British Journal of Neurosurgery, August 2014; 28(4): 447–451 © 2014 The Neurosurgical Foundation ISSN: 0268-8697 print / ISSN 1360-046X online DOI: 10.3109/02688697.2014.896872
ORIGINAL ARTICLE
Medical negligence. Legal theory and neurosurgical practice: informed consent Nicholas V. Todd 180 Portland Road, Sandyford, Newcastle upon Tyne, UK
was committed recklessly or intentionally, criminal charges might be brought.
Abstract This article discusses the principles of the law in relation to informed consent as applied to neurosurgical practice. Patient autonomy, forms of consent, capacity to consent, the nature of information that should be given to patients, the level of information given, alternatives to treatment, which doctor should consent and when, consenting children, differing opinions, euthanasia and respect for the state of scientific knowledge are discussed.
Patient autonomy Respect for the autonomy of others is an ethical principle based upon the moral authority of respecting the choices made by others. This principle was applied to consent for surgery as far back as 19143:
Keywords: informed consent; medical negligence; negligence; neurosurgery
“…every human being of adult years and sound mind has a right to determine what shall be done with his own body; and the surgeon who performs an operation without his patient’s consent commits an assault, for which he is liable in damages.”3
Introduction Informed consent is required for all medical procedures. This is a specific duty of care. The principles and practice of law in relation to consent will be helpful in achieving good practice. Consent for surgical procedures must always be in writing. Consent is, essentially, a meeting of minds. A doctor cannot assume that the patient has any knowledge or appreciation of the nature of the proposed procedure, its magnitude, risks and/or benefits and/or the alternatives to surgery. These must be explained. For complex surgery, consent will usually be a process rather than something that happens on a single occasion.
Informed consent can be considered from the point of view of (i) the patient or (ii) the doctor. For the patient, consent is the agreement to the proposed procedure, freely given by a competent adult, following an appropriate explanation of the risks, benefits and/or alternatives to the proposed procedure. For the doctor consent is the legal justification for the proposed procedure (which in the absence of consent would be a potentially actionable battery).
Consent is a shield Consent is a shield, used by the surgeon to defend himself. It cannot be used by a patient as a sword to enlarge the duties owed to a patient or to force a doctor to go beyond what the doctor believes is clinically necessary.4 If a doctor decides that a treatment requested by a patient is not clinically indicated the doctor is not obliged to provide the treatment; the doctor should always arrange a second opinion.4
Battery If any force is applied to another without lawful justification a battery has been committed. If any words or actions cause another to believe there is an immediate threat of battery, an assault has been committed. There is an absolute prohibition against touching.1 Exceptions include day-to-day physical contact, for example, being jostled at a railway station,2 or statutory powers of arrest. There is no exception made for any form of medical treatment. If a surgical procedure is performed without valid consent a battery has been committed by the surgeon upon the patient. This can lead to legal action in the civil court for damages. If the battery
Volenti non fit injuria Consent, in part, derives from the principle “volenti non fit injuria”, which means that no harm can be carried out to a willing person. As an example, if in a cage-fight one
Correspondence: Nicholas V. Todd, Consultant Neurosurgeon and Spinal Surgeon, 180 Portland Road, Newcastle upon Tyne, NE2 1DJ, UK. Tel: 0191 2305927. Fax: 0191 2302253. E-mail: [email protected] Received for publication 31 May 2013; accepted 16 February 2014
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man is seriously injured, the other fighter (who if the injuries occurred in a street fight would face serious charges) is absolved because both fighters entered the ring voluntarily, aware of the potential consequences. Similarly, if a patient is properly aware of a risk of surgery, and voluntarily accepts that risk in order to achieve the potential benefits of surgery, then if the risk eventuates informed consent may be a complete defence (a complete shield) to any claim.
Form of consent There is no common law requirement that consent must be in any particular form. Consent can be (i) by conduct (e.g. putting out an arm for a blood test or vaccination5), (ii) verbal (e.g. explaining the need for internal examination) or (iii) in writing. Written consent, of course, is the standard practice for surgical procedures. For adults there are three bases for consent: (i) legal capacity, (ii) consent must be voluntary and (iii) consent must be informed.
Capacity Adults are presumed to have capacity unless it can be shown that they lack capacity.6 An adult may lack capacity if they do not have one or more of the following: (i) an understanding of the relevant information, (ii) an ability to retain the information for long enough to make an informed decision, (iii) the ability to use the information to make the decision or (iv) the ability to communicate the decision.7 If a patient has capacity (mental competence) there is an absolute right to accept or refuse medical treatment even if the patient’s decision is felt by others to be bizarre, irrational or non-existent, even if the decision results in the death of the patient, or in pregnancy, the child. A 41-yearold lady was quadriplegic and ventilator-dependent following haemorrhage from an intramedullary spinal cord cavernous haemangioma.8 She requested disconnection of the ventilator. It was found that she was competent to make the decision to stop the ventilation that was keeping her alive. Similar decisions have been made in a case of ventilator-dependent quadriplegia following Guillain–Barré syndrome9 and nasogastric feeding in a patient with cerebral palsy.10 There are a number of “mother-v-baby” cases. In one case11 a mother, who was not a Jehovah’s Witness, refused blood transfusion having been influenced by her mother, who was a Jehovah’s Witness. An emergency Caesarean section was required. The mother was unconscious and required blood transfusion. It was found that she lacked capacity and the transfusion was given. A 31-year-old lady was 36 weeks pregnant, with severe pre-eclampsia.12 Caesarean section was recommended and refused by the patient. She was detained under the Mental Health Act 1983 and following the decision of a Court at first instance Caesarean section was performed. She appealed the decision and succeeded, because she was competent. The Caesarean section was unlawful and a battery was committed:
“A decision to refuse medical treatment by a patient capable of making the decision does not have to be sensible, rational or well considered. If a doctor overrides the decision of a competent adult and operates they commit a trespass.”12
Pre-existing mental illness A patient may have a profound mental illness and still retain capacity to consent to medical treatment. A man with an exceptionally low IQ and paranoid schizophrenia (in Broadmoor hospital) was found to have the capacity to refuse amputation of a gangrenous toe (from which he died).13 However, a woman with gangrene of both feet who refused amputation, refused to recognise the gangrene and refused to accept that the condition might cause her death was found to lack capacity.14 A 25-year-old lady with learning difficulties and behavioural problems refused dialysis for renal failure.15 It was found that she had capacity to make a competent decision. Whether a patient with a mental illness does, or does not, lack capacity will be determined by the facts of the individual case.
