Peterson v Merck Sharpe & Dohme

the pleadings 5 The group members to whom the proceeding relates are identified in par 2 of the Further Amended Statement of Claim as follows. The group members to whom this proceeding relates ("the group members") are all persons who: (a) after 30 June 1999 obtained from a medical practitioner in Australia one or more prescriptions of the non-steroidal anti-inflammatory drug rofecoxib sold as tablets under the trade mark or brand "Vioxx" ("Vioxx tablets") as pleaded in paragraph 6 herein; and (b) after 30 June 1999 completed one or more prescriptions of Vioxx tablets purchased in Australia as pleaded in paragraph 7 herein; and (c) at any time after completing their first prescription of Vioxx tablets purchased in Australia but before the day 30 weeks after last consuming a Vioxx tablet, suffered and were diagnosed as having suffered one or more of the following conditions: (i) myocardial infarction; (ii) thrombotic stroke; (iii) unstable angina (iv) transient ischaemic attack; (v) peripheral vascular disease ("the Vioxx cardiovascular conditions"). Paragraph 6 alleges that, after 30 June 1999, each of the group members obtained from a medical practitioner in Australia one or more prescriptions of Vioxx, and par 7 alleges that each of the group members "completed" one or more prescriptions of Vioxx tablets purchased in Australia. It is alleged that each of the Vioxx cardiovascular conditions suffered by each group member was caused by that group member's consumption of Vioxx tablets, and that the group member experienced pain and suffering, and suffered loss and damage, as a consequence. 6 In his negligence claims, the applicant alleges that the consumption of rofecoxib "materially increased the risk of suffering the Vioxx cardiovascular conditions", and that the first respondent knew or ought to have known of that circumstance. Accordingly, the first respondent owed to each of the group members a duty to take reasonable care, in the manufacture, packaging, labelling, marketing, distribution and supply of Vioxx, to avoid acts and omissions that may expose the group member to a material increase in the risk of suffering the Vioxx cardiovascular conditions as a result of consuming Vioxx tablets. 7 The applicant alleges that the first respondent used rofecoxib without making any or any adequate inquiries regarding the adverse side effects and health risks that may be associated therewith, without undertaking any or any adequate research, investigations, clinical trials or observational studies in order to ascertain what those side effects or health risks were, without having adequate regard to the results of research, investigations, clinical trials or observational studies undertaken on the subject, and without awaiting the results of any such research etc to ascertain whether the consumption of rofecoxib materially increased the risk of suffering the Vioxx cardiovascular conditions. 8 The applicant alleges that the first respondent failed to provide any or any adequate advice or warning on Vioxx packets, or associated labelling, to the effect that the consumption of rofecoxib or of Vioxx tablets materially increased the risk of suffering the Vioxx cardiovascular conditions. He alleges that the first respondent failed to provide pharmacists, medical practitioners and other healthcare professionals with any or any adequate information, advice or warning on the subject. He makes similar allegations with respect to the absence of any information, advice or warning to the general public, consumers and potential consumers of Vioxx tablets, and to those who may advise or treat such persons. 9 The applicant alleges that the first respondent developed and implemented a marketing strategy or campaign (described as "the Vioxx marketing campaign") by which it formulated and disseminated to pharmacists, medical practitioners and other healthcare professionals in Australia information about Vioxx which, in summary, emphasised the safety of Vioxx and the absence of adverse cardiovascular events, and generally exculpated Vioxx with respect to such suggestions as may then have been abroad as to the possible causative involvement of Vioxx in the onset of such events. This material is described by the applicant as the "Vioxx representations". In its Defence, the first respondent admits only that it developed marketing plans for Vioxx and that it marketed Vioxx to certain healthcare professionals. 10 The applicant alleges that the first respondent failed to take reasonable care, in the manufacture, packaging, labelling, marketing, distribution and/or supply of Vioxx, to avoid "acts and omissions that may expose each of the group members to a material increase in the risk of suffering the Vioxx cardiovascular conditions as a consequence of consuming Vioxx tablets". He alleges that the first respondent's breach of that duty of care caused each of the group members to be prescribed Vioxx by a medical practitioner, to complete one or more prescriptions of Vioxx, to suffer one or more of the Vioxx cardiovascular conditions, to experience pain and suffering and to suffer loss and damage. 11 In his case under s 52 of the Trade Practices Act, the applicant alleges that the first respondent knew that medical practitioners and other healthcare professionals in Australia would prescribe, and that pharmacists would supply under prescription, Vioxx tablets for the treatment of arthritis. He alleges that the first respondent knew that persons would consume Vioxx tablets for such a purpose. He alleges that the first respondent knew that many of those persons were likely to be elderly and, accordingly, at particular risk of suffering the Vioxx cardiovascular conditions. He alleges that the first respondent provided to pharmacists, medical practitioners and other healthcare professionals product information with respect to Vioxx which set out warnings and precautions, and which dealt with adverse reactions that may be associated with the consumption of rofecoxib or Vioxx tablets. He alleges that the information so supplied did not provide any advice or warning to the effect that the consumption of Vioxx tablets materially increased the risk of suffering the Vioxx cardiovascular conditions, and that the first respondent knew, or ought reasonably to have known, of that increase in risk. He alleges that the packaging and labelling of Vioxx did not provide adequate information, advice or warning as to that increase in risk; that the first respondent failed to provide pharmacists, medical practitioners and other healthcare professionals with any adequate information, advice or warning as to that increase in risk. He alleges that the first respondent had, in relevant respects, engaged in these acts and omissions in trade and commerce, and that its conduct was misleading or deceptive, or likely to mislead or deceive, in contravention of s 52. The applicant alleges that the Vioxx representations were misleading or deceptive, or likely to mislead or deceive, in that the consumption of rofecoxib or Vioxx tablets materially increased the risk of suffering the Vioxx cardiovascular conditions, that these representations were made in trade and commerce, and that the first respondent, accordingly, acted in contravention of s 52. The applicant pleads causation, and the occurrence of loss and damage, with respect to his s 52 allegations. 12 Under s 75AD of the Trade Practices Act, the applicant alleges that the first respondent manufactured, or is deemed to have manufactured, the Vioxx tablets. He alleges that the first respondent supplied, in trade or commerce, the Vioxx tablets consumed by each group member. He alleges that the first respondent marketed Vioxx to pharmacists, medical practitioners and other healthcare professionals for the treatment of arthritis, that it was reasonable to expect that those practitioners and professionals would prescribe, and that pharmacists would supply, Vioxx tablets for that purpose, that it was reasonable to expect that persons would consume Vioxx tablets so prescribed and supplied, and that many such persons would be elderly and, accordingly, at particular risk of suffering the Vioxx cardiovascular conditions, that the first respondent failed to provide such pharmacists etc with any adequate information, advice or warning to the effect that the consumption of rofecoxib or Vioxx tablets materially increased the risk of suffering the Vioxx cardiovascular conditions, that the packaging and labelling did not contain any adequate information, advice or warning in that regard, and neither did the relevant product information. The applicant alleges that the safety of the Vioxx tablets consumed by each group member "was not such as persons are generally entitled to expect". The applicant also alleges that the packaging and labelling of Vioxx tablets as such, and the Vioxx product information as such, did not contain any adequate information, advice or warning to the effect that the consumption of rofecoxib or Vioxx tablets materially increased the risk of suffering the Vioxx cardiovascular conditions, and that, as a result, the safety of the Vioxx tablets was not such as persons were generally entitled to expect. In the circumstances, the applicant alleges that the tablets had a defect within the meaning of s 75AD of the Trade Practices Act, by reason of which the group members