Peterson v Merck Sharp & Dohme (Australia) Pty Ltd

[2012] HCATrans 105

[2012] HCATrans 105

IN THE HIGH COURT OF AUSTRALIA

Office of the Registry
  Melbourne       No M152 of 2011

B e t w e e n -

GRAEME ROBERT PETERSON

Applicant

and

MERCK SHARP & DOHME (AUSTRALIA) PTY LTD (ACN 000 173 508)

Respondent

Office of the Registry
  Melbourne  No M153 of 2011

B e t w e e n -

GRAEME ROBERT PETERSON AS REPRESENTATIVE OF PERSONS WHO ALLEGE THEY ARE GROUP MEMBERS BY REASON OF THE CIRCUMSTANCE IN PARAGRAPH 2(c)(i) OF THE FURTHER AMENDED STATEMENT OF CLAIM IN PROCEEDINGS NO VID 451 OF 2006

Applicant

and

MERCK SHARP & DOHME (AUSTRALIA) PTY LTD (ACN 000 173 508)

Respondent

Applications for special leave to appeal

FRENCH CJ
CRENNAN J

TRANSCRIPT OF PROCEEDINGS

FROM CANBERRA BY VIDEO LINK TO SYDNEY

ON FRIDAY, 11 MAY 2012, AT 10.24 AM

Copyright in the High Court of Australia

__________________

MR D.F. JACKSON, QC:   If the Court pleases, I appear with my learned friend, MR B.F. QUINN, for the applicants in each matter.  (instructed by Slater & Gordon)

MR B.W. WALKER, SC:   May it please the Court, I appear with MR R.D. McINNES for the respondent in each matter.  (instructed by Clayton Utz, Lawyers)

FRENCH CJ:   Yes, Mr Jackson.

MR JACKSON:   Thank you, your Honours.  Your Honours, the written arguments in support of the applications are set out in the summaries and in the reply which the Court has seen.  May I just say something about the importance of the matter before going to deal with the aspects of the Full Court’s approach which go to the heart of the case. 

In relation to importance, this case, as your Honours will see from Mr Baker’s affidavit at page 698 in volume 2, affects a large number of persons.  You will see that at the bottom of page 698 and the top of page 699, your Honours, and, as we have submitted in our written submissions, at page 696 in paragraphs 44 to 45, this is a case where we would submit it is also otherwise a case for the grant of special leave.  May I, your Honours, go then to the Full Court’s approach.

FRENCH CJ:   I am sorry, before you do, Mr Jackson, your written submissions focus entirely, as I understand it, on the question of causation and is that, notwithstanding the matters canvassed in the draft notice of appeal, the basis upon which you raise the issues concerning the statutory causes of action?

MR JACKSON:   Yes, your Honour.  Could I just say this.  There is a slight difference between the case of Mr Peterson on the one hand and the other plaintiffs on the other.

FRENCH CJ:   Yes, and the class.  I understand that.

MR JACKSON:   Yes.  So far as his case is concerned and so far as all the cases are concerned, the issue in relation to the statutory causes of action – and may I simply refer to 74B and 74D – turn on the meaning of the expression “by reason of” in each of those provisions.  The view that has been taken and was not challenged below was that that imported the, if I could put it this way, common law view of what constituted causation and, your Honours, that is the approach that has been taken and we would submit is correct.  Whether it be that one looks at the matter from the point of view of causation under the general law in relation to persons other than Mr Peterson or the expression “by reason of” in relation to Mr Peterson and all the other plaintiffs, the issue to which your Honour has referred does arise.

CRENNAN J:   Mr Jackson, may I ask you this.  The special leave questions in grounds 1 to 6 in the draft notices of appeal invite us to consider the circumstances in which a material increase in risk is sufficient basis for inferring causation.  What I wanted to ask you before you go to the detail of the argument is this question.  However one characterises McGhee v The National Coal Board [1973] 1 WLR 1, whether it is an orthodox example of inferential reasoning and commonsense and so on or whether it is a modified rule of causation, am I right to see the argument set out in the written submissions from page 694 to 696 as inviting this Court to consider the issues raised not only in McGhee but also in Fairchild v Glenhaven Funeral Services Ltd [2003] 1 AC 32 and Barker v Corus [2006] 2 AC 572 and the Canadian Case which you mentioned, Resurface Corp v Hanke [2007] 1 SCR 333? I ask that question because the respondent’s written submissions seem to express a degree of uncertainty about whether we are being invited to consider those issues.

