=Acta
Acta Neurochir (Wien) (1992) 118:2-6
Ndurochirurgica 9 Springer-Verlag 1992 Printed in Austria
Ethico - Legal Aspects of High Risk Neurosurgery J. Garfield Southampton, England
Introduction In all Western Societies, and probably soon in others, the threat of medical litigation will inevitably loom large when so-called high risk Neurosurgery is contemplated. It is sad that this threat has provided the stimulus to a more critical examination of the ethical attitudes, despite the fact that the Law is a reflection of ethics which have evolved with the development of societies. Neurosurgery is particularly prone to ethical and legal criticism, especially when the indications and contra-indications for an operation are finely balanced and a matter of surgical opinion, dogma, or even ignorance. Since the indications for any operation depend upon the balance of the mortality and morbidity of the disease, the mortality and the morbidity of the operation, and the prospects of relief or cure of the disease, a definition of high risk surgery must encompass at least the first two of these factors. Thus if prospects for cure or relief of the disease by operation are accepted, a definition of high risk neurosurgery becomes: the immediate mortality and morbidity of surgery exceeds the immediate morbidity or mortality of the disease. When considering morbidity and mortality, be it of surgery or of the disease, morbidity in neurosurgery may well mean severe lasting disability. In these circumstances, whatever the attitudes of the patient or his family, the Surgeon may conclude, quite reasonably, that morbidity is of greater significance than mortality. On this basis it could be argued that the surgery of ruptured intracranial aneurysms is not "high risk" because the immediate mortality of the disease due to recurrent haemorrhage, greatly exceeds the mortality of surgery after appropriate selection of patients. The reality of "high risk Neurosurgery" is the high risk Neurosurgeon. Or put rather more aggressively,
high risk Neurosurgery can be equated with dangerous Neurosurgery, which, if we are to be quite honest, should be equated with the dangerous Neurosurgeon. The causes are to be found in: inadequate training inadequate delegation a stifling hierarchy failure of self-audit The following observations arise out of discussions in the Ethico-Legal Committee of the EANS (see Acta Neurochirurgia). The three-hundred and twenty-two cases which I have examined for the Medical Defence Union between 1977 and 1988 have provided some indications of the areas in which Neurosurgery may lead to litigation, including letters before action, service of writs or reporting of erros which have led to enquiries, (see Table 1). Some of the cases relate to General Practice, General Surgery, Orthopaedics, and Accident & Emergnecy Departments. Therefore particular attention was paid to those cases in which operative problems contributed significantly to adverse situations which led to litigation. Table 2 indicates those cases in which Neurosurgery or Orthopaedic Surgery, as opposed to erros or delayed diagnosis, was a major factor. In addition surgical errors or technical problems were at times compounded by defects in postoperative care, for which the Surgeon, however distinguished, must bear the responsibility.
