Turner v Bayer Australia Ltd (No 6)
[2023] VSC 244
•10 May 2023
| IN THE SUPREME COURT OF VICTORIA | Not Restricted |
AT MELBOURNE
COMMON LAW DIVISION
GROUP PROCEEDINGS LIST
S ECI 2019 02916
| PATRICE SARAH TURNER | Plaintiff |
| v | |
| BAYER AUSTRALIA LTD (ACN 000 138 714) & ORS | Defendants |
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JUDGE: | KEOGH J |
WHERE HELD: | Melbourne |
DATE OF HEARING: | 17, 20, 27 April 2023 |
DATE OF RULING: | 10 May 2023 |
CASE MAY BE CITED AS: | Turner v Bayer Australia Ltd (No 6) |
MEDIUM NEUTRAL CITATION: | [2023] VSC 244 |
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PRACTICE AND PROCEDURE — Court file — Release of documents used in trial to media — Documents containing personal data of natural persons residing in the European Union — Consideration of European Union data protection laws.
PRACTICE AND PROCEDURE — Application to amend defence — Withdrawal of pleading — Delay — Whether in the nature of admission — Reliance — Prejudice.
PRACTICE AND PROCEDURE — Application to amend lay witness statement — New evidence — Delay — Change of solicitors — Probative value — Prejudice.
PRACTICE AND PROCEDURE — Application to lead further factual evidence from expert witness — No new issue raised — Prejudice — Objections to expert witness report.
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APPEARANCES: | Counsel | Solicitors |
| For the Plaintiff | F Forsyth KC with F Ryan SC, E Levine and M Guo | Slater & Gordon |
| For the Defendants | D Collins KC with K Brazenor, D Wong and J Teng | Clayton Utz |
| For the Media Parties | C Jankie, Senior Lawyer for the Australian Broadcasting Corporation S White, Editorial Counsel for Nine Network Australia Pty Ltd and The Age Company Pty Ltd |
HIS HONOUR:
This representative proceeding is a product liability action concerning implanted permanent contraceptive medical devices identified collectively as the Essure device. The plaintiff brings the proceeding on behalf of all women who have had an Essure device implanted and suffered harm as a result. She claims damages for breach of the Australian Consumer Law[1] and Trade Practices Act 1974 (Cth), on the basis of allegations that the devices were not of acceptable quality and/or had a safety defect, and in negligence based on allegations of a defective design and failure to warn.
[1]Competition and Consumer Act 2010 (Cth), sch 2.
The trial of the proceeding commenced on 11 April 2023 and is estimated to run for 12 weeks.
Media organisations have sought access to transcript and some of the documents relied on by the parties at trial.
The second defendant, Bayer Aktiengesellschaft, is a corporation registered in Germany. The defendants have made discovery of documents that originated from Germany (‘EU documents’), some of which contain personal data of natural persons residing in the European Union (‘EU’), including names, job titles, signatures, business email addresses, street addresses and phone numbers, and personal email addresses, street addresses and phone numbers (‘EU data’). The defendants oppose the media having general access to transcript and EU documents used at trial because, they argue, the release of EU data would be a breach of applicable law of the European Parliament.
During oral argument it became clear that the defendants did not object to media having access to the limited number of documents sought to the date of oral argument. However, in relation to future access the defendants sought orders requiring that media apply to the Court for release of transcript and any EU documents tendered at trial and give details of the context and purpose underpinning their request when applying for access, provide the parties with time to object (suggested two days) to media access, and provide the parties further time (suggested two days) to redact personal information from documents to be released.
On 18 April 2023, I rejected the defendants’ submissions and made an order in the following terms:
A party that objects to a non-party to the proceeding accessing a document(s) on the Court file shall give notice of the objection by 9.30am on the business day following the request for access.
On 24 April 2023 the defendants applied for leave to:
(a) rely on an amended witness statement of lay witness Janet Padgham dated 20 April 2023 (‘Padgham statement’);
(b) lead lay evidence from one of their expert witnesses, Dr David Rosen, in accordance with an outline of evidence dated 24 April 2023 (‘Rosen outline’); and
(c) amend the defence of the first to fourth and sixth defendants (‘Bayer and AMSL defendants’).