MR JACKSON:   Yes.  Your Honour, may I say in response to that, first of all, without making any adverse comment about the way in which our learned friend has put their submissions, may I just say that we would approach the matter really in two ways.  One is that we would say that the approach actually taken by the primary judge was an approach which accorded with the principles of the general law as they are known and by that I mean, for the moment, your Honour, not treating the case as falling within any exception of the kind to which your Honour has referred.  I use the term shortly.

CRENNAN J:   Yes.  The failure was related to the failure to satisfy the “but for” test.

MR JACKSON:   Yes.  That is what the Full Court said.  But, your Honour, could I just say this, that we would say making the assumption that is correct, the case is he at one where what there was was a doubling of the risk of myocardial infarction and that in the circumstances was one which satisfied the requirements of a more liberal – if I might use that term – test that one based on increase of risk in the sense referred to in the cases which your Honour mentioned.  Your Honour, that is where the case would lie, but that is fundamentally the nature of it and that, in our submission, is an important issue. 

Your Honours, we also, if I might say this in addition, rely on the fact that the approach taken by the Full Court does seem to involve, if I may say so, with respect, some misinterpretation of what the primary judge said and what the nature of the evidence was.  I mention that and would propose to go to that very shortly because that does seem to lie behind some of the submissions at least on which our learned friends rely and saying this is not a case for special leave, and also to demonstrate that the judgment of the Court of Appeal is, in any event, one which should not be maintained, even on the basis on which it was done.

CRENNAN J:   Well, here there is something like eight risk factors, is there not?  I picked that up from 589, paragraph 86 of the Full Court’s decision.  It is a reference to what the primary judge said about the risk factors.  How would an exception of the McGhee sort apply in circumstances – putting it another way, how could the evidence, in circumstances where there are eight possible causative factors in play, ever rise above demonstrating a possibility that one of eight possible causes caused the actual event of the heart attack, I think it was?

MR JACKSON:   Yes.  Well, could I just say this, your Honour, and I need to go a little behind what your Honour has just put to me in answering the question.

CRENNAN J:   Yes.

MR JACKSON:   Your Honour will have seen there, and also a little later in the Full Court’s reasoning between, I think, paragraphs 92 and 125, that there is an attempt by the Full Court to say, well, this man was suffering from (a), (b), (c), (d) and (e) and therefore it might well have been one of those things and one cannot say that it was caused or materially contributed to by the consumption Vioxx.  The difficulty with that, your Honour, and this is a really important matter in the case, is that that does involve, with respect, a misinterpretation of the evidence that there was about the trials that had been conducted and which led to the view expressed by the trial judge as finding that the increase in risk brought about by the consumption of Vioxx was about two.  I can take your Honours to the passages, but essentially what the judge was saying ‑ ‑ ‑

FRENCH CJ:   This is the relative risk ratio?

MR JACKSON:   Yes, it is, your Honour.  What he was saying was that in the trials, which were controlled random trials, one had a situation where two groups, in effect, covering the field of people were selected.  The groups were the same but for the fact one group was taking Vioxx, the other was not.  The result of the trials, this is the approved trial, was that the number of persons suffering from heart attack in the Vioxx‑taking group was twice, in a fact a little more than twice, as high as that in the non‑Vioxx‑taking group.  So that one had a situation then, your Honours, that it is not right to say, as the Full Court seemed to say, that it could have been caused by all these other factors and that you could not say that the increase of twice made a difference, because the group in relation to which the figure of two was arrived at was itself a group which already took into account persons having all the factors that were present in the case of Mr Peterson.

So what the Full Court has done, in our submission, is to take into account, in effect, twice as against us the fact that some people with a condition like his might have a myocardial infarction, whether or not they took Vioxx, and that is where, if one goes to particularly paragraphs 771 and 772 of the primary judge’s reasons – and I will come to those shortly, your Honours.  It is at volume 1, page 376, I think, your Honours – one sees that the judge adopts a perfectly logical view in arriving at the conclusion that there was a material contribution.  Your Honours, could I go to that issue, which really does, in a sense, lie at the heart of the matter, in a little more detail?

CRENNAN J:   Yes.

