Original Article
Reductio ad absurdum: Informed consent
Medico-Legal Journal 2014, Vol. 82(1) 38–40 ! The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0025817213513699 mlj.sagepub.com
John Garfield, MChir, FRCP, FRCS Retired Neurosurgeon
Abstract Informing of possible or almost impossible risks of operations may reach absurdity as a form of defensive medicine which is not in the patient’s interest and can destroy faith in the surgeon. Its prevention is more a matter for lawyers than for doctors without diminishing the ethic of informed consent. True and hypothetical examples are considered.
Keywords Litigation, surgery, consent, risks, defence, informing
Surgeons, and indeed patients, may be wondering what the future holds for the process of informed consent. For the surgeon, the law’s requirements seem to be heading for the realms of Alice in Wonderland, even absurdity. For the patients, the path may be leading to unnecessary anxiety, even distress, to say nothing of loss of faith in their surgeons. This can lead to the growth of the multi-opinion syndrome, in which every additional opinion can cause increasing confusion, to which the dreaded internet can add its pseudo-authoritative voice. Sadly, the clock cannot be put back. Indeed, recent judgments have caused the clock face to be an accelerated merry-go-round. This is not to deny the importance of the law in protecting patients from unacceptable medical and particularly surgical practice. Whether the threat of medical negligence actions improves the practice of surgery can be disputed. What is even less certain is that it improves the relationship between patient and surgeon. I believe it can seriously impair trust and faith in the surgeon, which are essential ingredients for both surgeon and patients. Fear and anxiety have adverse effects pre-operatively and post-operatively and can also impair a surgeon’s confidence and objectivity. Looking back over my own 24 years of consultant neurosurgical practice which began 45 years ago, informed consent for operation posed few problems for either surgeon or patient. I was never sued for failure to warn of the risks of an operation. (I was sued three times in connection with management rather than with the surgery. I was disappointed – but the lawyers were not – that the cases collapsed and did not come to trial. Thus, I was denied the opportunity to
demonstrate the absurdity of the claims and the so-called experts could not be cross-examined.) It is non-life-threatening conditions and therefore not urgent which are most likely to lead to issues of consent. A good example is operations for prolapsed lumbar intervertebral disc and for degenerative lumbar spondylosis. The entry I always made in the clinical notes was: ‘‘I have explained fully to the patient the implications of this operation.’’ There was no list of possible risks or complications which had to be countersigned by the patient confirming that he had understood the explanations. Thereby, I accepted great responsibility for choosing the risks to be considered and explained. That a claimant can recover damages because a surgeon failed to explain fully the likely outcome if he did not undergo an operation1 underlines the importance of the discussion which should precede any advice given to patients. In many cases the assessment of the natural history (the course of the condition if untreated) is as difficult or even more difficult than the assessment of the severity and incidence of risks in percentage terms. Rightly or wrongly I never used figures; I simply did not have the certainty upon which to base them. It is therefore surprising that the courts are prepared to accept figures produced and agreed by experts; unfortunately, the courts have no alternative. In dealing with non-life-threatening conditions, thorough consideration and explanation of the indications for operation are essential. The natural history is Corresponding author: John Garfield, UK. Email: [email protected]
Downloaded from mlj.sagepub.com at WAYNE STATE UNIVERSITY on April 14, 2015
Garfield
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paramount. But to burden or over-burden the patient with every possible risk of an operation may not be in the patient’s interest and may certainly conflict with ‘‘good medicine’’.2 Indeed, it is very easy to deter a patient from an operation that could bring great benefit. As Lord Scarman put it in Sidaway:3 ‘‘Even if the risk be material the doctor will not be liable if upon a reasonable assessment of his patient’s condition he takes the view that a warning would be detrimental to his patient’s health.’’ In Sidaway, the risk of spinal cord damage was assessed at less than 1%, and therefore a warning was not required especially when the patient had not sought information about their risk. In O’Malley-Williams4 failure to warn of a remote risk, which the patient had not raised, was held not negligent. How a patient without medical knowledge could be expected to ask questions about remote risks is obscure. In Afshar,5 the standard of informing of risks was ‘‘To be judged in the context of good professional practice . . . ’’ Surely that leaves the issue to be continually re-examined. These comments may sit uneasily with the lawyers. The progression of common law does not augur well for the issue of consent in surgical practice and particularly, as some have argued, for innovative treatments. Afshar has been held up as a new line of causation in failure to warn of the risks of operation though the actual performance of the operation was not an issue in recovering damages. However, it should be noted that the court was not asked to examine that aspect, but counsel shrewdly sought to have it put on one side for consideration later should damages not be recovered on consent. In fact, there has been some misunderstanding of Afshar. Their Lordships did not find that Miss Chester would never have had the operation if the risks had been fully explained. If she had a similar operation at a later date the risk of damage would have been no more than about 2% or less. They accepted that the damage was probably caused by retraction at the L2-3 level at the first operation, a micro-discectomy through a relatively limited exposure. A similar approach at a later date would not necessarily have involved the same degree of retraction of the dura and the cauda equina and possibly the lower end of the spinal cord; therefore, the risk of damage would be no greater than that attaching to a correctly performed operation. De Costa6 drew attention to the notion of ‘‘proximity’’ in the American courts, and their concern that there should be a direct relationship between the breach of duty and the damage caused. At first sight Afshar might not appear to conform to the notion of ‘‘proximity’’. However it seems to me that proximity was satisfied: the damage was the materialisation of a risk of the operation of which the patient was not
warned, but should have been warned. Thereby she was denied the opportunity of declining the operation at that time. A significant advance in consent came from Smith v Barking and Havering,7 a case in which I assisted. The patient suffered from a congenital abnormality at the cervico-medullary junction, for which she had been operated upon some years previously. The problem recurred, causing a rapidly advancing neurological deficit. Following a second operation, she was profoundly disabled. She claimed that had she been fully informed of the risks of the operation she would not have consented to it. In the course of the trial, the defence accepted that the claimant had not been fully informed of the risks. The defence then pleaded that had she been fully informed she would still have agreed to the operation. The judge first had to decide whether he could try the case on that basis; he then did so and found for the defendant. Therefore this was a successful defence on causation, which is not common when a defence on liability has failed. The case also illustrated the balance between consent given by a patient who had not yet been harmed, and that given by a patient in retrospect who had been harmed by an operation. The consent issue was similar in Wallace v Kam.8 Unfortunately – or fortunately for the few but not for the reasonable practice of surgery – things have gone further. A patient was not warned of a risk which did not materialise; the patient claimed that the warning of that risk would have deterred him from having the operation at which damage of which he had been warned occurred. More alarming still is the possibility that one surgeon might be sued for warning of say only 49 possible risks of an operation, while another surgeon warned of the full 50, yet there was no operation. Had the first surgeon failed in his duty of care and was he therefore liable for damages? Quantum would be a difficult matter. At what level should risks be imparted to patients in obtaining consent for operation has been the subject of debate. A figure of 2% has been suggested, but that is quite arbitrary and it could be argued that any figure is a matter for the patient’s choice. Thus, some patients might want to know of risks which have only a half of 1% chance of materialising. Others (like myself!) may not want to know of any risks at all once they have placed themselves trustingly in the care of a respected surgeon who has carefully evaluated the indications for the operation. The potential severity of damage will also weigh in the selection of risks to be described. The danger, indeed the likelihood, is that the list of risks presented to patients will steadily increase in the years to come, a danger inherent in the Saatchi Bill. To what extent that will be driven by patients, by doctors, or by lawyers is
Downloaded from mlj.sagepub.com at WAYNE STATE UNIVERSITY on April 14, 2015
40
Medico-Legal Journal 82(1)
Table 1. Claims in ascending order of ‘‘absurdity’’. 1. 2. 3. 4. 5. 6.
Failure to warn of risks that did not materialise. Claimant denied opportunity to decline operation which caused damage of which claimant had been warned. Failure to warn of risk. Operation declined for reasons not related to risk. Failure by surgeon A who warned of only 49 risks while surgeon B warned of 50; claim whether or not an operation was done and whether or not any damage was related to the 50th risk explained by surgeon B. Failure to warn of very small risk (e.g. 0.1%); claimant denied opportunity to refuse operation at which no damage occurred. Warning given of very small risk (e.g. 0.1%); attention deflected from natural history and prognosis without surgery. Warning given of very small risk (e.g. 0.1%) deemed unnecessary, causing distress and anxiety. Operation declined. Claimant continued suffering from underlying condition.
