Odisho v Bonazzi [2012] VCC 558

County Court of Victoria|2012-05-08

1 The defendant is a specialist obstetrician gynaecologist. On 27 February 2006, the plaintiff consulted the defendant ("the first consultation") at the referral of her general practitioner for treatment in respect of a condition described in the referral letter as being:

"... abnormal per vaginal bleeding which was present on and off for the last three to four months and which had included prolonged per vaginal bleeding last September and intermittent menorrhagia."

3 It is alleged by the plaintiff that the use of tranexamic acid carried with it the risk of causing a thrombotic event in the form of a pulmonary embolism and that the existence of that risk was such that:**

(i) the defendant was negligent in prescribing tranexamic acid for the plaintiff's use; and

(ii) the defendant failed to obtain the plaintiff's informed consent to her prescription of tranexamic acid, in that the defendant failed to warn the plaintiff of the risk of developing a thrombotic complication in association with the use of the drug.

• that within one hour of having taken her first tablet of tranexamic acid she developed an unusual sensation in the area of her upper left chest; and that

• upon consulting the defendant as to those symptoms, the defendant failed to refer the plaintiff for urgent investigation and treatment, but rather, advised the plaintiff to increase her use of the drug;

with the result that the development by the plaintiff of multiple pulmonary emboli in her chest was both caused by and exacerbated by the defendant's conduct.

5 It is the plaintiff's case that by reason of these alleged failures:

• the defendant failed to comply with the duty of care which she owed to the plaintiff as her patient; and that

• the plaintiff has suffered loss and damage, in respect of which she is entitled to be compensated.**

**6 It is not in issue that the defendant owed to the plaintiff, as her patient, a duty of care in relation to both:

(ii) the treatment which she administered to the plaintiff;

in the course of her management of the condition with which the plaintiff presented to her.

7 The duty of care which the defendant owed to the plaintiff in respect to any treatment administered by her is defined by s58 of the Wrongs Act 1958 (as amended) ("the Act"), which 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."

8 As to the nature of the duty which the defendant owed to the plaintiff to warn her of the risks associated with any medication which she prescribed for the plaintiff's use, this was described by the High Court in Rogers & Whitaker[1] as follows:

"... 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 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."[2]

The Evidence Relevant to Breach of Duty And Causation

**9 The plaintiff was born on 19 September 1959 and migrated to Australia in 1991 as a refugee from Iraq. Having obtained a Bachelor of Arts in Multicultural Studies from RMIT University, the plaintiff undertook an interpreting and translating course, and in 2000, commenced working as a freelance interpreter. The plaintiff said that at the end of 2005 she commenced experiencing heavy periods and she consulted her general practitioner, Dr Singh, who arranged for the plaintiff to undergo blood tests, an ultrasound and a lung x-ray, diagnosed the plaintiff as suffering from fibroids in her uterus, and anaemia, and referred the plaintiff to the defendant.

10 The plaintiff said that upon consulting the defendant on 27 February 2006:

• She informed the defendant that she was a virgin, and that for this reason she declined an internal examination;

• The defendant advised her that three management options were available to her, namely, the use of tranexamic acid, the insertion of an intrauterine device (IUD) or the performance of an hysterectomy;

• The defendant recommended that her condition should be managed by the use of tranexamic acid, which she prescribed for the plaintiff in the form of 500-milligram tablets to be taken three times a day.[3]

11 The plaintiff said that the pattern of her period was not such that she was required to make use of the drug until 10 April 2006. She said that on that day, she took one tablet and that:**

"... between half-an-hour and an hour, I'm not sure, you know, I felt something wrong happen on my left side

...

... my body is not the same

Something wrong happened here."

(sic)

**12 In giving this evidence, the plaintiff indicated experiencing an unusual sensation which was present in the area of her left upper chest between the top of her breast and her collarbone.

13 The plaintiff said she informed her brother of the onset of these symptoms; that he advised her that she should consult the defendant;[4] that she took no further medication and rang the defendant's rooms and arranged to see the defendant on 11 April 2006.

14 The plaintiff said that upon consulting the defendant on 11 April 2006 at approximately 3.45 pm, she told the defendant that "I took one tablet and I feel something wrong happen here",[5] to which the defendant responded:**

"You are thinking too much. This medication does not have any side effects. If you need, take four tablets.

...

And I said 'Doctor, are you sure?' She said, 'Yes, sure'. She pat me on the back, Your Honour, and we went outside and start off charging me 150, she charged me only $50, Your Honour, because I only spent maybe not even two minutes with her. She didn't, Your Honour, clarify anything with me. She didn't ask me what sort of pain was it. She didn't use her stethoscope; she didn't examine me. The only thing she said is this sentence, and then she sent me home."[6]

(sic)

**15 The plaintiff said that the defendant failed to warn her of any adverse outcome which might be associated with the drug;[7] that when she attended the defendant on 11 April 2006 "at least she should have told me to go to the hospital"[8] and that the defendant at that time should have advised her to cease taking the drug.[9]

16 The plaintiff said that during the week following the second consultation she took a total of eleven further tablets over a period of four consecutive days, taking the last tablet at approximately midnight on the evening of Good Friday 2006.[10] The plaintiff said that on the following day whilst travelling with her family to church for midnight Mass, "I felt like sudden cough" (sic);[11]**

"I wake up on Sunday. I felt like whenever I wanted to breathe I had to put my hand under my breast and press to breathe properly. I spent all Sunday, Your Honour, in bed ... I couldn't breathe ... when I take a breath - like, deep breath, I couldn't, I had to put - like there was pain on this side.[12] I had to press here to breathe properly. If I don't press I cannot breathe properly."

