SCHERING-PLOUGH PTY LIMITED v PAGE

PARTIES : Schering-Plough Pty Limited - Appellant Billie-Jean Page - Respondent JUDGMENT OF : Meagher JA at 1; Sheller JA at 2; Brownie AJA at 45

LOWER COURT JURISDICTION : District Court LOWER COURT 4465/2000 FILE NUMBER(S) : LOWER COURT Garling DCJ JUDICIAL OFFICER :

COUNSEL : D Graham - Appellant K Andrews - Respondent SOLICITORS : Allens Arthur Robinson - Appellant Brazel Moore Daly - Respondent CATCHWORDS : Practice and Procedure - application for extension of limitation period under s60C(2) Limitation Act 1969 - consideration of factors listed in s60E - held that trial Judge erred in granting extension. LEGISLATION CITED : Limitation Act 1969 Sydney City Council v Zegarac (1998) 43 NSWLR 195 CASES CITED: Salido v Nominal Defendant (1993) 32 NSWLR 524 Beale v Government Insurance Office of NSW (1997) 48 NSWLR 430 Brisbane South Regional Health Authority v Taylor (1996) 186 CLR 541 DECISION : 1. Leave to appeal; 2. Appeal allowed; 3. Set aside the orders made by Judge Garling on 14 December 2000; 4. The opponent's application for an extension of time under s60C of the Limitation Act be dismissed; 5. The opponent to pay the claimant's costs of the hearing before Judge Garling, of the application for leave to appeal and of the appeal.

IN THE SUPREME COURT OF NEW SOUTH WALES COURT OF APPEAL

CA40018/01 DC 4465/00 MEAGHER JA SHELLER JA BROWNIE AJA

The opponent was granted an extension of time pursuant to s60C(2) of the Limitation Act 1969 to commence proceedings against the claimant. The opponent commenced proceedings on 31 May 1999, seeking damages for injuries alleged to have been caused by the claimant's failure to warn of the proper use and side effects of a nasal spray called Drixine, produced by the claimant.

The opponent began to use the spray in approximately July 1989. After three months of use, she became moody, nervous, easily irritated and had sleeping problems. By June 1993, she was feeling suicidal and her marriage was deteriorating. In November 1993 she read an article about the adverse effects of oxymetazoline, an ingredient of Drixine and discontinued use of the product. In December 1993, the opponent was advised that she did not have an arguable case. The opponent saw her present solicitors in mid-1995, and they drafted a letter to the claimant detailing the opponent's symptoms, to which the claimant replied, denying liability. Expert advice was not received until 1998.

The claimant sought leave to appeal against the decision to extend the limitation period. The submissions were that the trial Judge had failed to have regard to all the matters referred to in s60E, and that he had erred in finding that there was no "real prejudice to the defendant."

Held: (per Sheller JA, Meagher JA and Brownie AJA agreeing):

1. The trial Judge did not give adequate reasons for his conclusion that it was just and reasonable to extend the limitation period. Accordingly, it is appropriate for this Court to re-exercise the discretion and determine whether the limitation period should be extended.

Per Sheller JA and Meagher JA (Brownie AJA dissenting):

2. In relation to prejudice suffered by the claimant, there was evidence to show that the claimant would face difficulties in relation to causation, since in many cases the opponent did not know what advice she was given by pharmacists and doctors as to the use of Drixine.
3. The delay in bringing the proceedings forward, which appears in part to have been deliberate, and certainly in part is unexplained, together with the inevitable prejudice that flows to the claimant from such delay, leads to the conclusion, having considered the matters set out in s60E of the Limitation Act 1969, that it is not just and reasonable to extend the limitation period in this case.

The opponent has a strong prima facie case that the failure to warn was at least a major cause of the damage complained of. Issues of causation are minor or insignificant and do not justify the view that the claimant has suffered any significant prejudice.

The contentions advanced by the claimant as to the issue of mitigation amount only to speculation. The opponent's lack of recall in relation to the advice she received from medical practitioners is not sufficient to justify the conclusion that the claimant might have suffered prejudice in this regard. The arguments raised by the claimant in relation to the lost opportunity to examine the opponent while she was actually suffering from the relevant medical symptoms are baseless. The symptoms complained of dissipated almost immediately after the opponent ceased taking Drixine. As such, even if she had commenced proceedings as soon as practicable, it is unlikely that she would have had any symptoms when examined. While the time delay in initiating proceedings was substantial, the opponent was able to explain the delay. The fact that there is only minimal evidence to support her reasons for delay is not a matter of significance. Legislation Cited Limitation Act 1969

Cases Cited Sydney City Council v Zegarac (1998) 43NSWLR 195 Salido v Nominal Defendant (1993) 32 NSWLR 524 Beale v Government Insurance Office of NSW (1997) 48 NSWLR 430 Risbane South Regional Health Authority v Taylor (1996) 186 CLR 541

ORDERS 1. Leave to appeal; 2. Appeal allowed; 3. Set aside the orders made by Judge Garling on 14 December 2000; 4. The opponent's application for an extension of time under s60C of the Limitation Act be dismissed; 5. The opponent to pay the claimant's costs of the hearing before Judge Garling, of the application for leave to appeal and of the appeal. ********* IN THE SUPREME COURT OF NEW SOUTH WALES COURT OF APPEAL

CA 40018/01 DC 4465/00 MEAGHER JA SHELLER JA BROWNIE AJA Friday, 8 February 2002 SCHERING-PLOUGH PTY LIMITED v PAGE

Judgment 1 MEAGHER JA: I agree with Sheller JA. 2 SHELLER JA: Introduction The opponent, Billie-Jean Page, applied in the District Court for an extension of time pursuant to s60C(2) of the Limitation Act 1969 to commence proceedings against the claimant, Schering-Plough Pty Limited. On 14 December 2000 Judge Garling extended time pursuant to that subsection. The claimant applies for leave to appeal from that decision. Both parties agree that if leave is granted the Court should decide the appeal. We were told that through no fault of the parties the application for extension of time did not come on for hearing until twelve months after it was filed. 3 In the proceedings which were begun by statement of claim filed on 31 May 1999 and later amended on 14 July 2000 the opponent claimed, inter alia, damages for injuries alleged to have been caused by the claimant's negligence in failing to warn or adequately warn the opponent of the proper method of use of a nasal spray product called Drixine, which it manufactured, and the possibility of side effects. By a statement of defence filed on 23 November 1999 the claimant raised a limitation bar under the Limitation Act 1969.

