Carey-Hazell v Getz Bros & Co (Aust) Pty Ltd - [2004] FCA 853

FEDERAL COURT OF AUSTRALIA
Carey-Hazell v Getz Bros & Co (Aust) Pty Ltd [2004] FCA 853
TRADE AND COMMERCE – implant of mechanical or prosthetic mitral heart valve in applicant’s heart – subsequent development of thromboembolisms with serious consequences including need to replace valve with tissue or bio-prosthetic valve – liability of supplier – supplier as deemed manufacturer – liability under s 75AD of the Trade Practices Act 1974 (Cth) for supply by manufacturer of defective goods causing injuries – whether liability under Part VA of the Act is strict or limited by requirement of a defect – operation of s 75AC in determining the standard of safety of goods – whether applicant as an injured person is required to prove the existence of the defect in goods at the supply time – whether strength of link to be proved between defect and injuries suffered is affected by use of the words ‘because of’ in s 75AD – common sense approach in determining causation of individual’s injuries – whether safety of goods is such as might be expected by the public – instructional defects – whether failure to warn of risks rendered the goods defective – whether causation from failure to warn – whether causation from defect taken to have occurred in the manufacturing process – whether defect was present at the time the goods passed from manufacturer’s control – application of defence under s 75AK(1)(a) – liability under s 74B for supply by manufacturer of goods which are not reasonably fit for the purpose for which the goods are acquired – what a consumer could reasonably expect from the goods acquired – whether Parts V and VA of the Act operate as a statutory ‘pre-emption’ of the general law of negligence in relation to the supply of defective goods – defence of the provision of advice or warnings to learned intermediaries
TORTS – negligence – duty of care – medical practitioners – duty to exercise reasonable care and skill in the provision of professional advice – scope and content of duty – whether failure to advise or warn of material risks
Statutes
Trade Practices Act 1974 (Cth) Part VA, ss 75AD, 74A, 74A(4), 75AC, 75AK(1)(a), 75AK(2), 75AO(1), 74B, Part V, ss 75AC(1), 75AC(2), 75AD(c), 75AK(1), 82(1), 82, Part IV, ss 75, 75AR
Trade Practices Amendment Act 1992 (Cth)
Cases
Australian Competition and Consumer Commission v Glendale Chemical Products Pty Limited; Barnes v Glendale Chemical Products Pty Limited (1998) ATPR 41-632 Cons
Brooks v Medtronic, Inc. 750 F.2d 1227 (4^th Cir 1984) Refd
Ellis v Wallsend District Hospital (1989) 17 NSWLR 553 Foll
Elna Australia Pty Ltd v International Computers (Aust) Pty Ltd (No 2) (1987) 16 FCR 410 Cons
F v R (1983) 33 SASR 189 Foll
Glendale Chemical Products Pty Ltd v Australian Competition and Consumer Commission and Anor (1999) ATPR 41-672 Cons
Graham Barclay Oysters Pty Ltd v Ryan (2002) 211 CLR 540 Cons
Grant v Australian Knitting Mills, Ltd (1936) AC 85 Cited
H v Royal Alexandra Hospital for Children (1990) Aust Torts Reports 81-000 Refd
March v Stramare(E. & M.H.) Pty Limited (1991) 171 CLR 506 Appl
Perre v Apand Pty Ltd (1999) 198 CLR 180 Cited
Phelps v Sherwood Medical Industries 836 F.2d 296 (7^th Cir 1987) Refd
Rogers v Whitaker (1992) 175 CLR 479 Foll
Sidaway v Govenors of Bethlem Royal Hospital [1985] AC 871 Refd
Sterling Drug, Inc. v Cornish 370 F.2d 82 (8^th Cir 1966) Cons
Wardley Australia Limited & Anor v The State of Western Australia (1992) 175 CLR 514 Appl
OTHER AUTHORITIES
Explanatory Memorandum to the Trade Practices Amendment Bill (No. 2) 1991 (Cth)
Explanatory Memorandum to the Trade Practices Amendment Bill 1992 (Cth)
JD Heydon, Trade Practices Law: Restrictive Trade Practices, Deceptive Conduct and Consumer Protection, Lawbook Co., Sydney, 2001
KAREN CAREY-HAZELL v GETZ BROS & CO (AUST) PTY LTD, PETER THOMPSON and TREVOR NICHOLLS
W75 OF 2001
KIEFEL J
BRISBANE (HEARD IN PERTH) (VIA VIDEO LINK TO PERTH AND SYDNEY)
6 JULY 2004

INDEX
A.     BACKGROUND
B.     THE ISSUES
1.           CONCERNING THE FIRST RESPONDENT
2.           CONCERNING THE SECOND RESPONDENT
3.           CONCERNING THE THIRD RESPONDENT
4.           THE CLAIM RELATING TO LOSS AND DAMAGE

