Answers to questions
2 Save to the extent dealt with in my reasons below, the parties were in agreement as to the answers to be given to the questions referred to in App A to my reasons of 5 March 2010. In the circumstances, I shall deal only with the answers which were the subject of disagreement.
3 Question 4: It is convenient to take this question out of order, as my answer to it, and my reasons for giving that answer, will inform my approach to question 2.
4 Subject to a fairly narrow point made by the respondents to which I shall come in para 11 below, the parties agreed that the question should be answered, in part: �In the case of myocardial infarction, yes.� Beyond that, the parties were not in agreement. The respondents proposed that the question should otherwise be answered in the negative. The applicant proposed that so much of the question as relates to conditions other than myocardial infarction should be left open, and not answered at this stage. He submitted that his own case related to myocardial infarction, and that it was neither necessary nor appropriate for him to undertake the obligation of proving that the question should be answered in the affirmative with respect to each of the other pleaded cardiovascular conditions. He proposed that, henceforth, subgroups should be established under s 33Q(2) of the Federal Court of Australia Act 1976 (Cth), each having its own representative applicant who suffered from one of the other conditions.
5 The difficulty with the applicant�s proposal commences with the terms of his Application and Statement of Claim. Consistently with s 33H(1)(c) of the Federal Court Act, in para 5 of his Application, the applicant stated that �[t]he questions of law or fact common to the claims of the group members are those set out in the Schedule to the Amended Statement of Claim�. In that schedule, the applicant set out the following as a common question:
At all material times after 30 June 1999 did the consumption of rofecoxib or Vioxx tablets materially increase the risk of suffering the Vioxx cardiovascular conditions referred to in paragraph 2(c) of the Further Amended Statement of Claim?
What the applicant described as the �Vioxx cardiovascular conditions� were what I called, in my reasons of 5 March 2010, the �pleaded cardiovascular conditions�. All those conditions were set out in para 2(c) of the Further Amended Statement of Claim.
6 In para 1 of the Further Amended Statement of Claim, the applicant stated that he brought the representative proceeding on his own behalf and on behalf of the group members described in para 2. The group members included all persons who suffered, and were diagnosed as having suffered, one or more of the pleaded cardiovascular conditions. He alleged that each of the group members did suffer one or more of those conditions. He alleged that each such condition, as suffered by a group member, was caused by that group member�s consumption of Vioxx tablets. He alleged that the consumption of rofecoxib materially increased the risk of suffering every one of the pleaded cardiovascular conditions. The relationship between the consumption of Vioxx and the onset of each of the pleaded cardiovascular conditions (ie not myocardial infarction alone) was unquestionably part of the applicant�s case as pleaded.
7 From there one goes to the orders made on 30 March 2009 under s 33ZF of the Federal Court Act. It was there provided that the issues of fact and law set out in the schedule attached thereto that the court found to be common to the claims of the group members be determined at the same time as the applicant�s personal case, and in advance of all other issues in the proceeding. The opening sentence of the applicant�s final written submissions read as follows: �We submit that it is clear on the evidence that Vioxx materially increases the risk of the [cardiovascular] events pleaded, including heart attacks.� The applicant contended that question 4 was a common question, and should be answered: �Yes � all of the cardiovascular conditions�. The respondents contended otherwise, but more in the way of proposing that the question was not common as between different group members who suffered any one of the pleaded cardiovascular conditions, in that issues of risk necessarily depended on individual circumstances. Given the approach of the applicant in his pleading and by way of final submissions, it is, in my view, no longer open to him to contend that question 4 is not a common one with respect to each of the pleaded cardiovascular conditions. That being the case, I am required by the orders made on 30 March 2009 to determine that question at this stage of the proceeding.