History 4 The opponent began to use the nasal spray in about June or July 1989 to control nasal congestion. After about three months of such use she became moody and easily irritated, started having sleeping difficulties and found she was very nervous. She continued to use the product and found herself suffering from other symptoms such as anxiety attacks and tremors. By June 1993 she was feeling suicidal and her marriage relationship was deteriorating. She was still using the product to help with nasal congestion. On 7 November 1993 she read an article about the adverse effects of oxymetazoline, an ingredient of Drixine. Shortly afterwards she discontinued its use. 5 In December 1993 a solicitor and a barrister advised the opponent that there was nothing she could do about what she believed were the side effects of taking Drixine. On 19 January 1995 those solicitors wrote to the opponent a letter which said, inter alia: "If you do wish to pursue this matter further you should do so without delay. The Limitation Act provides a limitation period of six years in respect of causes of action which accrue to a plaintiff before 1 September 1990. In the case of personal injury actions for causes of action accruing after 1 September 1990 there is a general limitation period of three years running from the date when the cause of action first accrues. Accordingly, should you wish to pursue this matter further you should do so without delay. Should you decide to contact Cashman and Partners, please let the writer know and we will make available the contents of our file to that firm." 6 In June or July 1995 the opponent saw her present solicitors and a barrister. On 20 July 1995 those solicitors wrote to the claimant informing it that they acted for the opponent, referring to her use of the medication and its effects and saying: "In October 1993, she was informed of the relationship between oxymetazoline and psychotic responses thereto. Following being provided with the information relating to the physical consequences of her exposure to the chemical, she ceased using your product and has been restored to relative health and emotional strength. We have sought the advice of counsel and he has informed us that Mrs Page has a viable cause of action both in common law and under statute. Such rights arise, he advises, through common law negligence, breach of the Sale of Goods Act and probably breaches of the Trade Practices Act. He has further informed us that, because of Mrs Page's vulnerable psychiatric profile, any resort to litigation in this matter could well exacerbate her condition. Neither of us, of course, would want that result. We believe, therefore, that we have a duty to your company to inform it of the experiences of our client, her suffering and her search for relief. Accordingly, in the light of what we believe to be modern consumer law, your company should be aware of our client's response to your product and may well wish to discuss it with her. Your early reply is requested." 7 On 9 August 1995 the claimant replied advising: "…..we are not aware of any medical evidence which attributes symptoms such as psychiatric and physical decline or withdrawal from social groups to the use of Drixine Nasal. We deny any liability to Mrs Page at common law or under statute in relation to her use of Drixine Nasal. However, we are always interested in receiving patient feedback in relation to our products and assisting with patient management where possible. If Mrs Page's doctor wishes to submit additional medical information to us, our qualified medical research staff will be happy to provide information and assistance." The letter was not only a denial of liability but an invitation to submit "additional medical information". This invitation does not seem to have been taken up in any following correspondence. 8 The opponent's solicitors required $2,000 from her to cover the costs of obtaining expert advice. This the opponent was apparently not able to provide until May 1996. In April 1998 the solicitors received a report from Dr Crank, a toxicologist from the School of Chemistry at the University of New South Wales. In that report Dr Crank referred to medical literature which had identified serious side effects for products such as Drixine nasal spray containing oxymetazoline and recommendations by medical authorities that it should be used only for three to five days. Dr Crank expressed the view that the label of Drixine was deficient in a number of respects which he identified.

Limitation Act 1969 9 Part 3 of the Limitation Act concerns postponement of the bar imposed relevantly by s18A of three years from the accrual of the cause of action. Division 3 concerns personal injury cases and sub-division (2) of that division concerns what is called the "Secondary limitation period". Section 60A says that the purpose of the sub-division is to provide a procedure for a five year (maximum) extension of the three year limitation period for personal injury cases. It applies to causes of action that accrue on or after 1 September 1990. Section 60C applies to a cause of action, founded on negligence, for damages for personal injury. Subsection (2) provides: "If an application is made to a court by a person claiming to have a cause of action to which this section applies, the court, after hearing such of the persons likely to be affected by the application as it sees fit, may, if it decides that it is just and reasonable to do so, order that the limitation period for the cause of action be extended for such period, not exceeding 5 years, as it determines." 10 Section 60E headed "Matters to be considered by court" provides, so far as presently material, as follows: "(1) In exercising the powers conferred on it by section 60C or 60D, a court is to have regard to all the circumstances of the case, and (without affecting the generality of the foregoing), the court is, to the extent that they are relevant to the circumstances of the case, to have regard to the following: (a) the length of and reasons for the delay, (b) the extent to which, having regard to the delay, there is or may be prejudice to the defendant by reason that evidence that would have been available if the proceedings had been commenced within the limitation period is no longer available, (c) the time at which the injury became known to the plaintiff, (d) the time at which the nature and extent of the injury became known to the plaintiff, (e) the time at which the plaintiff became aware of a connection between the injury and the defendant's act or omission, (f) any conduct of the defendant which induced the plaintiff to delay bringing the action, (g) the steps (if any) taken by the plaintiff to obtain medical, legal or other expert advice and the nature of any such advice the plaintiff may have received, (h) the extent of the plaintiff's injury or loss."

