CAUSATION - Factual causation - Scope of liability - Whether warning would have made any difference - Whether medical causation established - Adeels Palace Pty Ltd [2009] HCA 48; (2009) 239 CLR 420 referred to - Wrongs Act 1958, ss 51 and 52.

1 In this matter I have had the advantage of reading in draft the reasons for judgment of Beach JA and McMillan AJA and I agree with their Honours that the appeal should be dismissed. I wish, however, to add three observations of my own.

2 First, despite the uncontested evidence of Dr Reti[1] that it was not normal practice to warn a patient of the perceived very slight risk of tranexamic acid causing thromboembolism, in this case the appellant presented to the respondent as a particularly anxious patient and, therefore, as it seems to me more likely, if warned of that risk, to attach significance to it. Hence, in my view, it was at least fairly arguable that the respondent was under a duty to warn the appellant of the risk.[2]

3 Secondly, like Beach JA and McMillan AJA, I consider it to be unnecessary to reach a concluded view on the question of duty, because I agree with the judge's conclusion that, anxious or not, the appellant failed to establish on the balance of probabilities that she would have declined the tranexamic acid if warned of the risk. It is one thing to accept, as I do, that the appellant presented as a particularly anxious patient and quite another thing to be persuaded that, because of a very slight possible risk of thromboembolism, she would have foregone the expected benefits of taking the tranexamic acid in the circumstances which she faced. Allowing that her anxiousness may have led to her attaching significance to the risk, it is inherently improbable that even the most anxious patient in her position, or thus she, would have declined the treatment offered.

4 Thirdly, and in any event, I consider that the judge was undoubtedly right to conclude that the appellant failed to prove on the balance of probabilities that her ingestion of tranexamic acid was a physical cause of her pulmonary emboli. On the evidence, which the judge and Beach JA and McMillan AJA have essayed, it was no more than possible that it played some part.

5 On 17 April 2006, Grazilda Odisho, the appellant, was taken to the Royal Melbourne Hospital with symptoms that were subsequently diagnosed as multiple pulmonary emboli. Over the following days, the appellant was admitted to the Royal Women's Hospital where she received treatment for her pulmonary emboli. Subsequently, the appellant commenced a County Court proceeding for damages against a specialist gynaecologist, Marcia Bonazzi, the respondent. The appellant consulted the respondent in her specialist capacity on 17 February and 10 April 2006. At the time the appellant consulted the respondent, the appellant was aged 46 years.

6 In the County Court proceeding, the appellant alleged that her pulmonary emboli were caused by the negligence of the respondent in failing to provide her with an appropriate warning concerning the side effects of a drug, tranexamic acid ('the drug').[3] The drug was prescribed by the respondent to treat abnormally heavy bleeding from which the appellant suffered. Specifically, the appellant alleged that the respondent was negligent in failing to warn her in respect of a risk that consumption of the drug may cause her to suffer a thromboembolic event.

7 After a five day trial in the County Court, Judge Saccardo dismissed the appellant's claim, concluding that:

(a) the exercise of reasonable care on the part of the respondent did not require her to warn the appellant that taking the drug carried with it the risk of thromboembolic events;

(b) the appellant had failed to establish that the tablets she took were a cause of her pulmonary emboli; and

(c) even if the appellant had been given a warning that the drug carried with it a small risk of suffering a thromboembolic event, the appellant would not have been dissuaded from taking the drug.

8 While the appellant's notice of appeal originally contained five grounds, at the commencement of the hearing, the Court granted leave to the appellant to amend the notice of appeal to replace those five grounds with two more targeted grounds as follows:

1. The judge erred in failing to find in all the circumstances that the appellant was not a patient in respect of whom the respondent should reasonably have been aware that, if warned of the risk, she would have been likely to attach significance to it.

2. The judge erred in failing to find that a cause of the appellant's injuries was the breach of duty by the respondent in failing to warn her of the remote risk that the drug might cause pulmonary emboli.