experienced one or more of the Vioxx cardiovascular conditions and suffered loss and damage. The first respondent generally denies, or does not admit, the applicant's allegations under s 75AD, in addition to which it denies that Vioxx tablets were "goods" as defined in s 74A(2) of the Trade Practices Act. 13 Under s 74B of theTrade Practices Act, the applicant repeats his allegation that the first respondent manufactured, or is deemed to have manufactured, the Vioxx tablets consumed by each of the group members. He alleges that Vioxx was supplied by the first respondent to pharmacists and medical practitioners in trade and commerce. He alleges that those pharmacists and medical practitioners acquired Vioxx for re-supply, and that the group members were consumers who were so supplied with Vioxx. He alleges that the group members acquired Vioxx for the purpose of consumption as a safe non-steroidal anti-inflammatory drug, which purpose was made known to the first respondent, either directly by each group member or through the intermediate supplier or suppliers from which he or she acquired Vioxx. He alleges that, by reason of the fact that the consumption of rofecoxib materially increased the risk of experiencing the Vioxx cardiovascular conditions, the Vioxx tablets consumed by each group member were not reasonably fit for the purpose of acquisition within the meaning of s 74B. He alleges that the group members suffered one or more of the Vioxx cardiovascular conditions and suffered loss and damage thereby. The first respondent generally denies, or does not admit, the applicant's allegations under s 74B, in addition to which it denies that Vioxx tablets were "goods" as defined in s 74A(2) of the Trade Practices Act. Further, it says that, if Vioxx was not reasonably fit for the group members' purposes, that was because of an act or default of some other person occurring after the tablets left its control, and that the group members did not rely, or it was unreasonable of them to have relied, on its own skill or judgment. 14 In his claim under s 74D of the Trade Practices Act, the applicant repeats his allegation that the first respondent manufactured, or is deemed to have manufactured, Vioxx tablets consumed by the group members. He makes allegations as to supply and re-supply along lines similar to those made under s 74B, and alleges that the Vioxx tablets were not of merchantable quality within the meaning of s 74D. Likewise, he alleges causation, loss and damage. The first respondent generally denies, or does not admit, the applicant's allegations under s 74D, in addition to which it denies that Vioxx tablets were "goods" as defined in s 74A(2) of the Trade Practices Act. 15 In its Defence to the Further Amended Statement of Claim, the first respondent either denies or declines to admit the bulk of the applicant's allegations. Additionally, it makes a number of positive allegations as to which, by the operation of O 11 r 14 of the Federal Court Rules, the applicant joins issue. 16 The first respondent alleges that Vioxx was registered on the Australian Register of Therapeutic Goods ("the ARTG") for the symptomatic treatment of osteoarthritis on 23 December 1999 and for the new indication of rheumatoid arthritis on 17 January 2002. It says that rofecoxib was a prescription only medicine, and that Vioxx could be made available only on the prescription of a permitted prescriber. It made product information, approved by the Therapeutic Goods Administration ("the TGA"), available to pharmacists and permitted prescribers from 17 January 2000. It says that that information was amended from time to time between 23 December 1999 and 23 December 2004, and at various times referred to cardiovascular effects in the "precautions" section, to cardiovascular adverse events in the "adverse reactions" section and to cardiovascular reactions in the "post marketing experience" section thereof. 17 The first respondent says that the statutory regime under which Vioxx was registered on the ARTG was a "legislative scheme for the approval of medicines" established by the Commonwealth, State and Territory governments. It says that Vioxx was registered upon the TGA being satisfied of the quality, safety and efficacy of Vioxx tablets. It reiterates that, under this scheme, Vioxx was obtainable only by prescription, and that it made information about Vioxx available to permitted prescribers. As a result, either it did not owe group members a duty of care or, if it did, it satisfied any applicable standard of care. It says that all these circumstances were also relevant to the questions whether its conduct was misleading or deceptive, whether Vioxx tablets were reasonably fit for group members' purposes, whether Vioxx tablets were of merchantable quality and whether Vioxx tablets had a defect - in each case for the purposes of the applicant's relevant allegations under the Trade Practices Act. It is also relevant, according to the first respondent, that it complied with all legislative requirements and with requirements imposed by the TGA, that Vioxx, like all prescription medicines, had inherent and unavoidable risks of side effects and, as prescribed by permitted prescribers, was consumed by patients with the expectation that there would be some beneficial effect on their health and that permitted prescribers would have, as a matter of course, assessed each group member's clinical needs and medical history, synthesised and assessed all relevant information and provided the member with adequate information, advice and warnings appropriate for him or her. The first respondent relies also on the fact that the prescription of a prescription only medicine involved a weighing up of the relevant risk of side effects and the expected beneficial effects. The first respondent makes claims to like effect in support of its allegation that it did not owe the group members a duty of care or, if it did, it satisfied the applicable standard of care. 18 The first respondent alleges that, before 30 September 2004, the state of scientific or technical knowledge was not such as would enable it to discover either the defects in Vioxx alleged by the applicant or the materially increased risk of suffering a Vioxx cardiovascular condition, to the extent that there was one. It alleges also that, if there were defects in Vioxx, they arose because of its compliance with mandatory standards. 19 The first respondent says that the applicant's common law claims must be determined in accordance with the Wrongs Act 1958 (Vic) and Part VIB of the Trade Practices Act, and that the claims of the other group members must be determined in accordance with that Part and with the Wrongs Act or, as applicable, the corresponding legislation of the other States and of the Territories. Specifically (but not exhaustively), it says that, if there was a risk associated with consuming Vioxx, it was an inherent risk for the purposes of s 55 of the Wrongs Act and of corresponding provisions in other relevant legislation. 20 The applicant's claim against the second respondent sounds in negligence only. He alleges that the second respondent manufactured rofecoxib, and supplied it to the first respondent for the production of Vioxx tablets. He alleges that the second respondent knew, or ought to have known, that the consumption of rofecoxib materially increased the risk of suffering the Vioxx cardiovascular conditions, that rofecoxibwould be used by the first respondent to manufacture Vioxx tablets, and that the first respondent would and did manufacture, package, label, market, distribute and supply Vioxx tablets for sale in Australia. He alleges that, in the circumstances, the second respondent owed a duty of care to the group members, in manufacturing and supplying rofecoxib to the first respondent, to avoid acts and omissions that may expose each of the group members to a material increase in the risk of suffering the Vioxx cardiovascular conditions. He makes allegations as to failure to have adequate regard to research, investigations etc similar to those which he makes against the first respondent. He alleges that the second respondent failed to provide to the first respondent, or to pharmacists, medical practitioners and other healthcare professionals any or any adequate information, advice or warning to the effect that the consumption of rofecoxib materially increased the risk of suffering the Vioxx cardiovascular conditions. He alleges that the second respondent failed until 30 September 2004 to withdraw or to recall rofecoxib which it had supplied to the first respondent, or to cause the first respondent to withdraw or to recall Vioxx tablets from sale. He alleges that the second respondent failed to take reasonable care to avoid acts and omissions that may expose each of the group members to a material increase in the risk of suffering Vioxx cardiovascular conditions. He alleges that the breach by the second respondent of its duty of care caused the group members to be prescribed Vioxx, to complete one or more prescriptions thereof, to suffer one or more of the Vioxx cardiovascular conditions, to experience pain and suffering and to suffer loss and damage. 21 The second respondent relies upon defences, and makes positive allegations, broadly similar to those relied upon and made by the first respondent (mutatis mutandis) as discussed in pars 16 - 19 above.