8 That question 4 be answered in relation to each of the pleaded cardiovascular conditions is consistent also with the way that the parties conducted their cases. In terms which were relevantly a matter of consensus as between the parties, the four cardiologists who gave evidence in the case were given an �agenda� to guide them in the preparation of their joint report which was, after they had conferred, tendered in evidence. That agenda defined �specified cardiovascular events�, as �any one or more of� the pleaded cardiovascular conditions. The cardiologists were asked for their opinion whether Vioxx increased a person�s risk of the specified cardiovascular events, in comparison to situations in which the person was taking other identified medication, or taking no medication at all. They were asked whether certain biological processes (including that proposed under the Fitzgerald hypothesis) were physiological mechanisms by which Vioxx increased �any� of those risks. In response to the first of these questions, the cardiologists said that there were insufficient data to draw meaningful conclusions concerning the Vioxx-related risk for unstable angina, transient ischaemic attack and peripheral vascular disease. Profs Harper and Zypes said that they had not examined in detail the data linking Vioxx with thrombotic stroke. Profs Cellemajer and Vaughan said that there were no data linking Vioxx to thrombotic stroke, and that there were compelling data to show that Vioxx did not predispose to thrombotic stroke. In the concurrent cardiology session of evidence in court, questions were addressed to the cardiologists which left little doubt but that the court was concerned to know, so far as it was possible to tell, what, if any, relationship existed between the consumption of Vioxx and each of the pleaded cardiovascular conditions.
9 In my reasons for judgment published on 5 March 2010, I concluded that it had not been established that the consumption of Vioxx gave rise to an increased risk of thrombotic stroke, or of any of the pleaded cardiovascular conditions other than myocardial infarction (see paras 583-584). That is to say, the applicant made allegations which were capable of being resolved during the course of the case which he conducted, and he failed to substantiate those allegations. In relevant respects, the questions which arose on the applicant�s case must, therefore, be answered favourably to the respondents.
10 It was submitted on behalf of the applicant that it would be unfair for the court now to answer question 4 in the negative with respect to conditions other than myocardial infarction. It would be unfair for the applicant, it was said, because it would implicitly require him to institute an appeal, with all the attendant costs and risks which that involved, when he had nothing to gain therefrom. It would be unfair for the other group members, in the sense that those who suffered from conditions other than myocardial infarction would be forever cut out from prosecuting their claims against the respondents in circumstances in which the only individual to have had his case considered by the court was one who had not suffered from any of those conditions. In my view, however, these submissions both beg the question and miss the point that this is a representative proceeding. By instituting the proceeding in the form that he did, and by making the broad allegations referred to above, the applicant assumed the responsibility of proving that Vioxx increased the risk of suffering each of the pleaded cardiovascular conditions, not merely myocardial infarction. It cannot be unfair, on him, to expect him to carry through with the undertaking upon which he embarked. Likewise, given the structure and assumptions of Part IVA of the Federal Court Act, group members who have not opted out must be taken to be content to have their claims dealt with by the applicant himself, at least to the extent that common issues are involved. Were it otherwise, the whole point of having a representative proceeding would, in my view, be undermined. It would be intolerable, after a lengthy and complex proceeding such as the present, for the applicant, having fallen short of making good his case in some respects, to be able to leave it to other group members to have a second try, as it were.
11 There was one qualification to the respondents� proposal that question 4 should be answered in the affirmative in relation to myocardial infarction. They submitted that the parenthetical qualifier �compared to placebo� should be added to the answer. The basis of this submission was that the statistical data upon which I had relied to find the existence of an increase in risk all involved comparisons as between Vioxx and placebo. I accept that so far as it goes, but it would, in my view, be inappropriate to add the qualifier proposed by the respondents. The fact that placebo was the comparator was a matter of evidence which justified the general conclusion which I reached. That conclusion having being reached, I consider that the answer to question 4 should reflect it in the simplest possible terms, rather than being set about with reminders of the evidentiary trail which I followed in my reasons.
12 For the above reasons, I propose to answer question 4 in the affirmative for myocardial infarction, and in the negative for other conditions.