9 There is no issue between the parties that the respondent did not advise the appellant of any risk of pulmonary emboli or thromboembolic events associated with the taking of the drug. In order to succeed on her appeal, the appellant must persuade this Court that the judge was wrong to conclude that there was no breach of duty by the respondent in failing to give a relevant warning (ground 1), and that the judge was wrong in failing to conclude that the appellant's consumption of the drug was a cause of her pulmonary emboli and that, given an appropriate warning, the appellant would not have taken the drug and developed pulmonary emboli (ground 2).

10 In Rogers v Whitaker,[4] the plurality[5] described the duty of care owed by a medical practitioner in the following terms:

The law imposes on a medical practitioner a duty to exercise reasonable care and skill in the provision of professional advice and treatment. That duty is a 'single comprehensive duty covering all the ways in which a doctor is called upon to exercise his skill and judgement'; it extends to the examination, diagnosis and treatment of the patient and the provision of information in an appropriate case. It is of course necessary to give content to the duty in the given case.

The standard of reasonable care and skill required is that of the ordinary skilled person exercising and professing to have that special skill ... .[6]

In Australia, it has been accepted that the standard of care to be observed by a person with some special skill or competence is that of the ordinary skilled person exercising and professing to have that special skill. But, that standard is not determined solely or even primarily by reference to the practice followed or supported by a responsible body of opinion in the relevant professional trade. Even in the sphere of diagnosis and treatment, the heartland of the skilled medical practitioner, the Bolam principle has not always been applied. Further, and more importantly, particularly in the field of non-disclosure of risk and the provision of advice and information, the Bolam principle has been discarded and, instead, the courts have adopted the principle that, while evidence of acceptable medical practice is a useful guide for the courts, it is for the courts to adjudicate it on what is the appropriate standard of care after giving weight to 'the paramount consideration that a person is entitled to make his own decisions about his life'.[7]

Whether a medical practitioner carries out a particular form of treatment in accordance with the appropriate standard of care is a question in the resolution of which responsible professional opinion will have an influential, often a decisive, role to play; whether the patient has been given all the relevant information to choose between undergoing and not undergoing the

treatment is a question of a different order. Generally speaking, it is not a question the answer to which depends upon medical standards or practices.

...

The law should recognise that a doctor has a duty to warn a patient of a material risk inherent in the proposed treatment; a risk is material if, in the circumstances of a 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.[8]

13 Since Rogers v Whitaker[9] was decided, the Parliament has enacted a number of provisions capable of bearing on the question of whether medical practitioners (amongst others), in particular circumstances, might be found liable in negligence to their patients. Specifically, s 50 of the Wrongs Act 1958 relevantly provides:

A person (the defendant) who owes a duty of care to another person (the plaintiff) to give a warning or other information to the plaintiff in respect of a risk or other matter, satisfies that duty of care if the defendant takes reasonable care in giving that warning or other information.

14 Section 58 of the Wrongs Act relevantly provides:

In a case involving an allegation of negligence against a person (the defendant) who holds himself or herself out as possessing a particular skill, the standard to be applied by a court in determining whether the defendant acted with due care is, subject to this Division, to be determined by reference to -

(a) what could reasonably be expected of a person possessing that skill; and

(b) the relevant circumstances as at the date of the alleged negligence and not a later date.[10]

15 At trial, a number of witnesses gave evidence relevant to the issue of whether the respondent should have warned the appellant about the risks of thromboembolic events. The respondent gave evidence that her position at the time she prescribed the drug for the appellant was informed by, amongst other things, her access to the full version of the product information provided by the manufacturer of the drug through her subscription to the MIMS Annual.[11] In the section dealing with precautions in relation to the drug in the MIMS Annual that was current in 2006, the following is recorded:

Although clinical evidence shows no significant increase in thrombosis, possible risk of thrombotic complications cannot be ruled out.

16 A little further on in the same MIMS entry, adverse reactions were dealt with in the following terms:

Adverse Reactions Gastrointestinal discomfort occurs in more than 30% of patients after oral administration of 6 g/day. This discomfort disappears when the dose is reduced.

Common side effects (> 1/100). Gastrointestinal nausea, vomiting, diarrhoea.

Less common side effects. Skin: allergic skin reactions.

