Chown v Upjohn & Anor

Is it just and reasonable to order that the limitation periods be extended? 56 The principles relevant to the exercise of the Court's discretion under s 60G were conveniently summarised by Mason P in Jones v Royal Hospital for Women (unreported, NSWCA, 24 July 1998) at p 11. "(1) The satisfaction of the preconditions to an exercise of discretion under s 60G do not give rise to a presumptive right to the exercise of discretion in favour of the applicant - see Commonwealth of Australia v McLean (Court of Appeal, unreported, 28 July 1997, earlier decision in same appeal reported at (1997) 41 NSWLR 389). Rather, the applicant has the positive burden of demonstrating that it would be just and reasonable for an extension of time to be granted in the circumstances of the particular case - see Brisbane South Regional Health Authority v Taylor (1996-1997) 186 CLR 451 at 544, 547, 554, 567. (2) The viability of the proposed claim is relevant - George v Estate of Bailey & Ors (1998) Aust Torts Rep ¶81-455 at pp 64,649-50 (and cases cited). (3) Although the ultimate onus of satisfying the court clearly rests upon the applicant, there is still an evidentiary onus on the opponent to 'raise any consideration telling against the exercise of the discretion' - Taylor at 547, 566-7. As explained by Kirby J (at 566-7) 'If a defendant does not call evidence, or calls evidence which is unpersuasive or insignificant, provided it is reasonable to infer that some evidence was available to it in the circumstances the defendant cannot complain if the court concludes that no particular prejudice, over and beyond the generalities, could have been established by it…' See also Sydney City Council v Zegarac (1998) 43 NSWLR 195 at 197. (4) It is not appropriate to balance the prejudice to each of the parties - Taylor at 549-550; McLean at 3. (5) The proper question to ask is whether 'the delay has made the chances of a fair trial unlikely' - Taylor at 550 per Toohey and Gummow JJ; or whether the commencement of an action beyond the limitation period would result in prejudice of a significant kind to the prospective defendant - Taylor at 544 per Dawson J, 555 per McHugh J. Cf Zegarac at 198-9. (6) The court is required to have regard to 'every relevant fact and circumstance that does not travel beyond the scope and purpose of the enactment authorising an extension of the limitation period' (per McHugh J in Taylor at 554) including the rationales for the existence of limitation periods - Taylor , per McHugh J at 551-553 and Kirby J at 563-564. Accordingly, evidence of presumptive and actual prejudice to a prospective defendant will be a most relevant consideration, if not determinative in the vast majority of cases - see Taylor at 548, 555 and George at 64,647-64,648. However, in exceptional cases other considerations may prove decisive, such as inordinate delay on the part of the applicant considering the extent of awareness of relevant issues under s 60I as explained by Gleeson CJ (as he then was) in Drayton Coal Pty Ltd v Drain (Court of Appeal, unreported, 22 August 1995)." 57 Recognising the applicant's burden of persuading the Court that the discretion conferred by s 60G ought to be exercised in her favour, I propose to consider firstly the viability of the claim the applicant wishes to bring.

Viability of claim 58 It is not incumbent upon the applicant on the present application to demonstrate that she has a cause of action by strict proof of the necessary ingredients in admissible form. The applicant is not, as it were, called upon to conduct a full dress rehearsal. What the applicant is required to show is that evidence exists that would be available at the trial to establish a cause of action: see Martin v Abbott Australasia Pty Limited (1981) 2 NSWLR 430; Williams v The Commissioner for Aboriginal Land Rights Act (1994) 35 NSWLR 497; and George v Estate of Bailey (supra). As Kirby P expressed it in Williams at 508, the applicant has "the need to demonstrate in an appropriately preliminary way, the apparent viability of the action and, thus, the utility of providing the extension of time sought. To permit an obviously hopeless case to proceed would be to condone the harassment of a defendant otherwise protected by a time bar." 59 What has the applicant shown here? 60 Material has been placed before the Court which establishes the existence of evidence that, if accepted, would prove that the intrathecal injection of Depo-Medrol may cause arachnoiditis. I do not propose to conduct an exhaustive review of the evidence in point, bearing in mind the nature of the present application. I do not understand, for the purposes of this application that Mr McCulloch has disputed the availability of evidence that, if accepted at a trial, goes to establish this matter. 61 It would appear that the evidence available to the applicant includes evidence from Dr David Wesolowski who prepared a statement for an earlier claim brought against the first and second defendants in the Federal Court by one Jodie-Anne Brooks. Dr Wesolowski conducted some research at the Cleveland Clinic in Ohio in consequence of which he concluded that virtually all patients covered by his study who had been given intrathecal Depo-Medrol developed arachnoiditis. He presented his findings at conferences held by the American Society of Neuroradiology in New Orleans in May 1978 and by the State Radiological Society in Cleveland in June 1978 and Dr Wesolowski said he made his findings known to the first defendant in 1978. Other documents tendered in the applicant's case also establish that the first and second defendants were aware that Depo-Medrol had been reported as causing arachnoiditis. For instance, on 13 March 1978 the then medical director of the second defendant wrote to the director general of the Department of Health in the ACT informing him, following contact with the first defendant, that a package insert used with Depo-Medrol in Australia contained a statement "Arachnoiditis has been reported following intrathecal administration." 62 The evidence tendered satisfies me that the applicant would be in a position to adduce evidence at trial which, if accepted, would prove that Depo-Medrol was capable of causing arachnoiditis if injected intrathecally; further, that the defendants were aware that the product was widely used for intrathecal injection; further, that evidence is available from which it would be open to conclude that notwithstanding the defendants' awareness of the hazards associated with such use nothing was done to discourage it and no adequate warning was given in the packaging, distribution, instruction or otherwise by way of instruction to the medical profession and to users of the product about the risks of intrathecal administration as at the dates that the applicant received her injections. 63 The contentious issue on the viability of this claim has been whether the applicant has established that there is evidence available to her, the acceptance of which would prove that she developed arachnoiditis in consequence of the intrathecal injections of Depo-Medrol. 64 The applicant does have evidence available to her that Dr Williams injected Depo-Medrol intrathecally on 17 July 1979 and further that there was a second intrathecal injection of Depo-Medrol on 20 January 1981. 65 The applicant relies upon reports of Associate Professor Yeo to establish the availability of evidence on the issue of causation. Those reports became Exhibit T. Professor Yeo based the opinions expressed upon medical records that had been made available to him. On 11 October 2000 Prof Yeo expressed the opinion that the applicant was suffering from a severe and persistent pain syndrome as a result of arachnoiditis "following the use of intrathecal injection of Depo-Medrol". In the subsequent brief report of the same date, Prof Yeo made it clear that his opinion was that the arachnoiditis not only followed chronologically such intrathecal injection but that it was the Depo-Medrol which was causative of her condition. 66 Mr McCulloch has submitted that Prof Yeo's reports are insufficient to satisfy the onus on the applicant on the issue of specific causation. He has submitted that the major report is internally inconsistent and that Prof Yeo has not addressed sufficiently other possible causes of the arachnoiditis which Dr Robson found the applicant to have been suffering from after the myelogram in February 1989. Mr McCulloch submitted that Prof Yeo had not addressed the contrary opinion of Dr Cashman, the radiologist whose report Mr McCulloch tendered. In his report, part of Exhibit 3, Dr Cashman addressed the known causes of arachnoiditis and the applicant's history. Dr Cashman concluded his report saying: "It is impossible to know what were the roles, if any, of the various events that happened to Ms Chown in the period between seven and twenty-three years ago, in terms of the causation and progression of radiological and possible clinical arachnoiditis." 67 Dr Cashman's report underlines the task in front of the applicant if her application succeeds of proving on the balance of probabilities at a trial what caused her arachnoiditis. It may be that ultimately a trial court would not accept the opinion of Prof Yeo. The applicant has a long and complicated medical history that must be considered. However it is not possible nor appropriate for the issue of causation to be determined on the present application. Whatever be the shortcomings of the reports of Prof Yeo, what they do evidence is an opinion held by a very experienced medical practitioner. That opinion supports the applicant's case on causation. 68 It seems to me that for the purposes of the present application the applicant has established an arguable case satisfying the obligation upon her at this stage as to the issue of causation, and also as to the existence of a cause of action against the first and the second defendants.