uncertain; my view is that it will be driven mainly by lawyers, perhaps a chauvinistic view. Today much is made of ‘‘defensive medicine.’’ Usually this implies over-zealous and unnecessary investigations which may reveal abnormalities quite irrelevant to the symptoms of which the patient is complaining. This can lead to interventions which carry risks (e.g. liver biopsy), the biopsy being unjustified. An example of the demonstration of irrelevant pathology is scanning of the lumbar spine for symptoms which are relatively mild and are not causing significant disability. In older patients, scans will show advanced pathology, for example, degenerative lumbar spondylosis, which may be present in people who have no symptoms at all. In Afshar, the scans showed abnormalities at three levels: L2-3, L3-4, and L4-5 which led to the initial operation of a micro-discectomy at those three levels. To determine pre-operatively which level is responsible for symptoms is very difficult and how extensive the operation should be. Over-zealous and unnecessary warning of the risks of operation is another form of defensive medicine. While protection of the patient is the prime consideration, protection of the surgeon against litigation can easily become too strong a motive in informed consent. In 1999, Adrian Whitfield, QC,9 wrote: ‘‘ . . . the law is catching up with good medical practice, which is to give as full an explanation including accurate answers to questions as the individual patient can take in without positive harm resulting from such an explanation.’’ I would venture to suggest that the law in certain
circumstances has overtaken good medical practice and can thus encourage poor medical practice. Lawyers will point out that the apparent absurdities are no more than the evolution of the rule of law, admittedly at times tortuous, or even opaque. But as Lord Bingham10 wrote: ‘‘Belief in the rule of law does not impart unqualified admiration of the law, or the legal profession or the courts or the judges.’’ The main hope for avoiding absurdities rests with our esteemed judiciary. I am quietly confident, or at least hopeful, that we shall not reach the Lewis Carroll scenario with the Queen of Hearts on the Bench crying indiscriminately ‘‘Off with his head.’’ References 1. Reible v Hughes 1980 2 SRC 880. 2. Garfield, J. Chester v Afshar. A Surgeon’s View. British Journal of Neuorsurgery 2005; 19(2): 120–121. 3. Sidaway v Governors of Bethlem Hospital 1985 AC 871. 4. O’Malley-Williams v Governors of National Hospital. Bridge J (1975). IBMJ 635. 5. Chester v Afshar (2004) UKHL 41; (2005) 1 AC 13. 6. De Costa. Liability for failure to warn of a risk that does not materialise? Medico-Legal Journal 2013; 81(20): 86–89. 7. Smith v Barking Health (1994) 5 Med LR. 8. Wallace v Kam (2012) NSWCA 82. 9. Whifield, A. The Law in Medical Negligence The Cranium, The Spine and The Nervous System. Ed. Garfield, J and Earl, C. Blackwell Science, Oxford, 1999. 10. Bingham, T. The Rule of Law, Allen Lane, London 2010.
Downloaded from mlj.sagepub.com at WAYNE STATE UNIVERSITY on April 14, 2015
Reductio ad absurdum: Informed consent
Medico-Legal Journal 2014, Vol. 82(1) 38–40 ! The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0025817213513699 mlj.sagepub.com
John Garfield, MChir, FRCP, FRCS Retired Neurosurgeon
Abstract Informing of possible or almost impossible risks of operations may reach absurdity as a form of defensive medicine which is not in the patient’s interest and can destroy faith in the surgeon. Its prevention is more a matter for lawyers than for doctors without diminishing the ethic of informed consent. True and hypothetical examples are considered.
Keywords Litigation, surgery, consent, risks, defence, informing
Surgeons, and indeed patients, may be wondering what the future holds for the process of informed consent. For the surgeon, the law’s requirements seem to be heading for the realms of Alice in Wonderland, even absurdity. For the patients, the path may be leading to unnecessary anxiety, even distress, to say nothing of loss of faith in their surgeons. This can lead to the growth of the multi-opinion syndrome, in which every additional opinion can cause increasing confusion, to which the dreaded internet can add its pseudo-authoritative voice. Sadly, the clock cannot be put back. Indeed, recent judgments have caused the clock face to be an accelerated merry-go-round. This is not to deny the importance of the law in protecting patients from unacceptable medical and particularly surgical practice. Whether the threat of medical negligence actions improves the practice of surgery can be disputed. What is even less certain is that it improves the relationship between patient and surgeon. I believe it can seriously impair trust and faith in the surgeon, which are essential ingredients for both surgeon and patients. Fear and anxiety have adverse effects pre-operatively and post-operatively and can also impair a surgeon’s confidence and objectivity. Looking back over my own 24 years of consultant neurosurgical practice which began 45 years ago, informed consent for operation posed few problems for either surgeon or patient. I was never sued for failure to warn of the risks of an operation. (I was sued three times in connection with management rather than with the surgery. I was disappointed – but the lawyers were not – that the cases collapsed and did not come to trial. Thus, I was denied the opportunity to
demonstrate the absurdity of the claims and the so-called experts could not be cross-examined.) It is non-life-threatening conditions and therefore not urgent which are most likely to lead to issues of consent. A good example is operations for prolapsed lumbar intervertebral disc and for degenerative lumbar spondylosis. The entry I always made in the clinical notes was: ‘‘I have explained fully to the patient the implications of this operation.’’ There was no list of possible risks or complications which had to be countersigned by the patient confirming that he had understood the explanations. Thereby, I accepted great responsibility for choosing the risks to be considered and explained. That a claimant can recover damages because a surgeon failed to explain fully the likely outcome if he did not undergo an operation1 underlines the importance of the discussion which should precede any advice given to patients. In many cases the assessment of the natural history (the course of the condition if untreated) is as difficult or even more difficult than the assessment of the severity and incidence of risks in percentage terms. Rightly or wrongly I never used figures; I simply did not have the certainty upon which to base them. It is therefore surprising that the courts are prepared to accept figures produced and agreed by experts; unfortunately, the courts have no alternative. In dealing with non-life-threatening conditions, thorough consideration and explanation of the indications for operation are essential. The natural history is Corresponding author: John Garfield, UK. Email: [email protected]
