TFS Manufacturing Pty Limited and Minister for Health
[2016] AATA 1069
•22 December 2016
TFS Manufacturing Pty Limited and Minister for Health [2016] AATA 1069 (16 December 2016)
Division
GENERAL DIVISION
File Number
2015/1447
Re
TFS Manufacturing Pty Limited
APPLICANT
And
Minister for Health
RESPONDENT
DECISION
Tribunal Deputy President K Bean
Date of Decision 16 December 2016 Date of written reasons 22 December 2016 Place Adelaide The Tribunal decides, pursuant to section 40A of the Administrative Appeals Tribunal Act 1975, to decline to issue the summons the subject of the request made by TFS Manufacturing Pty Limited on 13 October 2016.
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Deputy President K Bean
CATCHWORDS
PRACTICE AND PROCEDURE – Request to issue summons directed to third party material held by respondent – Respondent objection to issue of summons – Third parties' opposition to summons being issued – Applicable principles – Potential forensic purpose of summons – Request to issue summons declined.
LEGISLATION
Administrative Appeals Tribunal Act 1975, subs 40A(1)
Therapeutic Goods (Medical Devices) Regulations 2002
CASES
Wong v Sklovas [2014] FCAFC 120
SECONDARY MATERIALS
Coles, Benjamin – "The confetti of the justice system – Subpoenas, justice and third parties" Australian Bar Review (2016) 42 at 385
REASONS FOR DECISION
Deputy President K Bean
22 December 2016
The substantive application in this matter concerns a request by the applicant (TFS) for review of a decision made by the respondent on 27 February 2015. That decision affirmed an earlier decision to cancel TFS’s entry for a device described as “prosthesis, incontinence” ARTG 132657 (the TFS Device) from the Australian Register of Therapeutic Goods (the Register).
That decision was based, in part, on a conclusion that TFS had refused or failed to comply with an applicable condition that at all times while the device was included on the Register, TFS have available sufficient information to satisfactorily establish compliance with certain Essential Principles listed in the Therapeutic Goods (Medical Devices) Regulations 2002. The Essential Principles of most relevance are Essential Principle 14 relating to clinical evidence, Essential Principle 6 relating to whether the benefits of medical devices outweigh any undesirable effects, and Essential Principle 2 relating to design and construction of medical devices so as to conform with the safety principles.
I am expecting that a hearing of the substantive application will take place next year. Preparation for that hearing is well advanced as both parties have filed considerable evidentiary material and detailed Statements of Facts, Issues and Contentions.
It is in this context that on 13 October, TFS asked the Tribunal to issue a summons to produce documents directed to the Therapeutic Goods Administration (TGA). The respondent has objected to the issue of that summons, as have a number of third parties, and a hearing took place on 29 November 2016 with respect to whether the summons should issue. Both parties provided written submissions in advance of that hearing and made detailed submissions at the hearing. A number of third parties have also written to the Tribunal indicating their opposition to the summons and one of those third parties, Coloplast[1], was represented by Mr Simon Ower SC at the hearing, and he also made brief oral submissions.
[1] Mr Ower appeared for Coloplast AS and Coloplast Pty Limited.
I delivered my Decision and Reasons with respect to TFS’ application orally on 16 December 2016. However, following a request made by TFS and Coloplast on that day, I also indicated that I would publish my Reasons.
THE SUMMONS
The summons the subject of TFS’s original request had two paragraphs. However, the respondent has indicated that all of the material caught by the second paragraph is in fact already in the T-Documents, and TFS has accepted that assurance and no longer presses for that paragraph to be included in the summons. It follows that I need not have regard to that paragraph.
The balance of the materials sought by the proposed summons are described as follows:
1. Documents produced to the Therapeutic Goods Administration by sponsors of certain medical devices which were provided to demonstrate compliance with the Essential Principles (including, but not limited to, any safety and efficacy report or clinical evidence review) in relation to the products currently registered on the Australian Register of Therapeutic Goods that have the following ARTG IDs:
1.1ARTG ID: 104326
1.2ARTG ID: 160738
1.3ARTG ID: 190173
1.4ARTG ID: 165126
1.5ARTG ID: 190172
1.6ARTG ID: 150342.