Ethical Considerations The paranoia of Surgeons, may lead them to believe that the Law is a predator which has created its own unrealistic ethical standards. This is not so. In most non-totalitarian Societies, it is the natural and gradual evolution of ethical standards in Medicine, which has
J. Garfield: Ethico- Legal Aspects of high Risk Neurosurgery Table 1. The Medical Defenee Union 1977-1990 Head injury Lumbar/thoracic disc Aneurysm/AVM Cervical spondylosis Spinal injury Spinal tumour Pituitary Hydrocephalus Lumbar spondylosis Spinal abscess [ntracranial abscess Supratentorial glioma Supratentorial meningioma Acoustic schwannoma Pain Colloid cyst Miscellaneous
57 52 33 24 23 15 13 12 11 10 9 9 9 6 6 3 31
Total
322
Table 2. OperativeSurgical Problems Thoracic disc Lumbar disc: arterial damage Lumbar disc: cauda equina damage Cervical spondylosis Lumbar spondylosis Aneurysm Pain - posterior fossa Colloid cyst
4 4 11 19 9 4 4 3
neurosurgery neurosurgery neurosurgery neurosurgery orthopaedic neurosurgery neurosurgery neurosurgery
Neurosurgeon available. However this begs the question of whether great experience necessarily ensures operative results which cannot be achieved in any other way. In many Departments, and particularly outside the UK, surgery for ruptured intracranial aneurysm is accorded this "expert status", which makes it rare for the younger neurosurgical trainee to acquire personal operative experience until relatively late in his career. But is this attitude justified? In the UK, training in Neurosurgery prior to Consultant appointment in the National Health Service may take up to 5 years. In my own practice during the past four years patients with intracranial aneurysm for whom I was personally responsible, were operated upon as much by trainees (Senior Registrar and Registrar) as by myself. This meant that over half the operations were done by Surgeons with less than four years experience of operative Neurosurgery. Furthermore the overall operative mortality of about 2% was maintained despite the relative experience or inexperience of the Surgeon. Nevertheless the utlimate responsibility in all cases rests with the Consultant Neurosurgeon who acted as assistant, especially during the trainess earlier cases. Therefore provided training is conducted correclty and Consultant responsibility is maintained, the total duty of care does not imply that all high risk Neurosurgery must necessarily be done by the most experienced Neurosurgeon.
A General Duty to Society
led to standards which are acceptable to the Courts. This is so particularly in legal systems which depend largely upon "Case Law" rather than upon "Statute Law". Since the Courts will inevitably be guided by medical evidence, factual or expert, the Medical profession plays a large part in the evolution of Case Law. The ethical dilemmas and conflicts facing the Neurosurgeon responsible for high risk operations are: The total duty of care to the individual patient A general duty to Society The Neurosurgeon's duty to himself The demands from, and the Neurosurgeon's need for, a defined population The responsibility for facilities Total Duty of Care to the Individual Patient
In the context of high risk Neurosurgery the inevitable consequences of this duty, must be that every operation should be done only be the most experienced
It can be argued that the Neurosurgical Maestro or Prima Donna who does not allow others in his Department to do high risk Neurosurgery, is failing in an important duty to Society. That duty is to ensure that Society is provided with a series of Neurosurgeons competent to perform high risk Neurosurgery. Nature abhors a vacuum, and Neurosurgical Departments can suffer grievously from the vacuum so easily created by the departure of the Maestro. Years spent assisting the Maestro, but without personal operative responsibility, are often a poor substitute for real training and may do little to ensure the continuing health of the Neurosurgical Department, and its ability to continue to serve a population. The departing Maestro will be little mourned by a population which finds itself without the expertise which had been jealously, even avariciously, guarded by one individual. Sadly for reasons which may be far from philanthropic, and may at times be financial, such a situation is not rare.
4
The Neurosurgeon's Duty to Himself With inevitable and increasing specialisation within Neurosurgery, a Neurosurgeon's duty to widen his own experience, and to improve his technique may present him with a dilemma. Colleagues, and indeed lawyers, may be critical of attempts to pass through the early stages of learning in order to achieve a level of expertise which may then prove to be of great benefit to patients, and to a department. Prior to completion of traditional training (e.g. accreditation or Board certification) a correctly conducted training programme should spare the trainee from such a dilemma. But for the established or accredited Surgeon, the umbrella of the Maestro is no longer his protection; even if his training has made him familiar with techniques, that may be a far cry from expertise which is above criticism. Discretion may be the better part of valour, but discretion without courage produces fear which can stultify a Surgeon's personal development, without which he is unlikely to contribute to the subject in general, and to his department in particular. The balance between accepting ones inexpertise in certain areas of high risk neurosurgery and perservering in efforts to correct that inexpertise is a very delicate one, raises important ethical considerations, and may be examined ultimately by a Court.