13 Question 2: The parties accepted that the question should be amended by replacing the word �causing� with the phrase �contributing to the onset of� The parties also agreed that the question should be answered in the affirmative with respect to myocardial infarction. The respondents proposed that it should be answered in the negative with respect to the other pleaded cardiovascular conditions, while the applicant proposed that this part of the answer should be held over pending the continuation of the proceeding with respect to group members who had suffered from those other conditions. In relevant respects, the parties� positions were the same as those taken in relation to question 4. Consistently with the way I have dealt with question 4, I propose to answer question 2 in the negative for conditions other than myocardial infarction.
14 Question 3: The parties agreed that the mechanism required to be identified, in relation to myocardial infarction, should be �the aggregation of [thrombotic or thromboembolic] material in the vasculature as the result of the blocking of the production of prostacyclin by the inhibition of COX-2 in the absence of any blocking of the production of platelet thromboxane�. There was a minor dispute about the words in square brackets. The applicant submitted that the word should be �thromboembolic�, while the respondents submitted that the word should be �thrombotic�. With the consent of the parties, I have consulted Aaronson PI and Ward JPT, The Cardiovascular System at a Glance, 3rd ed, 2007, at p 99. In the sense in which the term is used in the proposed answer to question 3, I consider that �thrombotic� would more accurately convey the sense of the physiological mechanism identified in my reasons of 5 March 2010. I should make it clear, however, that I do not base the answer to this question upon any technical distinction between thrombotic and thromboembolic, and I do not regard it as significant that the thrombus or embolism did its presumptively pathological work at, near, or distant from, the site of original formation. So far as risk is concerned, what matters is that thrombotic material aggregated in the vasculature in the way proposed in the answer to the question.
15 Question 9(d): Part (d) of question 9 inquired whether MSDA failed to provide adequate information, advice or warning to the general public, or to health care professionals, to the effect that the consumption of Vioxx materially increased the risk of suffering the condition, a material increase in the risk of which was posited by an affirmative answer to question 5. Strictly, because of the way the question was expressed, and because of the answers given to parts (a) and (b) of question 6, question 9(d) was irrelevant. However, the parties accepted that, involved in question 9(d) was an inquiry whether MSDA failed to provide adequate information, advice or warning as to the signal of potential cardiovascular risk referred to. From this point, however, the parties parted company with respect to the appropriate answer to question 9(d).
16 The respondents proposed that, at the level of health care professionals who treated or advised individual group members, this was not a common question. They proposed that, at the level of the general public, and of health care professionals other than with respect to their treatment of or advice to individual group members, the question should be answered in the negative. The applicant submitted, in effect, that the respondentsďż˝ approach was more categorical than was fairly allowed by my reasons for judgment. He drew attention to the fact that I had found that no general communication by way of information, advice or warning had been conveyed to health care professionals, and that this much at least must now be taken to have been finally established as against MSDA. Allowing for the possibility that MSDA might, in the case of a particular group member other than the applicant, show that there was a particular communication which constituted adequate information, advice or warning, the applicant submitted that it should not be regarded as any longer open to MSDA to press for different conclusions at the general level, under the guise of dealing with questions which were not common.
17 The respondents submitted that, if I were disposed to make a distinction between communications to the generality of health care professionals, on the one hand, and communications to particular health care professionals, on the other hand, I should likewise recognise that, in my reasons of 5 March 2010, I held that the amended Product Information of November 2001 was, in point of content, an adequate warning to a professional audience. The respondents submitted that MSDA had failed in relevant respects only because of my finding that this warning had not been appropriately drawn to the attention of health care professionals and that, once one reaches this level of communication, the question itself becomes a non-common one.
18 With respect to health care professionals, I accept the applicant�s submission that, in my reasons of 5 March 2010, I found that MSDA had not, at the general level, provided any adequate information, advice or warning as to the signal of potential cardiovascular risk. I consider this to be a closed question, which it is no longer open to the respondents to re-agitate. However, to the extent that there were more limited communications made to particular professionals who advised or treated group members, I consider that question 9(d) is not common. Likewise, because of the potential for there to be such limited communications, I could not hold that the question whether MSDA�s failure to issue a general warning was �less than reasonable in all the circumstances� is a common one. The circumstances do, of course, include such limited communications as may have been made to individual health care professionals. I shall answer this question in a way that reflects these conclusions.