Delay 69 There is a need to have regard to the issue of delay in the commencement and in the pursuit of the plaintiff's cause and of this application. I propose to address as a separate issue the question of prejudice to the defendants in the event that an extension of time is granted. 70 It follows from what I have already written that I am satisfied that the plaintiff has accounted for the delay in commencing proceedings against these defendants in the period before she saw the television programme in November 1990. The plaintiff lacked awareness of the matters I have earlier identified in para 36 of this judgment. 71 I find that the plaintiff acted promptly enough in thereafter engaging the services of her solicitors, to whom verbal instructions were given on 30 November 1990. The plaintiff was reasonably prompt in completing the questionnaire which her solicitors requested her to complete, in providing the medical authorities required of her, and in giving the instructions that she gave in writing to Cashmans by letter dated 20 February 1991. 72 In considering the issue of delay, it is by no means irrelevant that the plaintiff is a person of limited education and a person whose financial resources were restricted. Exhibited to Mr Cashman's affidavit is an application form completed by the plaintiff, seeking legal aid. The plaintiff is and has been at relevant times a pensioner. Although the plaintiff and her husband apparently own their own home at Mossy Point, I am satisfied that the plaintiff lacked the resources to pursue expensive litigation against the defendants and that she has been at all relevant times dependent upon either obtaining a grant of legal aid or upon the willingness of her solicitors to assume responsibility for the conduct of the litigation without significant financial input from her. I find that the plaintiff never received a grant of legal aid. Indeed the Legal Aid Commission in this State refused her aid on 25 March 1992. 73 What happened to account for the delay between the time that the plaintiff gave her solicitors instructions at the end of 1990 and the time that the statement of claim and the notice of motion seeking an order extending the limitation period were filed? Such filings were respectively on 9 July and 31 August 1993. 74 The plaintiff engaged the firm Cashman and Partners. It later merged with Maurice Blackman and Co. in July 1999 and the firm Maurice Blackburn Cashman was formed. However nothing turns on this for present purposes. 75 As at the time instructions were received from the plaintiff, Cashmans practised in class action litigation or quasi class action type proceedings. This plaintiff was one of many who engaged the services of Cashmans in an effort to recover damages for harm allegedly caused by the injection of Depo-Medrol. When ultimately Cashmans filed the plaintiff's statement of claim in this court in July 1993, it was only one of over 100 statements of claim seeking damages against the defendants and others responsible for administering Depo-Medrol. 76 Dr Cashman made affidavits in these proceedings and he also gave oral evidence. From the evidence of this witness I make findings on the steps taken to obtain legal aid which I will now record. 77 As at the time when instructions were received from the plaintiff, Dr Cashman had not formed a view that those who had been injected with Depo-Medrol had cases warranting the commencement of proceedings. Accordingly Dr Cashman sought legal aid for advice on potential claims. Dr Cashman was then looking for expert opinion and for counsel's opinion. He perceived the need for such opinions before deciding to pursue any litigation. Aid was sought from the Commonwealth Attorney General's Department, from legal aid authorities in the various States and from the Federal Minister for the Aged and Family and Health Services. Dr Cashman made tentative arrangements to retain the services of Mr Daryl Williams, then Senior Counsel in Western Australia and Mr Peter Dowding, then a barrister practising in this State. Legal aid funds were never forthcoming and Dr Cashman explained that because of this and the impecunious circumstances of the various potential plaintiffs the services of those counsel were not obtained. 78 In November 1990 Dr Cashman actually attended a meeting with the West Australian Legal Aid Commission and in March 1991 there was a meeting of interstate directors of legal aid at which an "in principle" decision was made to establish a central committee to manage common interest claims such as those submitted on behalf of the Depo-Medrol claimants. At one time it was anticipated that there would be a centrally administered fund in place by 1 July 1991 but this did not occur. Various steps were taken by Dr Cashman in an effort to obtain funding in 1991, in 1992 and in 1993. These steps are recorded in the affidavit sworn by Dr Cashman on 10 October 2000. Dr Cashman's evidence in this regard is not in issue and I do not propose to set out the detail of it. 79 I accept, however, that the lack of legal aid was a factor that inhibited the investigation of the potential liability of the first and the second defendant and eventually when the statements of claim were filed this was done without any grants of legal aid. 80 On 27 March 1991 Dr Cashman submitted a memorandum to the office of legal aid administration and to State and Territory directors of legal aid supported by a submission, the purpose of which was to encourage a grant of funding in favour of the Depo-Medrol victims for whom the solicitor was then acting. It emerges from a consideration of the submission made that Dr Cashman was by that time aware of these matters:

(i) the identity of the manufacturer of Depo-Medrol and the identity of the distributor in Australia;

(iii) that one of those component parts was polyethylene glycol (PEG) and that this was toxic;

(iv) that Depo-Medrol had not been approved in Australia for epidural use and that an application for such use had been rejected here in 1982 by the Australian Drug Evaluation Committee;

(v) that it was Dr Cashman's belief that no adequate warning of hazards of the product had been provided to doctors or by the package insert;

(vi) although a warning against intrathecal use was included in the prescribing information then currently disseminated, it had been left off the package insert for years and was not incorporated into the entry in the Australian edition of MIMS until 1987;

(vii) that Depo-Medrol had never been evaluated by Australian health authorities, having been introduced onto the Australian market in 1959 before drug evaluation procedures were introduced;

(viii) that experimental and clinical trial data were inadequate;

(ix) that there was a considerable amount of evidence that PEG caused arachnoiditis;

(x) Dr Cashman believed that the defendants could be liable on a number of grounds, having regard to the toxic component, the failure of the manufacturer and distributor to provide adequate warnings to doctors or patients and the failure to carry out adequate experimental or clinical trial research. In assessing the potential liability, Dr Cashman was at that time focussing on breaches of the Trade Practices Act ;

(xi) Dr Cashman was alert to the limitation problems and that it may be appropriate to begin protective proceedings in some instances;

(xii) Dr Cashman considered that a test case should be brought in the Federal Court. 81 So much for the state of knowledge reflected in the submission 27 March 1991. 82 Dr Cashman gave evidence that his primary concern with the Depo-Medrol cases was to identify the scientific and the medical basis linking the use of the Depo-Medrol to the injuries caused to his clients. However, one year passed before Dr Rout was engaged on 6 April 1992. His engagement by the plaintiff's solicitors as a consultant followed a decision made by those solicitors that, despite lack of funding, the solicitors would increase the application of its own resources to deal with the Depo-Medrol claims, Dr Rout was engaged to review the medical and scientific issues with a view to advising on the generic issues. When Dr Rout was engaged, it was Dr Cashman's belief, according to his evidence in point, which evidence I accept, that there was possibly a case to be made against the first and the second defendants but Dr Cashman said: "I was not prepared to advise clients to embark upon litigation just on the possibility of proving cases. I was concerned to ensure that the case could be proven at trial." 83 I find that as at 6 April 1992 Dr Cashman did not regard it as appropriate to advise clients to start proceedings. Absent evidence to establish otherwise, I accept that Dr Cashman's attitude at that time before the receipt of Dr Rout's advice was reasonable and responsible, although the only reason for not engaging Dr Rout's services twelve months earlier would appear to have been a reluctance by the plaintiff's solicitors to commit their own resources. 84 Before Dr Rout was engaged, Dr Cashman said that he had conferred with persons who he understood to have some knowledge of the problems arising out the use of Depo-Medrol. Such persons included Dr Yeo, who had done a Master of Surgery thesis on the use of intrathecal Depo-Medrol on sheep. Dr Cashman had considered documents involving cases in the United States and he conferred also with American attorneys who had been involved in litigation against the first defendant arising out of the use of Depo-Medrol in the United States. 85 By early June 1992 Dr Rout completed his evaluation of the medical and scientific issues arising out the epidural administration of Depo-Medrol and was of the opinion that in a number of cases there were reasonable prospects of succeeding in legal proceedings against the first and the second defendants. Reporting on Dr Rout's conclusions Dr Cashman wrote to the Federal Office of Legal Aid on 30 June 1992: "In the light of the detailed research and report of Dr Rout it is apparent that: 1. Depo-Medrol is defective in that it contains an ingredient which is neurotoxic; 2. this fact was known to Upjohn some considerable time ago based on experimental research on laboratory animals; 3. the drug should clearly not have been used epidurally; 4. the Australian warnings were manifestly inadequate." 86 The evidence does not suggest that Dr Rout specifically considered the case of this plaintiff and it is to be recognised that whilst there were common to the claims of all Cashmans' clients what might be described as generic issues on causation and liability, there was a need to consider specific issues of causation and liability in each of the various cases. 87 So far as this plaintiff was concerned, it is plain that the plaintiff relied upon what her solicitors did in relation to generic issues but the plaintiff had a limited role in obtaining evidence referable specifically to her claim. It would seem that almost immediately after Dr Rout's advice was forthcoming the plaintiff was notified that her solicitors were experiencing difficulty in obtaining her medical records and the plaintiff went to Goulburn Hospital within one week of being so advised and obtained medical records which were forwarded to Cashmans. This was done in July 1992. The plaintiff was earlier called upon in June 1992 to complete a retainer and fee agreement and this was attended to by her promptly on 23 June 1992. At that time she completed a document submitted by her solicitors indicating her willingness to enter into a litigation loan arrangement. I do not find that any delay in the prosecution of the plaintiff's claim was attributable to failure on her part to attend to any request for evidence or information made by her solicitors. I shall return to consider as a discrete matter what was done to address the specific questions of causation and liability in relation to her claim, but I propose firstly to complete a review of what was done concerning what I have termed the generic issues. 88 In the period between 1990 and 1995 in particular, Dr Cashman had the overall responsibility for what I continue to describe as the Depo-Medrol litigation, that is to say those claims in which statements of claim were eventually filed. 89 Dr Cashman deposed in his affidavit of 10 October 2000 that in June 1992 he formed the view, no doubt influenced by Dr Rout's advice, that protective proceedings should be commenced "without further delay" on behalf of those clients who appeared to have "meritorious cases". This no doubt prompted the request to the plaintiff for assistance in obtaining her relevant medical records and the request for her completion of the retainer agreement. 90 Dr Cashman further deposed that instructions were subsequently received, on a date he has been unable to ascertain, for the filing on the plaintiff's behalf of the statement of claim that was filed in July 1993 "in order to protect her interests pending further investigations and research being carried out by Cashman and Partners for the purpose of determining the strength of the case on liability." 91 Dr Cashman visited the United States in 1993 to consider the pursuit of litigation in that country, but that was after the issue of the statements of claim here. Consideration was also given in 1993 to litigation against another defendant arising out of the injection of Myodil, but the plaintiff was never injected with Myodil, and in any event the distraction of such alternative litigation being contemplated in her case assumed no significance in considering the question of delay. 92 During 1993, on a date which Dr Cashman cannot now recall, he made the decision that it would be preferable not to serve the statements of claim filed for the Depo-Medrol claimants, including the plaintiff, until the test case chosen by him to be heard in the Federal Court was determined. That test case was brought by Jodi-Anne Brooks and the statement of claim in that case was filed on 24 June 1993. Eventually the hearing in that matter began on 8 March 1999 but the case was settled during the course of the trial on 19 April 1999. 93 The statement of claim in the present case was not served until 4 July 1995, and I would infer that it was only then served because a period of almost two years had elapsed from the date of filing. 94 The progress of the Depo-Medrol cases in this court was delayed by reason of applications by various defendants in many of the cases to have the causes transferred for hearing in other States and Territories of Australia. This prompted interlocutory hearings and appeals to the New South Wales Court of Appeal and the history in this regard is set out in paras 8-10 of the affidavit of Anthony O'Reilly sworn 30 September 2000. The Brooks case was, of course, proceeding between June 1993 and April 1999. It was acknowledged by the parties, including the first and second defendants "that the Brooks proceedings would function effectively as a test case" (see Mr O'Reilly's affidavit of 30 September 2000, para 21). Initially the first defendant disputed the jurisdiction of this court and filed a notice of motion to have service of the statement of claim set aside. It was not until after the Brooks claim was resolved that the first defendant filed an appearance on 21 July 1999. 95 Whilst Dr Cashman gave evidence to the effect that all the evidence necessary to prosecute the plaintiff's claim was not then available, I understand his oral evidence to be that he considered the commencement of proceedings in her cause, and indeed in the causes of the other Depo-Medrol claimants, to be warranted by the time the statements of claim were filed in July 1993. The preparation of the statements of claim would have been time-consuming, but it is not clear why, considering the generic issues, a period in excess of twelve months elapsed between Dr Rout's advice and the issue of the statements of claim. 96 Dr Cashman identified one problem referable to issues of specific causation in a number of cases was the unwillingness of doctors to make records available. Dr Cashman explained that access to records was "being routinely refused because of advice given by the medical defence organisations to doctors not to release their records unless an indemnity was given to them by my clients" (T 381) 97 Returning to the considerations specific to the preparation of the case of this plaintiff:

(i) As previously recorded, the plaintiff acted promptly following requests made to see that the records of the Goulburn Hospital were made available to her solicitors. This was done by July 1992. There is no evidence that efforts to obtain records in her case were frustrated by advice given by a doctor's insurer, such as to cause significant delay.

(ii) On 28 July 1992 Ms Evans, a solicitor with Cashmans, wrote to the plaintiff, advising her that specialist doctors would be assessing "a select number of clients" and that "all necessary clients would be informed of the times and the costs of assessment" in "the next weeks" . (The clients selected were presumably the thirteen clients named in Exhibit 58 to Dr Cashman's affidavit sworn 10 October 2000. The plaintiff was not one of them.) The plaintiff was also advised "We are keenly pursuing a possible representative action in the Federal Court."

(iii) On the following day Ms Evans wrote to Dr Robson requesting his report. Dr Robson replied quickly seeking payment in advance for his report and payment was proffered on 13 August 1992. The doctor's reports followed promptly on 20 August 1992.

(iv) Whilst Dr Robson reported that he saw the plaintiff on referral from Dr Berick, and this doctor's involvement in her case had been advised in the questionnaire the plaintiff earlier completed for her solicitors, it was not until 21 January 1993 that Ms Evans wrote to him seeking his medical records. Dr Berick had previously written to the Goulburn Base Hospital on 6 March 1991; Dr Berick's communication and that hospital's report addressed to him, dated 13 March 1992, which became Exhibit 4, were presumably available by July 1992 had they been requested then.

(v) On 11 August 1992 Ms Evans wrote to Dr Roebuck and followed this with a second letter on 2 September 1992. (It would seem that the first letter was written to the wrong address.) Records relating to the plaintiff's treatment were requested of Dr Roebuck. It was not until 29 January 1993 that Dr Roebuck responded that exhaustive searches had failed to produce any record of the plaintiff.

(vi) It does not appear that any correspondence was addressed to Dr Williams, who of course was ultimately joined as a defendant in the proceedings.

(vii) There is a file note in Cashmans' papers dated 1 April 1993 that records that "Dr Lyttle called last month to say he had retired and no longer kept records from between 1977 and 1981" (when first giving instructions the plaintiff had identified Dr Lyttle as a treating doctor).

(viii) The only other document in the solicitor's file as exhibited to the affidavit of Dr Cashman which warrants mention in the present context is a copy of a letter written to the plaintiff on 7 December 1992 advising her of the intention to issue a statement of claim "on behalf of all claimants with reasonable claims" . 98 Ms Evans gave no evidence on this application and no evidence was introduced from any other solicitor who may have been involved in the preparation of the plaintiff's case prior to the filing of the statement of claim. It does not emerge from a consideration of the evidence that the issues specific to the plaintiff's claim necessitated delay in the filing of her statement of claim until July 1993. 99 Dr Cashman acknowledged in his evidence, and this was clearly the case, that since his firm was acting for the plaintiff this attracted an individual duty of care. Mr McCulloch submitted it was not to the point that generic issues common to all cases, or specific issues peculiar to the various individual cases, may have occasioned delay. He submitted that if Cashmans did not have the resources to commit to the preparation of these cases and this factor caused delay, the plaintiff could not advance this to excuse delay. If the plaintiff's solicitor has been dilatory, Mr McCulloch submitted, the plaintiff must accept responsibility for this: see Salido v The Nominal Defendant (1993) 32 NSWLR 524 at 532 and Kinsett v McCourt (1999) 46 NSWLR 32 at para 39. I consider it to be correct in principle that as between the plaintiff and the present defendants, the plaintiff cannot excuse delay by attributing it to her own solicitors, but some allowance has to be made for the circumstance that the plaintiff's case was one of over 100 cases to be prepared, in which it was convenient, within reason, that they be grouped together in terms of their preparation. 100 This brings me to the period of almost two years between the date of filing of the plaintiff's statement of claim and those of the other Depo-Medrol claimants and the date of service. 101 There was a deliberate tactical decision taken by Dr Cashman not to serve the pleadings and to focus on the "test" case selected for trial in the Federal Court. In consequence there was in practical terms a further two year delay from July 1993 in the prosecution of the plaintiff's claim. Dr Cashman wrote on 30 April 1993 to the Office of Legal Aid and Family Services with the Commonwealth Attorney General's Department and in his letter said: "We do not at this stage propose to serve the New South Wales Supreme Court proceedings or actively prosecute such claims pending the outcome of proposed test cases in the Federal Court." 102 Had this decision been taken in consultation with the defendants' solicitors, any resultant delay in connection with the subject claim would have assumed no relevance provided the defendants were on notice of the particulars of the pending claims. However the defendants and their solicitors were unaware that this body of Depo-Medrol claims, including of course the plaintiff's claim, were on foot. 103 Eleven months before statements of claim were filed, Dr Cashman wrote to the Medical Director, Upjohn Pty Limited on 27 August 1992 seeking information as to the then composition of Depo-Medrol. He alerted the Medical Director in that letter to the fact that Cashmans were acting for a number of people who appeared to have experienced problems from the epidural administration of Depo-Medrol. This prompted Upjohn to alert its insurer. Then on 21 October 1992 Dr Cashman wrote another letter to the Managing Director of Upjohn Pty Limited, this time to invite a meeting with representatives of Upjohn for the purposes of discussion of claims of the firm's clients arising out of the administration of Depo-Medrol. Dr Cashman wrote: "In a number of cases we have advised clients against pursuing a claim and have only recommended that legal claims be pursued in appropriate cases after a painstaking and thorough review of the available medical and scientific information and after obtaining advice from counsel and independent experts." 104 Later, on 18 November 1992, the solicitors for Upjohn Pty Limited wrote to Cashmans: "We can see little point in meeting with you cold about the matter. We would therefore request from you particulars of the claim against Upjohn, including the name and age of the claimants, the treatment received by the claimants and an outline of the allegation of liability that your clients make against Upjohn." 105 Switzerland Insurance, as a liability insurer of Upjohn on risk from 30 September 1988, also wrote to Cashmans in November 1992 seeking details of the pending claims. 106 The requests for particulars were ignored by the plaintiff's solicitors and I have no doubt this was done deliberately. 107 On 21 June 1995 Cashmans wrote to Mr O'Reilly from Minter Ellison advising that proceedings had been commenced inter alia by seven named plaintiffs. Then on 3 July 1995 a further communication alerted Mr O'Reilly to a further 115 claims and inquired as to whether Minter Ellison had instructions to accept service. 108 In the course of his evidence in this Court Dr Cashman acknowledged that it would have been possible for him to have alerted the defendants to the fact that statements of claim had been filed but at the same time to have requested that no costs be incurred until service so as in this way to avoid any prejudice associated with further delay in prosecution. However, the reason for the decision which Dr Cashman took was stated thus (T 437): "…that step could have been taken. It wasn't, because in my experience, where other proceedings have been in existence, defendants have often, in my experience, sought to activate, if you like, those proceedings by way of requests for particulars, strike out applications, subpoenas and a multitude of other interlocutory steps which I have been unsuccessful, in my attempts, to resist in other litigation." 109 I accept the above response by way of explanation for what was done, but the decision carried with it the risk that the delay deliberately caused might occasion specific prejudice to the defendants. 110 It was not until 6 March 2000 that the notice of motion seeking an extension of time was actually served even though that motion was filed on 31 August 1993. That service was effected on 6 March 2000 is evidenced by Exhibit 7. When this matter was the subject of directions in this Court on 13 December 1999, the plaintiff was directed to file and serve any affidavit supporting the notice of motion on or before 1 March 2000. An affidavit was filed by the plaintiff on 3 March 2000 and a subsequent affidavit was filed on 3 October 2000. Nothing turns for present purposes on the non compliance with the direction as to time of filing and service but the earlier of the two affidavits of the plaintiff first advanced the outline of her evidence by way of support for the extension of time application. 111 The delay in pursuing the defendants prior to the end of 1990 has been satisfactorily explained by the plaintiff's lack of requisite knowledge. There can be no question but that when the plaintiff consulted her solicitors they were called upon to investigate a claim which had much complexity in terms of generic and specific causation issues and in terms of liability in general. Some delay was inevitable but I am not persuaded that all the delay up to the time of the issue of the statement of claim has been satisfactorily explained. There was the delay in engaging Dr Rout, and then there was further delay after the receipt of his advice and before the filing of the statement of claim. The potential consequences of the tactical decision taken thereafter at the time of filing the statement of claim I have adverted to earlier. Then there was the further delay before the plaintiff sought to have the application for an extension of time heard by the court. 112 It is necessary to address the consequences of the unnecessary delay, and indeed of all the delay that has occurred since the potential causes of action accrued.