The plaintiff opposed each application.
On 28 April 2023, I refused the defendants’ application in respect of the Padgham statement, save for some minor corrections and clarifications.
On 2 May 2023, I ruled in favour of the defendants in relation to the Rosen outline and the proposed amended defence.
The plaintiff objected to the admissibility of parts or paragraphs of the Rosen expert report on which the defendants seek to rely. On 3 May 2023, I ruled against the plaintiff in respect of all but two of the objections.
These are my reasons for the above rulings.
Objections to release of documents containing EU data
European law
The defendants relied on a report of Professor Dr Gregor Thüsing, a jurist and professor at the University of Bonn in Germany. Thüsing has expertise in data protection and data security in the context of European law.
Thüsing’s opinion
Data protection law enjoys a high status in European and German law. Since 2018 the conditions for the processing of personal data of natural persons residing in the EU have been contained in the General Data Protection Regulation (‘GDPR’), which is Regulation (EU) 2016/679 of the European Parliament.
Personal data means any information relating to an identified or identifiable natural person, and includes the name, identification number, location data, online identifier and identifying characteristics of that person.
The GDPR prohibits unnecessary processing of personal data. ‘Processing’ means any operation or set of operations performed on personal data, such as collection, recording, organisation, structuring, storage, adaption or alteration, retrieval, consultation, use or disclosure.
‘Controller’ means the natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data.
The right to protection of personal data is not absolute, and must be balanced against other fundamental rights in accordance with the principle of proportionality.
The purpose of the GDPR is not to block discovery in court proceedings.
Application of the GDPR depends on the location of the document controller. Outside the EU the GDPR applies under narrow conditions only, and does not bind the Supreme Court of Victoria.
A goal of the GDPR is that the protection offered in respect of personal data travels with the data. One way of achieving this is that data exporters from the EU enter into contracts that bind data importers located in countries outside the EU that have Standard Contractual Clauses (‘SCCs’) making those data importers subject to the provisions of the GDPR. In this case the EU data was exported by the second defendant to other defendants located in the United States of America (‘USA’) and Australia, and to the defendants’ lawyers. The SCCs allowed the EU data to be processed by the recipients if ‘necessary for the establishment, exercise or defence of legal claims’.
Because the Supreme Court of Victoria is not bound by the GDPR or the SCCs, it may therefore process the personal data in a way that would certainly not be permitted by the defendants.
In this case, to the extent it is governed by the GDPR data may only be processed when it is necessary for the establishment, exercise or defence of a legal claim. The ‘necessity test’ requires a close and substantial connection between processing the data in question and the purpose for which it is processed. The GDPR emphasises the need for personal data to be adequate, relevant and limited to what is necessary for that purpose. This requires careful assessment of whether anonymised or pseudonymised data would be sufficient. In this regard Article 49(1)(e) of the GDPR states:
As to the interests, rights and freedoms of the data subject which need to be taken into consideration, the possible negative effects, i.e. the risks of the data transfer on any type of (legitimate) interest of the data subject have to be carefully forecasted and assessed, by taking into consideration their likelihood and severity. In this regard, in particular any possible damage (physical and material, but also non-material as e.g. relating to a loss of reputation) needs to be taken into consideration. When assessing these risks and what could under the given circumstances possibly be considered as “suitable safeguards” for the rights and freedoms of the data subject, the data exporter needs to particularly take into account the nature of the data, the purpose and duration of the processing as well as the situation in the country of origin, the third country and, if any, the country of final destination of the transfer.[2]
What is deemed appropriate for the establishment, exercise or defence of legal claims is to be determined by weighing the interests of the parties to the proceedings and the data subjects only.
[2]European Data Protection Board, Guidelines 2/2018 on derogations of Article 49 under Regulation 2016/679, adopted 25 May 2018, p 16 (citations omitted).
The tension between the purpose limitation and the necessity principle has not been discussed in case law and literature in the EU, since European courts are bound by the GDPR.