THE PARTIES' MEMORANDUM OF SIGNIFICANT ISSUES 22 On 16 May 2008, I ordered that each party file a memorandum setting out what he or it anticipated would be the significant issues required to be resolved by the court in the proceeding. The parties filed memoranda in accordance with that order. 23 The applicant's memorandum of significant issues was as follows: A. Issues Common to all Causes of Action 1. Whether the consumption of rofecoxib materially increases the risk of suffering one or more of the cardiovascular conditions defined in paragraph 2(c) of the Further Amended Statement of Claim as "the Vioxx cardiovascular conditions". 2. Whether the consumption of Vioxx tablets was a cause of the myocardial infarction suffered by the Applicant on 8 December 2003. B. Issues Concerned with Negligence Claim Against Merck Australia 3. When did the First Respondent ("Merck Australia") know that the consumption of rofecoxib materially increases the risk of suffering one of more of the Vioxx cardiovascular conditions? 4. When ought Merck Australia to have known that the consumption of rofecoxib materially increases the risk of suffering one or more of the Vioxx cardiovascular conditions? 5. Whether by: (a) manufacturing from rofecoxib; (b) distributing and/or supplying for sale; (c) failing before 30 September 2004 to withdraw or recall from sale Vioxx tablets, Merck Australia breached its duty of care to the Applicant. 6. Whether Merck Australia provided adequate information, advice or warning to the general public or to pharmacists, medical practitioners and other health care professionals to the effect that the consumption of rofecoxib or Vioxx tablets materially increased the risk of suffering the Vioxx cardiovascular conditions. If not, whether that failure constituted a breach of its duty of care to the Applicant. C. Further Issues Concerned with the Section 52 Claim 7. Whether Merck Australia's failure to provide adequate information, advice or warning to the effect that the consumption of rofecoxib or Vioxx tablets materially increased the risk of suffering the Vioxx cardiovascular conditions was misleading or deceptive or likely to mislead or deceive in contravention of section 52 of the Trade Practices Act. 8. Whether the Vioxx representations referred to in paragraph 19A of the Further Amended Statement of Claim were misleading or deceptive or likely to mislead or deceive in contravention of section 52 of the Trade Practices Act. D. Further Issues Concerned with the Section 75AD Claim 9. Whether the safety of Vioxx tablets was not such as persons are generally entitled to expect: (a) in the "defect circumstances" set out in paragraph 33 of the Further Amended Statement of Claim or in any event, by reason of the fact that the consumption of rofecoxib or Vioxx tablets materially increased the risk of suffering the Vioxx cardiovascular conditions; (b) by reason of the fact that the packaging and labelling of Vioxx tablets and the Vioxx product information did not contain adequate information, advice or warning to the effect that the consumption of rofecoxib or Vioxx tablets materially increased the risk of suffering the Vioxx cardiovascular conditions. E. Further Issues Concerned with the Section 74AB and 74AD Claims 10. Whether the Vioxx tablets consumed by the Applicant; (a) were not reasonably fit for the purpose of acquisition within the meaning of section 74B of the Trade Practices Act; (b) were not of merchantable quality within the meaning of section 74D of the Trade Practices Act. F. Further Issues Concerned with Claim Against Merck Inc 11. When did the Second Respondent ("Merck Inc") know that the consumption of rofecoxib materially increases the risk of suffering one or more of the Vioxx cardiovascular conditions? 12. When ought Merck Inc to have known that the consumption of rofecoxib materially increases the risk of suffering one or more of the Vioxx cardiovascular conditions? 13. Whether Merck Inc failed to disclose information of which it was aware concerning adverse cardiovascular risks associated with the consumption of rofecoxib. If so, whether that failure constituted a breach of its duty of care to the Applicant. 14. Whether by: (a) manufacturing and supplying rofecoxib to Merck Australia; (b) failing before 30 September 2004 to withdraw or recall rofecoxib which it had supplied to Merck Australia; (c) failing before 30 September 2004 to cause Merck Australia to withdraw or recall Vioxx tablets from sale in Australia Merck Inc breached its duty of care to the Applicant. 15. Whether Merck Inc provided to Merck Australia, pharmacists, medical practitioners and other health care professionals in Australia or the Australian public adequate information, advice or warning to the effect that the consumption of rofecoxib materially increased the risk of suffering the Vioxx cardiovascular conditions. If not, whether that failure constituted a breach of its duty of care to the Applicant. 24 The respondents' memorandum of significant issues was lengthy, and I shall refer only to so much thereof as appears to be presently material. The following were amongst the facts said to be "not in issue": 8. The First Respondent ("MSDA") manufactured VIOXX tablets containing the active ingredient rofecoxib and was the Australian sponsor of VIOXX tablets for the purposes of the Therapeutic Goods Act 1989 (Cth) (the "TG Act"). 9. The Second Respondent ("Merck") manufactured the active ingredient in VIOXX, known as rofecoxib. 10. Merck conducted research on VIOXX for a number of years before submitting an application for marketing approval in the United States. This research included Phase I, II and II studies involving patients exposed to VIOXX or comparators. The research also compared the safety and efficacy of VIOXX against both placebo and traditional NSAIDs. 11. MSDA applied to the Therapeutic Goods Administration (the "TGA") for the registration of VIOXX tablets for the symptomatic treatment of osteoarthritis and the TGA granted approval for the marketing of VIOXX in Australia for this indication on 23 December 1999. 12. MSDA applied for the registration of a new indication, rheumatoid arthritis, and approval was granted on 12 January 2002. 13. In Australia VIOXX was classified as a prescription only medicine, that is, VIOXX could only be made available to a consumer on prescription of a medical healthcare professional. 14. In Australia, MSDA packaged VIOXX tablets and made VIOXX available for use for the approved indications, on the prescription of medical healthcare professionals, from January 2000. Product Information approved by the TGA and amended from time to time was made available to pharmacists and permitted prescribers in Australia. 15. MSDA knew that persons who were prescribed VIOXX tablets by a permitted prescriber and purchased VIOXX tablets under prescription from a pharmacist in Australia would consume VIOXX tablets for the approved indications in accordance with the instructions of their permitted prescriber. 16. On or about 30 September 2004 the Respondents voluntarily withdrew VIOXX from the market in response to interim results of the APPROVe study, a long-term placebo-controlled randomised clinical trial. In APPROVe, there was an increased incidence of confirmed thrombotic cardiovascular events among people taking VIOXX compared to people taking placebo which began to become apparent after approximately 18 months of continuous use and which did not become statistically significant until much later. 25 The following were amongst the significant issues as identified by the respondents: 18. The gist of the Applicant's complaint, both in negligence and for breaches of the TPA, is that the Respondents knew or ought to have known of the risk and are liable because they (a) utilised a non-steroidal anti-inflammatory drug (rofecoxib) that gave rise to the risk; (b) failed to conduct or undertake proper research to ascertain the risk; (c) failed to have regard to research about the risk; (d) failed to warn of the risk and understated its significance in their marketing; and that (e) the Applicant suffered a myocardial infarction on 8 December 2003 caused by his consumption of VIOXX and the risk. 19. It is not clear whether the Applicant alleges the increased risk is material in the sense that it elevates the chance of an event or is material in the sense that a reasonable person would be likely to attach significance to it or is material in some other sense. 20. It is not clear whether the Applicant alleges the risk is an increased risk in the sense of its magnitude or an increased relative risk (that is, compared to some other incidence rate) or a statistical association or is an increased risk in some other sense. 21. It is not clear whether it is alleged that the risk is affected by such things as duration of use, dose or other factors and whether it is alleged that the risk is the same for each of the five pleaded conditions and for each group member, regardless of any risk factors for the respective conditions that may or may not apply to each group member, such as smoking, high blood pressure and high cholesterol. 22. In considering these issues, it will be necessary for the Court to receive evidence as to the facts and circumstances surrounding the Applicant's medical history, his prescription and consumption of VIOXX, the facts and circumstances that are alleged to have materially increased his risk of suffering his cardiovascular injury and whether or not the Applicant suffered a myocardial infarction on 8 December 2003 caused by his consumption of VIOXX and the risk. … 28. …First, the Respondents contend that proper research was undertaken both before and after marketing approval. 29. It will be necessary for the Court to receive evidence about the history of VIOXX including its development and regulatory history, the medical, scientific and epidemiological understanding of the risks or side effects of VIOXX and what MSDA said about these risks and side effects insofar as they concerned the Applicant and his treating doctors. 30. Some of the facts concerning the history of VIOXX and its development set out in Annexure A may be agreed. We invite the Applicant, for the purposes of discussion as to case management, to indicate whether those facts are in issue. 31. Second, the Respondents contend that the scientific and medical evidence does not substantiate the assertion about the risk and that any condition the group members may have suffered was not caused by their consumption of VIOXX or the risk. An assessment of this medical, scientific and epidemiological evidence reveals discordant results, unsupported hypotheses and a lack of strength and consistency in any statistical association, with the result that it does not support an assertion of any causal connection between the consumption of VIOXX and the conditions. 