Bright v Femcare [2000] FCA 1179

FEDERAL COURT OF AUSTRALIA

Bright v Femcare [2000] FCA 1179 KERRIE BRIGHT v FEMCARE LIMITED AND ENDOVASIVE PTY LIMITED N 410 OF 1999 LEHANE J 22 AUGUST 2000 SYDNEY

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY N 410 OF 1999

BETWEEN: KERRIE BRIGHT

APPLICANT

AND: FEMCARE LIMITED

FIRST RESPONDENT

ENDOVASIVE PTY LIMITED

(ACN 061 512 132)

SECOND RESPONDENT

JUDGE: LEHANE J

DATE OF ORDER: 22 AUGUST 2000

WHERE MADE: SYDNEY

THE COURT ORDERS THAT: 1. The applicant file and serve, not later than 29 August 2000, draft short minutes of the orders for which she contends, consistently with these reasons. Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY N 410 OF 1999

BETWEEN: KERRIE BRIGHT

APPLICANT

AND: FEMCARE LIMITED

FIRST RESPONDENT

ENDOVASIVE PTY LIMITED

(ACN 061 512 132)

SECOND RESPONDENT

JUDGE: LEHANE J

DATE: 22 AUGUST 2000

PLACE: SYDNEY

REASONS FOR JUDGMENT 1 This is a group proceeding commenced under Pt IVA of the Federal Court of Australia Act 1976 (Cth). Its nature, the background circumstances and the claims which the applicant has made, for herself and on behalf of certain group members, are described in two earlier judgments (Bright v Femcare Ltd (1999) 166 ALR 743 and Bright v Femcare Ltd [2000] FCA 742). It is unnecessary to undertake that task again. 2 In the second of those judgments (the June judgment) I gave reasons which resulted in orders that, among other things, the third amended statement of claim filed by the applicant be stuck out but with liberty to replead. The applicant has, in exercise of that liberty, filed a fourth amended statement of claim. That document differs substantially from its immediate and more remote predecessors. For present purposes, however, the differences do not matter. The applicant makes, for herself and for group members falling within classes similar to those described in previous pleadings, substantially similar claims to those made previously under s 52 of the Trade Practices Act 1974 (Cth) and in negligence, on the basis of pleaded facts which do not differ, in any material way, from those pleaded in the third amended statement of claim and those established (for the purposes of the strike out motion) by the evidence discussed in the June judgment. 3 Now before me are a notice of motion filed by the applicant on 23 June 2000 and aspects of a notice of motion filed in Court by the second respondent, Endovasive, on 9 August 2000 (superseding a notice of motion filed by Endovasive on 8 August 2000). The applicant seeks an order that the parties be granted access to documents produced by the Therapeutic Goods Administration (to which I shall refer as the TGA) under a subpoena for production issued to it on 7 June 1999 (to which I shall refer as the TGA subpoena). Endovasive seeks an order that the TGA subpoena be set aside or, alternatively, that access be refused to documents produced under it. 4 This proceeding was commenced by an application filed on 10 May 1999. The TGA subpoena was issued before the first directions hearing, which took place on 18 June 1999. It was made clear at the second directions hearing that the questions whether the TGA subpoena should have been issued and whether documents produced under it should be inspected were controversial. Those two questions, however, were stood over at a number of successive directions hearings and in fact were not argued until 9 August 2000. The intervening period has been occupied principally with the controversy over the applicant's pleading, culminating in the strike out motion dealt with in the June judgment, and a challenge to the constitutional validity of Pt IVA, dealt with in the earlier of the two judgments, affirmed on appeal (Femcare Ltd v Bright (2000) 172 ALR 713) and now the subject of an application for special leave to appeal to the High Court. 5 The documents which the TGA subpoena required to be produced were described in a schedule, as follows: "Note: In this Subpoena the words "Filshie clip system" refer to the device manufactured by Femcare Limited (UK) (Femcare) and marketed and distributed in Australia by Endovasive Pty Ltd (Endovasive) and include Filshie sterilisation clips and Filshie sterilisation clip applicators. 1. Documents in relation to the investigation of the incident of failed sterilisations using the Filshie clip system reported to the TGA by the New South Wales Health Department in 1998 (the investigation) including but not limited to (excluding those created for the sole purpose of giving or obtaining legal advice): (a) Correspondence together with all annexures to and from the New South Wales Health Department. (b) Correspondence together with all annexures to and from Endovasive. (c) Correspondence together with all annexures to and from Femcare. (d) Correspondence together with all annexures to and from John Hunter Hospital. (e) Correspondence together with all annexures to and from Hunter Area Health Service. (f) Correspondence together with all annexures to and from any medical defence organisation including United Medical Protection, the Medical Defence Union and the Medical Protection Society. (g) Correspondence together with all annexures to and from the Royal Australian College of Obstetricians and Gynaecologists. (h) Correspondence together with all annexures to and from any medical practitioners other than those whose documents fall within any of the categories above. (i) Correspondence together with all annexures to and from any legal practitioners other than those whose documents fall within any of the categories above. (j) Correspondence together with all annexures to and from any corporations other than those whose documents fall within any of the categories above. (k) Correspondence together with all annexures to and from any individuals other than whose documents fall within any of the categories above. 2. File notes and memoranda made in relation to the investigation. 3. Documents relating to the incidents recorded on the IRIS Database referred to in the incident reporting database entry dated 4 August 1998 (copy attached). 4. Any internal TGA reports, including draft reports, recommending action to be taken as a result of the investigation. 5. Any documents evidencing consideration being given to a recall of the Filshie clip system. 6. Any warnings, media release or other documents which refer to problems or possible problems with the Filshie clip system arising from the investigation. 7. All product information in relation to the Filshie clip system from 1981 to date. 8. Incident reports involving the Filshie clip system from 1981 to date. 9. Documents referencing the design, manufacture or product literature of the Filshie clip system."