MR JACKSON:   Your Honours, I need to look a bit at what the Full Court was saying on the one hand and what the primary judge said on the other.  Could I invite your Honours also to have open page 592 in volume 2 which is where the Full Court’s reasons relevantly start.  You will see, your Honours, that at paragraph 92 the Full Court expressed the view that Justice Jessup, in paragraph 772 of his reasons, was making a finding that Vioxx made a material contribution to the occurrence of the applicant’s condition although he could not find that but for the Vioxx the heart attack would not have occurred.  That was rejecting an argument by the other side, to the opposite. 

Then one sees in paragraphs 93 and 94 the Full Court holding that the judge’s refusal to find that the heart attack would not have occurred but for the taking of Vioxx meant that an essential factual finding was missing.  You will see that, your Honours, also reflected in paragraph 99 on page 594.  Your Honours, when one goes back to paragraph 93, what the Full Court is saying is that the essential fact finding which is said to be missing is a finding that:

it was more probable than not that the consumption of Vioxx caused or materially contributed to the occurrence of [the infarction]. 

But, your Honours, that seems to be the very thing that the primary judge did find.  Could I go first to that.  You will see it at paragraph 772 in his reasons and your Honours will see that in paragraph 772 – your Honours, I will come back to it in a moment.  You will see a reference to the FitzGerald hypothesis and then at the end of the paragraph you will see the judge making a finding – the last three lines – that he is satisfied:

that some material contribution was played by the brake on the synthesis of prostacyclin applied by the inhibition of COX‑2, and therefore by the consumption of Vioxx.

Now, your Honours, I will come back to the FitzGerald hypothesis a little later, but if I could invite your Honours to look at paragraphs 771 and 772, your Honours will see that they represent conclusions that the judge arrived at after he had turned, in a part of his reasons for judgment that commence at paragraph 683, for the first time to the particular circumstances of the applicant.  Before that he had been dealing with the issues more generally.  Your Honours can see that by the index at the start of his reasons.  But after he had examined the circumstances, he came in paragraph 764, which is at page 373, directly to the causation issue.  At paragraph 766, the nature of the applicant’s condition in relation to what happened to him was discussed and at 767 the judge said that – he referred to the fact that one could not, of course, definitively determine which risk factor caused the heart attack and that, conversely, he might have had the same heart attack, even if he had not been taking Vioxx. 

Then, your Honours, one sees a discussion commencing at paragraph 768 on whether Vioxx increased the risk of the infarction and he is speaking there about the applicant, not speaking generally, speaking about the applicant, which is a matter of some significance, your Honours.  One sees in paragraph 768, your Honours, about line 39 on page 374 he says:

As to the applicant specifically, Profs Zipes and Harper expressed the view that the consumption of Vioxx increased the risk of him having this heart attack by a factor of about two.

Your Honours will see that elaborated upon in the passage that is quoted there in paragraph 764 ‑ ‑ ‑

FRENCH CJ:   The question is, is it not, whether this kind of material about risk, which is really ex ante probability – and this shadows the discussion, I think, in Booth – supports inferences about causation or whether you really need to move to something that looks a lot like a Fairchild position and say that risk itself generates the liability.

CRENNAN J:   Because in Fairchild the material increase in risk is equated to material contribution.

FRENCH CJ:   This is not necessarily against you.  This may be a special leave point. 

MR JACKSON:   Yes, that is right, your Honour.  That is what I was about to say, your Honour, if one makes those assumptions, it is a question meriting the attention of the Court and this would be an appropriate case, we would submit.  Your Honours, might I just perhaps conclude what I was about to say in relation to this part of the reasons for judgment of the judge.  If one goes to paragraph 771, after he has discussed the evidence, relating to the particular person, what your Honours will see is he refers to the fact that the experts cannot agree about various aspects you see there referred to, but he said, at the start of 771, that he was “required to make an assessment of the probability”, and your Honours will see that referred to.  Then in the remainder of that paragraph he arrived at the conclusion that the applicant was in a high risk group by 2 December, with the infarction being on 8 December.  At 772, your Honours, one sees a perfectly logical set of steps.  He says, in effect, first, the respondents say you have to show:

an acute risk of thrombotic outcomes from the consumption of Vioxx –

but that requires –

there be a potentially thrombotic environment in the vasculature –

In the third sentence of 772 he says –

That environment was, in the applicant’s case, present –

Then, your Honours, one sees a finding that –

the absence of prostacyclin in the immediate vicinity of his injured artery made some contribution to the formation of the thrombus or thrombi that caused the occlusion –