Population It is not necessary to equate high risk Neurosurgery with rare conditions. Since much of the risk is related to post-operative care, the population requirements for Neurosurgery become paramount. Without a sufficiently large population, the clinical material will be insufficient to allow the development of individual surgical expertise and specialisation within a department; nor can there be a team of sufficient quality to prevent the post-operative complications of the high risk surgery. Therefore the size of neurosurgical department and the population it serves becomes an ethical as well as a logistic or fianancial proplem. The responsibility for the solution of this ethical problem lies as much with neurosurgeons as with those who administer health services. The temptation for the individual Neurosurgeon in a small department, to jealously guard his own position and to resist amalgamation with neighbouring departments, is hardly acceptable in the interests of ethical stadards of neurosurgery and especially high risk neurosurgery. Neurosurgeons are by nature individualists, with a streak of Walter Mitty. Consensus and self-effacement do not come easily; it
J. Garfield: Ethico - Legal Aspects of High Risk Neurosurgery
is right that ethical considerations should bring them about, but sad if the Law has to play a part.
Facilities It is not ethical for a Surgeon to devolve responsibility for the facilities available, either for operation or for post-operative care upon the administrators of a hospital. However there may be a dilemma when facilities which a Neurosurgeon has sought have not been provided. In high risk Neurosurgery, for conditions that are not immediately life threatening, it may be more ethical to defer operation, or decline to carry out certain procedures, than to make do with what is available. These ethical considerations are readily translated into requirements in Law, although when a case cannot be successfully defended the responsibility for inadequate facilities may lead to protracted arguments over apportionment between Surgeons and hospital.
The Law In the limited space available only a few points of particular relevance to high risk Neurosurgery can be considered. All can be seen as an extension of ethical attitudes. They are: Choice of Surgeon Competence Acceptable levels of risk Informed Consent
Choice of Surgeon The relationships between a patient undergoing high risk Neurosurgery and his Surgeon may be a from of contract; or it may simply be a reflection of the type and method of obtaining consent for operation. The Untied Kingdom National Health Service consent form contains a specific clause which indicates that the patient understands that no guarantee is given that the operation will be performed by a particular Surgeon. In such circumstances some patients may ask for verbal assurance that the operation will be done by the National Health Service Consultant. Whether such assurance is given is a matter for the Individual Surgeon who may prefer to assure the patient that overall responsibility rests with the Consultant. In some ways this a reflection of the Courts willingness to accept, after examination, the Surgeon's view of acceptable level of competence. By contrast, in Private Practice,
J. Garfield: Ethico- Legal Aspects of high Risk Neurosurgery the patients would expect to have a clear choice of Surgeon, and would rightly expect to the operated upon by the Surgeon he or she has consulted at who has advised surgery.
Competence By its very definition high risk Neurosurgery must raise issues of competence. However the Law only becomes involved when "something goes wrong". The Law does not prescribe or proscribe levels of competence to specific types of surgery. But Courts will examine the general competence of a Surgeon, and of particular relevance in high risk Neurosurgery, his competence to perform the operation which led to litigation. If delegation was part of the surgical management, the appropriateness of that delegation would also be examined. Thus a Court will inevitably consider several different but related aspects of the competence in arriving at a judgement. There is a general principle that the level of competence required relates to that expected from a Surgeon at a particular stage in his training. Nevertheless Courts may have prolonged and critical examination of a Surgeon's competence to perform a high risk operation, in which expert advisers and especially Plaintiff's advicers, will argue that only the greatest competence, experience and expertise is acceptable if negligence is to be denied. Unfortunately an adversarial system can encourage Plaintiff's experts to dismiss everyday and normal levels of competence. It is the speciality of Neurosurgery itself which is to blame for the presentation of these artificial standards to a Court. Indeed for experts to be realistic calls for a greater measure of responsibility, a responsibility that goes further than the immediate needs of a Plaintiff. Although the Legal profession must shoulder much of the blaine for this situation, it is also Neurosurgeons acting as experts in Law-suits in high risk Neurosurgery who contribute to poor judgements.