(sic)

**17 The plaintiff said that on Easter Monday she was taken by her brother to The Royal Melbourne Hospital, where she was admitted to the Emergency Department and a diagnosis was made that she was suffering from "multiple clots in both lungs".[13]

18 In cross-examination, the plaintiff agreed that apart from presenting to the defendant with heavy bleeding, she was otherwise in very good health and that she had no history of medical problems in her family, in particular, no history of stroke or coronary artery disease, or heart disease of any type.[14]**

"Q: If the doctor had asked you 'Do you have any history of pulmonary embolism, heart attacks, stroke or anything like that', you would have said 'No'?---

A: Of course."[15]

**19 The plaintiff said that her virginity was important to her.[16]

20 It was put to the plaintiff that the defendant would give evidence that in the course of the first consultation she had made an appointment for the plaintiff to attend The Royal Women's Hospital and had requested blood tests to be undertaken, to which the plaintiff replied:**

"I don't dispute [that] at all, but I don't remember."[17]

**21 When asked as to the symptoms which manifested themselves shortly after she took the first tablet of tranexamic acid, the plaintiff described the symptoms as "Not pain, but shock".[18] She said that she thought that the symptoms were related to the tablet that she had taken and she agreed that she thought they must have been caused by the tablet.[19]

22 It was put to the plaintiff that during the second consultation she reported to the defendant that she was experiencing heavy bleeding, to which the plaintiff responded: "She's not telling the truth."[20]

23 The plaintiff said that after seeing the defendant on the second occasion and having taken the first tablet, the feeling in her chest came back straight away and it was thereafter present without change until the Sunday "when I wake up I felt like - it turns to pain",[21] and maintained that she first felt pain on the Sunday morning.[22]

24 The plaintiff described her symptoms prior to the Sunday morning as not involving pain, and accepted that the feeling was:**

"Q: It was extremely unusual?---

A: Yes. Shock to the system. My body was not the same."[23]

25 The plaintiff said that upon attending The Royal Melbourne Hospital, "I told them I had this medication".[24] She agreed that she may have given a history to the admitting officer at The Royal Melbourne Hospital that she had developed pain on the day prior to her presentation.[25] The plaintiff was asked, as to that history:

"Q: Why didn't you tell her that you had been feeling very unusual for a week?---

A: She didn't ask me.

Q: I know that. But why didn't ---?---

A: She ask me about the pain only.

Q: Ms Odisho, you are telling me lots of things I don't ask you, to make your point. Why didn't you tell her that you had been feeling unusual for a week?---

A: I don't - she ask me, 'What's wrong with you?' I said 'I have pain in my left side.' This is what you ... ."[26]

(sic)

**26 It was put to the plaintiff hat during the course of her admission to The Royal Melbourne Hospital she had undergone a dilatation and curettage and a hysteroscopy, which procedures were undertaken following the administration of a general anaesthetic. The plaintiff agreed that she had been advised that the performance of a general anaesthetic carried with it serious risks.

27 It was put to the plaintiff that she sought no alternative treatment to a general anaesthetic and just accepted the risks, to which the plaintiff replied**

**28 The plaintiff agreed that in May 2006 she underwent a further general anaesthetic to support the insertion of an intrauterine device and agreed that she accepted the risk associated with:

(i) the anti-clotting medication prescribed at The Royal Melbourne Hospital;

(ii) the general anaesthetic undertaken at The Royal Melbourne Hospital and subsequently, at the North Park Hospital;[28]

"Q: If you had been told there was a risk associated with tranexamic acid you would have not taken it?---

A: How do you take something serious like that, tell me?[29]

Q: Would you have taken that if the defendant had said to you, 'This tranexamic acid carries a risk' would you have said, 'I'm not going to take it'?---

A: Of course. And I was not desperate for this medication, Mr Curtain. I was not desperate.

Q: I understand you had been to your own GP and that your GP had referred you to an expert obstetrician and gynaecologist?---

A: Yes, GP.

Q: And you were prepared to go through that because of the discomfort you were getting with your heavy periods?---

A: Yes.

Q: And if the doctor had said to you, 'This contains a risk' would you have said, 'I'm not taking it'?---

A: Of course.

Q: Any risk?---

A: Any risk, of course.

Q: Any risk at all. So if she said ---?---

A: Not any risk. But this medication causes thrombosis.

Q: Don't worry about that, if she had said to you, 'This can cause you to become drowsy'?---

A: Drowsy, okay.

Q: If she said to you, 'This can cause you to feel nauseous'?---

A: I would say 'Yes, okay, nausea, okay'.

Q: So it is the risk of something major that might have affected your decision?---

A: Of course.

Q: If she said to you, 'There is a risk that you could have a stroke but it's one in a 100 million', would you have taken it?---

A: Not in a one trillion, not million.