Then, your Honours, one goes to the last two sentences of 772, the brake was caused by the inhibition of COX-2, itself a product of taking Vioxx.  Of course he says it was possible, it might have occurred in any event, but the probability was that the brake on the synthesis of prostacyclin effected by the consumption of Vioxx played a part.  Your Honours, that was an acceptance of the operation of the FitzGerald hypothesis.  Your Honours, that finding appears to have gone undisturbed by the Full Court.  Although this might be a little unclear from the reasons, if one goes to the Full Court’s subsequent reasons on costs, could I take your Honours to tab 4 of the supplementary book.  Your Honours, I am conscious of the time.  May I have two minutes?

FRENCH CJ:   Yes.

MR JACKSON:   Thank you, your Honours.  If one goes to tab 4, you will see the orders on costs, and at paragraph 9 their Honours say:

We do not consider that any of the primary judge’s answers to the questions relating to the group proceedings need to be altered.

You will see particular references to questions 3 and 5 in the last few lines.  If one goes to the actual questions, one sees them in volume 2 at page 640, you will see in the answer to question 2:

Is there a physiological mechanism by which the consumption of Vioxx is capable of causing any and which of the Vioxx cardiovascular conditions?

The worthy answer is:

“contributing to the onset of”:  In the case of myocardial infarction –

You will see question 3:

what is the physiological mechanism?

That is set out there and that is what the judge found, and that is the FitzGerald hypothesis.  You will see question 4:

Did the consumption of Vioxx increase the risk of suffering –

Answer:

In the case of myocardial infarction –

Question 5:

was the increase in risk material?

Answer, “yes”.  Now, your Honours, there are, of course, many other matters we would seek to argue, but we do submit, as I submitted earlier, this is a case of some importance meriting the Court’s consideration.

FRENCH CJ:   Yes, all right.  Thank you, Mr Jackson.  Yes, Mr Walker.

MR WALKER:   Please the Court.  Your Honours, of course paragraph 772, which is found in volume 1 at page 376, to which my learned friend has taken you, lends itself to the interpretation my friend has, with great respect, accurately put, but that was what was challenged in the Full Court and overturned, reversed indeed, by reference to findings of fact not in contest in the Full Court and certainly not contested or sought to be contested in this Court.  May I explain.

What my learned friend correctly summarises as showing “the acceptance of the of the FitzGerald hypothesis” in paragraph 772 is, as your Honours have seen from our written submissions, to be read in light of the repeated protestations, clear findings by the trial judge that he was not finding that the FitzGerald hypothesis was valid.  We have referred to that with some emphasis in our written submission.  There was a particular point which is a factual matter upon which would depend any possible interest in exploring whether there is any argument by analogy with McGhee, we say no, this is not cumulative exposures, it is not like Booth or anything like it, and we are a fortiori ‑ ‑ ‑

CRENNAN J:   Well, it is not only one causative factor.

MR WALKER:   Quite so, and nor do they all fit within a description that you could be forgiven for thinking from the other side’s application for special leave they seek to rely on here, namely, the multiply sufficient causes, what some people call the over‑determined outcome.  This case does not raise that case at all.  This is the familiar case of an outcome which can be only too easily explained without any implication by inference of the defendant’s medicine and no one disputed that there was a ready explanation by several different routes, but none of them involving Vioxx.  Vioxx, it was agreed, was not responsible for the atherosclerosis, it was not responsible for plaque formation, it was not responsible for plaque rupture, not responsible for the fact that the response of the body to plaque rupture is a clotting, potentially thrombotic event.

As your Honours know, the question was whether the Vioxx had an effect on an enzyme called COX‑2 which needed to be present in the endothelium at that point in order for Vioxx to have that effect, which in turn had a suppressing effect on prostacyclin which, relevantly, in such an event, in the vasculature, would be protective by balancing a clotting thromboxane.  So it was a prostacyclin thromboxane balance which, ex hypothesi, must have produced an excess in favour of thrombosis which led, matters of degree are involved, led to an occlusion which leads to the oxygen starvation of the heart muscle that produces the myocardial infarction.