The likelihood of the data transfer for the purposes of providing it to the media (or any third parties) constituting a breach of the SCCs (on the basis that it is not in line with the rules of the GDPR) increases:
(a) as the relevance of the personal data to the defence of the claim decreases;
(b) as the personal data becomes more ‘intimate’ or ‘sensitive’ (for example, personal addresses would be more ‘intimate’ than business addresses);
(c) as more people are provided with the data; and
(d) as more data and more data subjects are involved.
Consideration
I understand the EU data is largely if not entirely contained in records of the second defendant relevant to the conduct of its business in Germany. I accept EU documents were provided by the second defendant directly to the defendants’ lawyers in Australia, or indirectly by first being transferred by the second defendant to other Bayer entities in the USA before re-transfer to Australia.
The transfer of the EU documents to Australia, and the resulting processing of the EU data was necessary for the establishment, exercise or defence of legal claims in this proceeding, and therefore occurred in accordance with the SCCs.
If it were necessary, I would conclude for the following reasons that data processing by discovery was not a breach by the defendants or their lawyers of the GDPR or the SCCs. First, as Thüsing stated, the purpose of the GDPR is not to prevent or restrict proper discovery of documents in court proceedings. Second, discovery of the EU documents, and the processing of the EU data, was consistent with the purpose for which the documents were transferred to Australia.
Third, I regard the processing of the EU data that resulted from discovery as necessary. Questions of foreseeability, knowledge and constructive knowledge are at issue in this proceeding. It is evident from the document tender process that the names, occupations and employment positions of individuals may be relevant to a consideration of those issues.
Fourth, discovery of the EU documents by the defendants and the resulting processing of the EU data was governed by the laws of this jurisdiction and made pursuant to orders of this Court. I doubt that processing of the EU data was subject to the GDPR.
The application is made on the basis of two considerations. First, allowing media access to the personal data of European citizens is inconsistent with the protections provided by the GDPR that applied to the EU documents in the EU. Those protections should not be lost simply because the documents were transferred to Australia for the purposes of the proceeding. Second, release of the EU data to media exposes some of the defendants and their lawyers to the risk of penalties and damages for breach of the GDPR and/or the SCCs.
I rejected the defendants’ application. First, the orders sought by the defendants would provide, at best, only a very limited degree of protection of the EU data for the following reasons. The trial of the proceeding is being live streamed. Many of the documents that are tendered are publicly displayed in the court room and during the live stream process. Where transcript records EU data it will be as a result of discussion in open court. Media are free to report any EU data communicated in this way. It is difficult to understand the justification for restricting access to transcript and tendered documents on the court file after the information they contain has been openly displayed or discussed during the trial.
Second, it is likely the risk of harm to EU citizens from communication of personal data resulting from media access to documents on the court file in this proceeding is low. While personal data may be relevant to facts in issue in the proceeding it is likely to be peripheral to or remote from the issues that will be the focus of media reporting. No evidence has been provided of any significant reporting of this proceeding in the EU. If any reporting occurs in the EU it seems unlikely that it will include communication of sensitive EU personal data. To date media have sought access to only a very small number of documents that have already been tendered at trial.
Third, I do not accept that the material discloses any real risk of the defendants or their lawyers being prosecuted or subject to claims for damages if third parties are given access to documents on the court file that contain EU personal data. The EU documents were transferred to Australia and discovered by the defendants in compliance with orders made in this proceeding. There is no suggestion that by making discovery of the EU documents the defendants or their lawyers have breached the GDPR or the SCCs. Once the documents are used in the proceeding the question of access to them is a matter for the Court, not the parties. In terms of the GDPR, at that point the Court is the controller of the documents, and is the body processing the documents by allowing third parties access to the court file. Thüsing’s opinion about the risk of prosecution and damages claims proceeds on the false assumption that it is the defendants or their lawyers who would be communicating the EU data to media. The defendants and their lawyers have no power to grant or regulate access to documents on the court file.
Fourth, important principles of open justice should not be ignored. The orders sought by the defendants would delay media access to documents and restrict media access to some information. There is no justification for the openness of the proceeding to be restricted in this fashion.
As an exception to the above, I accept the defendants’ submissions that personal contact information of EU residents and more sensitive data such as information relating to health should not be released. In the first instance I will extend that exception to the surnames of EU residents recorded in the EU documents, or via those documents in transcript, save for the first letter of those surnames.