Q: Not in a trillion. All right. Thank you. If she said it was one person in all the doses in the world have ever got it, would you not have taken it then?---

A: I'm sorry, could you repeat?

Q: If they said, 'There's only one recorded episode of a clot here' would you have taken it then?---

A: No.

Q: Because you didn't want a clot?---

A: Who needs a clot Mr Curtain? And for your information this medication Dr Marcia prescribed it's not even suited for my condition. My problem was hormonal."[30]

**29 Dr Tuckfield, a consultant haematologist, who was involved in the management of the plaintiff's pulmonary emboli upon her admission to The Royal Melbourne Hospital, had provided three letters to Dr Singh (the plaintiff's treating general practitioner) dated 26 July 2006, 13 October 2006 and 20 April 2007 respectively.

30 In her letter dated 26 July 2006, Dr Tuckfield advised Dr Singh that the plaintiff had presented to The Royal Melbourne Hospital with significant pulmonary emboli -**

"... in the setting of recent tranexamic acid use of menorrhagia. The menorrhagia is primarily due to a large inter-uterine fibroid."

31 In the course of her letter, Dr Tuckfield commented:

"We found no underlying thrombophilia including no evidence of protein, CS or antithrombin deficiency, no evidence of Lupus anti-coagulants, anticardiolipin antibodies, prothrombin and gene or factor V Leiden mutation. I agree with Dr Roberts that it is probably a combination of her pelvic abnormality and tranexamic acid."[31]

32 In her letter dated 20 April 2007, Dr Tuckfield commented:

"I was happy to see Grazilda in haematology. We briefly admitted her after her last visit here. She was short of breath and there was some question as to whether there were new pulmonary emboli. After considerable review of her scans it was felt that they were old."[32]

• Dr Tuckfield gave evidence that the reason for the development of pulmonary emboli could be identified in only fifty per cent of cases where the presentation is "unprovoked".[33]

• Dr Tuckfield was asked to explain the statement made in her letter of 26 July 2006, to the effect that the plaintiff's pulmonary emboli were associated with her use of tranexamic acid, and was asked:**

"Q: Is it right to say that you formed that conclusion on the basis of a diagnosis of exclusion?---

A: Yes. On the basis that she had no personal history, no family history of thrombosis that we were able to ascertain, that the test that at least in 2006 and currently in 2012 we can't find an identifiable laboratory abnormality, and the two things she did have at the time were large uterine fibroid - so a pelvic abnormality which was producing the menorrhagia which is why she was given the medication to control that."[34]

• Dr Tuckfield responded to a question as to whether tranexamic acid caused pulmonary emboli, in the following terms:

"Tranexamic acid is an antifibrinolytic agent, which means it stops the breakdown of a 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."[35]

(sic)

"The only case reports of tranexamic acid, we know how it works, we know it to stop breakdown of a 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."

(sic)

"Q: When you say the epidemiological studies, you mean that tranexamic acid has not been proven to cause clots?---

A: There are guidelines which, for example, in the use of menorrhagia, sorry heavy periods, or uterine bleeding, there are guidelines which say you would not use it in the setting of active thrombosis or people with strong risk factors for thrombosis."[36]

34 It was put to Dr Tuckfield that there was no proven connection between the use of tranexamic acid and the development of pulmonary emboli, to which she responded:

"No proven strong evidence, yes. I mean it's all a balance of risk of bleeding versus risk of thrombosis and it's like using anything that can cause thrombosis, you know, putting women on the pill, you know, any thrombosis risk, so can I say that there's no good strong evidence, there's no peer reviewed large studies, placebo controlled studies looking into it, no."[37]

35 It was put to Dr Tuckfield that at the time she wrote the three letters which are Exhibit B:

"Q: You weren't able to say that Ms Odisho's pulmonary emboli were caused by her taking the tranexamic acid were you?---

A: Primarily caused by it - no.

Q: Following up on that, you can't say it was a cause of her pulmonary emboli. That is, you can't say that the tranexamic acid was a cause of her emboli?---

A: As the MIMS says, you can't exclude it as a contributing factor but can I say it's the cause? No.

Q: No?---."[38]

36 Dr Tuckfield was asked whether, on the balance of probabilities, it could be said that tranexamic acid was a cause of the development of the plaintiff's emboli, and opined:

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

Q: Yes?---

A: We know that because lots of - it's widely used and the number of case reports in the world in women who use this drug for menorrhagia and get pulmonary emboli are very, very few. So the incidence of using pulmonary emboli, using tranexamic acid for short periods of time, it's very low.

Q: So would this stop us from using tranexamic acid in the next person with the same scenario?---

A: No, it wouldn't.

...

A: Before you prescribe you think, what are the risk factors? No family history, no personal history, no this, no that. Is it reasonable with any drug? Yes, it's reasonable to use it. Are we aware of all the possible side effects when we take antibiotics or the pill or whatever? Yes we are. You know, does the benefit outweigh the risk? Yes it does. But can we say that you getting this antibiotic you are not going to have any anaphylactic reaction? No. Am I going to say you are not going to get pulmonary emboli when you go on the pill? Even though I know people get pulmonary emboli on the pill and there is a tentative association of tranexamic acid with pulmonary emboli by nature of the way it works.