For completeness, although little turns on it for my purposes, I note TFS has also conceded that the device described at 1.4 is in fact not currently registered and therefore the summons would not catch material relating to that item.
THE APPLICABLE PRINCIPLES
The parties agree that a summons or subpoena must have a legitimate forensic purpose and the documents sought must have apparent relevance to the issues in the substantive matter, and the Tribunal may decline to issue a summons which does not satisfy these tests. The applicable principles were helpfully summarised by the Full Court of the Federal Court in Wong v Sklovas [2014] FCAFC 120 at [12] as follows:
Although the parties referred to several authorities concerning the requirement for subpoenaed documents to have apparent relevance to an issue in a proceeding, in our opinion, the applicable principles are well established. The party issuing a subpoena bears the onus of demonstrating that the subpoena has a legitimate forensic purpose in relation to the issues in the proceedings: Santos Ltd v Pipelines Authority of South Australia (1996) 66 SASR 38 at 52. A subpoena may be set aside if it requires the production of documents which do not have apparent relevance to the issues arising on the pleadings: Trade Practice Commission v Arnotts Ltd (No 2) (1989) 88 ALR 90; Campaign Master (UK) Ltd v Forty Two International Pty Ltd (No 4) [2010] FCA 398; (2010) 269 ALR 76 at [39]-[40]; McHugh v Australian Jockey Club Limited [No 2] [2011] FCA 724 at [13]; McIlwain v Ramsey Food Packaging Pty Ltd [2005] FCA 1233; (2005) 221 ALR 785 at [35]; Dorajay Pty Ltd v Aristocrat Leisure Ltd [2005] FCA 558 at [17]. Other cases have used different terminology, but with essentially the same effect, for example, by requiring that, viewed realistically, the documents sought have a bearing on an issue which is not unreal, fanciful or speculative (R v Barton (1981) 2 NSWLR 414 at 420), or that the material sought is reasonably likely to add in some way to the relevant evidence in the case (Spencer Motors Pty Ltd v LNC Industries Ltd (1982) 2 NSWLR 921 at 927), or that it be “on the cards” that the documents sought will materially assist the party at whose request the subpoena has been issued: Allister v The Queen (1984) 154 CLR 404 at 414; Tamawood Ltd v Habitare Developments Pty Ltd [2009] FCA 364 at [13], [35]-[38].
It has been noted that “the notion of legitimate forensic purpose defines the content of apparent relevance”.[2]
[2]“The confetti of the justice system – Subpoenas, justice and third parties” – Coles, Benjamin – Australian Bar Review (2016) 42 at 390.
THE PURPOSE OF THE SUMMONS
As will be apparent, the summons is directed to material provided to the TGA by other manufacturers and which resulted in the respondent being satisfied that the nominated devices complied with the Essential Principles. TFS asserts that the identified medical devices are similar to the TFS Device.
In a letter dated 11 November 2016 directed to explaining the purpose of the summons, TFS contended that the material sought would be likely to assist the Tribunal in a number of ways. First, TFS contended that the documents would be likely to assist the Tribunal in determining the standard that should be applied in deciding whether a sponsor has complied with the Essential Principles. In other words, material illustrating the standard that the TGA had applied to other devices would assist the Tribunal in determining what standard should be applied in this matter and whether TFS had met the applicable standard.
In its written submissions provided on 25 November 2016, TFS also made reference to another potential forensic purpose of the summons as follows:
It is a matter for the Tribunal to determine whether documents the subject of the summons meets the test, and whether the documents will have probative value to an issue in the case. One of the issues in the case (in fact, the principal issue) is whether or not TFS Manufacturing has complied Essential Principles 2, 6 and 14. Expert evidence has been deployed by the TGA going to the issue of compliance. It will be necessary for the Tribunal to make findings by reference to the expert evidence of both parties. The making of such findings will necessarily involve accepting some experts and perhaps not others or accepting some experts in part.
The documents sought will evidence the calibre and extent of evidence which has been held to evidence compliance with the Essential Principles in relation to similar devices. The inconsistent positions which TFS Manufacturing has identified in the expert evidence now relied upon by the TGA as compared to the earlier evidence of the independent evaluators regarding the TFS device establishes the platform of relevance of how similar devices have been evaluated for compliance with the Essential Principles.