Temporary incapacity Incapacity may be temporary or permanent. The obvious examples of temporary incapacity are the unconscious patient who requires emergency surgery or where there is an unexpected finding, intraoperatively, in an anaesthetised patient. The doctor is entitled to act in accordance with what the doctor feels is in the “best interests” of the patient. Technically the doctor still commits an assault, but the defence is necessity; (e.g. if a bystander pulled a man out of the path of a runaway lorry and, in so doing, dislocated the man’s arm the bystander has committed an assault, but defends his actions as having been necessary to save the man’s life). There are limits to what may be done in the emergency situation. Surgery is limited to what is required at that moment. If there are options that can wait and then be discussed with the patient (upon reversal of the anaesthetic) the surgeon should not proceed to the further optional measures at that time.16,17 “Where, for example, a surgeon performs an operation without consent on a patient temporarily rendered unconscious in an accident, he should do no more than is reasonably required, in the best interests of the patient, before he recovers consciousness. I can see no practical difficulty arising from this requirement, which derives from the fact that the patient is expected, before long, to regain consciousness and can then be consulted about longer-term measures.”16 What this means is that, if during an emergency operation, you come to a point where there are options for treatment, for example in orthopaedic surgery a risk/benefit analysis for amputation of a limb; if there was no harm to the patient in allowing the patient to wake up and discuss the options, then that is what should be done. This is a concept that may be difficult for doctors who, by and large, are keen to carry
Medical negligence out definitive treatment at the time of the first operation, not to split up the surgical treatment into two, or perhaps more, operations. However, if there is a real issue in relation to what the patient would probably desire, then if emergency surgery is not required for that part of the operation it should be deferred and the patient’s consent obtained.
Permanent incapacity Where the mental capacity is permanent, views will be taken in the “best interests” of the patient. A 36-year-old woman had a mental age of four.16 She had been institutionalised since the age of 12. At the time she was in a sexual relationship with another patient. It was accepted that pregnancy would be “disastrous”. It was found that (i) incapacity was permanent, waiting was pointless, (ii) there was an obvious need for care and (iii) the best interests of the woman was to undergo sterilisation.16,17 Tony Bland18 suffered a hypoxic brain injury having been crushed at the Hillsborough football stadium. He was left alive but in persistent coma. It was found that (i) there was permanent incapacity, (ii) with no prospect of improvement, (iii) his doctors were under no absolute duty to prolong his life, (iv) medical treatment includes tube feeding and antibiotics, (v) medical treatment can be withdrawn and (vi) the test is the “best interests” of the patient. It was determined that: “The condition of the patient who is totally unconscious and in whose condition there is no prospect of any improvement is such that life prolonging treatment is properly regarded as being, in medical terms, useless…”18 Tube feeding was withdrawn and Tony Bland died. However in another case19 where a patient was in persistent coma as a consequence of medical negligence it was determined that provision for her care at home should be made, in her best interests, even though it was accepted that she was totally unaware of her surroundings. We do not need to understand the reasons for the decision in this case to appreciate that in patients with permanent incapacity, treatment decisions will be made in the “best interests” of the patient based upon the facts, as determined by the Court. It must be understood that what a doctor, or doctors, believe is the patient’s best interests is not the final word. Ultimately, the Court is the arbiter of a patient’s best interests. In another case of persistent coma and tube feeding: “…there should not be a belief that what the doctor says is the patient’s best interest is the patient’s best interest. For my part I would certainly reserve to the Court the ultimate power and duty to review the doctor’s decision in the light of all the facts.”20
Nature of the information Patients need to understand the nature of the proposed treatment, the risks and benefits and any alternatives.
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Fraud always negates consent. A dentist performed unnecessary dental procedures for profit.21 This deliberate misinformation meant that there was no voluntary consent for the procedures. A battery was committed. The Court distinguishes intentional misinformation (as above) from unintentional negligent misinformation. A man had a left carotid entarterectomy.22 The 10% risk of stroke and the 4% risk of death were not discussed with him; a permanent stroke occurred. He claimed he would not have had the procedure if he had known of the risk of stroke. It was found that the man should have been told of the risks but there was no deliberate intent to mislead, there was a negligent mistake; (the case succeeded in negligence).
