Carey-Hazell v Getz Bros & Co

PLACE: BRISBANE (HEARD IN PERTH) (VIA VIDEO LINK TO PERTH AND SYDNEY)

REASONS FOR JUDGMENT 1 This case concerns the implant of a mechanical or prosthetic mitral valve in the applicant's heart and her subsequent development of thromboembolisms with serious consequences including the need for further surgery to replace the valve with a tissue or bio-prosthetic valve. The applicant's case is that she continues to suffer symptoms which are attributable to the thromboembolisms and their aftermath. The symptoms deny her much of the enjoyment of life and of her capacity to earn income. The applicant's case is brought against the first respondent in its capacity as the supplier in Australia, at the relevant time, of the valve; against the second respondent as her cardiologist; and against the third respondent as her surgeon.

A. background 2 The applicant was born on 23 March 1962. At the age of 13 she was diagnosed as having Barlow's syndrome which involves a partial prolapse of the mitral valve of the heart. Her condition was monitored in the years following and from June 1983 by the second respondent. An echocardiogram examination conducted at the time confirmed mitral valve prolapse involving both leaflets of the valve. 3 In the period 1989 to 1996 the second respondent continued to monitor the applicant's condition and further examinations were conducted. The applicant also consulted neurologists about various other symptoms and in particular problems with her balance and vision. It is not necessary to detail them at this point. They will be further considered in connexion with her medical history. In this period the applicant was involved in two motor vehicle accidents, the first in March 1991 and the second in March 1993. On both occasions the applicant suffered soft tissue injuries to her neck. In the second accident her back and thigh were injured. In 1994 and 1995 she received radio frequency blocks on the cervical spine and right sacroiliac joint which had the effect of minimising her pain for some time. 4 In January and May 1996 the applicant and the second respondent discussed the prospect of surgery to the applicant's mitral valve. The applicant was subsequently referred by the second respondent to the third respondent and she consulted him on 16 June 1996. On 20 June 1996 the applicant underwent surgery at the Sir Charles Gairdner Hospital in Perth. Attempts to repair the mitral valve were unsuccessful and a mechanical mitral valve was implanted. The valve was one manufactured by St Jude Medical Inc ('the St Jude Medical valve'). Its place of business is in Minnesota USA. It does not have a place of business in Australia. The first respondent was the importer and supplier of the valve in Australia at the relevant time. 5 As explained by Prof Hirsh, a physician and haematologist, it is generally accepted that implanted mechanical mitral heart valves carry a risk of developing thrombi, or blood clots, upon the surface of the valve because of its foreign nature. A thrombus is formed from blood which undergoes physical changes wherein it is converted from a liquid to a solid state. Thrombi can produce complications by obstructing vessels where they occur or by breaking off from the site where they have formed and travelling to and obstructing small vessels distant from the original thrombus. The latter is referred to as an embolism. The process by which the embolism obstructs the vessel is called a thromboembolic event. The resultant sudden insufficiency of blood supply can cause tissue necrosis, or an infarction. The area of tissue damaged is called an infarct. When a thromboembolic event interrupts the blood supply to the brain, which occurs when an embolus travels to a cerebral artery, it can result in a stroke. 6 In order to minimise the risk of thromboembolic complications patients with mechanical heart valves are treated with anticoagulant drugs. The applicant was treated with the anticoagulant Warfarin. It is necessary that such a person remain on anticoagulants for the rest of their life. Even with anticoagulant therapy patients are still at risk of thromboembolic events. 7 To ensure the appropriate level of anticoagulant is maintained in a patient's blood it is monitored by a blood test known as prothrombin time, from which an International Normalized Ratio ('INR') is calculated. The INR level reflects the effect of the anticoagulant. If the blood is not sufficiently anticoagulated this is indicated by a low INR level. In this circumstance the patient is at risk of thromboembolism. If the INR level is too high, and the blood therefore too thin, they are at an increased risk of bleeding. 8 In patients with mechanical mitral valves it is generally recommended that their INR level be maintained at between 2.5 and 3.5. Persons not receiving anticoagulant therapy have an INR level of 1.00. It is not known why it is difficult to maintain the target INR level in some people. 9 The applicant was discharged from hospital on 27 June 1996. She had difficulty maintaining her INR levels within therapeutic range and experienced some thromboembolic events. In October 1996 infarcts to the spleen and left kidney were discovered on radiological examination. In March 1997 she suffered a midbrain stroke. 10 A conference of specialists reviewed the applicant's case and recommended that the St Jude Medical valve be removed. On 26 June 1997 the third respondent did so and replaced it with a porcine tissue valve. Generally speaking tissue valves have a lower incidence of the development of thrombus on them than mechanical valves and a patient with such a valve may not require life-long anticoagulant therapy. A disadvantage of tissue valves is that they require replacement about every eight to fifteen years. In younger persons they may require replacement more often. For this reason they are not usually recommended by surgeons for implant in persons under 65 years of age. 11 The St Jude Medical valve is a mechanical valve composed of four parts: an outer ring or orifice, a sewing ring and two leaflets which are hinged inside the outer ring. The outer ring and the leaflets are made from graphite which is covered with a layer of pyrolytic carbon. No issue arises as to the suitability of those materials. The orifice is the housing in which the left and right leaflets sit. The leaflets are semi-circular flaps which open and close to permit blood to flow through in a single direction. The sewing ring is made of fabric. It enables the valve to be sewn into the patient's heart tissue. 12 One of the surfaces of the leaflet is the 'bevelled edge surface' or outflow surface, characterised by the bevelled edge of the long straight side of the leaflet. The other semi-circular surface is known as the 'knife edge' or inflow surface. The long straight side of the leaflet is not bevelled on the knife edge surface. On each semi-circular flap there are two small modules known as 'ears' which protrude from each side of the flap near the long straight side of the leaflet. At the time of explant it was observed that the surface of the valve was covered with a thrombus in the nature of a white fibrinous tissue. 13 The explanted valve was returned to St Jude Medical Inc by the hospital for testing and was received on 25 July 1997. Microscopic examinations were undertaken by the field experience report analyst who received it and later by St Jude Medical Inc's consultant pathologist, Dr Titus. No abnormalities or defects were observed on the surface of the valve. In August 2001 the valve was subjected to further microscopic examination and analysis by a scanning electron microscope. The latter, but not the former, revealed the presence of a small chip on the left ear of the bevelled edge of the right leaflet. 14 The applicant brought these proceedings against the respondents on 13 March 2001. It is not disputed that the applicant's injuries, namely the infarcts to the spleen and left kidney and her stroke, and other thromboembolic events, were caused by thromboembolisms likely to have originated at the site of the St Jude Medical valve. The first respondent however denies that the chip found could have been responsible for the thrombus seen on explant and there is a further issue about when the chip came into existence. The cases against the second and third respondents relate to advices the applicant says that she should have received but did not - as to the problems associated with clotting on mechanical valves, that they required a lifetime of anticoagulant drugs, and as to the alternative of a tissue valve where the risk of clotting was less.

1. CONCERNING THE FIRST RESPONDENT 15 Part VA of the Trade Practices Act 1974 (Cth)('the Act') concerns liability for defective goods. Section 75AD provides a remedy where a person suffers injury as a result of defective goods supplied by a manufacturer: 'Liability for defective goods causing injuries - loss by injured individual If: (a) a corporation, in trade or commerce, supplies goods manufactured by it; and (b) they have a defect; and (c) because of the defect, an individual suffers injuries; then: (d) the corporation is liable to compensate the individual for the amount of the individual's loss suffered as a result of the injuries; and (e) the individual may recover that amount by action against the corporation; …' 16 It is not in dispute that a consequence of s 74A of the Act is that the first respondent is deemed to be a manufacturer of the St Jude Medical valve. Section 74A(4) provides: 'If: (a) goods are imported into Australia by a corporation that was not the manufacturer of the goods; and (b) at the time of the importation the manufacturer of the goods does not have a place of business in Australia; the corporation shall be deemed, for the purposes of this Division, to have manufactured the goods.' Section 75AC gives the meaning of goods having a defect: '(1) For the purposes of this Part, goods have a defect if their safety is not such as persons generally are entitled to expect. (2) In determining the extent of the safety of goods, regard is to be given to all relevant circumstances including: (a) the manner in which, and the purposes for which, they have been marketed; and (b) their packaging; and (c) the use of any mark in relation to them; and (d) any instructions for, or warnings with respect to, doing, or refraining from doing, anything with or in relation to them; and (e) what might reasonably be expected to be done with or in relation to them; and (f) the time when they were supplied by their manufacturer. (3) An inference that goods have a defect is not to be made only because of the fact that, after they were supplied by their manufacturer, safer goods of the same kind were supplied. (4) An inference that goods have a defect is not to be made only because: (a) there was compliance with a Commonwealth mandatory standard for them; and (b) that standard was not the safest possible standard having regard to the latest state of scientific or technical knowledge when they were supplied by their manufacturer.' 17 This aspect of the applicant's case has two bases: in the information provided to her and in the existence of the chip, which is alleged to be a defect arising during manufacturing. The latter defect is alleged to have caused a thrombus to form on the valve whilst it was implanted. The warnings which are said to have been absent from the first respondent's booklet, which is provided to patients, are that the risk of thromboembolism associated with the implant of the St Jude Medical valve exists despite a patient taking the anticoagulant drugs and that that risk was between 2 to 5 per cent per patient per anum. It is also alleged that the Patient Booklet published by St Jude Medical Inc contains an implied representation, by omission of the warning, that such a risk does not exist. 18 At least so far as concerns the applicant's case based on s 75AD of the Act, it is not alleged that warnings should have been provided by the first respondent to her at an earlier time so that it might have informed any choice she made regarding valves. Rather the applicant here focuses only upon what is contained in the booklet which she received after surgery. She alleges that had she been told of the risks at the time she received the booklet she would have urgently obtained advice and that advice may have avoided her subsequent injuries. 19 The first respondent admits that there was and is a risk of thromboembolism associated with the implantation of all artificial heart valves and that that risk existed regardless of whether a patient had optimal anticoagulation therapy. This risk was well known and recognised within the medical profession. The first respondent denies that the applicant was optimally anticoagulated. 20 The first respondent denies a lack of warning about the risk of thromboembolism. It alleges that the material it provides to cardiac surgeons contains advices as to the risk of thromboembolism as a potential side effect of its use. Further, the St Jude Medical Inc Patient Booklet entitled 'Living with your new heart valve: an educational booklet for recipients of the mechanical valve', published 1990, which was provided to the applicant contained a warning about the prospect of blood clots. The first respondent also relies upon the warnings which the second and third respondents say were given to the applicant. The first respondent denies that the Patient Booklet contains the alleged implied representation. And it denies that the lack of warning or information can constitute a 'defect' within the meaning of the Act. 21 So far as concerns the chip discovered on one of the leaflet ears of the valve, the first respondent contends that the chip was not present when the valve was released from St Jude Medical Inc's manufacturing facility; it was not present when the valve was returned after it had been explanted from the applicant; and it occurred during evaluation and testing of the valve after its return to St Jude Medical Inc. The first respondent relies upon s 75AK(1)(a) of the Act which provides: 'Defences (1) In a liability action, it is a defence if it is established that: (a) the defect in the action goods that is alleged to have caused the loss did not exist at the supply time; …' 22 So far as is relevant subs (2) provides that 'supply time' means the time when the goods were supplied by their actual manufacturer. 23 The first respondent also pleads that the claim is statute-barred, having been brought more than three years after the applicant knew, or ought reasonably to have known, of the existence of the matters said to give rise to the alleged defect or of the existence of the chip. Section 75AO(1) of the Actprovides: 'Time for commencing actions (1) Subject to subsection (2), a person may commence a liability action at any time within 3 years after the time the person became aware, or ought reasonably to have become aware, of the alleged loss, the defect and the identity of the person who manufactured the action goods.' 24 Section 74B, in Part V of the Act, provides that a manufacturer may be liable to a consumer who suffers loss or damage by reason that goods are not reasonably fit for their purpose: 'Actions in respect of unsuitable goods (1) Where: (a) a corporation, in trade or commerce, supplies goods manufactured by the corporation to another person who acquires the goods for re-supply; (b) a person (whether or not the person who acquired the goods from the corporation) supplies the goods (otherwise than by way of sale by auction) to a consumer; (c) the goods are acquired by the consumer for a particular purpose that was, expressly or by implication, made known to the corporation, either directly, or through the person from whom the consumer acquired the goods or a person by whom any antecedent negotiations in connexion with the acquisition of the goods were conducted; (d) the goods are not reasonably fit for that purpose, whether or not that is a purpose for which such goods are commonly supplied; and (e) the consumer or a person who acquires the goods from, or derives title to the goods through or under, the consumer suffers loss or damage by reason that the goods are not reasonably fit for that purpose; the corporation is liable to compensate the consumer or that other person for the loss or damage and the consumer or that other person may recover the amount of the compensation by action against the corporation in a court of competent jurisdiction. (2) Subsection (1) does not apply: (a) if the goods are not reasonably fit for the purpose referred to in that subsection by reason of: (i) an act or default of any person (not being the corporation or a servant or agent of the corporation); or (ii) a cause independent of human control; occurring after the goods have left the control of the corporation; or (b) where the circumstances show that the consumer did not rely, or that it was unreasonable for the consumer to rely, on the skill or judgment of the corporation.' In s 74B a manufacturer also includes a deemed manufacturer by reason of s 74A(4). 25 It is alleged that the conclusion about lack of fitness for purpose is reached because, notwithstanding that the applicant took the anticoagulant drugs as prescribed, clotting occurred on the surface of the St Jude Medical valve resulting in thromboembolisms. Alternatively the valve contained a chip on one of its leaflets which enabled a thrombus to form. 26 The first respondent denies that the applicant has suffered loss and damage 'by reason of' the unfitness for purpose of the valve. It contends that if the applicant did suffer symptoms attributable to thromboembolism, it does not follow that the valve was not reasonably fit for its purpose within the meaning of s 74B or defective within the meaning of s 75AC. The first respondent contends that if they were symptoms of thrombosis attributable to the valve, they were recognised complications. That does not render the device unfit for its purpose. The first respondent also pleads the defence of limitation of action to this claim. Such an action is to be commenced when the consumer first became aware, or ought reasonably to have become aware, that the goods were not reasonably fit for their purpose. 27 The applicant also claims against the first respondent for breach of its common law duty of care owed to her. That duty is said to arise because of the supply of the valve and is alleged to have been breached because the St Jude Medical valve was not fit for the purpose for which it was supplied and it had a defect which caused the thrombus which in turn caused thromboembolisms. Further the first respondent failed to warn the applicant and/or the second respondent and third respondent prior to implantation of the risks associated with the valve, including the risk of thromboembolism. 28 The first respondent denies that a duty of care was owed to the applicant. In that respect it is contended that Parts V and VA of the Act operate as a statutory 'pre-emption' of the general law of negligence in relation to the supply, including the deemed supply, of defective goods. It is further contended that, in any event the applicant was advised of the risks by the second respondent and the third respondent.

2. CONCERNING THE SECOND RESPONDENT 29 The applicant alleges that at the consultation with the second respondent on 20 May 1996 she indicated to him that she had felt weak and faint for some time and wished to have the mitral valve surgical repair without delay. She alleges that the second respondent said that the surgery was not required at that time and he would reassess her condition on a six monthly basis but that he agreed that she should undergo such surgery. Subsequent to the consultation she says that she spoke with the second respondent by telephone insisting that the surgery be performed as soon as possible and the second respondent then said that he would arrange it. 30 The second respondent agrees that the later telephone call occurred and says that he advised the applicant that the plans for surgery were not being brought forward because of any medical urgency, but at her request. As to the consultation on 20 May 1996, he says that the applicant spoke of having frequent episodes of fainting and palpitations, that she expressed a wish to have the surgery without delay and that he discussed the timing of the surgery with her and her husband. The second respondent says that he advised the applicant that he considered surgery was a difficult decision to make when she had only moderate mitral valve regurgitation and that he was not convinced that her symptoms were due to mitral valve prolapse or mitral regurgitation, but since there was now a trend towards earlier repair he would consider surgery. 31 The applicant alleges that the second respondent was under a duty to warn her of any material risks associated with the mitral valve repair procedure. The second respondent agrees and says that he discharged that duty by informing the applicant during the 20 May consultation of those and other risks, namely that: (a) mitral valve surgery involved a risk of mortality and a risk of stroke of 5 per cent; (b) the usual operation in this situation would be mitral valve repair but sometimes this was not possible and mitral valve replacement was sometimes necessary; (c) if the applicant underwent mitral valve replacement anticoagulants would be necessary for life as a prophylactic against the possibility of a stroke; and (d) mitral valve replacement entailed a risk of clot formation on the valve with a possibility of dislodgement of the clot with serious consequences. 32 The applicant denies that she was so advised. She alleges that the second respondent breached his duty of care to her by failing to advise her that there was a risk that repair was not possible and a valve replacement would be required. The applicant alleges that the second respondent was obliged to advise her specifically of the risk of thromboembolism associated with the use of a St Jude Medical or other mechanical valve. The risk associated with the St Jude Medical valve is alleged to occur in between 2 to 5 per cent of patients every year, even where they are optimally anticoagulated. Further, he failed to advise her of the alternative of a tissue valve and that the risk of thromboembolism with such valves was significantly less. 33 The applicant also alleges that she had told the second respondent, during consultations in 1994 and 1995, that she suffered from debilitating neck and back pain which was treated and controlled by surgical nerve block treatment. This treatment allowed her to live and work normally. The second respondent is alleged to have owed a duty to warn the applicant that if a mechanical, and not a tissue, valve was implanted the applicant would be required to take anticoagulant medication which would prevent her from having the nerve block treatment. 34 The second respondent says that the only mention made by the applicant that she was having nerve block treatment was on 25 July 1995. He denies that he was under a duty to warn that anticoagulants necessitated by a prosthetic mitral valve would make nerve block treatment impossible. And he denies that he was under a duty to warn of the risk of thromboembolism if a mechanical valve were used or to advise that a tissue valve was an alternative and the risk of thromboembolism lesser. He also alleges in his defence that tissue valves would not have been an appropriate procedure for someone of the applicant's age. An allegation that the second respondent should have recommended surgery earlier than 1996 is not now pursued.