Acceptable Levels of Risk It is very difficult to define the level of risk that is acceptable for a particular procedure, acceptability may not be a reflection of risk that is recorded, or even anticipated. Thus it is doubtful whether the described rate of complications will ever in itself provide a defence when a complication occurs. Furthermore Society's expectations are forever changing and advancing, Some Neurosurgeons attempt to spell out the risks of an operation in mathematical terms, particularly when obtaining, "informed" consent. The Law, at least in Eng-
5 land, does not require this, nor is there any definition of the term "significant" when applied to level of risk of complications. Since Law is a reflection of ethics, it is not surprising that ephemeral considerations cannot lead to the didactic. Nor will the fact that the complication is "well recognised" afford the Neurosurgeon protection when that complication occurs, although in those circumstances an error is less likely to lead to litigation than when a particular complication has not been described previously. The Law's responsible concern with the incidence of complications can be distorted and become unreasonable if protagonists of one particular surgical method act as intolerant and unreasonable expert advisers acting in an adverserial manner, instead of totally "assisting the Court". Operations in which different approaches are availabel to achieve the same objective, may easily lead to such situations. Thus the loss of facial nerve function after removal of an acoustic schwannoma, could in the future become the basis of litigation if experts claim that one particular approach compared to another carries an unacceptably high risk of that complication. Whether the "Bolam test" will suffice as a defence in these circumstances is by no means certain, even through a reasonable body of opinion rather than a majority opinion is sufficient in general for denial of negligence.
Informed Consent In recent years in the English jurisdiction, three cases have resulted in judgements which have important implications for informed consent in high risk Neurosurgery. The first case was a second operation for cervical spondylosis which resulted in a significant cervical cord lesion. The second was cervical rhizotomy for spasmodic torticollis, which resulted in a severe cervicomedullary lesion. The third was a second operation for a recurrent intramedullary cervical cyste, probably a syrinx, which resulted in quadraplegia. All three cases were successfully defended. In relation to informed consent the judgements clarified certain points. The risks which should be specifically described to patients before operation was a matter for medical judgement; the Courts were not in a position to demand that lists of specified risks be placed before patients. However it was within the competence of Courts to examine and pass judgement upon the warnings of complications that had been presented to a Plaintiff. In the third case the failure to give adequate warning of the risks of the operation was admitted. However the Judge decided
6 that he was able to deal with the issue of whether, had the patient been fully informed, she would still have agreed to the operation. The Judge the found that the patient would have agreed to the operation, and therefore the case was sucessfully defended on causation in that the damage was not the results of the alleged negligence of failing to obtain "informed consent". Conclusions
The greatest impediment to Courts understanding the realities of high risk Neurosurgery lies in the advice of neurosurgical experts who themselves are prepared to overlook those realities in support of a PlaintifFs case in an adversarial legal system. If such advice is taken to extremes, and Judges are unable to consider reality rather than perfection in formulating judgements, Neurosurgeons may be inhibited from performing some operations for which there are clear indications. Neurosurgeons in some Western Countries carry very high indemnity insurance, which follows from the high risk nature of Neurosurgery, patient's expectations, and, to some extent, from the activities of L'~wyers. However if all parties behaved reasonably, develop-
J. Garfield: Ethico - Legal Aspects of High Risk Neurosurgery
ments could continue which will in time lead to the "high risk' to today becoming the normal or low risk of tomorrow. Furthermore, given responsible behaviour by those who seek and who administer the Law, the Law could prove overall to be of benefit to the practice of Neurosurgery. Within the practice and organisation of Neurosurgery, it is the tradition of the Prima Donna which does most harm. The Prima Donna may find it very difficult to accept the "lesser" Donna for reasons which may be complex, and include personality, pride and financial gain. Such a situation may hinder the development of skills in high risk Neurosurgery. The solution lies in the design of training programmes and the appropriate delegation under supervision of Neurosurgery, which in the past was considered to be the province of the blessed, but really blinkered, few.
Correspondence and Reprints: John Garfield, M.D., Wessex Neurological Centre, Southampton General Hospital, Tremona Toad, Southampton SO9 4XY, U.K.
