5 May 2003

Informed consent – Parallels with Bolitho

Part 1 The Bolitho exception The leading case on informed consent to medical treatment is Sidaway v. Bethlem Royal Hospital 1985 AC 871. In that case the House of Lords held that the Bolam test was the appropriate test in deciding the appropriate standard of care in respect of a doctor's duty of disclosure of the risks of medical treatment. If a patient asked a doctor specific questions about his treatment and the risks involved, the doctor would usually be under a duty to answer those questions honestly, but in the absence of specific questions a doctor needed to disclose only such information as would be accepted as a minimum by a responsible and reasonable body of medical opinion. As with other areas of clinical negligence, this is not the whole story.

Lord Bridge, in Sidaway, said that "The judge might in particular circumstances come to the conclusion that disclosure of a particular risk was so obviously necessary to an informed choice on the part of the patient that no reasonably prudent medical man would fail to make it. The kind of case I have in mind would be an operation involving a substantial risk of grave adverse consequences as, for example, the ten per cent risk of a stroke which was the subject of the Canadian case of Reibl v. Hughes 114 DLR (3d) 1. In such a case, in the absence of some cogent clinical reason why the patient should not be informed , a doctor, recognising and respecting his patient's right of decision, could hardly fail to appreciate the necessity of an appropriate warning."

Following the case of Bolitho v. City and Hackney H A the Court of Appeal had to determine when a non-disclosure of risk, approved by a body of medical opinion, might nevertheless be categorised as negligent. In Pearce v. United Bristol Hospitals Healthcare NHS Trust 1999 PIQR P53 Lord Woolf M.R. quoted from Bolitho and said that "In a case where it is being alleged that a plaintiff has been deprived of the opportunity to make a proper decision as to what course he or she should take in relation to treatment, it seems to me to be the law ....... that if there is a significant risk which would affect the judgment of a reasonable patient , then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him or herself as to what course he or she should adopt."

In Pearce, the increased risk was 0.1 to 0.2%. Notwithstanding the gravity of the outcome if the risk materialised (stillbirth) Lord Woolf took the view that a risk of 1 or 2 in 1000 was insufficient to trigger the exception to the usual Sidaway/Bolam test. In discussions I have had with doctors in different specialisms, in many cases over the years, the threshold risk for disclosure of potentially serious consequences is often put by the doctors at 1%. This was the risk that the doctors agreed had to be disclosed in Chester v. Afshar (below).

In Pearce, however, Lord Woolf M.R. noted that one of the doctors had said in evidence that "I generally practice according to the belief that it is not the doctor's duty to warn of very small risks. If the risk, however, was of the order of 10%, for instance, then, of course, it would be my duty to warn against such a level of risk." In the circumstances and given Lord Bridge's reference to 10% (above) Lord Woolf leant towards 10% as being the threshold for a "significant" risk, and so triggering a duty of disclosure outside the usual Bolam test. Pearce was decided in 1998.

I doubt that any doctor practising in England in 2003 would consider it acceptable practice in the ordinary case not to warn of a 10% risk of a serious adverse outcome. For that reason, if the exception to Sidaway/Bolam is to be meaningful, judges will have to consider that changing times bring with them changing patient expectations. Will the common law adapt? My suspicion is that, unlike in other areas of clinical negligence law, the views of the medical profession will always prevail in informed consent cases, quite unlike the position in many other jurisdictions.

Part 2 - The Bolitho approach to causation

There is more joy for Claimants in informed consent claims, however, on the issue of causation. The scenario is as follows. A doctor negligently fails to warn of a risk. The patient is injured by the treatment, which nevertheless is administered with appropriate skill and care. It is necessary to consider alternative factual situations on the assumption that the risk been appropriately explained. Alternative 1 The patient would never have had the treatment. Alternative 2 The patient would have had the treatment, but performed by a different doctor. Alternative 3 The patient would have had the treatment, but performed by the same doctor 3 months later. Alternative 4 The patient would have had the treatment at the same time and place, with the same surgical team. Alternatives 1 and 4 need no further discussion.

The High Court of Australia considered Alternative 2 in the important case of Chappel v. Hart 1999 Lloyd's LR Med 223, the decision being by a majority of 3 to 2. It was held that the patient had succumbed to a random risk of surgery (infection). Had she been appropriately advised, she would have taken steps to have the surgery performed by " the most experienced surgeon with a record and reputation in that field". In the circumstances the claimant was entitled to succeed in full against the negligent surgeon. Alternative 3 was first considered in England by HH Judge Taylor, sitting as a Judge of the High Court in a case in which I acted for the Claimant in late 1999 (Burke v. Leeds H A).

There the judge found that parental consent to chemotherapy had been obtained by a negligent misrepresentation as to its effectiveness vis-a vis other forms of treatment. (This finding of fact was subsequently overturned by the Court of Appeal.) The judge went on to find that parental consent would, however, have been given 3 months later. He therefore found for the Claimant on a preliminary issue, leaving the issue of why the child had succumbed to profound brain damage to a second trial (random infection or inherent susceptibility?). Implicit in his judgement was his recognition that even if the child would have succumbed to the brain damage in any event, he was entitled to damages for the 3 months during which he would have remained uninjured. By a remarkable coincidence when the issues were next before the High Court they came before the same judge.

Once again the judge held that Chappel v. Hart should be followed in England and this time the Court of Appeal were asked to consider whether this was correct. The case was Chester v. Afshar 2002 3 All E R 552 and the Court of Appeal unanimously approved the decision. As in Sidaway there was a spinal operation that caused profound damage notwithstanding the absence of negligence in the performance of the operation.

Miss Chester would have sought a second or even a third opinion had she realised the risk. The defendant argued that for Miss Chester to succeed she would have to show that she would never have undergone the surgery at all. It was argued that the defendant had not increased the risk to which Miss Chester had been exposed, if she would have had an operation anyway. The Court of Appeal held that the injury suffered was a consequence of the problem that had taken the patient to the doctor and of the doctor's attempt to put it right. Furthermore it was a consequence about which the patient had expressed her concern and had been wrongly reassured. The patient was entitled to damages. The quantification of loss was dealt with as follows at 571a "

At the trial it was not suggested that the well-known risk of cauda equina damage resulting from this type of surgery advised and performed by the defendant was greater than 1% to 2%. Nor do we think that there was any evidence to show that the claimant's constitution made her abnormally vulnerable to this type of surgery. But this will be a matter for the court assessing damages.

On the assessment it will be open for the defendant to argue (and prove so far as he may be able to do so) that (i) it is more likely than not that the claimant would have undergone an operation with the same or similar risks in the future; and (ii) it is more likely than not that the same risk would have eventuated." ( I am not entirely convinced that the phrase "more likely than not" is apposite in the calculation of damages in this type of case as we are in the realms of "loss of a chance".) How far can the Chester v. Afshar principle be taken? What if, during the operation, lightning strikes the operating theatre? The Court of Appeal said that the "but for " test is necessary, but not always sufficient to establish causation in law. The defendant is not liable for coincidences which have nothing to do with him.

Can the Chester v. Afshar principle be used in areas outside informed consent cases? Let me take an example from another of my cases (with some adjustment to the facts). Because of allegedly negligent treatment the patient ends up with a plaster of Paris cast on his leg that is so tight it causes tissue necrosis. At the Accident and Emergency Department he is negligently turned away. Many days later he returns, the plaster is removed and a split skin graft is eventually attempted to save the leg. This fails because of a random but modest risk of surgery and the patient loses his leg. Had the patient not been turned away at A and E sufficient tissue would have been lost to necessitate a split skin graft anyway. Is there any liability on the A and E department?