Pharm-a-Care Laboratories Pty Ltd v Commonwealth of Australia

Federal Court of Australia|2010-07-15|Before: Mr P, Flick J

Subject to the form of notice annexed to the Notice of Motion as filed on 9 July 2010 being amended to include a statement that: (i) the proceeding has been set down for hearing for a period of three months commencing on 7 March 2011; (ii) the Individual Respondents were each officers of the Therapeutic Goods Administration; (iii) it is the Commonwealth acting through the Therapeutic Goods Administration which is alleged to have acted negligently; (iv) the sources at which relevant documents may be obtained being separately identified in the manner set forth in the "sample form" annexed to Practice Note CM 17; (v) the sources themselves being separately identified as set forth in that "sample form"; and (vi) subject to the form including the dates now fixed pursuant to these orders the form and content of that notice is approved for the purposes of s 33Y(2) of the Federal Court of Australia Act 1976 (Cth). 2. On or before 23 July 2010, the notice (as amended) is to be sent by or on behalf of the Applicant by ordinary post or e-mail to all "group members", being those "group members" identified in paragraph [2] to the Amended Application as filed on 28 April 2010. 3. The Registrar of the New South Wales District Registry of the Federal Court of Australia on or before 23 July 2010: (i) cause to be posted on the Federal Court website; and (ii) cause to be available for inspection at the District Registry of the Federal Court in Sydney, Canberra, Melbourne, Brisbane, Adelaide, Perth, Hobart and Darwin the Amended Application, the Further Amended Statement of Claim and Defences as filed in this proceeding. 4. If the solicitors acting for any party or IMF (Australia) Ltd, the Applicant's litigation funder, receive, on or before 27 August 2010 a notice purporting to be an opt-out notice referable to this proceeding, the solicitors shall file the notice in the New South Wales District Registry within seven (7) days and the notice shall be treated as an opt-out notice received by the Court at the time it was received by the solicitors or IMF (Australia) Ltd. 5. The Applicant's solicitors and the Respondents' solicitors have leave to inspect the Court file and to copy any opt-out notice filed by any group member. 6. Pursuant to s 33J(1) of the Federal Court of Australia Act 1976 (Cth) 27 August 2010 is fixed as the date by which a group member may opt out of this proceeding. 7. The costs of the Notice of Motion as filed on 9 July 2010 be costs in the cause.

Note:Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules. The text of entered orders can be located using Federal Law Search on the Court's website.

GENERAL DIVISION NSD 1991 of 2008

BETWEEN: PHARM-A-CARE LABORATORIES PTY LTD (ACN 003 468 219)

REASONS FOR JUDGMENT 1 The present proceeding was commenced on 23 December 2008 by the filing of an Application expressed to be an "Application Under Part IVA of the Federal Court of Australia Act 1976". Also filed on that date was a Statement of Claim. 2 The matter now before the Court this morning is a Notice of Motion filed on behalf of the Applicant on 9 July 2010. Orders are sought approving the form and content of a notice to be given to "group members" and fixing a date before which a "group member" may "opt out" of the present proceeding. Counsel for the First Respondent and Counsel for the Second to Sixth Respondents do not oppose the orders now sought. 3 Notice is required to be given pursuant to s 33X(1)(a) of the Federal Court of Australia Act 1976 (Cth). Section 33Y(2) requires that the Court approve the form and content of that notice and s 33J(1) requires the Court to fix a date before which a group member may opt out. 4 All of these provisions are found within Part IVA of the 1976 Act, being the Part dealing with what are there referred to as "representative proceedings". 5 Subject to a number of amendments, it is considered that the notice in the form annexed to the Notice of Motion should be approved and that 27 August 2010 be the date fixed pursuant to s 33J(1).