So that everything depended, the word “indispensable” was used, and this was a question of medical fact, everything depended as to the availability to be valid of the FitzGerald hypothesis on identification, observation, empirical data concerning COX‑2 in the relevant parts of the endothelium.  An issue was joined in the court below on the very point.  His Honour made findings which we relied upon in the Full Court and they destroyed the premise of 772.  It is not to be forgotten that 772 commences, as your Honours will have see, in its first line with the give away phrase “if valid” in relation the FitzGerald hypothesis.  If there was an assumption, we would submit, a speculation about validity of the FitzGerald hypothesis, then some of what follows might be thought to have internal logic.  But it was destroyed by his Honour’s findings which were attended to with great care and accuracy, with respect, by the Full Court in a way that is simply not attended to in the special leave argument against us.

May I take your Honours, first, in the second volume of the application book in the Full Court reasons to page 581.  This is the beginning of a sequence of findings that produce the critical, one off, that is, peculiar to this case, lack of findings necessary to permit a conclusion that on the probabilities, Vioxx materially contributed to Mr Peterson’s myocardial infarction.  First of all one goes to paragraph 62.  You will have noted, by the way, the description of the FitzGerald hypothesis in 61 upon which I drew in my earlier submission this morning.  At 62 one sees, in the third sentence, that:

all of the cardiologists –

and I stress, that means on both sides of the forensic contest –

agreed that that circumstance –

namely COX‑2 needed to be presented in the endothelium –

was a necessary precondition to the validity of the hypothesis.

Pause there.  How strikingly a fortiori our case is then than Amaca v Ellis where your Honours’ reasons commence with the acceptance, not controversial in the case, that both tobacco and asbestos were capable of producing the lung cancer in question.  A medical possibility, as Chief Justice Barwick called it in Fernandez.  That was challenged in this case, an anterior, factual position peculiar to the issues between these parties, medical science issues.  The findings by the trial judge, which are narrated in 62 and 64, pages 581 and 582 of the application book, produce, in due course, a very plain conclusion by their Honours in the Full Court.

But looking at how the first instance judge put it, one sees that there is not satisfactory resolution of a disagreement about whether COX‑2 was present, there being agreement of course it needed to be, and then in paragraph 63 there is a reference of a slightly puzzling kind, the puzzlement being expressed by the Full Court at the top of page 582, as to the continued significance of what is there called:

the established fact that COX‑2 is not presented in the atherosclerotic endothelium.

Then in 64, another test of whether COX‑2 was present to see whether it had had an effect by way of selective suppression, and one sees that the evidence relied upon by the experts called by my client to say, well, this is another experimental way of investigating whether this indispensable condition of the hypothesis’ validity can be seen ‑ ‑ ‑

CRENNAN J:   This is all directed, is it, Mr Walker, to a proposition that it simply was not open to the trial judge to be satisfied about a material contribution having regard to all this evidence about the other possible causative factors?

MR WALKER:   Exactly.  The other possible causative factors were more than sufficient, multiply so, to explain what had happened.

FRENCH CJ:   So, absent the FitzGerald hypothesis, you would have an epidemiological relative risk ratio?

MR WALKER:   This case was fought on the basis that the FitzGerald hypothesis was what enabled the finding to be made and that is what his Honour does in 772.  The FitzGerald hypothesis is the one that talks about the selective suppression of prostacyclin, et cetera.  That is the FitzGerald hypothesis.  That is what his Honour held probably had happened.

CRENNAN J:   That is the basis of finding there is a material increase in risk from the consumption of Vioxx.

MR WALKER:   That is right.  And he goes further of course as ‑ ‑ ‑

CRENNAN J:   Well, he goes further to material contribution.

MR WALKER:   Exactly.  But his Honour found against us at trial because of material contribution because of the FitzGerald hypothesis operating, as my learned friend put it this morning, with respect, correctly.  Paragraph 772 shows an acceptance – it is one of the only places accepted – of the validity of the FitzGerald hypothesis having operated in Mr Peterson’s case.  Elsewhere the trial judge says he is not finding it is valid, he goes at pains to say that, and he finds that that which is an indispensable condition to its validity is in fact (a) not demonstrated on the probabilities – so this is not one of Sir Owen Dixon’s accepted hypotheses - it is highly controversial, completely speculative, and then when you look at the empirical data, see for example the quotation set out in 64 by the Full Court, namely, “the opponents of the hypothesis”, looking at those data, seemed to the learned trial judge, to be intelligible – their rationale seemed to be:

intelligible, coherent and justified by the empirical evidence to which they point.