Acta Neurochir (Wien) (1992) 118:2-6
Ndurochirurgica 9 Springer-Verlag 1992 Printed in Austria
Ethico - Legal Aspects of High Risk Neurosurgery J. Garfield Southampton, England
Introduction In all Western Societies, and probably soon in others, the threat of medical litigation will inevitably loom large when so-called high risk Neurosurgery is contemplated. It is sad that this threat has provided the stimulus to a more critical examination of the ethical attitudes, despite the fact that the Law is a reflection of ethics which have evolved with the development of societies. Neurosurgery is particularly prone to ethical and legal criticism, especially when the indications and contra-indications for an operation are finely balanced and a matter of surgical opinion, dogma, or even ignorance. Since the indications for any operation depend upon the balance of the mortality and morbidity of the disease, the mortality and the morbidity of the operation, and the prospects of relief or cure of the disease, a definition of high risk surgery must encompass at least the first two of these factors. Thus if prospects for cure or relief of the disease by operation are accepted, a definition of high risk neurosurgery becomes: the immediate mortality and morbidity of surgery exceeds the immediate morbidity or mortality of the disease. When considering morbidity and mortality, be it of surgery or of the disease, morbidity in neurosurgery may well mean severe lasting disability. In these circumstances, whatever the attitudes of the patient or his family, the Surgeon may conclude, quite reasonably, that morbidity is of greater significance than mortality. On this basis it could be argued that the surgery of ruptured intracranial aneurysms is not "high risk" because the immediate mortality of the disease due to recurrent haemorrhage, greatly exceeds the mortality of surgery after appropriate selection of patients. The reality of "high risk Neurosurgery" is the high risk Neurosurgeon. Or put rather more aggressively,
high risk Neurosurgery can be equated with dangerous Neurosurgery, which, if we are to be quite honest, should be equated with the dangerous Neurosurgeon. The causes are to be found in: inadequate training inadequate delegation a stifling hierarchy failure of self-audit The following observations arise out of discussions in the Ethico-Legal Committee of the EANS (see Acta Neurochirurgia). The three-hundred and twenty-two cases which I have examined for the Medical Defence Union between 1977 and 1988 have provided some indications of the areas in which Neurosurgery may lead to litigation, including letters before action, service of writs or reporting of erros which have led to enquiries, (see Table 1). Some of the cases relate to General Practice, General Surgery, Orthopaedics, and Accident & Emergnecy Departments. Therefore particular attention was paid to those cases in which operative problems contributed significantly to adverse situations which led to litigation. Table 2 indicates those cases in which Neurosurgery or Orthopaedic Surgery, as opposed to erros or delayed diagnosis, was a major factor. In addition surgical errors or technical problems were at times compounded by defects in postoperative care, for which the Surgeon, however distinguished, must bear the responsibility.