...

Q: It is possible to say that it may have been a contributing factor rather than a primary cause?---

A: I'd be highly surprised if it was a primary cause. If I could say we knew why everyone got pulmonary emboli then you might be able to say that if this was the only factor, then, yes.

Q: So it's possible that it was a contributing cause but unlikely that it was the primary cause?---

A: Highly unlikely that it was the primary cause.

Q: Just to clarify evidence for the Court, you are saying, and correct me if I am wrong, that it's a possibility the tranexamic acid was a cause?---

A: A contributing factor, yes."[39]

37 Dr Tuckfield responded to the plaintiff's question as to whether tranexamic acid caused emboli:

"... 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."

38 Dr Tuckfield opined that she would be highly surprised if the development of a thrombosis was associated with the taking of one tablet of tranexamic acid,[40] commenting, in response to a question by the plaintiff as to what she would do if presented with a patient who had taken one tablet of tranexamic acid and had developed symptoms in her left chest:

"If I suspected pulmonary emboli, so if anyone presented to me with these symptoms and I suspected pulmonary emboli, then I would stop it, not thinking that was actually it but what else is going on because I don't think one single tablet, even if you had other risk factors would cause pulmonary emboli. I don't think one tablet of tranexamic acid, to the best of my knowledge and experience because I've never seen it, and I see lots of clots, would be sufficient to cause symptomatic significant clinical pulmonary emboli. But having said that, if someone came to me and I thought they had clots, I would stop it to make sure it didn't make things worse but I would be thinking why has she got these clots. But I wouldn't be thinking it's due to one tablet of tranexamic acid. I'd be highly surprised."[41]

39 The plaintiff's brother, Zaya Odisho, gave evidence that on 10 April 2006, the plaintiff had advised him -

"... that she had a tablet and she felt, you know, something wrong with her body. So I said to her 'who gave you that medication?' She said 'my specialist'. I told her to call the specialist and make an appointment with her so I can take her to the specialist who gave her the medication."[42]

40 Mr Odisho said that his sister subsequently advised him that she had telephoned the doctor, had been given an appointment to attend the next day and that he accompanied his sister to that appointment. At the conclusion of the appointment, Mr Odisho said that he had asked his sister what the doctor had told her to do and had been told by the plaintiff:

"She told me that Dr, you know, Bonazzi, she told her that there is nothing wrong with the medication. So we went home. We were at peace of mind, Your Honour and it passed through three days. Your Honour she was - looked to me, tired, you know, Your Honour, and there was Easter coming. I drive to the midnight Mass at the church - Catholic Church of Broadmeadows. Grazilda, she was with me, my dad, my mother and my younger brother, and all the way through the church Grazilda, she start coughing, continued coughing. We thought that in her chest, infection, so we went to the Mass. When finished we returned at home. She stay in her room. The next day, on Sunday, she was - stay in her room. You know, I went to ask her 'What's wrong? You still sick?' She told me, 'Yes, I still having, you know, something wrong with my body'. So the next day, the Monday, she asked me - she was very sick. She asked me to take her to the emergency hospital, Royal Melbourne emergency, so I took her on that day and they admit her at the hospital."[43]

41 In cross-examination, Mr Odisho said that on Easter Sunday his sister appeared to him to be sick. She was quiet and sleeping. He was asked:

"Q: She didn't tell you that she had chest pain on that Sunday?---

A: I cannot recall you know, what she - but by the looking of her, she was sick, you know."

"Q: So on the Monday she didn't tell you she had chest pain, is that right?---

A: She told me that she is very sick."[44]

42 In the course of cross-examination, Mr Odisho was taken to a statement prepared for him by the plaintiff's previous solicitors on 9 April 2010 which was tendered on behalf of the defendant. It was put on behalf of the defendant that the content of that statement, which contained a passage:

"The next day was Easter Sunday, 16 April, Grazilda remained unwell and stayed in bed. I went to see her to see what was wrong and I could see that she was not too good at all. I spoke to her and said, 'What's wrong?' She replied that she continued to suffer from disabling chest pain."[45]

was effectively a fabrication by Mr Odisho of the fact that the plaintiff's symptoms of chest pain had manifested themselves prior to 16 April 2006 and that this in turn spoke against his credit as a witness.

43 Contrary to the position put by the defendant, I find the general content of this statement to be consistent with, and to support, the viva voce evidence of Mr Odisho, and I do not accept the defendant's submission in this regard. In making this finding however, I should not be taken to be making a finding as to the reliability of the evidence given by Mr Odisho with respect to the complaint made by the plaintiff to him on 10 April 2006 that she felt something wrong with her chest after having taken one of the tablets prescribed for her by the defendant. I will make further comment and findings as to this evidence in the course of my judgment.

The Evidence of Marcia Teresa Baracat Chaib Bonazzi

**44 The defendant gave evidence that she was a legally qualified medical practitioner and that she had carried on practice as a specialist obstetrician gynaecologist since 2003.