3. CONCERNING THE THIRD RESPONDENT 35 At the consultation with the third respondent on 14 June 1996 the applicant says that the only advices the third respondent gave her after listening to her heart were: (i) that he agreed she should undergo surgical repair of her mitral valve as soon as reasonably possible; (ii) that there was a small chance that when surgery was commenced it may become evident that her mitral valve had deteriorated to such an extent that he would not be able to repair it; (iii) that in such circumstances the third respondent would have to replace the mitral valve with a mechanical valve and that such a valve would never need to be replaced and would outlive the applicant; (iv) that if this was necessary he would use a St Jude Medical valve; (v) that if a mechanical valve was inserted the applicant would require medication for life which would preclude her from having any further pregnancies. 36 She says that she enquired about the risks associated with such a procedure and the third respondent advised that she had about a 1 per cent chance of dying during it. The applicant does not allege that she advised the third respondent about her nerve block treatment, but she contends that he was obliged to make enquiries of her so that he would be properly informed about it. 37 The applicant alleges that the following warnings or advices were necessary but were not provided by the third respondent: (a) of the material risks inherent in the valve repair and the replacement procedures; (b) of the risk of a thromboembolism if a St Jude Medical or other mechanical valve was used to replace her valve; (c) of the alternative of a tissue valve to the use of a mechanical valve and that the risk of a thromboembolism was significantly less with a tissue valve; (d) that if a mechanical and not a tissue valve was implanted the applicant would be required to take anticoagulant medication which would prevent her having nerve block treatment. 38 The third respondent admits that he was obliged to advise the applicant of the matters in (a), (b) and (c) but says that he did so. The third respondent also says that at the June 1996 consultation he advised the applicant: (a) that there was a 20 per cent chance that he would be unable to repair her valve; (b) that if it were necessary to replace it the applicant could choose between a mechanical or a tissue valve; (c) that the advantages of the tissue valve were that it produced no sound which she would be able to hear and it had less of a tendency to produce blood clots and emboli than a mechanical valve, although it was the third respondent's practice to prescribe anticoagulant therapy even where a tissue valve was implanted; (d) that the disadvantages of a tissue valve were that it would have to be replaced every 6 to 14 years and there was an increasing risk of death with each operation to replace the tissue valve; (e) that the advantage of a mechanical valve was that, so far as was known, it did not undergo gradual deterioration like a tissue valve and therefore would not require replacement unless a problem arose such as an infection or thrombosis, and these were always possibilities; (f) that the disadvantages of a mechanical valve were that it created more noise and there was a greater risk that it would cause blood clots and to lower this risk as much as possible it would be necessary for the applicant to take anticoagulants. This would mean that she should not become pregnant, should avoid vigorous or heavy contact sports, should advise doctors that she was on anticoagulants prior to undergoing any surgical or dental procedure and she would require antibiotic cover during those procedures. Any tendency to bleeding would contra-indicate a mechanical valve. 39 The third respondent says that the applicant chose to have a mechanical valve in the event that replacement became necessary. 40 An allegation that the third respondent breached his duty of care by chipping the mechanical valve during surgery is not now pursued. 41 In each of the cases against the second and third respondents the applicant says that, had she been made aware prior to surgery that a mechanical valve would require lifelong anticoagulant medication, she would have elected to have a tissue valve in the event that replacement was necessary.

4. THE CLAIMS RELATING TO LOSS AND DAMAGE 42 The applicant alleges that she suffered the following injuries: (a) splinter haemorrhages; (b) kidney and spleen infarcts; (c) stroke; (d) occluded left vertebral artery and partially occluded right vertebral artery; (e) loss of life expectancy; (f) scarring to the heart associated with the surgery; (g) permanent visual injury, including blurred and double vision and blotching of vision and areas of loss or partial loss of vision; and (h) pericarditis. 43 There would not appear to be any doubt about (b) and (c). 44 As particulars of her pain, suffering and disability the applicant alleges that she suffers: 'i) Symptoms associated with the various medical complications the Applicant suffered prior to removal of the Applicant's St Jude Mitral Valve …; ii) symptoms associated with the surgery to remove the Applicant's St Jude Mitral Valve; iii) profound lethargy; iv) scarring to the heartin the region of the Applicant's St Jude Mitral Valve removal procedure; v) loss of reproductive organs through hysterectomy procedure; vi) anxiety and depression due to symptoms and effects of surgery; vii) increased symptoms due to an inability to receive nerve blocks for an unrelated condition, due to medication now prescribed for the Applicant by reason of her symptoms, injuries and surgery referred to above; viii) the Applicant has suffered and continues to suffer profound loss of enjoyment of life due to reduced social, recreational and other activities and loss of enjoyment due to her symptoms and disability resulting from the injuries she suffered because of the implantation of the Applicant's St Jude Mitral Valve; ix) risk of future operative death; x) loss of expectation of life; xi) limits on working capacity; xii) Arrhythmia with either a rapid or slow heart beat or erratic patterns different from her pre-1996 conditions; xiii) Risks of infection and the need to take antibiotics; xiv) Limits on driving due to visual problems pleaded herein, and xv) Sleep problems particularly associated with variations of heart beat.' 45 The applicant says that she suffered from only the following symptoms prior to her heart surgery: (a) intermittent pain in the neck and back; (b) reduced levels of fitness; (c) mild fatigue; (d) intermittent vision disturbance involving 'squiggly lines' or spots of bright colour; (e) intermittent palpitations; (f) intermittent faintness occurring every few months and with increasing frequency. 46 Apart from those in (a) and perhaps (d) I infer that the applicant's contention is that the other symptoms are attributable to her heart condition and should have been remedied by the first surgical procedure. 47 The applicant says that she now has the following symptoms and that she did not have them before: (a) sustained fatigue; (b) vision loss; (c) double vision; (d) slow heartbeat or an erratic pattern of heartbeat; (e) generalised weakness; and the following continue, but more frequently: (f) faintness; (g) neck and back pain. 48 The applicant says that she is now unable to work more than ten hours per week because of her fatigue. She is unable to undertake any activity for more than a few hours. She tires easily and this increases her neck and back pain and she gets headaches, vision disturbances and palpitations. Her neck and back pain, which she is unable to treat with nerve blocks, also contribute to her inability to work as does the medication she takes for them. The symptoms of headaches, visual disturbances, palpitations, weakness, feeling faint, anxiety and erratic heartbeat also contribute. The applicant claims damages for pain and suffering and loss of the enjoyment of life and of her expectation of life. 49 The applicant's claim for economic loss is now based upon her loss of the opportunity to earn income as an Investment Development Manager with Westpoint Pty Ltd or Westpoint Corporation (the company was referred to by various names in the course of the proceedings. I shall refer to it as 'Westpoint'). The company was one controlled by the applicant's brother. The claim for the net past value of the opportunity is $1,466,000.00 based upon the remuneration for such a position being $500,000.00 per year gross, before tax. After contingencies the value of the future loss of opportunity is said to be between $4,087,747.60 and $4,289,517.70. The only other claim is an unquantified claim for the cost of domestic care.

1. THE APPLICANT'S MEDICAL AND WORKING HISTORY prior to the implant

(a) Medical History 50 In 1986 the applicant saw Dr Gubbay, a neurologist. He noted at that time that she complained of a loss of balance, of a feeling of falling to the left, of what was a classic migraine with a blind spot and headaches at the back of her head and nausea. Doctor Gubbay later noted that the applicant had suffered from classic migraines, with loss of vision, on at least four occasions in the past five years. When the applicant reported that she was also suffering some loss of the co-ordination of her muscles in January 1987 Dr Gubbay considered the possibility that she was suffering from multiple sclerosis, which he discussed with her. At another point Dr Gubbay considered the possibility that the applicant was having thrombolic events and discussed with her how bits of thrombus can dislodge and enter the bloodstream. This was discounted after advices from the second respondent. On 6 April 1987 Dr Gubbay noted that she had neurological disturbances, diplopia and numbness in the left leg and right arm. Diplopia is referred to at other points in the evidence as double vision. The applicant also complained of fatigue at this point. The applicant sought to explain in her evidence that references by her to 'double vision' at this point, with hindsight, were really to blurred vision. The applicant says that it was not until after her stroke that she noticed the difference. Doctor Kermode, the applicant's current neurologist says that people often refer to 'double vision' when they mean blurred vision. 51 In August 1987 the applicant again saw Dr Gubbay and reported that she had difficulty judging distances, prolonged headaches, problems with vision, facial numbness and nausea. In December 1987 her knees were giving way and she had a tendency to drop ('drop attacks'). She had an impairment to the vision in her right eye and problems with her balance. These attacks, loss of balance, double vision and grey spots in her sight continued into late 1988. 52 Doctor Gubbay reported to her general practitioner in April 1989 that an eye specialist to whom the applicant had been referred could find nothing and he referred to the possibility of her suffering migraines. She continued to suffer migraines through to late 1998 and was at this time under a deal of stress because of problems with her first marriage. In December 1988 Dr Gubbay noted that she was still having drop attacks, occasional episodes of diplopia and grey spots. 53 In May 1990 the applicant was feeling weak and continued to have a tendency to fall to one side. Doctor Gubbay spoke to her about her condition having a functional element, which is to say that she believed she would fall and therefore she did. After her motor vehicle accident in 1991 she saw Dr Gubbay and complained of occasional dizziness, impairment of balance, blurred vision and feeling weak. In April 1991 she collapsed. Doctor Gubbay thought that her symptoms at this time might be related to anxiety and stress and he considered the possibility of conversion hysteria. Sometime afterwards the applicant stopped seeing Dr Gubbay. She said that she found him difficult to deal with. 54 The applicant had already seen another neurologist, Dr Carroll, in January 1991. The history she gave to him included references to intermittent transient disequilibrium and visual disturbances. She described intermittent diplopia to her doctor, he records, occurring usually when driving and she complained of blank spots in her vision. She said to him that she first experienced episodes of disequilibrium at the age of 18. In 1993, when seeing Dr Carroll again, the applicant reported that there had been no increase in her symptoms in the last two years. The motor vehicle accident in 1993 had exacerbated them slightly. She was suffering from severe headaches and loss of balance when fatigued. By April 1993 Dr Carroll considered the source of the applicant's visual symptoms to stem from the effects of migraines and to some extent introspection on her part over her physical and neurological state. He reported to her solicitor in August 1993 that she was having headaches every two to three days and finding it difficult to study. She related the headaches to her neck injury. In 1995 the applicant saw a third neurologist, Dr Bajada, who likewise advised her general practitioner that her problems with vision and balance were likely to have been brought about by migraine. 55 The applicant also presented to the second respondent with symptoms of palpitations, faintness and fatigue at various points from 1983 to 1996 when the second respondent periodically reviewed and monitored her cardiac condition. When the applicant consulted the second respondent in 1986 she complained of having palpitations associated with anxiety. In May 1991 the applicant undertook an exercise test in which she was found to perform at a level better than for her age. 56 On 10 May 1994 the second respondent wrote to the solicitors acting for her in the action arising out of the first motor vehicle accident and recorded that the deterioration in her state of health, such as frequent palpitations, was not related to her heart condition but to psychological factors, anxiety and stress and the deterioration of her physical fitness. The exercise tests undertaken by the applicant periodically did not suggest a deterioration in her cardiac condition. In early 1995 the applicant reported to the second respondent that she was feeling worse, but he again did not relate her symptoms, which included occasional palpitations, to her cardiac condition. The applicant attributed what she perceived as an increase of her symptoms in 1995 to her heart condition. In her evidence she sought to explain that she thought that they were brought about by her lower level of fitness. There seems little doubt however, from the second respondent's evidence in particular, that she was convinced her heart condition was responsible for the symptoms and this is why she was keen to have surgery. 57 Towards 1996 the applicant believed her symptoms were worsening. The second respondent did not however detect any deterioration in the condition of her mitral valve and it was the second respondent's opinion that most, if not all, of these symptoms were not attributable to her cardiac condition. 58 The applicant said in evidence that she felt that she was about 75 per cent recovered from the symptoms of the first accident by the time the second accident occurred in 1993. At the end of 1993 it was however recorded in a medico-legal report that she was unable to sit for more than twenty minutes at a time because of the pain in her back and this had worried her since 1991. She was continuing to have pain in her neck and back. 59 In about October 1994 the applicant received a radio frequency block from Dr Finch in the region of her neck injury. She mentioned to the second respondent in September 1994 that she would be having such treatment. She received a further block in June 1995 and in October 1995 to the right sacroiliac joint. She has not had any since. Doctor Finch reported to her solicitors in February 1996 that the applicant might, in his view, experience some long term problems in her cervical spine and her lower back. He was of the view that it was causing her some psychological problems as well. The applicant said in her evidence that Dr Finch referred her to a psychologist for counselling.

(b) Work History 60 Following her secondary schooling the applicant worked part time as a model. She says that she intended nevertheless to take up a career in business at some point in the future. Commencing in about 1982 and for about 14 months the applicant worked for her brother's company, Westpoint, as a marketing manager for its City Markets for a period. The centre had approximately 27 retail outlets and a food hall. She also maintained her own investments and in 1989 she completed a securities course which she had undertaken so as to better understand investments. In 1990 she was employed part time by Stockbridge Ltd to assist in their takeover bid of another company. Her tasks were not complex and consisted of contacting shareholders who had not lodged voting forms. As a result of this experience she subsequently engaged in buying small shareholdings in companies undergoing capital reconstruction, until a regulatory authority contacted her. She thereafter desisted from that practice. 61 In 1989 the applicant commenced university studies towards a degree in commerce, with a double major in finance and marketing. At the same time she obtained qualifications to sell real estate. The applicant completed two years towards the degree. Her studies were interrupted by the effects of the first motor vehicle accident and she did not return to them. She and her brother say that there was an arrangement with Westpoint that it would fund her university studies on the understanding that she would take up a position with the company at the conclusion of them. This accords with claims made in the litigation concerning the two motor vehicle accidents, where it is said that she would have earned $40,000.00 per annum as a marketing consultant, a position which would have also offered her the prospect of promotion. This differs markedly from the amounts now claimed. The applicant said in evidence that the figure of $40,000.00 was only a base salary. 62 In 1994 the applicant enrolled in a diploma of fine arts course at the Claremont Art School. The studies comprised 20 contact hours per week and she completed them in four years. She had some success in selling some of her art works, although I do not understand it to be suggested that substantial sums were involved. 63 The applicant worked full time as a bookkeeper for her husband's accountancy practice in May and June 1995. This appears to be the only time that she did work full time in the period prior to the first valve implantation. By 1996 she was only working ten to twelve hours per week. In the five years prior to the implantation of the St Jude Medical valve her highest income, including some social security payments, earned in the financial year ended 30 June 1996 was $15,662.00.