The Representative Proceeding - The Events to Date 6 Soon after the filing of the Application and Statement of Claim in December 2008 a dispute arose as to the causes of action sought to be advanced and the manner in which those causes of action had been pleaded. 7 All Respondents contended from the outset that the Statement of Claim suffered from a number of deficiencies. As early as 23 April 2009, a Notice of Motion had been filed by the Second to Sixth Respondents seeking a variety of orders, including orders that the Statement of Claim be struck out or dismissed. The First Respondent on the following day also filed a Notice of Motion seeking similar relief. 8 An Amended Statement of Claim was filed on 23 July 2009. Objections to the form of the Amended Statement of Claim were maintained. 9 Some, but not all, of those objections were canvassed at a hearing held on 15 March 2010 and resolved by a decision published on 16 April 2010: Pharm-a-Care Laboratories Pty Ltd v Commonwealth of Australia (No 3) [2010] FCA 361. 10 Orders were made on 27 April 2010 giving effect to those reasons for decision. On 19 May 2010 the proceeding was set down for hearing to commence on 7 March 2011. The proceeding was then set down for a period of three months. 11 Leave was given on 27 April 2010 to file an Amended Application and a Further Amended Statement of Claim. 12 It should also be noted that there are three other relevant proceedings presently before the Court: Markethaven Pty Ltd v Commonwealth of Australia et ors (SAD 130 of 2008); Vita Health Laboratories (Australia) Pty Ltd v The Commonwealth of Australia et ors (NSD 345 of 2009); and Australian Naturalcare Products Pty Limited v Commonwealth of Australia et ors (NSD 358 of 2009). Those three proceedings are not "representative proceedings" but involve to a substantial extent common questions of both fact and law. All proceedings have been set down for hearing together. Whether they will be heard concurrently or consecutively or in some other manner will be determined at the outset of the hearing in 2011.