Consideration of the defendants' conduct 113 However before considering whether prejudice has been occasioned by the delay identified, I propose to deal with the submission by Mr Connor that I should have regard to the conduct of the defendants in allowing Depo-Medrol to be used for intrathecal injection without having tested for its safety, without due warning in its packaging as to potential hazards associated with intrathecal injection, and notwithstanding reports of adverse consequences from injection into the cerebrospinal fluid. It is submitted that the defendants by their conduct contributed to the delay in the sense that because the first and second defendants did not warn of the risks of intrathecal injection, they contributed to the plaintiff's lack of awareness until such time as she was alerted by the television programme in November 1990. Hence it is submitted an assessment of the defendant's conduct is a relevant consideration in determining whether it is "just and reasonable" to extend the limitation period. It was submitted that the wrongful conduct of the first and second defendants accounted for the delay before 1990 and Mr Connor referred to the judgment of Deane J in Hawkins v Clayton (1988) 164 CLR 539 in particular at p 590 as affording support in principle for his submission. 114 In developing the submission, Mr Connor invited consideration of a number of documents referable to the period prior to the plaintiff's injections which he submitted led to the conclusion that the first defendant made a deliberate decision not to conduct toxicology studies because of the belief that the Food and Drug Administration (FDA) would consider Depo-Medrol unsafe for intrathecal use. Mr Connor invited attention to the following documents:

(i) letter from the FDA to the first defendant dated 24 October 1968;

(ii) internal memorandum of the first defendant dated 31 October 1968;

(iii) internal memorandum of the first defendant dated 10 February 1969 recording the following conclusion: "Even though the expected profit resulting from the decision to proceed with toxicology studies is positive, the odds against financial success are substantial. The most important factor in this analysis is the probability that the FDA will consider Depo-Medrol unsafe for intrathecal injections. Only if this probability was substantially reduced would the risk of financial failure to appreciably reduced."

(iv) there is a memorandum, again of the first defendant, dated 11 February 1969 recommending that no further clinical work be done with intrathecal Depo-Medrol;

(v) an internal memorandum of the first defendant written by Dr Kadrnka to Division Managers dated 13 May 1969 inviting intrathecal administration of Depo-Medrol;

(vi) the next document is again an internal memorandum apparently from Dr Smith dated 28 July 1969 informing of the reversal of a decision to cease promoting Depo-Medrol for intrathecal use and informing the addressees that intrathecal administration of Depo-Medrol may be promoted for multiple sclerosis, sciatica and chemical arachnoiditis;

(vii) the product insert dated October 1973 for Depo-Medrol contained no warning against any hazard of intrathecal use and indeed Mr Connor submitted that absent appropriate studies and tests the intrathecal injection of Depo-Medrol should have been contraindicated;

(viii) Mr Connor next referred to a Depo-Medrol booklet which referred to publications up to 1973 suggesting its publication after that time and inviting the reader to be aware that Depo-Medrol was available as a pharmaceutical benefit, specified purpose inter alia for intrathecal administration;

(ix) in a letter in the Medical Journal of Australia on 25 October 1975 the second defendant's medical director wrote a letter that could have been regarded as promoting to the medical community the use of Depo-Medrol intrathecally to reverse the cause of chemical meningitis;

(x) on 28 April 1976 the second defendant's managing director, Mr Kirsop, wrote to the secretary of the Pharmaceutical Benefits Advisory Committee concerning Depo-Medrol and the letter contained the assertion "Depo-Medrol is the only commercially available injectable steroid approved as a pharmaceutical benefit for intrathecal administration."

The letter broadly could be regarded as a promotional letter for the product;

(xi) the packaging insert for January 1976 contained no warning and no contraindication concerning intrathecal injection of Depo-Medrol;

(xii) there is a letter of 2 September 1976 from Dr Irvine to the Australian Drug Evaluation Committee responding to a letter from that organisation concerning reports of adverse reactions to Depo-Medrol;

(xiii) on 8 November 1976 the Australian Drug Evaluation Committee wrote again for information concerning those ads and its reports;

(xiv) Dr Irvine responded on 30 November 1976 that the parent company had very little information on adverse reactions to Depo-Medrol;

(xv) there is a letter from the Department of Health dated 16 August 1977 informing the second defendant that it was considered that the product was unsuitable for intrathecal use and a warning against such use should appear in product literature;

(xvi) there is an internal memorandum from Mr Kirsop, the general manager, to Dr Irvine referring to the communication of the Department of Health in which Mr Kirsop wrote: "My feeling is that if we can defend the intrathecal use of Depo-Medrol we should and if not, we have no option but to comply with the latest request."

(xvii) there is then a Prescription Products Guide covering the period 1977 to 1979 which, in relation to Depo-Medrol, states: "Intrathecal: for administration by lumber puncture after withdrawing a comparable amount of fluid. Multiple sclerosis, 40 to 80 mg. Repeat every two to four weeks as necessary. Sciatica, 40 to 80 mg. Repeat in one to two weeks if necessary."

The guide goes on to express contraindications in specifically defined circumstances.