2. THE SECOND AND THIRD RESPONDENTS' advices 64 The second respondent has practised as a cardiologist since 1972, currently practises at Sir Charles Gairdner Hospital and is a Clinical Professor of Medicine and Population Health. The third respondent practised as a cardiac surgeon for twenty-four years, until his retirement in 2000. 65 The accounts given by the applicant and her husband as to what was discussed by the second respondent at the consultation on 20 May 1996 differ from that of the second respondent. It is not disputed that the applicant was very keen to undertake the surgery and that the second respondent recommended she wait a further period. 66 The first discussion about mitral valve repair surgery between the applicant and the second respondent had taken place in January 1996. The applicant and her husband do not appear to have a good recollection of this consultation. At this point the second respondent said that such surgery might be necessary in the future. Her mitral regurgitation had remained moderate. The second respondent did not consider surgery to be warranted. The second respondent says that he stressed that open heart surgery was a major undertaking and that it was often possible to preserve a mitral valve for many years before undertaking what was a risky procedure. Nevertheless she wanted the second respondent to consider the prospect of surgery at this juncture. 67 The applicant says that at the outset of the consultation on 20 May 1996 she told the second respondent that she wanted to have surgery as soon as possible because she was feeling unwell; she felt that if her health deteriorated further should would have difficulty recovering from the operation; she needed surgery to her left knee and her orthopaedic surgeon had said to wait until after her heart surgery; and her poor health was making it difficult to care for her children who were getting older and were interested in physical pursuits and she wanted to join in them. 68 The applicant also said in her statement of evidence that she explained to the second respondent that nerve blocks had resolved her neck and back pain to a significant degree and she was looking forward to getting on with her life. She and her husband felt that if she had to have surgery at some time in the future it would be best to have it as soon as possible. The second respondent denies that there was any discussion about her nerve block treatment. The only time he had heard of it was in 1994. He agrees that he did not ask her questions which might have revealed that she intended to have further such treatment. 69 The applicant's evidence is that she left the second respondent's rooms that day on the basis of his recommendation that a review be had in 6 months and she was to have further holter monitoring, by a device which she was to wear. She returned the monitor after the requisite period. A few days later the second respondent telephoned her and said the results did not indicate any significant cardiac arrhythmia. She advised the second respondent that she and her husband had discussed the matter and wanted her to have surgery immediately. The second respondent agreed to arrange it and call her back. On this version of events there was no discussion of the details of the surgery, of the prospect of replacement rather than repair and what that involved. The applicant says the consultation was short. Her husband's evidence about what was not advised accords with that of the applicant. 70 The second respondent's evidence is quite different. It is to some extent based upon his practice with patients considering surgery. In other respects he said that he had a specific recollection of the meeting. 71 The second respondent says that the applicant reported to him that she was having frequent episodes of fainting and palpitations and that she could feel her heart beating hard, fast and irregularly. She said that she wished to undergo mitral valve surgery without delay. His initial advice was that they should investigate the cause of her tachycardia, or racing of the heart. She was convinced that many of her symptoms, particularly the fainting and palpitations, were directly related to her mitral valve disease. Given her complex medical history and the stress that had been caused to the applicant after the motor vehicle accidents the second respondent was not convinced that her symptoms were attributable to a worsening of her mitral valve regurgitation. He explained to her that her palpitations and fainting were not necessarily related to the mitral regurgitation. He said that he considered it to be unlikely that surgery would result in an improvement of her symptoms. 72 The second respondent says that he then turned to the timing of the surgery and the 'pros and cons' of proceeding with surgery at that time. He emphasised that it was not necessary to undergo surgery where the mitral regurgitation was only moderate, but that her condition would progress and it was feasible to consider surgery. Because the applicant was keen to proceed the second respondent says that he took particular care to emphasise to her that this was a relatively hazardous undertaking which should not be undertaken lightly. He explained that surgery would cause considerable pain and discomfort and also carried a 4 to 5 per cent risk of mortality and other complications including stroke. He explained that there had been an international trend in recent years towards earlier surgery. 73 The second respondent says that he told the applicant and her husband that, with modern techniques of cardiac surgery, he was hopeful that a mitral valve repair could be achieved. Sometimes however this was not possible and there was a small chance that the procedure might not be successful. He explained to her that mitral valve repair had come to prominence because it was superior to the alternatives of mitral valve replacement with a prosthetic valve, which carried a higher risk and required lifetime treatment with drugs to avoid clot formation on the valve and mitral valve replacement with a tissue prosthesis. In his evidence at the hearing the second respondent corrected this statement and said that he did not refer to the need for a lifetime of drugs at that point in the consultation. It was at a later point that he said that mechanical valves required drugs to be taken for life to prevent clots. He says that he did not discuss the percentage risks of blood clot formation with her as he had not discussed her care with a cardiac surgeon and did not know what type of valve might be chosen if repair surgery was unsuccessful. In his statement he said that he went on to advise the applicant that a tissue prosthesis would not be considered for young patients but at the hearing corrected this aspect of his evidence. He said that he did not in fact make such a statement. 74 The second respondent says that he went through the details of the mitral valve repair that the surgeon would attempt and used a model of a heart to do so. He also used a diagram drawn by him to explain how the surgeon would attempt to modify the valve in order to abolish the mitral regurgitation. The applicant denies this occurred. 75 The second respondent said he would discuss timing with the cardiothoracic surgeon, Mr Nicholls (the third respondent). He later accepted that he may not have named him but referred to him as an experienced cardiac surgeon. He said that he emphasised to her the need to discuss the details of the surgery with the surgeon. It was his usual practice to recommend that she and her husband take all of their outstanding questions to the surgeon. 76 As was his practice, the second respondent wrote to the applicant's general practitioner that day. He says that he always did so and dictated the letter in the presence of the patient unless it was necessary to defer the report whilst tests were undertaken. He says that he preferred patients to listen to his concluding remarks. He dictated from his notes. 77 The second respondent's note of the consultation recorded the applicant as looking well and that he had discussed the 'pros and cons'. The latter was said by him to refer to surgery. By the first mentioned observation he meant only that she was not looking acutely unwell. His letter dated 20 May 1996 to the applicant's general practitioner, Dr Veling, contained the observation that she looked a little pale and run-down and that she had been under a lot of stress recently. The second respondent noted that the applicant wanted to know when surgery would be possible. The second respondent advised Dr Veling that he had arranged a holter monitor to check for arrhythmia, which might explain her fainting spells ('syncope'). Another test might also be necessary - a 'tilt table' test. The letter to Dr Veling went on: 'I have emphasised to her that the syncope may well be unrelated to the mitral valve prolapse and she should not rely entirely on the prospect of mitral valve surgery to solve all her problems.' 78 The applicant says that although the second respondent promised to arrange surgery when they discussed the holter monitor results a few days after the consultation of 20 May, she did not hear from him for a week or so. She then telephoned him and left a message at his rooms. When he called back he advised the name of the surgeon and the date of surgery. 79 The letter of referral to the third respondent is dated 13 June 1996. In it the second respondent said that the applicant is now ready and very keen for surgery. He went on: 'I hope she is able to have mitral valve repair, but I have warned her of the possibility of mitral valve replacement and the need for long term anticoagulatation [sic] therapy.' 80 The applicant saw the third respondent on 14 June 1996. The applicant says that the third respondent told her that he had spoken to the second respondent, that her notes had not arrived, but that that did not matter. The third respondent listened to her heart. After that examination and as she was dressing he returned to his desk. He said there was a slight chance that when he went to repair the valve it would be beyond repair and he would replace it with a valve that would never need replacement and which would outlast her. She remembers this in particular because she wondered if the sound of her heart had led him to say that or whether he said it to all of his patients. The applicant and her husband say that they did not know, up to this point, that a prosthetic mitral valve was the alternative to repair of the applicant's mitral valve. The applicant believed, and had told her husband, that she might need a complete heart transplant at some point. It is not apparent how she came to this belief. The second respondent did not give any such advice. They say that they expressed no surprise when they were informed about the possibility of a prosthetic valve and discussed afterwards that they were fortunate to have waited for surgery, believing the valve to be a new development. 81 The applicant says that she asked what the risks of surgery were and the third respondent said the statistics did not apply to her as most patients were elderly and had other complicating health problems. She pressed him for a risk rate and he said because she was young, fit and otherwise healthy that the risk of not surviving the surgery was around 1 per cent. He did not refer to any risks other than those relating to the surgery itself. The third respondent told her that if the valve was replaced she would be on medication for the rest of her life and she would not be able to have any more children. He asked if this was a problem and she and her husband said it was not. The applicant says they had no time to discuss it and thought the choices were either children or death. 82 The applicant says they were not made aware that there were tissue valves which did not exclude pregnancy. The applicant says the third respondent did not state what the medication was or what it was for. They assumed it was to stop her body rejecting the valve. Her husband had asked the third respondent what the chances were of her body rejecting the valve and he said there was no chance, as the valve did not have a blood supply. The third respondent explained pre-admission procedures, how long she would be in hospital and when it might be appropriate for her children to visit her. The third respondent discussed the nature of the incision and other details of the surgery. Again the applicant's evidence about what was not said is supported by the evidence of her husband. His evidence with respect to the second respondent and the third respondent was characterised by little recollection of what was actually said but an apparently clear recollection of what was not. 83 The third respondent says that the second respondent had told him that the echocardiogram of January 1996 showed a prolapse of both the anterior and posterior leaflets of the mitral valve. He says that he knew that that would be likely to make the repair of the valve more difficult and increased the chances of a prosthetic valve being necessary. 84 The third respondent agreed that the applicant gave the impression that she believed that her mitral valve would be repaired. It was in part because of this that he told her that there was a 20 per cent chance that it would need to be replaced. He considered that, although that figure was high, it was appropriate because both leaflets were prolapsing. He recalled listening to her heart and commenting that some of her symptoms would not be relieved by surgery. He was thinking of the palpitations in particular. In cross-examination he says he did not only comment in passing about the prospect that he might be unable to repair her mitral valve, but made much of it. It is always important, he explained, that a patient knows that in this type of operation a surgeon may fail. He always made this plain to patients. He would not have said that there was only a slight chance of failure. He would not have done so because she had prolapse of both leaflets. In such circumstances no surgeon would have said so. 85 The third respondent says that he discussed the operation at length with her, including the extent of the incision and the use of the heart-lung machine. He informed her that he would first attempt to repair the valve and if the repair did not stop the valve leaking then he would proceed to replace the valve with an artificial valve. 86 The third respondent says that he discussed both tissue and mechanical valves with the applicant. He showed her and her husband a tissue valve, a Star Edwards valve and a St Jude Medical valve which he kept in his rooms. He said that the tissue valve had the advantage of being quiet and post-operatively it was less necessary for the patient to take anticoagulant blood-thinning tablets, although it was necessary during the first 6 to 12 weeks and it was his practice to usually carry on the anticoagulants, provided the patient was having no problem with them. He said that it would be necessary to replace a tissue valve every 6 to 14 years and there was an increasing risk of death with each operation to replace a tissue valve. 87 The third respondent says that he advised that the mechanical valve made a clicking noise which was annoying at first but that he only had one patient who continued to complain of it. He said it was a long-lasting valve, or words to the effect that the valve would outlast her. He said that provided there was no complication such as a thrombus, or infection or a structural defect, it should last a lifetime and not need replacing. 88 The third respondent recalls the applicant, or her husband, asking questions about 'rejection' and that he advised that it was not an issue. He also recalls the word 'transplant' being used in conversation at some earlier point. He particularly recalls these references because the words are unusual in the context of mitral valve surgery. He did say that with tissue valves changes might occur which could be regarded as rejection. 89 The third respondent says that he explained that the disadvantage of the mechanical valve was that it was more likely to form clots and that in order to minimise this risk the applicant would have to take anticoagulants, that is blood-thinning drugs, for the rest of her life. In cross-examination he denied that he used the word 'medication' in connexion with anticoagulants and says he most likely ran 'anticoagulant' together with 'blood-thinning drugs'. He said that he advised the applicant that the anticoagulants would be monitored with daily blood tests while she was in hospital, twice daily for two to three weeks after returning home and then at weekly intervals extending to a monthly test. The third respondent says that he advised her, as he did with all patients, that this would make her more likely to bleed with minor cuts and to bruise more easily. She would, for the most part, have to confine herself to a lifestyle which avoided hard contact activity or sport. Prior to any surgery she would have to inform the surgeon she was on anticoagulants and that she had an artificial valve. 90 The third respondent says that he advised that anticoagulants were a great problem during pregnancy and that because of this if a person wanted to become pregnant then a mechanical valve was contra-indicated. However if this was not the case, and the applicant and her husband assured him that it was not, then he would advise her to have a mechanical valve implanted. Although this was his recommendation, he told her that it was her choice provided she understood the pros and cons and his recommendation. The applicant told him that if it were necessary to have a valve she would have a mechanical valve. 91 The third respondent cannot recall if the applicant asked for an assessment of the risks of surgery but they did discuss it and he advised her that the risk of death from the operation was approximately 1 per cent and there was a long list of possible complications, including heart attacks, strokes, clots and infections on the lungs and many others. However the two things he considered to be specific to the operation, clots forming on the valve and infection, had been discussed earlier in the consultation. 92 The third respondent told the applicant that the operation would last two to five hours and that she would be returned to the Intensive Care Unit afterwards where she would be closely monitored. He explained to her in some detail how she would feel and what would take place shortly afterwards. He discussed the appropriateness of her children visiting her whilst she was in the Intensive Care Unit. He discussed the length of her hospitalisation, her convalescence, the length of time for which she would need household help and that during convalescence her anticoagulant or blood-thinning regime would be stabilised. The entire consultation he says lasted one hour. 93 The applicant did not discuss her nerve block treatment with the third respondent, he says. He said in evidence that, generally speaking, he would have expected the second respondent to advise him of any relevant continuing treatment. 94 Prior to her surgery the applicant signed a consent form following admission to the Sir Charles Gairdner Hospital which referred to 'operation/procedure of mitral valve replacement'.

3. medical evidence as to MECHANICAL and tissue valves 95 The expert medical witnesses were agreed that the development of a thromboembolism in a patient with a mechanical mitral valve such as the St Jude Medical valve and on anticoagulant drugs was uncommon but well known amongst cardiologists and cardiac surgeons in 1996. It was not possible to predict how a patient would react to the implant of a valve. Professor Hirsh said there had been research in recent years to determine whether some people have a genetic predisposition to the development of thrombi but it had not been established. Mr Newman is a consultant cardiothoracic surgeon at Sir Charles Gairdner Hospital who was at the conference which discussed the applicant's case and he was present when the St Jude Medical valve was explanted. His advices to the applicant when he first saw her in hospital implied that she might have some constitutional predisposition. It would seem that there is a possibility that the applicant suffers from a genetic clotting disorder. It can be put no higher. Doctor Baker, a clinical haematologist, considered that it was plausible that a particular gene mutation could increase the applicant's risk to thrombosis but the clinical significance of the particular mutation is currently uncertain. Professor Hughes is Head of the Cardiothoracic Surgical Unit Office at Royal Prince Alfred Hospital. He said that there are a number of factors which affect the way anticoagulants are metabolised by a person. The St Jude Medical valve was not said by any of the witnesses to have any higher rate of risk of creating thromboembolic events than other valves and Prof Hughes considered that its risk was somewhat lower than its competitors. The witnesses identified different rates of risk of thromboembolism but it is low and of the order of 2 to 3 per cent with anticoagulants, according to Prof Buxton. Professor Buxton is the Director of Cardiac Surgery at Austin Hospital, University of Melbourne and at Epworth Hospital. Professor Hughes considered the rate of complications to be 2 to 5 per cent per annum if a patient is taking anticoagulant drugs. If they are optimally anticoagulated the rate is 0.5 to 2 per cent. The rate of 2 to 5 per cent was contained in a letter written by Prof Hughes in February 1998 which was provided to the applicant some time in March 1998. The applicant says that this was the first time she had ever heard of the risk. 96 The experts were also agreed that tissue valves had a lesser risk of the development of thromboembolism. Professor Hughes said that they were not immune from complications but they were rare. The evidence of the second respondent, Professors Feneley, Buxton and Hughes and Dr Bernstein is to the effect that medical studies have not established that the risk of thromboembolic events in the case of a tissue valve with no anticoagulant therapy is significantly less than the risk associated with a mechanical valve where anticoagulants are taken. Professor Feneley is the Director of Cardiology at St Vincent's Hospital and Dr Bernstein is Staff Cardiologist at Royal Prince Alfred Hospital. 97 The second respondent gave evidence that he would always prescribe a lifelong anticoagulant regime even with a tissue valve. The opinion held by the majority of expert witnesses was that this may not be necessary. Professor Hughes said that in his experience anticoagulant drugs are rarely required. Some views were expressed that had the applicant first received a tissue valve she would nevertheless have been prescribed lifelong anticoagulants. It is not possible however to discern from the evidence whether some of these views were reached with hindsight and with knowledge of the applicant's problems with thromboembolic events. 98 Tissue valves are sometimes recommended where a young patient desires to have children, or to pursue a very active lifestyle or where there is some problem with their taking anticoagulants. A tissue valve may require replacement every eight to ten years or ten to fifteen years, whereas mechanical valves had lasted 20, 30 and sometimes 40 years. Failures of mechanical valves are extremely rare, Prof Hughes said. Tissue valves break down more quickly in younger patients. The risk of death in a re-operation increases. Professor Hughes said that the risk on a re-operation was twice that of the original operation and the more re-operations that are had, the greater the risk. For these reasons no witness suggested that a tissue valve was appropriate for a younger patient, which is to say someone younger that 65 years of age. He would not, in discussions with a young patient, even refer to a tissue valve as an option. In his view a cardiologist would never recommend it. If asked about it by the patient he would explain why he would not recommend it and would refer further questions to the surgeon. 99 The doctors, apart from Dr Finch, were agreed that a regime of anticoagulants is not a contra-indication to surgery. And it was also said by Prof Hughes that the drugs should not prevent a patient pursuing a reasonably active lifestyle so long as they took some care to avoid injury. He would not recommend a tissue valve simply because a person wished to have an active lifestyle. 100 Doctors Finch and Gee are consultants in pain management and specialist anaesthetists. Doctor Gee was of the view that a condition such as the applicant's can be managed whilst undertaking nerve block treatment without significant risk of bleeding or clotting. Professor Feneley also said that surgery is frequently performed on patients taking anticoagulants. Warfarin is replaced with intravenous Heparin therapy and the Heparin is then stopped over the time of surgery. I understand this to have been undertaken when the applicant had her second heart operation and when she had her hysterectomy. Doctor Finch however said that he would not perform a nerve block on a patient with the applicant's history of clotting. The procedure involves the use of needles. Even with the replacement of Warfarin he would not consider injections around the spine in a patient who did not have normal coagulation. He had heard of one such patient suffering from the potentially serious complication of an epidural haematoma.

4. INFORMATION PROVIDED BY St Jude Medical INC TO DOCTORS 101 The St Jude Medical Mechanical Heart Valve Physician's Manual, published 1995, is provided with a St Jude Medical valve when packed. It is largely concerned with technical information and techniques of implanting the valve. With respect to post-operative considerations it says that it recommends patients be maintained on anticoagulants. The potential side effects and complications with heart valves listed include thrombus or thromboembolisms. 102 More relevant in the present case is the Physician's Reference Manual which is made available to cardiac surgeons around the world. There is evidence that the third respondent was supplied with a copy of it, and I take that to have occurred at a time prior to his seeing the applicant. Apart from technical information the manual contains a number of articles and some of them deal, in some detail, with valve-related complications including valve thrombosis and discuss rates of occurrence. One study put the rate of valve-related complications at 2.1 per cent per patient year.

(a) At Assembly 103 St Jude Medical Inc maintains a history of each mechanical mitral valve from assembly to the patient and has protocols for subsequent examinations of valves which have been the subject of complaint or adverse experience. The applicant's valve, serial number 60242545, model number 31MEC-102 was fabricated, tested, sterilised and packed in Puerto Rico according to the Device History Record as explained by Mr Monaghan, who was then a Quality Control Inspector employed by St Jude Medical Inc. 104 The orifices and leaflets are manufactured separately. The carbon-coated components are machined and polished to a high degree and readied for inspection, sorting and assembly. Each leaflet and orifice is assigned an identification number so that it can be tracked during the manufacturing process. Each assembled valve is assigned a serial number. Each step in the inspection, testing and assembly of the valve by St Jude Medical Inc post-manufacture is recorded on documents known as 'travellers' which are compiled into a file for the assembled valve called the Device History Record. Mr Monaghan referred to those relating to the applicant's explanted valve in discussing the procedures undertaken with respect to it. The procedures include inspections designed to detect and identify any irregularities on the surfaces of the leaflets and orifices such as pits, depressions, bumps, scratches, stains and discolouration. 105 The inspections include computer-aided dimensional testing, measurement of the thickness of the leaflet ears and a visual inspection at 7x magnification. A discrepancy report was generated with respect to the left leaflet of the applicant's valve, although this appears only to have indicated that the computer was unable to detect a component due to improper positioning. The leaflet subsequently passed all tests and met specifications making it acceptable for assembly. A discrepancy report with respect to the right leaflet, after a visual inspection, noted the presence of a stain on the knife side. The presence of stains does not mean that the component should be rejected and they arise for a number of reasons. 106 The right leaflet was subjected to further assessment by a manufacturing engineer and quality assurance engineer and a decision was made to rework the leaflet to remove the stain, following the 'Carbon Rework Procedure'. The procedure requires that the carbon surface of the valve be hand polished, using a cotton swab and diamond paste. The paste contains minute diamond particles measured in microns. The procedure is undertaken in a 'clean room' where the environment is controlled. A microscopic visual inspection of the reworked area is undertaken, usually at 7x magnification, following rework. The rework was completed and passed the visual inspection test. After further checks on the leaflet's dimensions it was approved for assembly. 107 At assembly the orifice is spread open and the leaflets inserted so that they fit into a swivel within the orifice butterflies. The assembled valve is then subjected to a functional test and further cleaning and visual inspection at 7x magnification. The valve passed this inspection. The sewing cuff is then mounted onto the valve assembly. The valve and cuff are then subjected to further visual inspection at 7x magnification. The valve passed this examination. The valve was then cleaned, sterilised, packed and shipped.