Decision at first instance 11 Judge Garling, after dismissing the opponent's claims for breach of the Trade Practices Act and the Sale of Goods Act, a dismissal which the opponent has not challenged, summarised the nature of the opponent's cause of action as being "essentially a failure to warn" and continued as follows: "The first question is what section of the Limitation Act applies? The plaintiff was advised on 12 November 1993 not to use this product any longer. She then started to research the product and looked to see what was in it for what may have been causing her problems. The plaintiff saw her current solicitors on 23 June 1995. She had seen a barrister before, but he did not think she had an arguable case. In April 1998 she received a report from an expert, Dr Crank, and it was at this time she said she knew she had a claim. I am satisfied that April 1998 is not the correct starting point for a limitations argument. It seems to me that one could take either of two dates, 12 November 1993, or perhaps June 1995, and in either case the plaintiff has commenced her action outside the three year limitation period and needs the leave of the Court. In 1993 the plaintiff knows that there is a problem caused by her taking Drixine and by July 1995 she has been told that she has a cause of action. The defendant argues that s60(C)(2) applies and it applies as if the limitation period commenced on 12 November 1993 and expired on 11 November 1996. If I accept that argument for the purpose of considering this application then I would turn to s60E and look at those matters set out there, that is, the length of and reasons for the delay. The length of, of course, up to the present is about seven years, but this matter has been on foot for sometime. The reasons are set out fully in the plaintiff's evidence. Secondly, the extent to which having regard to the delay there is, or may be prejudice to the defendant, and I will return to that. There was nothing the defendant did, in my view, which extended or stopped the plaintiff from bringing an action and most of the other matters speak for themselves. This really comes down to whether it is just and reasonable to extend the limitation period and whether the plaintiff has satisfied the Court that the defendant can have a fair trial. I am not satisfied that there is any real prejudice to the defendant brought about by the delay. It is argued that all relevant documents are available to the defendant. Details of the plaintiff's treatment is available. Each party can obtain their own expert reports about the product, which is freely available for testing and therefore the defendant cannot claim that they are prejudiced. The defendant argues that there is prejudice. It comes from the plaintiff's lack of recollection of certain matters, from her inability to name every pharmacist she attended, from her inability to remember some things in the past and from the length of time that has passed itself. The plaintiff's inability to remember those things may, of course, injure or harm the plaintiff's case, but I am not satisfied that they are of such a nature that the defendant could not have a fair trial. I am referred to what Sheller JA said in Holt v Wynter 49 NSWLR at 128, and that is: 'An application for an extension of time under the limitations legislation should be refused if the effect of granting the extension would result in significant prejudice to a particular defendant.' I can see no significant prejudice to the defendant in this matter. There are, as with every case, some problems, but I am sure that those problems can be overcome in the running of the case and that a fair trial can be had. The defendant has been on notice since 1995. I am therefore, satisfied by the plaintiff that there is no reason why there could not be a fair trial of this matter and accordingly I intend to extend the limitation period ……" 12 His Honour extended the limitation period up to and including the date of the filing of the amended statement of claim and ordered the opponent to pay the claimant's costs at the conclusion of proceedings.

General Observations 13 The opponent last used the product on 12 November 1993. That was the last day upon which a cause of action for negligence against the claimant accrued. Accordingly, pursuant to s18A of the Limitation Act, an action on that cause of action was not maintainable if brought after the expiration of a period of three years running from the date of accrual, that is to say after 11 November 1996. 14 The most the Court could do under s60C(2) was to extend the three year period by five years to an eight year period. The intention of his Honour's order was to enable causes of action which accrued to the opponent within the period of eight years before the filing of the amended statement of claim to be maintained.

The approach to be taken 15 In approaching an application for an extension of the limitation period under s60C(2) the Court must take into account all of the circumstances of the case including each factor mentioned in s60E(1) to the extent that it is relevant to the circumstances of the case; Sydney City Council v Zegarac (1998) 43 NSWLR 195 at 199. In doing so, the Court should be mindful of the matters referred to in the judgment of Gleeson CJ in Salido v Nominal Defendant (1993) 32 NSWLR 524 at 532-3. The discretion conferred upon the Court is to be exercised judicially in a manner that furthers the purposes of the statutory context, the immediate purpose, as with any limitation period, being to protect defendants against the injustice of stale claims and to promote forensic diligence. Bearing those matters in mind, the question is whether in the circumstances of each individual case the applicant for leave has demonstrated that it is just and reasonable that leave should be granted. The diligence or lack of diligence shown by a plaintiff or a plaintiff's representatives in ascertaining and asserting his or her rights will ordinarily be a material factor, as will the extent of the relevant delay, and the reason for it. The nature and extent of any forensic disadvantage to a defendant resulting from a plaintiff's delay will also be material. The effect, if any, of the delay upon the defendant's ability to defend an action is a matter to be taken into account, and may in some cases be of decisive importance. 16 Sections 60C and 60E spell out expressly matters which to some extent, at least, are embraced by the Chief Justice's remarks. The judge here was bound to have regard to all the circumstances of the case and to the extent that they were relevant to the circumstances of the case the matters listed in paras (a) to (h).