(xviii) on 6 February 1978 the Department of Health wrote to the second defendant again seeking comments in relation to the concern earlier expressed about the intrathecal use of Depo-Medrol;

(xix) on 13 March 1978 Dr Irvine wrote back advising that he had contacted the parent company which was unable to supply any detailed information "as injections of Depo-Medrol intrathecally is not an approved indication in the United States" and advising that the package insert for that product states under "Adverse Reactions" : "Arachnoiditis has been reported following intrathecal administration";

(xx) on 28 March 1978 the Department of Health wrote again to the second defendant reminding it of an earlier suggestion that a warning be included in all product literature against the use of Depo-Medrol intrathecally;

(xxi) on 5 April 1978 Dr Irvine, in an internal memorandum, recommended a warning in product literature under "Adverse Reactions" to be expressed in these terms: "Arachnoiditis has been reported following intrathecal administration" ;

(xxii) on 11 April 1978 Dr Irvine wrote to the Department of Health advising that the pages in the booklet on Depo-Medrol referring to intrathecal administration would be deleted and that a caution would be included concerning Depo-Medrol: "Arachnoiditis has been reported following intrathecal administration." Mr Connor was unable to indicate whether the booklet on Depo-Medrol was published in an amended form prior to the plaintiff being injected in July 1979. However the PP Guide issued for the three years 1977 to 1979 earlier referred to remained current during the year of the plaintiff's first injection;

(xxiii) the product insert for Depo-Medrol printed in September 1979 stated under "Adverse Reactions" : "Arachnoiditis has been reported following intrathecal administration." There was still no warning in that insert that intrathecal administration was contraindicated;

(xxiv) on 21 July 1981 there was written an internal memorandum from the first defendant to Dr Jacobs in Australia stating the first defendant's policy to be that the intrathecal use of Depo-Medrol was contraindicated;

(xxv) this was followed by a memorandum dated 18 August 1981 from Mr Williams of the second defendant to pharmaceutical and hospital personnel and to sales people that contained the instruction that no further reference may be made by Upjohn sales staff to the use of Depo-Medrol by intrathecal injection. The author went on to say: "Clearly we cannot directly dissuade practitioners from the use of these techniques if they have accumulated personal experience which is satisfactory to them. However, nothing further will be done to promote or sustain the use of these techniques by the sales staff."

(xxvi) in the Medical Journal of Australia on 19 September 1981 Dr Jacobs wrote that Depo-Medrol was not recommended for intrathecal administration and it is to be observed from other material to which Mr Connor drew attention that this sparked some concern from medical practitioners who regarded intrathecal injection of the product as being appropriate (see the MJA for 9 January 1982);

(xxvii) on 13 November 1981 there is a memorandum from the first defendant addressed to Dr Jacobs in Australia drawing attention to data available to the American company as at 11 February 1981 which concerned adverse reactions to patients following the intrathecal administration of Depo-Medrol;

(xxviii) in reply, on 1 December 1981, Dr Jacobs wrote to Mr Theoret a letter that contained the following statement: "I think we all agree that intrathecal can no longer be supported and the evidence is overwhelming."

(xxix) the MIMS guide for 1990 did contain a warning that Depo-Medrol was not recommended for intrathecal administration and it did alert the reader to the fact that arachnoiditis had been reported following intrathecal administration;

(xxx) the MIMS publication for 1991 went further and expressed intrathecal administration as being contraindicated. 115 I have not dealt exhaustively with all the documents to which Mr Connor took me in support of the submission I am at present considering. However, Mr Connor submitted that the statement from Dr Jacobs in the memorandum of 1 December 1981 recognised a state of affairs which should then have led to positive action by both defendants, particularly the second defendant, to make it known that intrathecal injection of Depo-Medrol was contraindicated. Mr Connor submitted that the documentary material to which he referred in submissions established that the defendants had failed to do so and that the defendants did nothing which might have led to the plaintiff becoming aware of the harm caused to her by the Depo-Medrol before the end of 1990. Even in a letter written by Dr Jacobs which was published in the Medical Journal of Australia on 7 July 1984, Mr Connor submitted that no unequivocal stand against intrathecal injection was expressed. What Dr Jacobs wrote was: "Regarding intrathecal injections of Depo-Medrol, no application was made [referring to an application for approval to the Department of Health] nor is that route of administration recommended." 116 Mr McCulloch submitted that the assessment of what he referred to as the "selective" documentary material to which Mr Connor took me was irrelevant for the purposes of this application. However I consider it does have some relevance. 117 Having regard to the negligence pleaded, and to the times at which the plaintiff was injected, the documents identified in para 114 (iii) to (xxiii) above are relevant to the issue as to whether the plaintiff has a viable cause of action, and the material assists the plaintiff as to this. 118 It may be that it is also relevant to have regard to the defendants' conduct to the extent that it may have contributed to the plaintiff's lack of awareness of any link between the injections administered to her and the acts or omissions of the defendants upon which the plaintiff seeks to base her claim. However it is unnecessary for me to determine whether this is so because without resort to any consideration of the defendants' conduct, I have made the findings earlier expressed in para 36 of this judgment.

