Review
Informed consent Paul Nisselle, MB BS, FRACGP To appreciate how failure of informed consent might represent negligence needs first an understanding of the components of ‘negligence’. For an action in negligence to succeed, three points must be established. 1. That the doctor had a duty of care to the patient. 2. That there had been a breach of that duty of care. 3. That a quantifiable damage had flowed from that breach of the duty of care. The principles underlying a ‘duty of care’ were established in the famous Donoghue v. Stevenson case in 1932. Lord Atkin in that judgement stated that ‘the rule that you are to love your neighbour becomes in law you must not injure your neighbour . . . you must take reasonable care to avoid acts or omissions which you can reasonably foresee would be likely to injure your neighbour’. The next important precedent was the Bolam v. Friern hospital case in 1957, which defined the duty of care with respect to medical treatment. In this case it was established that the law would look to the medical profession to tell it what is the appropriate standard of care. It was accepted that a doctor who has acted in accordance with ‘accepted practice’ has discharged his or her duty of care to the patient. Since then, each party in a litigation will bring forward expert evidence and the court will form a view on the balance of medical opinion. The next important case was Sidaway v. Board of Governors of Bethlehem Hospital. This case, in 1985, confirmed the application of the Bolam principle to informed consent. Mrs Sidaway was an elderly woman who underwent cervical disc surgery. The risk of spinal cord damage from such surgery is between 1% and 2%. In Mrs Sidaway’s case the cord was damaged and quadriplegia
resulted. The case was brought not on the grounds of alleged operative negligence, but on the failure to warn of this very serious complication. In support of the neurosurgeon who performed the operation, a number of neurosurgeons told the court that whilst they recognise the complication is serious, it is so rare that it was not their practice to routinely warn of that complication. Applying the Bolam principle, the court, and various courts of appeal, accepted the advice given to the courts by the peer group of the defendant neurosurgeon. There are, though, some contrary precedents. King C J in F v. R (1983) in South Australia stated, in his judgement, ‘the ultimate question however is not whether the defendant’s conduct accords with the practice of his profession, or some of it, but whether it conforms to the standard of reasonable care demanded by the law’. Whilst the law will listen to what the medical profession tells it is the standard, the law will reserve unto itself the rights to impose a different standard, if the law disagrees with what the medical profession is telling it. In Ellis v. Wallsend District Hospital (1988) Cole J said he preferred the approach of King C J in F v. R rather than the approach adopted in the House of Lords in Sidaway. Then in 1990, in the now famous Whittaker v. Rogers case, Campbell J also took a different approach to that adopted in Sidaway, but I believe that Campbell J’s decision has been misinterpreted. Many commentators stated with this decision we have moved away from the English ‘reasonable doctor’ standard, to the American ‘reasonable patient’ standard. In America, it is presumed that all patients are ‘reasonable’ and the standard of reasonableness adopted is that of the judge hearing the case. This presumes that any ‘reasonable’ person would want to know every possible complication
Reprint requests: Dr Paul Nisselle, Australasian Representative Office, The Medical Protection Society, 293 Royal Parade, Parkville, Victoria 3052, Australia. Informed consent
279
or side effect or hazard, and therefore every doctor has the burden to tell every patient everything about a proposed treatment. Whilst I am not sure that this really does apply in the United States, I am quite certain that the WhittakerlRogers decision does not introduce it to Australia. My interpretation of the Whittakerl Rogers decision is that a doctor must be seen to have made an individual assessment of each patient seen, as to the amount of information that that particular patient wants or requires or needs at that particular time. It is no longer enough to say ‘I tell all my patients the following about (e.g.) sterilising procedures . . .’. Whilst you may have some general principles that you observe, you cannot simply have, for example, a standard handout that is given to all patients, and believe that by giving every patient that standard handout you have discharged your responsibilities. For some patients that will almost certainly be more information than they want or require, and for others it may well be less. The point at issue in the WhittakerlRogers case was that Mrs Whittaker asserted that she made very specific requests for detailed information and notwithstanding that a number of senior ophthalmologists stated that they would not routinely warn patients of the risk of sympathetic ophthalmia, the judge held that Mrs Whittaker did not receive the information she requested and required to make an informed decision about her surgery. Whilst this case is still under appeal, it would still be prudent for all doctors to review their procedures for informing patients, in the light of that decision. The introduction of new technology, such as excimer laser, also raises specific problems with informed consent. It is my belief that if a doctor contemplates providing a treatment which will be considered by many of his or her colleagues to be new or different or outside conventionally accepted, mainstream therapy, then he or she has a particular burden to so inform the patient. However, it is a total copout for the doctor then to simply bury the patient under a monstrous amount of highly technical information. Whilst there is a greater burden of disclosure, the doctor still must provide information in a form that is understandable by that patient, and that patient specifically. There are some patients who will say ‘don’t bother telling me all this doctor,
