Quayle v Smith and Nephew Surgical Pty Ltd
[2020] ACTSC 229
•24 August 2020
SUPREME COURT OF THE AUSTRALIAN CAPITAL TERRITORY
Case Title: | Quayle v Smith & Nephew Surgical Pty Ltd |
Citation: | [2020] ACTSC 229 |
Hearing Date: | 26 June 2020 |
DecisionDate: | 24 August 2020 |
Before: | McWilliam AsJ |
Decision: | See [135] |
Catchwords: | PRACTICE AND PROCEDURE – PRELIMINARY DISCOVERY – whether sufficient foundation for the causes of action identified exists – whether reasonable inquiries have been made – whether documents are in ‘possession’ of a party – whether there is a legal right to request documents from another source – whether the documents sought would help the applicant to decide whether to commence proceedings |
Legislation Cited: | Competition and Consumer Act 2010 (Cth) - Sch 2 (ss 9, 54, 55, 138) Civil Law (Wrongs) Act 2002 (ACT) - s 43 Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) – Sch 1, Sch 3 |
Cases Cited: | Arnaout v Arnaout [2019] NSWSC 565 Ashton and Ors v The Australian Capital Territory [2019] ACTSC 93 Waller v Waller [2009] WASCA 61 |
Parties: | Jason Quayle (Applicant) Smith & Nephew Orthopaedics Ltd (First Respondent) Smith & Nephew Surgical Pty Ltd (Second Respondent) |
Representation: | Counsel J Sheller SC (Applicant) M Walsh SC (Second Respondent) |
| Solicitors Rise Lawyers (Applicant) Norton Rose Fulbright Australia (Second Respondent) | |
File Number: | SC 476 of 2019 |
McWilliam AsJ:
Introduction
This is an application for preliminary discovery pursuant to r 651 of the Court Procedures Rules 2006 (ACT) (Rules). The applicant is a recipient of two hip prostheses described as the Smith & Nephew Birmingham Hip Resurfacing (BHR) system (the prostheses). He alleges that he suffered personal injury as a result of receiving the two prostheses in June 2013 and August 2013 to his right and left hips respectively. The applicant subsequently had revision surgery on 21 July 2015 for the right hip, and on 18 May 2016 for the left hip.
The first respondent, Smith & Nephew Orthopaedics Ltd, is the manufacturer of the prostheses (the manufacturer). The second respondent, Smith & Nephew Surgical Pty Ltd, is the ‘sponsor’ of the prostheses (the sponsor) for the purposes of the Therapeutic Goods Act 1989 (Cth) (TG Act).
The applicant is considering bringing proceedings against either the manufacturer or the sponsor of the prostheses (or both) and has applied to this Court for the discovery of documents preliminary to the taking of any such action. The causes of action in contemplation fall into two categories. The first is an action in negligence. The second is a statutory action under Sch 2 of the Competition and Consumer Act 2010 (Cth) (Australian Consumer Law) for a number of contraventions, discussed below.
The present application only proceeded against the sponsor, due to a service issue with the manufacturer, who is based in the United Kingdom.
The application has been brought because the applicant asserts that neither the sponsor nor the manufacturer have provided him with information sufficient to enable him to decide whether the causes of action he has in contemplation may reasonably be commenced.
The Court’s power
The Court’s power to grant the relief sought by the applicant is to be found in r 651 of the Rules, which is in the following terms:
651 Discovery to identify right to claim relief
(1)This rule applies if –
(a) a person (the applicant) has, or may have, a cause of action against someone (the potential defendant); and
(b) either –
(i) the applicant, after making reasonable inquiries, cannot obtain sufficient information to decide whether to start a proceeding in the court against the potential defendant for the cause of action; or
(ii) … ; and
(c) the applicant has reasonable grounds for believing that the potential defendant has or has had possession of a document or thing that can assist in deciding whether to start the proceeding, or make the claim for relief, against the potential defendant; and
(d) inspection of the document or thing by the applicant would help in making that decision.
(2) If subrule (1)(b)(i) applies, the applicant may apply to the court by originating application for an order under this rule (and, if relevant, an order under rule 715 (inspection, detention, custody and preservation of property – orders etc)) against the potential defendant.
(3) …
(4) The application must be supported by an affidavit stating the facts on which the applicant relies, and stating the kinds of documents or things in relation to which the application is made.
…
(5) The court may order the potential defendant to produce the document or thing to the applicant.
(6) … .
It can be seen from the above rule that the power to grant discovery requires consideration of the four matters set out in each of the paragraphs enumerated in r 651(1), as the power is only enlivened upon their satisfaction. The sponsor contests each of those matters. Therefore, the key issues for determination on this application are:
(a) First, does the applicant have, or may the applicant have, a potential cause of action?
(b) Second, have reasonable inquiries been made?
(c) Third, does the applicant have reasonable grounds for believing that the potential defendant has or has had possession of documents that can assist in deciding whether to start the proceeding?
(d) Fourth, would inspection of the documents help in deciding whether to commence proceedings?
In previous applications of this type, the third and fourth questions have been dealt with together, as possession has not been in issue and the questions of whether documents can assist, and then whether inspection of the documents sought would assist, partially overlap. The dispute between the parties in those cases has not been about possession, but about the breadth of the documents sought (see, eg Ashton and Ors v The Australian Capital Territory [2019] ACTSC 93 (Ashton) at [46]-[77]). In the present case however, the sponsor contests whether there are reasonable grounds for believing that it actually possesses information which could assist in deciding whether to commence proceedings. The issue of ‘possession’ therefore requires separate consideration.
General principles applicable to the exercise of the Court’s discretion under r 651
In other jurisdictions, similar powers exist for courts to make orders for preliminary discovery. There are some differences in the wording of the respective procedural rules. For example, in New South Wales, r 5.3 of the Uniform Civil Procedure Rules 2005 (NSW), the test is whether ‘it appears to the court’ that the applicant may have a right to obtain relief, that the prospective defendant likely has possession of documents and that inspection would assist. In the Federal Court of Australia, r 7.23 of the Federal Court Rules 2011 (Cth) (previously O 15A r 6) requires a reasonable belief on the part of the applicant as to the abovementioned matters, to the satisfaction of the Court.
Noting those differences and the caution that must be applied as a result, some of the general principles that have been applied in other jurisdictions remain applicable to r 651 and guide the exercise of the Court’s discretion. I have included below what I consider to be the principles relevant to the circumstances of this case. It is not an exhaustive list.
The Court’s discretion
If the preconditions for the making of an order for preliminary discovery are made out, the making of such an order remains in the discretion of the Court: Arnaout v Arnaout [2019] NSWSC 565 (Arnaout) at [32]. The discretion is to be exercised where it is ‘necessary in the interests of justice’: John Fairfax & Sons Ltd v Cojuangco (1988) 165 CLR 346 at 357.