Claimant's submissions 17 The claimant put submissions under three heads: that the judge incorrectly applied the statutory test by failing to pay regard to all the matters referred to in s60E, that he wrongly found that there was no "real prejudice to the defendant" and that he failed to give sufficient reasons for his decision. 18 The first and third submissions are inter-related and can be dealt with together. To my mind, leaving aside for the moment questions of prejudice, the significant matters for attention on this application were the length of and reasons for the delay (para (a)) and the time at which the opponent became aware of a connection between the injury and the claimant's act or omission (para (e)). 19 As to para (a), his Honour said: "The length of [sic], of course, up to the present time is about seven years, but this matter has been on foot for some time. The reasons are set out fully in the plaintiff's evidence." 20 From this one can infer that his Honour accepted the plaintiff's evidence about the reasons for delay at least in part. But the section requires more than a recital of relevant factors without findings about how these factors bear on the just and reasonable question. 21 The same comment can be made about para (e). His Honour said that in April 1998 the opponent received a report from Dr Crank and "it was at this time she said she knew she had a claim" (my emphasis). He said that he was satisfied that April 1998 was not the correct starting point for a limitations argument. It is not clear to me what was meant by this sentence. His Honour said that one could take either of two dates, 12 November 1993 or perhaps June 1995. On the case as presented to the judge if these refer to the last day upon which a cause of action accrued to the opponent the date could only be 12 November 1993. His Honour said: "In 1993 the plaintiff knows that there is a problem caused by her taking Drixine and by July 1995 she has been told that she has a cause of action." There is no finding by his Honour as to the time at which the opponent became aware of the connection between the opponent's alleged injury and the claimant's alleged omission to warn. 22 In Beale v Government Insurance Office of NSW (1997) 48 NSWLR 430 Meagher JA said at 443: "….where certain evidence is important or critical to the proper determination of the matter and it is not referred to by the trial judge, an appellate court may infer that the trial judge overlooked the evidence or failed to give consideration to it……a judge should set out any material findings of fact and any conclusions or ultimate findings of fact reached. 23 In addition to the matters already referred to, the claimant's counsel took us to evidence of prejudice. The opponent had forgotten the names of medical practitioners to whom she had gone about her treatment and the nature of their advice. The evidence suggested that the opponent had more than a suspicion that she had a cause of action well before April 1998, when Dr Crank's report was received, and simply failed to do anything about it. She did not begin proceedings until a year later. 24 After saying that he would turn to s60E and "look at those matters set out there, that is, the length of and reasons for the delay", Judge Garling referred to a length of seven years, perhaps from November 1993 when the last cause of action accrued to November 2000 when his Honour heard the application. Regard should have been had to delay throughout the whole period from the accrual of the cause of action. Delay continued from the time the limitation period expired in November 1996 to the date proceedings were brought in May 1999, about three years. The limitation period had expired in respect of claims arising from use of the nasal spray on earlier occasions after the first use of it in June or July 1989. Judge Garling held that nothing the defendant did "extended or stopped the plaintiff from bringing an action, which disposed of s60E (f) as a relevant consideration". His Honour said: "Most of the other matters speak for themselves". With due respect, the requirements of s60E cannot be appropriately met in this way. 25 To illustrate the point it is useful to refer to para (a) "the length of and reasons for the delay". The following seems to be the position: Not until 7 November 1993 did the opponent become aware that oxymetazoline, an ingredient of Drixine, could have "adverse affects". Thereafter she discontinued its use.

In December 1993 she was advised by a solicitor and a barrister that nothing could be done about it.

There the matter rested until June or July 1995 when she saw her present solicitor and a barrister with the result that the letter was written to the opponent stating, inter alia, that the opponent had sought the advice of counsel and that "he has informed us that Mrs Page has a viable cause of action both in common law and under statute".

In August 1995 the claimant denied liability and at the same time invited the submission of additional medical information, an invitation which apparently was not taken up.

Money was then requested to obtain expert advice. The opponent could not provide this until May 1996.

Two years later in April 1998 Dr Crank's report was received. On 7 December 1998 a report was prepared by Dr Morse, a consultant psychiatrist, for the opponent's solicitors. Dr Morse's report included the following opinion: "Medically it is well recognised that one should not use decongestant nasal sprays for more than a few days. This is something that I was aware of from knowledge of a particular patient in my final year as a medical student in 1964. The major reason for this is the onset of rebound congestion which has been described in accompanying material and referred to above. This means that there is a build-up of blood vessels and other supporting soft tissue causing even greater and virtually permanent blockage in the nose. It is also well recognised that substances such as oxymetazoline act in a similar manner to sympatheticamines of which the most commonly known is adrenaline and can cause anxiety and panic attack-like symptoms if a person has them for long enough. Generally with short-term use of a couple of times a day for a maximum of five to seven days the material is not absorbed systemically, ie, doesn't go into the general circulation so that the brain and the nervous system are affected. However, with repeated and prolonged use there is no doubt that this material can be absorbed into the body and attack the brain and the nervous system, causing anxiety and panic-like symptoms which Miss Page reports. The dangers of these compounds causing anxiety and panic-like symptoms are well-known in psychiatry and medicine generally."

Dr Morse referred to Dr Crank's report and then said a little later: "It is generally accepted medical practice that a doctor would warn a patient not to take nasal sprays such as oxymetazoline because of the definite risk of rebound congestion for using it for more than a few days, the risk of systemic use is not high but is certainly real enough to be another reason not to continue its use. …. There is no evidence she suffered any psychotic phenomena in response to the Drixine. In my opinion, given the absence of previous emotional disorder and for the reasons outlined above the oxymetazoline was the cause of her anxiety and panic attacks. As mentioned above, the relationship with her husband was markedly affected as outlined and even though she recovered from the effects of the medication the relationship had changed so much that they both decided to separate and this has been on the whole amicable. It is always difficult to outline the part played by difficulties in a relationship in a person's emotional state and in her case the cause and effect at this point of time cannot be ruled out but accepting that they had a good relationship before and the extreme emotional state that she was in, leading to the effect on her relationship, there is no doubt that her emotional state had an important bearing on the break-up of her marriage."