Ethical Considerations The paranoia of Surgeons, may lead them to believe that the Law is a predator which has created its own unrealistic ethical standards. This is not so. In most non-totalitarian Societies, it is the natural and gradual evolution of ethical standards in Medicine, which has
J. Garfield: Ethico- Legal Aspects of high Risk Neurosurgery Table 1. The Medical Defenee Union 1977-1990 Head injury Lumbar/thoracic disc Aneurysm/AVM Cervical spondylosis Spinal injury Spinal tumour Pituitary Hydrocephalus Lumbar spondylosis Spinal abscess [ntracranial abscess Supratentorial glioma Supratentorial meningioma Acoustic schwannoma Pain Colloid cyst Miscellaneous
57 52 33 24 23 15 13 12 11 10 9 9 9 6 6 3 31
Total
322
Table 2. OperativeSurgical Problems Thoracic disc Lumbar disc: arterial damage Lumbar disc: cauda equina damage Cervical spondylosis Lumbar spondylosis Aneurysm Pain - posterior fossa Colloid cyst
4 4 11 19 9 4 4 3
neurosurgery neurosurgery neurosurgery neurosurgery orthopaedic neurosurgery neurosurgery neurosurgery
Neurosurgeon available. However this begs the question of whether great experience necessarily ensures operative results which cannot be achieved in any other way. In many Departments, and particularly outside the UK, surgery for ruptured intracranial aneurysm is accorded this "expert status", which makes it rare for the younger neurosurgical trainee to acquire personal operative experience until relatively late in his career. But is this attitude justified? In the UK, training in Neurosurgery prior to Consultant appointment in the National Health Service may take up to 5 years. In my own practice during the past four years patients with intracranial aneurysm for whom I was personally responsible, were operated upon as much by trainees (Senior Registrar and Registrar) as by myself. This meant that over half the operations were done by Surgeons with less than four years experience of operative Neurosurgery. Furthermore the overall operative mortality of about 2% was maintained despite the relative experience or inexperience of the Surgeon. Nevertheless the utlimate responsibility in all cases rests with the Consultant Neurosurgeon who acted as assistant, especially during the trainess earlier cases. Therefore provided training is conducted correclty and Consultant responsibility is maintained, the total duty of care does not imply that all high risk Neurosurgery must necessarily be done by the most experienced Neurosurgeon.
A General Duty to Society
led to standards which are acceptable to the Courts. This is so particularly in legal systems which depend largely upon "Case Law" rather than upon "Statute Law". Since the Courts will inevitably be guided by medical evidence, factual or expert, the Medical profession plays a large part in the evolution of Case Law. The ethical dilemmas and conflicts facing the Neurosurgeon responsible for high risk operations are: The total duty of care to the individual patient A general duty to Society The Neurosurgeon's duty to himself The demands from, and the Neurosurgeon's need for, a defined population The responsibility for facilities Total Duty of Care to the Individual Patient
In the context of high risk Neurosurgery the inevitable consequences of this duty, must be that every operation should be done only be the most experienced
It can be argued that the Neurosurgical Maestro or Prima Donna who does not allow others in his Department to do high risk Neurosurgery, is failing in an important duty to Society. That duty is to ensure that Society is provided with a series of Neurosurgeons competent to perform high risk Neurosurgery. Nature abhors a vacuum, and Neurosurgical Departments can suffer grievously from the vacuum so easily created by the departure of the Maestro. Years spent assisting the Maestro, but without personal operative responsibility, are often a poor substitute for real training and may do little to ensure the continuing health of the Neurosurgical Department, and its ability to continue to serve a population. The departing Maestro will be little mourned by a population which finds itself without the expertise which had been jealously, even avariciously, guarded by one individual. Sadly for reasons which may be far from philanthropic, and may at times be financial, such a situation is not rare.
4
The Neurosurgeon's Duty to Himself With inevitable and increasing specialisation within Neurosurgery, a Neurosurgeon's duty to widen his own experience, and to improve his technique may present him with a dilemma. Colleagues, and indeed lawyers, may be critical of attempts to pass through the early stages of learning in order to achieve a level of expertise which may then prove to be of great benefit to patients, and to a department. Prior to completion of traditional training (e.g. accreditation or Board certification) a correctly conducted training programme should spare the trainee from such a dilemma. But for the established or accredited Surgeon, the umbrella of the Maestro is no longer his protection; even if his training has made him familiar with techniques, that may be a far cry from expertise which is above criticism. Discretion may be the better part of valour, but discretion without courage produces fear which can stultify a Surgeon's personal development, without which he is unlikely to contribute to the subject in general, and to his department in particular. The balance between accepting ones inexpertise in certain areas of high risk neurosurgery and perservering in efforts to correct that inexpertise is a very delicate one, raises important ethical considerations, and may be examined ultimately by a Court.