Part IVA - The Form and Content of an Opt-Out Notice 13 Part IVA of the Federal Court Act provides for the manner in which a "representative proceeding" may be commenced and further provides for the manner in which such a proceeding is to be thereafter conducted. 14 Of present relevance are sections 33J, 33X and 33Y. 15 Section 33J provides as follows: Right of group member to opt out (1) The Court must fix a date before which a group member may opt out of a representative proceeding. (2) A group member may opt out of the representative proceeding by written notice given under the Rules of Court before the date so fixed. (3) The Court, on the application of a group member, the representative party or the respondent in the proceeding, may fix another date so as to extend the period during which a group member may opt out of the representative proceeding. (4) Except with the leave of the Court, the hearing of a representative proceeding must not commence earlier than the date before which a group member may opt out of the proceeding. 16 Division 3 of Part IVA thereafter deals with the form and content of notices to be given to group members. Section 33X(1) provides in relevant part as follows: Notice must be given to group members of the following matters in relation to a representative proceeding: (a) the commencement of the proceeding and the right of the group members to opt out of the proceeding before a specified date, being the date fixed under subsection 33J(1); … The remaining provisions of s 33X(1) deal with applications for dismissal of a proceeding for want of prosecution and an application to withdraw under s 33W. Those provisions are of no present relevance. Of relevance, however, are the terms of s 33Y which provides as follows: Notices - ancillary provisions (1) This section is concerned with notices under section 33X. (2) The form and content of a notice must be as approved by the Court. (3) The Court must, by order, specify: (a) who is to give the notice; and (b) the way in which the notice is to be given; and the order may include provision: (c) directing a party to provide information relevant to the giving of the notice; and (d) relating to the costs of notice. (4) An order under subsection (3) may require that notice be given by means of press advertisement, radio or television broadcast, or by any other means. (5) The Court may not order that notice be given personally to each group member unless it is satisfied that it is reasonably practicable, and not unduly expensive, to do so. (6) A notice that concerns a matter for which the Court's leave or approval is required must specify the period within which a group member or other person may apply to the Court, or take some other step, in relation to the matter. (7) A notice that includes or concerns conditions must specify the conditions and the period, if any, for compliance. (8) The failure of a group member to receive or respond to a notice does not affect a step taken, an order made, or a judgment given, in a proceeding. On 28 June 2010 the current Chief Justice of this Court issued Practice Note CM 17. It commenced on 5 July 2010 and applies, as far as circumstances permit, to both existing representative proceedings and future such proceedings. That Practice Note usefully sets forth a "sample form" of notice. 17 The opt-out requirements of Part IVA are "an important element of the scheme laid down by that part of the Act": Vernon v Village Life Ltd [2009] FCA 516 at [59] per Jacobson J. The ability to opt out of a representative proceeding assumes particular relevance because the consent of a person to be a group member is not required, except in specified circumstances not of present relevance: s 33E. See also: Australian Competition and Consumer Commission v Chats House Investments Pty Limited (1996) 71 FCR 250 at 252 per Branson J; Guglielmin v Trescowthick (No 2) [2005] FCA 138 at [14], 220 ALR 515 at 519 per Mansfield J. 18 Section 33X(1)(a), it will be noted, does not make express provision for the point of time at which the notice required by that provision is to be given. That point of time will be dictated by the facts and circumstances of each individual proceeding. Where amendments to the causes of actions being advanced for resolution are being contemplated, or where the very definition of the "group members" may itself change, it may be appropriate to defer the giving of any notice until those matters have been resolved. It may also be appropriate to defer the giving of any notice until after any Notices of Motion seeking to have a proceeding stayed or dismissed are resolved. To do so may limit the extent to which further notices to group members may be required. 19 It is also of importance that the notice given accurately informs persons of the "right … to opt out of the proceeding" before the date specified under s 33J(1) and be drafted in a manner so as not to mislead: King v GIO Australia Holdings Ltd [2001] FCA 270. Sackville, Hely and Stone JJ there amended the form of notice that had been approved by the primary Judge in King v GIO Australia Holdings Ltd [2000] FCA 1869. There in issue was the liability of a group member to pay legal costs to the Applicant's solicitors, Maurice Blackburn Cashman. When addressing this issue their Honours concluded: [14] In our opinion, the notice in its current form is capable of creating a misleading impression in group members who receive it. In particular, they may be led to believe that MBC will act on behalf of the applicant, insofar as he seeks damages and other relief on behalf of group members, to the point of judgment. This impression would not be accurate, since MBC will act on behalf of a group member to establish the individual elements of his or her cause of action (notably reliance, causation and loss or damages) only if that group member enters into a Fee and Retainer Agreement. In other words, in the absence of a global settlement approved by the Court, an individual group member cannot obtain a favourable judgment without engaging a lawyer or representing himself or herself. [15] This misleading impression might well affect the decision of a group member whether or not to opt out of the proceedings. The principal purpose of the notice given under s33X(1)(a) and s33Y(2) is to ensure that group members can make an informed decision concerning their rights: see Law Reform Commission, Grouped Proceedings in the Federal Court (Report No 46, 1988), para188, para190; Femcare Ltd v Bright (2000) 100 FCR 331, at 336-337, 349. We do not think it is an answer, as Mr Burnside QC (who appeared with Ms Hanscombe for the applicant) suggested it was, that a group member who is misled by the form of notice approved by the Court could apply for and expect to receive an extension of the period during which he or she can opt out of the representative proceeding: s33J(3). The represented group is large and group members are likely to have widely varying degrees of understanding of the claims