Downloaded from mlj.sagepub.com at WAYNE STATE UNIVERSITY on April 14, 2015
Garfield
39
paramount. But to burden or over-burden the patient with every possible risk of an operation may not be in the patient’s interest and may certainly conflict with ‘‘good medicine’’.2 Indeed, it is very easy to deter a patient from an operation that could bring great benefit. As Lord Scarman put it in Sidaway:3 ‘‘Even if the risk be material the doctor will not be liable if upon a reasonable assessment of his patient’s condition he takes the view that a warning would be detrimental to his patient’s health.’’ In Sidaway, the risk of spinal cord damage was assessed at less than 1%, and therefore a warning was not required especially when the patient had not sought information about their risk. In O’Malley-Williams4 failure to warn of a remote risk, which the patient had not raised, was held not negligent. How a patient without medical knowledge could be expected to ask questions about remote risks is obscure. In Afshar,5 the standard of informing of risks was ‘‘To be judged in the context of good professional practice . . . ’’ Surely that leaves the issue to be continually re-examined. These comments may sit uneasily with the lawyers. The progression of common law does not augur well for the issue of consent in surgical practice and particularly, as some have argued, for innovative treatments. Afshar has been held up as a new line of causation in failure to warn of the risks of operation though the actual performance of the operation was not an issue in recovering damages. However, it should be noted that the court was not asked to examine that aspect, but counsel shrewdly sought to have it put on one side for consideration later should damages not be recovered on consent. In fact, there has been some misunderstanding of Afshar. Their Lordships did not find that Miss Chester would never have had the operation if the risks had been fully explained. If she had a similar operation at a later date the risk of damage would have been no more than about 2% or less. They accepted that the damage was probably caused by retraction at the L2-3 level at the first operation, a micro-discectomy through a relatively limited exposure. A similar approach at a later date would not necessarily have involved the same degree of retraction of the dura and the cauda equina and possibly the lower end of the spinal cord; therefore, the risk of damage would be no greater than that attaching to a correctly performed operation. De Costa6 drew attention to the notion of ‘‘proximity’’ in the American courts, and their concern that there should be a direct relationship between the breach of duty and the damage caused. At first sight Afshar might not appear to conform to the notion of ‘‘proximity’’. However it seems to me that proximity was satisfied: the damage was the materialisation of a risk of the operation of which the patient was not
warned, but should have been warned. Thereby she was denied the opportunity of declining the operation at that time. A significant advance in consent came from Smith v Barking and Havering,7 a case in which I assisted. The patient suffered from a congenital abnormality at the cervico-medullary junction, for which she had been operated upon some years previously. The problem recurred, causing a rapidly advancing neurological deficit. Following a second operation, she was profoundly disabled. She claimed that had she been fully informed of the risks of the operation she would not have consented to it. In the course of the trial, the defence accepted that the claimant had not been fully informed of the risks. The defence then pleaded that had she been fully informed she would still have agreed to the operation. The judge first had to decide whether he could try the case on that basis; he then did so and found for the defendant. Therefore this was a successful defence on causation, which is not common when a defence on liability has failed. The case also illustrated the balance between consent given by a patient who had not yet been harmed, and that given by a patient in retrospect who had been harmed by an operation. The consent issue was similar in Wallace v Kam.8 Unfortunately – or fortunately for the few but not for the reasonable practice of surgery – things have gone further. A patient was not warned of a risk which did not materialise; the patient claimed that the warning of that risk would have deterred him from having the operation at which damage of which he had been warned occurred. More alarming still is the possibility that one surgeon might be sued for warning of say only 49 possible risks of an operation, while another surgeon warned of the full 50, yet there was no operation. Had the first surgeon failed in his duty of care and was he therefore liable for damages? Quantum would be a difficult matter. At what level should risks be imparted to patients in obtaining consent for operation has been the subject of debate. A figure of 2% has been suggested, but that is quite arbitrary and it could be argued that any figure is a matter for the patient’s choice. Thus, some patients might want to know of risks which have only a half of 1% chance of materialising. Others (like myself!) may not want to know of any risks at all once they have placed themselves trustingly in the care of a respected surgeon who has carefully evaluated the indications for the operation. The potential severity of damage will also weigh in the selection of risks to be described. The danger, indeed the likelihood, is that the list of risks presented to patients will steadily increase in the years to come, a danger inherent in the Saatchi Bill. To what extent that will be driven by patients, by doctors, or by lawyers is
Downloaded from mlj.sagepub.com at WAYNE STATE UNIVERSITY on April 14, 2015
40
Medico-Legal Journal 82(1)
Table 1. Claims in ascending order of ‘‘absurdity’’. 1. 2. 3. 4. 5. 6.
