Ethicon Sarl & Ors v Gill & Ors [2021] HCATrans 187 (5 November 2021)

Last Updated: 9 November 2021

[2021] HCATrans 187

IN THE HIGH COURT OF AUSTRALIA

Office of the Registry
Sydney No S47 of 2021

B e t w e e n -

ETHICON SARL

First Applicant

INC ETHICON

Second Applicant

JOHNSON & JOHNSON MEDICAL PTY LIMITED ACN 000 160 403

Third Applicant

and

KATHRYN GILL

First Respondent

DIANE DAWSON

Second Respondent

ANN SANDERS

Third Respondent

Application for special leave to appeal

KEANE J
GORDON J
GLEESON J

TRANSCRIPT OF PROCEEDINGS

AT CANBERRA BY VIDEO CONNECTION TO BRISBANE, MELBOURNE AND SYDNEY

ON FRIDAY, 5 NOVEMBER 2021, AT 1.30 PM

Copyright in the High Court of Australia

____________________

KEANE J: In accordance with the protocol when the Court is sitting remotely, I will announce the appearances for the parties.

MR B.W. WALKER, SC appears with MR D.T.W. WONG for the applicants. (instructed by Clayton Utz)

MR A.J.L BANNON, SC appears with MS Z.L.M. HILLMAN for the respondents. (instructed by Shine Lawyers)

KEANE J: Yes, Mr Walker.

MR WALKER: May it please your Honours. The appeal for which we seek special leave is an appeal which would accept what might be called primary findings of fact. The very extensive record would not require to be ransacked or paraded before the Court in order to make the points we want to make. We do, however, say that there are ultimate conclusions of characterisation both for the purposes of statutory liability and common law negligence which raise issues of principle that go far beyond the issues joined between the parties in these representative proceedings.

The medical devices in question are those to which names are given and purpose explained in paragraphs 12 and following in our special leave application in the book at 1887. I need not dwell on them except to remind your Honours that there are stress urinary incontinence devices – the SUI. There were five at trial, four of which are still in commerce in this country. There were four pelvic organ prolapse devices which are no longer on the market, but those five plus four – nine – were the group of devices for which we have been held liable, to the extent that that is a straightforward statement in representative proceedings.

Though it is not of moment to our special leave argument, your Honours will have seen in paragraph 18 of our special leave application the particular use of particular devices of particular named applicants. One of them, that is, Mrs Sanders, was implanted with TVT which is one of the SUI or tape products.

So, at the outset of the case, one can see that by dint of compliance with the injunctions granted to control the marketing or commercialising of these products – as to the four still in commerce, your Honours know that they are treated by the court, that is, the Federal Court at trial and the Full Court dismissing an appeal, to be products, which, so long as injunctions are complied with – principally concerning warnings to accompany their distribution – they are fit to be in commerce, that is, they are not unsafe at any speed.

It is in that connection that we call in aid, first of all, and in particular regard to the statutory count that there are, in our submission, anomalies, disconnects, in the reasoning by which a conclusion could be achieved that that goods were defective in the sense that their safety was not such as persons generally are entitled to expect.

As your Honours know, these are highly specialised devices. They are not available over the counter. They are not the subject of marketing to patients or prospective patients. They are not the available of any dealing between manufacturer and patients. Their use is only by reason of a hospital or doctor acquiring them for use according to that surgeon’s assessment of a particular patient, both as to the patient’s understanding of risk and the patient’s perception of the position in which she is placed by these physical conditions.

Of the physical conditions it can be said, like many, but to a marked degree, they might be regarded as, alas, incurable, the alleviation of symptoms being the main aim of therapy. These artificial devices are devices which provide support which the body’s own tissues no longer provide, either against incontinence or prolapse.

It is for those reasons that any alleviation could not sensibly ever be regarded as a permanent fix or even, in a curative sense, a fix at all. It is for those reasons, all of this being common ground we submit, it is for those reasons that the typical role of highly specialised medical practitioners – sub‑speciality of pelvic surgery – is, in our submission, a critical factor to be considered in applying these general statutory provisions and, for that matter, general duty of care which apply from ginger beer bottles through to pencils and everything in between, to these highly specialised devices. Yes, the law applies to them. But the circumstances which are required upon the law to be considered, and which the statute plainly requires to be considered, particularly in terms of what persons generally are entitled to expect, must include – must include the pivotal role – gateway.....it may be said – of the expert treating surgeons. That is why ‑ ‑ ‑

GLEESON J: Mr Walker, what is the purpose of the warnings that are the subject of the injunctions that are now in place?