32. Third, the Respondents contend that MSDA adequately and properly disclosed information about the cardiovascular safety of VIOXX. An assessment of the regulatory history of VIOXX reveals that the TGA, a unit of the Australian Government, assessed VIOXX and was satisfied with its quality, safety and efficacy and approved the information that was made available to pharmacists and permitted prescribers. This is relevant to the Court's determination of the common law standard of care and whether MSDA was in breach of the provisions of the TPA. 26 In par 30 of the respondents' memorandum, an Annexure A was referred to. That annexure was as follows: ANNEXURE "A" - VIOXX and its Development What is VIOXX? 34. VIOXX is a prescription pharmaceutical that belongs to a group of drugs called non-steriodal anti-inflammatory drugs (NSAIDs). This class includes many other drugs used for pain relief and anti-inflammatory effects that are sold either over the counter or by prescription. 35. NSAIDs work by inhibiting cyclooxygenase (COX), which is one of numerous enzymes that synthesise prostaglandins in different parts of the body. Amongst other things, prostaglandins can promote pain and inflammation. 36. Traditional NSAIDs are a sub-set of NSAIDs that have long been used by patients seeking relief from pain or inflammation associated with osteoarthritis, rheumatoid arthritis and other conditions. As with all drugs, this benefit does not come without adverse side effects. Most notably, because prostaglandins also protect the stomach lining, traditional NSAIDs are associated with adverse gastrointestinal (GI) side effects. 37. In the early 1990s, the COX enzyme was discovered to have at least two forms, now called COX-1 and COX-2, which appeared to be associated with distinct effects in various parts of the body. It was hypothesised that COX-2 was more closely associated with inflammatory processes, whilst COX-1 may be responsible for protection of the stomach lining. The traditional NSAIDs inhibited both COX-1 and COX-2. 38. This led to a hypothesis that NSAIDs designed to inhibit only COX-2 could offer the same relief from inflammation and pain as traditional NSAIDs, but with less adverse GI side effects. VIOXX Development 39. Merck and other pharmaceutical companies developed drugs that, to varying degrees, preferentially inhibit COX-2 compared with COX-1. These became known as "selective COX-2 inhibitors" (also known as coxibs). 40. The development process for any new drug requires research designed to characterise its quality, safety and efficacy. This involves pre-clinical laboratory and animal studies followed by clinical studies in humans. 41. The data obtained from that research forms the basis of an application for registration. 42. Merck followed this process with VIOXX. The clinical data was derived from about 60 phase I, II and III studies involving more than 9,000 patients. These studies included a comparison of the safety and efficacy of VIOXX against placebo and traditional NSAIDs. 43. VIOXX was approved for registration in the United States and Australia following submission data by Merck to the United States Food and Drug Administration (FDA) and MSDA to the Therapeutic Goods Administration (TGA). This required the TGA to conclude that the quality, safety and efficacy of VIOXX had been satisfactorily established. Continuing Investigations 44. The scientific and medical understanding of almost all drugs continues to develop post-registration. This is particularly true for new drug classes, such as coxibs. This is reflected in regulatory requirements for post-marketing surveillance and reporting to the TGA. 45. Following registration, VIOXX was the subject of several ongoing clinical trials and other investigations by both Merck and non-Merck bodies. These included investigations into safety and efficacy issues such as GI events, cardiovascular (CV) events and potential further uses in additional patient populations. 46. During development and following registration, competing hypotheses were proposed about possible effects of coxibs on the CV system. These included that coxibs may have either: (a) beneficial effects due to their anti-inflammatory properties; or (b) adverse effects because they may alter the balance of certain chemicals involved in homeostasis in a way that might have the net effect of increasing blood's propensity to clot. 47. These hypotheses informed the ongoing investigation of coxibs' safety and efficacy by Merck and others, which included analysis of existing datasets and conduct of clinical trials. Merck Clinical Investigation 48. Two randomised, double-blinded clinical trials conducted by Merck concerning VIOXX were the: (a) VIOXX Gastrointestinal Outcomes Research Trial (VIGOR) - which investigated the relative incidence of serious GI adverse events in rheumatoid arthritis patients treated with VIOXX as compared to naproxen, a traditional NSAID; and (b) Adenomatous Polyp Prevention on VIOXX Trial (APPROVe) - which investigated the potential utility of VIOXX in prevention of the recurrent neoplastic polyps in the large bowel in patients with a history of colorectal adenomas. 49. VIGOR confirmed that patients taking VIOXX suffered significantly fewer serious GI side effects than patients taking naproxen. There were more reported serious CV thrombotic events in patients taking VIOXX compared to those taking naproxen. 50. It was hypothesised that this difference in CV events could reflect the play of chance, a cardio-protective effect of naproxen or an effect attributable to VIOXX. Other data available at the time did not show any increased risk among people taking VIOXX compared to people taking placebo or people taking traditional NSAIDs. These data, as well as other data including pharmacological studies showing the sustained anti-platelet effects of naproxen, supported the conclusion that the most likely explanation for the VIGOR results was the cardio-protective effect of naproxen. 51. The APPROVe data first became known to Merck in September 2004. 52. On 23 September 2004, the external safety monitoring board recommended that Merck terminate the study early in light of interim data on thrombotic CV events. Merck did so on 30 September 2004. 53. Since that time, additional data has become available concerning the CV safety of all NSAIDs, both traditional and selective. 27 So far as the court has been informed, the applicant has not responded to the invitation contained in par 30 of the respondents' memorandum.

THE RESPONDENTS' MOTION UNDER S 33N 28 Section 33N(1) of the Federal Court of Australia Act provides as follows: The Court may, on application by the respondent or of its own motion, order that a proceeding no longer continue under this Part where it is satisfied that it is in the interests of justice to do so because: (a) the costs that would be incurred if the proceeding were to continue as a representative proceeding are likely to exceed the costs that would be incurred if each group member conducted a separate proceeding; or (b) all the relief sought can be obtained by means of a proceeding other than a representative proceeding under this Part; or (c) the representative proceeding will not provide an efficient and effective means of dealing with the claims of group members; or (d) it is otherwise inappropriate that the claims be pursued by means of a representative proceeding. In the motion before the court, the respondents relied upon pars (c) and (d) of this sub-section. 29 Counsel for the respondents made it clear that they were not concerned to challenge the propriety of the proceeding having been commenced under Part IVA of the Federal Court Act. They recognised that a proceeding such as the present may involve separate acts or omissions of the respondents done or omitted to be done in relation to individual group members: see s 33C(2)(b)(ii). However, they pointed out that s 33N necessarily contemplated a situation in which, notwithstanding that the requirements of s 33C were satisfied, the court might, in its discretion, take the view that it was no longer in the interests of justice that the proceeding be a representative one. They contended that such a situation arose in the present case. 30 It was submitted on behalf of the respondents that it is apparent, by reference to the nature of the claims in the case and of the applicant's non-expert evidence, that there are no substantial issues in the proceeding beyond those which are involved in the applicant's individual claim; or, to the extent that there are such issues, that they do not justify the proceeding remaining as a representative one. It was submitted that resolution of the applicant's claim will not, or at least will not necessarily, resolve issues which are substantial enough to justify the procedure for which Part IVA of the Federal Court Act provides. These broad submissions were supported by reference to an analysis of the causes of action on which the applicant sues, to the allegations which he makes in his pleading, and to the legal consequences of the resolution of his case. 31 As to the applicant's claim in negligence, counsel for the respondents pointed out that the applicant had to establish the existence of a duty of care, the breach of that duty, the events which were caused by that breach and the suffering of loss or damage as a result of those events. While they accepted that the applicant's factual case with respect to some of these elements might be expected to resolve corresponding issues in the cases of other group members, they submitted that the other elements, which related only to the applicant, would be so significant, and so weighty in the parties' evidentiary cases generally, as to make it inappropriate for the proceeding to be a representative one. 32 Counsel submitted that, in any negligence claim, the existence and content of the duty of care must necessarily take into account the particular circumstances of those to whom it is presumptively owed, but the present case involves additional complications. First, the consumption of Vioxx is mediated through the medical practitioners who prescribe it and the pharmacists who dispense it. That is to say, the influences which may be presumed to have borne upon the applicant and others who took Vioxx were not, even as alleged, merely the doing of the first respondent. Secondly, there is no suggestion by the applicant of negligence in the manufacturing process of Vioxx. This was a specific product which was made as intended and was, moreover, approved for consumption by the TGA. Rather, the applicant's case was that the consumption of Vioxx carried with it the risk of unwanted side-effects. This means that the content of the respondents' duty of care would depend upon the availability from time to time of information relevant to the risk alleged, and the interaction of that risk with other factors, varying as between individuals, which predispose them towards cardiovascular outcomes of the kind referred to in the applicant's pleading. Thirdly, the applicant's case involves a range of alternative allegations and fall-back positions varying with reference to the level and duration of the use of Vioxx. It is said that the applicant claims, for instance, not only that the first respondent should have withdrawn Vioxx from the market, but alternatively that it should have advised consumers to use it only under certain conditions, for certain periods or in certain doses - depending, in each case, upon the circumstances of the particular person and the advice which he or she received from his or her practitioner. Counsel for the respondents submitted that the existence of these complications will shift the centre of gravity of the forthcoming trial far away from issues which the applicant's case will have in common with the cases of others and towards issues which relate to his case alone. And to this, according to counsel, must be added the indisputably individual aspects of any negligence case, causation and damages. 