In exercising the discretion whether to grant an application for preliminary discovery, the Court may consider a variety of factors. To that end, the following extract from Central Exchange Ltd v Anaconda Nickel Ltd [2002] WASCA 94; 26 WAR 33 at [83] per Steytler JA, is of assistance:
A Court, in considering whether or not to exercise the discretion afforded it … or, to put it differently, in considering whether or not the order is reasonably necessary to achieve the proper administration of justice, will ordinarily take into account a range of factors. Without attempting to be exhaustive, these will usually include such things as the likelihood that a cause of action of the kind suggested will be found to exist, the nature and significance of that potential cause of action, the likely effect, on the person against whom discovery is sought, of the making of an order of the kind contended for, whether there is any other adequate means, available to the intending plaintiff, of obtaining the information which it seeks, the nature and confidentiality of the documents proposed to be obtained, the possible significance of the information contained within those documents to the decision whether or not to commence the contemplated proceedings, whether the applicant is able to compensate the potential party for its cost of complying with the order and whether there is any evidence of bad faith on the part of the applicant.
In forming a view about what is ‘necessary’ in the interests of justice, the Court may also take into account the availability of discovery procedures (including subpoenas for the production of documents, notices to produce, discovery and interrogatories) against a defendant after the commencement of substantive proceedings, and any restrictions on the availability of interlocutory discovery procedures provided for in the Rules or in a practice direction: Arnaout at [35].
Extraordinary nature of the relief
Relief under r 651 of the Rules is extraordinary, in that any order made pursuant to that rule affects persons who are not yet involved in litigation. Courts must therefore be cautious when deciding whether to make such an order: Ashton at [47], citing Elmaraazey v The Law Society of the Australian Capital Territory [2006] ACTSC 124; 205 FLR 445 at [18].
However, although the cautious exercise of the power means that an order under r 651 is not made as a matter of course, the rule is to be construed beneficially: see RinRim Pty Ltd v Deutsche Australia Ltd [2013] NSWSC 1762 at [43] and the cases there-cited.
The threshold for relief
The threshold set by r 651 is low, because all that is required is that the applicant may have a cause of action, and that a prospective defendant has a document which can assist in a decision whether to make a claim for relief based on the particular cause of action: see O’Connor v O’Connor [2018] NSWCA 214 (O’Connor) at [23].
The interlocutory character of an application for preliminary discovery also needs to be borne in mind, so that the Court should not dismiss at a preliminary stage what may be a legitimate and arguable case. The Court would not lightly conclude that an application should be dismissed as not supporting a conclusion that the applicant may have had a cause of action: see O’Connor at [69]-[76], cited in Arnaout at [32].
Information which bears upon the decision to start proceedings
Information bearing upon an applicant’s decision whether or not to commence proceedings against a prospective defendant may include questions such as:
(i) ‘whether there exist defences that might defeat a claim; and
(ii) whether a claim would potentially be worthwhile in the sense of yielding an award of damages or other order sufficient to justify the commencement of proceedings’: Arnaout at [32].
In considering whether an applicant has sufficient information to decide whether or not to commence proceedings against a prospective defendant, an objective assessment of the information already held by the applicant is required: Arnaout at [32].
Onus
The onus is on the applicant to satisfy the Court of each of the matters required under r 651: Morton v Nylex Ltd [2007] NSWSC 562 (Morton) at [33], cited in Hall v Commonwealth [2018] ACTSC 79 (Hall) at [22] and Ashton at [11].
Documents sought in the present application
The documents sought by the applicant are set out in ‘Annexure 1’ to the Originating Application filed on 20 September 2019 under six different ‘categories of discovery’. The list is detailed. A summary of the documents by reference to their categories is as follows:
Category 1 documents relating to the prostheses’ conformity assessment
Category 2 documents supporting the prostheses’ declaration of conformity
Category 3 information pertaining to the manufacturer’s quality management system
Category 4 information in relation to production quality assurance procedures
Category 5 documents held by the manufacturer comprising product quality assurance procedures
Category 6 other notification information held by the sponsor and the manufacturer
The reference to a ‘conformity assessment’ is a reference to a procedure required under the TG Act relating to the application of quality management systems for medical devices (ss 41D and 41DA). Such systems ensure that a medical device complies with ‘essential principles’, a term defined in s 41CA of the TG Act by reference to Sch 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) (Regulations).
Schedule 1 of the Regulations is itself very detailed, but by way of general understanding only, the ‘essential principles’ cover areas such as safety, performance, benefits and risks. They include requirements like ensuring that a medical device does not compromise health and safety in its design, that any risks associated with its use are compatible with a high level of protection of health and safety, and that the device performs in the way intended by the manufacturer.
For the purposes of this application, it is not necessary to explain further the requirements for conformity assessments, nor the detailed procedures and declarations under the TG Act. It suffices to note that in meeting the requirements under the TG Act, manufacturers are required to retain certain written information about their products, and sponsors are required to have arrangements in place whereby they can compel access to that information, part of which the applicant seeks through the present application.
Similarly, the references to terms such as ‘quality management system’, and ‘product quality assurance procedures’ are each referred to in the Regulations. The specific clauses where those terms are to be found was provided in Annexure 1.
However, the last category of the above list does require further explanation in order to understand it and the breadth of documents being sought under it. The ‘notification information’ sought includes the following:
(a) three annual reports provided to the Therapeutic Goods Administration (the TGA) following inclusion of the prosthesis on the Australian Register of Therapeutic Goods (the Register);
(b) all information about adverse events, including all information mentioned in s 41MP(2) of the TG Act;
(c) all complaints received by the sponsor or manufacturer relating to the use of the device (however named) in other countries;
(d) any corrective action and recalls of the device, made in any jurisdiction; and
(e) all details of any legal claims made against either the sponsor or manufacturer in relation to the device, particularly in relation to safety, fitness, durability, fault or defectiveness of the prosthesis.
The reference to s 41MP of the TG Act refers to a criminal offence provision. Under sub-s (1) of that section, if a person (relevantly in this case, a sponsor) knows that particular information is of a kind mentioned in sub-s (2) and fails to give that information to the Secretary of the Register within a certain period specified in the Regulations, that person commits a criminal offence, the penalty for which is imprisonment for 12 months or 1,000 penalty units or both.
Subsection (2) is a detailed list of the kinds of information that trigger sub-s (1). As it is important in the reasoning below as to how to exercise the discretion (concerning the nature and breadth of the documents sought by the applicant), it is set out in full as follows:
(2)The information with which subsection (1) is concerned is information of the following kinds:
(a)information relating to:
(i) any malfunction or deterioration in the characteristics or performance of the kind of device; or
(ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or
(iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;
that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health;
(b)information relating to any technical or medical reason for a malfunction or deterioration of a kind referred to in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed;
(c) information that indicates that a device of that kind does not comply with the essential principles;
(d) information that indicates that a certificate or other document (other than a certificate or other document issued by the Secretary under this Act) used for the purpose of an application under subsection 41FC(1) to signify:
(i) compliance with the essential principles; or
(ii) the application of relevant conformity assessment procedures to a device of that kind or the application of requirements, comparable to those procedures, to a device of that kind;
has been restricted, suspended, revoked or is no longer in effect.