MR WALKER: Your Honour, of course, is asking me to justify a remedy that I had fought against, but as we understand the reasoning, it is that so long as the conduct which is brought about by compliance with those injunctions is undertaken, it will be in order, that is, not in breach of a legal norm, for those devices to be commercialised. In other words, that conduct is conduct which removes the vice from the conduct for which we have been held liable.

GLEESON J: So, I take it from that that you do not see it – your case does not include accepting any utility in relation to those warnings.

MR WALKER: No, quite. Part of our case is precisely that - there was, we submit, a marked failure of two kinds with respect to the evidence, and an error with respect to what might be called, in shorthand admittedly, onus. Let me explain.

The expert treating surgeon for each of the named applicants did not give evidence that had they been given different or additional information in order to consider their advice and warnings to their patients, the approach they would have taken clinically, therapeutically, with those patients, would have altered.

One would have thought, without needing to distinguish between common law or statutory count, that that was a pretty obvious aspect of an advice on evidence. If it is said that there is statutory defectiveness because of a lack of a warning, or that there is a negligence because of lack of a warning, and it is said that in each case they are actionable so as to provide liability in damages, then of course there has to be a loss demonstrated by the suffering of an event which would have been a different event had the shortcoming in conduct not occurred. In all cases, that must go through the pivotal gateway of the response of the treating surgeons, highly skilled ‑ ‑ ‑

GORDON J: Is that right, Mr Walker? I had understood that it was in effect four steps that were undertaken – and it may be that the evidence – that element of proof is done by a different way, but I thought that the primary judge had regard both to what were described as evidence of both pelvic surgeons and non‑clinical experts.

MR WALKER: Yes, that is true.

GORDON J: The non‑clinical experts were used, as I understand the reasoning, to ascertain the risk of the devices – of using the devices.

MR WALKER: No, your Honour.

GORDON J: The evidence of the surgeons established that they did not know of the risk of the pleaded complications which your client accepted ultimately were not only right but inevitable in a sense, and then there was no error, as I understood, in having regard to the non‑clinical expert for the purpose of ascertaining the risk of the devices which the pelvic surgeons did not know about. Do I have that wrong?

MR WALKER: A bit, your Honour, a bit.

GORDON J: What is the bit?

MR WALKER: First of all, in relation to what I will call non‑clinical experts, we have addressed that question in paragraph 24 of our special leave application. The risks in question are the risks of bad outcomes expressed in clinical health and amenity terms for the patients. The risks are not synonymous with the postulated or, in some cases, demonstrated means by which, not surprisingly, the introduction of a foreign body into a human body may bring in its wake detrimental effects on the human body. All foreign bodies – in surgery and medicine generally – are obviously subject to just such a possibility against which, no doubt, testing, screening, certification and the like is intended to protect.

But one thing is for sure. The fact that they are foreign bodies – just like surgery involves trauma – is not regarded as a risk of which surgeons were unaware, let alone any treating clinicians in the case. That is the first thing. The second thing is that in terms of the risks in question, as I say, there was not the straightforward – in our submission, the only proper course taken of establishing through the practitioner’s specialists – the experts – whose consideration and advice had produced the undertaking of surgery by the named woman – that there was no proof that they would have acted differently in that regard had there been – to jump to the end of the story – compliance with what was later required by the injunctions.

It is for those reasons that one links that with the second anomaly in this regard – as can be perhaps inferred from the fact that the court has left these devices to be commercialised so long as the injunctions are complied with – and they are not injunctions against commercialising, they are injunctions against the supply of information.

It can be seen that there is nothing odd or defective about the striking metaphor being used that, at least with the SUI devices in particular, they represented, according to the evidence before their Honours of eminent experts – Professor Korda included among them, called by our opponents – of those products representing the gold standard, the metaphor meaning none better.