So that, if anything, the party that needed to show for it to have the FitzGerald hypothesis operating, that the COX‑2 in the endothelium which could trigger the sequence that his Honour drew on in 772, tried and failed.  If anything, the quotation from 503 set out at 64 in the Full Court rather suggests that it is my clients who succeeded in showing that the state of science suggested COX‑2 was not there.  So when one turns over the page to 67 – that is page 583 – one sees again their Honours setting out findings of the trial judge upon which they are about to draw for their own conclusion.  At about line 28:

His Honour repeated the fact that there was no scientific consensus as to the presence of COX‑2 in the endothelium or as to its activity in a situation of atherosclerosis.

Then I need not read on, but your Honours see that quoted from the trial judge’s reasons are matters which, in the last two lines –

added to, rather than reduced, the uncertainty associated with the consequences ­

et cetera.  In paragraph 68 we simply draw to attention what correctly the Full Court, with respect, lent by way of their emphasis to their quotation from his Honour’s paragraph 527.  The speculative nature of an hypothesis which required a medical fact to be probably correct, which medical fact was explored and held could not be said to be probably correct, and, if I may put it this way, probably was not, is simply departed from, incorrectly, by the trial judge in 772.  That was the way the Full Court reasoned.  It is a one‑off factual position about medical evidence which is not sought to be challenged in this Court.

CRENNAN J:   It really comes down to knowing Vioxx can cause a heart attack does not mean it probably did on this evidence.

MR WALKER:   Well, that is a second rank – I do not mean lesser, I mean it is another line of defence for us and it is a very important one.  It is one that draws on orthodox reasoning not sought to be challenged in Amaca v Ellis, because that the asbestos could cause, could contribute was a starting point in the argument there.  Whether it had been shown on the evidence to have done so on the balance of probabilities was the issue.  We are a fortiori because that first starting point was challenged and held in our favour by factual findings not sought to be disturbed in this Court.  It means that there are no interesting issues about the adequacy of purely statistical evidence, et cetera, to be made good in the proposed appeal to this Court.

At pages 600 and 601 of the application book, paragraphs 115 and 116 – I will not need to read them – your Honours see that that is the way the Full Court concluded as to this critical, this indispensable matter to the operation of the hypothesis upon which 772 of the trial judge had turned and that is not sought to be attacked as a matter of fact in this Court.  At 589, paragraph 83, their Honours make some important observations, similar to those I have been putting, about the trial judge’s 772 and we, with great respect, urge paragraph 83 as an explanation of the outcome in the Full Court wholly satisfying as to its correctness and logic, clearly now not sought to be challenged as to its factual basis and an explanation of the position as it is now presented today which deprives the case of any doctrinal significance.  There is no exploration of the now you see it now you do not suggestion that Fairchild should be adopted into our law given paragraph 83.  We do not begin to get there and so it is for those reasons ‑ ‑ ‑

CRENNAN J:   In Barker v Corus the House was pretty clear that, to the extent that Fairchild was an exception to the usual rules in relation to causation, it was one which should be limited to facts where there was a single causative agent.  It was suggested by some of the members that were it to have a wider scope, one may get into territory where there is an injustice to defendants, just as the Fairchild exception was formulated to address the issue of injustice to in certain circumstances arising out of an inability to satisfy the sine qua non test.

MR WALKER:   Yes, and, as your Honours are aware, since then Sienkiewicz has done nothing to, how shall I say, add gloss to the ‑ ‑ ‑

CRENNAN J:   Widen the scope?

MR WALKER:    ‑ ‑ ‑ add gloss to the claims of Fairchild to be adopted and it is significant that there is not Amaca v Ellis, there is not Amaca v Booth, there is not Royal, there are not any of the cases, going back to March, which are to the slightest degree sought to be disturbed by the argument proposed for an appeal to this Court in these proceedings.

FRENCH CJ:   There is a second strand in the Full Court’s judgment, is there not, reflected in paragraph 120 at page 603?

CRENNAN J:   Yes, this is the other ‑ ‑ ‑

FRENCH CJ:   It is not all about FitzGerald.

MR WALKER:   No, of course not.

CRENNAN J:   This is the other candidate’s point.

MR WALKER:   Yes, and that was a very ‑ ‑ ‑

FRENCH CJ:   This is the epidemiological evidence.