Issue 1: Does the applicant have a potential cause of action?
A potential cause of action must first be identified. Rule 651 does not apply so as to facilitate ‘an open inquiry as to whether any cause of action might exist’: Hall (at [10] per Elkaim J).
Once a cause of action has been identified, some ‘tangible backing’ or ‘objective foundation’ that makes the identified cause of action more than a mere allegation or suspicion must also be demonstrated: Waller v Waller [2009] WASCA 61 at [75]; Minerva (Aust) Pty Ltd v Suburban Land Agency [2018] ACTSC 103 at [25]; Hall at [18]; and Hooper v Kirella Pty Ltd [199] FCA 1584; 96 FCR 1 at 11-12.
The wording of r 651 includes that the applicant ‘may’ have a cause of action. Accordingly, the applicant is not required to demonstrate that a prima facie case on a cause of action exists: see Hall at [10]; and Hatfield v TCN Channel Nine Pty Ltd [2010] NSWCA 69; 77 NSWLR 506 (Hatfield) at [47]. Nor is it necessary that an applicant specify with precision the cause of action proposed, beyond particularisation of the nature of the relief in contemplation: Arnaout at [32].
However, it is insufficient to point to a mere possibility that a cause of action exists or to engage in suspicion or conjecture. The evidence must ‘incline the mind’ towards the matter or fact in question, and it will be sufficient if there is reasonable cause to believe that the applicant may have a right of action against the respondent resting on some recognised legal ground: Hatfield at [49], cited in O’Connor at [27].
Has a cause of action been identified?
Here, the Originating Application identifies three potential causes of action under the Australian Consumer Law, described as follows:
(a) the safety of the implants was not such as persons were entitled to expect pursuant to ss 9 and 138 of the Australian Consumer Law;
(b) the implants were not reasonably fit for purpose within the meaning of s 55 of the Australian Consumer Law; and
(c) the implants were not of acceptable quality within the meaning of s 54 of the Australian Consumer Law.
There is also a cause of action in negligence under consideration, identified in the Originating Application in the following terms:
(d) The potential defendants were negligent in the design, manufacture or warnings in respect of the device.
Do the causes of action identified have an objective foundation?
For the purposes of this application only, the following facts were not contested:
(a) the applicant is 51 years of age;
(b) the applicant has undergone hip surgery, first to his right hip on or about 13 June 2013, and then to his left hip on or about 26 August 2013;
(c) on each occasion, the applicant received a Smith and Nephew BHR system hip prosthesis; and
(d) the manufacturer and the sponsor of each prosthesis are the respondents named in the present application.
The clinical notes and reports indicate that the applicant suffered metallosis affecting his right and left hips. That conclusion arises either as an inference to be drawn from the medical observations of steadily climbing serum metal ion levels in the applicant’s blood tests in the case of the right hip, or, in the case of the left hip, as diagnosed by the applicant’s orthopaedic surgeon. Revision surgery was required for each hip. This was undertaken on 21 July 2015 for the right hip, and 18 May 2016 for the left hip, and resulted in a total hip replacement due to ‘progressive metal bearing wear’.
The applicant’s submissions
The applicant believes he suffered personal injury as a result of a ‘product liability incident’. He believes the prostheses were faulty, either in their manufacture, design or in the warnings given in relation to their use. Alternatively, the applicant is considering whether the prostheses were not ‘fit for purpose’ or not of ‘acceptable quality’, those terms being the language used in the statutory guarantees set out in ss 54 and 55 of the Australian Consumer Law.
As part of these investigations, the applicant is attempting to determine whether the manufacturer complied with its duties under s 41FN of the TG Act and Sch 3, cl 1 of the Regulations. The applicant asserts that the causes of action depend, in part, on the clinical testing conducted on the prostheses, whether the requirements for inclusion of the prostheses on the Register were complied with, and on the labels and warnings provided with the prostheses.
Section 41FN of the TG Act creates conditions which must be complied with when a medical device is included on the Register.
Among others, there are conditions about:
(a) having sufficient information available to substantiate compliance with the ‘essential principles’ at all times, including having a written agreement in place with the relevant manufacturer to ensure that such information can be obtained within the period specified in the Regulations: s 41FN(3)(a);
(b) having sufficient information available to substantiate that the ‘conformity assessment procedures’ have been applied, or a written agreement with the manufacturer to obtain the said information within the time specified in the Regulations: s 41FN(3)(b);
(c) ensuring that advertising material relating to the medical device in question is consistent with its intended purpose: s 41FN(5); and
(d) a general condition that inclusion in the Register is subject to such further conditions as are prescribed in the Regulations: s 41FN(5A).
The applicant also drew attention to s 41MPA of the TG Act, which is a civil penalty provision for failing to notify the Secretary of the Register with information concerning the malfunction, inadequacy, contrary use or failure to comply with the regulation requirements of a device on the Register.
Among the evidence relied upon by the applicant was publicly available information about a number of hazard alerts issued by the TGA concerning the BHR system. The latest of these was on 9 May 2016 and included a warning concerning the BHR prosthesis with respect to males aged under 65 years with a BHR prostheses femoral head size over or equal to 50mm, the type of prosthesis the applicant in fact received.
The applicant also identified legal principles relevant to the causes of action in contemplation, drawing the Court’s attention to a judgment of the Federal Court of Australia in Gill v Ethicon Sarl (No 5) [2019] FCA 1905 (Gill) as to what steps a ‘reasonable manufacturer’ would take when placing medical devices on the market.
The applicant submits that the above facts established by the clinical records, combined with the statutory obligations, the publicly available information and the legal principles set out in Gill create sufficient foundation for the Court to be satisfied the claims in contemplation have ‘tangible backing’.
Sponsor’s submissions
The sponsor argues that on the available evidence, the potential causes of action do not go beyond being a mere allegation, suspicion or assertion. A number of arguments were made in support of that conclusion, some of which are conveniently dealt with together as all being directed to an insufficiency of evidence:
(a) The applicant has not provided enough evidence as to the factors leading him to characterise any ‘product liability incident’ other than the need for revision of the prostheses.
(b) The applicant has not provided admissible evidence of the harm or personal injury occasioned (through lay or expert evidence regarding his injury), within the meaning of the Civil Law (Wrongs) Act 2002 (ACT). The sponsor submits that the Court is left to speculate as to the nature of the injury which it is asserted the applicant did suffer.
