumstances. However, the same cannot be said of in house guidelines as a defendant could not set their own Bolam standard of care.
- What ultimately matters are whether the conduct fell within a Bolam compliant practice in the usual way. Clinical guidelines are relevant, and should be considered, but were no substitute (or shortcut) for clinical judgment and expert evidence.
Thorley (by his litigation friend) v Sandwell and West Birmingham NHS Trust  EWHC 2604 (QB)
In February 2002 Graham Thorley was diagnosed with atrial fibrillation and prescribed a daily 3.5mg dose of warfarin.
In March 2005 Mr Thorley suffered chest pain and a coronary angiogram was arranged. On advice, Mr Thorley stopped his daily dose of warfarin for a 6 day period (4 days prior to, and one day post procedure).
The angiogram was uneventful and Mr Thorley was discharged home. He asked about the warfarin dose and it was agreed that he would not restart it until he attended the follow up clinic post procedure. At the clinic, Mr Thorley was advised to restart the drug on a reduced dose of 3mg.
3 days after the angiogram, Mr Thorley suffered an ischaemic stroke resulting in permanent and severe physical and cognitive disability.
Mr Thorley asserted that the Trust was in negligent breach of duty in that the cessation of warfarin should have been limited to the three days prior to the angiogram, and should have been restarted the same day as the procedure at the usual dose of 3.5mg, as set out in the 2004 guidance (Anticoagulation and Surgery (Sandwell)). These breaches caused or materially contributed to the occurrence of the stroke.
The Trust denied the breach, save as to admit that warfarin should have been restarted by no later than the day after the angiogram at the usual dose of 3.5mg. As to causation, the Trust asserted that Mr Thorley would have suffered the stroke in any event.
The Court rejected the case that those treating the claimant should have applied the provisions within the 2004 document. The existence of the 2004 guidance did not mean that it had been ‘illogical’ to have applied an alternative and responsible practice of a body of competent practitioners. The expert evidence provided no basis to conclude that a three day period of omission of warfarin would have constituted ‘better’ practice when compared to four or five days.
In respect of the decision to wait until the day after the procedure to restart the warfarin, there was a body of competent and responsible practitioners, including Dr C who gave expert evidence on behalf of the Trust, who would have deferred the restart of warfarin until the day after the practice.
In light of these findings, the ‘but for’ case on causation was academic.
It was reiterated that the principle test remained that a doctor was not negligent if he had acted in accordance with a practice accepted as proper by a reasonable body of medical men skilled in that particular art (as per Bolam). Further, the Court had to be satisfied that the exponents of the body of opinion relied upon could demonstrate that such an opinion had a logical base (Bolitho).
The Court affirmed that any Judge determining such a case would need to be satisfied that the experts had directed their minds to the comparative risks and benefits, and had reached a defensible conclusion.
Points to take away from both cases
The headline point is clear – the law as set out in Bolam and Bolitho stands.
Whilst clinical guidelines are important and may provide evidence of ‘a reasonable body of medical men’ to satisfy the Bolam test, they are not necessarily determinative. A failure to follow guidelines does not automatically mean that a practitioner has been negligent provided that they are able to evidence that they have relied upon or considered alternative reputable expert advice. In any case, the individual circumstances need to be considered and the risks and benefits carefully weighed up.
In short – following guidelines may amount to a defence (provided that they are considered and not simply applied without any consideration). Not following guidelines will likely require explanation but does not automatically equate to negligence.