Lyons Davidson’s Clinical Negligence team explores informed consent
The general rule on informed consent
Prior to performing any procedure, it is imperative that doctors obtain the patients fully informed consent otherwise they could make themselves the object of an allegation of assault. In order to obtain fully informed consent, a doctor is only required to advise the patient of significant or frequently occurring risks. The court does not expect a doctor to recite an exhaustive list of risks of any given procedure. More frequently, patients are provided with a leaflet to read about the proposed procedure and associated risks.
Prior to surgical procedures, it is usual to obtain consent via a signed consent form. The consent form is likely to authorise “such further or alternative operative measures as may be found to be necessary during the course of the operation.” However, this only covers treatment linked to that already consented for. Treatment of a different nature would have to be justified by the physician’s right to act in an emergency to protect a patient’s health. A claimant would need to persuade the court that the additional treatment was not related to the original procedure and not necessary to protect their health.
Where a procedure is performed under a local anaesthetic, it can be considered reasonable to ask for verbal consent for any related surgery during the procedure for which consent has already been given. This is because the patient is awake and a further similar procedure with another administration of local anaesthetic would be avoided. Of course, the clinician must be satisfied that the patient is aware of the risks of the associated procedure, especially if they are materially different to the procedure that the patient has already undergone and consented to. It is ideal to obtain written consent, but in certain circumstances, especially during procedures with local anaesthetic, verbal consent, while criticised, is unlikely to be deemed negligent. This is because it cannot often be foreseen as to what related procedures may be necessary.
Risks of surgery
The fundamental aspect of a consent case is in demonstrating that the doctor did not advise the patient of all material or frequently occurring risks and that, had the patient been informed, then they would not have undergone the procedure. It is also necessary to show, where verbal consent is obtained during a local anaesthetic, that the procedure was unrelated and the risks were significantly different. Further the complication(s) experienced needs to be demonstrated to be a direct result of the second, rather than first, procedure. A claim is likely to fail where the complication experienced is a risk of both procedures as it would be difficult to state which procedure resulted in the ‘injury’.
Approach taken by the courts
The courts are more than aware that cases surrounding the issue of consent arise after something has gone wrong during surgery; a patient claims that, had they known of the particular risk, then they would not have consented to the procedure, no matter how small that risk might have been. The courts therefore increasingly look at a patient’s situation prior to the procedure and the benefits of the procedure had it have been successful. They also consider what alternative treatment options, especially those that are less invasive, were available.
In consent cases, the same test of breach of duty applies. This means that the claimant would need to establish that the defendant could not show that, at the time of treatment, there was a body of reasonable medical opinion, albeit a minority, that would have acted and advised the claimant in the same way at that time. In other words, the defendant would only need to produce one or two competent physicians who would have conducted the consenting process in the same manner at that time, in order to successfully defend an allegation of failing to obtain informed consent.
In the case of Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital , the judge found that the patient had not been told of all the material risks but was satisfied that the surgeon, in giving the limited disclosure that he did, was following a practice that was backed by a body of responsible medical opinion at the time of the operation. As such the judge declared that the claimant must fail.
The test for consent cases
It has therefore been established that the following tests need to be satisfied in order to have a chance at succeeding with a consent case:
- That there is no body of medical opinion (even a minority one) that would have found it acceptable not to give the information. You would then have to prove that this information was not given;
- The patient then has to show that if this advice had been given, he would never have undergone this procedure. If there is no substantially better alternative, they would have to show that they would have declined the treatment;
- Even if he can show that he would have declined the treatment, he has to show that his current condition is substantially worse than it would otherwise have been.
Consent claims in practice
Consent cases are notoriously difficult to prove and are rarely successful. The onus is on the claimant to show that they would not have consented to the procedure had the risks been explained, that they would not have consented had there been no alternative treatment and that their current condition is substantially worse than it would have been in the absence of treatment. Further, it would need to be shown that the complications the claimant suffered were directly attributable to the procedure they had undergone and were not from an underlying condition.
These are notoriously high tests to satisfy. A patient would need to demonstrate that a he/she would not have consented to a procedure when the benefit appears to be greater than the associated risks. Indeed, the courts are aware that such claims are brought as an afterthought once something has gone wrong and as such proceed very carefully when providing judgment.
Posted on Mar 25th, 2013 by Lyons Davidson