Population It is not necessary to equate high risk Neurosurgery with rare conditions. Since much of the risk is related to post-operative care, the population requirements for Neurosurgery become paramount. Without a sufficiently large population, the clinical material will be insufficient to allow the development of individual surgical expertise and specialisation within a department; nor can there be a team of sufficient quality to prevent the post-operative complications of the high risk surgery. Therefore the size of neurosurgical department and the population it serves becomes an ethical as well as a logistic or fianancial proplem. The responsibility for the solution of this ethical problem lies as much with neurosurgeons as with those who administer health services. The temptation for the individual Neurosurgeon in a small department, to jealously guard his own position and to resist amalgamation with neighbouring departments, is hardly acceptable in the interests of ethical stadards of neurosurgery and especially high risk neurosurgery. Neurosurgeons are by nature individualists, with a streak of Walter Mitty. Consensus and self-effacement do not come easily; it
J. Garfield: Ethico - Legal Aspects of High Risk Neurosurgery
is right that ethical considerations should bring them about, but sad if the Law has to play a part.
Facilities It is not ethical for a Surgeon to devolve responsibility for the facilities available, either for operation or for post-operative care upon the administrators of a hospital. However there may be a dilemma when facilities which a Neurosurgeon has sought have not been provided. In high risk Neurosurgery, for conditions that are not immediately life threatening, it may be more ethical to defer operation, or decline to carry out certain procedures, than to make do with what is available. These ethical considerations are readily translated into requirements in Law, although when a case cannot be successfully defended the responsibility for inadequate facilities may lead to protracted arguments over apportionment between Surgeons and hospital.
The Law In the limited space available only a few points of particular relevance to high risk Neurosurgery can be considered. All can be seen as an extension of ethical attitudes. They are: Choice of Surgeon Competence Acceptable levels of risk Informed Consent
Choice of Surgeon The relationships between a patient undergoing high risk Neurosurgery and his Surgeon may be a from of contract; or it may simply be a reflection of the type and method of obtaining consent for operation. The Untied Kingdom National Health Service consent form contains a specific clause which indicates that the patient understands that no guarantee is given that the operation will be performed by a particular Surgeon. In such circumstances some patients may ask for verbal assurance that the operation will be done by the National Health Service Consultant. Whether such assurance is given is a matter for the Individual Surgeon who may prefer to assure the patient that overall responsibility rests with the Consultant. In some ways this a reflection of the Courts willingness to accept, after examination, the Surgeon's view of acceptable level of competence. By contrast, in Private Practice,
J. Garfield: Ethico- Legal Aspects of high Risk Neurosurgery the patients would expect to have a clear choice of Surgeon, and would rightly expect to the operated upon by the Surgeon he or she has consulted at who has advised surgery.
Competence By its very definition high risk Neurosurgery must raise issues of competence. However the Law only becomes involved when "something goes wrong". The Law does not prescribe or proscribe levels of competence to specific types of surgery. But Courts will examine the general competence of a Surgeon, and of particular relevance in high risk Neurosurgery, his competence to perform the operation which led to litigation. If delegation was part of the surgical management, the appropriateness of that delegation would also be examined. Thus a Court will inevitably consider several different but related aspects of the competence in arriving at a judgement. There is a general principle that the level of competence required relates to that expected from a Surgeon at a particular stage in his training. Nevertheless Courts may have prolonged and critical examination of a Surgeon's competence to perform a high risk operation, in which expert advisers and especially Plaintiff's advicers, will argue that only the greatest competence, experience and expertise is acceptable if negligence is to be denied. Unfortunately an adversarial system can encourage Plaintiff's experts to dismiss everyday and normal levels of competence. It is the speciality of Neurosurgery itself which is to blame for the presentation of these artificial standards to a Court. Indeed for experts to be realistic calls for a greater measure of responsibility, a responsibility that goes further than the immediate needs of a Plaintiff. Although the Legal profession must shoulder much of the blaine for this situation, it is also Neurosurgeons acting as experts in Law-suits in high risk Neurosurgery who contribute to poor judgements.