(b) After Explant 108 On 3 July 1997 Ms Mitrangas received the St Jude Medical valve and completed a record of a therapeutic device problem. On 7 July 1997 the applicant's solicitors wrote to the hospital requesting notification of the testing and that the valve not be disposed of. 109 Ms Bethel, a Field Experience Report Analyst at St Jude Medical Inc, received the valve, which was contained in a small specimen tube, and opened a file. The Field Experience Report department investigates complaints or adverse experiences regarding products. It records and investigates each adverse event regardless of whether they are subject to mandatory reporting. St Jude Medical Inc maintained a Protocol for testing and reporting. It was Ms Bethel's responsibility to co-ordinate the activities relating to the physical handling of the applicant's explanted valve, to analyse the condition of the valve as received and to oversee its function and dimensional testing. 110 Following the Protocol Ms Bethel photographed the packaging and the valve and documented the condition of the valve on the Returned Valve Examination Data Sheet after conducting an examination. She conducted a gross visual examination after removing the valve from the specimen tube using forceps. She looked at the pivot guards, valve orifices, valve leaflets and sewing cuff for the purpose of detecting any abnormality, breakages, cuff abnormal tissue growth, scratches or surface imperfections. She did not notice any imperfections but did notice the presence of tissue at various points. The leaflets opened and closed with some resistance, which she thought to be due to the presence of tissue growth. She then sent the valve to Dr Titus. 111 Doctor Titus also conducted a gross visual examination. He observed that the leaflets could be closed with moderate pressure and that there were fibrinous deposits on the surface of both leaflets with large amounts in both of the recessed pivot covers. His usual practice was then to gently remove the majority of the tissue and check for scratches or dents on the surface. He did not note any. He then conducted a microscopic examination at both 5x magnification and 10x magnification , aided by a dissecting light. He did not record any blemishes on the carbon surface or any imperfections. He observed that a large portion of the material observed on the leaflets and in the recessed pivot areas was fresh fibrin 'containing moderate numbers of intact red blood cells and leukocytes in a somewhat layered and generally scattered fashion'. In his view they were only a few days old when stored in the tube. He then conducted a detailed microscopic examination but found no abnormalities or defects and noted that the valve was free from defects. 112 On 12 August 1997 the packed valve was sent to the St Jude Medical Inc engineering test laboratory for functional testing, which duplicated its operation under simulated conditions. Prior to being sent, Ms Bethel cleaned it under 10x magnification and checked for defects. She made no note of any. On its return to her Ms Bethel disassembled the valve for dimensional analysis using special equipment to preserve the integrity of the surface. She used a mechanical spreader, gently opening the orifice, so as to allow the leaflets to disassemble and fall out. It was then sent to another facility for analysis. 113 On 18 September 1997 St Jude Medical Inc sent a report to the third respondent. When the applicant did not receive a copy she contacted Mr Newman who wrote to her on 24 November 1997 and advised that the valve had appeared normal under testing except for the thrombus on it. He advised that the extent of the thrombus, despite anticoagulants, was a quite rare event, but that it had been mentioned before in connexion with mechanical valves. 114 Sometime in November or December 1997 the applicant visited Dr Nigel Buxton, a pathologist, to find out if St Jude Medical Inc's testing of the valve had been adequate. He told her that it had been viewed under inadequate magnification and raised other issues. He helped her to compose questions which the applicant forwarded to St Jude Medical Inc on 20 January 1998. She later requested that the valve be returned to her. St Jude Medical Inc responded that it would not return the valve but some agreement for a protocol for testing might be reached. In July 1998 the applicant again indicated that she wished to have the explanted valve independently tested and in August 1998 she advised St Jude Medical Inc that she intended to pursue legal action in relation to the valve. It was not until after commencement of her action in March 2001 that the retrieval of the valve appears to have been revisited. 115 In late July or early August 2001 Ms Smentek of St Jude Medical Inc was asked to obtain the applicant's explanted valve from storage and arrange for examination using a scanning electron microscope so that the condition of the valve could be recorded prior to the valve being released. The applicant's valve was in a disassembled state, and the sewing cuff and each leaflet were in separate plastic bags. She retrieved the valve and undertook a normal microscopic examination at 10x magnification to assess whether the valve was in a condition suitable for scanning electron microscope photographs, having regard to the presence of any dust or other particles. She did not observe any abnormalities. She then took nine digital photographs of the valve components, but did not identify each view. She undertook this procedure using rubber-tipped forceps. 116 On 14 September 2001 Mr Long, then a materials engineer with St Jude Medical Inc, undertook a scanning electron microscope examination and reported the presence of a spall or small chip on the left ear of the bevel edge of the right leaflet under magnifications of 11x and 75x. The chip was 400 microns in length and 200 microns wide. Ms Smentek later reviewed the photographs taken by Mr Long. The chip can be seen at those numbered 813 and 814. She undertook another microscopic visual analysis at 10x magnification and could then clearly see the chip.

OPINIONS CONCERNING THE CHIP ON THE VALVE 117 It is necessary to interpolate here what was observed in relation to the valve on explant by those present including the third respondent and Mr Newman, who had attended because the applicant's case was so unusual. Mr Newman described the valve as having a thin velvety coating of a sort of fibrinous material over the entire surface and on at least one side of the leaflets of the valve. It may have been on both sides. The appearance of the coating was most unusual. It was uniform over the surface. It did not appear to be localised thrombus formation around the sewing ring or the hinged areas. This accords with the third respondent's observations. The doctor who recorded the hospital's operation report, but who was not called as a witness, however wrote that there was 'thrombus predominant in the area of the hinge mechanism'. 118 Part of the applicant's case assumes that the chip later found on the right leaflet of the explanted mitral valve was present when implanted into her and was the cause of thrombus or thrombi forming on the valve. As to the latter, Prof Hirsh said that it was possible that a chip on a leaflet could cause some disturbance in the blood flow which would increase the likelihood of a thrombus developing on the valve. An important consideration here however was that on explantation the thrombus on the valve was observed to be widespread, on both of the leaflets and on both sides of the leaflets and on the sewing ring. It was not localised to the area near the chip. If the chip was the source of a thrombus one would expect the focus of the nidus of the thrombus to be at the site of the chip and perhaps spreading to the immediate area. In his view a chip such as this would not have caused thrombus to form across the valve. 119 The only evidence suggesting the chip as the source of the applicant's thrombi was that of Prof Brandwood. Professor Brandwood has a background in biomedical engineering and is a consultant to innovators of medical devices. He did not disagree with Prof Hirsh's view that a thrombus associated with the chip would be expected to be more closely associated to the hinged pivot area. Professor Brandwood considered one particular photograph of the leaflet (PB1010) to be particularly instructive. It showed a concentration of attached thrombus adjacent to the pivot area. It was not however possible for him to distinguish which was the right or left leaflet. He accepted in cross-examination, and with the aid of clearer photographs, that the material he was referring to was on the right side knife edge of the right leaflet and that, correctly orientated, there was no material apparent on the left ear of the bevelled edge of the right leaflet. He agreed that it provided no support for the presence of thrombus near the chip in the valve. 120 Professor Williams, Professor of Clinical Engineering and Professor of Tissue Engineering at Royal Liverpool University Hospital, England also gave evidence that all synthetic materials have an intrinsic ability to activate platelets and the blood clotting process. Further, all designs of heart valve influence the characteristics of blood flow. The greater the disturbance produced, for example by the flow of blood around leaflets or hinge mechanisms, the greater the effect on this tendency to produce clots. All manufacturers were aware of the potential for the formation of thrombus because of chips and other defects, Prof Williams explained. It is possible that surface defects might influence thrombus formation. He was not however aware of any evidence to suggest that a chip of these dimensions increases the risk of thrombus formation. 121 Professor Buxton also considered that there was no way of quantifying the risk of a chip of this size causing thrombus. He considered that the development of a thrombus usually commences in the area of the valve hinge mechanisms where the flow of blood is relatively low. 122 The valve in question was removed sometime after the formation of the thrombus or thrombi on it which resulted in the applicant's stroke. Professor Hirsh pointed out that the extent of the thrombus observed at explant was not necessarily what had developed prior to the emboli moving into the applicant's blood system. Nevertheless I understood all the witnesses to proceed upon the basis that what was seen on explant was reliably indicative of how thrombus developed on the valve implanted in the applicant. There was no other reliable evidence as to how it developed at the relevant time. 123 Professor Brandwood postulated that the widespread thrombus formation over the valve might be connected to factors affecting the area of the leaflet near the hinge where the chip existed. He thought that a thrombus at this point, which I take him to say would have originated in the chip, may have so impaired the movement of the leaflets that it caused the widespread formation of the thrombus. There was some evidence from Dr Titus that upon his examination both leaflets were nearly fixed in an open position and it had been recorded following explant that the thrombus was predominant in the hinge area. Professor Hirsh however said that it was difficult to interpret what Dr Titus saw and that more reliance should be placed on what the third respondent and others had observed at explant. The applicant also pointed to the note by Dr Maher in the hospital's operation report which suggested a preponderance of material at the hinge. This would appear to be consistent with the view expressed by Prof Buxton and others that one might expect the development of thrombus in this area. That does not assist a conclusion that a chip in the area was the cause of the thrombus. Moreover Prof Brandwood's theory of impaired movement of the leaflets creating the widespread thrombus, after the thrombus had developed on the chip near the hinge, requires that the impairment be substantial. Professor Hirsh however explained that if the movement of the leaflets had been so impaired one would have expected impairment of ventricular function and symptoms of heart failure, unless it occurred just at the time of surgery. Professor Hirsh was unaware of any published literature which might confirm Prof Brandwood's hypothesis. 124 It would follow from Prof Brandwood's theory that the chip was present when the valve was implanted. He thought this was possibly the case. In his opinion it was possible that polishing or reworking the leaflet could have resulted in damage to the brittle thin coating of the valve if the opposite, downward, side of the valve had been resting on a hard particle of grit or dust which then impacted on the surface. 'Although unlikely', the possibility of a defect having been introduced to the leaflet during the rework could not be ruled out, in his view. 125 Professor Brandwood's approach was to discount various possibilities until only one feasible option remained. Generally he was of the view that the location of the chip was almost inaccessible to physical interference or impact when the valve was assembled. Therefore damage to the valve at any time following initial valve assembly and before disassembly by Ms Bethel is to be discounted. This would appear to leave the alternative possibilities of damage during manufacture prior to assembly or during handling post explant. In both these respects Prof Brandwood agreed that the methods for inspection were adequate and that 7x magnification was clearly sufficient to detect the chip. In his opinion the only feasible occasion for damage during manufacture was during reworking. As already noted, whilst the likelihood of its occurrence was low, Prof Brandwood considered that it could not be discounted. 126 Mr Monaghan said that any reworking would have been done in a clean environment and that the presence of a hard particle of dust or other material of a size sufficient to cause this chip was highly unlikely in such an area. In his view downward pressure whilst cleaning would not be enough. 127 Professor Williams did not consider that the hypothesis of damage during rework of the leaflet was open on the information available. In his view the appearance of the chip was consistent with contact between the valve leaflet and a sharp instrument, such as forceps. It seems to have been accepted by those giving evidence that damage was unlikely to have been occasioned by the use of forceps during explant. 128 Professor Buxton considered that there was also very little prospect that the chip occurred during implantation, for the same reason, namely that the site of the chip was inaccessible to instruments. In his view it was more likely that it was caused during extraction of the valve leaflet from its housing prior to electron microscopy. 129 Professor Brandwood, understandably, was not in a position to explain how no chip was seen on examination after the rework or on later examinations. He agreed that it could be seen at 7x magnification. Ms Bethel and Dr Titus, in his view, might have overlooked the chip in the assembled valve because it was on a part located within the hinge area and difficult to see when assembled. He discounted the prospect of damage by Ms Bethel during disassembly because force was then applied to the ring, not to the leaflets and she used rubber-tipped forceps. He also discounted the possibility of damage during transit to Mr Long although he conceded, when questioned, the possibility that the leaflet could have been dropped or mishandled at this point. He did not regard Ms Smentek's photographic records to be necessarily complete because they did not identify the area being photographed. He says that it is possible that the area now known to be chipped was not photographed by her. The lack of suitable photographic evidence was considered by Prof Brandwood to affect the reliability of Ms Smentek's visual examination. He said that it raises the 'strong possibility' that the valve was not completely examined and that the chip may have been overlooked. Professor Brandwood did not explain how such a conclusion was reached. I am unable to understand how any deficiency in identifying or recording the photographs should detract from the visual examination by Ms Smentek of the valve itself. Nevertheless her examination and the photographs do not support the theory that the chip occurred during disassembly by Ms Bethel.