280
just go ahead and do what you think is best’. This is regarded by some as a waiver of the right to informed consent, but it may not hold up in law, and you cannot assume that such a statement from the patient will absolve you of all responsibility. Once again you have the specific burden of ensuring that that patient has sufficient information, provided in a form that will enable that patient to make an informed decision. Finally there is the question of how you should document informed consent. ‘Consent Forms’ are not worth the paper they are written on! They are not evidence in themselves of consent. They are simply evidence that a process occurred as a result of which the patient felt able or was pressured or was coerced into placing his or her signature on a piece of paper. The signature is evidence that on a particular date two people came together as a result of which the signature became appended to the paper. There will still be the need to take sworn statements, to place in evidence, detailing exactly what was said to the patient in that process. For example, a small percentage of sterilising procedures come undone, by recanalisation of one vas or tube, and the patient or spouse becomes pregnant again. In the vast majority of these circumstances a consent form for surgery will have been signed before the procedure was performed. Unless that consent form specifically states ‘I acknowledge that I have been warned that total loss of fertility cannot be guaranteed’, patients may still be able to say that whilst they had consented to the surgery, they had not been informed of the risk of pregnancy - and if they had been so warned, they would not have proceeded with the surgery. In summary, in assisting a patient to make an informed decision about the treatment you suggest, you need to make your own decision as to the level of information that that specific patient requires to give valid consent. Next, you need not only to document, by a signature, that consent was obtained, but also to document, in skeletal or summary form, the extent and content of the information you provided to the patient, as a result of which the patient agreed to proceed. T o take the example I mentioned above, the words ‘warned re risk of pregnancy’ on a gynaecologist’s notes may be worth about $20 000 per word!
Australian and New Zealand Journal of Ophthalmology 1992; ZO(4)
Informed consent Paul Nisselle, MB BS, FRACGP To appreciate how failure of informed consent might represent negligence needs first an understanding of the components of ‘negligence’. For an action in negligence to succeed, three points must be established. 1. That the doctor had a duty of care to the patient. 2. That there had been a breach of that duty of care. 3. That a quantifiable damage had flowed from that breach of the duty of care. The principles underlying a ‘duty of care’ were established in the famous Donoghue v. Stevenson case in 1932. Lord Atkin in that judgement stated that ‘the rule that you are to love your neighbour becomes in law you must not injure your neighbour . . . you must take reasonable care to avoid acts or omissions which you can reasonably foresee would be likely to injure your neighbour’. The next important precedent was the Bolam v. Friern hospital case in 1957, which defined the duty of care with respect to medical treatment. In this case it was established that the law would look to the medical profession to tell it what is the appropriate standard of care. It was accepted that a doctor who has acted in accordance with ‘accepted practice’ has discharged his or her duty of care to the patient. Since then, each party in a litigation will bring forward expert evidence and the court will form a view on the balance of medical opinion. The next important case was Sidaway v. Board of Governors of Bethlehem Hospital. This case, in 1985, confirmed the application of the Bolam principle to informed consent. Mrs Sidaway was an elderly woman who underwent cervical disc surgery. The risk of spinal cord damage from such surgery is between 1% and 2%. In Mrs Sidaway’s case the cord was damaged and quadriplegia
resulted. The case was brought not on the grounds of alleged operative negligence, but on the failure to warn of this very serious complication. In support of the neurosurgeon who performed the operation, a number of neurosurgeons told the court that whilst they recognise the complication is serious, it is so rare that it was not their practice to routinely warn of that complication. Applying the Bolam principle, the court, and various courts of appeal, accepted the advice given to the courts by the peer group of the defendant neurosurgeon. There are, though, some contrary precedents. King C J in F v. R (1983) in South Australia stated, in his judgement, ‘the ultimate question however is not whether the defendant’s conduct accords with the practice of his profession, or some of it, but whether it conforms to the standard of reasonable care demanded by the law’. Whilst the law will listen to what the medical profession tells it is the standard, the law will reserve unto itself the rights to impose a different standard, if the law disagrees with what the medical profession is telling it. In Ellis v. Wallsend District Hospital (1988) Cole J said he preferred the approach of King C J in F v. R rather than the approach adopted in the House of Lords in Sidaway. Then in 1990, in the now famous Whittaker v. Rogers case, Campbell J also took a different approach to that adopted in Sidaway, but I believe that Campbell J’s decision has been misinterpreted. Many commentators stated with this decision we have moved away from the English ‘reasonable doctor’ standard, to the American ‘reasonable patient’ standard. In America, it is presumed that all patients are ‘reasonable’ and the standard of reasonableness adopted is that of the judge hearing the case. This presumes that any ‘reasonable’ person would want to know every possible complication