Rare side effects ( > There was no evidence that the oral dose in gynaecological use could cause thromboembolism, however we didn't have enough studies yet.

...

At the time, I had never heard before about pulmonary embolus being a common complication or a complication. I must admit I have never seen a case. I've never come into any conference that that case was put to us.[12]

18 Dr Annabel Tuckfield, a consultant haematologist who was involved in the management of the appellant's pulmonary emboli, gave evidence that the reason for the development of pulmonary emboli could be identified in only 50% of cases where the presentation was 'unprovoked'. Dr Tuckfield said:

Tranexamic acid is an antifibrinolytic agent, which means it stops the breakdown of clot. So we use it in a number of settings. It is commonly used in the control of menorrhagia due to fibroids or endometrial abnormalities. It is commonly used in cardiac surgery. It is commonly used in trauma surgery, and more recently in the controlling of bleeding in non-cardiac perioperative care. The precautions that we take are in people with active thromboembolic disease. Say, for example, if someone had pulmonary emboli, or is known to have pulmonary emboli, or a recent stroke, you would be very cautious in giving tranexamic acid. But it's a balance ─ bleeding versus risk of clotting.

...

The only case reports of tranexamic acid, we know how it works, we know it to stop breakdown of clot; but in the broad population it is a precaution rather than an absolute medicine. You wouldn't use it in someone who has got an active clot, but no-one can say if you give it it's going to cause the problem. There are case reports but not epidemiological studies.

...

The way we look at it is in all the people who take tranexamic acid for this (the appellant's) situation, a similar patient, what would be the chance of getting a pulmonary emboli? Extremely low.

19 Dr Leslie Reti, the Clinical Director of Gynaecology and Cancer Services at the Royal Women's Hospital, gave evidence about the association between tranexamic acid and pulmonary emboli as follows:

The association between tranexamic acid ... and pulmonary embolus is not evidence based. There have been case reports of such an association, but no randomised control trials which would implicate tranexamic acid in the causation of pulmonary embolus.

...

The most recent published data in The Lancet in 2010, in a different clinical setting, compared approximately 10,000 patients who took tranexamic acid and 10,000 who took a placebo. Vascular occlusion occurred in 33 of the first group, which was 0.3% and 48 of the placebo group, which was 0.5%. This was not statistically significant and the data strongly suggests that there is not an excess of thromboembolic phenomenon in patients taking tranexamic acid.

20 Dr Reti gave evidence that it was his practice when prescribing tranexamic acid to counsel that it is common to have nausea, that some people experience headache with tranexamic acid, that tranexamic acid was the most effective and safest way of managing heavy bleeding, and that it was more effective than hormonal treatment ─ the prescription of which carried with it a well proven but rare side effect of thromboembolism. As to the practice of telling patients about any risk of thromboembolism from tranexamic acid, Dr Reti said:

I do not believe that it's normal practice or a standard of care to alert patients prescribed tranexamic acid of the risk of pulmonary embolus.

21 The trial judge concluded that he was not satisfied that the appellant had established that the respondent owed her a duty of care to warn her of the risk of thromboembolic events. Specifically, his Honour said:

I am not satisfied that the plaintiff has established that the defendant owed her a duty of care to warn her that thromboembolic events were described as being a rare side effect associated with the use of tranexamic acid because it could be said that a reasonable person in the patient's position, if warned of that risk, would be likely to attach significance to it.[13]

22 His Honour identified nine matters which led him to this conclusion. Those matters were:

(i) Tranexamic acid was a drug very commonly prescribed for the control of heavy menstrual bleeding and was the drug of choice in managing that condition in a forty-six year old patient whose medical history was such that its prescription was not contraindicated;

(ii) The plaintiff did not fall into any category of patients for whom the prescription of tranexamic acid was contraindicated by reason of her medical history;

(iii) It was not the practice within the gynaecological profession to warn patients to whom tranexamic acid was being prescribed of the risk of a thrombus or embolism developing in association with the use of the drug;

(iv) The plaintiff presented to the defendant with a condition which, whilst in no way life threatening, was one which was likely to be associated with considerable inconvenience to her in that it involved menorrhagia of such a degree that she was required to wash and clean herself as described in her evidence;