Now, “none better” in a field where nothing is a panacea, alas, none better where surgery is involved with all the surgical risk for an individual, and individual circumstances involved, and of course, none better in the field where native tissue is inadequate, artificial – that is, foreign body support is called for and decided upon between doctor and patient, not between manufacturer and doctor or manufacturer and patient, but between doctor and patient and where, it follows, the fact that there may be and have been held to have been, in these cases, detrimental consequences – that is, being worse off as a result of surgery using these devices – that is the finding against us that we would not seek to challenge in any appeal.

That necessarily says nothing about either defectiveness - people generally are not entitled to expect that they could not be worse off by a surgeon considering it appropriate to give advice which leads a patient to have material used in an attempt to alleviate a condition, which condition is not merely not alleviated, let alone in the long term but is eventually and sometimes only too soon made worse.

That is not something that one can pronounce as a general matter of law, let alone as a matter of what might be called societal value, of which there need be no demonstration by evidence or logic. The fact is these are conditions which do not lend themselves to the straightforward, well‑established, scientifically demonstrable, efficacious cure and it is not alone in that ‑ ‑ ‑

KEANE J: Mr Walker – I am sorry, Mr Walker, I did not mean to interrupt.

MR WALKER: No, of course.

KEANE J: How does the contention that you are developing sit with the findings of the Full Court, or the reasons of the Full Court at paragraphs 401 to 404 at pages 1690 to 1693 in the application book?

MR WALKER: Well, may I take the sidelining of our reliance upon Professor Korda in paragraph 402. Without a reversal of onus, it will not do, with respect, to say, in effect, not all the experts are in favour of, in that case, the appellant, because whether one is talking about what one is generally entitled to expect under a statute, or reasonableness under common law, it simply cannot be the case – it does not take upon its impossible role of deciding which school of thought in medicine or surgery should be preferred, it cannot be held that it would be negligent to proceed in accordance with an entirely respectable body of thought.

We, in fact, do not have the arrayed opposing camps that one notoriously sees in certain pleadings of medico‑legal dispute in this case. What we had rather was a shortage to the point of real non‑existence of specialist expert opinion that these are products which could not or should not have been used at all, full stop, unsafe at any speed.

That is why, no doubt, the Court does not, in effect, ban by injunction, but regulates information by injunction. It is for those reasons that one comes, of course, to the question of warning. In that regard, one therefore comes to the way in which their Honours dealt with a critical passage in her Honour’s reasons. Can I take your Honours ‑ ‑ ‑

GLEESON J: Mr Walker, just in relation to paragraph 401, is your client’s case that the pelvic surgeons did not need to know of the pleaded complications, or that they did not need to be informed of the pleaded complications by your client?

MR WALKER: It is both, but the latter is the one that sticks out most obviously, your Honour. That is why a failure to reduce evidence against us or, when we call witnesses, a failure to extract concessions against us with regard to what might be called a unique body of knowledge possessed only by us that would have made the difference with respect to the acceptability of these devices, through the gateway of consideration by experts who did not need to be instructed by us of some surprise, perhaps why, in our submission that amounted to error ‑ ‑ ‑

GORDON J: Mr Walker, can I ask about that. I had thought that the findings against you were not only did the surgeons not know of the pleaded complications, but, moreover, they did not know at the time and it only emerged many years after they were supplied to the market and largely after this litigation was commenced. This is in the context where your client maintained that there was nothing wrong with them, and that the pleaded complications were of no moment until halfway through the trial.

MR WALKER: Your Honour, the evidence and findings concerning the evidence with respect to what I will call learned bodies of surgery plus experts on both sides called I am afraid does not include what might be called unknown phenomena by way of adverse outcomes outside the understanding of the profession or the relevant professionals.

Now, it is true that in the different but related question of negligence in relation to pre‑market testing/post‑market monitoring that it is obvious that information which is gathered only by us is not known by others until and unless they are shared with regulators or others. But that does not mean the generic nature of dangers which are inherent in the use of foreign bodies in reconstructive surgery is outside the understanding of the practitioners in question.

GORDON J: I am sorry to labour the point. At 554 on page 1746 their Honours in short summarise their position, identifying that “the treating surgeons did not know” – this is the primary judge’s findings which they uphold – and that if they had known “they would have communicated them to their patients”.

