Education And Debate

Informed consent: lessons from Australia

BMJ 2002; 324 doi: http://dx.doi.org/10.1136/bmj.324.7328.39 (Published 05 January 2002) Cite this as: BMJ 2002;324:39
  1. Loane Skene, professor of law (l.skene{at}unimelb.edu.au)a,
  2. Richard Smallwood, Commonwealth chief medical officer (Richard.Smallwood{at}health.gov.au)b
  1. a Faculty of Law, University of Melbourne, Parkville, Victoria 3010, Australia
  2. b Department of Health and Aged Care, Alexander Building, Furzer Street, Woden, ACT 2606, Australia
  1. Correspondence to: Professor Skene

    Courts in Australia and England have begun applying a tougher standard to the information that doctors should give their patients—that of what a reasonable patient might expect rather than of what a reasonable body of doctors might think. Loane Skene and Richard Smallwood outline some recent cases in Australia and argue that doctors have not yet caught up with this change in judges' thinking and are thus laying themselves open to negligence claims

    The information that doctors are legally required to give patients before they investigate or treat them has been debated for over a decade. Until recently English courts have generally adopted the standard of accepted medical practice. This is based on the “Bolam test” of negligence—that practitioners are not negligent if they act in accordance with practice accepted by a responsible body of medical opinion.1 However, recent judgments in both English and Australian courts suggest that judges are moving away from accepting what “reasonable doctors” might do to supporting what “reasonable patients” might expect. This tougher (for doctors) standard requires that doctors understand their obligations. But, despite judges setting out their criteria and specific guidance, experience in Australia suggests that doctors haven't yet caught up with this change in judges' thinking. There are probably lessons here for Britain, and other countries with similar legal systems.

    Summary points

    In the past decade both English and Australian courts have adopted a more patient centred standard in deciding what risks doctors must disclose to patients

    Professional bodies have issued guidelines to help doctors inform their patients

    Yet in Australia many doctors still do not understand their legal duties and many are being held liable for their failure to inform

    An empirical study of doctors' understanding and practices might be useful in the United Kingdom

    Changing case law

    Recent English case law suggests that the Bolam test is being modified so that a court can reject medical opinion if it is not “reasonable or responsible.”2 For example, in Smith v Tunbridge Wells Health Authority it was “neither reasonable nor responsible” for a surgeon not to mention the risk of impotence from rectal surgery, even if some doctors do not mention that risk.3 And in Pearce v United Bristol Healthcare NHS Trust the court of appeal applied a “reasonable patient” standard4: “If there is a significant risk which would affect the judgment of the reasonable patient, then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him or herself as to what course he or she should adopt.”4

    The similarity of this test to the test stated by the high court of Australia in 1992 in the well publicised case of Rogers v Whitaker5 makes recent Australian experience relevant to the English scene, together with the efforts of professional bodies in each country to explain the law to doctors.69 In Rogers v Whitaker an ophthalmologist failed to mention the possibility of sympathetic ophthalmia, a rare but serious complication of eye surgery, despite the patient asking about possible harm to the non-operated “good” eye. This complication occurred and the patient became, in effect, blind. The high court, in finding 6-0 against the ophthalmologist, said it is part of the doctor's duty of care to disclose “material” risks. A risk is material, if: “in the circumstances of the particular case, a reasonable person in the patient's position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is, or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it.”5

    The matters Australian courts consider relevant to disclosure are shown in box 1. We believe that an English court would consider similar factors.

    Australian courts have held doctors negligent for failure to disclose risks in a number of cases (box 2), but a doctor who fails to disclose a material risk will not be held liable on that account alone. The patient must also prove that he or she suffered injury or loss and that the injury or loss was caused by the doctor's negligencew1-3 (references to the legal cases appear on bmj.com). In effect, patients must persuade the court that they would not have agreed to the intervention had they been told about the risk, although if a patient is too ill to testify the jury can draw its own inferences.w4 Note also that the Australian test (like the English test) is what that particular patient would have done if warned, not simply a reasonable person in the patient's position.w1 w5 In several recent cases patients have failed in their suit because they could not establish this causal link.w3 w6-8

    Box 1: Relevant factors

    The high court of Australia considers the following factors important in deciding whether a risk is material and must be mentioned to a patient.5

    The nature of the matter to be disclosed—More likely and more serious harms require disclosure.

    The nature of the proposed procedure—Complex interventions require more information, as do procedures where the patient has no illness.

    The patient's desire for information—Patients who ask questions make known their desire for information and should be told.

    The temperament and health of the patient—Anxious patients and patients with health problems or other relevant circumstances that make a risk more important for them (such as their medical condition or occupation) may need more information.

    The general surrounding circumstances—The information necessary for elective procedures, where several consultations are possible, may be different from that required in an emergency department.

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    Box 2: Recent Australian cases

    In recent judgments Australian courts held that the following risks should have been disclosed to patients—in the particular circumstances of that case.