(v) The methods available to manage the plaintiff's menorrhagia involved:

• the prescription of tranexamic acid
• the implementation of hormone-based therapy
• the insertion of an intrauterine device
• the performance of an hysterectomy

(vi) The implementation of hormone replacement therapy carried with it a proven complication, although rare, of the development of thrombosis and pulmonary embolism;

(vii) The plaintiff's virginity was important to her and for this reason it is likely that the plaintiff would have been reluctant to choose the insertion of an intrauterine device as the first option for, and preferred method of, managing her menorrhagia;

(viii) The relevant product literature described tranexamic acid as involving a 'rare side effect' in the form of thromboembolic events which was described in that literature as follows:

• 'The risk of occurrence of the side effect was ( > (ix) The defendant's knowledge as to the possible risk of the plaintiff developing a thrombotic complication by reasons of her use of tranexamic acid was as was described by the defendant in her evidence.[14]

23 In concluding that the appellant had not satisfied him that the respondent owed the appellant a duty to warn her of the risk of thromboembolic events, his Honour was saying that the respondent's duty to exercise reasonable care in the giving of professional advice to a reasonable person in the appellant's position in this case did not require the giving of a warning or information about the risk of thromboembolic events.

24 Having determined the question of whether a reasonable person in the appellant's position would, if warned of the risk, have been likely to attach significance to it against the appellant, the trial judge then considered whether the respondent should reasonably have been aware that the appellant as 'the particular patient' would, if warned of the risk, have been likely to attach significance to it.[15] As with the issue concerning a reasonable person in the position of the appellant, his Honour determined this issue against the appellant, saying there was nothing in the evidence that suggested the appellant presented to the respondent as someone with 'special needs or concerns'[16] who would be likely to attach particular significance to a warning about the risks of thromboembolism.

25 In his submissions on ground 1, senior counsel for the appellant placed emphasis upon the second of these two issues, namely the issue of whether the evidence disclosed that the appellant was a person whom the respondent should have been aware would, if warned of the risk of thromboembolism, have been likely to attach significance to it. It was submitted that, contrary to his Honour's conclusion, the respondent's own evidence supported this proposition, when she swore:

The main reason I remember the consultation is because she told me about she came from Iraq. She was very, very agitated, anxious about the bleeding, about the fact that if she needed to have a treatment it may mean that she didn't have ─ she would have a hysterectomy and she couldn't have babies, and the fact that she was a virgin in case I needed to insert an IUD. She was very, very anxious and agitated, in my opinion. I couldn't say more than that.

26 It may be accepted that the evidence discloses that the appellant was very anxious and very concerned when she consulted the respondent. However, the levels of concern and anxiety being expressed related to the appellant's symptoms, the fact that the appellant was a virgin (and the impact any treatment might have on this position), and the fact that the appellant did not want to undergo any treatment which might compromise her ability to have children in the future. Having considered this evidence, we agree with the trial judge in his conclusion that the evidence did not disclose circumstances which should reasonably have made the respondent aware that the appellant, if warned of the risk of thromboembolism, would have been likely to attach significance to it.

27 However, it seems to us that there was a real issue, on the evidence, as to whether a warning in the terms of the MIMS publication should have been given on the basis that a reasonable person in the appellant's position would be likely to attach significance to it. The risk of thromboembolism was described in MIMS as being rare and less than one in a thousand. However, as the evidence also discloses, a risk of thromboembolism is a serious matter, and potentially life threatening. Notwithstanding the evidence that suggested it might not be usual practice for gynaecologists who prescribe tranexamic acid to give warnings to their patients of the risk of thromboembolism (the relevance of which evidence we do not pause here to debate), there seems to us to be reasonable grounds for contending that reasonable care required a warning in the terms of the MIMS annual to be provided by the respondent. That said, having regard to the conclusions we have reached on the issue of causation, we do not find it necessary to finally resolve this matter.