19 With respect to so much of question 9(d) as relates to the �general public� it is clear from para 853 of my reasons of 5 March 2010 that the question must be answered in the negative.
20 Question 9(e) was the source of some difficulty. I must say that, in retrospect, it demonstrates the unwisdom of my uncritical acceptance of all of these questions as originally proposed by the parties. The question uses imprecise terms which might be appropriate in a court�s reasons for judgment, but which, in my view, have no place in binding orders. I refer here to such loose concepts as developing and implementing a marketing strategy or campaign and to the formulation and dissemination of representations. The question rolls up into one compound grammatical structure several internal questions (even before one reaches the Roman numerals). Instead of asking whether MSDA formulated certain representations, and, if so, whether it then disseminated those representations, the question asked whether MSDA developed and implemented a marketing strategy or campaign �by which� it formulated and disseminated etc. To answer the question as posed, the court would be obliged to concern itself with the �development� of a �strategy�, and, if such an event had occurred, whether the strategy involved the �formulation� of each of the representations referred to. All this, and no finding would yet have been made that any of those representations reached the ears of any relevant addressee.
21 In written submissions recently filed, the applicant proposed that question 9(e) should be answered in the following terms:
Merck Australia developed and implemented a marketing campaign by which it formulated and disseminated to medical practitioners in Australia representations concerning the safety of Vioxx, however it will be a matter for individual claimants to prove whether this campaign generally, or individual representations within it, were causally relevant.
It will be noted that this proposal does not amount to an unqualified affirmative answer to question 9(e), and does not deal specifically with the numbered elements within the question. The applicant submitted that my reasons �[supported] the answer that representations to this effect were elements of the campaign, and that [MSDA] made every attempt to ensure its messages were communicated in a consistent way�. This is not the language of question 9(e). Neither does the applicant�s proposed answer correspond with my reasons insofar as it proposes that MSDA �disseminated� representations concerning the safety of Vioxx.
22 For their part, the respondents originally submitted that question 9(e) should be answered as follows:
[MSDA] developed a marketing strategy or campaign by which it intended to disseminate certain messages about Vioxx. The Applicant has not established that by reason of this marketing strategy or campaign any particular representation was made to any particular prescribing doctor.
While this answer is broadly consistent with the flow of my reasons, it does not reflect any particular finding made therein. I also consider that such an answer would be neither appropriate by way of judicial determination of particular facts in this litigation, nor satisfactory as a basis for the resolution of the claims of other group members.
23 To the extent that the evidence justifies general conclusions of the kind with which question 9(e) is apparently concerned, the matter was dealt with in paras 259-296 of my reasons of 5 March 2010. The utility of the findings which I made about MSDA�s marketing and promotional activities will lie in the support they provide for such evidence as may subsequently be called about the dissemination of representations by MSDA to the other group members themselves, or to the health care professionals whose treatment or advice is relevant to their circumstances. That utility would not, in my view, be advanced by attempting to close off, in very general terms which could not anticipate those circumstances, some but not all of the relevant issues for determination. Although much of the evidence will, fairly obviously, be common to all group members, the context of its application will necessarily depend upon such evidence as there is on the matter of dissemination. For reasons previously given, the latter aspect cannot be regarded as common to all group members.
24 I propose to answer question 9(e) by saying that the dissemination of representations to health care professionals is not a common question, and that, in other respects, it is inappropriate to answer the question.
25 Question 10: Consistently with paras 810-811 of my reasons of 5 March 2010, the respondents submitted that this question should be answered in the negative. If the question is to be understood as confined to the issue whether reasonable behaviour required MSDA to withdraw Vioxx from the market before 30 September 2004, the applicant also accepted that it should be answered in the negative. His only concern with such an answer was that it might convey, implicitly if not otherwise, that �all of the circumstances� included the absence of adequate information, advice or warning accompanying the distribution of Vioxx. I do not regard question 10 as concerned with the presence or absence of warnings or the like. The question is, in my view, confined to the bare fact of the distribution, or non-distribution, of Vioxx into the Australian market. As so understood, the question should be answered in the negative.