33 With respect to the case under s 52 of the Trade Practices Act, counsel for the respondents made a distinction between the applicant's allegations of positive conduct - such as the making of the so-called Vioxx representations - and the applicant's allegations of omissions. As to the former, counsel submitted that the applicant's case apparently would be based on the first respondent's communication to its employees and representatives (largely those who are alleged to have interacted with the medical profession) of information about Vioxx that should be regarded as having been misleading or deceptive. It was submitted that a corporation's communications with its own staff could not be regarded as conduct capable of giving rise to a s 52 claim by a third party. What mattered was the content of the communication made to that third party, and in the assumed circumstances of the present case that was done not by the first respondent but by persons over whom it had no control, the various prescribing practitioners. And even then, in one of its aspects the applicant's case is, it was said, more problematic again, in that these practitioners were themselves alleged to be influenced in what they prescribed by the so-called key opinion leaders in the profession. Here the respondents were not making the point that the applicant's s 52 case was likely to fail: rather, they were indicating respects in which that case will inevitably not be made good without a consideration of the messages that were conveyed to him as an individual by his own treating practitioners, and, without a consideration of the other professional influences to which those practitioners were subject. These last aspects, it was submitted, would not be common ones as between the applicant and other group members. 34 To the extent that the applicant's s 52 case is based on omissions, counsel for the respondents submitted that it was, apparently, an allegation of conduct by silence. Whether the conduct was misleading or deceptive necessarily depended on the body of information actually or constructively available to the first respondent from time to time, and the relevance of that information to the individual circumstances of each group member. As I understood them, counsel for the respondents made the same kind of submissions here as they made with respect to so much of the applicant's negligence case as alleged a failure to act at various points in time and in various circumstances. There was, they submitted, a great deal in the applicant's own case that is unlikely to have relevance to the cases of other group members. 35 Against the broad understanding of the points they made as summarised above, counsel for the respondents dealt somewhat more compendiously with the applicant's case under other provisions of the Trade Practices Act. With respect to s 74B, they submitted that the case was not to be approached on the assumption that the single purpose (of consuming Vioxx) which was common to all group members was relief from the discomfort of arthritis. They submitted that the purpose of each group member was an individual factual entity, as it were, which depended on the particular state of his or her condition and the advice which he or she had received from his or her treating practitioner. Since Vioxx was not an "off-the-shelf" item, a single common purpose could not be assumed. With respect to s 75AD, they submitted that the identification of the defect alleged - particularly in the light of the instruction in s 75AC(2) to have regard to "all relevant circumstances" - required a consideration of the needs of the particular group member. This was so because at least an important aspect of the applicant's case was that Vioxx gave rise to a risk of encountering side effects, rather than that Vioxx was toxic as such. Counsel made the same point with respect to the matter of merchantable quality arising under s 74D, emphasising the need to have regard to "all the other relevant circumstances": see sub-s (3). 36 Counsel for the respondents next submitted that such findings as the court might make in relation to the case of the applicant would not be binding on any of the other group members. Absent a formal splitting of the trial under O 29 of the Federal Court Rules, a finding made at any time before final judgment on the whole case would be interlocutory only and thus not binding. In this respect, counsel drew my attention to the warning against attempting to make interlocutory declarations given by Gummow and Hayne JJ in Graham Barclay Oysters Pty Ltd v Ryan (2002) 211 CLR 540, 590-591 [128] and repeated by Hayne and Callinan JJ in Dovuro Pty Ltd v Wilkins (2003) 215 CLR 317, 363 [143]. The result of observing that warning, according to counsel, would be that group members other than the applicant could, at some later point but before the final determination of the proceeding, put in contest not only findings made, but also rulings on evidence given, in the course of the applicant's own case. Thus the determination of the applicant's case, and the questions which arose in it, would have been of no utility with respect to the cases of the other group members. 37 In support of their motion, the respondents pointed also to the non-expert evidence which has recently been filed (in the form of witness statements) on behalf of the applicant (by reference to which also they justified the timing of the motion). That evidence relates to the personal circumstances of the applicant himself, and to his general practitioners' decision to prescribe Vioxx for him. The evidence deals with the applicant's personal, occupational and recreational background, with his living habits, with the medical conditions which he encountered over the years, with the joint pain from which he suffered, with the steps he took to alleviate that pain, with the circumstances in which he came to be prescribed Vioxx, with his practitioners' thinking on that subject, with the rate at which, and the period over which, he consumed Vioxx, with a myocardial infarction which he suffered in December 2003, with the treatment he received in relation thereto and his recovery therefrom, and with the effect of that infarction on his life, habits and work. The applicant's practitioners' witness statements deal also with their interactions with drug companies and with the kind of things they tended to take into account when prescribing drugs for the relief of pain. 38 In summary, the essence of the respondents' position was that the applicant's claims, properly understood, involved so many important questions which were not common to the group members as should lead the court to take the view, in the exercise of its discretion, that it was not in the interests of justice for the proceeding to continue under Pt IVA because it would not provide an efficient and effective means of dealing with claims of group members, or because it was inappropriate that those claims be pursued by means of a representative proceeding. 39 It is, of course, well within the contemplation of Part IVA that a proceeding properly commenced, and prosecuted, thereunder will have non-common questions, or questions which relate to group members as individuals. That is recognised by s 33C itself, to which might be added ss 33Q and 33R. However, when the point is reached at which it appears that the proceeding "will not provide an efficient and effective means of dealing with the claims of group members", the discretion under s 33N(1)(c) is enlivened. The comparison which is implicitly required by this provision is between the continuation of the Part IVA proceeding in its existing format and the bringing of separate actions by all group members to prosecute the claims which they presumptively have. In the present case specifically, the comparison is between maintaining the status of the proceeding under Part IVA and converting the proceeding to one which is concerned with the applicant's claim alone, thereby leaving each other group member to bring his or her claim against the respondents or either of them. It must be assumed that every one of them would do so. 40 It will be apparent from the survey of the pleadings set out earlier in these reasons that there remain very substantial areas of factual dispute with respect to questions that go beyond the individual circumstances of the applicant. A very large question in the proceeding will be whether the consumption of rofecoxib, and therefore of Vioxx, causes, or had a tendency to cause, the cardiovascular conditions referred to in the Further Amended Statement of Claim, or increased the risk of those conditions arising. In addition to purely medical, or scientific, questions of this kind, the proceeding also raises the question of the timing and extent of the respondents' appreciation of such risks as there were. It is true that, jurisprudentially, in at least a number of ways the applicant puts his case, the respondents' liability may depend to a large extent on how a reasonable supplier would have reacted to a growing body of scientific and medical evidence as had potential relevance to the applicant himself. But that is not to gainsay the relevance, or the significance, of that evidence as such to all group members. In other words, although the evidence may have a relevance which differs in point of detail between group members, it will, almost by definition, have a relevance. 