    • Sympathetic ophthalmia after eye surgery (risk 1:14 000)5

    • Impairment of the patient's voice from mediastinitis and laryngeal nerve damage after oesophageal surgery (the patient was an education officer and had mentioned concerns about her voice before surgery)w1

    • Rectovaginal fistula after hysterectomy and vaginal repair (risk of perforation 1:500; risk of repaired perforation breaking down 1:200)w9 though a different result was reached in another casew10

    • Perforation of uterus and pelvic inflammatory disease after insertion of intrauterine devicew11

    • Anal stenosis after haemorrhoidectomy (patient at increased risk of anal stenosis because of her inflammatory bowel disease)w12

    • Failure of elective eye surgery with vision worse after surgeryw13

    • Hypertrophic scarring after laser removal of tattoos,w14 breast augmentation,w15 and abdominoplastyw16

    • Temperomandibular joint problems after orthognathic surgery (risk 10%)w8

    • Recanalisation after laparoscopic sterilisation by means of Filshie clips (risk 1:500)w17

    • Facial asymmetry, nerve damage, and dimpling of lips after faceliftw18

    • Nerve damage after surgery to remove lymph node from neckw19

    • Anaesthesia dolorosa after neurectomyw20

    • Gastroparesis after stomach surgeryw21

    • Accidental dural puncture during anaestheticw22

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    Australian courts have also held that a doctor's duty to disclose is subject to a “therapeutic privilege” which may justify withholding information that would harm the patient's health5 w23; but it does not justify withholding information that might prevent a patient consenting to a non-essential procedure.w9 Even seriously ill patients (such as an elderly man with profound parkinsonian symptoms who needed brain surgeryw24), or patients who required surgery that could safely be delayed (such as a patient who needed surgery but could have reduced the risk by taking time to consult a more experienced surgeon if she had been told about the riskw1), must be informed about risks. Risks should be described in percentage terms where possible, or a broad band or range of figures, rather than by “subjective terminology, such as small risk, slight risk, and rare.”w24

    A risk does not have to be life threatening to require disclosure. For example, a risk of faeces leaking into the vagina, which is unpleasant but not life threatening, must be mentioned.w9 A doctor cannot discharge the duty to inform simply by providing pamphlets about a proposed procedure, such as a pamphlet mentioning “capsulation,” infection, asymmetry, or change in nipple-breast sensation as risks of breast enlargementw15; or the Australian Society of Plastic Surgeons' brochure, Patient Information on Abdominoplastyw16; or a pamphlet on orthognathic surgery, taken from the doctor's surgery.w8 Patients considering cosmetic procedures particularly need to be told what they can reasonably expect because they often have overoptimistic expectations.w18

    Figure1

    Litigation costs are rising: provisions for clinical negligence made by NHS in England 1995-2000. Data from summarised accounts for England 1995-6 to 1999-2000, reproduced from National Audit Office.11

    Write it down

    Disputes often arise about what information was in fact provided in a given case. Doctors have relied on notes in the medical records and evidence of their “usual practice” in proving disclosure.w3 Courts have sometimes rejected such evidence, but good note keeping is still a doctor's best defence. Doctors should note carefully questions or concerns raised by patients and how they replied. The courts have recognised that patients' evidence may be tainted by hindsight and self interest,w2 w7 and ultimately courts must decide who is the more credible witness. In some cases doctors are believed; but in one case the evidence of a patient was preferred over that of a doctor who claimed to remember verbatim conversations 10 years earlier.w14 A doctor's credibility is obviously increased by clear, contemporaneous notes.

    Doctors' ignorance

    What do doctors understand about their legal duty to inform? In 1993 Australia's National Health and Medical Research Council produced general guidelines on providing information to patients and sent them to all doctors in Australia. Two years later a survey showed that despite the media publicity of Rogers v Whitaker5 and the research council's guidelines, many doctors still did not know, or misunderstood, their legal obligations.10 The study found considerable divergence between common medical practice and the law (see box 3)

    Box 3: Ignorance of the law

    Questionnaires were sent to 950 doctors in Victoria and Tasmania; 246 replied (26%).10

    • Fewer than half the respondents realised that Dr Rogers was held negligent in not disclosing the 1:14 000 risk of sympathetic ophthalmia and had to pay substantial damages

    • About 40% of respondents thought they had to tell patients all possible risks or outcomes (an almost impossible standard). Many were therefore hostile to providing information

    • Many doctors apparently did not give enough information and relied on questionable grounds for withholding information (such as the patient's physical condition or “mental instability”)

    • A third of respondents said they had not received the guidelines and only 20% of respondents had kept them

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    Conclusion

    Negligent failure to inform has been alleged in many actions in Australia since Rogers v Whitaker, and, despite the National Health and Medical Research Council's efforts to explain the legal requirements, some doctors are still not providing enough information. The practice of courts in Australia and the United Kingdom to put more emphasis on the needs of patients is part of a wider social movement in both countries to give greater weight to individual rights. Doctors who do not understand these changes in society and in the law are at increased risk of liability in negligence (see figure). Moreover, patient care may be compromised: informed patients are likely to be more cooperative and compliant and recover more quickly. A survey of British doctors' knowledge and practice seems worthwhile as guidelines are more widely disseminated. The Australian experience suggests that there is still much remedial work needed to minimise future litigation and promote patient care.

    Footnotes

    • Competing interests None declared.

    • Embedded ImageReferences to the legal cases appear on bmj.com

    References

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