the applicant's medical history and events FOLLOWING IMPLANT

(a) Medical 130 After the first operation, on 20 June 1996, the third respondent attended upon the applicant and explained to her that her mitral valve had been too badly damaged for repair to be possible. He said that he had replaced the valve with a mechanical valve. 131 A few days after surgery the applicant was shaving her legs and cut herself. The extent of the bleeding which followed was explained by a nurse as an effect of the anticoagulant drugs she was taking. The applicant says that this was the first time she realised she was taking such drugs. 132 At about this time the applicant was provided with a booklet published by St Jude Medical Inc entitled 'Living with your new heart valve: an educational booklet for recipients of the mechanical valve', which she read. It provided general advice to recipients as to lifestyle changes which would be necessary. It gave advice about undertaking exercise, diet, warned of fluid retention and the risk of endocarditis, an infection which can develop in the tissue around an artificial valve. It advised recipients that their doctor might prescribe anticoagulant medication to prevent blood clots forming on the valve and advised that they maintain recommended levels of anticoagulants and to check with their doctor before taking any other medication. It listed a number of symptoms and advised the recipient to consult their physician if they develop. The applicant recalls thinking that the anticoagulant medication must have been what the third respondent had discussed with her. The evidence on this topic is somewhat confusing. The applicant says that the nurse's advice was the first time she knew about anticoagulants. In cross-examination she said that at this point she also understood that anticoagulants prevented clotting, because she had read the booklet. And she says she understood that if clots formed they could travel to other parts of her body. That advice was not given in the booklet. 133 In mid July 1996 the third respondent performed an echocardiographic examination of the applicant which showed that the mechanical valve was functioning normally. The applicant says that in this period she felt unwell and experienced pain in her fingers and patches of disturbed vision. Whilst visiting her general practitioner on one occasion she fainted. Upon recovery it was observed that she had blood under her fingernails. Her general practitioner expressed the view that they might be splinter haemorrhages, but the second respondent did not think so when the applicant saw him shortly afterwards. The applicant says that over the following months she experienced this symptom several times. 134 In this period, from discharge to 24 September 1996, the applicant's INR levels fell below the recommended range. This was the case on three occasions between 20 and 24 September 1996. On 24 September 1996 and again on 15 October 1996 the applicant attended the hospital complaining of acute abdominal pain. On 16 October 1996 the applicant underwent tests which revealed a large infarct to the spleen and a small infarct to the left kidney. A computed tomography of the applicant's cranium did not show any infarct to the brain. 135 During this period of hospitalisation echocardiographic examinations were undertaken. That conducted on 16 October 1996 showed some evidence of echoes on the ventricular surface of the anterior portion of the St Jude Medical valve, consistent with loose chordae or vegetations. That of 21 October 1996 revealed echoes on the atrial surface of the mitral valve ring consistent with fibrin strands, vegetation or thrombus. Upon her discharge the second respondent set the applicant's INR goals at 3.5 to 4. 136 On 27 October 1996, whilst an in-patient, the applicant was reviewed by Dr Kermode, a neurologist. She gave him a long history of paroxysmal episodes of disequilibrium and of episodes of skew deviation when looking down. These symptoms often occur together. She had, for many years, had visual 'squiggles' in her eyesight of brief duration. Her other medical problems included the continuing symptoms from the motor vehicle accidents. Of more concern, in his view, prior to her admission on 14 October 1996, were the two episodes she had suffered of bilateral lower limb weakness and paraplegia. Doctor Kermode's later evidence reveals that he believed these episodes to have been thromboembolic in origin, but that they later resolved. I infer that they may have been the precursors to the infarcts. 137 He explained to her that the infarcts had been caused by blood clots forming on the valve and travelling through her bloodstream. He advised her that she was at risk of a stroke from the same cause. The applicant was additionally prescribed the drug Heparin. 138 On 11 December 1996 the applicant was admitted to the hospital having suffered from headaches, dizziness and syncope or fainting. Her INR level at admission was 1.5. Examinations of her cranium were unremarkable. 139 On 9 January 1997 the second respondent reviewed the applicant and recommended her INR level be maintained at 3.0 to 3.5. When the applicant was referred again to the second respondent on 26 February 1997 she reported having had fainting spells and bleeding under the nails. The second respondent was of the view that there were no clinical signs of endocarditis and blood tests then taken confirmed this. 140 On 7 March 1997 an echocardiographic examination revealed that the St Jude Medical valve was functioning normally with no evidence of thrombi or vegetations. On the morning of 21 March 1997 the applicant felt unstable whilst showering at home. Her condition worsened. She experienced double vision, was unable to walk in a straight line and lost some of her motor functions. She was admitted to hospital and reviewed by Dr Kermode the following day. Scans were undertaken. She had suffered a right thalamic and midbrain infarction. Doctor Kermode says that mild vascular anomalies were also demonstrated. The second respondent recommended to Dr Kermode at this point that the applicant also take Aspirin to increase the anticoagulant effects of the Warfarin. 141 In April 1997 the applicant suffered from menorrhagia, or excessive menstrual flow. She had had this condition previously and in particular in 1992, although she said the bleeding was not then as heavy as that she had in 1997. Nevertheless it would appear that it was sufficiently heavy to confine her to her home for a time. On the morning of 4 April 1997 she awoke in a pool of blood. The heavy bleeding continued and she was admitted to hospital. The applicant continued to suffer menorrhagia on occasions thereafter. 142 When the second respondent reviewed the applicant on 8 May 1997 she reported episodes of sudden weakness, lack of co-ordination and episodic double vision. She was distressed, weak and unsteady. The second respondent was unable to detect any abnormalities in her cardiovascular system and the St Jude Medical valve sounded normal. Twenty-four hour electrocardiogram monitoring did not indicate any matter for concern. 143 On 25 May 1997 the second respondent again saw the applicant. She reported that she felt somewhat better since commencing on another drug. The applicant however says that in early June she attended upon the second respondent because she was unwell and had been collapsing frequently. She collapsed in his waiting room. She told the second respondent that she could not continue with these symptoms and says that he advised her, in effect, that she should be finding ways of coping with her life. 144 On 12 June 1997 the applicant was taking the family dog to her childrens' school to show to the students. She felt dizzy as she left the classroom and as she walked to her car was unable to walk properly. As she got to the car she lost the use of her right arm. She was unable to get into the car. She observed in the car mirror that the left side of her face had dropped. She fell to the ground and was unable to raise herself. The applicant was admitted to hospital with right-sided weakness. An echocardiographic examination of the applicant on 16 June 1997 showed the St Jude Medical valve to be functioning normally and there was nothing to indicate material on the surface of the valve. An arch aortogram undertaken on 18 June 1997 confirmed total occlusion of the left vertebral artery. It also showed that the artery was hypoplastic, or under-developed, a condition which was probably constitutional, in Dr Kermode's view, and lifelong. Similarly it showed the applicant's intracranial posterior circulation to be low. 145 In 1997 the applicant's condition was reviewed in a conference of seven specialists, including Dr Kermode. In view of the applicant's series of thromboembolic events it was recommended that the St Jude Medical valve be replaced. The applicant was, understandably, frightened of the prospect of this surgery and her family distressed. She was concerned that she might not survive the surgery or suffer a catastrophic stroke. 146 As earlier mentioned the applicant received a replacement tissue valve on 27 June 1997. Since then she has been maintained on Warfarin and is likely to be required to take anticoagulants for the rest of her life. 147 On 8 July 1997 the second respondent reviewed the applicant. She reported feeling well. A further examination on 14 July 1997 revealed the tissue valve to be functioning normally. On 20 July 1997 however the applicant was admitted to hospital suffering chest pain which was thought to be reactive pericarditis. 148 The applicant says that after leaving hospital she wrote to the second respondent advising that she did not wish to consult him further. She says that the reason for this was that she did not believe that he was able to diagnose her condition accurately. In fact it was not until 22 February 1998 that the applicant wrote to the second respondent advising that she had asked Dr Hands to assume management of her heart condition. In the letter she said that on a number of occasions he had not been available for consultation when she was hospitalised. In cross-examination she agreed that that did not represent her true view. The true reason for discontinuing his services was because he had not believed what she had said, which she somehow equated with her earlier statement concerning his inability to diagnose. 149 There had been correspondence between the applicant, her solicitors and the second respondent productive of some disharmony in late 1997. On 11 October 1997 the second respondent provided a report, at the request of her solicitors, for the purpose of her action concerning the second accident. In it he said that her cardiovascular status had been a major limiting factor in her inability to work over the past eighteen months and she had not been capable of full time or part time work. On 17 October 1997 the applicant wrote to the second respondent saying that she was 'shocked and dismayed' to read the report and indicated that she had in fact been employed in the last eighteen months. She was annoyed because he had told her to return to work and resume a normal life and she had attempted to do so, but now he was saying that she was unable to work. The second respondent rang her and invited her to write to him with full details of the employment she had undertaken. She advised that she had managed to work on almost a full time basis in the past five years with Westpoint. This appears to be something of an overstatement. She related her principal inabilities to her neck and back pain. It is clear enough that she sought to have the second respondent place less emphasis upon the impact of the heart surgery on her ability to work. In his report of 11 November 1999 the second respondent outlined in more detail the work she was able to do and her return to work as a bookkeeper following the second operation and noted that she had had difficulties with her back and neck even prior to the first operation. It is not suggested that the second respondent did not believe what he wrote on the second occasion to be correct. The applicant relies upon the second respondent's description of the changes to his report as minor when they were more substantial. I do not consider it conveys anything about the second respondent's credit. It is however indicative of the applicant's ability to make demands of her medical practitioners. 150 In August 1997 Dr Kermode's differential diagnosis was either that the applicant's congenital hypoplastic cerebral circulation was predisposing her to intermittent neurological disturbance at times of mild hypotension or that the episodes may have been due to migraine sine hemicrania. The intermittent neurological disturbances to which the doctor refers in this connexion are the positive visual disturbances, the disequilibrium and incoordination of the limbs with nausea and disruption of coordination. By January 1998 Dr Kermode had a third differential diagnosis, namely that the disturbances resulted from emboli having a cardiac origin, although he considered this to be the least likely of the causes. Scans taken in July 1998 showed no evidence of any cerebral infarct apart from that which had occurred in March 1997. That scan, and those undertaken since, do not provide any evidence to support the third differential diagnosis, Dr Kermode accepts. 151 In the period October 1997 to mid-January 1998 the applicant presented to the hospital with facial numbness and loss of balance, palpitations associated with dizziness, collapse, episodic double vision, visual disturbance, dizziness and occasional fainting and 'muddy spots' over the sight in the right eye. The second respondent's clinical examinations did not reveal any cardiac problems. 152 On 20 January 1998 the applicant attended to the hospital again with chest pains, shortness of breath, light-headedness and palpitations and on 17 February 1998 with left upper quadrant pain. The second respondent reviewed the applicant in hospital and on 18 February 1998 recommended further twenty-four hour holter electrocardiographic monitoring and advised that her current condition of anaemia could be contributing to her symptoms. The applicant first consulted Dr Hands on 19 February 1998. 153 The applicant continued to consult Dr Kermode. In June 1998 she reported experiencing diplopia rarely, but some visual phenomena once to twice a week. In July 1998 she had recurrent diplopia and disequilibrium. A further scan undertaken on 30 July 1998 showed no recent infarction of the brain. The applicant again reported to Dr Kermode on 10 August 1998 that she had woken with diplopia, loss of balance and slurred speech and that these symptoms had lasted several hours. A further scan showed no change. In a letter to Dr Anell in May 1999 Dr Kermode noted that the applicant was still having significant periods of diplopia with occasional positive visual phenomena, which he ascribed to migraine. By 17 August 2000 he was able to tell Dr Anell that she had not had any diplopia for a period of several days. The problem occurred when she looked from right to left, especially when driving. He also recorded that she had occasional pre-syncope. He expressed the view that, whilst the diplopia was migrainous, the effects of the stroke could be contributing to the risk of its occurrence. 154 On 18 August 1998 the applicant underwent a hysterectomy. In a report to her solicitor of December 1998 Dr Hands observed that prior to this time she had suffered fatigue which he thought to be secondary to anaemia caused by the heavy menstrual bleeding. She had reported as feeling much improved after the hysterectomy. The depression she had initially felt after the surgery, and for which she had received psychiatric treatment, had resolved. 155 In a report of 21 December 1998 Dr Hands summarised the other problems the applicant had had that year as including light-headedness; palpitations; diplopia (which he noted Dr Kermode was treating) and left hypochondrial pain. In the latter respect however there was no evidence of any further infarcts. The new valve was functioning normally. He went on: 'Other than occasional episodes of light-headedness, occasional palpitations and occasional episodes of intermittent left hypochondrial discomfort, she is well and enjoying good energy levels.' 156 In July 1999 the doctor observed that her symptoms were unchanged and were relatively infrequent and tolerable. Her anticoagulant therapy was under control. 157 The applicant continued to suffer a number of different symptoms. On 29 January 1999 the applicant presented to the hospital with left-sided chest pain radiating to her left shoulder. Episodes of chest pain, shortness of breath and associated symptoms continued through to June 2001. The various diagnoses at discharge from the hospital on these occasions included tachycardia, atypical chest pain, chest wall pain and paroxysmal atrial fibrillation. 158 From September 2000 the applicant reported symptoms of syncope, palpitations, dizziness, faintness and lethargy, weakness and dizziness. In November 2001 Dr Hands considered two methods of testing for the syncope. The first, tilt table testing, did not show anything. In February 2002 the doctor arranged for her to have a specialdevice fitted. It is not apparent from the evidence to which I was taken what the outcome of that test was. By January 2003 the applicant was reporting that the episodes of weakness and dizziness, associated with palpitations, were increasing. On 23 September 2003 she presented to the hospital with chest palpitations which had occurred during the past 3 weeks and severe headaches. 159 Doctor Hands was not called to give evidence by the applicant. It would appear from a letter from the applicant to Dr Hands on 13 December 1998 that the applicant did not wish to do so. The letter explained that she was intending to 'take court action' against the first respondent and St Jude Medical Inc. They had previously indicated that they would defend any action by claiming that her injuries were caused by the negligence of her medical team. I interpolate that the employee of Getz Bros & Co (Aust) Pty Ltd to whom this is attributed denies giving such advice. The applicant then said: 'Accordingly I am planning to join Professor Thompson and Dr Nichols [sic] in this action to compel them to give evidence which I expect will support my claim and refute the claim made by Getz Bros.'

(b) Work History 160 After the two heart operations and between October 1997 and late 1998 the applicant did undertake some further work. Her brother agreed to finance her in the establishment of a chain of fashion stores. Her health did not permit her to work full time and she was only able to manage the undertaking with the assistance of a full time assistant. The four stores were not trading at a profit at the time the venture failed because of the applicant's health. They had not however traded for a long time. She had designed a range of clothes which were manufactured in China. She was about to launch the range in the stores when she was required to have a hysterectomy as a matter of some urgency and she was unable to work for over a month. She and her brother then decided to abandon the project. In 2002 she undertook some further studies towards a degree in fine arts. The applicant otherwise continues to work for her husband's firm for eight to ten hours per week. At the time her statement concerning her economic loss was filed, on 8 July 2002, she did not believe that she could hold a similar position in the workforce. 161 The applicant says that she is presently employed by Westpoint as the Executive Manager of its Multimedia Unit which was established in January 2003 as an independent unit. It produces Westpoint's printed, electronic and display materials, signage and websites. She is able to organise the hours she works to suit her. She says that she is usually able to work ten hours per week but her health problems sometimes restrict the number of days she can work even further. She is not required to provide time sheets. It would also appear that she continues to work for her husband's firm, for up to ten hours per week. The applicant also attends between four and six meetings in Canberra per year, in her role as ministerial appointee to committees concerned with cardio-vascular and stroke strategies and medical devices. 162 The applicant says that presently she is paid $52,000.00 per annum plus a performance bonus which is 10 per cent of net profit if the budget turnover target is met. It is not clear what the figure for profit is taken from. To date however she has redirected her performance bonus entitlement to her Operations Manager who carries the main burden of the work and has to assume her role when she is not available.

the applicant's opportunities to earn income 163 The duties associated with the applicant's position include the development of a business plan, monitoring costs and budgets and supervising design and production. The applicant says that were she well enough she would be able to carry out both her tasks and that of the Operations Manager. One person would normally fulfil both tasks. In addition to the income received as Executive Manager she could earn another $77,480.00 for the Operations Manager's role. 164 The applicant's principal case is that, had she not suffered the injuries or symptoms she attributes to the implantation of the St Jude Medical valve, she could have earned considerable sums selling financial products and earning commissions for Westpoint. This would not appear to be the same position the applicant has referred to in previous litigation, despite the applicant and her brother suggesting that it is. 165 The applicant's brother, Mr Carey, said that a position selling financial products would have been available to her if she had been able to finish her commerce degree. An offer to that effect had been made in 1991 but had to be withdrawn in 1997 when she could not complete her studies. Nevertheless he said that she was again offered such a position in 1998. The applicant put the date at 2000. In 1998 the applicant was taken up with the fashion stores and Mr Carey's date seems unlikely, as does the prospect that the offer was in fact made. I take it that the position is a demanding one and not one where a person can choose when they work. Indeed the applicant's case is that she could not undertake the role. There would seem to me however to be little difference in the physical disabilities she recounts as current and her state in 1998 and 2000. This raises the question why the offer would have been made. Nevertheless Westpoint does have persons undertaking these roles and there is evidence of other commission agents and the prospect that she might have considered such a role remains to be considered. 166 Westpoint finances its developments by raising between 50 to 60 per cent of the project cost from a major bank; funds from equity investors at between 10 to 30 per cent of the project cost; and mezzanine finance of the same order. Equity investors are obtained through Westpoint and its brokers and agents. Likewise, Westpoint, agents and brokers identify investors for the 'mezzanine finance' which is usually facilitated by promissory notes which they negotiate. 167 Although Mr Carey said that employees of Westpoint sourced investors as well as external agents and brokers there was no evidence as to their earnings. There was a reference to 'these project finance arrangers', which would appear to extend to Westpoint's employees in its Financial Products Division, earning commission. The percentage commissions he goes on to refer to however are attributed to external brokers and agents only. And while he refers to the large sums Westpoint has paid by way of commission no records were produced to show any individual's earnings from Westpoint and none were produced with respect to Westpoint's employees. The evidence ought to be viewed with considerable suspicion. He said that a broker or agent could expect to receive 2 to 5 per cent commission on funds invested by equity investors, 5 to 10 per cent on amounts over $100,000.00 on mezzanine finance together with a further commission of 5 to 8 per cent each time the promissory note is rolled over or the fund reinvested, and 3 to 6 per cent of the amount of direct property investments. It is these sums which he says his sister could have earned. He thinks that she could earn $500,000.00 per annum and this equates with amounts of commissions paid by Westpoint in the period 1998 to 2003. How the figure is arrived at was not gone into. 168 Mr Carey believes that his sister has the ability to earn sums of the kind mentioned. He points to the considerable network of contacts she developed whilst she was a model and the advantage she would have as a member of his family. He points to the work she performed in the early 1980s when she assisted in the management of the City Markets for Westpoint. He identifies three occasions when the applicant introduced potential or actual purchasers to Westpoint. And he refers to the experience she had in the fashion business which she was unable to pursue. 169 Mr Beck is a person whose company, Needlers End Nominees Pty Ltd, has earned commissions of the order Mr Carey spoke of in recent years. His work as an agent includes work for Westpoint but it is not his company's sole source of income. He is also a consultant to and a director of some companies within the Westpoint group. He has considerable experience in the Australian property industry. Mr Beck gave evidence of the earnings of a business development manager recently employed by him in his business. She is about thirty years of age with little experience in property but she has previous experience as a business development manager. Her task is to undertake necessary research work for him to enable him to attend meetings and deliver presentations to raise capital from clients. Just what is involved was not gone into in detail. She then follows up on what he has achieved. Her remuneration is 11 per cent of capital raised or $60,000.00 per annum plus superannuation and normal entitlements, whichever is the greater, according to her letter of appointment. Additionally, she is to receive 25 per cent by way of share in the net profit of the company on a quarterly basis. In evidence Mr Beck said that he anticipates that she will earn $375,000.00 in this year, of which $200,000.00 represents her 1 per cent share of commission. The balance was said to be her profit share. It was not obvious to me what use is to be made of this evidence. Mr Beck's position would not appear to be comparable to an employee of Westpoint. There is no obvious parallel with his manager's agreed remuneration and what Westpoint might pay.