45 She said that the plaintiff first presented to her at the referral of her general practitioner on 27 February 2006. She said that in the course of her practice, and with respect to this consultation with the plaintiff, she prepared notes on her computer which was fitted with a program described by her as "Genie Software". The defendant said that notes recorded via that program were tamperproof in that, once the details of a consultation had been recorded, those details could not be altered, and that if any additions were made to practice notes which had been logged within the Genie program at a subsequent time:**

"I can do on the same date but the hour will be there";[46]

"The computer will enter the time and the date I have created. It doesn't allow me to change."[47]

**46 The defendant said that at the time of the plaintiff's presentation to her on 27 February 2006, she obtained a history from the plaintiff:

(ii) that she had been experiencing abnormal bleeding on and off for the last three to four months;

(iii) that an ultrasound had revealed that the plaintiff had a fibroid uterus[48] and that before she examined the plaintiff:**

"She had raised the issue that she had never had sexual intercourse. When a person doesn't have sexual intercourse it is a routine, if the patient allows, that we do a PR examination. A PR examination is when we do an examination by the rectum. I must admit it is not comfortable and I had to ask her permission. Was I very keen to do it? I tried but I wasn't that keen, and I asked her permission. Because when Grazilda came to see me, she was very agitated, very anxious, she even discussed - she was worried about the bleeding and she was worried about - she was a virgin, she told me from the beginning that she was worried that what this bleeding could cause in relation to her having babies in the future."

47 The defendant said that because the plaintiff did not have private health insurance it was the defendant's intention that the plaintiff's future management be undertaken at The Royal Women's Hospital:

"... because she was a virgin and very worried about her virginity I think The Royal Women's Hospital always have a better team approach. And she would have a psychiatrist, she would have [been] counselled, she would have an interpreter, if necessary. If you have to insert an IUD to a lady that has never had sex before, it is better that one or two senior gynaecologists discuss the case and we do a team decision."[49]

48 The defendant said that in the course of the first consultation she had prescribed tranexamic acid for the plaintiff, commencing the plaintiff on a dose of one tablet to be taken three times a day (the normal prescription being two tablets taken three times a day), and that she adopted this practice because:

"I didn't feel that she had much bleeding on the pad and probably I didn't increase it because her haemoglobin came 117 and that is just two points below normal. So it wasn't really heavy bleeding and I told her to continue because if there was more bleeding she would be very close to her appointment. Usually this medication is just a precaution for the bleeding and usually we don't use more than three months. There is no evidence about more than three months or four months will make an effect."

"Q: Do you believe you gave any warnings to the plaintiff about this - about tranexamic acid?---

A: It's my practice to tell side effects but do I remember clearly telling her? No.

Q: What is your practice to say?---

A: The most common side effects.

Q: What are they?---

A: Diarrhoea, vomiting, gastrointestinal upset.

Q: She says you didn't tell her anything about pulmonary embolism. Do you agree with that or disagree with it?---

A: I would not be able to say one hundred per cent."

**50 As to her knowledge of the risks and complications likely to be associated with the prescription of tranexamic acid, the defendant said that her position at the time at which she prescribed the drug for the plaintiff was informed by:

• access to the full version of the product information provided by the manufacturer through her subscription to the MIMS annual;[50]

• her attendance at scientific meetings and "continual medics' education, we are supposed to have 75 points in three years";[51]

• her reliance on her computer software, which operated such that:**

"As I prescribe, the MIMS engine will alert me if on her history there are any contraindications so is safe to order the new - as soon as I typed 'tranexamic acid' the software will show me the MIMS before I prescribe. If there are any contraindication a beep will alarm."

**In this respect, the defendant said that the material available to her via the Genie software program at the time at which the subject prescription was made for the plaintiff was similar in content to that contained in Exhibit G.[52]

• information as disseminated by the Royal College of Obstetricians and Gynaecologists in their annual journal, together with discussions in the course of staff meetings conducted in the course of her practice at The Royal Women's Hospital;[53]

and that from these sources her state of knowledge as to the risk of thromboembolic events being associated with the prescription of tranexamic acid as at 2006 was:**

"There was no evidence that the oral dose in gynaecological use could cause thromboembolism, however we didn't have enough studies yet."[54]

51 The defendant further explained her position as follows:

"At the time, I had never heard before about pulmonary embolus being a common complication or a complication. I must admit I've never seen a case. I've never come into any conference that that case was put to us."[55]

**52 As to the plaintiff's presentation to the defendant on 11 April 2006, the defendant took issue with the plaintiff's evidence that she had reported the presence of chest symptoms in association with her use of the drug; the defendant's position being that the plaintiff's only complaint at that time was of having experienced continuing menorrhagia.

53 The defendant gave evidence that her note of this consultation recorded via her Genie software computer program was as follows:**

"Patient came back because is stressed about bleeding. However, only two pads a day."[56]

54 Dr Leslie Lewis Reti, an obstetrician and gynaecologist, who currently holds the position of Clinical Director of Gynaecology and Cancer Services at The Royal Woman's Hospital, and prior to which he held the position of Head of Gynaecology 1 Unit at The Royal Women's Hospital for twenty years, which "dealt with heavy menstrual bleeding";[57] gave the following evidence:

"The association between tranexamic acid, Cyklokapron, 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.[58]

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 per cent, and 48 of the placebo group, which was 0.5 per cent. This was not statistically significant and the data strongly suggests that there is not an excess of thromboembolic phenomenon in patients taking tranexamic acid."[59]