Even so proceedings were not begun until 31 May 1999. 26 No doubt these matters speak for themselves but the opponent was cross-examined and there was an issue about the opponent's understanding of when and whether she knew her condition was related to the use of the nasal spray. I refer to the following passages in the cross-examination before Garling DCJ: "Q. Ms Benjamin also obtained reports from two of your treating doctors, Dr Kennett and Dr Edwards? A. Yes. Q. And the reports were obtained in 1994. Perhaps I could just ask you this, do you recall being shown reports from Dr Edwards and Dr Kennett about your condition? A. Yes. Q. They were asked also whether the Drixine was associated with the psychological conditions you'd been suffering from, correct? A. Whether they thought it had been, yes. Q. And to cut it short both of those doctors agreed that your condition was probably related to the use of the Drixine spray? A. Yes. Q. Those reports were obtained in early 1994, to be precise 13 February 1994 for Dr Edwards and 3 February for Dr Kennett, is that right? A. Yeah, what I remember too is that they did say that they weren't specialists in that, they weren't toxicologist, so all they could say given that this produce could cause these side effects and I was using the products and had the side effects that they thought that it could be connected to it. Q. But they confirmed all the literature that you had obtained from the University of Sydney as well as the article that came from the chemist about the connection? A. Yep. Q. In 1995 you then changed solicitors with your present solicitor, Mr Brazel, and early on he set up a conference with a barrister, Mr Stevens? A. Yes. Q. At that conference in June 1995 or mid 1995 there was a discussion about your claim or a claim, wasn't there? A. Yes. Q. And a decision was made to - first of all, the advice that you received was to write a letter to Schering-Plough informing them of what had happened from your use of Drixine, correct? A. Yes. Q. To tell Schering-Plough that you had a viable cause of action and what were they going to do about it, to paraphrase? A. Yep. Q. Is that correct? Sorry, you've got to answer? A. Yes. Q. And to think again about what was going to happen - I withdraw that. And if Schering-Plough wasn't going to do anything about it to commence proceedings against them, it, correct? A. Yes. … Q. Following receipt of that letter, and keeping with the plans from the conference that you've told his Honour about, you then proceeded to give instructions for proceedings to be commenced, correct? A. Yes. [The letter referred to was the claimant's letter of August 1995.] …… "Q. I though you'd already told his Honour that the instructions that you gave at the conference and the plan of action that had been agreed upon was to first write a letter to Schering-Plough telling them about what you had suffered as a result of using the Drixine? A. Mm, mm. Q. To tell them that you had a viable cause of action and to ask them what they were going to do about it? A. Yes. Q. Do you recall telling his Honour about that? A. Yep. Q. And if that plan, Plan A I'll call it, wasn't successful then Plan B was to commence proceedings against Schering-Plough for damages for the psychological problems and the rebound congestion that you had suffered from using Drixine, correct? A. Yes. Q. Plan A had failed by 9 August 1995? A. Mm, mm. Q. Then plan B was to be brought into operation which was for you to give instructions to your solicitor to commence proceedings against Schering-Plough for damages from the psychological conditions that you had suffered and the rebound congestion as a result of using the Drixine, correct? A. Yes. What I'm concerned about is when you say the term proceedings. I don't know whether that's where something is lodged and we say from this date or whether - my point was that that was when they started saying okay litigation is going to go ahead, we need to get this information, that information, to be able to conclusively say that this has caused that. So if that's what you're asking then yes the further investigation commenced from that point. Q. First step of that was for you to give instructions to your solicitor to in turn tell the barrister to draft a statement of claim that could be lodged in court, correct? A. I don't know what that part of the process is. All I know is that yes I said we will - you know like it was agreed that we would continue, so at what point the paperwork was shuffled, I don't know when different things were lodged. I'm not aware at which stage those things happened. So I'm reluctant to comment on when that happened. Q. But you gave instructions after that letter from Schering-Plough--- A. Yeah. Q. ---go ahead and progress your claim? A. Case, yes. Q. And I understand that there was a problem coming up with $2000 to obtain another expert's report, correct? A. At one stage, yes. Q. Any you've managed to get that money together by early 1996? A. Yes. Q. And you gave that to your solicitor, Mr Brazel? A. Yes. Q. And notwithstanding providing that money and giving your instructions to proceed with the claim an actual writ and statement of claim was not filed with the Court until May 1999, correct? A. Like I say I don't want to comment on when the paperwork was shuffled because I'm really not familiar with dates and that part of it. Q. But you knew, after Schering-Plough had said no, we're not going to entertain any claim from you, you knew at that stage that they hadn't warned you of those problems with psychological problems or rebound congestion, didn't you? A. I knew there was no warning on the package. Q. You knew that the drug within Drixine could cause what you had suffered, correct? A. Yes. Q. And you had obtained that information both through scientific literature on the topic, correct? A. Yeah. Q. Through articles obtained by a chemist, correct? A. Yes. Q. And also through two doctors supporting your claim, correct? A. Yes. Q. The fact of the matter is that when you received Dr Crank's report in 1998 he essentially confirmed to you what you already knew, correct? A. What I suspected, yes. Q. No, what you already knew, correct? A. No. I can't agree that it was what I already knew. I had suspicions, but it wasn't until - it was all pulled together by someone who was recognised as a professional in that field that this was the connection, A had led to B, so. Q. His opinion corroborated all that other evidence that you had assembled beforehand, correct? A. Yes. Q. Just one other thing, when you changed solicitors did Mr Brazel give you any advice that there were problems with the limitation period along the same lines that Ms Benjamin had given you? A. It was discussed and how it was explained to me was that the period started from when a reasonable person would determine that I had led to be and that was defined, a reasonable person was defined to me in terms of a judge. So if I was to go to a judge and say - yes, well, you know-- HIS HONOUR: That wasn't very good advice was it." 27 At the end of her cross-examination the opponent said: "I think for me, just to make it really clear, I knew, I believed that that product could cause those side effects and I also knew I had those side effects. It wasn't until that point when we got the reports from Dr Crank and the psychiatrist that I believed that the two were interrelated. Up until that point I did, like I say, believe those other two things but that they came together. It wasn't confirmed for me until that point. Q. You had evidence supporting your claim, but it wasn't until that stage that you obtained that additional comfort-- A. Yeah. Q. --that you wanted, correct? A. Well that I believed. Until that point I would consider it a strong suspicion." 28 Garling DCJ made no findings which addressed the inconsistencies in this evidence. He bypassed the question by saying that it really came down to whether it was just and reasonable to extend the limitation period and whether the opponent had satisfied the court that the claimant could have a fair trial. This brought him to the second matter listed in s60E(1) namely, (b) the extent to which, having regard to the delay, there is or may be prejudice to the defendant by reason that evidence that would have been available if the proceedings had been commenced within the limitation period is no longer available". 