THE applicant'S CURRENT symptoms AND THEIR EFFECTS 170 The focus of the applicant's description of her symptoms which have caused and do cause her difficulty are her dizziness, weakness, fatigue and collapse. She identifies a number of occasions since 1996 or 1997 on which she has fainted or felt faint. The occasions identified continued through to 2002, although I take the applicant to say that she continues to suffer these symptoms. They prevent her from a large number of activities, including those with her children, travelling, and affect her ability to carry out work. She is nervous of driving and has an arrangement with her husband to telephone him every few minutes if the symptoms commence. Because of these and other symptoms the applicant is unable to work full time. 171 The applicant is of the view that she is obliged to remain on anticoagulants for the rest of her life, although she now has a tissue valve, because she has sustained damage to her vascular system as a result of the thromboembolisms. I infer that the applicant is maintained on anticoagulants because of her history of thromboembolic events and the possibility that she is predisposed to thrombosis. The applicant understands that she cannot risk bleeding whilst on anticoagulants and therefore cannot undertake activities such as skiing, bike riding and horse-riding. She cannot go camping with her sons. She says that she is unable to have further nerve block treatment. 172 The applicant continues to suffer from diplopia, but she says that since suffering the stroke it is different from that suffered before. The applicant also considers that she has suffered some permanent vision loss due to the accumulation of emboli in the blood vessels in her eyes. When it combines with transient vision loss she is unable to drive. There was no evidence from any eye specialist as to these matters. 173 The applicant continues to suffer palpitations. She is required to take Dioxin to assist in the stronger beating of her heart and she is of the view that she is therefore at risk of Dioxin toxicity. She also requires Flecainide acid to make her heart beat less erratically but this causes side effects. Clearly enough the applicant also attributes that condition of her heart, which these drugs are prescribed for, to the St Jude Medical valve or its aftermath, including explantation. 174 The applicant continues to suffer neck and back pain. She understands that she cannot have nerve block treatment to reduce or eliminate the pain which I infer is significant. She has not taken any other measures to reduce the pain.

the medical evidence as to the applicant's symptoms 175 The applicant has not continued with any management for her neck and lower back pain. No medical practitioner was called to give evidence concerning the current status of these conditions. In October 1996 Dr Finch did however write to her solicitors advising that the pain amounted to a continuing partial disability and that it was unlikely that her symptoms would greatly improve. 176 Doctor Hands did not give evidence, as I have observed. He appears, from his written records and advices, to have been concerned that the episodes of her fainting were related to her heart functioning. It has not however been established that they have that connexion. 177 As to the applicant's symptoms prior to 1996, Prof Buxton says that her symptoms appear to be non-specific and vague. The connexion between mitral valve prolapse and loss of balance is tenuous. The symptoms of mild chest pain and episodes of palpitations may be connected to mitral valve prolapse, but the link is vague. Holter monitoring usually clarifies whether palpitations represent the onset of atrial fibrillation. It may be recalled that the second respondent undertook this monitoring periodically and nothing was shown. I take Prof Buxton to agree with the second respondent's opinion that the applicant's symptoms for the most part were not caused by the prolapse of her mitral valve. 178 Professor Feneley appears to be of a like view. The applicant's mitral incompetence at the time of her first valve surgery did not necessarily indicate that this was the cause of her symptoms. Palpitations and chest pain are reported by patients with mitral valve prolapse, but the symptoms correlate poorly with the degree of incompetence. He would have advised her that her symptoms might not be relieved by surgery, because he doubted they were caused by the condition. He notes references in her medical records to conditions of anxiety and conversion hysteria suffered by her. He considers there is considerable doubt as to the cause of the partially occluded vertebral artery. 179 Professor Feneley made another observation. The exercise test undertaken by the applicant in May 1991 showed excellent exercise tolerance, which would be expected with mild mitral incompetence. The finding does not support the attribution of the symptoms of weakness, shortness of breath and reduced energy levels to her mitral valve prolapse. 180 There is no doubt that the applicant suffered a stroke in the midbrain and infarcts to the spleen and kidney. There is no suggestion however that the latter infarcts resulted in any residual disability. Professor Hirsh is of the view that they were brought about largely because the level of anticoagulant which the applicant was able to maintain at the time was subtherapeutic. 181 Doctor Kermode was clearly of the view that the applicant had suffered symptoms having their basis in a type of migraine condition prior to her surgery in 1996. That condition had caused dizziness, visual disturbances including diplopia, paroxysmal disequilibrium and incoordination of the limbs. Doctor Kermode considered that, prior to the stroke, the applicant had suffered two episodes of neurological disturbance which were not migrainous in origin. There is no suggestion that they have resulted in any residual disability. The midbrain stroke itself initially caused her significant impairment of balance and vision and she developed dysarthria and vertical diplopia, in Dr Kermode's view. She has made a very good recovery from the stroke. It has left her with mild impairment of equilibrium different from the paroxysmal disturbance of equilibrium. It may affect her, for example, when walking on uneven ground. And I understand Dr Kermode's opinion to be that the structural damage caused by the stroke is likely to predispose her to an increase in the frequency and severity of the episodes of diplopia which she has suffered for some time.

(a) The claim under s 75AD 182 Part VA was introduced by the Trade Practices Amendment Act 1992 (Cth). The applicant submitted, in support of her contention that liability under the Part is strict, that it resulted from Report No 51, 'Product Liability', by the Australian Law Reform Commission (the 'ALRC'). The Explanatory Memorandum to the Trade Practices Amendment Bill (No. 2) 1991 (Cth) does not support the applicant's contention. It says that the purpose of the Bill is to introduce into Australia 'a strict product liability regime based on the 1985 European Community Product Liability Directive …'. It appears from what follows in the Explanatory Memorandum however that liability was to be limited by the requirement of a defect. In JD Heydon, Trade Practices Law: Restrictive Trade Practices, Deceptive Conduct and Consumer Protection, Lawbook Co., Sydney, 2001, at [16A.80] it is observed that s 75AC(1) is a departure from strict or absolute liability. The Memorandum states that the regime of strict liability provided for, when a person suffers injury as a result of a defective product, is that they have a right of compensation against the manufacturer without the need to prove negligence on the part of the manufacturer. Another aspect of Part VA, which a Full Court observed in Glendale Chemical Products Pty Ltd v Australian Competition and Consumer Commission and Anor (1999) ATPR 41-672at 42,592, is that it permits recovery irrespective of the existence of any contractual relationship between the manufacturer and the person injured. 183 The provisions of Part VA follow closely the European Community Directive of 25 July 1985 (Directive 85/374/EEC, OJ No L210, 7.8.1985, p 29). The approach recommended by the ALRC went further. Pursuant to it a person would not need to establish that the goods did not comply with a standard of safety or quality. It rejected the need to limit liability by some concept such as 'defect'. 184 The Outline to the Explanatory Memorandum continued: '2. The key concept of the new Part VA inserted by this Bill is that a person who is injured, or whose personal property is damaged, by a defective product will have a right to compensation against the manufacturer of the product. Goods are 'defective' if they do not have the degree of safety which persons generally are entitled to expect in all the circumstances. 'Manufacturer' has the same extended definition as currently applies for the purposes of Division 2A of Part V of the Trade Practices Act. 3. The manufacturer can escape liability where it can prove one of a number of defences, the most significant being that the goods were not defective when supplied by the manufacturer or that the goods represented the "state of the art". The Bill also provides that, where goods contain a defect only because of compliance with a mandatory standard imposed by the Commonwealth, the Commonwealth and not the manufacturer should be liable to compensate the consumer. The amount of compensation payable is reduced by contributory acts by the injured party.' 185 There are three aspects to an action brought under s 75AD: the supply of goods by a corporation in trade or commerce; the goods having a defect; and a person suffering injuries 'because of' the defect. 186 The standard referred to in s 75AC(1), that goods are defective if they do not provide the level of safety which persons generally are entitled to expect, was described in the Explanatory Memorandum (at par 14) as an objective standard. It is based upon what the public at large, rather than any particular individual, is entitled to expect. Further, the standard does not require that the goods be absolutely free from risk (at par 14). The subsection has been construed in this way by Emmett J in Australian Competition and Consumer Commission v Glendale Chemical Products Pty Limited; Barnes v Glendale Chemical Products Pty Limited (1998) ATPR 41-632at 40,970 and by the Full Court on appeal (Glendale Chemical Products Pty Ltd v Australian Competition and Consumer Commission and Anor at 42,595). 187 Section 75AC(1) is intended to apply to a number of different goods. It applies even if there is no inherent defect in the goods: Heydon's Trade Practices Law at [16A.106]. At par 15 of the Explanatory Memorandum it is said: 'It should be noted that there are a number of different types of potential defects. Design defects relate to matters such as the form, structure and composition of the goods. Manufacturing defects are those related to matters such as the process of construction and assembly. Instructional defects are those caused by incorrect or inadequate warnings and instructions. All these categories of "defect" fall within the definition of defect in section 75AC.' 188 In assessing the safety of the product s 75AC(2) provides that all relevant circumstances are to be taken into account. Relevant to this case is the following discussion in the Explanatory Memorandum (at par 21): 'As noted above, in addition to the factors specified in subsection 75AC(2), the court must take all relevant circumstances into account in determining the safety of goods. Safety expectations may also depend on matters such as the nature of the product and community knowledge of that product. For example, there are a number of known negative side effects associated with certain pharmaceuticals and vaccines. It is also generally accepted and known that these side effects cannot be avoided. Such products are known to confer substantial benefits which flow to the wider community at large. The small statistical chance of injury associated with them does not of itself mean that they are "defective".' 189 The Explanatory Memorandum to the Trade Practices Amendment Bill 1992 (Cth) suggests that so far as instructions or warnings are concerned, it may be relevant in a particular case to take into account the role of 'intermediaries' such as treating doctors (at par 24): 'The role which intermediaries may play in the supply of goods may also need to be taken into account. For example, prescription pharmaceuticals are supplied to the consumer by a qualified pharmacists and only on the prescription of a qualified medical practitioner. Due to the complex nature and effects of these products, complete instructions and warnings may not be provided to the consumer by the manufacturer. However, detailed product information is provided to doctors and pharmacists by the manufacturer so these learned intermediaries are sufficiently informed to be able to decide whether or not it is appropriate to dispense pharmaceuticals to particular consumers. This factor will be relevant in determining whether a pharmaceutical is defective, particularly where a claim of a defect in information provided is made. …' 190 An issue arises in this case concerning whether the applicant is obliged to prove, as part of her case concerning the chip, that it was present when the valve was implanted. The first respondent submits that the applicant cannot establish, as s 75AD(c) requires, that she suffered injury 'because of the defect' unless she establishes this fact. The applicant counters that the legislature could not be taken to have intended that an injured person be required to prove the existence of the defect at the time of the supply. 191 The applicant's submission must be correct, in my view. A person bringing a claim under s 75AD is to establish the existence of a defect in the goods and the fact of their injury. Additionally they must prove causation, which is to say that the injury came about 'because of' the defect. I shall return to that question shortly. If the manufacturer has no statutory defence, the scheme of Part VA is that liability is established. It would not be consistent with the requirements of the defence provisions, such as s 75AK(1), to require an applicant to establish the existence of the defect at a point before injury. If the necessary link between defect and injury is established it is to be inferred that the defect was present at the time of the injury, unless the manufacturer shows otherwise. The first respondent's defence, relevant to these proceedings (under s 75AK(1)(a)), is that the defect did not exist when the goods left the control of the actual manufacturer, St Jude Medical Inc ('the supply time'). The Explanatory Memorandum to the Trade Practices Amendment Bill (No. 2) 1991 (Cth) described the nature of the evidence that a manufacturer might have to give in this connexion (at par 39): 'To succeed in this defence, the manufacturer must show, on the balance of probabilities, that the (admittedly) defective goods were defect free when they left the manufacturer's control. Factors such as the nature of the goods, the level of use of the goods, and the length of time between the goods leaving the control of the manufacturer and the damage will be important. Depending on the nature of the defect, the manufacturer may also need to provide detailed evidence on the manufacturing process and quality control to which the alleged defective good (not just goods of that type generally) was subjected, in order to show that this particular good was not defective when it left the manufacturer's control.' 192 The applicant also submitted that it may be that the extent to which she is required to prove a link between a defect in the valve and her injuries is lessened by the subsection. The submission rests upon the choice of the words 'because of' (the defect) in s 75AD(c), which may be contrasted with the use of the word 'by' in s 82(1). It has been suggested that there may be differences in terms of causation, remoteness and the measure of damages flowing from the use of the various terms 'because of' and 'as a result of' in different sections in Pt VA and 'by' in s 82: see Heydon's Trade Practices Law at [16A.150] and at [18.1260]. 193 Gummow J in Elna Australia Pty Ltd v International Computers (Aust) Pty Ltd (No 2) (1987) 16 FCR 410at 418 held that the nature or quality of the causation of which s 82 speaks is to be determined as a question of statutory construction. In his Honour's view common law analogies would not offer appropriate guidance to a statute such as the Trade Practices Act 1974 (Cth)(at 419). The use of the word 'by' is to be understood in a context where a contravention of Parts IV or V need not be the only cause of the loss or damage. 194 Deane J in Wardley Australia Limited & Anor v The State of Western Australia (1992) 175 CLR 514at 542 ('Wardley') adopted a similar approach to s 82. The majority however did not. They do not appear to have considered that the word 'by' conveyed anything apart from the notion of causation. Their Honours (at 525) held that 'by' should be understood as taking up the 'common law practical or common-sense concept of causation' discussed in March v Stramare(E. & M.H.) Pty Limited (1991) 171 CLR 506('March v Stramare'). In March v Stramare Deane J considered that the question of causation is: '… whether an identified negligent act or omission of the defendant was so connected with the plaintiff's loss or injury that, as a matter of ordinary common sense and experience, it should be regarded as a cause of it …' (at 522 and see 515 per Mason CJ). In the context of s 82(1) acts done in reliance upon a misrepresentation furnish a sufficient connexion. 195 The words in s 75AD denote clearly the requirement of causation. The approach taken in Wardley and in March v Stramare does not permit consideration of the strength of the link required. In the context of s 75AD the defect must be shown to have caused an applicant's injuries by applying a common sense approach. In any event, were reference to the words and statutory context possible, there is nothing in the subsection which would support the applicant's contention of there being some lesser link necessary. 196 The applicant's case relies upon instructional defects and defects which can be taken to have occurred in the manufacturing process. In the former regard reliance is placed upon the lack of warning about the risk of thromboembolism developing on the valve in the Patient Booklet. It is also alleged that the booklet was misleading in that it conveyed that there was no risk. The first respondent contends that these do not render the valve defective within the meaning of s 75AC(2). It is however accepted that the chip is a defect if it was present after manufacture and when supplied by St Jude Medical Inc to the first respondent. I should add that in final submissions for the applicant it was sought to widen the applicant's case to allege a defect arising because the first respondent had failed to warn the applicant prior to implant. This does not arise from the pleading and was not part of the case opened for the applicant. I will not take it into account in relation to the case concerning s 75AD. It does however arise for consideration with respect to allegations of breach of duty at common law. 197 There are a number of facts which are relevant to a consideration as to whether the safety of the St Jude Medical valves generally is such as might be expected by the public. And it is important to bear in mind that the fact that a risk of complication attends their use would not of itself render them defective, as the Explanatory Memorandum to the Trade Practices Amendment Bill (No. 2) 1991 (Cth) points out. Goods are not required to be completely free of defect. 198 The evidence shows that the product has been made available to many persons. The incidence of complications shows that many people have benefited from it. The valve is not particularly prone to the development of thrombus and it was described by one witness as relatively thrombus-resistant and perhaps even more so than other valves. The risk cannot be eliminated, even with optimal anticoagulation. The risk which is present is, and was at the relevant time, well known by cardiologists and surgeons even without the Physician's Reference Manual. They were in a position to convey information concerning the risk in a meaningful way to their patients. In these circumstances I do not see how it is possible to conclude generally that the St Jude Medical valve was defective. The fact that it was the cause of thromboembolisms in the applicant establishes only that she unfortunately fell within a small number of persons who suffer such a complication. 199 In any event the applicant's case, apart from reliance upon the chip, is not based upon the general quality of the valve but upon what she was told about it after implant. In some cases a failure to warn might render a product defective in the sense spoken of in the subsection. Without a warning or instruction its use might be unsafe. A warning might be necessary to remove some inherent dangerous quality. A warning of the risk and rate of risk of thromboembolism despite anticoagulation could have no such effect here. Assuming however that the concept of goods being defective is much wider, and extends to any warning relevant to a person's informed choice, this does not avail the applicant. The decision to have the valve has been made at the point when she receives the booklet. The applicant does not and cannot allege that the failure to warn afterwards was causally connected to the injuries she sustained save that she may have sought further advice. 200 The chip on the valve can be considered a defect. The first question which arises with respect to it is whether it could itself cause the development of a thrombus which then broke away from the valve, travelled through the applicant's system and caused the infarcts and stroke from which most, if not all, of her injuries are alleged to stem. 201 Some evidence suggests that there is a theoretical possibility that a chip such as this could cause a thrombus to develop. Had that been the case one would have observed at explant a localised build-up of material at the site of the chip, whereas here it was quite generalised across the whole surface of the valve. Professor Brandwood did not disagree with this and conceded that one would expect a concentration of clotting at the site of a chip. Professor Brandwood's hypothesis accepts that the thrombus is widespread across the valve. He considered that there is evidence that at explant it was greater and more concentrated near the hinge which is close to the site of the chip. This is to be derived from the evidence of Dr Mahon's notation and the observations of Dr Titus. 202 Doctor Mahon was not called as a witness and Dr Titus was not questioned on this topic. The observation that a thrombus first develops, or develops to a greater extent, in the hinge area is unreasonable. It does not take the matter of the possible relationship with a chip in the area very far. Even if it be accepted as likely that a thrombus first formed in the hinge area, this does not establish that the chip was the cause of it. A thrombus is more likely to be created because of the effects on the movement of blood through that area. Professor Brandwood's thesis concerning the build up in the hinge area requires that it be substantial and such as would impede the movement of the leaflets and create the spread of the thrombus across the whole of the valve. Professor Hirsh however explained that if the movement of the leaflets had been so impeded the adverse effects upon the applicant would have been noticeable and serious, approaching heart failure. Further, one would have expected to see some indication of the problem in the echocardiograms which were taken. 203 The development of a thrombus because of the chip found on the leaflet of the St Jude Medical valve in question is a scientific possibility. There is however no scientific literature or other evidence which can elevate it to a higher level. The observations made of the valve on explant suggest to the contrary. The applicant therefore cannot establish that the chip was the cause of the thromboembolic events she suffered from. 204 There remains the question whether the chip was present at the time of supply to the first respondent, on the assumption that the evidence did establish causation. This has been the subject of considerable evidence. 205 Professors Brandwood and Williams are at least agreed that of the three possible mechanisms by which a chip could be caused the more likely is local physical impact. Professor Brandwood considers that the only periods in which it could have been caused were during manufacture and assembly or during post-explantation handling associated with testing. He did not explain why he initially discounted the latter and later conceded it was also a possibility. His view would appear to be based upon the prospect that Ms Smentek had not completely examined each aspect of the surfaces. This conclusion is arrived at because her recording of the photographs was not full and it could not be said that she photographed each ear of the disassembled valve. This failure on her part may have removed the confirmation of her visual inspection at 10x magnification which the photographs provided. It cannot in my view be said to follow that her examination and the record of it is to be taken as wholly unreliable. There is therefore evidence that the valve leaflet, viewed in a disassembled state, did not disclose a chip prior to the analysis by Mr Long using a scanning electron microscope. As against that it should be added that the hypothesis favoured by some of the other witnesses, namely that the chip occurred when it was disassembled post-explant, would have the chip present when Ms Smentek viewed it. There remains the possibility however that it occurred between the time Ms Smentek undertook her examination and packaged it for testing and when the further testing by Mr Long was undertaken. 206 Accepting for present purposes that there may have been some difficulty in viewing the chip on the valve leaflet in its assembled state, the only other occasion when its component parts were viewed and examined was prior to initial assembly. Professor Brandwood suggests the possibility that the chip occurred during the reworking process, but does not put it at higher than a possibility. It is clearly a hypothesis which is unsupported by evidence. There was no criticism made of the procedures for testing, reworking and re-testing prior to assembly. Mr Monaghan's evidence is that the reworking took place in an especially clean environment. It is not possible to infer that a hard particle was likely to have been present during the reworking of the leaflet surface or that the pressure involved in the cleaning would have created this chip. The evidence simply does not permit it. Moreover the theory does not take account of the further visual examination at 7x magnification after reworking. No defect was then recorded. 207 The defence under s 75AK(1)(a) requires that it be shown that the defect found in the goods did not exist at the time they passed from the manufacturer's control. It does not require the manufacturer to establish that it occurred at a later time, although if this were possible it would obviously deny the earlier existence of the defect. The first respondent cannot establish as a fact that the chip occurred during or subsequent to Ms Smentek's examination, although they would appear to be the most likely of the scenarios. The number of examinations prior to the scanning electron microscope examination, at which such a chip would have been visible under the magnifications used, strongly suggests the absence of a chip up to this point. 208 The evidence of the examinations of the valve's component parts prior to assembly establishes the likelihood that any chip present would have been detected. The prospect of a chip being created in the reworking process is only a hypothesis. The evidence concerning the process does not point to it as a very likely prospect. In any event it cannot stand the detailed records of examinations after the rework and the many examinations undertaken after explant. The first respondent would therefore succeed on its defence. 209 It is not necessary to deal with the first respondent's alternative defence, that the applicant brings this action outside the period limited for its commencement, but I make the following observations. It is accepted that the applicant did not have actual knowledge of the existence of the chip until 26 June 2003. The first respondent's point is that the applicant could have known of it earlier had she followed up on her request to have tests conducted on the valve released to her for that purpose. It is to be noted however that it is most unlikely that St Jude Medical Inc would have released the valve, but it may be that it would have agreed to testing in conjunction with the applicant if a protocol had been agreed. The difficulty with the defence is that it assumes that the chip was in existence and available to be discovered by 13 March 1998. The evidence does not establish this.