55 Dr Reti explained this evidence in the following terms:

"Thrombosis leading to embolism occurred in [a] statistically equal proportion in the two groups, those taking the drug and those not taking the drug in 10,000 individuals.[60]

● I do not believe that it's normal practice or a standard of care to alter patients' prescribed tranexamic acid of the risk of pulmonary embolus.[61]

● It is, however, normal practice to use tranexamic acid with caution or not at all in those patients who are considered high risk of vascular thromboembolism.[62]

● The natural history of deep venous thrombosis and subsequently pulmonary embolism is such that it usually evolves over days and weeks. The possibility that the plaintiff would have suffered a pulmonary embolism soon after taking one tablet of tranexamic acid is clinically extremely remote and hardly plausible.[63]

**56 Dr Reti was taken to the plaintiff's evidence that between half-an-hour and an hour of taking one tablet of tranexamic acid she felt an unusual pain in her left chest, and opined:

• "Any pain in the chest is potentially a sign of pulmonary embolism. But the other way round, a pain in the chest has many, many aetiologies."[64]

• That a symptomatic thrombus was commonly associated with calf pain but not always;

• That the upper chest can be a site for the development of a pulmonary embolus but that this site was less likely and more commonly preceded by a peripheral thrombus developing in one of the limbs;[65]

• That the plaintiff was properly assessed and treated by the defendant, having regard to her presentation at the time of the first consultation;[66]

• That at the time of the second consultation, if, "as the defendant's notes suggest, that the patient came back because [she was] distressed about bleeding, 'however only two pads per day', I believe the continuation of tranexamic acid as directed was appropriate".

57 Dr Reti said that he also used the Genie software program employed by the defendant for the purpose of making data entries in the course of his practice and that the software automatically inserted the date and time of an entry. He said that once an entry had been inserted into the software, unless the entry was altered within "about an hour", the software would allocate a new time stamp, or date stamp, to any subsequent entry.[67]

58 In cross-examination, Dr Reti said that it was his practice when prescribing tranexamic acid, to "counsel that it is common to have nausea and some people experience headache with tranexamic acid";[68] that tranexamic acid was the most effective and safest way of managing heavy bleeding and that it was more effective than the hormonal treatment,[69] the prescription of which carried with it a well-proven but rare side effect of thromboembolism.[70]

59 Dr Reti agreed that thrombosis could be a very serious condition, that it could cause a stroke, a heart attack and could cause death.[71]

60 Dr Reti opined that had the plaintiff presented to him with pain in the chest after taking one tablet of tranexamic acid:**

"I would find it difficult to associate the two things. However, any patient who would come to me with pain in the chest, being a gynaecologist it's not my speciality, I would refer them to the emergency department for assessment."[72]

61 Dr Reti described the MIMS publication as one which reproduced the information provided from the product manufacturer of the particular drug.[73] He said that when prescribing a new drug, if he was unfamiliar with the product, he would review the production information, but would not do so if he was familiar with the drug. He agreed that when prescribing medication, a medical practitioner should be aware of all possible complications no matter how remote.[74]

62 Dr Sarah Leung gave evidence that she was presently a Fellow of the Royal Australian College of Physicians but that in 2006 she held the position of Medical Registrar to The Royal Melbourne Hospital. She was taken to two pages of The Royal Melbourne Hospital medical record, being her notes of the plaintiff's presentations at the hospital on 17 April 2006. She said that while she had no memory of the plaintiff's presentation at that time, she had recorded the following history:

"A forty-six year old lady presented with multiple pulmonary emboli in a setting of recent commencement of tranexamic acid from menorrhagia, clearly secondly to fibroids. Past history. ... No. 1 menorrhagia since August 2005 referred to gynaecologist one month ago. The defendant 9348 1800. Ultrasound results fibroids. Recommended tranexamic acid if menorrhagia occurs. No. 2 Hayfever. No past history of bleeding tendency. Medication tranexamic acid 500 milligrams three times a day ... Social History. Lives with parents and three brothers. Independent with activities of daily living. Translator. History of presenting complaint 10 days ago started tranexamic acid three times a day for menorrhagia. Taken total of 12 tablets, that is four days. No current vaginal bleeding. 1 day history of left-sided pleuritic chest pain and dry cough. No shortness of breath, haemoptysis, dizziness of syncope. No fever or (indistinct) no calf swelling or pain. Presented to emergency department had a (indistinct) scan which showed multiple pulmonary emboli. More on the left compared to the right. Risk factors for thromboembolism. No past history or family history of deep vein thrombosis or pulmonary emboli. No recent immobilisation, long travel, air travel, surgery or fracture. No oral contraceptive pills, no smoking, no miscarriages. No history of malignancy.[75]

...

Impression No. 1 Multiple pulmonary emboli ?secondary to tranexamic acid ?secondary to underlying thrombophilia including possibility of malignancy related to menorrhagia. No. 2 Her vaginal bleeding (indistinct) haematologist and gynaecologist for D and C at Royal Woman's Hospital query on Thursday to exclude endometrial carcinoma. Anti coagulation with Clexane. No Warfarin at this stage."[76]

63 Within Dr Leung's treatment plan, the following relevant notation was made:

64 Dr Leung was asked as to her usual practice in obtaining a history as to the onset of the presenting complaint, and commented:

"I ask the patient directly how long he or she has had the symptom and then write it down accordingly."[78]

65 Dr Leung said that if the plaintiff had advised that the plaintiff had developed a funny feeling in her chest and how within an hour of taking a tablet, that she would have recorded that history. She was asked:

"When you were taking a history from a patient in April 2006, how would you have asked about the onset of the symptoms? What sort of words would you have used?