MR WALKER:   Quite so, and it really meant that there was a factual finding, once his Honour’s error about the FitzGerald hypothesis 772 was displaced, there was a factual finding which, in our submission, presents no issue of principle going beyond the interests of the parties to this case.  My learned friends do not seek any enunciation of doctrine which differs at all, let alone significantly, from what has already been said in this Court on repeated occasions concerning the proper use of epidemiological observations as a basis for inferring causation, and that is, in fact, how our learned friends put it – I think it is paragraph 22 – of their written submissions in this Court.  It is a question, with respect, it is put correctly – yes, page 683 of the application book.  I am so sorry I have gone to the wrong part. 

It is simply a question, in our submission, as to whether or not the epidemiological observations can produce, in the circumstances of this case, an inference of contribution, that is, causal contribution.  That is why the epidemiological strand, if you like, was never separated from the FitzGerald hypothesis approach in the arguments below.  They succeeded at trial because of an error.  That error was fixed.  Nothing is sought to be changed in our law concerning the availability of inference, but the limits.  In other words, merely finding risk will not be enough.  You have to be going on to find, in the circumstances of the case, inferred causation and if you put forward a theory of the case that says it needs COX-2 in the endothelium and you fail to show that has been observed – indeed, the evidence rather supports the contrary – that is the end of the case in an orthodox but unremarkable factual conclusion.

Your Honours, reference was made to the costs argument.  You were taken to paragraph 9 where their Honours are at pains to say that the answers are correct.  They need, of course, to be read in light of our reasons.  The reasons, of course, include all the passages to which I have taken you which show that there was not an acceptance either by the trial judge mostly, except for 772, or by the Full Court at all of the validity of the FitzGerald hypothesis, particularly given the indispensable medical fact needed for its operation.  That means that the word “capable” in question 2, to which an answer is given, has to be understood as being one of these, I think some people call them, un-excluded possibilities looking toward what might be called the march of science that remains to be seen.  No one can say never, but it has not yet been seen.  It is for those reasons that there is, of course, no contradiction in what their Honours in the costs judgment were saying.

In the costs judgment, it has to be borne in mind that the passages that they particularly note as explaining why they will not alter question 3 are passages where they are refuting an argument by Mr Peterson.  Mr Peterson wanted question 3 altered so as to add what I will call an ongoing effect of Vioxx consumption after you had finished having it, and all of those – it starts at page 605, goes through to page 610, I do not have time to take your Honours to the passages, but it is clear that they were there at pains to say why as a matter of the empirical data that Justice Jessup

had considered and upon the basis on which he had ruled against Mr Peterson’s argument, why that should not be disturbed by the cross‑appeal should (a) be determined and (b) be determined against Mr Peterson.  I say “be determined” because quite curiously the cross‑appeal which was put on during the hearing of the appeal was then the subject of a lively argument where the cross-appellant was saying do not decide the point. 

All of the reasoning, therefore, in the costs argument is saying why question 3 should not have anything added to it, because the cross-appeal had been dismissed, and otherwise they are correct because they have to be read in light of our reasons and our reasons, say the Full Court, involve a very direct and complete rejection of the essential factual premise of 772 at first instance.  It is for those reasons that there are, in our submission, no special leave points.  May I add one sentence about the other grounds.  We have put this in writing but, in our submission, it is clear from the way my learned friend put it that it is causation only.

FRENCH CJ:   Yes, there seem to be some constructional issues put in some of the ‑ ‑ ‑

MR WALKER:   Therefore, on any view of the merits of this application, there are proposed grounds of appeal that should not be allowed.  May it please the Court.

FRENCH CJ:   Thank you.  Yes, Mr Jackson.

MR JACKSON:   Your Honours, may I say fundamentally two things.  The first is that our learned friend’s argument, in very significant measure, turns on picking up from what was said by the judge various aspects when he was considering the matter generally speaking.  What I mean by that is, if one goes to page 14 of volume 1, you will see the index that the judge had to his reasons for judgment and one of the aspects of it is:

PART IV – VIOXX AND THE RISK OF CARDIOVASCULAR DISEASE

and you will see then, going through the various headings, the third heading is “The Bradford Hill criteria” and then he discusses “The FitzGerald hypothesis” between [477] and [531] and refers to the “Other Bradford Hill criteria” at [563].  But could I just say in relation to the point that my learned friend has much relied on, when he is dealing with the topic of the FitzGerald hypothesis which commences at paragraph 477, you will see at page 255 in paragraph 495 that he is dealing with the aspect much relied on by our learned friends and, in particular, if one goes to page 255, about line 15, you will see he says:

On the other hand, to the extent that the respondents’ endeavour was to disprove (forensically) the FitzGerald hypothesis by establishing the falsity of the third and fourth points . . . I would have to find that they have not done so.