41 Of the items on the applicant's list of significant issues, Nos 1, 3, 4, 7, 8, 9, 11 and 12 would appear to raise questions the utility of the determination of which will not be confined to the applicant's claims as an individual. Further, the first aspect of each of items 6, 13 and 15 would appear to be in the same category. Of the items on the respondents' list, Nos 8-16 (although described as "not likely to be in issue"), parts (a)-(d) of No 18 and Nos 28-32 (including Annexure A) would appear to be in the same category. These will be significant and weighty matters. The advantages of addressing them in a single proceeding, rather than dealing with them again and again each time an individual group member makes his or her own claim, are too obvious to require emphasis. 42 There is also the matter of discovery. In this proceeding, the bulk of the time taken in the interlocutory stages so far has been occupied by the respondents making discovery of documents. The enormity and expense of that undertaking has been stressed to me on various occasions by the respondents themselves. As I understand it, the vast bulk of the discovery (and therefore of the work which lies behind it) relates to circumstances other than those concerning only the applicant and his treating practitioners. If this proceeding were not to continue as a representative one, that discovery would have to be given again and again to every other applicant who chose to commence proceedings for damages against the respondents. The respondents' answer to this consideration is to suggest that their experience in giving discovery to the applicant in the present case would inform their approach in other cases, and lead to the saving of time and expense. Undoubtedly that would be correct so far as it goes, but the response fails to take account of the circumstance that, in this proceeding, discovery has been given by reference, originally, to a protocol proposed by the respondents and accepted by the applicant and, since late 2007, by reference to categories proposed by the applicant and accepted by the court. Since then, the court has held the applicant to his categories. That approach would not be available if all the group members came before the court in separate proceedings. Each would be entitled to agitate for a regime of discovery that appeared to be productive in the eyes of his or her own legal practitioners. Such an approach would, in my view, be neither efficient nor effective. 43 As mentioned earlier, counsel for the respondents emphasised the limited nature of the non-expert evidence filed on behalf of the applicant. It is true that that evidence is concerned very substantially with the applicant himself and with his practitioners. There are, however, two things to be said about that. First, the present application is to be determined by reference to the questions that will arise at trial as disclosed by the pleadings. The filing of evidence - in effect a forewarning designed to promote the efficient conduct of the trial - is not to be regarded as limiting in this respect. Secondly, the applicant has not yet filed his expert evidence. In the lexicon of the parties in this proceeding, "expert" evidence is not limited to opinion evidence. Without knowing what the applicant's expert evidence will be, I am in no position to decide the respondents' motion as though all of the applicant's evidence has been filed. I must assume that the applicant will attempt to make good all the allegations in his Further Amended Statement of Claim. 44 For the purposes of deciding the present motion, I am prepared to accept the respondents' thesis that, structurally, the negligence part of the case will involve a degree of complexity in the resolution of the applicant's individual claims that is not necessarily present in any product liability action as such. The interposition of medical practitioners, pharmacists and others between the first respondent and the applicant and the apparent circumstance that Vioxx was a product made and supplied as indented, and registered on the ARTG after having been through a process of approval will, for example, provide that complexity. However, even those aspects of the case are not without factual dimensions that, once addressed in the applicant's case, are likely to present common questions that, once answered, will have been answered for all group members. As alleged by the applicant, the first respondent's dealings with practitioners in relation to the flow of information about Vioxx was systematic, rather than random. The very fact of ARTG registration, and the consequences of it with respect to the first respondent's duty of care to consumers generally, are matters which are not confined to the applicant's case. I mention these aspects as examples only. The general proposition which the submissions made on behalf of the respondents have not gainsaid is that, even with respect to the content of such duty of care which the respondents owed to the applicant, there are important matters of fact which, once decided, will conveniently carry forward into the resolution of the cases of the other group members. 45 The case for granting the respondents' motion is, if anything, weaker yet to the extent that it relies upon the applicant's claims under the Trade Practices Act. Whether the first respondent breached the norm of conduct stated in s 52 is, it appears to me as presently advised, a question the resolution of which depends to no extent upon the individual circumstances of the applicant. It is true that the applicant will be entitled to damages under s 82(1) only if he suffered loss or damage by the first respondent's conduct, but the conduct itself, to the extent that it occurred, at least prima facie has a freestanding presence apart from the applicant. Counsel for the respondents accepted that it would not be necessary for the applicant to show that a misleading or deceptive representation was made to the applicant, and that it would be sufficient if, for example, such a representation was made to an intermediary and the applicant suffered loss or damage as a result. In the applicant's s 52 case, there is manifestly a deal to be determined that will have potential application to other group members. 46 With respect to the case under s 74B, the applicant alleges that each group member acquired Vioxx "for the purpose of consumption as a safe non-steroidal anti-inflammatory drug". That allegation is denied. It is true that purpose, as contemplated by s 74B and as alleged by the applicant, is an individual thing. However, s 74B will be contravened - other requirements thereof being satisfied - if Vioxx was not "reasonably fit" for the purpose alleged by the applicant. That is to say, it will be a common question whether Vioxx was reasonably fit for consumption as a safe non-steroidal anti-inflammatory drug. Whether any particular group member had that purpose, and whether he or she made it known to the first respondent are, of course, matters to be determined individually. But that circumstance does not deny the utility of trying the fitness point once only in the applicant's proceeding. 47 The question arising under s 74D in the present case - whether Vioxx was of merchantable quality - will require consideration of whether the tablets were "as fit for the purpose or purposes for which goods of that kind are commonly bought as it is reasonable to expect having regard to" various matters, including, as the respondents point out, "all the other relevant circumstances". Here the issue will centre not on the purpose of a particular consumer, but on the purpose for which Vioxx is "commonly bought". The utility of maintaining the present proceeding as a representative one to the extent that it relies on s 74D is, in my view, self-evident. 48 Likewise, a significant question arising under s 75AD will be whether the Vioxx tablets consumed by the applicant had a "defect". Vioxx will be found to have had a defect if its "safety [was] not such as persons generally are entitled to expect": see s 75AC(1). The statutory norm here is concerned with a characteristic of the goods themselves, rather than with the effect of consumption upon a particular person. Although, again, s 75AC(2) requires reference to be had to "all relevant circumstances", the examples given in pars (a)-(f) are concerned with the general rather than the particular. 49 The respondents' argument based upon Graham Barclay Oysters and Dovuro seems to be such as would have application to any representative proceeding under Part IVA of the Federal Court Act. The argument might, if sound, stand in support of a proposition that Part IVA should not be in the Act at all. However, I do not consider the argument to be sound, at least in the categorical way it was put here. It is true that, until final orders are made in any case, nothing said or done, and no rulings given by the court can finally affect the rights of the parties. A declaration, by definition, does finally establish the rights of the parties affected thereby. But there is no suggestion by the applicant that the disposition of his claim under Part IVA must be accompanied by a declaration made before the stage is reached at which the making of final orders is appropriate. 50 What sets a Part IVA proceeding apart from other proceedings with multiple parties is that the named party - the applicant - represents others who are not on the record. Steps taken by the applicant in the conduct of the case are binding on the group members because he acts as their representative. Likewise, findings and rulings made in the course of the applicant's case are binding on the group members not because they have the legal status of final orders but because the group members are represented by the applicant. There is, of course, a point at which the individual claims of group members may need to be considered. Depending on the measure of success which the applicant achieves at trial, that point may never be reached. However, if it is, I accept that there is likely to be a problematic interface between the issues which have already been determined and the issues which will relate to each group member's separate claim. The existence of such an interface, in my view, is a necessary complexity in the conduct of any proceeding of a kind for which Part IVA of the Act provides, and is contemplated by s 33Q. It is not such as should persuade the court that it is not in the interests of justice for the present proceeding to remain as a representative one. 51 For the reasons stated above, I dismissed the respondents' motion under s 33N. In summary, I was not satisfied that it was in the interests of justice to order that the present proceeding no longer continue under Part IVA. I was persuaded neither that the proceeding, in its existing format, will not provide an efficient and effective means of dealing with the claims of group members nor that it was otherwise inappropriate that those claims be pursued by means of a representative proceeding.