C.     THE EVIDENCE
1.           THE APPLICANT’S MEDICAL AND WORKING HISTORY PRIOR TO THE IMPLANT
(a)    Medical History
(b)    Work History
2.           THE SECOND AND THIRD RESPONDENTS’ ADVICES
3.           MEDICAL EVIDENCE AS TO MECHANICAL AND TISSUE VALVES
4.           INFORMATION PROVIDED BY ST JUDE MEDICAL INC TO DOCTORS
5.           THE EXAMINATION AND TESTING OF THE VALVE
(a)    At Assembly
(b)    After Explant
6.           OPINIONS CONCERNING THE CHIP ON THE VALVE
7.           THE APPLICANT’S MEDICAL HISTORY AND EVENTS FOLLOWING IMPLANT
(a)    Medical
(b)     Work History
8.           THE APPLICANT’S OPPORTUNITIES TO EARN INCOME
9.           THE APPLICANT’S CURRENT SYMPTOMS AND THEIR EFFECTS
10.          THE MEDICAL EVIDENCE AS TO THE APPLICANT’S SYMPTOMS

D.     LIABILITY
1.           THE LIABILITY OF THE FIRST RESPONDENT
(a)    The claim under s 75AD
(b)    The claim under s 74B
(c)    The claim for breach of duty
2.           THE LIABILITY OF THE SECOND AND THIRD RESPONDENTS
3.           THE APPLICANT’S INJURIES
4.           ECONOMIC LOSS

E.     SUMMARY AND ORDERS

IN THE FEDERAL COURT OF AUSTRALIA

WESTERN AUSTRALIA DISTRICT REGISTRY

W75 OF 2001

BETWEEN:

KAREN CAREY-HAZELL
APPLICANT

AND:

GETZ BROS & CO (AUST) PTY LTD
FIRST RESPONDENT

PETER THOMPSON
SECOND RESPONDENT

TREVOR NICHOLLS
THIRD RESPONDENT

JUDGE:

KIEFEL J

DATE OF ORDER:

6 JULY 2004

WHERE MADE:

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

THE COURT ORDERS THAT:
1.        The application be dismissed.
2.        The applicant pay the respondents’ costs including any reserved costs.
Note:    Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

IN THE FEDERAL COURT OF AUSTRALIA

WESTERN AUSTRALIA DISTRICT REGISTRY

W75 OF 2001

BETWEEN:

KAREN CAREY-HAZELL
APPLICANT

AND:

GETZ BROS & CO (AUST) PTY LTD
FIRST RESPONDENT

PETER THOMPSON
SECOND RESPONDENT

TREVOR NICHOLLS
THIRD RESPONDENT

JUDGE:

KIEFEL J

DATE:

6 JULY 2004

PLACE:

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

REASONS FOR JUDGMENT

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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
B. THE ISSUES
1. CONCERNING THE FIRST RESPONDENT
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; …’
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.’
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.
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.
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.
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.

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; …’
So far as is relevant subs (2) provides that ‘supply time’ means the time when the goods were supplied by their actual manufacturer.
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 Act provides:
‘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.’
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).
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.
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.
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.
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
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
The third respondent says that the applicant chose to have a mechanical valve in the event that replacement became necessary.
An allegation that the third respondent breached his duty of care by chipping the mechanical valve during surgery is not now pursued.
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
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.
There would not appear to be any doubt about (b) and (c).
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 heart in 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.’
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.
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.
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.
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.
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.
C.       THE EVIDENCE
1.        THE APPLICANT’S MEDICAL AND WORKING HISTORY PRIOR TO THE IMPLANT
(a)       Medical History
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.

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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.’
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.
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.’
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.
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.

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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
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.
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.
5. THE EXAMINATION AND TESTING OF THE VALVE
(a) At Assembly
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.
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.
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.
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.
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
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.
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.
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.

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

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.
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.
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.
The applicant’s case against each of the second and third respondents is not made out.
3. THE APPLICANT’S INJURIES
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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
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.
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.
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
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.
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

IN THE FEDERAL COURT OF AUSTRALIA
WESTERN AUSTRALIA DISTRICT REGISTRY	W75 OF 2001

BETWEEN:	KAREN CAREY-HAZELL APPLICANT
AND:	GETZ BROS & CO (AUST) PTY LTD FIRST RESPONDENT PETER THOMPSON SECOND RESPONDENT TREVOR NICHOLLS THIRD RESPONDENT
JUDGE:	KIEFEL J
DATE OF ORDER:	6 JULY 2004
WHERE MADE:	BRISBANE (HEARD IN PERTH) (VIA VIDEO LINK TO PERTH AND SYDNEY)

JUDGE:	KIEFEL J
DATE:	6 JULY 2004
PLACE:	BRISBANE (HEARD IN PERTH) (VIA VIDEO LINK TO PERTH AND SYDNEY)

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