(c) The applicant has failed to provide evidence from his treating orthopaedic surgeons as to any causal relation between the injury suffered and the prostheses, or from any relevantly qualified expert as to any safety defect, lack of fitness for purpose or departure from acceptable quality of the prostheses, within the meaning of the Australian Consumer Law.
(d) The applicant has not provided evidence which demonstrates any negligence in the design and manufacture of the prostheses, nor in relation to any warnings.
Part of the evidence on the application also included ‘hazard alerts’ issued by the TGA. One of the problems raised by the applicant in terms of the available information (discussed below) was that the underlying reasons for issuing those alerts are not publicly available. The sponsor argues that the lack of reasoning behind a hazard alert does not inform or establish a belief that the applicant may have a cause of action against the sponsor.
In relation to the potential statutory causes of action under the Australian Consumer Law, the sponsor again argues that they are merely speculative. There is no objective basis for a belief as to a potential cause of action based on whether the sponsor complied with the conditions for inclusion of the prostheses on the Register.
The sponsor referred to part of the affidavit evidence of the solicitor for the applicant, which was in the following terms:
It is crucial to our client’s claim that we understand specifically … information provided to the notified body in respect of approval of the device … information that came to it following and during its circulation of the product and prior to supply of the product to our client, … and the consumer facing information that your client provided to the public, treatment providers and our client prior to our client’s receipt of the prothesis.
The sponsor argues it is ‘officious’ to seek the information required to be provided by the sponsor under ss 41FN and 41MPA of the TG Act (which govern the conditions of inclusion on the Register) as part of an application for preliminary discovery. Provision is made in the TG Act for the keeping of information and documents regarding compliance to support the duties and powers of the Secretary of the Register. To seek such information intrudes upon those duties and powers. Similarly, the power to require a sponsor to ask for information from a manufacturer is a power exercisable by a particular person (the Secretary), and for a particular purpose.
The sponsor submits that whether it has complied with the conditions applicable to inclusion of the device on the Register is the function assigned to the Secretary under the legislation. The purpose of preliminary discovery for a potential personal injury claim does not reach the provision of information necessary to assess compliance with the legislation.
The sponsor also submits that it is erroneous for the applicant to invoke compliance with the Register conditions in support of a cause of action in negligence. The matter of compliance goes only to a question of breach of the TGA. In any event, the sponsor submits that the existence or content of any duty of care owed by the sponsor is not informed by that fact and is without foundation.
The sponsor further says that the decision in Gill is distinguishable from the current application because that case did not involve a situation such as an application for preliminary discovery in which the court is not provided with all the relevant evidence. Further, the circumstances of the litigation in Gill and the subject surgical mesh medical devices in question in those proceedings are significantly different to those which inform the applicant’s BHR devices.
Consideration
The applicant has provided sufficient clinical records to establish that he has had the prostheses inserted, that he did experience problems following the insertion of the prostheses, and that he did have to undergo revision surgery. Although there was not an expert report from an orthopaedic surgeon provided, there were in evidence clinical reports from the treating orthopaedic surgeon as to what he thought the issues were, giving rise to the need for revision surgery. They included a diagnosis of metallosis and of a need for further surgery due to progressive metal bearing wear.
It is also not disputed that the revision surgery was undertaken within two to three years, which indicates that something was not right and leading to a reasonable concern about whether the prostheses were of suitable quality, or fit for purpose in a man of the applicant’s age. That is further supported by the hazard alert of at least 9 May 2016 (referred to at [42] above).
I accept that there are gaps in the evidence, and that the mere fact that further surgery was required does not of itself establish either negligence or a contravention of the Australian Consumer Law. However, that does not mean that the facts rise no higher than a suspicion or a bare assertion. There is sufficient factual foundation in the evidence on the application to give rise to an objective concern that the prostheses were not operating as they should. That in turn suggests that the prostheses were either defective or that they were not the right medical device for a man aged around 50. The exact details of the cause of action in negligence or under the Australian Consumer Law are not yet formulated, but the authorities referred to above establish that it is not necessary that either action be specified with that type of precision.
The submissions made by the sponsor as to an insufficiency of evidence set the bar too high on an application of this type. Where detailed clinical records including a report from the treating orthopaedic surgeon are in evidence, it is not necessary for an applicant considering a claim in negligence to support an application for preliminary discovery with evidence sufficient to establish the cause of action as if proceedings had already been commenced.
The submissions directed to the statutory causes of action under the Australian Consumer Law were somewhat misconceived. The sponsor’s submissions focused on the documents sought by reference to the TG Act (discussed below as part of a consideration of whether the sponsor has documents which would assist), rather than addressing whether the existing facts and law objectively created some foundation for the causes of action in contemplation.
While the sponsor is correct to submit that compliance under the TG Act is a legally distinct issue from the causes of action under contemplation, it does not follow that compliance is only relevant to a question of a breach of the TG Act (with the converse submission that any non-compliance with the TG Act is irrelevant to negligence or a statutory action under the Australian Consumer Law).
Part of the legal matrix relevant to causes of action in negligence and the Australian Consumer Law includes the provisions of the TG Act. This is because the TG Act places requirements upon sponsors and manufacturers which may inform both the duty of care in negligence and the statutory duty to ensure a medical device is of suitable quality and fit for purpose.
For example, a claim in negligence against the sponsor (as supplier of the prostheses) will require consideration of what standard of care was required and whether the sponsor met that standard. Section 43 of the Civil Law (Wrongs) Act expressly directs attention to what precautions against the risk of harm were taken. The provisions of the TG Act assist in creating the legal framework relevant to what a reasonable manufacturer or sponsor would have done to guard against a risk of either a defective medical device, or a prosthesis that was inappropriate for a certain age and gender. The question of what a reasonable sponsor would have done will no doubt be informed by the assumption that a reasonable sponsor would have complied with the requirements of the TG Act and the Regulations.
The standard of investigation and evaluation prior to marketing a medical device, and what a sponsor knew about the risks of using such a device compared with what they told the public, are also matters that are likely to be relevant to the statutory causes of action in contemplation, in addition to being matters relevant to compliance with the TG Act.
The decision of Gill also forms part of the legal framework by which the Court ascertains whether there is an objective foundation for the causes of action in contemplation. It is not to the point that the decision in Gill was not concerned with an application for preliminary discovery. It is relied upon by the applicant simply to provide further support to his belief that he may have a right of action existing against the sponsor, resting on some recognised legal ground, in that Gill concerned causes of action similar to what the applicant has in contemplation here.
Further, in Gill, both the manufacturer and the sponsor were among the respondents to the causes of action, which were brought in negligence and under the Australian Consumer Law. Justice Katzmann in the Federal Court of Australia found that the applicants in the case before her Honour were injured because of a defect in the particular medical devices the respondents in that case (two manufacturers and a sponsor) supplied to them. They were therefore entitled to compensation. Her Honour further found that the applicants were injured because of other contraventions, including of the Australian Consumer Law, and were therefore entitled to damages.