"A: How long have you had symptoms?

Q: If a patient presented with chest pain, what would you ask?---

A: How long have you had chest pain?"[79]

66 In cross-examination, Dr Leung was asked why she gave the direction that the plaintiff's use of tranexamic acid should be ceased, and replied:

"When a person has developed a blood clot, that included deep vein thrombosis or pulmonary emboli, we try to stop anything that is going to cause the blood to clot. Furthermore, and our understanding is that tranexamic acid can potentially do so. That's why we've stopped - my instruction was to stop it."[80]

67 Mr Mohammed is a practising pharmacist. Mr Mohammed submitted a statement[81] that:

"... tranexamic acid (commonly marketed in tablet form as Cyklokapron in Australia) is an antifibrinolytic used to treat or prevent excessive blood loss during surgery and in various other medical conditions such as trauma and menstrual bleeding. The most common side effects reported include nausea, vomiting and diarrhoea. Although less frequent, thromboembolic events including retinal, artery and vein obstruction have been reported."

68 Mr Mohammed gave evidence that he had no specific knowledge as to accuracy of the statement he had made, but that he had cut and pasted the statement from the Australian Medicines Handbook, this being an authoritative source. Having regard to this evidence given by Mr Mohammed and the reception of the evidence contained in Exhibit G, I am of the opinion that the evidence of Mr Mohammed adds nothing to the case additional to that which is provided within Exhibit G.

Finding as to the information provided by the defendant to the plaintiff as to complications associated with her prescription of tranexamic acid for the plaintiff's use

**69 In the circumstances of the present case, the first issue which arises for my determination is whether the defendant had an obligation to advise the plaintiff that her prescription of tranexamic acid for the plaintiff's use exposed the plaintiff to a risk that the use of the drug may cause the plaintiff to suffer a thromboembolic event.

70 It is clear that the defendant had a duty to provide such a warning to the plaintiff if:

(i) The risk that the use of tranexamic acid may cause the plaintiff to suffer a thromboembolic event was a risk which, given the circumstances of the plaintiff's presentation to the defendant, a reasonable person in the plaintiff's position, if warned of the risk, would have been likely to attach significance to it; or alternatively**

(ii) The defendant was aware, or should reasonably have been aware, that the plaintiff if warned of the risk, would be likely to attach significance to it.[82]

(i) In the course of her consultation with the defendant on 27 February 2006, the defendant prescribed tranexamic acid for her use and gave her no information as to the side effects associated with the use of the drug;

(ii) In the course of her consultation with the defendant on 11 April 2006, the defendant told her that there were no side effects associated with the use of the drug.

72 The defendant has no memory of any conversation between herself and the plaintiff as to the side effects associated with the drug. It is her position however, that if such a conversation did take place, it would have involved the defendant advising the plaintiff as to the most common side effects associated with the drug; namely diarrhoea, vomiting and gastrointestinal upset.

73 Given the answer by the defendant to the plaintiff's Interrogatory 8, I am satisfied that at no time did the defendant warn the plaintiff of any risk of a thrombotic complication being associated her use of tranexamic acid.

74 In assessing the nature of the duty of care which the defendant owed to the plaintiff to provide her with appropriate warnings or advice as to the side effects associated with her prescription of tranexamic, it is clear that the approach which I should adopt is that laid down by the High Court in Rogers v Whitaker[83] which was further explained by the Court in the course of its decision in Rosenberg v Percival;[84] namely:**

"... 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 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."[85]

**and that in considering this issue I must employ:

(i) an objective approach in undertaking an analysis as to whether, 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;

(ii) a subjective approach in undertaking an analysis as to whether 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.[86]

75 Further, it is clear that in considering the issue as to whether the duty to warn as to the presence of a material risk has been breached in the circumstances in which a plaintiff is seeking compensation for an injury allegedly suffered by reason of a failure to issue a warning as to the presence of a particular risk, the failure to warn must involve a failure to warn as to the occurrence of the injury which was in fact occasioned.[87]

76 It follows that in deciding the issue which arises in this case; namely whether the defendant failed to provide the plaintiff with any warning as to the risk that she might develop a thrombus or embolism in association with her use of tranexamic acid:

(i) any failure by the defendant to mention possible side effects in the form of diarrhoea, vomiting or gastrointestinal upset is irrelevant;

(ii) it is only the failure by the defendant to warn the plaintiff that a thrombotic complication may be associated with her use of tranexamic acid which is to be considered when deciding whether the defendant fulfilled her duty of care to the plaintiff.

77 In considering the objective arm of the duty to warn to which I have referred,[88] I am satisfied that the analysis of this question must be undertaken:

(i) on the basis of the position described by Dr Reti in his evidence, that the defendant was expected to be aware of all material risks associated with the prescription of tranexamic acid as disclosed by the product literature, no matter how rare; but also

(ii) taking account of any specific expertise, learning or understanding possessed by the defendant that informed her as to the nature and extent of the risk at the time at which the drug was prescribed.