28 On the issue of causation, the trial judge held against the appellant on two bases. First, his Honour was not persuaded that the appellant's consumption of tranexamic acid was a cause of her pulmonary emboli. Secondly, his Honour was not persuaded that had the appellant been given a warning of the rare risk of thromboembolism that the giving of the warning would have made any difference.

29 While much has been written on the subject of causation in medical negligence cases, the provisions that now govern the issue of causation are to be found in ss 51 and 52 of the Wrongs Act 1958. Those sections provide:

51. General principles

(1) A determination that negligence caused particular harm comprises the following elements-

(a) that the negligence was a necessary condition of the occurrence of the harm (factual causation); and

(b) that it is appropriate for the scope of the negligent person's liability to extend to the harm so caused (scope of liability).

(2) In determining in an appropriate case, in accordance with established principles, whether negligence that cannot be established as a necessary condition of the occurrence of harm should be taken to establish factual causation, the court is to consider (amongst other relevant things) whether or not and why responsibility for the harm should be imposed on the negligent party.

(3) If it is relevant to the determination of factual causation to determine what the person who suffered harm (the injured person) would have done if the negligent person had not been negligent, the matter is to be determined subjectively in the light of all relevant circumstances.

(4) For the purpose of determining the scope of liability, the court is to consider (amongst other relevant things) whether or not and why responsibility for the harm should be imposed on the negligent party.

52. Burden of proof

In determining liability for negligence, the plaintiff always bears the burden of proving, on the balance of probabilities, any fact relevant to the issue of causation.

30 In Adeels Palace Pty Ltd v Moubarak,[17] the High Court had to consider the operation of s 5D of the Civil Liability Act 2002 (NSW). Section 5D of the Civil Liability Act is the New South Wales equivalent of s 51 of the Wrongs Act.[18] The Court said:[19]

Section 5D(1) of that Act divides the determination of whether negligence caused particular harm into two elements: factual causation and scope of liability.

Dividing the issue of causation in this way expresses the relevant questions in a way that may differ from what was said by Mason CJ, in March v E & M H Stramare Pty Ltd,[20] to be the common law's approach to causation. The references[21] in March v Stramare to causation being 'ultimately a matter of common sense' were evidently intended to disapprove the proposition 'that value judgment has, or should have, no part to play in resolving causation as an issue of fact'. By contrast, s 5D(1) treats factual causation and scope of liability as separate and distinct issues.

It is not necessary to examine whether or to what extent the approach to causation described in March v Stramare might lead to a conclusion about factual causation different from the conclusion that should be reached by applying s 5D(1). It is sufficient to observe that, in cases where the Civil Liability Act or equivalent statutes are engaged, it is the applicable statutory provision that must be applied.

Next it is necessary to observe that the first of the two elements identified in s 5D(1) (factual causation) is determined by the 'but for' test: but for the negligent act or omission, would the harm have occurred?[22]

31 In Adeels Palace, the Court concluded that factual causation was not made out. While there was a discussion about the operation of s 5D(2), the Court was not called upon to consider the provisions in s 5D dealing with the scope of liability. In submissions before us, the respondent conceded that if the appellant made out factual causation, there was no issue so far as scope of liability was concerned ─ causation would be established.[23]

32 The trial judge set out in some detail the evidence concerning the question of whether or not the appellant's consumption of tranexamic acid was a cause of her pulmonary emboli. To his Honour's summary, we would also add the evidence given by Dr Tuckfield in re-examination:

QUESTION: Does tranexamic acid ─ yes or no?

...

ANSWER: It's not a cause ─ I don't ─ it may slightly increase the risk in some people but generally in those known to have risks for thrombosis.

33 Similarly, we would add reference to the study reported in The Lancet in 2010, and about which Dr Reti gave evidence. That study apparently involved 10,000 people who were given tranexamic acid and 10,000 who were given a placebo. Far from showing any causal link between tranexamic acid and thromboembolic events, there were a greater number of vascular occlusions in the placebo group. While the results of this study could not bear upon the question of whether or not a warning should have been given in 2006, they are capable of bearing on the question of whether tranexamic acid is actually a cause of pulmonary emboli.