Level of information What level of information should be given to patients? Initially the Courts took a doctor-centred approach. In Bolam23 (the basis of the primary “Bolam” test of duty of care) it was found to be reasonable not to give Mr Bolam the option of an anaesthetic for electroconvulsive therapy (which would have avoided a consequent fracture) because some doctors were of the view that anaesthesia was not needed. A woman had a cervical myelopathy requiring decompressive cervical laminectomies.24 The risk of quadriplegia was found to be 1–2%. Mrs Sidaway was not told of this risk; postoperatively she was quadriplegic. The majority judgement was doctorcentred on the basis that the majority of neurosurgeons in the 1980s did not warn of this risk and therefore it was reasonable for Mrs Sidaway not to be informed. However, in a partially dissenting judgement, Lord Scarman felt that a patient had a right to know of a “real” or “material” risk of surgery: “Ideally the Court should ask itself whether in the particular circumstances the risk was such that this particular patient would think it significant if he was told it existed…what would a reasonably prudent patient think significant…” Lord Scarman here substituted a prudent-patient principle for the doctor-centred principle. The Sidaway principle (the reasonable practice of responsible medical men) was upheld in a case where a woman was not told that prolonging an overdue pregnancy was associated with a 0.1–0.2% risk of stillbirth; stillbirth eventuated.25 The Sidaway principle was rejected in Wyatt26 where it was found not to be reasonable to fail to explain that there was a small risk of congenital abnormalities following chickenpox infection during pregnancy. In another jurisdiction Bolam and Sidaway were felt to be inappropriate approaches in relation to consent.27 In the High Court in Australia it was set out that there was a duty to warn of material risks of treatment if the reasonable patient would attach significance to the information or if the doctor should be aware that the patient would attach significance to the information.27 In Chester v Afshar28 (cauda equina syndrome [CES] caused by laminectomies for lumbar canal stenosis) all five law Lords agreed that the appropriate test for consent was that of material risk. All material risks should be explained to the patient. These include common risks
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of surgery, such as superficial infection, even if this is of no longstanding significance, and rare risks that might lead to long-term harm (such as CES).
Alternatives to treatment Alternatives to the proposed treatment should be discussed. A patient underwent cerebral catheter angiography having consented to a 1% risk of stroke.29 Stroke eventuated. The patient was not told that MR angiography (MRA) was an option that carried no risk of stroke (although diagnosis was less certain with MRA). Because Mrs Birch did not know that MRA was an option: “She was denied an informed choice…the failure to discuss these matters could not be described in law as reasonable, responsible or logical.”29
Which doctor and when? GMC guidelines are that consent should be taken by (i) the surgeon who is to undertake the operation or (ii) someone who is capable of carrying out the operation, because only a surgeon who is capable of carrying out the procedure can properly understand the risks and benefits of surgery and therefore explains all material matters to the patient.30–32 If consent is taken by a junior doctor in training who is not capable of carrying out the operation the presumption may be that informed consent was not obtained. I increasingly see risks and benefits of surgery being explained by specialist spinal nurses or physiotherapists which could never satisfy the appropriate tests. When informed consent should be obtained is less clear. For complex procedures, including some surgical procedures, it may be that consent is a process rather than something that occurs on a single occasion. Material consequences of surgery explained after the operation (irreversibility of sterilisation) do not constitute informed consent.33 Consent taken on the day of surgery is not informed consent. A man underwent a lumbar microdiscectomy, postoperatively he had CES.34 He claimed he had never been told of a risk of CES. The surgeon claimed that CES had been explained on the day of surgery. The Judge found that even if CES had been discussed on the day of surgery this would not represent informed consent because the patient would not have had sufficient time to digest and reflect upon this new and material risk. All material risks of surgery must be explained in advance of the procedure.35 How far ahead is not known. It may be that explaining new material risks following admission to hospital, on the evening before major, planned, surgery would also not represent informed consent and for the same reasons. Current reasonable practice is, probably, to see all patients who require planned surgery in a pre-admission clinic 1–2 weeks preoperatively, to go over the material risks of surgery and obtain written consent (copied to the patient). This gives the patient time to consider/reconsider the options (i.e. to give the patient a cooling-off period) and to cancel the operation if, upon reflection, the patient decides to defer, or postpone indefinitely, the operation.
Consent in children Children achieve majority at the age of 18. Children are presumed to achieve capacity to consent to medical treatment at the age of 16.36 Below the age of 16 children can demonstrate that they understand the nature of the treatment in sufficient detail to give consent (Gillick competence). Until a child becomes Gillick competent, the authority to consent lies with the parents (or those with parental responsibility). Gillick37 was a mother of five girls, all under the age of 16. Mrs Gillick sought an injunction that it would be unlawful to prescribe contraceptive medication to girls aged less than 16 without parental consent. Mrs Gillick failed provided the child under the age of 16 had the understanding and intelligence to make an informed decision. A similar decision was made in respect of abortion.38 Treatments have been authorised against the wishes of the child in respect of anorexia,39 blood transfusion40,41 and cardiac transplantation.42
Euthanasia Euthanasia was, and remains, unlawful even if the doctor’s intention is to prevent suffering. There has, however, only been one case where a doctor was convicted of attempted murder in an attempt to relieve suffering.43 Dr Cox, a rheumatologist, had a patient, Mrs Boyes, who had multiple medical problems and was in severe uncontrolled pain. Mrs Boyes asked Dr Cox (and others) to end her life, which to her was intolerable. Dr Cox injected Mrs Boyes with potassium chloride with the intended purpose of causing death. He was convicted of attempted murder.