Gill may or may not ultimately assist in any proceedings that are commenced, but for the present application, it has relevance to the extent that it is an example of the application of recognised legal principles in a factual context involving both manufacturer and sponsor as respondents to the same causes of action being contemplated by the applicant.
I am therefore satisfied the applicant has established the first consideration, namely that he may have the potential causes of action identified.
Issue 2: Have reasonable inquiries been made without sufficient information being obtained?
Whether reasonable inquiries have been made ‘is a question of fact, to be considered in all the circumstances of the particular case’: Steffen v ANZ Banking Group Ltd [2009] NSWSC 666 (Steffen) at [15]. The Court can take into account factors such as the existence of other means of obtaining the information and the potential uncertainties, costs and delay connected to that. The relationship between the potential parties should also be considered: Steffen at [15].
As to the absence of sufficient information, an applicant must first disclose what information he (in this case) already has, and identify what information is lacking. This is because preliminary discovery should not be used to build up a case which an applicant has already decided, or could decide to bring: Morton at [33].
Applicant’s submissions
The applicant submits that reasonable inquiries to obtain information have been made. The affidavit of Ms Rosemary Listing, both the solicitor on the record and the solicitor with carriage of the matter for the applicant, affirmed 10 January 2020, outlines that on behalf of the applicant she has made a number of inquiries to obtain whatever relevant information is publicly available and has also sought documents and information from the sponsor. Ms Listing’s efforts have been summarised as follows:
(a) She has sought and obtained the applicant’s clinical notes in relation to his treatment at Calvary Hospital, Canberra Hospital and from specialist surgeons.
(b) She has sought and received email confirmation from the sponsor’s lawyers as to the identity of the manufacturer and sponsor of the hip prostheses received by the applicant.
(c) She has issued a freedom of information request to the TGA seeking a copy of the application for conformity assessment with respect to the hip prostheses received by the applicant. The TGA did not possess the relevant information because the hip prostheses in question had been assessed by an overseas notified body.
(d) She has then sought from the sponsor’s lawyers a copy of the TGA conformity assessment application and any information supplied in support of that application.
(e) She has sought from the sponsor’s lawyers information held by the manufacturer and sponsor of the hip prostheses in compliance with their obligations under the TG Act and the Regulations.
(f) She has undertaken investigations of publicly available information relating to the efficacy of the hip prostheses received by the applicant and his type of injury. This uncovered various hazard alerts, additional warnings and a recall. As far as she has been able to determine, the reasons for the hazard alerts (which I take to mean any test data or records of actual problems in patients) and the product use instructions are not publicly available.
(g) She has undertaken searches of the United states’ ‘Federal Drug Agency’ Alternative Summary Reporting Database, which I have taken to mean the US Food and Drug Administration. From the 300 reports found, it was not possible to discern which of those related to the precise device received by the applicant.
(h) She has also undertaken searches of the adverse events reporting database which forms part of the Register. Again, it was difficult to discern from the total notifications found which notifications related to the precise device received by the applicant, or correlated to the precise symptoms he suffered.
In relation to (d) and (e) above, the response received from the sponsor was first to state that the scope of information sought was wider than the scope of information their client was obliged to produce. Ms Listing has communicated that she was prepared to receive the documents the sponsor considered were within an appropriate scope (in addition to seeking the further documents by other means such as this application), and has explained in detail the importance of the information sought to the applicant’s contemplated claims. The documents sought have not been produced by the sponsor.
Relevant only to the sponsor, Ms Listing deposes to the belief that despite the information obtained, the applicant cannot obtain information sufficient to decide whether the sponsor complied with its obligations with respect to the automatic conditions applicable for the prosthesis to be included in the Register, and therefore whether:
(a) the safety of the implants was not such as persons were entitled to expect pursuant to ss 9 and 138 of the Australian Consumer Law;
(b) the implants were not reasonably fit for purpose within the meaning of s 55 of the Australian Consumer Law;
(c) the implants were not of merchantable quality within the meaning of s 54 of the Australian Consumer Law; and
(d) the sponsor was negligent in the warnings in respect of the product.
Sponsor’s submissions
The sponsor submits that the applicant has not discharged his burden of proving that reasonable inquiries have been made. It submits that the information sought in Annexure 1 of the Originating Application is ‘similar to, if not the same in substance’ as the information sought by the applicant in his freedom of information request to the TGA. Despite being told that the documents ‘do not exist’ by reason of being held by a notified body and not the TGA, the applicant’s solicitor still requested the information from the sponsor, by email to their solicitor.
The sponsor further submits that there is more information publicly available to the applicant than that detailed in the affidavit of Ms Listing. The affidavit of Ms Jessica Luppino, solicitor with carriage of the matter for the sponsor, sworn 12 June 2020, contains examples of what the sponsor submits is additional information publicly available to the applicant. The annexures include a ‘hazard alert’ for the ‘Birmingham Hip Modular Head’, seemingly sourced from the TGA website, and a 2019 annual report submitted to the Australian Orthopaedic Association relating to total resurfacing hip replacements of various models (the relevance of which on this application was unclear), along with a list of 103 reports generated from the TGA Database of Adverse Event Notifications.
The sponsor also takes issue with the request for information from the TGA, arguing that it was ‘limited, modest and abbreviated’, because it was limited to the manufacturer’s application and supporting documentation for conformity assessment of the device.
The sponsor submits that there is no evidence that the applicant followed up with the TGA in relation to the documents sought in Annexure 1 which fall outside the scope of the limited request. There is no evidence as to why further inquiries were not made with the TGA in relation to the specific facts of the applicant’s hip prostheses, such as reports of adverse events, records and the facts and circumstances leading to hazard alerts concerning the prostheses.
Other arguments by the sponsor about why the inquiries referred to above are not reasonable are submissions that were made with regard to the first issue but repeated as being relevant also to the second issue. The sponsor submits that the applicant has not identified a proper basis at law to seek to enforce the obligations of and the duties imposed upon the sponsor by operation of the TG Act, and again that Gill is distinguishable. The same reasoning as that set out in respect of the first issue applies to those arguments.
Consideration
I accept that when the Court is considering the reasonableness of the inquiries that have been made, such inquiries are not limited to those made only of the prospective defendant: Papaconstuntinos v Holmes a Court & Anor [2006] NSWSC 945 at [27]. However, the mere fact that further inquiries could have been made (from others such as the TGA) does not require a conclusion that there was a failure to make reasonable inquiries: Steffen at [15] and [82]-[90].
I also accept the sponsor’s submission that effort does not necessarily equate with reasonable inquiries, and the Court must look to what is the proper forensic approach. However, the words of the rule are that the applicant has made ‘reasonable inquiries’. The rule does not require that the applicant has previously made ‘all reasonable inquiries’, or ‘all necessary inquiries’ from other persons, nor that the applicant have exhausted all other avenues of inquiry.