29 In the course of his careful submissions on behalf of the claimant, Mr D Graham of counsel emphasised, by reference to the evidence, difficulties the claimant faced in dealing with causation. The opponent said that she had consulted several doctors but had no recollection of what advice she was given in relation to the continued use of the nasal spray. Mr Graham referred to the statement by Dr Morse that it was generally accepted medical practice that a doctor would warn a patient not to take nasal sprays such as oxymetazoline because of the definite risk of rebound congestion for using it for more than a few days. The risk of systemic use was not high but was certainly real enough to be another reason not to continue its use. The opponent had consulted her general practitioner, Dr Sally Kennett. According to the opponent she was following directions that if symptoms persisted over a certain period of time a doctor should be consulted. She was consulting her doctor. The opponent said that Dr Kennett felt that the sinus problem was related to her pregnancy and that she would need to continue use of the nasal spray. The opponent said: "I wouldn't say she advised me to, she said that the sinus was probably related to my pregnancy and that I would more than likely have problems with it for the duration of my pregnancy, so in terms of the medication she - I don't recall her making any comments specifically about that." 30 She could not recall whether Dr Kennett provided advice one way or the other on the continued use of Drixine. On 12 October 1990 the opponent saw a doctor at Lake Munmorah but could not remember the doctor's name. She had not asked her solicitors to chase down the doctor to get the records. The following cross-examination took place: "Q. But at the time you were starting to be suspicious or have concerns that the Drixine may be responsible or connected with your psychological problems? A. Well what happened was I would ask - I asked him and I said 'Could this be causing my problems', and he referred to the MIMS, the latest edition of the MIMs, looked it up and showed me that no this manual tells us all of the related side effects associated with any drugs that are available in Australia and assured me that these symptoms are not related to this drug, so when I left I was under the impression that, no, this definitely isn't causing my problem, so, you know, I can't say that-- Q. But you were suspicious at that time? A. I wasn't when I left. When I went in there I made an inquiry and when I left I didn't think so. Q. Did you tell that doctor that - I withdraw that. You were continuing to take Drixine every day? A. Yes. Q. And did you tell that doctor how often you were taking the drug? A. Well it was 10 years ago, I can't recall whether I told him, but I would imagine he would've asked. You know, like I say I was still following the directions so I would imagine he would've assumed I was following the directions. I can't recall whether he asked me how often I was taking it. Q. Did he give you any advice about the continued use of that drug? A. He said that if it was concerning me I could go onto a steroid nasal spray to help get me off it, basically. Q. Did he advice you that there was a problem with the continued use and that it would be better to have a steroid spray to clear the problem? A. Not necessarily. He just offered it as an alternative and would I like to try it. Q. Well you said he told you that there was another drug, another nasal spray that would help you get off the Drixine, that's what you said? A. Yeah. Q. So did you tell him that you were having problems getting off the Drixine and not using it? A. I would imagine that I would've - I certainly knew that it was something that I needed to use otherwise the congestion was intolerable, so I certainly would've stressed that to him, so I would imagine that he would've offered this as an alternative to, you know, so not necessarily whether the language was to get off it but perhaps as an alternative for me to try. Q. You found, at that time, that if you didn't use the Drixine the nasal congestion would return? A. Mm. Q. Isn't that so? A. Yeah, yeah. Q. And you were finding it difficult to break that cycle? A. Yes. Q. Of the congestion returning when you stopped using it? A. Yep. Q. Or if you didn't use it, I should say, that's correct, isn't it? A. Yep. Q. And his advice about the steroid nasal spray was to stop that problem of the congestion returning again and again, correct? A. I'm not sure. I'm not sure that that's how he put it. I'm not sure that he was just saying as an alternative. I don't know that it was offered up to me as a better option. I think it may well have been offered up as an alternative to try. Q. Was it offered up to break that cycle of-- A. That's what I don't recall. See at that time I still wasn't clear whether I had a problem with sinus still or whether it was a result of the rebound congestion, that term had never, you know, used." [MIMS is a reference to the well-known Australian publication which provides medical practitioners and other health care professionals with the drug information they need to make prescribing decisions.] 31 The opponent had but a vague recollection of having seen a counsellor at the Womens Health Centre in Gosford in October 1990. She was asked about a referral to Dr Thompson, a psychiatrist. She said that he did not give her any advice about the Drixine that she told him she was continuing to take. She said she asked him once did he think it could be related. He got the MIMS out again and looked it up and once again reassured me that "no it is not related to the Drixine". Of the marriage counsellor, Bill Stewart, whom she saw about six times, she could only say he was in Victoria somewhere. Asked what pharmacies she bought the Drixine from she said it would be so many. She used it consistently for nearly four years "I bought, you know, I mean 40 different chemists." 32 When she received the article from her father in 1993 she was immediately suspicious "that it had caused my problems but I didn't necessarily believe that it was causing me problems because I had been using it for so long". 33 In 1994 the opponent had received reports from Dr Kennett and Dr Edwards. As emerged in the cross-examination already quoted, according to the opponent they agreed that her condition was probably related to the use of Drixine. 34 From the claimant's point of view the problem was that it did not know what advice was given in many cases. Nor did the opponent. Further it was said that the ability to have an examination of the opponent by a medical practitioner while she was still in the tapering off period had been lost. Though there was no evidence of this, the opponent said that it could not find key witnesses. The claimant accepted that it bore an evidentiary onus to put on evidence of actual prejudice but effectively could only rely upon what it said was gleaned from cross-examination. Its submission was that Judge Garling had never properly weighed up these matters or, if he did, gave no reason for the conclusion that he came to having done so. 35 A further question that emerges from the cross-examination is what findings were made to determine (d) "the time at which the nature and extent of the injury became known to the plaintiff" and (e) "the time at which the plaintiff became aware of the connection between the injury and the defendant's act or omission". No doubt the answer to the matter raised in (c) "the time at which the injury became known to the plaintiff" is from three months after first use when she started having sleeping difficulties and found she was very nervous up to and including the period when she started suffering from other symptoms such as anxiety attacks and tremors which goes through until at least June 1993.