Defendants’ applications
Evidence
The parties relied on the following evidence relevant to the defendants’ applications:
(a)Two affidavits of Gregory John Williams, solicitor for the defendants, sworn 24 April 2023.
(b)Two affidavits of Rory John Walsh, solicitor for the plaintiff, affirmed 26 and 27 April 2023.
Background
The proceeding was commenced by writ filed by the plaintiff in June 2019.
The Bayer and AMSL defendants filed their defence in September 2020. In that defence the Bayer and AMSL defendants plead that the commercial supply period for the Essure device in Australia was between about 2001 and 28 August 2017 (‘commercial supply period’).
Throughout the commercial supply period it appears that a number of Australian entities played a role in the importation and distribution of the Essure device in Australia. The Bayer and AMSL defendants plead that the fifth defendant, Gytech Pty Ltd (‘Gytech’), was the exclusive distributor of the Essure device in Australia from about August 2010 to January 2015 (‘Gytech distribution period’), and that the sixth defendant, Australasian Medical & Scientific Ltd (‘AMSL’), imported (or arranged the importation of) the Essure device into Australia for distribution between about 1 January 2015 and 31 May 2017 (‘AMSL distribution period’).
The Essure device operated by being inserted into the fallopian tube lumen, where it was intended to remain and elicit a tissue response that occluded the fallopian tube.
The plaintiff alleges the Essure device had certain inherent defects and carried the risk of failure defects, and that these matters led to the risk of women who had the devices inserted suffering adverse events. The plaintiff alleges that a woman who experienced adverse events or other complications associated with implantation of the Essure device may be unable to resolve those matters without abdominal surgery, and likely removal of one or more organs (‘removal limitation’).
As part of her case the plaintiff alleges the defendants were responsible for publication of materials including patient information brochures (‘PIBs’) directed to potential recipients of the Essure device that did not adequately disclose the inherent defects, failure defects, risk of adverse events and/or removal limitation.
The Bayer and AMSL defendants allege that during the commercial supply period, publications were available to doctors and patients in Australia regarding the Essure device that contained information and risk warnings relevant to the matters alleged by the plaintiff. The documents were particularised in paragraphs 19 and 21 of the defence as PIBs, Instructions For Use (‘IFUs’) (dated 2013 and 2015) and a Physician Training Manual (‘PTM’) (dated 2015). The defendants pleaded that further particulars may be provided after discovery.
Relevantly, the Bayer and AMSL defendants pleaded in paragraph 25(b) of the defence:
(i)prior to a doctor carrying out an Essure Device Procedure, that doctor would, as a matter of course, have:
A. consulted with the patient and discussed their personal circumstances relevant medical history, individual contraception needs, alternative contraceptive options and the relative risks and benefits of each and any other relevant considerations;
B. as a result of that doctor’s specialist training, skill and experience, synthesised and assessed all relevant information including:
1) information provided by the patient about their personal circumstances, medical history, individual contraception needs and any other relevant considerations;
2) information provided by the Australian supplier and information from other sources about the Essure Device and Essure Device Procedure; and
3) information available about alternative contraceptive options;
C. provided to the patient information and advice about the Essure Device Purpose, its manner of operation, and the Essure Device Procedure, and information, advice and warnings about any risks associated with the Essure Device (such as those referred to in paragraphs 19 and 21 above) relevant to that patient; and
D. having regard to these matters, determined their recommendation as to the most appropriate course or option for the patient in all of the circumstances (which may have been the implantation of the Essure Device, the use or implementation of some other form of contraception, or no further action);
(ii) in the circumstances described in paragraph 25(b)(i) above, it was reasonable for the Defendants (or any of them) to expect that any patient considering undergoing an Essure Device Procedure and receiving one or more Essure Inserts would be informed by their doctor to the degree that the doctor considered appropriate of:
A. the availability of alternative contraceptive options including surgical and nonsurgical options and options including and not including an implantable device; and
B. the risks and benefits associated with any alternative contraceptive options under consideration and of the Essure Device, including those referred to in paragraphs 19 and 21 above;
The Bayer and AMSL defendants rely on these allegations as being relevant to elements of both the statutory and common law claims made against them by the plaintiff.