In the present case, the applicant has no relationship with the sponsor by which he can seek or compel the production of the information he seeks, apart from invoking the assistance of the Court such as through the present application. He has obtained all the relevant medical information specifically pertaining to his surgeries. He has made reasonable efforts to obtain further information about the particular medical devices in question from the regulatory body, the sponsor, and the manufacturer (through this application, with the manufacturer preserving its right to set aside service at the time this application was heard), and through publicly available information in Australia.
Whether the applicant, through his solicitors, could have engaged in further correspondence with the TGA, and what such further inquiries might have produced, might have taken on greater significance if I had formed the view that the applicant’s initial attempts to obtain information from the TGA, the sponsor, and through other means were insufficient or unreasonable, either because they were too limited in the scope of documents sought or because of the ready availability of other sources of information, or because sufficient time had not been allowed for a meaningful response to the inquiries being made. That is not the case.
On the contrary, the affidavit evidence of Ms Listing establishes that over the course of more than a year, she has made substantive inquiries, including through public research, private correspondence and formal channels such as a freedom of information request. Her efforts were not misdirected. Forensically, she has taken a reasonable approach, in that she has asked for a number of the documents now listed in Annexure 1 from the very people who it was reasonable to think might have them, namely the regulatory body, the manufacturer and the sponsor.
Bearing in mind the liberal construction to be afforded to r 651 (given its beneficial purpose), the applicant has taken a reasonable forensic approach to obtaining information necessary for the applicant to assess whether to commence proceedings. In my view, the applicant has met the threshold for establishing that reasonable inquiries have been made.
Issue 3: Are there reasonable grounds for believing the sponsor possesses information which can assist in deciding whether to commence proceedings?
There are two aspects to this issue. The first is whether the sponsor ‘possesses’ the documents or information sought. The second is whether the documents sought can assist in the making of the decision.
Does the sponsor possess the documents?
‘Possession’ is defined in the dictionary to the Rules as including ‘custody and power’. Mossop J outlined the authorities on the concept of ‘power’ in Talada Investments v Rovera Scaffolding [2017] ACTSC 160 at [24]:
The concept of “power” for the purposes of discovery has been the subject of considerable discussion. The authorities are usefully summarised by Ward J in Bova v Avati [2009] NSWSC 921 at [359]-[365]. It extends to capture those documents where there is a presently enforceable legal right to examine the document. A person will not have that right if the person is able to inspect the document only if a third person who has control of the document agrees to permit inspection or agrees to refrain from so exercising the person’s control so as to prevent inspection: Taylor v Santos (1998) 71 SASR 434 at 438.
Applicant’s submissions
Applying the definition above, the applicant argues that the information sought in Annexure 1 is either directly in possession of the sponsor, or to the extent that it refers to documents held by the manufacturer, is also within the power of the sponsor because of the requirements set out in the TG Act and the Regulations, discussed above (at [39] and [40] of these reasons).
In particular, it will be recalled that s 41FN of the TG Act requires the sponsor to have available sufficient information to substantiate compliance with the essential principles and that the conformity assessment procedures have been applied, or alternatively, to have in place a written agreement which enables it to gain access to that information from the manufacturer within the time specified in the Regulations (20 working days as prescribed by reg 5.6).
The applicant submits that before this application was brought, the sponsor had indicated in email correspondence an apparent willingness to provide some of the manufacturer’s documents, which has led the applicant to believe that the sponsor does have at least some of the manufacturer’s documents in its direct physical possession.
Sponsor’s submissions
The sponsor submits that many of the documents listed in Annexure 1 are not in its possession, but rather in the possession of the manufacturer, and that fact renders the request ‘oppressive’.
The sponsor reiterates that procedures for obtaining information prescribed in the TG Act are for the benefit of the Secretary of the Register alone and that the terms of s 41FN(3) of the TG Act do not require the sponsor to create, through a written agreement, the power or legal right to obtain the documents requested from the manufacturer in circumstances other than where a request has been made by the Secretary. They assert that the documents are therefore not within the sponsor’s ‘possession’ within the meaning of the Rules.
Consideration
The detailed provisions of the TG Act, as to what information is required by statute to be kept and made available, establish ‘reasonable grounds’ for the belief of the applicant (being the language of r 651(1)(c)) that the sponsor has documentation requested in Annexure 1. The sponsor may not in fact have all of the information listed, particularly given that Categories 1 to 5 describe documents held by the manufacturer. However, because of the words of the TG Act, there is a reasonable basis for the applicant’s belief that an Australian sponsor has documents relating to conformity assessments and quality management systems in its possession.
However, as to ‘possession’, the sponsor’s argument must be accepted. Any written agreement between the sponsor and the manufacturer was not in evidence. The provisions of the TG Act do not expressly require that the sponsor have a legal right to obtain each of the documents sought in Annexure 1 from the manufacturer, absent any request from the Secretary of the Register. The precise corporate arrangements between the manufacturer and sponsor were also not in evidence, so that it cannot be determined whether there is a level of control exercised in the Smith & Nephew Group that would extend to legal control over another’s documents.
In the absence of such evidence, to the extent that there are documents falling within the categories of Annexure 1 held by the manufacturer and not by the sponsor, those documents are not in the possession of the sponsor. The sponsor does not have the necessary degree of power, in the sense of control over, or a present legal right to obtain, documents held exclusively by the manufacturer.
The position is of course different where there are documents held by both the manufacturer and the sponsor. Such documents are within the direct, physical custody and power of the sponsor. That much was accepted by counsel for the sponsor during the hearing of the application.
Can the documents assist the decision-making of the applicant?
Turning then to the second aspect of the question, namely whether the documents sought can assist the applicant to make a decision whether a cause of action exists, or whether to commence proceedings, the applicant has listed the issues with which the documents can assist (referred to at [70] above).
At an overview level of the documents, Categories 1 and 2 of Annexure 1 seek information leading up to registration of the prosthesis. In seeking those documents, the applicant will be able to consider what safety measures were taken in terms of clinical evaluations and investigations, and whether they were good enough to identify any risks of the harm suffered by the applicant.
The applicant emphasised in submissions that it is the manufacturer, not the regulator, who decides whether requirements for registration have been met, so that the regulator essentially relies on a representation made by a manufacturer. The relevance of that fact is that it cannot be assumed from the existence of a declaration of conformity or its recognition by the TGA that any regulatory body issuing the declaration has a level of control over the standard of evaluation conducted for things such as safety of a medical device and instructions for its use.
I accept that documents comprising the conformity assessment and declaration of conformity (Categories 1 and 2 of Annexure 1) can assist with deciding whether to bring an action. The level of thoroughness with which research and clinical evaluations were conducted will be relevant to any claim in negligence (as to the system by which safety of the device was declared fit for Australian patients) and any statutory cause of action based on the device being of suitable quality or fit for purpose.