…
If, as the TGA contends, it is entirely a matter for the Tribunal on a merits review to make the correct or preferable decision, then evidence which assists the Tribunal to assess the probative value of expert evidence now proffered by the TGA will plainly be relevant to and add in a material way to the resolution of the issues in the case. This is because evidence of the evaluation of similar devices which have been and remain registered (because compliance has been demonstrated with the Essential Principles) is evidence of the regulatory framework to which the Tribunal can have regard in reaching its own decision in the present case.[3]
[3] Applicant’s submissions dated 24 November 2016, at [1.3], [1.4] and [1.7].
In its written submissions, TFS also maintained that the material sought by the summons would assist the Tribunal in determining the applicable standard.
ORAL SUBMISSIONS
In his oral submissions on behalf of TFS, Mr Harris QC focussed more on the alternative forensic purpose, that is, the potential use of the material in testing the expert evidence called by the respondent. He drew attention to the affidavit of Mr Kelly, First Assistant Secretary, dated 15 June 2015 and filed on behalf of the respondent. This affidavit explained the background to the respondent’s decision to remove the TFS Device from the Register.
In the affidavit, Mr Kelly explained that the TGA has power to conduct post-market reviews and that the TGA had initiated an “own motion” review in 2012 of stress urinary incontinence and pelvic organ prolapse medical devices included on the Register.[4] As I understand it, it was this post-market review which ultimately led to cancellation of the registration of the TFS Device, while the other devices listed in the proposed summons were also subjected to the review but registration of those devices was not cancelled. In other words, the other devices were found to be compliant with the Essential Principles.
[4] Affidavit of Lawrence Francis Kelly dated 15 June 2015, [17].
Mr Harris contended that in this context, the material put forward by the sponsors of other devices to satisfy the Essential Principles was of potential relevance to the task facing the Tribunal. For example, Mr Harris pointed out that the expert evidence currently relied upon by the respondent was critical of a literature search provided by TFS, and referred to the Cochrane standard as being the “gold standard” for literature reviews. Mr Harris contended that the nature and type of literature reviews submitted by the other sponsors could be relevant to the Tribunal’s task of determining whether the literature review provided by TFS, in conjunction with the other evidence put forward, was sufficient to satisfy the Essential Principles.
As I understand the proposition put by Mr Harris, in this part of his submission he was not contending that the Tribunal should gauge the applicable standard from the material provided in other matters and then apply that standard here. Rather, he was suggesting that TFS may seek to put the summonsed material to the experts giving evidence for the respondent at the hearing in order to test the validity of their opinions. For example, if it transpired that none of the other sponsors had provided literature reviews which met the Cochrane standard and yet they were all assessed as compliant with the Essential Principles, this may lead to concessions from the respondent’s experts, or support a contention that their approach to the application of the Essential Principles should not be accepted. In other words, Mr Harris suggested that the summonsed material could potentially provide fodder for cross-examination of the respondent’s experts, which may, in turn, provide the basis for a submission that the experts were applying an arbitrary or inappropriately high standard in considering whether the TFS Device met the Essential Principles.
Mr Harris also drew my attention to the fact that the experts now relied upon by the respondent had expressed the opinion that in considering whether TFS had met the Essential Principles, it was relevant to consider the extent to which randomised controlled trials had been carried out, whereas the internal TGA evaluators did not refer to the need for randomised controlled trials. Again, he submitted that in these circumstances it was relevant for TFS to be able to explore whether randomised controlled trials had been conducted by the other sponsors. If not, it would be open to TFS to question the respondent’s experts about this with a view to establishing whether the standard they had applied in determining whether the Essential Principles were met was unduly and inappropriately high, or their approach was in some way flawed.
Mr Harris contended that it was not speculation on the part of TFS that an inappropriate standard may have been applied by the respondent’s experts, given the lack of consistency between the approach taken by the internal evaluators and that now taken by those experts.
Mr Harris contended that there was, accordingly, a real possibility that material sought by the summons would assist in resolution of the controversy between the experts as to the standard to be applied in determining compliance with the Essential Principles, and the approach which should be taken to assessing compliance.