Prejudice 119 Mr Connor's submission that prejudice to the defendants is not a relevant consideration must be rejected. It is well settled that prejudice assumes relevance: see Brisbane South Regional Health Authority v Taylor (supra); Jones v Royal Hospital for Women (supra); and BHP Steel (AIS) Pty Limited v Lakovski [2000] NSWCA 334. 120 In Taylor (which concerned the Limitation of Actions Act 1974, Queensland) Toohey and Gummow JJ said at 548, addressing the exercise of the court's discretion to extend time: "A material consideration (the most important consideration in many cases) is whether, by reason of the time that has elapsed a fair trial is possible. Whether prejudice to the prospective defendant is likely to thwart a fair trial is to be answered by reference to the situation at the time of the application. It is no sufficient answer to a claim of prejudice to say that, in any event, the defendant might have suffered some prejudice if the applicant had not begun proceedings until just before the limitation period had expired." 121 In the same case McHugh J said at 555: "Legislatures enact limitation periods because they make a judgment, inter alia, that the chance of an unfair trial occurring after the limitation period has expired is sufficiently great to require the termination of the plaintiff's right of action at the end of that period. When a defendant is able to prove that he or she will not now be able to fairly defend him or herself or that there is a significant chance that this is so, the case is no longer one of presumptive prejudice. The defendant has then proved what the legislature merely presumed would be the case. Even on the hypothesis of presumptive prejudice, the legislature perceives that society is best served by barring the plaintiff's action. When actual prejudice of a significant kind is shown, it is hard to conclude that the legislature intended that the extension provision should trump the limitation period. The general rule that actions must be commenced within the limitation period should therefore prevail once the defendant has proved the fact or the real possibility of significant prejudice. In such a situation, actual injustice to one party must occur. It seems more in accord with the legislative policy underlying limitation periods that the plaintiff's lost right should not be revived than that the defendant should have a spent liability reimposed upon it. This is so irrespective of whether the limitation period extinguishes or merely bars the cause of action." 122 In Jones the considerations referred to in the above dicta in Taylor were regarded as applicable in a case involving s 60G of the Limitation Act (see the dicta of Mason P referred to earlier). 123 In Lakovski, which also concerned s 60G, Meagher JA, with whose judgment the other members of the court agreed, observed that the differing expressions in Taylor did not pose different tests. His Honour referred to a decision of the Court of Appeal in Holt v Wynter, which case concerned s 52(4) of the Motor Accidents Act, saying (at para 9): "But the main bone of contention before his Honour on s.60G was whether the principles laid down in Brisbane South Regional Health Authority v Taylor (1996) 186 CLR 541 precluded the applicant's victory. At the time of the trial the decision of the High Court in that case was considered to pose a conundrum - whether, in a case of long delay like the present, the delay itself would give rise to a presumption of prejudice to a defendant, which, if, "significant", should be sufficient to refuse the applicant (a view said to be espoused by McHugh J);or whether the application should only be refused if the delay made "the chances of a fair trial unlikely" (a view said to be espoused by Toohey and Gummow JJ). Happily, the problem has evaporated, as this Court has since held that there were no distinctly differing tests laid down in Taylor's Case : see Holt v Wynter (2000) 49 NSWCA 128. Indeed, the logic of Taylor's Case would otherwise be difficult to follow: what factor could make a fair trial unlikely except prejudice engendered by delay? And how can prejudice become "significant" unless it renders a fair trial unlikely?" 124 In my opinion, it is of very real importance here, in addressing s 60G, to determine whether, by reason of the lapse of time since the plaintiff's causes of action accrued, the delay has engendered significant prejudice such as to make a fair trial unlikely. 125 Some prejudice to the defendants could be assumed, having regard to the very lengthy period which has elapsed since the causes of action accrued to the plaintiff. Inevitably the quality of human recollection is diminished by the effluxion of time, but the full extent of prejudice due to delay may not be appreciated. I refer to what McHugh J said in point in Taylor (supra) at 551: "Sometimes the deterioration in quality is palpable, as in the case where a crucial witness is dead or an important document has been destroyed. But sometimes, perhaps more often than we realise, the deterioration in quality is not recognisable even by the parties. Prejudice may exist without the parties or anybody else realising that it exists. As the United States Supreme Court pointed out in Barker v Wingo (1972) 407 US 514 at 532., 'what has been forgotten can rarely be shown'. So, it must often happen that important, perhaps decisive, evidence has disappeared without anybody now 'knowing' that it ever existed. Similarly, it must often happen that time will diminish the significance of a known fact or circumstance because its relationship to the cause of action is no longer as apparent as it was when the cause of action arose." 126 In this case the defendants are not content to rely on assumed prejudice. The defendants have adduced evidence directed to establishing actual prejudice. The evidence that requires consideration goes to the issue of causation of the plaintiff's arachnoiditis as well as the issue of disability resulting from such condition if proved to exist. In addition it is alleged that the defendants are prejudiced by the loss of witnesses who at one time or another were employed by one or other defendant, and by being no longer in a position to thoroughly investigate the issue of liability. 127 I have identified earlier in this judgment a number of doctors who the plaintiff consulted in the period between 18 July 1977 and the first injection of Depo-Medrol on 17 July 1979. I have also identified those doctors who treated the plaintiff subsequently. In his affidavit of 18 September 2000 Mr Villa, a solicitor with the daily conduct of this cause on behalf of the first and second defendants, outlined the steps which he has taken to obtain as full a picture as possible of the plaintiff's medical history, her treatment and her condition at times since July 1977. 128 The first difficulty confronted by the defendants was the lack of any records of the plaintiff's employment at Kenmore Hospital. No records are available to the defendants from this source. The plaintiff made a claim for workers' compensation benefits and eventually, in approximately 1980, the plaintiff accepted a lump sum settlement in redemption of her workers' compensation rights and that settlement would have required approval under the workers' compensation legislation. There may well be court records and a transcript concerning that redemption and it may be that the insurer is capable of being identified and that there is a file in existence which would have some relevance to this present claim. However, the evidence is silent about that. What is established is that the plaintiff's employer at the time of her accident in 1977 has no records of any type, relating to her injury or to her resulting claim. What is also apparent is that the back injury suffered by the plaintiff at Kenmore Hospital must have been serious, because apart from a period of nine days in November 1977 the plaintiff was unable to work again. 129 The plaintiff's local treating practitioner was Dr Lyttle. There is a note in the plaintiff's solicitors' file (part of the material identified in Dr Cashman's affidavit as exhibit 59 to it), which note is dated 1 April 1993. It reads: "Dr Lyttle called last month to say he had retired and no longer kept records from between 1977-1981." 130 There are in existence two referral letters from Dr Lyttle, one to Dr Hayman in April 1978 and one to Dr Williams in June 1979, but these referral letters are not informative of the history of Dr Lyttle's treatment. These letters do not disclose when Dr Lyttle first saw the plaintiff about her back condition, how often he did so, and what the plaintiff's complaints were on those consultations. There are some detailed notes behind the first of the referral notes from Dr Lyttle which form annexures to Mr Villa's affidavit of 18 September 2000, but the detailed notes appear to be those of Dr Hayman who first saw the plaintiff on 11 April 1978. So it would appear Dr Lyttle is unable to assist in this matter. 131 The defendants do have available some medical records subsequent to the employment injury. There are a number of reports from Dr Hayman who first saw the plaintiff in April 1978 and who referred her to Dr Roebuck in that year. Dr Hayman also referred the plaintiff to Dr Ness and there are reports from Dr Ness which detail the plaintiff's complaints to him and his assessment of her. Then there are the hospital records for the plaintiff's admission to the Goulburn Base Hospital in July 1979. The defendants have access to a number of reports written by Dr Williams after he administered the first of the intrathecal injections. 132 The next phase of treatment was when the plaintiff was admitted to Canberra Hospital under the care of Dr Roebuck. Unfortunately Dr Roebuck now has no records of his own concerning treatment of the plaintiff and he has no recollection of it, but there are extensive hospital records. They contain a note concerning the myelogram which the plaintiff had in February 1980. It is to be noted that the chemical injected was not oil based but rather it was a brand of metrizamide. The plaintiff also had a CT scan of the lumbar region. Reports of these procedures are available, and I commented on them earlier, but, significantly, the films themselves are not. 133 The final significant phase of treatment was that to which I referred earlier (para 24 above) when Dr Robson operated on the plaintiff. Dr Robson's reports and the relevant historical records are available for that surgery. 134 The plaintiff was involved in a car accident in October 1990, sustaining injury to her neck. The plaintiff also complained that her back ache was increased following that accident. The last of the missing x-rays were taken at this time. There is a report from Dr Silva, orthopaedic surgeon, dated 15 March 1991 (Exhibit 5). This report addresses the sequelae of the car accident which appear to centre upon injury to the plaintiff's neck. Having considered Dr Silva's report, it does not seem to me that this event in 1990 is of potential significance concerning the issue of arachnoiditis. 135 Before Dr Hayman saw the plaintiff, the plaintiff was seen by Dr Tony Hodgkinson but there is evidence that Dr Hodgkinson has no records about seeing the plaintiff and has no recollection of having done so. I observe here that I doubt that the defendants are disadvantaged by this. Dr Hayman reported to Dr Roebuck in June 1978 that Dr Hodgkinson had been of the opinion that all that the plaintiff had suffered was deep bruising which would improve in time. 136 The plaintiff was referred to Miss Coles, a physiotherapist. Miss Coles has no records of having treated the plaintiff, but I doubt that the defendants are significantly disadvantaged by this. 137 Dr Ryan swore an affidavit in these proceedings and he also gave oral evidence. He is Associate Professor of Surgery at the University of Sydney and specialises in orthopaedics and spinal surgery. I accept the evidence this witness gave. Dr Ryan's evidence is that the link between radiological arachnoiditis and clinical arachnoiditis is not well understood. A person may have radiological arachnoiditis without clinical symptoms. The condition of arachnoiditis may, in the doctor's opinion, be caused by a variety of causes, including infection, lumbar disc disease, significant back trauma, back surgery, the introduction of a needle into the intrathecal space and the injection of a contrast media into the intrathecal space, such as metrizamide, which the plaintiff was given in 1980. 138 In Dr Ryan's opinion, a radiologist who has not been asked to look for arachnoiditis may not identify changes that appear on the myelographic film in the report prepared. It is necessary to see the myelographic film, not just a report of the film, to determine whether a patient had radiological arachnoiditis when a particular myelogram was performed. Whilst a radiology report is available for the procedure that was performed at Canberra Hospital in 1980, the films of the radiculogram are not available. Dr Ryan emphasised the need to review notes of the treating doctors to determine when the plaintiff first reported symptoms consistent with clinical arachnoiditis and a history of back pain. Whilst the Canberra Hospital records are available, Dr Roebuck's are not and he has no recollection of the plaintiff. 139 Whilst the records available to the defendants include reports on x-rays, Mr Villa's affidavit discloses that films to which certain of the various reports relate are not available. The significance of the absence of the films is to be determined with Dr Ryan's evidence as to the importance of seeing the films themselves very much in mind. Films are no longer available in relation to the procedures carried out at Canberra Hospital in February 1980, the myelogram in February 1989 or x-rays of the lumbo-sacral spine in October 1990. Other films are available: there are x-rays available for 16 October 1987, 20 March 1990 and 14 February 1991. 140 The defendants also rely upon the report of Dr Cashman (Exhibit 3). Dr Cashman is a specialist radiologist whose evidence I accept. He commented that the development of arachnoiditis may have been due to the lumbar radiculogram that was conducted on 12 February 1980. He also commented upon the significance of the plaintiff's history. He identified a number of events that could have been the cause of arachnoiditis. There was the trauma at work in 1977, there were the intrathecal injections of Depo-Medrol, there was the procedure in Canberra in 1980, and, of course, there were the later surgical procedures. Dr Cashman opined that the disc pathology which led to the surgical procedures could itself have caused arachnoiditis. Dr Cashman wrote: "It is challenging for the clinician to determine whether the complex of symptoms and signs that remains with Ms Chown is due to arachnoiditis, to the degenerative disc disease from which she suffered, to the aftermath of the spinal fusion or to a combination of two or more of these factors. A possible complicating factor in such cases is the recurrence of disc protrusion." 141 Dr Cashman went on to conclude: "It is impossible to know what were the roles, if any, of the various events that happened to Ms Chown in the period between seven and twenty-three years ago, in terms of the causation and progress of radiological and possible clinical arachnoiditis." 142 A further matter of prejudice urged by Mr McCulloch in relation to the plaintiff's treatment is the inability now to identify the doctor who administered the second of the intrathecal injections of Depo-Medrol. It emerged in the plaintiff's evidence (T 27-28) that Dr Williams did not perform this procedure although it was done in his presence, but the records do not disclose who the doctor was. It is possible of course that he could be identified by Dr Williams, although the evidence is silent as to this. Mr McCulloch submitted that because the defendants do not know who that doctor was, they are unable to determine why he undertook to administer the Depo-Medrol intrathecally. They are unable to determine whether the decision was based upon his clinical experience or whether it was based upon what he had read about Depo-Medrol and whether he was influenced in any way by the product insert, the inadequacies of which the plaintiff relies upon as a particular of negligence. 143 Any history that the plaintiff can now give to any doctor qualified, and any evidence the plaintiff may be able to give in the future, no matter how honestly given, has to be related to events so long ago. It must suffer in terms of reliability. As Dr Ryan emphasised, and as I readily accept, the reliability of the plaintiff's history is of real importance for any opinion based upon it. 144 Dr Cashman's conclusion recorded in para 141 above highlights the difficulty confronting the plaintiff on the issue of causation. However, it also emphasises the difficulty the defendants would now have, so long after the injections were administered, in meeting the contention that the injections caused arachnoiditis, particularly having regard to the plaintiff's history. I consider that the defendants must inevitably be prejudiced in addressing that issue of causation and their potential liability to the plaintiff by the shortcomings in the evidence now available and by what has been lost to them in the passage of time. 145 Mr O'Reilly, in his affidavit sworn 30 September 2000, has addressed other aspects of prejudice advanced. Because of his experience in the Brooks litigation, I accept that Mr O'Reilly has a practical knowledge of the difficulties in preparing to meet issues common to Brooks and the current cause. Mr O'Reilly has identified a number of other reasons why it is claimed that the defendants are prejudiced by the effluxion of time:

(iv) inability to address alleged inadequacies of warnings in MIMS and in the PP Guide;

(v) inability to establish the circumstances in which the intrathecal administration of Depo-Medrol got PBS listing in the 1970s.