MR WALKER: In our submission, all of that, as we argued below, depends upon what I might call an absence of primary facts, and that was a reversal of onus. Both below and in its endorsement on the first appeal, that was an approach that said unless the manufacturer shows of any particular doctors, including those not before the court, at the behest of the claimants – unless they show that he or she already knew enough, then I infer – a misuse of the word “infer” - then I infer what your Honour draws to attention in 554(1). That was, using forensic spatula, beyond its capacity to bear a load, your Honours, and it did involve that shift of a burden. It does not matter whether it is evidentiary or legal. There should have been no shift of a burden.....appropriate evidence against us of that kind.

Your Honours, I am aware of the time. May I very briefly draw to attention a critical part, as we would see it, of the Full Court’s reasoning?

KEANE J: Yes, go ahead, please, Mr Walker.

MR WALKER: Your Honours, at 1765 and following of the application book commencing at paragraph 624, if your Honours turn to a paragraph that was the subject of considerable criticism by us in the appeal below, namely, paragraph 4401 of the primary judge’s approach to the statutory question, which is of self‑evident general importance, her Honour there appears to reason in such a way that the warning – that is, lack of warning or inadequacy of warning – is removed from that which comprises a defect.

Now, that would have the effect of course that our complaint that doctors had not shown – had not been called to show that any different outcome would have inured for these unfortunate claimants had there been the putative deficient warnings given, because it enabled the court, apparently, to say it is defective regardless of warning. That, in our submission, is a fundamental error in the approach taken. Your Honours
see the words emphasised by their Honours in that extract, notes the defect - her Honour said:

the defect is not the absence or inadequacy of the warnings . . . but the fact that the device has a propensity to cause harm that persons generally would not reasonably expect.

It is that last phrase that members of the Full Court then take up as if it were to say that, in fact, the learned trial judge must be taking into account warnings because warnings are the milieu and circumstances in which expectations by persons generally must be seen to be generated.
Now, when warnings go, not to lay‑prospective patients, but to very expert sub‑speciality medical practitioners, then all the more obviously there will be a serious problem created by an apparent finding that as a matter of law, under such a statute, a warning notwithstanding a product may be defective. That is the disjunction of which we complain that fits the case for special leave on that point. It cannot be coherent or proper for the court simultaneously to say these goods are defective, but I will permit them to be commercialised. True, so long as injunctions are complied with, but on this reasoning the goods are defective regardless of compliance with injunction. It is for those reasons, in our submission, the case is appropriate for special leave. May it please the Court.

KEANE J: Thanks, Mr Walker. Yes, Mr Bannon.

MR BANNON: Your Honours, her Honour the primary judge delivered an initial judgment as a result of which the respondents had established an entitlement to damages based on a liability in four respects: firstly, in negligence, based on a failure to warn of the pleaded complications; secondly, for supply of a product with a defect; thirdly, negligence based on a failure to undertake adequate pre‑market and post‑market evaluation; and in the case of Mrs Sanders only, misleading conduct in failing to warn of the pleaded complications.

Consequential upon that judgment, because different non‑economic loss heads applied to the different negligence versus statutory claims, the respondents elected for their damages to be awarded by reference to the negligence claim and, whether it is negligence based on failure to warn, or negligence based on failure to undertake adequate pre‑market investigations or post‑market makes no difference.

The result is that the damages verdicts which the respondents obtained and in respect of which this punitive appeal would seek to set aside must be tested, at least in the – from one instance by reference to that claim, and in relation to that claim and in relation to the other established liabilities we say, firstly, there is no special leave point arises and there are no or no sufficient prospects of success.

Can I address then, for that reason, the “failure to warn” case. The applicants were found to have breached their duty to take reasonable care to avoid injury to recipients of the devices by failing to warn pelvic surgeons of risks specific to the devices of causing identified adverse effects or complications, and they earned the moniker “the pleaded complications”, which risks were clinically significant. For example, one of those risks was the risk of the patient suffering severe chronic pain.

The concurrent findings of fact of the primary judge and the Full Court, which we do not understand to be contested, can be set out in relation to that claim as follows. Firstly, the pleaded complications were risks specific to the devices, that is to say, they were not general risks of surgery. We have referred to the relevant findings in our response at paragraph 10(a), no challenge. Second, the severe chronic pain and other injuries, which were in fact suffered by the respondents, were firstly pleaded complications and secondly were caused by the devices, and those findings are referred to in our response at paragraph 14, in particular in the Full Court judgment at 68, 73, 75. There was debate in the Full Court about some of the injuries, but 854 to 861 of the Full Court found that all of the injuries were caused.