made on their behalf and the possible outcomes of representative proceedings. It is important that any decision they make concerning opting out of the proceedings not be based on a notice that is apt to mislead them. [16] We agree with the primary Judge that clarity and simplicity are essential if a notice is to have its intended effect. We also agree that an attempt to provide detailed information is likely to create more difficulties than it resolves. Nonetheless, we think that, in order to remove the misleading impression to which we have referred, group members should be informed that, unless the proceedings are settled, MBC will not represent them to the point of judgment unless they assume a responsibility for their own legal fees. It is "imperative that any communications made to group members, … be accurate": Williams v FAI Home Security Pty Ltd (No. 3) [2000] FCA 1438 at [24] per Goldberg J. 20 When approving the form and content of an opt-out notice it is also of importance for the Court to ensure that the notice is written in "plain English": Courtney v Medtel Pty Ltd [2001] FCA 1037 ("Courtney"). Sackville J there relevantly observed: [10] It is also important to bear in mind that, as was said by Wilcox J in McMullin v ICI Australia Operations Pty Ltd (1998) 156 ALR 257, at 260: "Any notice that is to be issued to members of the public in connection with a representative proceeding must be readily comprehensible by non-lawyers. It should be written in plain English." [11] I would add a further observation. Any opt-out notice should be framed so as not to cause unnecessary alarm or distress to intended recipients. Practising lawyers, and for that matter judges, may tend to underestimate the impact that publication or service of a Court ordered notice may have on members of the represented group. The recipients of a notice under s33X of the Federal Court Act may become anxious when they learn for the first time of legal proceedings which may affect their legal rights and in respect of which they must decide whether or not to participate. They may be concerned by technical language that is difficult to understand. The notice may also alert them, particularly in personal injury cases, to the possibility that they are at risk of future harm. People who are at risk of harm or who are otherwise vulnerable, such as elderly persons, may be particularly susceptible to anxiety or distress. Notices must be accurate but should be drafted with sensitivity to these considerations. It is, accordingly, of importance to ensure that a notice does not contain unnecessary information which may simply have the potential to either confuse or intimidate the persons to whom it is addressed. The nature of the information being communicated may well depend upon the issues being advanced for resolution in the representative proceeding itself - the more complex a proceeding may be, the greater may be the need to include more rather than less information. Inevitably a balance may have to be struck when approval is sought in respect to each individual proceeding. 21 As was also observed by Sackville J in Courtney, when approving the form and content of an opt-out notice, consideration should also be given to the category of persons who are group members. What may be an appropriate manner in which to convey information to group members better qualified to understand that information may be inappropriate (and may have to be differently expressed) where it may be expected that group members are less able to understand the information sought to be conveyed. There would be little point in expressing an opt-out notice in terms which a lawyer may well understand but in terms totally confusing to the intended recipient. 22 The date "before which a group member may opt out of a representative proceeding" for the purposes of s 33J must also be dictated by the facts and circumstances of each individual proceeding. Again, s 33J is largely silent as to when such a date is to be fixed or at the stage of the proceeding when it is be fixed. An express constraint is that imposed by s 33J(4), namely that the hearing of a representative proceeding must not commence earlier than the date before which a group member may opt out except with the leave of the Court. Subject to the potential application of that constraint, when fixing that date, it is otherwise of importance to ensure that there is sufficient time given to a group member to make an informed decision. Adequate time must thus be allowed between the receiving of the notice and the date by which a recipient has to make a decision. By way of example, in Crawford v Bank of Western Australia Ltd [2005] FCA 949 Lee J referred to orders previously made that the notice be given by 2 April and 7 May of the same year be fixed as the date by which a group member could opt out. Where a little more time will not impact upon the preparation of a case for hearing, or potentially impede any forthcoming mediation, perhaps a little more time should be permitted. 23 In summary form, and subject to the power of the Court to dispense with requirements otherwise imposed, the task of the Court when approving the form and content of a notice pursuant to s 33Y(2) is to ensure that the notice: · contains such information as has been prescribed by the Legislature in the Federal Court Act; · complies with Practice Note CM 17, except where a departure from the "sample form" set forth in that Practice Note is considered appropriate; · sets forth that information in a manner which is as readily understandable to those to whom it is addressed as is possible in the circumstances of any individual proceeding; · sets forth that information in a manner which is not misleading; and · sets forth that information in a manner which is otherwise appropriate to promote the object and purpose for which it is being given. When fixing a date pursuant to s 33J(1), the task of the Court is to · fix a date before which a group member may opt out, that date being a date sufficiently after the giving of the notice as permits an informed decision to be made. 24 It should finally be noted that the Court retains an important and continuing role in managing representative proceedings in the public interest: Johnstone v HIH Ltd [2004] FCA 190. Tamberlin J there said: [105] The Court has an important and continuing role in managing representative proceedings in the public interest to rectify any potentially misleading communications to class members or potential class members, in order to ensure that there is no misunderstanding engendered by such communications, particularly when they emanate from legal advisers, as to rights and obligations and procedures to be followed by recipients of such communications. In an appropriate case, an order may thus be made that a correcting notice may be issued to remedy any misstatements that may be made during the course of a proceeding: Jarra Creek Central Packing Shed Pty Ltd v Amcor Limited [2008] FCA 575.