The common questions, which were largely agreed upon by the parties and have been resolved by order, include:
14.What information was provided about risks associated with the Essure device, during what periods and was this information provided to:
a.Recipients of the Essure device in Australia (consumers); and/or
b.Users of the Essure device in Australia (health care practitioners and health care institutions);
and if so, by which Defendants?
The Bayer and AMSL defendants have discovered iterations of the IFUs and PTMs in addition to those particularised in the defence. In issue between the parties is what IFUs and PTMs were used in Australia, when and in what context they were provided to doctors, and what information was provided to recipients of the Essure device.
Padgham statement
Padgham’s original statement was filed and served in April 2022 pursuant to case management orders made in the proceeding.
In her original statement Padgham said she was the managing director and co-founder of Gytech. Her original statement was filed on behalf of Gytech.
Until recently Gytech was separately represented from the Bayer and AMSL defendants. On the day before the first day of trial the lawyers for Bayer and AMSL assumed conduct of the proceeding for Gytech.
Case management orders required that any objections to lay witness evidence be filed and served on a date prior to trial so as to provide for the orderly resolution of those matters. In accordance with those orders the plaintiff served objections to Padgham’s original statement on 29 March 2023. Gytech did not respond to the plaintiff’s objections.
Williams states that after his firm assumed conduct of the proceeding for Gytech one task which needed attending to was responding to the plaintiff’s objections to Padgham’s original statement. He said one purpose of the Padgham statement was to respond to the objections by putting Padgham’s evidence in admissible form.
The Padgham statement was served on the plaintiff on the evening of 20 April 2023.
Padgham was called to give evidence in the week commencing 1 May 2023.
The Padgham statement contained significant new evidence that did not form part of her original statement.
Rosen outline
The Bayer and AMSL defendants engaged Rosen as an expert witness and filed and served a report he prepared in July 2022.
Rosen’s report contains some factual evidence about the Essure device in Australia. The Rosen outline sets out some brief further factual evidence about the Essure device proposed to be led from him.
The plaintiff objects to two aspects of the proposed further Rosen evidence. First, that the box in which the Essure device was supplied to him for use contained a copy of an IFU for the Essure device. Second, that he also received copies of IFUs by way of training manuals that he refers to in his expert report, which he says were provided to him by Conceptus Inc (‘Conceptus’) and distributors of the Essure device.
Proposed amended defence
In paragraph 17 of the statement of claim, the plaintiff pleaded how the Essure device was designed to operate and included, to assist with that description, a figure from a 2014 PTM. The Bayer and AMSL defendants’ defence admitted the accuracy of the image, but pleaded that the 2014 PTM was a document distributed in the USA and not in Australia.
The Bayer and AMSL defendants now seek leave to amend the defence by withdrawing the pleading that the 2014 PTM was distributed in the USA not in Australia.
The relevance of this amendment is that the defendants wish to rely on the 2014 PTM as information provided by them to Australian gynaecologists for part of the commercial supply period. The plaintiff objects to the amendment on the basis that the impugned pleading was an admission by the Bayer and AMSL defendants on which she relied, and that she would be substantively and procedurally prejudiced if the amendment were allowed.
The proposed amended defence was served on the plaintiff on 5 April 2023, one business day before the commencement of trial.
Williams said the 2014 PTM contains:
(a) trademark and address information for Bayer in the USA;
(b) a statement to the effect complaints should be reported to the USA Food and Drug Administration (‘FDA’) accompanied by a FDA website and telephone number; and
(c) a list of resources that appear to be relevant to the USA.
Williams further notes that the 2014 PTM uses Americanised English.
Williams said that when the defence was filed on instructions in September 2020, neither the Bayer and AMSL defendants nor his firm had access to any Gytech, Conceptus or Bayer employee from the period to which the 2014 PTM relates, who was able to provide direct instructions about the PTMs that were provided to and used by Gytech during 2014. He said that accordingly, the instructions that underpinned the 2014 PTM pleading were based on the characteristics of the document referred to above, and the absence of other information known at the time that suggested the 2014 PTM had been provided to Gytech for use in Australia.