(b) The claim under s 74B 210 Section 74B provides that a manufacturer, which includes a deemed manufacturer, is liable to compensate a consumer who acquires goods which are not reasonably fit for the purpose for which they were acquired and suffers loss or damage by reason that they were not reasonably fit for that purpose. 211 The purpose which the applicant says should be seen as accompanying her acquisition of the St Jude Medical valve was to replace her damaged natural mitral heart valve and provide, for life, an effective, safe, functioning mitral heart valve. She alleges that it was not fit for this purpose because it caused her to suffer injury despite her being on anticoagulant drugs, and it contained a chip. My findings as to the presence of the chip at the time of supply and as to whether it could be regarded as causative of the thromboembolisms exclude the latter allegation. 212 This is not a case where the purpose was made known to the manufacturer. Given that the only purpose of the valve is to replace damaged natural mitral valves it would not seem to be necessary that there be communication. In such a case the manufacturer's knowledge may be assumed: Grant v Australian Knitting Mills, Ltd (1936) AC 85at 99. The St Jude Medical valve cannot however be regarded as unfit for that purpose because there was a known risk that thromboembolisms might develop and cause injury of the kind the applicant suffered. The applicant has identified only that she fell within the category of persons who develop such a complication. The question whether goods which have a use are reasonably fit for it must be assessed not only by reference to the fact that they failed to accomplish their purpose, but also by reference to what a consumer could reasonably expect from the goods. 213 The evidence here clearly establishes that the risk in question was well known to medical practitioners. The applicant was advised of this risk, as I later discuss. In my view, for the reasons I give later it could not therefore have been reasonable for the applicant to expect that there was no prospect that the valve would cause the development of thrombi. This claim is not made out. 214 The first respondent additionally relies upon the fact that, on the applicant's own evidence, she knew of the risk when she received Prof Hughes' report dated 13 February 1998. Her claim is therefore statute-barred. The evidence however is that the applicant did not receive the report until 25 March 1998. This defence is not made out.

(c) The claim for breach of duty 215 The first respondent's threshold contention is that any action under the common law is not available to the applicant because the Trade Practices Act 1974 (Cth) should be seen as the only source of liability for manufacturers of goods. The submission rests upon the doctrine of 'pre-emption' developed in the United States, referred to in Perre v Apand Pty Ltd (1999) 198 CLR 180at 247 and more recently in Graham Barclay Oysters Pty Ltd v Ryan (2002) 211 CLR 540at 591 ('Graham Barclay Oysters'). Sections 75 and 75AR provide that nothing in Parts V and VA shall affect any right or remedy that a person would have had if those Parts had not been enacted. Gummow and Hayne JJ in Graham Barclay Oysters however considered that the question whether alternative claims could be made in negligence and under the Trade Practices Act 1974 (Cth)was an open one, and one not yet considered by the High Court (at 591). In view of my findings on the facts of this case it is not however necessary for me to further consider this question. 216 The first breach of duty alleged is that the first respondent supplied a valve which was not fit for the purpose for which it was supplied. My findings in connexion with the claim under s 74B apply here. No breach is established. 217 The third alleged breach is one of failure, on the part of the first respondent, to warn the second and third respondents of the need to warn the applicant of the risks of using the St Jude Medical valve including the risk of thromboembolism despite anticoagulants. If it were necessary to do so, the Physician's Reference Manual conveyed this warning to the third respondent. In any event, like other practitioners in their field, the second and third respondents were well aware of the risks and did not need instruction. This claim fails. 218 The remaining allegation is that a failure to warn the applicant herself of the risks constitutes a breach of the first respondent's duty of care owed to her. The first respondent responds that no such duty was owed to the applicant. It relies upon the defence of the provision of advice or warnings to 'learned intermediaries', to which reference was also made in the Explanatory Memorandum to the Trade Practices Amendment Bill 1992 (Cth). 219 The effect of a 'learned intermediary' upon a manufacturer's duty has been the subject of considerable case law in the United States. In Sterling Drug, Inc. v Cornish 370 F.2d 82 (8th Cir 1966)the term was used in relation to a physician who acted as a liaison between patient and drug manufacturer. The content of the manufacturer's duty was to warn prescribing physicians. The doctrine has since been extended to medical device cases: Phelps v Sherwood Medical Industries 836 F.2d 296 (7th Cir 1987)(which involved the manufacturer of a heart catheter) and Brooks v Medtronic, Inc. 750 F.2d 1227 (4th Cir 1984)(a cardiac pacemaker). It has been explained that the reason for describing the duty in this way is because it is a physician's duty to remain abreast of product characteristics and to decide which facts should be told to the patient. Once adequate warnings are given to the physician, the choice of treatment and the duty to disclose properly fall upon the doctor. And it has been held in Australia that the duty to warn rests with the treating physician not the manufacturer or distributor: see H v Royal Alexandra Hospital for Children (1990) Aust Torts Reports 81-000. 220 In my view it is not necessary to resort to the doctrine. The risks were well known to doctors and the second and third respondents in fact conveyed this to the applicant. If there be a duty owed to the applicant as alleged any failure to warn her could have no effect, given the information she received from others.

2. THE LIABILITY OF THE SECOND AND third respondentS 221 The law imposes upon a medical practitioner a duty to exercise reasonable care and skill in the provision of professional advice. The standard of reasonable care and skill required is that of the ordinary skilled person exercising and professing to have that special skill: Rogers v Whitaker (1992) 175 CLR 479at 483 ('Rogers'). In the provision of relevant information the skill is not so much medical as it is in communicating the relevant information to the patient in terms which they are likely to understand: Rogers at 490. The Courts, in adjudicating on what was necessary to be said, give weight to the fact that a person is entitled to make their own decisions as to whether they will accept the treatment proposed: Rogers at 487 and at 486, referring with approval to the judgment of Lord Scarman in Sidaway v Govenors of Bethlem Royal Hospital [1985] AC 871at 876. The question whether a patient would have declined the treatment or taken another course, which is necessary to be addressed in connexion with causation, is to be approached subjectively and from their perspective, not objectively: Ellis v Wallsend District Hospital (1989) 17 NSWLR 553at 559, 580-582. This approach is consistent with the observations made in Rogers as to the relevance of the advice to a patient's decision-making. 222 Their Honours in Rogers (at 490) agreed with King CJ in F v R (1983) 33 SASR 189at 192-193, that the amount of information or advice which a careful and responsible doctor would disclose would depend upon a number of factors including the nature of the treatment, the desire of the patient for information and the health of the patient. Their Honours went on (at 490): 'The law should recognize 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 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. This duty is subject to the therapeutic privilege.' 223 No issue here arises concerning privilege from providing the necessary information. 224 In the present case it was necessary that the applicant be told of the risks associated with the surgery itself, including the risk that repair of her mitral valve might not be possible. It was necessary that she be apprised of the procedure which would be undertaken in that event including the implant of a prosthetic valve. The risk of thromboembolism occurring, because of the possibility of clots forming on a valve, and the consequent risk of stroke and other complications had to be explained to her. It would follow that she would need to be advised of the need to take anticoagulants for life and what this might mean to her. I do not understand the second and third respondents to deny their duty extended to these advices. I do not however consider that it was necessary that the applicant be advised of the rate of risk of thromboembolisms developing on a St Jude Medical or other mechanical valve. A patient would need to know that the risk is a real one, but I do not think reference to statistics such as 2 to 5 per cent would inform them further in any meaningful way . 225 I have had some doubt that it would be necessary to advise a patient about tissue valves where a doctor would not recommend it and indeed is likely to be wholly opposed to it in the case of a young patient who is able to have a mechanical valve and to take anticoagulants. The evidence suggests that if a young patient made a wrong choice, for a tissue valve, they would be counselled. I took this to mean counselled until persuaded to a contrary view. It is not clear though whether a surgeon would proceed to implant it if the patient remained firm as to their choice. 226 Most of the medical witnesses said that it is their practice to usually provide information about tissue valves. Whilst this is not conclusive of there being a legal obligation to do so, it may show that they recognise that there is some element of choice for the patient. It may be inferred that they wish patients to be well-informed. Further, there are both advantages and disadvantages to each of the types of valves. Whilst doctors may seek to influence a young person's choice, the choice remains the patient's. In these circumstances it seems to me, on further reflection, that advices concerning tissue valves, the advantages and the disadvantages should also be given. 227 So far as concerns treatments such as nerve blocks it seems to me that a doctor or surgeon ought to enquire of a patient whether they are intending to have further surgery or treatment, where an intended drug regime is likely to have an effect upon surgery or treatment. The question which arises in this case is whether anticoagulants do prevent such treatment being undertaken. I shall return to it later in these reasons. 228 On 20 May 1996 the second respondent was not referring the applicant for surgery. He was arranging more tests and arranging to review her condition in six months. It was only when she later rang and, in effect, demanded surgery, that he agreed to that course. In these circumstances it must be considered as possible that he did not discuss the surgery in any detail or discuss what would happen if repair was not possible. There are a number of factors however which suggest that he did so. 229 If, as he noted and advised her general practitioner, he spoke of the 'pros and cons' of surgery it is likely that he discussed the prospect that the repair might be unsuccessful. It is difficult to imagine that a cardiologist would not. The evidence shows that it is a known risk, especially with a prolapse of the mitral valve of the kind that the applicant was suffering from. If he did so, he must surely have mentioned the only alternative - the implant of a prosthetic valve. He may however have done so in terms of the valve being replaced, rather than discussing a prosthetic valve. The terms of his letter of referral of 13 June 1996 suggest this. That may account for the applicant and her husband failing to appreciate just what was involved until the consultation with the third respondent. I add that the fact of that advice by the third respondent would negate any causal effect of a failure on the part of the second respondent to himself advise the applicant. 230 The letter of referral stands as strong evidence of what was said by the second respondent to the applicant and her husband. It is sufficiently close enough in time to 20 May 1996 to stand as a reliable record of what the second respondent had discussed. It gives the impression that he is recalling his conversation with her as he writes. The second respondent is not likely to have conveyed a conversation which he did not actually recall. 231 It may be taken from the letter that the second respondent discussed the possibility that the valve may need to be replaced and the need for anticoagulant drugs. Just how much detail was provided and whether the second respondent provided explanations by sketches or otherwise is less certain. It is not however necessary to determine the complete content of his advices. The issues raised by the applicant require only an additional consideration as to what advices he may have given about the risk of complications such as stroke. 232 It would not appear that the second respondent advised the applicant that the risk of the development of thromboembolisms, associated with a mechanical valve or the St Jude Medical valve, was between 2 to 5 per cent, as the applicant alleges he should have. He did not know which valve the third respondent would choose and says that he did not therefore discuss the percentage risks of blood clot formation on the valve and the risks of failure of anticoagulation. The risks of complications of which he spoke, and put at between 4 to 5 per cent, related to the surgery itself. However I do not consider the second respondent was obliged to furnish such advice, for the reasons I have given. 233 I do not consider it likely that the applicant's nerve block treatment was discussed at the meeting with the second respondent on 20 May 1996. There would seem to me no reason why the applicant would raise it. There was no need to. She would not connect it as relevant to anticoagulant therapies. The prospect that the applicant just happened to mention that nerve block had resolved her neck and back pain to a significant degree and that she was looking forward to getting on with her life is not high. Her evidence in this respect suggests reconstruction when she later discovered that Dr Finch would not allow her to have further nerve blocks. 234 I accept however that the applicant and her husband did not appreciate fully what they were told by the second respondent. The fact that they were still speaking of a transplant when they came to see the third respondent tends to support this, although they might have been referring to the implantation of a prosthetic valve. The evidence is not clear. When they saw the third respondent they appeared to be of the firm belief that the applicant was to undergo mitral valve repair surgery. The applicant had been convinced of this and that the surgery would resolve her symptoms for some time, and they are likely to have been focussed upon it. This may explain, in part, why they did not absorb the information the second respondent was providing. Another factor would appear to be that the consultation with the second respondent was relatively short, even on his account of what was discussed. 235 The third respondent is, in my view, likely to have said that there was a real possibility that he would be unable to repair the applicant's mitral valve. He had every reason to ensure that she understood this. I accept that it would not be in a surgeon's interest to have a patient facing serious surgery unaware of this. Further there seems no reason to doubt the third respondent's evidence that any surgeon would have warned her of the risk given that she had a prolapse of both leaflets which rendered the risk of failure higher. To have referred to it as a 'slight chance' would be inconsistent with the opinion the third respondent held. The third respondent, I accept, stated the risk at 20 per cent, a figure which he regarded as high. The applicant may not however have appreciated that. 236 Accepting that the prospect that the applicant's mitral valve might need to be replaced with a prosthetic valve was discussed, one would have expected the second respondent and the third respondent to discuss the regime of anticoagulant drug therapy which would then be necessary. It was life-long, required management and some lifestyle changes. Were a female patient to take the drugs she would be advised not to have children. These are matters which would call for discussion by a treating doctor or surgeon. I have accepted that the second respondent discussed anticoagulants, although the evidence as to the extent of the discussion was not clear. The evidence of the applicant and her husband shows that the need for her to take drugs for life and the effect on her ability to have children was discussed with the third respondent. What they have not recalled is the content of the advices and the context in which the question about having children was put to them. 237 I accept the third respondent's evidence that he spoke of the mechanical mitral valve as more likely to form clots and therefore necessitate the taking of anticoagulants or 'blood-thinning drugs'. He had every reason to advise a patient of these matters. It is difficult to imagine why he would not. 238 The evidence of the applicant and her husband concerning their understanding of what the third respondent was telling them about the drugs she would need to take is somewhat confusing. She said that, at the time of the consultation with the third respondent, the applicant and her husband assumed that the drugs were to stop her body rejecting the valve. But they also say that the third respondent told them rejection was not an issue, so this could not be a basis for their understanding about the drugs. It may suggest reconstruction about what they thought. Then the applicant said that she did not know she was taking anticoagulant drugs until the nurse told her after she cut herself whilst in hospital some days after surgery. She said that she then appreciated that this was what the third respondent had been talking about, which suggests perhaps that there was more said by the third respondent which she was then able to recall. And she said that at the time of the conversation with the nurse she appreciated that clots could form and travel through her system. The applicant attributed this to the Patient Booklet which presumably she had read. The booklet did not refer to clots moving through a person's system. If she had read the booklet she would however have appreciated that she was likely to have been prescribed anticoagulant drugs. 239 I also consider it unlikely that neither the applicant nor her husband would not have enquired about the purpose and nature of the drugs at the consultation. This is especially the case so far as concerns the applicant. It is also unlikely that the applicant suddenly discovered she was taking them post-operatively and made no mention of it to, nor made an enquiry of, either the second respondent or third respondent. 240 I accept that the third respondent did discuss the different types of valves and their advantages and disadvantages before enquiring of the applicant and her husband whether they intended to have children. That enquiry by the third respondent was brought about because anticoagulants would be necessary if a mechanical valve were used. It is likely to have arisen in the context of a discussion about mechanical valves. The third respondent is also likely to have discussed the alternative of a tissue valve, in my view. Whilst he was going to recommend a mechanical valve, and he may therefore have spent only a little time discussing tissue valves, I see no reason to doubt that he did discuss tissue valves. He customarily did so and there were good reasons for such a practice. There is some support for a conclusion that it was likely to be his practice from the evidence of the practice of other surgeons. 241 Given that the third respondent did provide advices concerning tissue valves, any failure on the second respondent's part to do so has played no part in the applicant's choice or her ability to understand the types of valves prior to surgery. The second respondent also contended that he was under no duty to advise about different types of valves as he was not sure which the surgeon would recommend. This would not have prevented him from discussing generally mechanical and tissue valves, but he says that he knew that their respective advantages and disadvantages would be discussed by the third respondent. It seems to me however that if there was a choice to be made about valves and they carried different risks he was under a duty to advise of them. He could not assume the advice would be given by the third respondent. Any omission on his part to do so has however had no effect upon the applicant's choice or understanding about the valves. She had the necessary advice from the third respondent. 242 I do not consider the applicant or her husband to have a complete or accurate recollection of what was conveyed at either consultation, although they recall some particular advices. Mr Hazell in particular seemed to recall little of what was said. The applicant did not recall the second respondent's fairly firm advice that repair surgery was not likely to resolve her symptoms. She construed his advice in a selective way to be that not all her symptoms would be resolved. Similarly the applicant discounted the advice the third respondent gave her about the possibility that repair might not be possible. She appears to have been convinced that it would. The applicant and her husband have recalled elements of the third respondent's advice but not the detail and not the sequence in which it was given. In particular they did not recall the connexion between anticoagulants, mechanical valves and childbirth. They did not recall either the second respondent or third respondent speaking about anticoagulant drugs when they almost certainly would have done so. When prompted in cross-examination the applicant was able to recall some further topics. Their evidence suffers from the further difficulty that they have discussed it with each other over a long period of time. I substantially discount Mr Hazell's evidence as corroboration for that reason. The applicant and her husband may have convinced themselves that many things were not discussed, but I am unable to have confidence in their recollection. 243 It was submitted for the applicant that she and her husband were more likely to have a memory of what was said because the consultations were important to them, and were 'one-off events', as compared with the second respondent and the third respondent who had no reason in particular to recall the occasions. The consultations were obviously of importance to the applicant and her husband. It may be accepted that they were concerned, if not anxious, although the applicant was quite determined to have surgery. It does not follow that they took in all of what was said to them. Indeed they recalled little of the January consultation, which was also important. 244 The consultation with the third respondent was more lengthy than the applicant and her husband recall, in my view. Even the topics which they recall being discussed would have taken longer to discuss than the fifteen to twenty minutes they refer to. It is more likely to have taken the hour that the third respondent says it did. The advice was detailed and much of the information was new to the applicant and her husband. It is quite possible in such circumstances that they recall only those parts which were of importance to them and which they understood. The fact that the applicant was so focussed on the surgical repair of her mitral valve is also likely to have affected this process. 245 It was also submitted for the second and third respondents that the applicant made no complaint of their lack of advice until these proceedings were brought and expressed no surprise when she found herself with the implanted valve and on a life-long regime of anticoagulant drugs. I would usually be cautious about drawing too much from the fact of lack of complaint from a person such as a patient to their doctor. In the case of the applicant however she is an intelligent and confident woman. She has had a lengthy medical history and has some medical knowledge. She does not present as a person likely to be daunted by the position or authority of medical specialists and she has shown herself to be quite capable of voicing her opinion or criticism and demanding corrections of the second respondent. In these circumstances it seems to me most unlikely that the applicant would have remained silent if she felt that she had not been properly advised. 246 At the time the applicant wrote to the second respondent in February 1998, in effect terminating his services, she had not received Prof Hughes' advice about the rate of risk of thromboembolism. When she did receive it she says that she thought to herself that she had not been advised of this. She was now aware of the effects and lifestyle changes brought about by anticoagulants and she knew about the alternative of tissue valves. She made no mention of the lack of advice she had received on these matters. In the letter she wrote to Dr Hands in December 1998 she made no mention of them. By then she also knew about the rate of risk of thromboembolism associated with mechanical valves. If she had some sensitivity about giving the true basis for her case against the second and third respondents to Dr Hands, a matter which I should add she did not raise, it is difficult to understand why the applicant did not make some complaint to the second or third respondent directly. It may be inferred from the letter that the main target of her intended litigation was St Jude Medical Inc and that she believed by this point that the problem had been with its valve. There is nothing to suggest that the applicant and her husband were focussed upon claims against the second and third respondents at this time. This is likely to have had the consequence that they did not attempt to recall the content of conversations with them until a point closer to the commencement of proceedings. Their recollection is therefore likely to be impaired. 247 The second and third respondents' evidence is in part, and perhaps even a substantial part, based upon their practice in advising patients. The third respondent at least however impressed me with a reasonably clear independent recollection of his consultation with the applicant. Reliance upon their customary advice to patients facing surgery of this kind does not seem to me to be poorly based. It may be accepted that a cardiologist, and perhaps even more so a surgeon, would have a mental list of matters that they would ensure they discussed. It is in their own interests that a patient is made aware of the prospect of an implant being necessary and what this would involve. They were well aware of the rate of risks of complications and what anticoagulant therapy means to the lifestyle of a patient. It does not seem sensible to me that they would make no mention of these matters to a patient. 248 The applicant's allegation that she was not told that there was a risk that repair of her mitral valve might not be possible is not made out. Both the second respondent and third respondent brought this to the attention of the applicant and her husband and the third respondent emphasised it. Indeed the applicant's evidence on the point was not that no mention was made, but that it was made only in passing by the third respondent. If that is her recollection it is faulty and explained perhaps by her focus upon having a successful repair operation. 249 Similarly the applicant's allegation that she was not advised of the risk of clotting and stroke and the need for anticoagulants is not established. I have found that both the second respondent and third respondent did so and the third respondent in some detail. What the respondents' evidence does not however establish is that the rate of risk was of the order of 2 to 5 per cent. I have however held that their duty to advise did not extend to this detail. I do not consider the information would have meant much to a patient. I have also found that the third respondent is likely to have discussed tissue valves with the applicant and her husband. 250 Neither the second respondent nor third respondent made an enquiry of the applicant which would have revealed her intention to have further nerve block treatment. In my view it was not necessary for them to do so. The evidence does not establish that the taking of anticoagulant drugs is a contra-indication to treatment such as nerve blocks or surgery. Whilst a treating doctor might be more circumspect, the withdrawal of anticoagulants for a short time can be managed without significant risk of bleeding or clotting. Whilst Dr Finch holds his view that nerve blocks should not be undertaken on the applicant, the majority of the medical witnesses had not experienced difficulties in managing risks in other patients. And it will be recalled that the applicant had undertaken this process when she had her second valve implant and when she had her hysterectomy. It is not to be expected that a doctor would have advised the applicant that she would be unable to have surgery in the future or treatment such as a nerve block. Neither the second respondent nor the third respondent were therefore obliged to do so. They may have been under a duty to advise that surgery carried additional risks and would require a change in her drug regime but the third respondent did convey this to the applicant. 251 The applicant's case against the second respondent and third respondent for failure to advise or warn of material risks fails. It is nevertheless necessary to consider what the applicant would have done had she been fully aware of what she was being told. The applicant says that she would have chosen a tissue valve even if it was not recommended. It is difficult however to accept that she would have done so when told of the need for continual replacement of a tissue valve, with an increasing risk to her life on each re-operation, when a mechanical valve might not need replacement in her lifetime. The applicant says herself that she was afraid of the second operation and she is now fearful of re-operations. 252 The perceived benefits that the applicant says she would have taken into account are misconceived and would not have been the subject of advices to her. She would not have been told that nerve block treatment would not be possible if she took anticoagulants. And the advice would not have been that the implant of a tissue valve unaccompanied by anticoagulant drugs carries a risk significantly less for a person than would be the case if they had a mechanical valve and anticoagulants. The only advantage which would have been conveyed to her would be that she may not need to take anticoagulant drugs. But the applicant's belief that she is unable to undertake a number of activities because she is on anticoagulants is also largely erroneous. The medical evidence is that the taking of anticoagulants means only that she should exercise care. 253 Regard must be had to what a person says they would have done. This issue is not to be approached on the basis of what a reasonable person would have done. Nevertheless the applicant's case is unrealistic. In my view the applicant has reached the views she holds because of her experience with the thromboembolisms. She is unable to place herself in a position where she is exercising a choice prior to surgery and when she would have been told that there was some risk of thromboembolism developing and stroke. Even if she had been told it was between 2 to 5 per cent this would not have added much to the warning. There was nothing at that point to indicate that she had any predisposition to clotting or that her INR levels would be difficult to maintain. 254 The applicant's case against each of the second and third respondents is not made out.

