Bateley v Land & Anor [2001] NSWSC 64

New South Wales Supreme Court

CITATION : Bateley v Land & Anor [2001] NSWSC 64 FILE NUMBER(S) : SC 11765/90 HEARING DATE(S) : 12 February 2001 JUDGMENT DATE : 21 February 2001

Christopher Mark Bateley (Plaintiff) v PARTIES : Dr William A Land (First Defendant)

Roche Products Pty Limited (Second Defendant) JUDGMENT OF : Davies AJ at 1

P: Mr D E Graham COUNSEL : 1D: mentioned for 2D: Mr H J Marshall P: Maurice Blackburn Cashman SOLICITORS : 1D: Blake Dawson Waldron 2D: Clayton Utz CATCHWORDS : Practice - Amendment of Statement of Claim - no point of principle Sale of Goods Act 1923, s 19 LEGISLATION CITED : Trade Practices Act 1974, ss 74B, 74D Limitation Act 1969, s 14 Supreme Court Rules 1970, Pt 20 r 4 CASES CITED : Birks - Introduction to the Law of Restitution DECISION : See paragraph 29.

IN THE SUPREME COURT OF NEW SOUTH WALES COMMON LAW DIVISION PROFESSIONAL NEGLIGENCE LIST

DAVIES AJ

WEDNESDAY, 21 FEBRUARY 2001 11765/90 - CHRISTOPHER MARK BATELEY v DR WILLIAM A LAND & ANOR JUDGMENT 1 HIS HONOUR: This is an application to amend the Statement of Claim. On the motion, Mr D E Graham of counsel appeared for the plaintiff and Mr H J Marshall of counsel appeared for the second defendant. The solicitors for the first defendant have written to say that they do not wish to contest the application. 2 It appears that, for some months on and from 27 April 1984, the plaintiff was treated for cystic acne by the first defendant, Dr W A Land, involving the use of the drug Roaccutane. This drug was produced and distributed by the second defendant, Roche Products Pty Ltd ("Roche"). It is alleged that the plaintiff had a very serious adverse reaction to the drug leaving him with permanent problems. 3 In a Statement of Claim filed on 20 April 1990, almost eleven years ago, the plaintiff alleged failure by Dr Land to use due skill and care in his treatment. The plaintiff alleged that the treatment was effected pursuant to an agreement between himself and Dr Land and also between himself and Roche. The plaintiff alleged that Roche failed to exercise reasonable care not to injure him. Reliance was also placed upon the statutory provisions with respect to merchantable quality contained in s 19 of the Sale of Goods Act, 1923 and s 74B and s 74D of the Trade Practices Act, 1974 (Cth). 4 The proposed Amended Statement of Claim alleges that the drug Roaccutane was used on the plaintiff in the course of a trial of that drug conducted by the first and second defendants. The plaintiff alleges that there was an agreement between himself and the two defendants. 5 On 24 March 1982, Roche had submitted to the Department of Health an application for approval to market Roaccutane generally. This application was not finally determined until 7 March 1985 when approval was given. In the meantime, among other investigations that were undertaken, approval for the use of the drug could be obtained from the Department of Health in respect of specific patients. 6 In April 1984, on the application of a Dr J F Scattini, the Department of Health gave permission for the use of the drug on the plaintiff, but the approval noted that the clinical use of the drug must be regarded both legally and medically as experimental. The letter required, inter alia, that the principles set out in the National Health and Medical Research Council's "Statement on Human Experimentation" be followed and that details of any suspected adverse drug reactions, predictable or otherwise, be reported as soon as possible to the Australian Drug Evaluation Committee. A copy of the approval was sent to the Managing Director of Roche for information with a note which provided that a summary of case reports received should be submitted to the Department at regular intervals. 7 It is alleged in the proposed Amended Statement of Claim that, by proceeding with the trial, the first and second defendants either impliedly or expressly entered into an agreement with the plaintiff and agreed to the terms and conditions set out in the Department's letter of approval. If the letter of approval be looked at on its own, the matter appears to have proceeded by way of an application by a medical practitioner to the Department of Health for approval to use the drug in the course of the treatment of a patient. 8 Other material suggests, nevertheless, that Roche had at least some interest in the treatment of individual patients in this way. There is in evidence, for the purposes of this motion, a Protocol published by Roche which was designed to establish parameters for individual patient usage of Roaccutane in Australia. The Protocol stated one of its objectives as being, "To obtain experience with Roaccutane in Australia under controlled conditions". Criteria for a patient's selection were stated and also relevant factors with relation to clinical evaluation. The Protocol spoke of "the study" and provided that:- " ALL DATA MUST BE COMPLETED TO ALLOW FULL INTERPRETATION OF THE STUDY. The originals will be sent to Roche Products Pty. Limited and copies maintained in the investigator's file." 9 The Protocol provided that, "The study will be monitored in person and by telephone at appropriate intervals by representatives of the Sponsor". There appears to be a dispute as to whether Roche was the relevant "Sponsor". 10 It is clear that a principal issue in the case will be whether the treatment of the plaintiff should be considered as merely the individual treatment of a patient by his doctor or whether the treatment was part of an ongoing trial of the new drug, Roaccutane, in which the plaintiff and the two defendants all took part with others. This was an issue which was raised by the 1990 Statement of Claim although it is expressed more clearly in the proposed Amended Statement of Claim. 11 One new issue of fact which is sought to be raised concerns the treatment by another medical practitioner of another patient, Justin Abrahams, in the middle of 1983. Mr Abrahams had adverse reactions to the drug Roaccutane which were similar to those later suffered by the plaintiff. The allegation which is sought to be raised is that, although Roche did not become aware of the adverse reactions of Justin Abrahams until about July 1984, about the time when the plaintiff's treatment was concluding, Roche failed in its duty to the plaintiff by failing to monitor Mr Abrahams' response to the drug. 12 It seems to me that, although this allegation raises an additional issue of fact, it falls within the ambit of the allegations made in the 1990 Statement of Claim and that the amendment should be allowed. Roche should not be prejudiced by the delay which has occurred as Roche was, until recently, a defendant to legal proceedings instituted by Mr Abrahams. Roche should be well aware of the facts surrounding the treatment of Mr Abrahams. 13 A more important allegation made in the proposed Amended Statement of Claim is that the circumstances were such that each of the first and second defendants had a fiduciary duty to the plaintiff. No purpose would be served by discussing the law on fiduciary duty or by forming any view about the prospects of success of this allegation. In my opinion, the amendments sought in this respect should be allowed. It will be incumbent upon the Court to determine the nature of the relationship, if any, which existed between the plaintiff and each of the defendants and it will be necessary for the Court to determine the duties, if any, which each defendant owed to the plaintiff. Accordingly, to add an allegation of breach of fiduciary duty adds little to the claims already made. The 1990 Statement of Claim already makes relevant the circumstances under which the treatment of the plaintiff was carried out. 14 Paragraph 13 of the proposed Amended Statement of Claim alleges fiduciary relationships. So far as Roche is concerned, it alleges breach of fiduciary duty in paragraph 47. Paragraph 47 sets out the following two allegations of breach:- "(a) permitted a conflict, or the possibility of a conflict, to develop between its own interest and its duty to the plaintiff.