He refers to the scientific evidence and then says in the last four lines –

If the FitzGerald hypothesis is otherwise to be regarded as providing a plausible biological explanation for the results of the APPROVe study, I am not persuaded that it should be disqualified by the established fact that COX-2 is not present in the atherosclerotic endothelium.

Your Honours will see that he then has taken the view that is really quite adverse to the proposition advanced by my learned friend that this matter was absolutely critical to the acceptance of the FitzGerald hypothesis.  Could I just say this, your Honours, that one does see that this was a case where, at a great length – I should not say that in any offensive way – but at considerable length the primary judge had dealt with the various criteria that are commonly described as the Bradford Hill criteria.  He dealt with the epidemiology and the biological plausibility of the condition and, your Honours, that is just what he was doing in the earlier parts of his reasons and then he comes to his conclusion at paragraphs 771 and 772 and that involves, your Honours, the findings that are set out in paragraph 772. 

In our submission, your Honours, the case is one where the basic material has been found by the judge in our favour and we end up with a situation where, we would submit, (a) each of the propositions to which he has referred in paragraph 772 was perfectly open to him on the material.  Nothing that was said in, for example, paragraphs 62 to 64 of the Full Court’s reasons is against that.  They are reciting what the evidence was and views of the judge expressed at various parts of his consideration.  Your Honours, we do say that this is a case where, on one or other of the bases that I referred to earlier, the question of causation was established.  Your Honours, those are our submissions.

FRENCH CJ:   Now, in relation to the statutory matters, there seem to be aspects of the grounds that travel beyond causation, construction of purpose and so forth.

MR JACKSON:   Yes, they do, your Honour.  Could I just say something about those.  Your Honours, the reason for that is that the Full Court set aside the findings in the applicant’s favour in the case of both provisions, that is, 74B and 74D, because of the causation issue.  You can see that at paragraphs 175 and 179, but it relied on another basis in each case, each of

those provisions.  In relation to section 74B, the relevant provision or the relevant part of the Full Court’s reasons is in volume 2, page 624, paragraphs 172 and 173. 

What the Full Court did was, in effect, to say that in relation to a purpose that a customer would, in effect, have to say to the pharmacist something like, “But I do not want the prescription if it would double the risk of a heart attack.”  That, your Honours, seems a bit odd and the argument is very short.  It seems a bit odd in the light of the words “or by implication” that one sees in section 74B(1)(c).  Your Honours, I will not go to them in detail, but the views of the primary judge, we would submit, on that issue are plainly to be preferred.  One can see them in paragraphs 943 to 944, 947 to 948 and 952 to 953.

FRENCH CJ:   Thank you, Mr Jackson.

MR JACKSON:   I was going to say, your Honours, in relation to section 74D, the only basis in addition to causation was that relied on by the Full Court at page 628, paragraph 181, that is, possible reliance on section 74D(3) which you will see at the top of page 627.  Your Honours, in relation to that, we would simply refer to what the primary judge said at paragraph 971.  Your Honours, may I say that if the Court were otherwise minded to grant special leave, one way of dealing with the statutory causes of action might be for the Court to permit the application for special leave in relation to them to be dealt with by the Full Court.

FRENCH CJ:   Yes, thank you, Mr Jackson.  The Court will adjourn briefly to consider the course it should take.

AT 11.16 AM SHORT ADJOURNMENT

UPON RESUMING AT 11.26 AM:

FRENCH CJ:   The Court is of the view that, having regard to the findings of fact of the primary judge and the Full Court’s treatment of them, the applications are not suitable vehicles for the consideration of the questions of principle which would warrant the grant of special leave.  Special leave will be refused with costs.

MR WALKER:   If it please the Court.

FRENCH CJ:   The Court will now adjourn briefly so that the video link to Adelaide can be established.

AT 11.26 AM THE MATTER WAS CONCLUDED