34 When one considers the evidence to which we have just referred and the evidence summarised by the trial judge in his reasons for judgment, we are left with the conclusion that his Honour was correct when he held that the appellant had not established that the tranexamic acid she consumed was a cause of her pulmonary emboli. At best for the appellant, the question is one that invites speculation. Nothing in the evidence leads us to conclude that, as a matter of probability, the appellant's consumption was a cause of her pulmonary emboli.

35 Having regard to the conclusion just expressed, it is strictly not necessary to deal with the second aspect of causation (whether a warning would have made any difference in this case). However, in the event that our conclusion on medical causation is wrong, we turn now to deal with the question of whether a warning would have made any difference in any event.

36 Consistently with the way the appellant ran her case below, his Honour identified four possible courses that could have been taken in respect of the appellant's condition. They were:

37 In argument before us, senior counsel for the appellant accepted that the evidence disclosed that the implementation of hormone-based therapy, the insertion of an intrauterine device and the performance of a hysterectomy were not viable options. However, he submitted that there was a fifth option that was open when the appellant consulted the respondent. At the time the appellant consulted the respondent, the cause of her bleeding was unknown. The respondent ordered various tests to be performed and made appropriate referrals for these to be undertaken. Senior counsel for the appellant submitted that it was open to the respondent (as a fifth option) to recommend to the appellant that no treatment should be prescribed until the results of these tests were known.

38 Unfortunately for the appellant, the appellant did not run this case at trial. The failure to run that case gives rise to two problems. First, there is no evidence of what the appellant would have done had the respondent given her this advice. Secondly, the respondent has not been given any opportunity to respond to this proposition. More particularly, as a result of this case not being put at trial, there was no exploration in the evidence about the viability of this so-called fifth option.

39 Senior counsel for the appellant sought to overcome these difficulties by taking us to passages in the transcript which he said supported the proposition that the appellant's bleeding condition was not particularly serious. From this we were asked to infer that it really did not matter that the appellant's new case was not put below because it was, in any event, logical, appropriate and supported by the evidence. We reject this submission. The appellant's condition was serious enough to have warranted referral from her general practitioner to a specialist gynaecologist. Further, as we have already said, the evidence was that the respondent was very worried about the bleeding from which she was then suffering. We see no basis for concluding that had the respondent given the advice it is now suggested should have been given (delay treatment until the results of tests are known), that the appellant would have taken this course.

40 At trial, the appellant was cross-examined as to what she would have done had she been warned of a risk of stroke or blood clot. She was asked and answered the following questions:

If she said to you, 'there's a risk that you could have a stroke but it's one in a hundred million', would you have taken it? - - - Not in a one trillion, not million.

Not in a trillion. All right. Thank you. If she said it was one person in all of the doses in the world have ever got it, would you not have taken it then? - - - I'm sorry, could you repeat?

If they said, 'there's only one recorded episode of a clot here' would you have taken it then? - - - No.

Because you didn't want a clot? - - - Who needs a clot.

41 Evidence of what a person would have done if warned, which is given with the benefit of the hindsight of what actually occurred, has been described as 'so hypothetical, self-serving and speculative as to deserve little (if any) weight, at least in most circumstances.'[24] The dangers that may be associated with the acceptance of such evidence were, in our view, well-illustrated in the present case. The exaggerated nature of the appellant's answers to the questions put to her on the issue of what she would have done had she received a warning well justified the trial judge's rejection of this evidence. When one looks at the whole of the evidence, including the evidence of treatment to which the appellant was prepared to consent, like the trial judge, we are unpersuaded that an appropriate warning of the risk of pulmonary emboli would have made any material change to the events that occurred.

42 Before leaving the question of causation, we should refer to the submissions made by senior counsel for the appellant that the appellant established sufficient facts on the question of causation to cause an evidentiary onus to shift to the

42 respondent. In making this submission, reliance was placed upon the separate judgments of Gaudron J, McHugh J and Kirby J in Chappel v Hart.[25]

43 However, in our view, this was not a case which involved the shifting of any evidentiary onus. Even if it were such a case, the respondent called evidence on the question of causation and, on the whole of the evidence, the trial judge was correct to conclude that the taking of the drug had not been shown to be a cause of the appellant's pulmonary emboli. In the circumstances, we leave for another day the question of whether any of the analysis on shifting evidentiary onuses on the issue of causation survives ss 51 and 52 (and in particular s 52) of the Wrongs Act 1958.