The Form and Content of the Opt-Out Notice 25 The Notice of Motion as filed on 9 July 2010 annexes to it the form of notice for which approval is sought. 26 That Annexure substantially follows the sample form of notice now set forth in Practice Note CM 17 and, accordingly, sets out information under each of the following headings, namely: · Why is this notice important? · What is a class action? · What is Opt Out? · The Pharm-a-care class action · Are you a group member? · Will you be liable for legal costs? · What will happen if you do not opt out? · How can you remain a group member? · How can you opt out of the class action? · Further information The sample form of notice set forth in Practice Note CM 17, it may be noted, variously refers to a "class member" and a "group member". The form of proposed notice annexed to the Notice of Motion refers throughout to "group member", but nothing presently turns upon any difference in terminology. 27 Having considered the form of the proposed notice alongside the sample form, a number of amendments are considered appropriate. 28 First, the proposed notice does not state that the proceeding has been set down for hearing. It is considered that there should be included under the heading "Why is this notice important?" the following additional statement: This proceeding has been set down for hearing for a period of up to three months commencing on 7 March 2011. In some - perhaps many representative proceedings - it may not be possible in the notice forwarded to group members to notify them of the date a hearing is set down to commence. But where a proceeding has been set down for hearing, group members should be notified of that fact. It is a proceeding, after all, being pursued by an Applicant on its own behalf and on behalf of group members. They may wish to attend. 29 Second, it is considered that there should be a number of amendments to the information set forth under the hearing "The Pharm-a-care class action". That part of the noticeas annexed to the Notice of Motion states in part as follows: The Pharm-a-care class action The class action, Federal Court proceeding NSD 1991/2008, is brought by Pharm-a-care (the Applicant) on its own behalf and on behalf of all persons who are group members as defined in the Amended Application. (That definition is referred to below under the heading "Are you a group member?".) The Respondents to the class action are the Commonwealth of Australia (the Commonwealth), Terry Slater, Rita MacLachlan, Pio Cesarin, Robert Tribe and Noel Fraser (the Individual Respondents). The Applicant's claim centres on the decisions of one or more of the Individual Respondents to: · suspend Pan's licence under the Therapeutic Goods Act 1989 (Cth) (TG Act) without giving notice to Pan (Pan Suspension); · cancel from the register of therapeutic goods all products manufactured by Pan under section 30(1)(a) of the TG Act without giving notice to Pan (Pan Cancellation); · require Pan, under section 30(6) of the TG Act, to undertake a mandatory safety related consumer level recall of all products manufactured by Pan "since 1 May 2002" which were registered with the TGA against Pan's name as a sponsor (Pan Recall); · impose a condition, under sub section 28(3) and 28(4)(a) of the TG Act, on the registration or listing of all products manufactured by Pan that Pan Sponsors cease supply of all products manufactured by Pan since 1 May 2002 (Sponsor Prohibition on Supply); and · "strongly encourage" all Pan Sponsors to immediately undertake a voluntary safety related recall of all batches of products manufactured by Pan since 1 May 2002 (Sponsor Voluntary Recall), and the subsequent implementation of those decisions, as well as the publication of advertisements and warnings to the public in newspapers and on the TGA website advising consumers that Pan's products were unsafe (Pan Consumer Warnings). In general terms, the Applicant claims that each of the Pan Suspension, the Pan Cancellation, the Pan Recall, the Sponsor Prohibition on Supply, the Sponsor Voluntary Recall and a direction to make the Pan Consumer Warnings, was an invalid or unauthorised act or omission, done knowingly or maliciously in abuse of power by a public officer (being one or other of the Individual Respondents) in the purported discharge of their public duties, which caused loss or harm to the Applicant and the group members. The Applicant claims that such conduct constitutes the tort of misfeasance in public office and that each of the Individual Respondents is liable directly or as a joint tortfeasor in respect of those torts, and that the Commonwealth is liable vicariously for the conduct of the Individual Respondents. The Applicant also claims that the Commonwealth acted: · negligently, in breach of duties of care it owed to the Applicant and Pan Sponsors, in making a request to Pan Sponsors to carry out a "voluntary" consumer level product recall; · negligently, in breach of duties of care it owed to the Applicant, Pan Sponsors and Pan Distributors, in making the Pan Consumer Warnings; · negligently, in breach of duties of care it owed to the Applicant and group members, made and implemented the Pan Suspension, Pan Cancellation, Pan Recall and Sponsor Prohibition on Supply. The Applicant claims that this conduct constitutes the tort of negligence and that the Commonwealth is liable in respect of those torts. The Respondents deny the allegations and are defending the class action. The specific allegations made by the Applicant in the class action are set out in the Further Amended Statement of Claim. Relevant documents also include the Amended Application and the Defences. Copies of these documents may be obtained by inspecting them on the Federal Court website: www.fedcourt.gov.au or by visiting a District Registry of the Federal Court in Sydney, Canberra, Melbourne, Brisbane, Adelaide, Perth, Hobart or Darwin: the addresses for these registries are available at www.fedcourt.gov.au or by calling the District Registry of the Federal Court of Australia. You can also inspect these documents, by appointment, between 9am and 5pm at the offices of McLachlan Thorpe Partners, the Applicant's solicitor, at level 21, 1 Castlereagh Street, Sydney, NSW, 2000 (see the contact details below). 30 One amendment is directed to that part of the notice which identifies the Respondents. Even though the notice accurately identifies the Respondents, it is considered that reference should be made to the status of the individual Respondents as officers of the Therapeutic Goods Administration. It is the Therapeutic Goods Administration which is later alleged to owe a variety of duties of care and to have breached those duties. It is thus considered that the existing notice should be amended by including the following italicised words: The Respondents to the class action are the Commonwealth of Australia (the Commonwealth), Terry Slater, Rita MacLachlan, Pio Cesarin, Robert Tribe and Noel Fraser (the Individual Respondents). The Individual Respondents were each officers of the Therapeutic Goods Administration. A related amendment is addressed to that part of the notice which sets forth the fact that the Applicant "claims that the Commonwealth acted: … negligently". Although the Further Amended Statement of Claim identifies the Therapeutic Goods Administration as the entity which owed the various duties of care and which is alleged to have breached those duties, paragraphs [7] and [8] of the Further Amended Statement of Claim earlier plead the involvement of the Commonwealth as follows: 7 At all relevant times, the TGA Members had been given responsibility by the Commonwealth for administering the TG Act and when so acting exercised the executive power of the Commonwealth in maintaining and executing a law of the Commonwealth. 8. In this pleading, references to the TGA are references to the Commonwealth acting through its Department of State, the Department of Health and Ageing (the TGA being a unit of that Department of State), and the TGA Members. Notwithstanding paragraphs [7] and [8], and an accepted objective of keeping the proposed notice as simple and as concise as possible, it is nevertheless considered that the statement "that the Commonwealth acted: … negligently" should be amended such that the following italicised words be inserted: The Applicant also claims that the Commonwealth acting through the Therapeutic Goods Administration acted: … This amendment simply attempts to summarise the allegations as presently set forth in the Further Amended Statement of Claim. 31 Finally, the sample form of notice set forth in Practice Note CM 17 sets forth as the last of the issues to be addressed the question as to where copies of "relevant documents" may be obtained. The form of notice proposed as annexed to the Notice of Motion includes this information as part of the description of "The Pharm-a-care class action". Although the Practice Note simply sets forth a "sample form" of notice, being a "sample" which should necessarily be regarded as but a guide to both the manner in which information may be set forth and the nature of the information to be set forth, there is considered to be considerable merit in separately identifying the sources from which "relevant documents" may be obtained. To separately identify those sources serves to both simplify the content of the information describing the nature of the "representative proceeding" under consideration and emphasise separately where the actual documents may be located. There is no good reason to warrant any departure from the "sample form" as set forth in the Practice Note. 32 It is thus considered that this part of the information should be: (i) deleted from where it presently appears in the form of proposed notice and relocated under the separate heading - i.e., "Where can you obtain copies of relevant documents?" - in accordance with the sample form annexed to Practice Note CM 17; and that:

(ii) each of the separate "sources" from which relevant documents may be obtained should also be separately identified, again as set forth in Practice Note CM 17. 33 The "sample form" also contemplates a statement that the relevant documents may be available from the Applicant's solicitor's web-site. In the present proceeding, it is submitted that "technical limitations" to the solicitor's web-site may inhibit or preclude the information there being made available. Any order that it be there made available may thus confront difficulties and may generate more confusion than enlightenment. In such circumstances, a departure from the "sample form" is warranted.

Conclusions 34 Irrespective of whether or not the Applicant should have addressed attention to the mandatory requirements imposed by ss 33J, 33X and 33Y at a far earlier stage in the proceeding than it did, an appropriate time has now come when the notice required by those provisions should be given. Indeed, it may have been premature to have given the notice required by s 33X at any earlier point of time given the fact that it was not until 27 April 2010 that leave was given to file an Amended Application and a Further Amended Statement of Claim. Moreover, the Notice of Motion filed by the Second to Sixth Respondents seeking that the proceeding be struck out or dismissed was not itself dismissed until April 2010. 35 The form of notice should be amended in the various ways identified. Subject to those amendments being made, the form of notice is approved pursuant to s 33Y(2). 36 The content of the notice, and its statement in summary form as to the issues to be resolved and the explanation as to the right to "opt-out" and the manner in which that right may be exercised is further considered to be accurate and not apt to mislead. 37 Such orders as are now made address those matters required to be specified pursuant to s 33Y(3). The notice is to be forwarded to each group member by ordinary post or by e-mail. Given that that form of order was itself proposed by the Applicant, it may safely be assumed that those methods of service are "reasonably practicable, and not unduly expensive" for the purpose of s 33Y(5). 38 The notice is to be given no later than 23 July 2010 and, for the purposes of s 33J(1), the date which is fixed before which a group member may opt out of the present proceeding is 27 August 2010.