In her original witness statement, Padgham relevantly said she believed the 2014 PTM was provided to Gytech by the third defendant, Bayer HealthCare LLC (‘BHC’) in around 2014.
Williams said that when he and his team members received the original Padgham statement they ‘did not give much weight to these statements from Ms Padgham in relation to the 2014 PTM because part of her evidence states that she received this document from Conceptus (notwithstanding that the 2014 PTM is a Bayer-branded document).’ He said:
Furthermore, it was not until intensive preparation for trial in 2023 that I and, on the basis of my discussions with them, my team understood the potential significance of the 2014 PTM. From early 2023 Clayton Utz undertook work to investigate the evidence relating to the distribution and use of Physician Training Manuals in Australia. As a result of that work, I and, on the basis of my discussions with them, my team came to-the view that the 2014 PTM was in fact used, for a short time, in Australia.
Williams does not further explain the significance of the 2014 PTM, or the basis for the view that it was in fact used in Australia for a short time.
Williams said the culmination of his team’s trial preparation work in relation to PTMs is an aide memoire that sets out by date range the five PTMs the defendants say were used in Australia during the commercial supply period. The aide memoire refers to the content of each PTM that is sought to be relied on. The aide memoire does not contain any reference to evidence that establishes the period during which each PTM was used or how it was used. The defendants have provided a similar aide memoir relating to IFUs.
Particulars
In its defence Gytech pleaded that during its supply period publications were available to doctors and patients in Australia regarding the Essure device that contained information and risk warnings about relevant matters. It particularised those publications as three PIBs and one IFU dated 2013, and said ‘further particulars may be provided after discovery’.
In response to a request from the plaintiff for further particulars of a paragraph of its defence that is not currently relevant, Gytech said:
The alleged Inherent Defects, alleged Failure Defects and alleged Removal Limitation were matters upon which doctors who inserted the Essure Device were trained by Gytech (or the predecessor suppliers of the Essure Device). Gytech has made (informal) discovery of training materials upon which doctors were trained (with formal discovery to be completed shortly). The Plaintiff is able to ascertain from Gytech’s discovery what evidence will be called about the training given to doctors, and therefore about the process of consultation, advice and warning expected to be carried out by doctors prior to implantation of the Essure Device. We note, for example, the following warnings contained in the Physician Training Manual:
Clinical Data from the first year of reliance in the Pivotal Trial referred to abdominal pain, musculo-skeletal pain and genitourinary pain. It also referred to possible menorrhagia and dysmenorrhea.
“The most common (≥10%) adverse events resulting from the placement procedure were cramping, pain, and nausea/vomiting. The most common adverse events (≥3%) in the first year of reliance were back pain, abdominal pain, and dyspareunia.”
“Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. In addition, some patients may develop an allergy to nickel if this device is implanted.”
“Never attempt to advance Essure insert(s) against excessive resistance. If tubal or uterine perforation occurs or is suspected, discontinue procedure and work-up patient for possible complications related to perforation, including hypervolemia. Do not attempt hysteroscopic Essure insert removal once placed unless 18 or more trailing coils are seen inside the uterine cavity due to risk of fractured insert, fallopian tube perforation or other injury.”
“A patient may need a surgical procedure to manage a situation where Essure has perforated the fallopian tube or uterus or there is persistent pelvic pain. One patient in clinical trials requested removal for pain. Removal will likely require surgery, and may necessitate abdominal incision, general anaesthesia, or possible hysterectomy”.
This quote is from the 2014 PTM.
The plaintiff sought further particulars from the Bayer and AMSL defendants of the information and documents they alleged were made available to doctors and patients regarding the Essure device. The defendants responded by relying on the particulars set out in the defence and saying that the issue was otherwise a matter for evidence at trial.
The Rosen expert report, filed and served by the Bayer and AMSL defendants in July 2022, referred to earlier versions of the PTM that had not been expressly particularised by the defendants.
Prejudice alleged by the plaintiff
Walsh said the plaintiff had prepared her case, including cross-examination, on the existing pleaded defences and filed evidence, and had not had the opportunity to conduct a detailed investigation of the new material. He said the plaintiff relied on the Bayer and AMSL defendants’ pleading about the 2014 PTM.