THE RESPONDENTS' MOTION UNDER S 33zf 52 In the alternative, it was submitted on behalf of the respondents that, if the proceeding is to remain as a representative one, the court should now identify and define, with precision, the common issues that will be determined as part of the applicant's case. It was said that s 33ZF of the Federal Court Act provided a statutory vehicle for such a procedure. It was not, however, proposed that the court make an order for the separate determination of particular questions under O 29, which was said to be "perilous, … an absolute minefield". The precise identification of issues was, however, said to be necessary so that the parties may know what they were contesting in the applicant's case, whether particular evidence was admissible, and the like. 53 The respondents' contention had two limbs. The first was that it was not open to the applicant to insist upon a trial that would deal with his own claims and with whatever common issues he chooses to propound. Absent a formal order for the separate determination of particular questions, the whole of the case would be in suit and would be litigated at the hearing listed for the second quarter this year. It was the court, not the applicant, that had both the power and the responsibility to define the issues. The second, and alternative, limb, was that, if the applicant could set out his common questions, then the present schedule to the applicant's pleading was inadequate in that it set out issues at a level of generality which did contemplate the specificity of individual claims and the extent to which those claims will depend upon particular circumstances. They submitted that the court should now specify the "issues" which were to be determined as part of the applicant's case, including the issues that he contended were common to himself and to other group members. 54 Counsel for the applicant resisted the suggestion that the court should attempt to embark upon any such exercise. They submitted that, in accordance with the scheme of things contemplated by Part IVA of the Federal Court Act, the applicant would conduct his case this year as though he were a conventional litigant. That case would necessarily involve general questions about the marketing of, the research into and the science concerning, Vioxx, the risks associated with Vioxx, and the information actually or constructively available to the respondents at various times with respect to those risks (amongst others). Such matters would be relevant at trial not because they were "issues" which were common to all group members, but because they necessarily arose in the proof of the applicant's own case. At the conclusion of the applicant's case, the court would make findings which were relevant thereto, and the other group members would be able to rely upon, and would be bound by, those findings. How the court proceeded in the circumstances then obtaining would depend on what those circumstances were. Counsel submitted that the court would have a flexible discretion to do justice according to the needs of the parties, having recourse, to the extent necessary, to s 33Q of the Federal Court Act. 55 I accept the broad characterisation of a Part IVA proceeding given by counsel for the applicant. In my view, the obvious course is for the applicant's case to be conducted within the confines of his pleading. I would not exclude the realistic possibility that, in the course of the conduct of that case, some evidence might be admitted which would not be strictly relevant if the proceeding related to the applicant alone. However, that prospect is not sufficient to justify the court in departing from the long-established convention that it is the content of the parties' pleading that give definition to the matters to be litigated at trial. 56 Earlier in these reasons, I set out extracts from the parties' memoranda of significant issues thought to be presented by this proceeding. To an extent, those memoranda are tendentious. There are respects in which they pass each other like ships in the night. This is not intended as a criticism of the parties, and, indeed, their memoranda valuably cast light upon their own perceptions of the dynamics of the litigation as a whole. However, as a structural framework for the definition of matters to be litigated at trial, they are no substitute for the parties' pleadings. 57 I take the view that any attempt on the part of the court to draw up an inventory of matters or issues to which the trial would be confined would serve only to provide considerable scope for later argument, particularly with respect to the admissibility of evidence. Questions which ought to be resolved by reference to the pleadings might then, in the contention of one or other of the parties, have to be resolved also by reference (or rather by reference) to the inventory. In other words, any such inventory would introduce a layer of complication, with the additional delays and costs necessarily attendant thereon. It would, in my view, inevitably generate more heat than light. I propose to conduct the trial according to a conventional template, subject only to such modifications as are, in particular respects, seen to be desirable in the light of the circumstance that the proceeding is a representative one. 58 For the above reasons, I dismissed the respondents' Notice of Motion under s 33ZF.

THE APPLICANT'S DISCOVERY MOTION 59 The applicant's Notice of Motion, filed on 28 November 2008, sought the following orders: 1. The First Respondent discover all documents which in any way pertain to, refer to, name or otherwise describe Dr John Dickman. 2. The First Respondent discover all workbooks, job records and all other file notes of the sales representatives Christopher Brown, Kym Carter/McCarthy, Marcus Daddo, Noel Whelan, Stephen Bognar, Laurie Pascazio, Arty Kissas and Andrew Hall. 3. The First Respondent discover all documents pertaining to its relationships and interactions with all individuals who were members of its Australian Arthritis Advisory Board between 1999 and 2004. 4. The Second Respondent discover the 93 documents produced in the United States VIOXX litigation that are identified by Bates numbers in exhibit "PS20" to the Affidavit of Paula Shelton sworn on 27 November 2008 in this proceeding. 5. All documents produced under Orders 1 to 4 above be provided to the Applicant without redactions for claimed relevance or confidentiality. 6. Such other orders as the Court sees fit. Paragraph 4 of the Notice of Motion was resolved by the agreement of the parties, and I made an order in accordance with that agreement. Paragraph 5 relates to the form in which documents, otherwise ordered to be provided pursuant to the Notice of Motion, were made available for inspection. The applicant's substantive claims, still outstanding, are those referred to in pars 1, 2 and 3 of the Notice of Motion. 60 Dr Dickman was the main general practitioner who prescribed Vioxx for the applicant. The sales representatives referred to in par 2 of the Notice of Motion were those who, according to documents already discovered by the first respondent, called upon Dr Dickman's practice within the period which may be considered material for the purposes of the present proceeding. The Australian Arthritis Advisory Board was, as its name suggests, an advisory board set up by the first respondent to advise it on matters which included the use of Vioxx for the treatment of arthritis. 61 Originally, the process of discovery in this proceeding was done according to a protocol proposed by the respondents, and accepted by the applicant. This led to the respondents producing large numbers of documents for inspection by the applicant, in successive tranches. The respondents' original estimates as to the time within which discovery, according to this protocol, would be complete proved, however, optimistic. More than once, the respondents indicated to the applicant, and to the court, that the size and complexity of the task was such that considerably more time was required to complete it than had originally been estimated. At this stage the court had not been involved in the process of discovery at all. 62 By about the middle of 2007, the applicant's advisers had commenced to express disquiet as to the progress and utility of discovery according to the then protocol. In October 2007, the applicant filed a Notice of Motion seeking orders that would require the respondents to give discovery according to categories then proposed by the applicant, and to do so by 31 March 2008. The applicant's motion was heard on 23 November 2007. The respondents resisted it. They filed affidavit material which showed the extent of the resources which they were then devoting to the task, and submitted that additional resources would be required if the task were to be completed within the time frame, and according to the categories, proposed by the applicant. 63 At the hearing of the applicant's motion in November 2007, counsel for the applicant said that the categories then proposed by him were "now our complete request for discovery in the proceeding". He said that the applicant desired "an end point" in relation to discovery. I broadly accepted the submissions then made on behalf of the applicant. I allowed the respondents a little more time than was proposed in the applicant's Notice of Motion for the purpose of completing discovery, and, with the assistance of constructive submissions made by both sides, I effectively settled the applicant's list of categories by reference to which discovery would be completed. I gave the applicant leave, pursuant to O 15 of the Federal Court Rules, to file a notice for discovery addressed to the first respondent seeking discovery of documents according to those categories. 64 The categories settled upon in November 2007 were the following:

1. All scientific research, documentation and studies concerning VIOXX and/or rofecoxib ("VIOXX").
2. All internal communications and documents sent between the First Respondent's employees and other employees of the First Respondent or third parties retained by the First Respondent concerning: (a) the cardiovascular effects of consumption of VIOXX; (b) clinical trial programs for VIOXX; (c) information provided to Australian pharmacists, medical practitioners and other healthcare professionals by the First Respondent concerning VIOXX; (d) the design and content of labelling on VIOXX packaging in Australia; (e) sales and marketing strategies for VIOXX; (f) retaining third parties to promote VIOXX within Australia; (g) promotional and/or educational events held or organised by the First Respondent and attended by pharmacists, medical practitioners and/or other healthcare professionals concerning VIOXX; (h) the First Respondent's interactions with the Therapeutic Goods Administration concerning VIOXX.
3. All communications and documents sent between the First Respondent and the Second Respondent concerning VIOXX.
4. All communications between the First Respondent and third parties retained by the First Respondent for the purpose of promotion [sic] VIOXX within Australia, including medical practitioners, researchers, academics, and public relations companies.
5. All versions of VIOXX Produce Information, VIOXX packaging and VIOXX package inserts used within Australia.
6. All communications and documents sent by the First Respondent (or a third party retained by the First Respondent) to Australian pharmacists, medical practitioners and other healthcare professionals concerning VIOXX or evidencing the circulation and intended recipients of such communications.
7. All documents: a. evidencing communications between the Applicant's general practitioner Dr John W Dickman of Towerhill Medical Centre, Frankston, and the First Respondent; b. relating to Dr Dickman; and/or c. relating to seminars, meetings or events attended by Dr Dickman which were sponsored, organised or attended by the First Respondent.
8. All communications and documents (including regulatory submissions and filings) sent between the First Respondent or the Second Respondent and the Therapeutic Goods Administration concerning VIOXX.
9. All documents and communications detailing training and other work instructions concerning VIOXX provided to sales representatives employed or engaged on behalf of the First Respondent.
10. All promotional materials and sales aids used by the First Respondent's sales representatives in promoting VIOXX to pharmacists, medical practitioners and other healthcare professionals in Australia.