ORDERS 39 The Orders of the Court are: 1. Subject to the form of notice annexed to the Notice of Motion as filed on 9 July 2010 being amended to include a statement that: (i) the proceeding has been set down for hearing for a period of three months commencing on 7 March 2011; (ii) the Individual Respondents were each officers of the Therapeutic Goods Administration; (iii) it is the Commonwealth acting through the Therapeutic Goods Administration which is alleged to have acted negligently; (iv) the sources at which relevant documents may be obtained being separately identified in the manner set forth in the "sample form" annexed to Practice Note CM 17; (v) the sources themselves being separately identified as set forth in that "sample form"; and (vi) subject to the form including the dates now fixed pursuant to these orders the form and content of that notice is approved for the purposes of s 33Y(2) of the Federal Court of Australia Act 1976 (Cth). 2. On or before 23 July 2010, the notice (as amended) is to be sent by or on behalf of the Applicant by ordinary post or e-mail to all "group members", being those "group members" identified in paragraph [2] to the Amended Application as filed on 28 April 2010. 3. The Registrar of the New South Wales District Registry of the Federal Court of Australia on or before 23 July 2010: (i) cause to be posted on the Federal Court website; and (ii) cause to be available for inspection at the District Registry of the Federal Court in Sydney, Canberra, Melbourne, Brisbane, Adelaide, Perth, Hobart and Darwin the Amended Application, the Further Amended Statement of Claim and Defences as filed in this proceeding. 4. If the solicitors acting for any party or IMF (Australia) Ltd, the Applicant's litigation funder, receive, on or before 27 August 2010 a notice purporting to be an opt-out notice referable to this proceeding, the solicitors shall file the notice in the New South Wales District Registry within seven (7) days and the notice shall be treated as an opt-out notice received by the Court at the time it was received by the solicitors or IMF (Australia) Ltd. 5. The Applicant's solicitors and the Respondents' solicitors have leave to inspect the Court file and to copy any opt-out notice filed by any group member. 6. Pursuant to s 33J(1) of the Federal Court of Australia Act 1976 (Cth) 27 August 2010 is fixed as the date by which a group member may opt out of this proceeding. 7. The costs of the Notice of Motion as filed on 9 July 2010 be costs in the cause. I certify that the preceding thirty-nine (39) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Flick.

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