Walsh said while cross-examination materials had been prepared in relation to Padgham’s evidence, there had been no investigation of any additional evidence about the availability and use of the 2014 PTM in Australia. He said the additional investigations that would have been undertaken by the plaintiff had she been on notice of the new evidence would have included potential lay evidence. He said there was insufficient time to undertake that investigation during the trial.
Walsh said the new material had already resulted in the plaintiff having to divert resources away from trial preparation. If the pleading amendment and new evidence was allowed the plaintiff would be forced to respond in a rushed way and without knowing whether there was additional evidence she could have deployed to contradict the new or more detailed position now being advanced by the defendants.
Relevant authorities and principles
The principles set out in Aon Risk Services Australia Ltd v Australian National University[3] are applicable to a late pleading amendment and, in a general sense, to the late service of evidence.[4] In this case relevant considerations include unfair prejudice, case management issues, and the explanation for late service of evidence.[5] These considerations are relevant to determination of whether the interests of justice dictate that a late application to amend or to introduce evidence should succeed or fail.[6]
[3](2009) 239 CLR 175.
[4]Thomas v Powercor Australia Limited (Ruling No 3) [2011] VSC 391; Northern Health v Robert Kuipers [2015] VSCA 172, [29] (Kyrou and McLeish JJA) (‘Kuipers’).
[5]Kuipers (n 4) [28].
[6]Ultra Thoroughbred Racing Pty Ltd v Those Certain Underwriters at Lloyd’s, London [2011] VSC 370, [8] (J Forrest J); Kuipers (n 4) [33].
A party may only withdraw a pleaded admission or any other matter operating to the benefit of another party with the consent of that party or leave of the court.[7] The court may grant leave to amend for the purpose of determining the real question in controversy between the parties.[8] An amendment to withdraw an admission will not be permitted where the prospect of irremediable prejudice is raised by evidence, and is not then excluded by the party seeking to amend.[9]
[7]Supreme Court (General Civil Procedure) Rules 2015 (Vic), r 25.02(5).
[8]Ibid r 36.01(1)(a).
[9]Gregorich v Khouri [2020] VSC 5; Ryan v PG Nominees [2020] VSC 48.
Padgham statement
For the following reasons I concluded that leave should not be granted to the defendants to rely on most of the new evidence in the Padgham statement.
First, the statement was served at the end of the second week of trial, one year after the time for Gytech to provide its lay witness evidence pursuant to case management orders.
Second, the change in representation of Gytech that occurred on the first day of trial is not an adequate explanation for the late delivery of the statement. In Illinois Tool Works Inc v Airco Fasteners Pty Ltd, discussing change of counsel as explanation for delay, Rofe J said:
In several decisions of the Full Court, it has been held that without more, the fact that there has been a change of counsel is insufficient to justify a grant of leave to raise grounds of appeal that were not agitated in the court below: see, eg, BLX16 v Minister for Immigration and Border Protection [2019] FCAFC 176 at [31]; DKT16 v Minister for Immigration andBorder Protection [2019] FCAFC 208 at [31].
While the present case arises in a different context, the above principle can be instructive about the weight to be given to an explanation for delay being a change of counsel. A mere change of legal team or counsel may not be an acceptable reason for delay.[10]
[10](2022) 166 IPR 514, 549 [242]–[243].
Gytech was represented by experienced lawyers at all times. A change in legal representation does not explain why the need to lead further evidence from Padgham was not identified and action taken well before the end of the second week of trial. This is particularly so in circumstances where there is an apparent common interest between the defendants, and where the Bayer and AMSL defendants had an interest in the further Padgham evidence. There was no reason why the Bayer and AMSL defendants could not have brought what they saw as shortcomings in Padgham’s evidence to the attention of Gytech’s then lawyers, so that the issue was dealt with well before trial.
Third, I do not accept that the evidence now sought to be led from Padgham was exclusively within the province of Gytech and its lawyers. Witnesses who could give evidence about documents and training provided in Australia during the Gytech distribution period potentially include individuals from the first, third and fourth defendants to the extent they were involved in provision of relevant documents and training of Gytech employees; other former Gytech employees; and doctors, hospitals and clinics that may have received the documents and the training.