Respect for the knowledge base When recommending a neurosurgical procedure it may be necessary to let patients know that the scientific basis for the procedure may not be well-established. A neurosurgeon can have great confidence in recommending a line of treatment where there is randomised controlled trial evidence for that treatment. Following International Subarachnoid Aneurysm Trial we can say with confidence that a ruptured aneurysm should be coiled if it can be coiled because coiling is safer than surgery, and if it cannot be coiled it should be clipped because clipping is safer than the natural history of the condition. However, there are many procedures where the benefits of surgery are not well-established and that would include, for example, spinal fusion for lumbar degenerative disorders. There have been a number of randomised controlled trials for spinal fusion compared with the natural history of the condition, none of which have shown convincing long-term benefit to fusion. Despite that, spinal fusion is a common operation for spinal degenerative disorders. Many spinal neurosurgeons have seen patients with disabling mechanical back pain where pain and function have dramatically improved following spinal fusion. Nevertheless, in the light of current scientific knowledge, where a surgeon is considering spinal fusion it would probably be prudent to explain to the patient that in groups of patients it has not yet been possible to demonstrate benefit to fusion compared to the
Medical negligence natural history of the condition and in any individual patient, that is, the patient sitting in front of you, whether that patient would benefit from fusion surgery and the extent of benefit (if benefit occurred at all) is wholly unpredictable. It is probably illogical and therefore probably unacceptable, to give a patient the impression that all treatments have the same scientific authority. Where there is uncertainty as to whether the treatment is likely to benefit the patient, he/she should be informed of the uncertainties.
Summary Doctors are under a duty of care to consider whether a patient is competent to consent to a medical procedure (competence can be assumed in adults, in the absence of knowledge to the contrary). Alternatives to treatment, all material risks, and the benefits of the proposed procedure, need to be discussed with the patient. For elective procedures there should be a cooling-off period between the consenting process and the procedure. For complex procedures consent should usually be a process rather than a one-off discussion. Declaration of interest: The author reports no declaration of interest. The author alone is responsible for the content and writing of the paper.
References 1. Malette v Shulman [1990] 72 OR (2d) 417, [1991] 2 Med LR 162 (Ont CA). Available at: http://www.lexisnexis.com/uk/legal/ 2. Wilson v Pringle [1987] QB 237, [1986] 2 All ER 440. Available at: http://www.lexisnexis.com/uk/legal/ 3. Schloendorff v. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 92 (1914). 4. Burke v GMC [2005] EWCA Civ 1003, [2006] QB 273. Available at: http://www.lexisnexis.com/uk/legal/ 5. O’Brien v Cunard SS Company [1891] 28 NE 266. Available at: http://www.lexisnexis.com/uk/legal/ 6. S1 (2) Mental Capacity Act 2005. Available at: http://www. lexisnexis.com/uk/legal/ 7. SS 1,2,3,4 Mental Capacity Act 2005. Available at: http://www. lexisnexis.com/uk/legal/ 8. Re B (adult: refusal of medical treatment) [2002] EWHC 429 (fam); [2002] 2 All ER 449, CA. Available at: http://www.lexisnexis.com/ uk/legal/ 9. Nancy B v Hôtel-Dieu de Québec [1992], 15 BMLR 95, 86 DLR (4th) 385 (Que. S.C.). Available at: http://www.lexisnexis.com/uk/ legal/ 10. Bouvia v Superior Court [1986] 179 Cal. App. 3d 1127, 225 Cal. Rptr. 297 (1986). Available at: http://www.lexisnexis.com/uk/legal/ 11. Re T (adult: refusal of medical treatment) [1992] 4 All ER 649, [1993] Fam 95, [1992] 3 WLR 782. Available at: http://www.lexisnexis. com/uk/legal/ 12. St George’s Healthcare NHS Trust v S [1998] 3 All ER 673, CA. Available at: http://www.lexisnexis.com/uk/legal/ 13. Re C (Adult: Refusal of Treatment) [1994] 1 All ER 819, [1994] 1 WLR 290. Available at: http://www.lexisnexis.com/uk/legal/
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14. State of Tennessee v Northern [1978] 563 SW 2d 197 [Tenn Ct App]. Available at: http://www.lexisnexis.com/uk/legal/ 15. Re JT (adult: refusal of medical treatment) [1998] 2 FCR 662, [1998] 1 FLR 48. Available at: http://www.lexisnexis.com/uk/legal/ 16. F v West Berkshire Health Authority [1989] 2 AC 1, [1989] 2 All ER 545. Available at: http://www.lexisnexis.com/uk/legal/ 17. Mental Capacity Act 2005 Section 4(3). Available at: http://www. lexisnexis.com/uk/legal/ 18. Airedale NHS Trust v Bland [1993] AC 789, [1993] 1 All ER 821. Available at: http://www.lexisnexis.com/uk/legal/ 19. Ahsan v University Hospitals Leicester NHS Trust [2006] EWHC 2624 (QB), [2007] PIQR P271, [2006] All ER (D) 451 (Jul). Available at: http://www.lexisnexis.com/uk/legal/ 20. Frenchay Healthcare NHS Trust v S [1994] [1994] 2 All ER 403, [1994] 1 WLR 601. Available at: http://www.lexisnexis.com/uk/ legal/ 21. Appleton v Garrett [1997] 8 Med LR 75, 34 BMLR 23, [1996] PIQR P 1. Available at: http://www.lexisnexis.com/uk/legal/ 22. Reibl v Hughes [1980] 2 SCR 880, 114 DLR (3d) 1, 14 CCLT 1 (Can SC). Available at: http://www.lexisnexis.com/uk/legal/ 23. Bolam v Friern Hospital Management Committee [1957] 2 All ER 118, [1957] 1 WLR 582. Available at: http://www.lexisnexis.com/ uk/legal/ 24. Sidaway v. Bethlem Royal Hospital Governors [1985] [1985] AC 871, [1985] 1 All ER 643, [1985] 2 WLR 480, 129 Sol Jo 154, 1 BMLR 132. Available at: http://www.lexisnexis.com/uk/legal/ 25. Pearce v United Bristol Healthcare Trust (1998) 48 BMLR 118, [1998] CLY 3986. Available at: http://www.lexisnexis.com/uk/ legal/ 26. Wyatt v Curtis [2003] EWCA Civ 1779, [2003] All ER (D) 493 (Oct). Available at: http://www.lexisnexis.com/uk/legal/ 27. Rogers v Whitaker [1993] 4 Med LR 79, 16 BMLR 148, 175 CLR 479, 109 ALR 625, 67 ALJR 47. Available at: http://www.lexisnexis.com/ uk/legal/ 28. Chester v. Afshar [2004] UKHL 41, [2005] 1 AC 134. Available at: http://www.lexisnexis.com/uk/legal/ 29. Birch v University College Hospitals NHS Trust [2008] EWHC 2237 (QB), 104 BMLR 168. Available at: http://www.lexisnexis.com/uk/ legal/ 30. GMC Consent: Patients and doctors making decisions together. June 2008 - para 26. Available at: http://www.lexisnexis.com/uk/ legal/ 31. GMC Good Medical Practice Nov 2006 - para 54. Available at: http://www.lexisnexis.com/uk/legal/ 32. GMC Consent: Patients and doctors making decisions together. 2013. Available at: http://www.lexisnexis.com/uk/legal/ 33. Lybert v Warrington HA [1996] 7 Med LR 71, 25 BMLR 91. Available at: http://www.lexisnexis.com/uk/legal/ 34. Moses v Vafadis [2007] (SA130052). Available at: http://www. lexisnexis.com/uk/legal/ 35. Department of Health Reference guide to consent for examination and treatment. May 2009 - para 31. Available at: http://www. lexisnexis.com/uk/legal/ 36. s8 Family Law Reform Act 1969. Available at: http://www. lexisnexis.com/uk/legal/ 37. Gillick v West Norfolk and Wisbech Area Health Authority [1986] AC 112, [1985] 3 All ER 402. Available at: http://www.lexisnexis. com/uk/legal/ 38. Re P (a minor) [1986] 80 LGR 301, [1986] 1 FLR 272, [1982] CLY 2077. Available at: http://www.lexisnexis.com/uk/legal/ 39. Re W (a minor) (medical treatment) [1993] Fam 64, [1992] 4 All ER 627. Available at: http://www.lexisnexis.com/uk/legal/ 40. Re S (a minor) (consent to medical treatment) [1994] 2 FLR 1065. 41. Re E (a minor) [1993] 1 FLR 386, [1992] 2 FCR 219. Available at: http://www.lexisnexis.com/uk/legal/ 42. Re M [1999] 2 FCR 577, [1999] 2 FLR 1097. Available at: http:// www.lexisnexis.com/uk/legal/ 43. R v Cox (1992) 12 BMLR 38. Available at: http://www.lexisnexis. com/uk/legal/
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ORIGINAL ARTICLE
Medical negligence. Legal theory and neurosurgical practice: informed consent Nicholas V. Todd 180 Portland Road, Sandyford, Newcastle upon Tyne, UK
was committed recklessly or intentionally, criminal charges might be brought.
Abstract This article discusses the principles of the law in relation to informed consent as applied to neurosurgical practice. Patient autonomy, forms of consent, capacity to consent, the nature of information that should be given to patients, the level of information given, alternatives to treatment, which doctor should consent and when, consenting children, differing opinions, euthanasia and respect for the state of scientific knowledge are discussed.
Patient autonomy Respect for the autonomy of others is an ethical principle based upon the moral authority of respecting the choices made by others. This principle was applied to consent for surgery as far back as 19143:
Keywords: informed consent; medical negligence; negligence; neurosurgery
“…every human being of adult years and sound mind has a right to determine what shall be done with his own body; and the surgeon who performs an operation without his patient’s consent commits an assault, for which he is liable in damages.”3
Introduction Informed consent is required for all medical procedures. This is a specific duty of care. The principles and practice of law in relation to consent will be helpful in achieving good practice. Consent for surgical procedures must always be in writing. Consent is, essentially, a meeting of minds. A doctor cannot assume that the patient has any knowledge or appreciation of the nature of the proposed procedure, its magnitude, risks and/or benefits and/or the alternatives to surgery. These must be explained. For complex surgery, consent will usually be a process rather than something that happens on a single occasion.
Informed consent can be considered from the point of view of (i) the patient or (ii) the doctor. For the patient, consent is the agreement to the proposed procedure, freely given by a competent adult, following an appropriate explanation of the risks, benefits and/or alternatives to the proposed procedure. For the doctor consent is the legal justification for the proposed procedure (which in the absence of consent would be a potentially actionable battery).