11. All public statements made by the First Respondent concerning VIOXX. 65 The assumption against which counsel for the applicant moved for the orders sought in his present Notice of Motion was that those orders, if made, would require the respondents to discover documents beyond the categories established in November 2007. That is to say, it is not now suggested that the respondents have failed in some respects to give discovery in accordance with those categories. The case appears to be put on the basis that, having perused the scope and contents of the documents which have been discovered by the respondents, it is now possible to identify further documents the relevance of which is reasonably apparent and which would, in the normal course, be discoverable. However, as I attempted to make clear in an earlier ruling on discovery given in this proceeding - Peterson v Merck Sharpe & Dohme (Australia) Pty Ltd (No 2) [2008] 1468 - the price which I should regard the applicant as having paid for the certainty (in point of both of time and of scope) which he achieved in November 2007 is that, barring the emergence of unforeseeable circumstances, the court has a fairly strong predisposition to regard the categories of discoverable documents as then having been closed. The applicant's then case was, in effect, that the process of discovery by the respondents could not be allowed to drag on indefinitely, that a line had to be drawn in the sand and, as I have said, that there should be an "end point" in relation to that process. 66 Against those general considerations, I turn to the present Notice of Motion. Paragraph 1 thereof is almost entirely covered by par 7 of the November 2007 categories. Any difference is, in my view, a matter of wording rather than substance. Counsel for the applicant were unable to identify any respect in which their client was disadvantaged by having the benefit only of par 7 of the November 2007 categories and not also of the proposed par 1. I took the view that no case had been made out to effect what would essentially be no more than a terminological reconfiguration of the first respondent's obligations as established by the former. 67 A consideration of par 2 of the present Notice of Motion requires a reference to the disposition of a Notice of Motion filed by the applicant on 2 September 2008, and heard on 10 September 2008. Amongst the relief then sought were orders that: 1. The First Respondent discover all documents concerning the marketing, promotion and sale of VIOXX and interaction with Australian medical practitioners and their staff sent to, made by or received from the Peterson sales representatives referred to in paragraph 9 of the affidavit of Paula Shelton sworn on 1 September 2008. 2. The First Respondent discover the notes of sales calls made by all sales representatives in its employ promoting VIOXX to Australian medical practitioners and their staff within Australia. a. Recorded in the First Respondent's "Genesys" system, b. Recorded in internally-used spreadsheets or table, or c. Recorded by other means. On that motion, I made an order on 16 September 2008 that a new par 12 be added to the November 2007 categories as follows: All documents concerning the marketing, promotion and sale of VIOXX and interaction with Australian medical practitioners and their staff sent to made by or received from the Peterson Sales Representatives (being the persons referred to in paragraph 9 of the affidavit of Paula Shelton sworn on 1 September 2008), including the notes of sales calls made by the Peterson Sales Representatives recorded in the first respondent's "Genysys" system, in the period between 1 January 2000 and 31 December 2003. 68 Subsequently, a controversy arose as to the meaning of the opening words of par 2 of the November 2007 categories. The applicant's position was that those words included file notes and the like by which information was recorded for the purpose of retention, and were not confined to documents actually sent to others. The respondents did not accept that interpretation of the paragraph. Accordingly, on 22 October 2008, the applicant filed a Notice of Motion which sought an orders that: In category 2 of the Schedule of Discoverable Documents annexed to the orders of this Court made on 26 November 2007, the phrase "internal communications" includes file notes and other like documents in which information is recorded by an employee of the First Respondent for the purposes of being retained amongst or within the company's internal records, as well as documents sent to other employees or agents of the company. On 29 October 2008, I upheld the respondents' position on this point, and dismissed the applicant's motion. 69 Paragraph 2 of the present Notice of Motion is in one sense an application to extend the scope of par 2 of the November 2007 categories beyond the construction which I placed on it on 29 October 2008, but limited to the stated records etc made by identified sales representatives. It seems that all of those representatives are within the class of "Peterson Sales Representatives" with which the new par 12 of the November 2007 categories is concerned. At its widest, par 12 requires the first respondent to discover all documents concerning interaction with Australian medical practitioners and their staff made by those representatives. Against the general considerations referred to in par 66 above, I can see no obvious utility in supplementing that obligation with the very similar one proposed by par 2 of the present Notice of Motion. 70 Counsel for the applicant supported their claim for the relief sought in par 2 by demonstrating that the notes of sales calls entered electronically in the first respondent's "Genysys" system had in most cases proved to be very spare, and submitted (in part by reference to other documents which had been discovered) that it was highly probable that corresponding, and more extensive, hard-copy file notes etc existed in addition to those entries. This was, however, little more than a supposition on their part and, while it may have provided a ground for an order for further discovery under conventional, or traditional, regimes, it is not, in my view, sufficient to displace the presumption implicit in the establishment, and the later amendment, of the November 2007 categories that those categories should state exhaustively the first respondent's obligations in relevant respects. 71 In support of the orders sought in par 3 of his Notice of Motion, the applicant referred to a number of publications, alleged to have been ostensibly independent, but in fact sponsored or facilitated in some way by the first respondent. There were, it is alleged, leading professional specialists who regularly featured as authors of these publications, and many of them were, according to the applicant, "paid members of the first respondent's Australian Arthritis Advisory Board". Foremost amongst them was Prof Henry Krum who, according to the applicant, "published a number of seminal studies and publications into the safety of Vioxx…." It is said that Prof Krum "had and maintains a substantial commercial relationship with the respondents". In her affidavit sworn on 27 November 2007, the applicant's solicitor summarised the position thus: In my opinion, there are reasonable grounds to infer that there is likely to have been substantial intercourse between Professor Krum and one or both Respondents prior to the publication of his various public comments about VIOXX. All of the other studies which exist and which have been relied upon by Merck in US proceedings as demonstrating the safety of VIOXX, were either designed or influenced by senior employees of Merck. Further direct evidence of the Respondents' involvement in the presentation of the expert opinion of Professor Krum will enable the applicant to assert that the Respondents influenced material presented to regulatory authorities and doctors in Australia. 72 On 26 November 2007 - ie on the same day as I made the order establishing the categories of documents discoverable by the first respondent - I gave the applicant leave to serve a subpoena on Prof Krum seeking production of the following documents: (a) all correspondence, briefs, instructions and other materials provided by the First Respondent in connection with VIOXX while retained by the First or Second Respondent; (b) all notes or other documents produced as a result of personal research into cardiovascular effects of VIOXX; and (c) all correspondence with third parties concerning VIOXX produced while retained by the First and Second Respondent. This leave, and the terms of par 2, 4 and 6 of the categories, leaves little doubt about the then existence of reasonable grounds to suppose that the first respondent might well be in possession of documents of the kind now sought by par 3 of the Notice of Motion. Again on the application of the applicant, on 6 March 2008 I gave leave for the service of a subpoena - expressed in the same terms as that addressed to Prof Krum - upon other members of the Arthritis Advisory Board. 73 Counsel for the applicant informed me that few documents were produced as a result of the service of the subpoenas to which I have referred. They supposed that that might have been because these medical specialists tend not to retain documents, or copy documents, recording their interactions with the first respondent. There is, however, no factual basis for that supposition. I recognise that, in November 2007, the applicant might well have obtained an order for discovery in the terms now proposed. However, he chose to go about the matter in a different way. He opted for discovery obligations in the terms of pars 2, 4 and 6 of the November 2007 categories. There is a clear overlap - perhaps a very substantial overlap - between the content of the obligations set up by those paragraphs and the content of the new obligations now sought to be imposed. Indeed, if anything, the earlier obligations are in many ways the wider of the two. As I have said, it is apparent from the terms of the subpoena served upon Prof Krum that the applicant's advisers were alive to the realistic potential for the first respondent to have in its possession documents of the kind now sought to be discovered. In all the circumstances, and against the considerations referred to in par 66 above, I was not persuaded that a case had been made to impose these new obligations on the first respondent. 74 For those reasons, save for the consent order resolving par 4 of the applicant's Notice of Motion, I dismissed that motion. I certify that the preceding seventy-four (74) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Jessup.

Counsel for the Applicant: Mr J Burnside QC with Mr B Quinn and Mr P Gordon

Counsel for the Respondents: Mr TGR Parker SC with Mr A Morrison and Mr CB Loveday