26 Question 12: Again, the parties accepted that parts (a) and (c) of this question should be understood by reference to the signal of potential cardiovascular risk, rather than, as expressed, by reference to a materially increased risk. As so understood, the respondents proposed that part (a) of question 12 should be answered in the negative, since I had not found, save in the applicant�s own case, that MSDA had failed to provide, on the label, any such adequate information, advice or warning as is inquired about (see para 835 of my reasons). The applicant proposed that the question should be answered consistently with his own evidence and that, in effect, the respondents had not discharged the evidentiary onus thereby thrown upon them to show that other labels were not the same as those to which the applicant encountered. I do not accept that any such onus was thrown upon the respondents. The absence of a proper warning on the label was part of the applicant�s case. He gave evidence only in the very limited terms referred to in para 835 of my reasons. There was no evidence as to the labelling practices of MSDA � whether there was a single label for all supplies of Vioxx, whether the label was altered at some point along the way, or anything else. In those circumstances, I am disposed to hold that question 12 (a) is not common to all group members.
27 The parties agreed that parts (b) and (c) of question 12 should be answered consistently with the answers to parts (d) and (e), respectively, of question 9.
28 Question 13: After some debate, the applicant accepted the respondents� proposal that this question should be answered consistently with para 888 of my reasons, namely, by stating that MSDA�s promotional interactions with prescribers were in trade or commerce within the meaning of the Trade Practices Act 1974 (Cth).
29 Question 14: The parties agreed that I should answer this question consistently with my answer to question 12.
30 Question 20: The parties were not agreed on the answer to this question. The applicant proposed that it should be regarded as a common question, and, in the absence of �any other information, advice or warning that consumption of Vioxx tablets may materially increase the risk of myocardial infarction�, should be answered in the affirmative. The respondents submitted that this was not a common question, save to the extent to which I made findings in paras 917-921 of my reasons. I consider that the applicant�s proposal more closely captures the sense of what I decided on 5 March 2010. The substance of that decision was that the safety of Vioxx tablets was not such as persons generally were entitled to expect by reason of the material increase in the risk of suffering a myocardial infarction, and the circumstances which I took into account included the absence of any sufficient information, advice or warning associated with the supply of the medication. I take the view that, at the general level, the absence of any such information, advice or warning has been established on the evidence, and should not be re-litigated. However, the applicant�s proposed answer to this question recognises that, in an individual case, there may have been some such information, advice or warning conveyed to a group member or to his or her practitioner which would, in that individual case, justify a different answer to this question. Save to make it clear that the qualification applies only in an individual case, I shall adopt the applicant�s proposal by way of answer to question 20.
31 Question 21: With respect to packaging and labelling, consistently with my answer to question 12(a), I consider that question 21 is not common to all group members. With respect to the Product Information, it follows from paras 918-921 of my reasons of 5 March 2010 that the question should be answered in the affirmative, but I would emphasise that the absence of adequate information, advice or warning in the Product Information was but one of the circumstances which led me to conclude that the safety of Vioxx was not such as persons generally were entitled to expect. I shall answer question 21 consistently with these views.
32 Question 22: The respondents submitted that this was not a common question, referring in this respect to para 935 of my reasons of 5 March 2010. The applicant submitted that the question should be answered thus: �If the purpose of acquisition of the Vioxx tablets was for use as an anti-inflammatory drug, yes�. In this instance, I consider that the respondents� proposal accurately reflects my reasons of 5 March 2010. In the light of those reasons, I should not attempt to anticipate the purpose of another group member by making the answer to the question a hypothetical one. In my view, question 22 is not common.
33 Question 23: Although the answers they proposed differed, the parties were agreed that I should answer question 23 consistently with my answer to question 22. I shall follow that course.
34 Question 26: The parties agreed that this question should be answered consistently with my answers to question 6. I shall follow that course.