Reprint requests: Dr Paul Nisselle, Australasian Representative Office, The Medical Protection Society, 293 Royal Parade, Parkville, Victoria 3052, Australia. Informed consent
279
or side effect or hazard, and therefore every doctor has the burden to tell every patient everything about a proposed treatment. Whilst I am not sure that this really does apply in the United States, I am quite certain that the WhittakerlRogers decision does not introduce it to Australia. My interpretation of the Whittakerl Rogers decision is that a doctor must be seen to have made an individual assessment of each patient seen, as to the amount of information that that particular patient wants or requires or needs at that particular time. It is no longer enough to say ‘I tell all my patients the following about (e.g.) sterilising procedures . . .’. Whilst you may have some general principles that you observe, you cannot simply have, for example, a standard handout that is given to all patients, and believe that by giving every patient that standard handout you have discharged your responsibilities. For some patients that will almost certainly be more information than they want or require, and for others it may well be less. The point at issue in the WhittakerlRogers case was that Mrs Whittaker asserted that she made very specific requests for detailed information and notwithstanding that a number of senior ophthalmologists stated that they would not routinely warn patients of the risk of sympathetic ophthalmia, the judge held that Mrs Whittaker did not receive the information she requested and required to make an informed decision about her surgery. Whilst this case is still under appeal, it would still be prudent for all doctors to review their procedures for informing patients, in the light of that decision. The introduction of new technology, such as excimer laser, also raises specific problems with informed consent. It is my belief that if a doctor contemplates providing a treatment which will be considered by many of his or her colleagues to be new or different or outside conventionally accepted, mainstream therapy, then he or she has a particular burden to so inform the patient. However, it is a total copout for the doctor then to simply bury the patient under a monstrous amount of highly technical information. Whilst there is a greater burden of disclosure, the doctor still must provide information in a form that is understandable by that patient, and that patient specifically. There are some patients who will say ‘don’t bother telling me all this doctor,
280
just go ahead and do what you think is best’. This is regarded by some as a waiver of the right to informed consent, but it may not hold up in law, and you cannot assume that such a statement from the patient will absolve you of all responsibility. Once again you have the specific burden of ensuring that that patient has sufficient information, provided in a form that will enable that patient to make an informed decision. Finally there is the question of how you should document informed consent. ‘Consent Forms’ are not worth the paper they are written on! They are not evidence in themselves of consent. They are simply evidence that a process occurred as a result of which the patient felt able or was pressured or was coerced into placing his or her signature on a piece of paper. The signature is evidence that on a particular date two people came together as a result of which the signature became appended to the paper. There will still be the need to take sworn statements, to place in evidence, detailing exactly what was said to the patient in that process. For example, a small percentage of sterilising procedures come undone, by recanalisation of one vas or tube, and the patient or spouse becomes pregnant again. In the vast majority of these circumstances a consent form for surgery will have been signed before the procedure was performed. Unless that consent form specifically states ‘I acknowledge that I have been warned that total loss of fertility cannot be guaranteed’, patients may still be able to say that whilst they had consented to the surgery, they had not been informed of the risk of pregnancy - and if they had been so warned, they would not have proceeded with the surgery. In summary, in assisting a patient to make an informed decision about the treatment you suggest, you need to make your own decision as to the level of information that that specific patient requires to give valid consent. Next, you need not only to document, by a signature, that consent was obtained, but also to document, in skeletal or summary form, the extent and content of the information you provided to the patient, as a result of which the patient agreed to proceed. T o take the example I mentioned above, the words ‘warned re risk of pregnancy’ on a gynaecologist’s notes may be worth about $20 000 per word!
Australian and New Zealand Journal of Ophthalmology 1992; ZO(4)