(i) The death of witnesses 146 The following potential witnesses were proved to be deceased:

(iv) Dr Irvine 147 (i) Dr Gardner was one of two doctors who carried out research on the intrathecal administration of Depo-Medrol on behalf of the first defendant. The work was done at the Cleveland Clinic in the 1960s and included:

(b) conducting autopsies on patients who had received Depo-Medrol intrathecally;

(c) the conduct of animal research. 148 The evidence of the work done by these two doctors is clearly relevant on the issue of liability in this cause. Dr Gardner died in 1987. However Mr Hirsch, a partner with Maurice Blackburn Cashman, has deposed to having located Dr Sehgal, the second doctor engaged in the research with Dr Gardner. According to the affidavit of Mr Hirsch, Dr Sehgal recalls the research work and has expressed his willingness to come to Australia to give evidence if need be. Mr Hirsch was not cross examined on his affidavit and I accept for present purposes what has been attributed to Dr Sehgal. His availability would, prima facie, meet the prejudice that would otherwise have been occasioned to the defendants by the death of Dr Gardner. 149 (ii) Dr Harter died in July 1996. He spent twenty-two years with the Food and Drug Administration in the USA, and in that capacity was resistant to an insert revision in the packaging of Depo-Medrol in 1989 such as to state that Depo-Medrol was contraindicated for intrathecal administration. Correspondence in point comprises Annexures E to O to Mr O'Reilly's affidavit. Mr O'Reilly has stated that Dr Harter was perceived to have been an important witness concerning the intrathecal use of Depo-Medrol. This may be so. Certainly the defendants have lost the opportunity of determining precisely what evidence he would have given on the wide ranging allegations of negligence pleaded in this cause. 150 It has been submitted by Mr Connor that Dr Harter's evidence would have been irrelevant because the correspondence identified was from September 1988 until December 1989, well after the plaintiff's injections. Annexure Q to Mr O'Reilly's affidavit however reveals that Dr Harter started with the agency in 1973, reviewing applications for new drugs, and it is not to be assumed that any evidence he could have given would be irrelevant to this cause. The defendants have been deprived of the opportunity of determining what evidence could have been given by Dr Harter who evidently influenced package insert warnings. The plaintiff relies upon the alleged inadequacies of such warnings as evidence of the defendant's negligence and it seems to me that Dr Harter's death has deprived the defendants of a relevant source of investigation. 151 (iii) Dr Stubbs died in 1992. The significance of evidence he might have been able to give was addressed by Mr O'Reilly in his oral evidence (T 181): "Q. In what respects do you say that the fact that Dr Stubbs is not available to give evidence, having regard to the documents that are available, there is prejudice suffered by the defendants? A. Well, my understanding was that Dr Stubbs was either the clinical monitor for the Depo-Medrol or was the person within the medical unit for the US parent who had responsibility for Depo-Medrol. It is suggested in the litigation that the decision, or the act of the second defendants seeking to register the epidural administration of Depo-Medrol was medically inappropriate. He was the principal decision maker with the assistance of Dr Theoret, and I believe it was important that we were able to get, if we could, evidence from Dr Stubbs to explain his process of reasoning, to say what factors he took into account, to say what papers he considered, or the literature, and what he felt was the significance of certain adverse reactions if he thought they were the reasons why they weren't relevant to this particular use. There were a whole host of medical issues that were left in the dark without someone to explain all that." 152 I observe that Dr Stubbs features in the correspondence upon which Mr Connor addressed in his submissions considered in para 114 and following. I accept for the purposes of this application that the late Dr Stubbs had relevant decision making functions concerning Depo-Medrol and that the defendants are disadvantaged by the loss of this potential witness. 153 Nor can the defendants look to Dr Theoret to substitute for him. Whilst it would seem that Dr Theoret had relevant responsibilities with the first defendant and that he assisted Dr Stubbs, Dr Theoret left the first defendant's employment in 1983 and he cannot be located. 154 Dr Stubbs had added importance to the defendants because he had supervisory responsibilities over Dr Jacobs, the successor to Dr Irvine as medical director of the second defendant. Dr Jacobs' name appears frequently in the material upon which Mr Connor addressed the Court in his submissions considered at para 114 and following. Dr Jacobs is alive and living in Sydney but I accept that he is unwilling to assist the defendant. I refer to the evidence that Mr O'Reilly gave (T 187): "He's not available to us to give evidence. I tried to get Dr Jacobs to come and see us some years ago through contact being made by a representative of the company, and Dr Jacobs declined to participate because of an issue he had with the company. We then, during the Brooks litigation, again tried to get Dr Jacobs to talk to us and while he spoke with us on the phone, he was unwilling to co-operate as a witness." 155 Further, Mr Hirsch deposed to having assisted in the preparation of a statement from Dr Jacobs in October 1998. Whilst I did not allow into evidence what Mr Hirsch indicated were the contents of such statement, it would seem to be at least possible that Dr Jacobs, who was willing to be interviewed on behalf of the plaintiff, could give evidence for the plaintiff if the present application succeeds. Of course, Dr Jacobs' unwillingness to assist his former employer is not itself to be attributed to the delay in bringing this claim, but it is a factor which has a bearing on whether there is prejudice to the defendants because of delay. The prejudice the defendants suffered by reason of having lost Dr Stubbs and Dr Theoret is to be considered against this background. 156 Mr O'Reilly referred to evidence available to the plaintiff in the Brooks proceedings in statement form, and to the disadvantage in not having Dr Stubbs to call, should the like evidence be adduced in the plaintiff's case in the event of the success of the present application (T 226): "Yes there were two statements. One was a statement by a Dr Ashley who was put forward as an expert regulatory witness, and in his statement he made some criticisms of the conduct of the first defendant, in particular matters for which Dr Stubbs was responsible. And the second statement was a statement filed by Dr Jacobs who had been an employee of the second defendant but had fallen out of - was no longer on good terms with the company. Dr Jacobs was the local medical director and Dr Stubbs was his superior, and we were only getting one side of the picture if we only got Dr Jacobs' evidence." 157 (iv) Dr Irvine was the medical director of the second defendant in the period between 1970 and 1979. Dr Irvine died in 1995. He was the medical director then in the year in which the first of the intrathecal injections of Depo-Medrol was given to the plaintiff. I would accept that had Dr Irvine survived, he could have been expected to be able to give material evidence on the marketing of Depo-Medrol and on other aspects of the issue of liability and that the defendants are disadvantaged by his death. I would add that he appears to have been the author of or the addressee in respect of communications to which Mr Connor referred in the submissions at para 114 and following. 158 Mr Connor submitted that because there are other witnesses available to the defendants with involvement in the period 1970 to 1979, and he identified Messrs Goodwin, Kirsop, Todd and Williams, the defendants were not disadvantaged by the death of Dr Irvine. None of those men was of course a medical practitioner and it was Dr Irvine who participated in the correspondence abovementioned. It does not appear to me that the availability of the lay witnesses should be regarded as meeting the prejudice identified concerning Dr Irvine any more than it should be so regarded as to the prejudice in relation to Dr Stubbs and Dr Theoret. The involvement of Dr Irvine was such that it could safely be assumed he had knowledge relevant to the issues in this cause. It seems to me that the defendants must be considered to be disadvantaged in being deprived, at the very least, of the opportunity of being able to determine what evidence could have been adduced from Dr Irvine.