Acceptable Levels of Risk It is very difficult to define the level of risk that is acceptable for a particular procedure, acceptability may not be a reflection of risk that is recorded, or even anticipated. Thus it is doubtful whether the described rate of complications will ever in itself provide a defence when a complication occurs. Furthermore Society's expectations are forever changing and advancing, Some Neurosurgeons attempt to spell out the risks of an operation in mathematical terms, particularly when obtaining, "informed" consent. The Law, at least in Eng-
5 land, does not require this, nor is there any definition of the term "significant" when applied to level of risk of complications. Since Law is a reflection of ethics, it is not surprising that ephemeral considerations cannot lead to the didactic. Nor will the fact that the complication is "well recognised" afford the Neurosurgeon protection when that complication occurs, although in those circumstances an error is less likely to lead to litigation than when a particular complication has not been described previously. The Law's responsible concern with the incidence of complications can be distorted and become unreasonable if protagonists of one particular surgical method act as intolerant and unreasonable expert advisers acting in an adverserial manner, instead of totally "assisting the Court". Operations in which different approaches are availabel to achieve the same objective, may easily lead to such situations. Thus the loss of facial nerve function after removal of an acoustic schwannoma, could in the future become the basis of litigation if experts claim that one particular approach compared to another carries an unacceptably high risk of that complication. Whether the "Bolam test" will suffice as a defence in these circumstances is by no means certain, even through a reasonable body of opinion rather than a majority opinion is sufficient in general for denial of negligence.
Informed Consent In recent years in the English jurisdiction, three cases have resulted in judgements which have important implications for informed consent in high risk Neurosurgery. The first case was a second operation for cervical spondylosis which resulted in a significant cervical cord lesion. The second was cervical rhizotomy for spasmodic torticollis, which resulted in a severe cervicomedullary lesion. The third was a second operation for a recurrent intramedullary cervical cyste, probably a syrinx, which resulted in quadraplegia. All three cases were successfully defended. In relation to informed consent the judgements clarified certain points. The risks which should be specifically described to patients before operation was a matter for medical judgement; the Courts were not in a position to demand that lists of specified risks be placed before patients. However it was within the competence of Courts to examine and pass judgement upon the warnings of complications that had been presented to a Plaintiff. In the third case the failure to give adequate warning of the risks of the operation was admitted. However the Judge decided
6 that he was able to deal with the issue of whether, had the patient been fully informed, she would still have agreed to the operation. The Judge the found that the patient would have agreed to the operation, and therefore the case was sucessfully defended on causation in that the damage was not the results of the alleged negligence of failing to obtain "informed consent". Conclusions
The greatest impediment to Courts understanding the realities of high risk Neurosurgery lies in the advice of neurosurgical experts who themselves are prepared to overlook those realities in support of a PlaintifFs case in an adversarial legal system. If such advice is taken to extremes, and Judges are unable to consider reality rather than perfection in formulating judgements, Neurosurgeons may be inhibited from performing some operations for which there are clear indications. Neurosurgeons in some Western Countries carry very high indemnity insurance, which follows from the high risk nature of Neurosurgery, patient's expectations, and, to some extent, from the activities of L'~wyers. However if all parties behaved reasonably, develop-
J. Garfield: Ethico - Legal Aspects of High Risk Neurosurgery
ments could continue which will in time lead to the "high risk' to today becoming the normal or low risk of tomorrow. Furthermore, given responsible behaviour by those who seek and who administer the Law, the Law could prove overall to be of benefit to the practice of Neurosurgery. Within the practice and organisation of Neurosurgery, it is the tradition of the Prima Donna which does most harm. The Prima Donna may find it very difficult to accept the "lesser" Donna for reasons which may be complex, and include personality, pride and financial gain. Such a situation may hinder the development of skills in high risk Neurosurgery. The solution lies in the design of training programmes and the appropriate delegation under supervision of Neurosurgery, which in the past was considered to be the province of the blessed, but really blinkered, few.
Correspondence and Reprints: John Garfield, M.D., Wessex Neurological Centre, Southampton General Hospital, Tremona Toad, Southampton SO9 4XY, U.K.