Thirdly, the respondents were not warned by their treating surgeons of the risks of suffering those injuries, that is the Full Court upholding that finding at 846 - we have referred to this in our special leave response at 26. That was based on the evidence of the respondents who were called who gave evidence. It was also based on contemporaneous notes of doctors. Yes, their treating surgeons were not called, but as the Full Court points out, the evidence was filed and read at a time when the respondents still denied that these complications were in fact caused, and also pleaded a state of art defence to say the state of science at all relevant times was not such to enable the respondents to know that these were pleaded complications.

As their Honours said, there was no Jones v Dunkel inference to be drawn, but whatever all the circumstances were taken into account, it can hardly be thought that the respondents might have predicted what in fact happened in circumstances where they were saying, effectively, nobody could have warned about these, we did not know about them, the state of art, of science, did not let us know about those. In any event, their Honours confirmed the findings of the court and we do not understand that to be a factual finding challenge, namely, they were not so warned by their treating surgeons.

Fourthly, if the respondents had been warned of those risks by their treating surgeons, they would not have agreed to the implantation of the devices and would not have suffered those injuries. Those findings are set out at paragraph 862 of the Full Court’s judgment in summary form on page 1851, and also confirmed at 868. That was after reviewing the evidence and the reasoning of her Honour, and we do not understand that to be a finding which is challenged. It certainly would not be a special leave point.

Fifthly, the respondents’ treating surgeons were not aware of those risks. That is a finding of their Honours at paragraph 846 of the judgment at 1845, and if I could just pause for a moment, in addition to referring to the paragraphs of trial judge’s judgment, their Honours here refer to:

given the evidence, it could not be inferred or assumed that the treating surgeons of [the respondents] were aware of the pleaded complications. It could not be inferred or assumed that their treating surgeons decided not to discuss with their respective patients all of the potential risks of which they were aware. It could not be inferred or assumed that had the appellants made them aware of the pleaded complications, the treating surgeons would not have informed their patients . . . devices. The weight of the evidence in each respect was to the contrary and the primary judge so found.

In other words, that is another finding based on the evidence that they do not contest, namely, the individual treating surgeons were not aware of the risks.

The sixth proposition, which is not challenged, is the applicants did not warn any treating surgeons, including the respondents’ treating surgeons, of those risks. There is no issue about that.

Seventhly, the treating surgeons generally were not aware of those risks. That is the finding which was made by the Full Court after a vigorous challenge in the Full Court, and again we do not understand that to be a factual finding sought to be disputed.

Eighthly, if the applicants had provided warning of the pleaded complications including those risks, the respondents’ treating surgeons would have passed on that warning to the respondents. The references there are referred to in SLR26 and the underlying paragraphs in 846 through to 848 and it is a process of reasoning which proceeds along these lines.

Firstly, these were risks which no surgeon conceivably would not provide to patients, if they were aware of the risks, including the risk of chronic pain. No doctor called by the respondent came along to say, “If I had been aware of those risks, I would not have warned the patient in relation to them”. No cross‑examination of any of the applicants’ surgeons’ experts were called - was suggested to them that anyone would not have warned about them.

Your Honours will have seen a reference to a belated RANZCOG statement admittedly in relation to some of the devices, because they were still on the market, which said to doctors, “You must warn about these things, particularly chronic pain”, being a RANZCOG statement which was quite different to earlier ones – which demonstrates a couple of things, firstly, that there was a growing knowledge over time, particularly after commencement of litigation, and, secondly, consistently with the findings about the trial judge and the Full Court, that one – if a doctor was aware, had been warned by the IFU of the complications, inevitably they would have passed them on. In any event, we do not understand anything in the special leave application to suggest that that factual finding by the – concurrent finding is in issue or would be sought to be overturned.

Then, ninthly, at all relevant times, the applicants were aware of the pleaded complications including those risks – there is no issue about that. The pleaded complications including those risks were clinically significant. So, there are 10 factual findings which we submit could not be overturned but are not sought to be overturned.