By way of reply on this issue, counsel for the respondent, Mr Begbie, maintained that the material would not assist, as each assessment process was different. For example, he said the TGA did not contend here and would never contend that every application for registration of a device similar to the TFS Device must be accompanied by a literature review to the Cochrane standard, or must have been the subject of a randomised controlled trial. He submitted that in every case the assessment was a complex process taking account of a range of different factors and the whole of the evidence submitted by the sponsor. For example, he submitted that in the context of a different device, whether there was a randomised controlled trial or a literature review to the Cochrane standard may not have been significant in view of the other evidence available.
Mr Begbie also contended that in fact the respondent’s experts did not advance the need for a literature review to the Cochrane standard or randomised controlled trials in the way suggested by Mr Harris. He contended that in each case the question was how all of the supporting material interacted, and whether as a whole it satisfied the Essential Principles.
CONSIDERATION
Having carefully considered all of these submissions, I acknowledge that the question of whether a summons should be issued in the terms sought by TFS is a relatively finely balanced one, particularly when regard is had to the second purpose advanced by TFS, namely the purpose of testing the evidence of the respondent’s experts.
With respect to the first purpose articulated, namely the purpose of assisting the Tribunal to determine what the applicable standard is, I am not satisfied that this would be a sufficient basis for issuing the summons in the terms sought.
I accept the respondent’s submission that it simply cannot assist for the Tribunal to receive information about the standard applied in other matters by the TGA. In my view, it is for the Tribunal to determine in the context of this matter what the appropriate standard is and whether or to what extent the TGA has applied that standard in the past cannot assist (assuming this could be determined). Put simply, whether the TGA has applied a different standard in the past is not something which is relevant for the Tribunal’s purposes.
When it comes to the purpose of testing the evidence of the respondent’s experts, however, I consider that TFS are on somewhat stronger ground, and I note that Mr Begbie did not contest the proposition that if material sought by a summons can potentially be used in cross-examination to produce relevant evidence, that may be sufficient to give it a legitimate forensic purpose.
Mr Harris’ contention is that if inconsistencies are revealed between the approach that the respondent’s experts have taken in giving their opinions in this matter and the way similar evidence has been evaluated by the TGA in other contexts, this may provide fertile ground for cross-examination, and assist the Tribunal in better understanding why the respondent’s experts have formed the view that particular requirements should be met by TFS in order to comply with the Essential Principles. In other words, Mr Harris submitted that even if the material sought by the summons is not relevant in its own right, it can potentially be used during cross-examination to produce relevant evidence from the respondent’s experts, and may be relevant to assessing their evidence.
Evaluating this submission accordingly involves attempting to assess the likelihood that material produced in answer to the summons would ultimately be put to the respondent’s experts and, if it is put to them, the likelihood that this would in fact yield relevant evidence.
I accept that if the summons was issued and if TFS formed the view that the approach taken by the TGA with respect to the other devices, or any of them, was inconsistent with the approach the respondent’s experts have taken to the TFS device, it is likely that some aspects of the summonsed material would be put to the respondent’s experts during cross-examination. However I have greater difficulty in accepting that this would be likely to yield relevant evidence which would be of assistance to the Tribunal.
There are a number of reasons for this.
First, the respondent’s experts have been asked, as experts in their fields, to give evidence which the respondent now relies upon in preference to the opinions of the internal evaluators. They have been asked to address very specific issues which are inherently matters of opinion and which they appear to be qualified to address, such as whether the TFS device conforms to safety principles, whether the benefits of the device outweigh any undesirable effects, and whether TFS has provided sufficient clinical evidence to demonstrate compliance with the other Principles. In these circumstances, it is to some extent inherently unlikely that their opinions on these issues would be influenced by the opinions reached by internal TGA evaluators or decision-makers with respect to other devices on the basis of different material. This is not a situation where the material sought to be put is inherently likely to bear upon the opinion of the expert – such as where a doctor may change their opinion when given a different history with respect to a particular patient. Here the matter which is sought to be put relates to an opinion formed by another expert with respect to a different device in the context of entirely different material. Arguably, there is little reason to expect that this would have any direct bearing on the opinion formed and expressed by the relevant experts, or lead them to re-visit any aspect of their opinions.