Categories 3 to 5 are directed to production of the device once it was registered, and ascertaining how quality of the devices was managed. I accept that documents pertaining to the manufacturer’s quality management system and quality assurance procedures, including instructions for use and warnings, can also assist with the applicant’s decision. In that regard, I accept the applicant’s submission that whether and how the manufacturer identified risks and mitigated risks is a threshold question as to whether the manufacturer met its duty of care.
The sponsor submits that it is only the documents in Category 6 of Annexure 1 which specifically relate to information held by the sponsor. That is an important point and care must be taken to ensure that the parameters of r 651 are maintained – the rule only permits documents to be sought from the prospective defendant (as opposed to any person). It is important to consider whether the documents sought can assist with determining whether a claim may be brought against the sponsor.
Categories 1 to 5 are expressly directed to the conduct of the manufacturer in registering the prosthesis and then the quality management in producing it for supply. However, as the decision of Gill demonstrates, as promotor and supplier of a given medical device in Australia, sponsors may be equally liable for causes of action in negligence and under the Australian Consumer Law (in respect of the contraventions the applicant is contemplating here).
It is more difficult to determine the assistance to be provided by the documents sought in Category 6 of Annexure 1, under the broad umbrella of ‘other notification information’.
The applicant has not established how the three annual reports purportedly provided to the TGA pursuant to s 41FO(2) of the TG Act, can be of assistance. Section 41FO(2) is a provision which contains a general list of conditions that the Secretary may impose. The conditions include the keeping of records, but the evidence did not establish that the Secretary did impose such a condition, nor what question or gap the information in the annual report was capable of resolving.
If the intention was to capture any summary document of adverse events or complaints, or to capture the response to any adverse event reports, that should have been made clear in Annexure 1 and by the evidence and submissions. It may be that parts of the annual report fall within other paragraphs of Annexure 1, but it is unhelpful to speculate on the use to which the documents could be put and at present I am unconvinced that those documents can assist.
Separate attention needs to be given to the documents sought which fall within the description of information mentioned in s 41MP(2) of the TG Act, being one of the items listed under Category 6. That section has been set out earlier in these reasons at [28]. Rule 652 of the Rules provides that an order for preliminary discovery does not require the person against whom the order is made to produce any document that, on the ground of privilege, the person could not be required to produce if the application for the order had started a proceedings against the person, or had made the person a party to the proceeding.
Information concerning adverse events and complaints regarding the prostheses can assist with deciding whether a cause of action exists regarding each of the matters set out at [70] of these reasons. The existence of an adverse event or complaint and the response to it will be directly relevant to elements of a cause of action in negligence, such as reasonable foreseeability and response to a risk of harm. It will be similarly relevant to any action under the Australian Consumer Law, that the safety of the prostheses was not such as persons were entitled to expect. However, such information may well be afforded the privilege against self-incrimination, given that the provision creates a criminal offence.
The remaining two parts of the ‘notification information’ sought, dealing firstly with corrective action and recalls, and secondly with details of any legal claims made, are broad enough to encompass documents that can have some relevance to the matters set out at [70], but they may also include documents that have no bearing whatsoever to the matters which are of concern to the applicant. No separate submission was directed to supporting those two items, including the breadth of documents covered by them. That has an impact in terms of the next issue to be considered, and the overall exercise of the Court’s discretion.
Issue 4: Would inspection of the documents help the applicant to decide?
Preliminary discovery should only be granted to the extent that it is reasonably necessary in order to overcome the insufficiency of information already possessed by the applicant for making a decision as to whether or not to commence proceedings: see Pesec v Consolidated Builders Ltd [2019] ACTSC 142 at [53], citing Kusa v Vong (trading as Allen Vong & Associates) [2018] ACTSC 254 at [83].
In other words, the purpose of preliminary discovery is not to provide a potential plaintiff with all the documents and information that would be discoverable had proceedings been commenced: Ashton at [46], citing SmithKline Beecham plc v Alphapharm Pty Ltd [2001] FCA 271 at [19].
That guides the Court’s exercise of discretion as to the breadth of the documents that may be ordered to be produced on discovery.
Applicant’s submissions
The applicant submits that the sponsor, through the affidavit evidence of Ms Luppino, does not object to or contest the applicant’s identification of the documents sought as necessary for deciding whether to commence proceedings against the respondent. The solicitor for the applicant sent an email to Ms Luppino as long ago as 16 August 2019 (the relevant extract of which is set out at [48] above). In short, Ms Listing explained that what she wanted was:
(a) information provided to the relevant regulator in respect of approval of the device;
(b) information that came to the sponsor during circulation of the product and prior to the supply of the prostheses to the applicant; and
(c) information that the sponsor provided to the public.
The applicant’s solicitor then stated in her email:
If you say this information is not relevant to our client’s claim, kindly provide the reason for this.
The applicant places emphasis on the fact that no response was provided as an indication that there was not, at that time, a contest.
The applicant’s submissions as to how inspection of the documents sought will be of assistance otherwise overlap with the submissions already made as to whether the documents can assist and it is unnecessary to repeat those arguments.
Sponsor’s submissions
The sponsor’s primary argument is again that because the TG Act involves its own regulatory scheme involving pecuniary penalties and other sanctions, the information sought in relation to compliance with the TG Act and the Regulations is likely to be of little assistance in any personal injury claim.
Further arguments are made as to the scope of the documents listed in Annexure 1, to the end effect that the application is said to be oppressive. First, it is pointed out that the categories were extremely broad, without temporal or geographic limit.
Second, the sponsor takes issue with the content of what is sought, in that the category descriptions are at too high a level of generality. The documents sought to be discovered appear to be non-specific to the applicant and more akin to a general inquiry into Smith & Nephew hip prostheses. This captures so many documents as to be disproportionate to the decisions required to be made by the applicant.
Consideration
The reasons as to whether the applicant had a reasonable belief that the sponsor possesses documents that can assist the applicant to make a decision overlap with this fourth issue of whether inspection of those documents would help the applicant in making the decision whether a cause of action exists and whether to commence proceedings.
The argument as to the separate regulatory scheme created by the TG Act, and that it is not for the applicant to assume the duties and obligations imposed on the regulator, has been addressed above in relation to Issue 1. The argument was rejected as misconceiving the purpose of the applicant’s reliance on the legislation.
At the outset, and before any consideration of proportionality or what is ‘reasonably necessary’ to overcome the applicant’s disadvantage, the applicant has established that inspection of the documents he seeks will help him to form a view as to:
(a) whether reasonable care was taken to ensure that the prosthesis was fit for purpose and safe, or that appropriate warnings were given, before the prosthesis was listed on the Register; and
(b) if reasonable care was taken, whether the response to any identified (i.e. foreseeable) risk was adequate, including, where warnings were issued, such as the hazard alert issued by the TGA in 2016, and whether such an alert should have been issued at an earlier date on the information known to the manufacturer and sponsor at the time.