44 Finally, we should say that neither at trial nor before us was it contended that this was 'an appropriate case' where if negligence could not be established as a 'necessary condition of the occurrence of harm', then 'in accordance with established principles' factual causation should be taken to have been established in accordance with s 52(2) of the Wrongs Act 1958.[26]

[1] Who is the Clinical Director of Gynaecology and Cancer Services at the Royal Women's Hospital.

[2] Rogers v Whittaker [1992] HCA 58; (1992) 175 CLR 479, 490.

[3] Distributed in Australia in tablet form, under the name Cyklokapron.

[4] [1992] HCA 58; (1992) 175 CLR 479.

[5] Mason CJ, Brennan, Dawson, Toohey and McHugh JJ.

[6] [1992] HCA 58; (1992) 175 CLR 479, 483 (citations omitted).

[8] Ibid 489-490. While as the plurality said the duty to warn is subject to the therapeutic privilege. The issue of therapeutic privilege did not arise in this proceeding.

[9] [1992] HCA 58; (1992) 175 CLR 479.

[10] See further, ss 48 and 49 of the Wrongs Act. See also s 59 ─ but note that s 60 provides that s 59 does not apply to a liability arising in connection with the giving of or the failure to give a warning or other information in respect of a risk.

[11] MIMS Annual is a publication setting out TGA (Therapeutic Goods Administration) approved product information in relation to medicines available to be prescribed by medical practitioners. The acronym MIMS is derived from a predecessor publication, Monthly Index of Medical Specialties.

[12] The respondent qualified overseas, having done three years specialisation in Brazil and one year in Milan, before coming to Australia in 1992.

[13] Odisho v Bonazzi [2012] VCC 558 ('Reasons') [80].

[15] Cf Rogers v Whitaker [1992] HCA 58; (1992) 175 CLR 479, 490.

[17] [2009] HCA 48; (2009) 239 CLR 420.

[18] The text of the sections is identical, save in two respects. First, while s 51(2) contains the words 'in an appropriate case', s 5D(2) contains the words 'in an exceptional case'. Secondly, while s 5D(3) mirrors the subjective test set out in s 51(3), s 5D(3) goes on to provide that 'any statement made by the person after suffering the harm about what he or she would have done is inadmissible except to the extent (if any) that the statement is against his or her interest'.

[19] [2009] HCA 48; (2009) 239 CLR 420, 440.

[20] March v E & M H Stramare Pty Ltd [1991] HCA 12; (1991) 171 CLR 506.

[21] Ibid 515; quoting from Fitzgerald v Penn [1954] HCA 74; (1954) 91 CLR 268, 277.

[23] See further, Lederberger v Mediterranean Olives Financial Pty Ltd [2012] VSCA 262, [110]-[123].

[24] See Hoyts Pty Ltd v Burns [2003] HCA 61; (2003) 77 ALJR 1934, 1944 [54] (Kirby J). See also Chappel v Hart (1998) 195 CLR 232, 272-3 and Rosenberg v Percival [2001] HCA 18; (2001) 205 CLR 434, [16], [24], [26], [109], [155] and [158].

[25] (1998) 195 CLR 232, and see specifically the judgment of Kirby J at [93].

[26] Cf Adeels Palace Pty Ltd v Moubarak [2009] HCA 48; (2009) 239 CLR 420, 443 [57] where the High Court dealt with s 5D(2) of the Civil Liability Act 2002 (NSW), but note that the reference to 'an appropriate case' in s 51(2) of the Wrongs Act could not include the Fairchild v Glenhaven Funeral Services Ltd [2002] UKHL 22; [2003] 1 AC 32 mesothelioma type case referred to by the High Court because s 45(1)(e) of the Wrongs Act excludes those kinds of cases (subject to an irrelevant exception) from the operation of s 51.