Informed consent: lessons from Australia

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.6^–9 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 negligence^w1-3 (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}

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 health^{5 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 surgery^w24), 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 risk^w1), 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 enlargement^w15; or the Australian Society of Plastic Surgeons' brochure, Patient Information on Abdominoplasty^w16; 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

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

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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)

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.