Consent is a shield Consent is a shield, used by the surgeon to defend himself. It cannot be used by a patient as a sword to enlarge the duties owed to a patient or to force a doctor to go beyond what the doctor believes is clinically necessary.4 If a doctor decides that a treatment requested by a patient is not clinically indicated the doctor is not obliged to provide the treatment; the doctor should always arrange a second opinion.4
Battery If any force is applied to another without lawful justification a battery has been committed. If any words or actions cause another to believe there is an immediate threat of battery, an assault has been committed. There is an absolute prohibition against touching.1 Exceptions include day-to-day physical contact, for example, being jostled at a railway station,2 or statutory powers of arrest. There is no exception made for any form of medical treatment. If a surgical procedure is performed without valid consent a battery has been committed by the surgeon upon the patient. This can lead to legal action in the civil court for damages. If the battery
Volenti non fit injuria Consent, in part, derives from the principle “volenti non fit injuria”, which means that no harm can be carried out to a willing person. As an example, if in a cage-fight one
Correspondence: Nicholas V. Todd, Consultant Neurosurgeon and Spinal Surgeon, 180 Portland Road, Newcastle upon Tyne, NE2 1DJ, UK. Tel: 0191 2305927. Fax: 0191 2302253. E-mail: [email protected] Received for publication 31 May 2013; accepted 16 February 2014
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man is seriously injured, the other fighter (who if the injuries occurred in a street fight would face serious charges) is absolved because both fighters entered the ring voluntarily, aware of the potential consequences. Similarly, if a patient is properly aware of a risk of surgery, and voluntarily accepts that risk in order to achieve the potential benefits of surgery, then if the risk eventuates informed consent may be a complete defence (a complete shield) to any claim.
Form of consent There is no common law requirement that consent must be in any particular form. Consent can be (i) by conduct (e.g. putting out an arm for a blood test or vaccination5), (ii) verbal (e.g. explaining the need for internal examination) or (iii) in writing. Written consent, of course, is the standard practice for surgical procedures. For adults there are three bases for consent: (i) legal capacity, (ii) consent must be voluntary and (iii) consent must be informed.
Capacity Adults are presumed to have capacity unless it can be shown that they lack capacity.6 An adult may lack capacity if they do not have one or more of the following: (i) an understanding of the relevant information, (ii) an ability to retain the information for long enough to make an informed decision, (iii) the ability to use the information to make the decision or (iv) the ability to communicate the decision.7 If a patient has capacity (mental competence) there is an absolute right to accept or refuse medical treatment even if the patient’s decision is felt by others to be bizarre, irrational or non-existent, even if the decision results in the death of the patient, or in pregnancy, the child. A 41-yearold lady was quadriplegic and ventilator-dependent following haemorrhage from an intramedullary spinal cord cavernous haemangioma.8 She requested disconnection of the ventilator. It was found that she was competent to make the decision to stop the ventilation that was keeping her alive. Similar decisions have been made in a case of ventilator-dependent quadriplegia following Guillain–Barré syndrome9 and nasogastric feeding in a patient with cerebral palsy.10 There are a number of “mother-v-baby” cases. In one case11 a mother, who was not a Jehovah’s Witness, refused blood transfusion having been influenced by her mother, who was a Jehovah’s Witness. An emergency Caesarean section was required. The mother was unconscious and required blood transfusion. It was found that she lacked capacity and the transfusion was given. A 31-year-old lady was 36 weeks pregnant, with severe pre-eclampsia.12 Caesarean section was recommended and refused by the patient. She was detained under the Mental Health Act 1983 and following the decision of a Court at first instance Caesarean section was performed. She appealed the decision and succeeded, because she was competent. The Caesarean section was unlawful and a battery was committed:
“A decision to refuse medical treatment by a patient capable of making the decision does not have to be sensible, rational or well considered. If a doctor overrides the decision of a competent adult and operates they commit a trespass.”12
Pre-existing mental illness A patient may have a profound mental illness and still retain capacity to consent to medical treatment. A man with an exceptionally low IQ and paranoid schizophrenia (in Broadmoor hospital) was found to have the capacity to refuse amputation of a gangrenous toe (from which he died).13 However, a woman with gangrene of both feet who refused amputation, refused to recognise the gangrene and refused to accept that the condition might cause her death was found to lack capacity.14 A 25-year-old lady with learning difficulties and behavioural problems refused dialysis for renal failure.15 It was found that she had capacity to make a competent decision. Whether a patient with a mental illness does, or does not, lack capacity will be determined by the facts of the individual case.
Temporary incapacity Incapacity may be temporary or permanent. The obvious examples of temporary incapacity are the unconscious patient who requires emergency surgery or where there is an unexpected finding, intraoperatively, in an anaesthetised patient. The doctor is entitled to act in accordance with what the doctor feels is in the “best interests” of the patient. Technically the doctor still commits an assault, but the defence is necessity; (e.g. if a bystander pulled a man out of the path of a runaway lorry and, in so doing, dislocated the man’s arm the bystander has committed an assault, but defends his actions as having been necessary to save the man’s life). There are limits to what may be done in the emergency situation. Surgery is limited to what is required at that moment. If there are options that can wait and then be discussed with the patient (upon reversal of the anaesthetic) the surgeon should not proceed to the further optional measures at that time.16,17 “Where, for example, a surgeon performs an operation without consent on a patient temporarily rendered unconscious in an accident, he should do no more than is reasonably required, in the best interests of the patient, before he recovers consciousness. I can see no practical difficulty arising from this requirement, which derives from the fact that the patient is expected, before long, to regain consciousness and can then be consulted about longer-term measures.”16 What this means is that, if during an emergency operation, you come to a point where there are options for treatment, for example in orthopaedic surgery a risk/benefit analysis for amputation of a limb; if there was no harm to the patient in allowing the patient to wake up and discuss the options, then that is what should be done. This is a concept that may be difficult for doctors who, by and large, are keen to carry
Medical negligence out definitive treatment at the time of the first operation, not to split up the surgical treatment into two, or perhaps more, operations. However, if there is a real issue in relation to what the patient would probably desire, then if emergency surgery is not required for that part of the operation it should be deferred and the patient’s consent obtained.