(ii) Loss of recollection of surviving witnesses 159 Mr Goodwin was the managing director of the second defendant from 1969 to 1976 and with Dr Irvine was one of four principle former employees of the second defendant who have been identified by Mr O'Reilly as persons who might have been expected to have knowledge as to the marketing of Depo-Medrol for intrathecal administration in the period from the 60s to the mid 70s. Although Mr Goodwin advised Mr O'Reilly by phone that he had no recollection of the second defendant promoting Depo-Medrol for intrathecal injection, Mr Hirsch has deposed to having also spoken to Mr Goodwin. According to Mr Hirsch, and again he has not been cross examined on this, Mr Goodwin said that he had a general recollection of the controversy that surrounded Depo-Medrol and as to efforts made to have the drug registered for epidural and extra-dural use. Mr Goodwin told Mr Hirsch that decisions concerning the promotion and marketing of Depo-Medrol came from the first defendant. 160 Mr Goodwin also said he was available to give evidence in court if required but he did say to Mr Hirsch that he could not guarantee his recollection of the detail of events would be "spot on" after all these years. Hence what Mr Goodwin told Mr Hirsch is a reminder, if such be required, of the disadvantage under which any witness would be giving evidence in this case in seeking to recall events so long ago, but Mr Goodwin is available, and, indeed, would have been available to the defendants on the present application. The defendants made no application to introduce evidence from Mr Goodwin and offered no explanation for not doing so. I infer his evidence would not have advanced the defendants' case on prejudice, although I accept, consistently with what he told Mr O'Reilly and Mr Hirsch, that his memory of events must suffer to some extent by the passage of time. 161 Dr Smith was the medical director of the second defendant from 1968 to 1970, that is immediately before Dr Irvine. He told Mr O'Reilly by telephone that he had no recollection of the second defendant ever promoting Depo-Medrol for intrathecal use but when one looks at Exhibit E there are documents in that exhibit which tend to indicate his recollection may be faulty as to this. However Dr Smith is available and the defendants will have the opportunity if this application is granted of conferring with him. The availability of Dr Smith does not counter the loss of Dr Irvine.

(iii) The inability to trace witnesses 162 Mr O'Reilly deposes to having inquired of former sales representatives of the second defendant in an attempt to determine the extent to which the second defendant promoted the intrathecal administration of Depo-Medrol. He said that he spoke to six or seven representatives but located none who recalled promotion of the intrathecal use of Depo-Medrol. 163 One of those to whom Mr O'Reilly spoke was Mr Todd, variously described as "the training manager" for the second defendant during the 1970s (affidavit of Mr O'Reilly, para 35), as holding a senior sales position in the 1970s (T 183) and as the "house librarian" who "was well aware of issues involving Depo-Medrol" (affidavit of Mr Hirsch, para 6). Mr Connor submitted that Mr Todd is "a significant source of information" who was not called to support the defendants' case. Mr Todd informed Mr O'Reilly he did not want to participate in this litigation, stating he was seventy-six years old. I am unable to determine one way or the other what assistance, if any, Mr Todd could be to the defendants, but inevitably the passage of time must have had an effect on any evidence he may be able to give. 164 It emerged though that Mr Williams, who held a responsible management position in sales in 1978, is available and, indeed, Mr O'Reilly in cross examination said that he had seen him twice in conference in the past four years for the purpose of the Brooks case. He was one of the people who Mr O'Reilly identified as having no recollection of the promotion in point. Mr O'Reilly said that he took Mr Williams "through all the material that we have gone through here that related to the period of time in which he had worked as either a sales representative or a sales manager and that's like I did with all the other sales representatives and that's in relation to his position, that he could not remember the intrathecal administration being promoted." (T 174) 165 Mr O'Reilly said this was so even when he showed Mr Williams the letter from the second defendant addressed to the Director of the Department of Health dated 11 April 1978 which comprises part of Exhibit E. 166 I accept what Mr O'Reilly has said in para 37 of his affidavit of 30 September 2000 to the effect that it is his perception that the second defendant is not in a position to lead evidence from any witness as to the circumstances in which the intrathecal administration of Depo-Medrol was marketed in Australia. 167 In considering the second defendant's disadvantage in tracing witnesses, the changes that have taken place in the defendant companies to which Mr O'Reilly referred in paras 24 to 26 of his affidavit are not to be overlooked. The Upjohn Company merged with a Swedish pharmaceutical company in 1995 and with that merger there were significant retrenchments worldwide and in Australia. More recently, there was a further merger with another company with retrenchment of a further thirty percent of employees.

(iv) Inability to address alleged inadequacies of warnings in MIMS and in the PP Guide 168 It is apparent from the evidence that MIMS is considered to be an authoritative publication concerning drugs for the benefit of doctors and other health care professionals. MIMS lists products and provides information as to the use to which particular drugs may be put, and it also lists contraindications, precautions, advised dosages, adverse reactions and other information. Mr O'Reilly has deposed to the circumstance that the second defendant has no records of communications with the publisher of MIMS and that he has been unable to locate any person or former employee of the second defendant who is able to provide him with information as how what was written about Depo-Medrol in MIMS in the period from 1978 to 1986 came to be published. It would appear that inadequacy as to the warnings in MIMS during that period against intrathecal administration of Depo-Medrol is relied upon in the plaintiff's case, and I accept that the second defendant is prejudiced in not being able to find out or seek to prove how the listings in question appeared. 169 Mr O'Reilly deposes to a similar difficulty in the listing for Depo-Medrol in the 1977, 1978 and 1979 edition of the PP Guide (another product guide concerning drugs), which did recommend intrathecal administration of Depo-Medrol. Once again the second defendant has no records of communications with the publisher of the guide as to the circumstances in which the relevant description in the guide appeared and once again Mr O'Reilly has been unable to locate any person or past employee of the second defendant who can assist on this issue. 170 I am satisfied that there is relevant prejudice on the issues associated with the listings in MIMS and the PP Guide.

(v) The inability to establish the circumstances in which the intrathecal administration of Depo-Medrol got PBS listing in the 1970s 171 Mr O'Reilly made inquiries of the Therapeutical Goods Administration (TGA) Division of the Federal Department of Health concerning the PBS listing for the intrathecal administration of Depo-Medrol during the 1970s (that is the Pharmaceutical Benefits Scheme listing). TGA records do not contain any correspondence to record the circumstances in which Depo-Medrol was listed for intrathecal use and Mr O'Reilly says that he has been unable to find out from any past or present employee of the second defendant how this listing came about. 172 Mr Connor submitted that Mr Kirsop, the managing director from 1976 to 1986 or thereabouts should know the answer to this, having regard to what he wrote in his letter of 28 April 1976 addressed to the Secretary, PBA Committee, which reads in part: "Further to the above, Depo Medrol is the only commercially available injectable steroid approved as a Pharmaceutical Benefit for intrathecal administration. During the 15 years that this drug has been evaluated clinically by the intrathecal route, other steroid preparations were also used but all were discarded as unsuitable because they produced meningeal irritation. This was particularly noticeable when steroid formulations contained a water soluble component. No such reactions have been reported in human patients when Depo Medrol has been administered intrathecally." 173 The above extract records Mr Kirsop's knowledge of the PBS listing but it does not follow that the writer had knowledge as to how that listing came about. The evidence does not indicate that Mr Kirsop was qualified to participate in any clinical evaluations such as were referred to in the above communication. 174 In assessing the case of actual prejudice advanced by the defendants, I do not lose sight of the fact that the defendants have Mr Kirsop available to them, and that he was the managing director of the second defendant from 1976 to 1986 or thereabouts (T 158). The defendants also have available to them his immediate predecessor in that position, Mr Goodwin, who was the managing director from 1969 until 1976. As Mr Connor submitted, Mr Goodwin was managing director at the time that the first defendant gave the second defendant the "go head" to market intrathecal Depo-Medrol in Australia, and when Depo-Medrol was listed for intrathecal use on the PBS. He was also the managing director at a period that overlapped with Dr Irvine's period as medical director. However, it does not seem to me that the availability of these two former managing directors ought be considered as meeting prejudice occasioned by the unavailability of the other witnesses who have been identified and whose loss I have been asked to consider in the present context. 175 I find myself persuaded by the evidence of Mr O'Reilly that the defendants would be prejudiced in their investigations of the plaintiff's claim and in seeking to meet it, should this present application be granted. I am so persuaded notwithstanding the thorough submissions advanced by Mr Connor and his extensive cross examination of Mr O'Reilly. The areas of prejudice are those I have identified above, in particular the prejudice occasioned by

(i) the deaths of Dr Stubbs and Dr Irvine, and to a lesser extent by the death of Dr Harter;

(iii) the inability of trace witnesses to deal with the extent of the promotion of the intrathecal administration of Depo-Medrol;

(iv) the inability to address inadequacies in the warnings in MIMS and in the PP Guide;

(v) the inability to establish how the intrathecal administration of Depo-Medrol obtained PBS listing. 176 In addition there is the prejudice earlier considered in addressing the claim that the plaintiff suffered a condition of arachnoiditis caused by intrathecal injections of Depo-Medrol and that such condition was causative of the ongoing symptoms and disabilities about which the plaintiff gave evidence in this Court. 177 I am acutely mindful of the consequences of the failure of this application for the plaintiff. However, I have reached the conclusion that the prejudice that the defendants would suffer in consequence of an order extending time would be significant, and to be such that there could not be a fair trial. The plaintiff has the burden of proving that it is "just and reasonable" that the limitation periods be extended, and consistently with the authorities to which I have referred and my assessment of the evidence on this particular application, I have decided that the plaintiff has not discharged this burden. 178 Accordingly, the notice of motion is dismissed. I reserve the question of costs. **********

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