78 In undertaking my analysis upon this issue, I adopt the approach described by Gummow J in Rosenberg;[89] namely that in determining whether a reasonable patient, or the particular patient respectively, would be likely to attach significance to a particular risk, the following criteria are relevant:**

(i) the nature of the medical condition in respect of which treatment was being sought;

(ii) the magnitude of the risk associated with the treatment;

(iii) the degree of probability of the occurrence of the risk;

(iv) the difficulty and inconvenience involved in pursuing a course of alternative treatment.

79 In respect of this analysis, the evidence satisfies me that at the time at which the defendant prescribed tranexamic acid for the plaintiff:

(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;[90]

(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;[91]

(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 _( > "51(1) A determination that negligence caused a particular harm comprises the following elements -

(a) that the negligence was a necessary condition for 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 harm so caused ( the scope 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 the 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 the 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 upon the negligent party."

88 Dr Annabel Tuckfield had commented upon the issue of causation in her letter of 26 July 2006, in which she stated that the plaintiff had presented to The Royal Melbourne Hospital:

"...with significant pulmonary emboli in the setting of recent tranexamic acid use of Menorrhagia ...

... we found no underlying thrombophilia, including no evidence of protein C, S or antithrombin deficiency, no evidence of Lupus anticoagulants, anticardioliphin antibodies, prothrombin gene or factor V leiden mutation. I agreed with Dr Roberts that it is probably a combination of her pelvic abnormality and tranexamic acid."[95]

**89 The viva voce evidence given by Dr Tuckfield as to whether or not the plaintiff's use of tranexamic acid could be implicated in the cause of her emboli was however far more equivocal.

90 In the course of her evidence, Dr Tuckfield opined:**

"As the MIMS says, you can't exclude it as a contributing factor but can I say it's a cause? No."[96]

"A: It's possible that it may have been a contributing factor rather than a primary cause. I'd be highly surprised if it was a primary cause. If I could say we knew why everyone got pulmonary emboli then you might be able to say that if this was the only factor, then, yes. So it's possible that it was a contributing cause but unlikely that it was the primary cause, highly unlikely that it was primary cause.

Q: Just to clarify your evidence for the Court, you're saying, and correct me if I'm wrong, that it's a possibility that tranexamic acid was a cause?---

A: A contributing factor, yes."[97]

**91 Dr Tuckfield also opined that even in the presence of other risk factors for the development of pulmonary emboli, she did not believe that the taking of one single tablet of tranexamic acid would cause the development of pulmonary emboli.[98] Upon this issue, there is uniformity in the opinions expressed by Dr Tuckfield and Dr Reti.[99]

92 Dr Reti's evidence as to the likelihood of tranexamic acid leading to the development of pulmonary emboli was more unequivocal than that of Dr Tuckfield, Dr Reti ruling out any association between the use of tranexamic acid and the development of pulmonary emboli other than one which was coincidental in nature.

93 Both Dr Tuckfield and Dr Reti opined that the reason for the development of pulmonary emboli is identified in only fifty per cent of cases where the presentation is "unprovoked"; Dr Reti agreeing that this meant that -**

"... pulmonary embolisms in fifty per cent of the population who suffer from it are not able to have a defined cause."[100]

**94 It was the plaintiff's evidence that within half-an-hour to an hour after she took the first tablet of tranexamic acid, she felt "something wrong" in the upper quadrant of her left chest, which feeling had thereafter persisted, and that she reported the presence of those symptoms to the defendant in the course of the second consultation.

95 The plaintiff's evidence as to this issue was supported by the evidence given by her brother, Mr Zaya Odisho, in a general sense. Whilst Mr Odisho was not present during the consultation between the defendant and his sister, he said that;

(i) On Monday 10 April 2006, the plaintiff had complained to him of aching, having taken the tablet, and feeling that there was "something wrong with her body";[101]

(ii) He had advised the plaintiff to contact the doctor who had prescribed the drug; that on the next day (11 April 2006), he had driven the plaintiff to the defendant's;

(iii) In the days following that consultation, the plaintiff appeared tired, developed a cough on the evening of 15 April 2006, and complained of the presence of chest pain on 16 April 2006.**

**96 There is no issue in the case that the plaintiff did present to the defendant on 11 April 2006.

97 Nor is there an issue as to whether, had the plaintiff presented to the defendant at the second consultation with the symptoms about which the plaintiff gave evidence, appropriate medical management necessitated the plaintiff's referral to a hospital emergency department for further investigation.[102]

98 The defendant takes issue with the plaintiff's evidence that the onset of symptoms in her chest manifested themselves within one hour of her taking her first tablet of tranexamic acid and that the plaintiff complained of chest symptoms when she presented to the defendant on 11 April 2006. It is the defendant's position that the plaintiff presented to her complaining of having experienced continuing menorrhagia and not with chest symptoms.

99 The defendant's note as to her consultation with the plaintiff on 11 April 2006 is as follows:**

"Patient came back because is stressed about bleeding. However, only two pads a day."[103]

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