Then the last question is, a reasonable person, they found, in the position of the applicants, ought to have included in the IFU supplied with these devices the warning of the pleaded complications. The challenge to that finding - it is unclear what it is. If one goes to the book at 1796, one will see at paragraph 707, the Full Court noting that:

as the respondents submitted, the appellants did not contend that the primary judge was wrong to conclude that patients should have been warned about the matters set out in the answer to common question 18 before they were implanted with any of the devices.

Just pausing there, if one goes to answers to common question 18, one will find that at page 1874 – and there is 18 at the bottom – one can see matters such as what appears in (a), (c) – in particular over the page (e), (f), (g)(v) and (vi), (h) and (m). If I can come back to 1796, their Honours record:

As the respondents noted, the appellants submitted to the primary judge –

this is final submissions:

It is uncontroversial that manufacturers of a product owe duties of care to consumers to take reasonable steps to safeguard consumers against foreseeable risks of injury, and that the duty extends to ensuring appropriate and necessary information about the product is communicated to persons who will use the product.

Then again, at paragraph 716, at page 1798, in the middle of that paragraph, there is a reference about the middle of the way down – halfway down:

The appellants do not resile from that acceptance –

of the duty:

Nor do they directly challenge the primary judge’s conclusion at TJ[3627] that, insofar as this aspect of the respondent’s claims is concerned, the relevant duty of care included a duty to provide accurate information about the performance and safety of the devices -

So, we submit it is opaque as to what the basis could ever be of setting aside the duty – the failure to take reasonable care by failing to warn on any appeal and certainly no special leave question arises. The only point argued on appeal, substantively, on this issue, was, did we satisfy our onus of demonstrating that doctors generally were not aware. Their Honours referred to that in paragraphs 708 on page 1796, that the case ultimately, they did not need to provide the warning because doctors were already aware, and that is what they rejected. Similarly, at 724.

Their Honours at paragraphs 418 and 419, that is 1700 – I do not need to go to it – noted there was no submission made that these were obvious risks. Now, my friend has not referred to it, but in the written outline of argument there is a suggestion that the trial judge and the Full Court failed to undertake.....or prospective approach in relation to assessing the duty of care and the content of the duty, but we say that is absolutely wrong - 722, for example, of the Full Court’s judgment, the whole passage from 713 through to 726 makes it clear that it is prospective analysis, it is in relation to significant risks only and it is in circumstances where they already have IFUs which included an adverse reaction section warning, which included warnings about ultimately fairly mild things, but not the critical ones.

So there was no cost to them to do the reasonable thing to do and, indeed, they had a statutory duty under the relevant legislation as part of getting approval for release on the Australian market to comply with the essential requirements which included attempting to design out risks of harm, but to the extent they could not be, then those residual safety risks had to be the subject of information provided with the goods. So, we submit it is not possible to envisage a different outcome in this Court on any putative appeal in relation to the negligence finding – failure to warn.

If I could then come to defect, much of what I have said already informs the question of defect, insofar as the findings of defect of all devices were found to be based on the failure to warn of pleaded complications, in addition to other matters. Those other matters included, for example, that this is not a life‑threatening condition, there are other alternative native tissue treatments for dealing with these conditions which had not been shown to be materially worse and, in circumstances of the significance of the risks which are involved and consistently with the legislation which requires one of the matters to be taken into account – information provided with the goods including warnings, including all relevant circumstances, the court – the primary judge and the Full Court comfortably found that this was a defect.

My learned friend makes – puts in issue the proposition it must be incongruous to have something which is still on the market – could be on the market yet be defective. Well, the answer is, as the Full Court made clear and, indeed, Merck made clear, Carey‑Hazell made clear, the explanatory memorandum made clear, you can have a defect in the statutory sense if there is insufficient information about risks because the question to be concerned is does the good have the safety that persons generally are entitled to expect.

If they are unaware of risks, such as, for example, severe chronic pain, for something to alleviate stress urinary incontinence or non‑life‑threatening conditions, then that is a safety less than what they are entitled to expect. In the Vioxx case, your Honours will recall ‑ ‑ ‑

GORDON J: Mr Bannon, is it the position that what is set out at pages 1778 to 1779 at 656 and 657 is in a sense the way in which you put it?