Extension applications 36 Applications such as the present are of very considerable importance to the parties. If the applicant fails then a valid, though stale, claim to recover compensation for injury can be lost forever. From the defendant's point of view, if the application succeeds, the defendant may find itself facing a substantial liability for damages which prima facie had been barred by the Limitation Act. Despite this, parties themselves place inadequate evidence before the Court. This may of course reveal the weakness of the case. However, it is the duty of the judge hearing the application to bear in mind its importance. In this case the sections of the Act carefully lay out the approach that is to be taken and require the various headings to be addressed, the evidence relevant to them weighed and findings made. When this has been done the considerations listed must be considered in the course of deciding whether or not an extension should be granted. I do not accept the opponent's submissions that in the present case the reasoning in the judgment of 14 December 2000 adequately explains the decision.

Re-hearing 37 Understandably the parties are anxious to avoid the matter going back to the District Court for re-hearing with possibly further delays and certainly further cost. The claimant has argued with some force that the judge did not accept all of the opponent's evidence which makes the task for this Court, if it is to exercise the discretion itself, more difficult than usual. 38 In my opinion, the delay in beginning the proceedings weighs heavily against the opponent. The expiry of the limitation period should not be treated as little more than a marker. Time factors may make it impracticable to obtain an extension before the period has expired though I would have thought that solicitors, conscious of the impending expiry of the limitation period, who feel that the point has not been reached in the evidence collecting process which would enable them to begin proceedings with confidence, would file an application for extension and see if the other side is prepared to consent. In the present case this was particularly important because the use of the nasal spray and hence injury by its use may have begun as early as 1989. Once the 1990 amendments to the Limitation Act reduced the period of limitation to three years, there was a risk that by the time the current solicitors received their instructions the three year time bar was applying in a way which affected the opponent's entitlement to damages. 39 By February 1994 Dr Edwards and Dr Kennett had reported to the opponent that the Drixine in their opinion was associated with the psychological conditions she was suffering from. Both doctors agreed that her condition was probably related to the use of Drixine. By 20 July 1995 when her solicitors wrote to the claimant the opponent knew of her "psychotic responses" and that she had a viable cause of action. Even accepting that the opponent did not become aware of a connection between her injury and the claimant's failure to warn until Dr Crank's report was received, the obtaining of that report was inexplicably delayed for nearly two years during the early part of which the limitation period expired. A further delay until May 1999 was unexplained and inexcusable. 40 Judge Garling said that he was not satisfied that there was any "real prejudice to the defendant brought about by the delay". He referred to the fact which the claimant concedes, that all relevant documents were available to it. Details of the opponent's treatment was available. Each party could obtain their own expert reports about the product which was freely available for testing. His Honour said: "[T]herefore the defendant cannot claim that they are prejudiced. The defendant argues that there is prejudice. It comes from the plaintiff's lack of recollection of certain matters, from her inability to name every pharmacist she attended, from her inability to remember some things in the past and from the length of time that has passed itself. The plaintiff's inability to remember those things may, of course, injure or harm the plaintiff's case, but I am not satisfied that they are of such a nature that the defendant could not have a fair trial." 41 In Brisbane South Regional Health Authority v Taylor (1996) 186 CLR 541 at 551 McHugh J said: "The longer the delay in commencing proceedings, the more likely it is that the case will be decided on less evidence that was available to the parties at the time that the cause of action arose." As time passes memories dim and witnesses become more difficult to find. The opponent took no steps, as she might and probably should have done, to give evidence that witnesses were available and recalled contemporary conversations with the opponent about the history she gave them and the advice they gave her. It is quite true that the case is a warning case. The principal question is whether what appeared on the label was sufficient. But the claimant is entitled as a matter of causation and, no doubt, mitigation to demonstrate that the warning should have led the opponent to consult her doctor, which she says she did, and that the doctor acting with due diligence would have advised her if told of her history and symptoms to cease using the nasal spray. There will be an issue about the advice that the opponent was given by her doctors and pharmacists and how she reacted to it. Apparently time has dimmed her memory to the extent that she cannot remember in many if not all instances. Nothing is known about the recollections of the doctors who advised her in 1994 or the pharmacists who supplied her before 1993. 42 The opponent's case is that she suffered significant injury by using the claimant's product. By 1995 her solicitors were writing to the claimant pointing out that their client had a viable claim. To some extent the claimant was put on notice by this but had no practical and realistic way of doing more than it did, namely inviting further information from the doctors concerned. This was not produced. Another four years passed before the claim was formally made, by which time the limitation period had expired.

Conclusion 43 In my opinion, Judge Garling's reasons were inadequate, the claimant is entitled to have leave to appeal and to have the appeal upheld and his Honour's orders set aside. The delay in bringing the proceedings forward, which appears in part to have been deliberate, and certainly in part is unexplained, together with the inevitable prejudice that flows to the claimant from such delay, leads me to the conclusion, having considered the matters set out in s60E of the Limitation Act, that it is not just and reasonable to extend the limitation period in this case. Accordingly the Court should refuse to do so.

Orders 44 I propose the following orders: 1. Leave to appeal; 2. Appeal allowed; 3. Set aside the orders made by Judge Garling on 14 December 2000; 4. The opponent's application for an extension of time under s60C of the Limitation Act be dismissed; 5. The opponent to pay the claimant's costs of the hearing before Judge Garling, of the application for leave to appeal and of the appeal.