3. THE APPLICANT'S INJURIES 255 Although no respondent has been found to be liable, it is necessary for me to deal with what injuries were suffered by the applicant as a result of the thromboembolisms which emanated from the St Jude Medical valve. 256 The applicant suffered two infarcts to her spleen and kidney and a midbrain stroke as a result of thromboembolisms. Doctor Kermode is also of the view that she may have suffered further thromboembolic events prior to her stroke but these resolved without injury. The infarcts did not produce any residual disability and the applicant made a good recovery from the stroke. Doctor Kermode however considers that the stroke has now predisposed her to an increase in the frequency and severity of her diplopia and has produced mild impairment to her equilibrium, different from the disequilibrium she had previously experienced. 257 The applicant has clearly suffered from diplopia for many years. The applicant gave evidence that what she had reported to medical practitioners prior to the implantation of the mechanical valve as double vision was actually blurred vision and that the nature of this condition changed after her stroke. Doctor Kermode's evidence does not support this. He said that when he saw her prior to her first stroke she gave a good description of true diplopia. Further the applicant herself appears to have drawn the distinction between blurred and double vision on occasions when she reported her symptoms to the neurologists over the years. And it is difficult to accept that what was recorded by the neurologist as diplopia or double vision is instead blurred vision, especially in the absence of any evidence from Dr Gubbay and others. If patients can confuse the descriptions of the two conditions and neurologists know this, it would seem to me likely that neurologists would be careful to ascertain just what a patient was reporting. Further there is no evidence to explain the change in the state of the applicant's vision since the stroke. This aspect of the applicant's evidence does not reflect well upon her credit. 258 The symptoms from which the applicant suffers which appear to have the most impact upon her is her fainting, or feeling that she may faint, combined with fatigue. There is however no evidence which connects these symptoms to the injuries sustained by the applicant as a result of the thromboembolisms or to the need for the second operation. Indeed the applicant's case was characterised by an absence of medical evidence as to her present medical state and the cause of her symptoms. It appears to rely largely upon her own evidence. It is however plain that she has suffered these symptoms for many years prior to the events in question, at least since 1987, albeit that their cause does not appear to have been determined despite the second respondent conducting tests from time to time. The applicant appears to have believed that her fatigue at least would be resolved by the repair to her mitral valve, although the second respondent counselled her against such a hope. 259 The applicant's disequilibrium and problems with incoordination, headaches and vision disturbances including diplopia are shown to have a cause, but it is not associated with her heart nor the effects of the St Jude Medical valve. They most likely stem from a type of migraine condition. The applicant has suffered from diplopia since 1987 and has had intermittent episodes of disequilibrium since she was 18 years old. 260 It may also be accepted that the applicant suffered splinter haemorrhages after the first implant, but the evidence does not make it clear whether they are linked to the thromboembolisms. The evidence relating to the dangers of replacement surgery provides some support for the allegation that the applicant has sustained some adverse effects to her heart because she had to have a second operation. This might affect the extent to which she is at further risk when she has to have further surgery and it may affect her life expectancy. It is not clear. There is no evidence to support the contention that she suffered an occluded left vertebral artery as a result of the thromboembolisms. The evidence is that it is constitutional in nature. There is no evidence as to partial occlusion of the right vertebral artery. The applicant did suffer pericarditis after the tissue valve was implanted. It has not however been established that this was due to the aftermath of the implant of the mechanical valve. 261 The applicant suffered arrhythmia prior to her surgery but no cause was determined for this condition. There is no evidence linking the arrhythmia she suffers now to the thromboembolisms or surgery. I notice that an article in the Physician's Reference Manual refers to patients with mechanical valves suffering from arrhythmia on occasions and it may be that this is the case with tissue valves. No witness however referred to the cause of the applicant's condition or connected it with the injuries she suffered. 262 The applicant felt depressed following her hysterectomy in April 1997 and received some counselling. This aspect of the applicant's case, that her hysterectomy was causally related to the mechanical mitral valve, is based upon her taking anticoagulant drugs which caused her excessive menstrual bleeding, which in turn led to the need for a hysterectomy. There was some evidence that when she suffered from menorrhagia in April 1997 it was thought that the combination of Warfarin and another drug were contributing to or causing it. This is not however sufficient to establish that Warfarin was the cause of her condition and the need for surgery. She had suffered from this condition in the past and before she took anticoagulants. 263 It follows in my view that the applicant's inability to undertake many activities, household tasks and her inability to work are not causally connected to the effects of the stroke. The symptoms which render her unable to work and enjoy life are largely pre-existing conditions of either undetermined cause or attributed to her migraine condition. To those symptoms need to be added the effects of the injuries to the applicant's neck and back from the motor vehicle accidents. 264 In addition to the pain and suffering caused to the applicant by the thromboembolic events the applicant required hospitalisation on two occasions. It may be accepted that she was very anxious at their occurrence. Although she made a good recovery from the stroke she may experience more severe diplopia and experience it more often. Her balance is mildly impaired. In all, I would have assessed the applicant's damages under this head at $40,000.00.

4. economic loss 265 It follows from my findings as to the extent of the injuries suffered by the applicant as a result of the thromboembolic events, and what causes her inability to work, that she has not suffered any substantial loss of earnings or earning capacity. The infarcts and stroke resulted in hospitalisation and required a period for recovery in which time the applicant was not able to work. That work was however limited to ten hours per week for her husband's firm. The applicant now undertakes that work and also works for her brother's company for about the same number of hours. 266 There is no basis shown for attributing the applicant's inability to earn other than a limited income to the problems which arose from the implant of the St Jude Medical valve. I should however make some observations on the evidence concerning her capacity to earn, assuming for present purposes that she would have been fit to work if those events had not occurred. 267 There are two aspects to the claim that she would be able to earn of the order of $500,000.00 as an Investment Development Manager. The first concerns her experience and ability to do so, the second concerns the reliability of the evidence concerning what she might earn in such a position. 268 The respondents submitted that the applicant's background and limited exposure to financial transactions at this level would not suggest that she would be able to undertake this role and, I infer, that she would not be likely to be offered a position in her brother's company to do so. I do not think that her lack of experience would be a complete bar. The applicant is a very intelligent and confident woman. She was able to successfully complete part of a degree in commerce. She has an understanding of business. The role of investment managers did not seem to me to involve complex concepts and the transactions are readily understandable. The applicant did not strike me as unable to undertake them. The role of such a person, at least at the level of a consultant such as Mr Beck, obviously requires more than an understanding of how transactions work. There needs to be an ability to communicate with clients and to persuade them. The applicant has obtained investors for her brother and for others in the past. I do not therefore discount the prospect that she could successfully undertake this role 269 Mr Beck's income does not in my view furnish a very reliable basis as to what the applicant might earn in a position in her brother's company. There was no suggestion that she would undertake a business such as Mr Beck's. He has considerable experience and his business involves many clients. Even so, I observe that his earnings, at a level referable to that spoken of by Mr Carey, have not been earned over a long period and he has earned less at some points. And, whilst her brother gave evidence of a figure of $500,000.00 as capable of being earned, no evidence was led as to what investment managers within the company in fact earn. His evidence, of earnings of $1m and in one case much more, related to persons external to the company and whose work might extend beyond Westpoint's investors. The fact that no evidence was called confirms me in the view which I formed, that the figure to which Mr Carey referred is not reliable and is one which has been chosen to advance the applicant's interests rather than reflecting what is reasonably achievable. I am confirmed in that view by the fact that in the litigation arising out of the motor vehicle accidents the applicant and her brother did not suggest that she would earn more than $40,000.00. That figure is likely to be somewhat higher now. Neither of them however explained how the much more lucrative position within the company was not earlier thought of by them, if such a position exists and persons are earning the sums spoken of. I take it that I am intended to infer from Mr Carey's statement that there has been some expansion of Westpoint's business which has allowed for this, but I do not consider it a satisfactory explanation. When the applicant's original claim, for just over $7.8m for economic loss based upon commissions related to individual products, was not sought to be proved Mr Carey provided the figure of $500,000.00 as that which she might earn in his company. This does not give me confidence in his evidence. I assess the amount she would have earned, by reference to the figures used in the earlier litigation, at $50,000.00 per annum. 270 The applicant's alternative case was that she could have undertaken the role of Operations Manager in addition to the role she presently undertakes and for which she receives $52,000.00. On her case she would earn another $77,480.00 although there is no documentary record of these salaries. I accept that if she were well she would be capable of undertaking both roles, but I do not have confidence that she would be paid in the order of $120,000.00 for it. The position she presently occupies has apparently been created for her by her brother in the course of litigation and relatively close to trial. It is difficult to accept that most employers would pay $52,000.00 for ten hours work in such a role. In the absence of other evidence to suggest this figure and a combined figure for the two roles as realistic, I do not accept the evidence. 271 The only other claim was with respect to domestic expenses. There was no evidence which would permit an assessment of them.

e. summary and orders 272 The applicant has been unable to establish liability in any of the respondents. So far as concerns the first respondent it has not been shown that the St Jude Medical valve was defective or unfit for its known purpose. The first respondent did not otherwise breach a duty of care owed to the applicant under the common law, assuming that such a claim remains open to her. The necessary advices about the prospect of a prosthetic valve being necessary, the risks associated with it and the need for a lifetime regime of anticoagulant drugs were provided by the second or third respondents. If it was necessary to advise the applicant of the alternative of a tissue valve, the third respondent did so. The applicant was therefore sufficiently informed. In any event I do not accept that she would have elected to have a tissue valve and not a mechanical valve. Almost all of the applicant's present symptoms and inability to work are caused by her pre-existing conditions. Had she established liability her damages would be limited. 273 The application will be dismissed with costs. I certify that the preceding two hundred and seventy-three (273) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Kiefel.

Associate: Dated: 6 July 2004 Counsel for the Applicant: Mr BHK Donovan QC with Mr CP Shanahan

Solicitor for the Applicant: Wojtowicz Kelly

Counsel for the First Respondent: Mr NC Hutley SC with Mr D Villa

Solicitor for the First Respondent: Minter Ellison

Counsel for the Second and Third Respondents: Mr WS Martin QC with Mr AS Derrick

Solicitor for the Second and Third Respondents: Clayton Utz

Dates of Hearing: 9, 10, 11, 12, 13, 16, 17, 18, 19, 20, 25, 26, 27 February 2004

Date of Judgment: 6 July 2004