MR BANNON: Yes. The short answer is that there is nothing unremarkable about consumer legislation which is designed to ensure for the safety of the consumers that, albeit a product may be highly beneficial, nevertheless they need to be told of safety risks so they can be taken into account, and in a case of a pharmaceutical or a product such as this, that information has to be ‑ ‑ ‑

GORDON J: If they were not told of those risks, it is defective in that manner?

MR BANNON: Correct. It is important to understand, as in the Vioxx case – and if one goes to 1859 of the judgment, at paragraph 888 the Full Court found that the mere establishment that there was a defect does not mean that a person who suffers any injury using a product has a cause of action, just as in Vioxx. In Vioxx, the product was found to have a defect, but the plaintiff – the applicant could not show that the myocardial infarction suffered by the applicant was caused by Vioxx. There was also a state‑of‑the‑art defence which arose in any event.

But as here the Full Court says the defect is the risk of harm against which there is not a warning, and you have to ask what would – in asking the question was the injury caused by the defect, there are two things to be answered. One is that the risk which is not the subject of a warning.....did you suffer chronic pain, for example, and secondly, if there had been a warning, would or would you have not accepted the goods? In other words, it is not materially different to the outcome in relation to failure to warn.

As their Honours pointed out in that paragraph, that is the correct test of causation and it was satisfied in this case by reason of the matters I have already taken your Honours to. So, in other words, when our learned friends say how could it be that failing to identify any risk makes it defective, well, the answer is that if it is a significant risk, it is defective if persons generally are not aware of it.

But that does not mean it is going to be a cause of action unless that defect in the two senses I have indicated causes the injury, namely, the risk falls in and you ask what would have happened if the warning had been there? So, there is nothing unremarkable about it. The findings of fact are not remarkable, and the outcome is not remarkable in any sense, and no special leave issue arises.

Then lastly in relation to - my friend has not said anything about it - the pre‑market evaluation, I think the point in the outline is to say, if we already knew about the risks, what more did we have to do? This is only in relation to some of the products because some of the products have been found – if I can just, sorry, finish this one sentence, if I may, your Honour.

KEANE J: Go ahead, Mr Bannon.

MR BANNON: Yes, thank you, I am sorry. What the Full Court found – correctly, we say – is a proper pre‑market evaluation in accordance with the duty of care required, if the risks could not be designed out of the product, they had to be included in a warning. What their Honours found was that having regard to the behaviour of this company, if one looks in the counterfactual, acting negligently, a proper evaluation would have been.....inclusions of those risks, would this company have ever launched
that product with those risks? They said no, a factual finding which is not challenged.

They said no because this is a company who set about – notwithstanding knowledge of the risks – of not informing consumers and, indeed, defending the proceedings right up until the time Dr Hinoul got into the box, and under cross-examination finally told the truth. So that factual finding and that causal chain is not the subject of any contest, nor could it be – and the prospects of success on that issue are both, we say, non‑existent and do not raise any special leave issue. May it please the Court.

KEANE J: Thanks, Mr Bannon. Mr Walker, anything in reply?

MR WALKER: One point only. Your Honours, paragraph 846, page 1845 of the application book, there is an example of what might be called a form of reversal of onus reasoning. It is not a legitimate shift of evidentiary burden, given that there was no evidence of what, significantly, their Honours said in the alternative might be assumed. In truth it was only ever assumption, and it is for those reasons, in our submission, that in a case concerning the very important area of information being made available by a manufacturer of a device not available to the public to persons who are clinically expert in the use of foreign‑body devices in their sub‑speciality surgery, then this was not a matter that could or should ever have gone by assumption. May it please the Court.

KEANE J: Thank you, Mr Walker. The Court will adjourn briefly to consider the course it will take in this matter.

AT 2.18 PM SHORT ADJOURNMENT

UPON RESUMING AT 2.25 PM:

KEANE J: The appeal foreshadowed by this application would not turn on any issue of general principle. In any event, the proposed appeal does not enjoy sufficient prospects of success to warrant the grant of special leave to appeal. The application is dismissed with costs.

The Court will now adjourn until 10.00 am on Tuesday, 9 November. Please adjourn the Court.

AT 2.26 PM THE MATTER WAS CONCLUDED