45 BROWNIE AJA: The facts and the relevant law are set out in the judgment of Sheller JA which I have had the privilege of reading in draft form. 46 As his Honour points out, the learned primary judge did not explicitly go through the paragraphs of section 60E(1) of the Limitation Act 1969, although that subsection required the court to consider the matters listed there, to the extent to which they are relevant. Whilst I am content to accept that his Honour intended to deal explicitly with the matters mentioned in paragraphs (a), (b) and (f), and did that much, and that he intended to deal with the matters mentioned in the other paragraphs by the expression: "most of the other matters speak for themselves", I do not accept that this was, in the circumstances, adequate. 47 As Sheller JA has observed, there were inconsistencies in the evidence going to the matters set out in paragraphs (a) and (e), but Garling DCJ did not make findings of fact on these topics; and it is scarcely possible to find a satisfactory set of reasons without this much. Since the parties joined together in asking us not to remit the case to the District Court, we need to deal with these factual issues, and then to exercise afresh the discretion given by the statute. 48 As often happens in cases of this kind, the claimant did not itself lead any evidence: it merely cross-examined the opponent, and made submissions. Fundamentally, her case was that the claimant had been negligent, in failing to put an adequate warning on its Drixine labels. The opinions of Drs Crank and Morse established a prima facie case to this effect, and they were not challenged, except in that the opponent said in cross-examination that she had spoken to two medical practitioners, Dr Thompson and an unnamed man at Lake Munmorah, and that each of them had consulted MIMS, and had said, in effect, that that publication did not show a connection between Drixine and the opponent's symptoms. 49 The claimant points to a question whether there was a causal connection between the opponent consuming Drixine, and the development of her symptoms. On this issue, this weakening, if that is what it is, of the opponent's case does not seem to me to be significant. It perhaps suggests that in addition to there being a failure to give an adequate warning by the opponent, the last two medical practitioners mentioned also failed to warn her, or that MIMS was deficient; and perhaps it could be used to deny that the claimant was negligent in not giving a warning, or a different warning; but on the present evidence, the opponent has a strong prima facie case that there was a negligent failure by the claimant to warn, which was either the cause or at least a major cause of the damage complained of. Whether one focuses on any one paragraph within section 60E(1), or all of the matters set out in the subsection, the question seems to be a minor one. 50 It seems to me that what the claimant is really trying to do at this point is to invite us to infer that some medical practitioner or practitioners advised the opponent that there was a causal connection between her use of Drixine, and her symptoms, and that this evidence has been lost to the claimant, by reason of the delay. The opponent in effect denied that, Garling DCJ seems to have accepted the main thrust of her evidence, and on the transcript I see no reason to disbelieve her. That is, on the present evidence, I consider that the supposed negligence of the claimant was at least a cause, if not the cause of the supposed loss, and the evidence does not justify the view that the claimant has suffered any significant prejudice in relation to the question of causation. 51 The claimant is on stronger ground in relation to the issue of mitigation, that is, the proposition advanced by the claimant that the opponent failed to mitigate her loss, by consulting appropriate experts, and then following their advice, the contention being that she would have ceased to use Drixine at an earlier date, and that her symptoms would therefore have abated earlier. In a practical sense the claimant suggests that either she consulted some people she no longer recalls, or that she received advice that she does not recall, or that this might have happened, and that the claimant can no longer prove some fact in this area, because of her lack of recall. It was suggested that the claimant had suffered some forensic prejudice arising from her lack of recall, including presumably the circumstance that the claimant is unable to follow up any leads that might have become apparent if her recall had been better. 52 Remembering the purpose of the Act, and the likelihood of prejudice arising from delay (see eg Brisbane South Regional Health Authority v Taylor (1996) 186 CLR 541 at 551), it does not seem to me that the evidence goes as far as the claimant needs to take it, on this point. What it in effect asks for is the drawing of an inference that, notwithstanding the evidence of the claimant, there was or there might have been someone who said something to the opponent, which might have resulted in her ceasing to use Drixine before November 1993; and I do not accept that the evidence permits more than speculation to this general effect. The opponent was cross-examined at length, and her evidence tended to the contrary. It is true that she could not remember the names of people to whom she had spoken, but that falls short of justifying the view that one of those people said something, quite different to the things she remembered being told, which constituted advice that she ought to have followed, and which advice, if followed, would have had the effect of reducing her loss. One might speculate that the claimant might have suffered prejudice, but the evidence tends to point to the contrary. 53 The claimant also suggested that it had lost the opportunity of having the opponent medically examined whilst she was still suffering from the relevant symptoms. However, in the circumstances of this case that complaint seems rather artificial: once the opponent realised in November 1993 that Drixine was (or might be) the cause of her symptoms, she promptly ceased taking it, and the symptoms promptly disappeared. No matter how quickly she had made a claim upon the claimant after appreciating the possibility that she might have had a claim, and no matter how quickly it had requested and then arranged a medical examination, it is unlikely that the opponent would have had any relevant symptoms when examined. That is, on the evidence, there never was a real opportunity for the opponent to have had the examination said to have been lost. 54 On the opponent's case, the delay that occurred has been explained, although the evidence is sparse. She said, in summary, that she suspected, or believed, or thought (her evidence lacked the clarity that lawyers like to see) that there was a causal connection between her symptoms and the Drixine, and that the labelling might have been deficient; she took appropriate advice; she was advised that she needed more evidence; she was asked for money to fund the search for further evidence, and needed some months to procure that money; she then put the matter into the hands of her solicitors; they proceeded slowly, but eventually procured what they regarded as sufficient evidence; and the claim then proceeded. There is a conspicuous shortage of evidence as to the detail of the solicitors' inquiries, and it is easy to visualise that other solicitors, with different experience or personalities, might have proceeded more quickly, or more aggressively, but this delay occurred at a late stage, and either of itself or in combination with the other circumstances does not seem likely to have caused any prejudice to the claimant. One must of course remember the need to encourage forensic diligence, but in the circumstances of this case, this matter does not seem to me to be significant. 55 Neither party submitted that anything turned upon any of the matters mentioned in paragraphs (c), (d), (f), (g) or (h) of s60E(1), but weighing up all of the matters mentioned in the subsection, I consider that in the circumstances it is just and reasonable to order that the limitation period be extended for the period specified by Garling DCJ. I agree with Sheller JA at [12], as to the effect of that order. 56 I propose that leave to appeal be granted, but that the appeal be dismissed with costs. ******

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