Secondly and more importantly, in my view it is even less likely that the respondent’s experts could provide meaningful comment on the TGA’s assessment of other devices, or make meaningful concessions in light of this, without being able to review the totality of the material provided to support the registration of the relevant device. For example, I accept Mr Begbie’s point that it could potentially transpire that even if no randomised controlled trials had been done in relation to another device, and no Cochrane review had been undertaken, in light of the other evidence provided, neither of those things was considered necessary, either by the TGA or the respondent’s expert. It is very unlikely in my view that the respondent’s experts would be in a positon to comment on these issues without having reviewed all of the relevant material relating to the relevant device. Even if they were willing to comment without having reviewed all of the relevant material, it is unlikely in my view that such evidence would assist the Tribunal. For the same reasons, it is also very unlikely that, unaccompanied by expert analysis, the material by itself would assist the Tribunal in assessing the evidence of the experts.
I acknowledge that if the respondent’s experts were invited to review all of the material provided to support registration of all or any of the other five devices, having done so they may be in a position to make some observations which would be of interest in the context of this matter.
However, I am also of the view that it would not be appropriate for the respondent’s experts, or indeed for any of the experts, to be asked or required to review all or any of the material provided to support the registration of devices which are not the subject of the application to the Tribunal. This would greatly enlarge the dispute, greatly add to the complexity and cost of the litigation, and be likely to add significant delay, all for very little benefit in my view given the very limited bearing the resulting evidence would be likely to have on the ultimate issue before the Tribunal. In effect, this would involve the Tribunal, under the guise of conducting a merits review with respect to the TFS device, also conducting an inquiry into the assessment process relating to a number of other devices, not the subject of any application to the Tribunal. Arguably, this would involve straying beyond the proper limits of the Tribunal’s jurisdiction. In any event, it would not be consistent with the Tribunal’s statutory objective of providing a mechanism of review which is fair, just, economical, informal, quick and proportionate[5].
[5] AAT Act, s 2A.
As it would not be appropriate for the experts to be asked to review material provided to the TGA with respect to the other devices with a view to providing opinions about the assessment of those devices, it follows in my view that even if the summons yielded evidence which TFS regarded as relevant and this was put to the respondent’s expert witnesses, the likelihood of this resulting in relevant evidence which would assist the Tribunal is extremely low. As I have already indicated, I also do not consider that the material will have any relevance in its own right. It therefore follows that I am not satisfied that the material sought by the summons has apparent relevance to the issues in the substantive application.
In addition, if the summons was issued, it would involve a significant infringement of the confidentiality which would generally attach to material of this nature. I accept that considerations of this kind are not central to whether a summons should issue. However nor are they irrelevant. Each of the owners of the relevant material have come forward and objected to it being provided to TFS. They have asserted that the material is commercial in confidence and/or contains trade secrets. These concerns could potentially be addressed to some extent by confidentiality orders restricting access to TFS’ lawyers. However, consideration would need to be given to the extent to which this was practical. It may not be feasible for example for TFS’ lawyers not to be able to take instructions about the material or its implications.
In my view, these considerations also militate against the issue of the summons.
For these reasons, I have ultimately concluded that the documents sought by the summons do not have apparent relevance to the issues in the application and therefore the summons does not in fact have a legitimate forensic purpose. Although they are minor considerations, I also consider that the confidential nature of the material and the public interest in maintaining that confidence militate against issuing the summons.
DECISION
I have accordingly decided pursuant to s 40A of the AAT Act to decline to issue the summons the subject of the request made by TFS on 13 October of this year.
I certify that the preceding 40 (forty) paragraphs are a true copy of the reasons for the decision herein of Deputy President K Bean ........ [Sgd] .........................................
Administrative Assistant
Dated 22 December 2016
Date of hearing 29 November 2016 Counsel for the Applicant Mr A Harris QC Solicitors for the Applicant Mr A Rosser
Cosoff Cudmore KnoxCounsel for the Respondent Mr T Begbie Solicitors for the Respondent Mr K Teoh
Regulatory Legal Services Branch Department of HealthCounsel for the Other Party Mr S Ower SC
Solicitors for the Other Party Norton Rose Fulbright
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