Discovery of the documents in Annexure 1 (subject to the findings above in relation to Category 6), will help the applicant to form a view about the adequacy of the investigations and evaluations undertaken before the prosthesis was listed on the Register, and to identify the extent to which the harm that he alleges was caused was a known risk by the sponsor, including the timing of any concern about the use of the prosthesis in patients of his gender and age.
However, there is some force to the arguments as to the lack of temporal and geographic limits which, when combined with the general nature of the categories, results in a request for documents that goes beyond what is reasonably necessary in order to overcome the insufficiency of information already possessed by the applicant for making a decision as to whether or not to commence proceedings. As counsel for the sponsor submitted, the application should not result in the sponsor being required to conduct a general trawl through every document held by it that might touch upon compliance issues relevant to negligence and statutory consumer actions.
Regard must also be had to the existence of full discovery, including through subpoenas and notices to produce, which will be available in the event that proceedings are commenced.
What documents then, are reasonably necessary to overcome the insufficiency of information, as opposed to documents that are relevant and generally useful to establishing each element in a cause of action?
Categories 1 and 2 of Annexure 1 include the documents comprising and supporting the conformity assessment and declaration of conformity, which are critical to whether reasonable care was taken by the sponsor before it applied to list or market the prosthesis. The registration commencement date for the prosthesis appears to have been 26 February 1999. The conformity assessment, declaration of conformity and the documents supporting the certification must have occurred prior to that date. Counsel for the sponsor indicated that the pre-registration stage was approximately 1 January 1997. That appears to be an appropriate date by which to limit the documents provided, so as to keep discovery proportionate and only capture those documents ‘reasonably’ necessary.
Discovery should therefore be provided of the documents falling within those two categories over the period 1 January 1997 to 26 February 1999, and limited to those documents in the direct physical custody of the sponsor.
Categories 3 to 5 of Annexure 1 are directed to the quality management system and assurance procedures. Again, many of those documents are more likely to be in the possession of the manufacturer than the sponsor. However, to the extent that the sponsor has in its direct physical custody ‘information in relation to’ the quality management system and ‘assurance procedures’ referred to in Categories 3 to 5, those documents should be produced.
Again, there is no time limit specified in any of those categories. Given the obligation on a manufacturer as to quality management and assurance is an ongoing one, there is a potential for the documents caught by Categories 3 to 5 to span more than 20 years. I consider a reasonable (including a proportionate) limit at a preliminary stage would be the five years leading up to when the first prosthesis was inserted on 13 June 2013. The starting date is therefore 14 June 2008 and the period should extend until the date the second prosthesis was inserted.
In relation to Category 6, and having regard to the concerns about the various documents sought in that category outlined above, for the applicant to be in a better position to make a decision about the claims he has in contemplation, it is only reasonably necessary for him to have access to the information that reveals what the sponsor knew about any problems with the medical device leading up to the date when the applicant first had surgery.
It is too onerous an obligation on the Australian sponsor to require discovery of what corrective action was taken ‘in any jurisdiction’, unlimited as to time, and in the absence of tying the corrective action to a particular complaint, issue or legal claim. Having reviewed the extracted information from the TGA Database of Adverse Event Notifications exhibited by Ms Luppino as part of her affidavit evidence, the device may be supplied under a different name, and there may have been ‘adverse events’ that have no bearing whatsoever on the type of injury that led the applicant to undergo revision surgery.
Once the applicant has identified any specific previous adverse events or complaints, if there remains a significant information lacuna directly relevant to a claim the applicant is considering against the sponsor, there is nothing preventing the applicant from making a further, more targeted, application for discovery in the future.
At present, I am only satisfied that the discretion should be exercised to order the sponsor to discover ‘notification information’, limited to information held by the sponsor concerning any adverse events or complaints in relation to the medical device of the kind supplied to the applicant, again over the five year period before the first prosthesis was inserted, and extending up to when the second prosthesis was inserted. Such discovery may be affected by the application of r 652 and the privilege afforded to the sponsor. I will make that clear in the orders that are made.
Conclusion, and Orders Costs
It will be apparent from the above reasons that the applicant has established sufficient grounds for the Court to exercise its discretion pursuant to r 651(5) to make orders for preliminary discovery, but only insofar as the documents are in the sponsor’s possession, are limited in time, and are what I consider to be reasonably necessary for the applicant to make a decision.
The sponsor is currently in the same position of a subpoenaed party and would ordinarily be entitled to any expenses of production.
As to the costs of the present application, the applicant has had mixed success in relation to the categories of documents sought. The terms of Annexure 1 have been limited by specifying a time period, by applying an uncontroversial definition of ‘possession’, and by rejecting categories of documents where the applicant had not sufficiently articulated why the documents in those categories were not just relevant, but were reasonably necessary to the applicant’s decision-making in whether to commence proceedings. In those circumstances, the Court has effectively granted an indulgence in granting the application subject to limits, rather than rejecting the application outright due to the breadth of documents sought. It is not known what the sponsor’s attitude would have been if a more limited form of documents had been sought initially. I consider it reasonable for the applicant to pay the sponsor’s costs of the application.
However, if the applicant does ultimately commence proceedings against the defendant, then the costs of the application and the costs of the defendant complying with pre-trial discovery may be revisited, as it is likely that many, if not all, of the documents that will be produced following this application would form part of any formal discovery processes in subsequent substantive proceedings.
The Orders of the Court are:
(1) Pursuant to r 651(5) and subject to r 652 of the Court Procedures Rules 2006 (ACT), the second respondent is to produce to the applicant:
(a) the documents listed in Categories 1 and 2 of Annexure 1 to the Originating Application (Annexure 1) that are in the direct physical custody of the second respondent, limited to the period 1 January 1997 to 26 February 1999;
(b) the documents listed in Categories 3 to 5 of Annexure 1 that are in the direct physical custody of the second respondent, limited to the period 14 June 2008 to 26 August 2013; and
(c) the ‘notification information’ in the direct physical custody of the sponsor, limited to information held by the sponsor concerning any adverse events or complaints in relation to the use of the medical device described as the Smith & Nephew Birmingham Hip prosthesis, limited to the period 14 June 2008 to 26 August 2013.
(2) Subject to Order 3, the applicant is to pay the second respondent’s costs of the application and the reasonable costs of complying with Order 1 above.
(3) The costs referred to in Order 2 are to abide any further order made in subsequent proceedings, on any cause of action alleged to have arisen out of the information contained in the documents in respect of which preliminary discovery has been ordered.
| I certify that the preceding one hundred and thirty-five [135] numbered paragraphs are a true copy of the Reasons for Judgment of her Honour Associate Justice McWilliam. Associate: Date: 24 August 2020 |
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