Failure to warn of risks that did not materialise. Claimant denied opportunity to decline operation which caused damage of which claimant had been warned. Failure to warn of risk. Operation declined for reasons not related to risk. Failure by surgeon A who warned of only 49 risks while surgeon B warned of 50; claim whether or not an operation was done and whether or not any damage was related to the 50th risk explained by surgeon B. Failure to warn of very small risk (e.g. 0.1%); claimant denied opportunity to refuse operation at which no damage occurred. Warning given of very small risk (e.g. 0.1%); attention deflected from natural history and prognosis without surgery. Warning given of very small risk (e.g. 0.1%) deemed unnecessary, causing distress and anxiety. Operation declined. Claimant continued suffering from underlying condition.
uncertain; my view is that it will be driven mainly by lawyers, perhaps a chauvinistic view. Today much is made of ‘‘defensive medicine.’’ Usually this implies over-zealous and unnecessary investigations which may reveal abnormalities quite irrelevant to the symptoms of which the patient is complaining. This can lead to interventions which carry risks (e.g. liver biopsy), the biopsy being unjustified. An example of the demonstration of irrelevant pathology is scanning of the lumbar spine for symptoms which are relatively mild and are not causing significant disability. In older patients, scans will show advanced pathology, for example, degenerative lumbar spondylosis, which may be present in people who have no symptoms at all. In Afshar, the scans showed abnormalities at three levels: L2-3, L3-4, and L4-5 which led to the initial operation of a micro-discectomy at those three levels. To determine pre-operatively which level is responsible for symptoms is very difficult and how extensive the operation should be. Over-zealous and unnecessary warning of the risks of operation is another form of defensive medicine. While protection of the patient is the prime consideration, protection of the surgeon against litigation can easily become too strong a motive in informed consent. In 1999, Adrian Whitfield, QC,9 wrote: ‘‘ . . . the law is catching up with good medical practice, which is to give as full an explanation including accurate answers to questions as the individual patient can take in without positive harm resulting from such an explanation.’’ I would venture to suggest that the law in certain
circumstances has overtaken good medical practice and can thus encourage poor medical practice. Lawyers will point out that the apparent absurdities are no more than the evolution of the rule of law, admittedly at times tortuous, or even opaque. But as Lord Bingham10 wrote: ‘‘Belief in the rule of law does not impart unqualified admiration of the law, or the legal profession or the courts or the judges.’’ The main hope for avoiding absurdities rests with our esteemed judiciary. I am quietly confident, or at least hopeful, that we shall not reach the Lewis Carroll scenario with the Queen of Hearts on the Bench crying indiscriminately ‘‘Off with his head.’’ References 1. Reible v Hughes 1980 2 SRC 880. 2. Garfield, J. Chester v Afshar. A Surgeon’s View. British Journal of Neuorsurgery 2005; 19(2): 120–121. 3. Sidaway v Governors of Bethlem Hospital 1985 AC 871. 4. O’Malley-Williams v Governors of National Hospital. Bridge J (1975). IBMJ 635. 5. Chester v Afshar (2004) UKHL 41; (2005) 1 AC 13. 6. De Costa. Liability for failure to warn of a risk that does not materialise? Medico-Legal Journal 2013; 81(20): 86–89. 7. Smith v Barking Health (1994) 5 Med LR. 8. Wallace v Kam (2012) NSWCA 82. 9. Whifield, A. The Law in Medical Negligence The Cranium, The Spine and The Nervous System. Ed. Garfield, J and Earl, C. Blackwell Science, Oxford, 1999. 10. Bingham, T. The Rule of Law, Allen Lane, London 2010.
Downloaded from mlj.sagepub.com at WAYNE STATE UNIVERSITY on April 14, 2015