Permanent incapacity Where the mental capacity is permanent, views will be taken in the “best interests” of the patient. A 36-year-old woman had a mental age of four.16 She had been institutionalised since the age of 12. At the time she was in a sexual relationship with another patient. It was accepted that pregnancy would be “disastrous”. It was found that (i) incapacity was permanent, waiting was pointless, (ii) there was an obvious need for care and (iii) the best interests of the woman was to undergo sterilisation.16,17 Tony Bland18 suffered a hypoxic brain injury having been crushed at the Hillsborough football stadium. He was left alive but in persistent coma. It was found that (i) there was permanent incapacity, (ii) with no prospect of improvement, (iii) his doctors were under no absolute duty to prolong his life, (iv) medical treatment includes tube feeding and antibiotics, (v) medical treatment can be withdrawn and (vi) the test is the “best interests” of the patient. It was determined that: “The condition of the patient who is totally unconscious and in whose condition there is no prospect of any improvement is such that life prolonging treatment is properly regarded as being, in medical terms, useless…”18 Tube feeding was withdrawn and Tony Bland died. However in another case19 where a patient was in persistent coma as a consequence of medical negligence it was determined that provision for her care at home should be made, in her best interests, even though it was accepted that she was totally unaware of her surroundings. We do not need to understand the reasons for the decision in this case to appreciate that in patients with permanent incapacity, treatment decisions will be made in the “best interests” of the patient based upon the facts, as determined by the Court. It must be understood that what a doctor, or doctors, believe is the patient’s best interests is not the final word. Ultimately, the Court is the arbiter of a patient’s best interests. In another case of persistent coma and tube feeding: “…there should not be a belief that what the doctor says is the patient’s best interest is the patient’s best interest. For my part I would certainly reserve to the Court the ultimate power and duty to review the doctor’s decision in the light of all the facts.”20
Nature of the information Patients need to understand the nature of the proposed treatment, the risks and benefits and any alternatives.
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Fraud always negates consent. A dentist performed unnecessary dental procedures for profit.21 This deliberate misinformation meant that there was no voluntary consent for the procedures. A battery was committed. The Court distinguishes intentional misinformation (as above) from unintentional negligent misinformation. A man had a left carotid entarterectomy.22 The 10% risk of stroke and the 4% risk of death were not discussed with him; a permanent stroke occurred. He claimed he would not have had the procedure if he had known of the risk of stroke. It was found that the man should have been told of the risks but there was no deliberate intent to mislead, there was a negligent mistake; (the case succeeded in negligence).
Level of information What level of information should be given to patients? Initially the Courts took a doctor-centred approach. In Bolam23 (the basis of the primary “Bolam” test of duty of care) it was found to be reasonable not to give Mr Bolam the option of an anaesthetic for electroconvulsive therapy (which would have avoided a consequent fracture) because some doctors were of the view that anaesthesia was not needed. A woman had a cervical myelopathy requiring decompressive cervical laminectomies.24 The risk of quadriplegia was found to be 1–2%. Mrs Sidaway was not told of this risk; postoperatively she was quadriplegic. The majority judgement was doctorcentred on the basis that the majority of neurosurgeons in the 1980s did not warn of this risk and therefore it was reasonable for Mrs Sidaway not to be informed. However, in a partially dissenting judgement, Lord Scarman felt that a patient had a right to know of a “real” or “material” risk of surgery: “Ideally the Court should ask itself whether in the particular circumstances the risk was such that this particular patient would think it significant if he was told it existed…what would a reasonably prudent patient think significant…” Lord Scarman here substituted a prudent-patient principle for the doctor-centred principle. The Sidaway principle (the reasonable practice of responsible medical men) was upheld in a case where a woman was not told that prolonging an overdue pregnancy was associated with a 0.1–0.2% risk of stillbirth; stillbirth eventuated.25 The Sidaway principle was rejected in Wyatt26 where it was found not to be reasonable to fail to explain that there was a small risk of congenital abnormalities following chickenpox infection during pregnancy. In another jurisdiction Bolam and Sidaway were felt to be inappropriate approaches in relation to consent.27 In the High Court in Australia it was set out that there was a duty to warn of material risks of treatment if the reasonable patient would attach significance to the information or if the doctor should be aware that the patient would attach significance to the information.27 In Chester v Afshar28 (cauda equina syndrome [CES] caused by laminectomies for lumbar canal stenosis) all five law Lords agreed that the appropriate test for consent was that of material risk. All material risks should be explained to the patient. These include common risks
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of surgery, such as superficial infection, even if this is of no longstanding significance, and rare risks that might lead to long-term harm (such as CES).
Alternatives to treatment Alternatives to the proposed treatment should be discussed. A patient underwent cerebral catheter angiography having consented to a 1% risk of stroke.29 Stroke eventuated. The patient was not told that MR angiography (MRA) was an option that carried no risk of stroke (although diagnosis was less certain with MRA). Because Mrs Birch did not know that MRA was an option: “She was denied an informed choice…the failure to discuss these matters could not be described in law as reasonable, responsible or logical.”29
Which doctor and when? GMC guidelines are that consent should be taken by (i) the surgeon who is to undertake the operation or (ii) someone who is capable of carrying out the operation, because only a surgeon who is capable of carrying out the procedure can properly understand the risks and benefits of surgery and therefore explains all material matters to the patient.30–32 If consent is taken by a junior doctor in training who is not capable of carrying out the operation the presumption may be that informed consent was not obtained. I increasingly see risks and benefits of surgery being explained by specialist spinal nurses or physiotherapists which could never satisfy the appropriate tests. When informed consent should be obtained is less clear. For complex procedures, including some surgical procedures, it may be that consent is a process rather than something that occurs on a single occasion. Material consequences of surgery explained after the operation (irreversibility of sterilisation) do not constitute informed consent.33 Consent taken on the day of surgery is not informed consent. A man underwent a lumbar microdiscectomy, postoperatively he had CES.34 He claimed he had never been told of a risk of CES. The surgeon claimed that CES had been explained on the day of surgery. The Judge found that even if CES had been discussed on the day of surgery this would not represent informed consent because the patient would not have had sufficient time to digest and reflect upon this new and material risk. All material risks of surgery must be explained in advance of the procedure.35 How far ahead is not known. It may be that explaining new material risks following admission to hospital, on the evening before major, planned, surgery would also not represent informed consent and for the same reasons. Current reasonable practice is, probably, to see all patients who require planned surgery in a pre-admission clinic 1–2 weeks preoperatively, to go over the material risks of surgery and obtain written consent (copied to the patient). This gives the patient time to consider/reconsider the options (i.e. to give the patient a cooling-off period) and to cancel the operation if, upon reflection, the patient decides to defer, or postpone indefinitely, the operation.
Consent in children Children achieve majority at the age of 18. Children are presumed to achieve capacity to consent to medical treatment at the age of 16.36 Below the age of 16 children can demonstrate that they understand the nature of the treatment in sufficient detail to give consent (Gillick competence). Until a child becomes Gillick competent, the authority to consent lies with the parents (or those with parental responsibility). Gillick37 was a mother of five girls, all under the age of 16. Mrs Gillick sought an injunction that it would be unlawful to prescribe contraceptive medication to girls aged less than 16 without parental consent. Mrs Gillick failed provided the child under the age of 16 had the understanding and intelligence to make an informed decision. A similar decision was made in respect of abortion.38 Treatments have been authorised against the wishes of the child in respect of anorexia,39 blood transfusion40,41 and cardiac transplantation.42
Euthanasia Euthanasia was, and remains, unlawful even if the doctor’s intention is to prevent suffering. There has, however, only been one case where a doctor was convicted of attempted murder in an attempt to relieve suffering.43 Dr Cox, a rheumatologist, had a patient, Mrs Boyes, who had multiple medical problems and was in severe uncontrolled pain. Mrs Boyes asked Dr Cox (and others) to end her life, which to her was intolerable. Dr Cox injected Mrs Boyes with potassium chloride with the intended purpose of causing death. He was convicted of attempted murder.
Respect for the knowledge base When recommending a neurosurgical procedure it may be necessary to let patients know that the scientific basis for the procedure may not be well-established. A neurosurgeon can have great confidence in recommending a line of treatment where there is randomised controlled trial evidence for that treatment. Following International Subarachnoid Aneurysm Trial we can say with confidence that a ruptured aneurysm should be coiled if it can be coiled because coiling is safer than surgery, and if it cannot be coiled it should be clipped because clipping is safer than the natural history of the condition. However, there are many procedures where the benefits of surgery are not well-established and that would include, for example, spinal fusion for lumbar degenerative disorders. There have been a number of randomised controlled trials for spinal fusion compared with the natural history of the condition, none of which have shown convincing long-term benefit to fusion. Despite that, spinal fusion is a common operation for spinal degenerative disorders. Many spinal neurosurgeons have seen patients with disabling mechanical back pain where pain and function have dramatically improved following spinal fusion. Nevertheless, in the light of current scientific knowledge, where a surgeon is considering spinal fusion it would probably be prudent to explain to the patient that in groups of patients it has not yet been possible to demonstrate benefit to fusion compared to the
Medical negligence natural history of the condition and in any individual patient, that is, the patient sitting in front of you, whether that patient would benefit from fusion surgery and the extent of benefit (if benefit occurred at all) is wholly unpredictable. It is probably illogical and therefore probably unacceptable, to give a patient the impression that all treatments have the same scientific authority. Where there is uncertainty as to whether the treatment is likely to benefit the patient, he/she should be informed of the uncertainties.
Summary Doctors are under a duty of care to consider whether a patient is competent to consent to a medical procedure (competence can be assumed in adults, in the absence of knowledge to the contrary). Alternatives to treatment, all material risks, and the benefits of the proposed procedure, need to be discussed with the patient. For elective procedures there should be a cooling-off period between the consenting process and the procedure. For complex procedures consent should usually be a process rather than a one-off discussion. Declaration of interest: The author reports no declaration of interest. The author alone is responsible for the content and writing of the paper.
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