Fourth, much of the new Padgham evidence appears to be a rationalisation based on a review of Gytech documents rather than direct evidence of what occurred from time to time during the Gytech distribution period. I am not satisfied that the evidence would have had significant probative value had it been allowed.
Fifth, I am satisfied the plaintiff would have been significantly prejudiced if the defendants were given leave to rely on the new Padgham evidence. Cross-examination of Padgham was to occur within two weeks of the statement being provided. Padgham’s evidence could not be further delayed within the trial timetable. Thirty-nine additional documents are identified in the Padgham statement. Thirty-six of those documents had not been included in the electronic court book by 26 April 2023. Two documents that are potentially material had not previously been discovered. It is apparent that the parties’ lawyers are consumed by the requirements of ongoing trial preparation. It would have been very difficult and perhaps impossible for the plaintiff’s lawyers to fully investigate and test the new Padgham evidence against the documents discovered in the proceeding.
Rosen outline
The only contentious aspect of the evidence now sought to be led from Rosen relates to the provision of IFUs.
The proposed further Rosen evidence does not raise any new issue. The defendants have always relied on the provision of IFUs to doctors. There is already evidence in lay witness statements consistent with the evidence proposed to be led from Rosen. In her original statement Padgham said that each box containing an Essure device provided to Gytech for distribution in Australia contained an IFU. Dr Samy Saad, the current Managing Director of AMSL, gave similar evidence in relation to the AMSL distribution period. The plaintiff has not served any lay witness addressing this issue.
There is no irremediable prejudice to the plaintiff from allowing evidence in accordance with the Rosen outline. The proposed new evidence is relevant to an issue in dispute. In the circumstances I will give the defendants leave to lead evidence in accordance with the outline.
Pleading amendment
For the following reasons I will give the Bayer and AMSL defendants leave to withdraw the pleading that the 2014 PTM was a document distributed in the USA and not in Australia.
First, I accept Williams’ explanation that the need for the amendment only became apparent to his team as a consequence of intensive trial preparation undertaken in the period shortly before trial.
Second, the pleading that the Bayer and AMSL defendants now seek to withdraw is not in the nature of an admission. The plaintiff did not plead any allegation in the amended statement of claim about the 2014 PTM or any other PTM. The Bayer and AMSL pleading about the 2014 PTM simply sought to clarify that it was not an Australian document.
Third, the Bayer and AMSL defendants have always pleaded that information and documents available to doctors in Australia included PTMs. The defendants’ pleading was not confined to a specific iteration of the PTM. The plaintiff did not persist with a request for particulars in an attempt to identify precisely the PTMs that the defendants alleged were used. I have already referred to Padgham’s evidence in her original statement in relation to the availability of the 2014 PTM to Gytech during its distribution period, and to Gytech’s pleading relying on the 2014 PTM.
Fourth, the plaintiff could not rely on the impugned pleading to resolve the issue of whether the 2014 PTM was available for use and was used in Australia. As Walsh said, ‘the distribution of the 2014 US Manual is an issue in dispute in the proceeding.’ In the above context it is difficult to understand what reliance the plaintiff could have placed on the impugned pleading.
The amendment will not cause irremediable prejudice to the plaintiff.
In the above circumstances I conclude it is just to allow the Bayer and AMSL defendants to withdraw the pleading in relation to the 2014 PTM.
Plaintiff’s objections to the Rosen report
The Rosen report discloses that he is a gynaecologist and specialist laparoscopic surgeon. In his report Rosen describes his extensive experience with the Essure device which includes having been engaged by the fourth defendant (then called Conceptus) as a contractor from 2000 to 2005 to train fellow gynaecologists, training and lecturing in Australia and internationally on the Essure procedure, and performing over 150 Essure procedures himself. In his report, Rosen discusses the contraceptive options available to women in Australia, the Essure device and the procedure for implantation, the consultation process and information provided to women regarding contraceptive options, and the factors relevant to deciding on tubal ligation versus the Essure device as a means of permanent female contraception. Rosen was also asked to comment on some aspects of the expert witness report of Professor Andrew Korda that has been filed and served by the plaintiff.
The defendants conceded one of the plaintiff’s objections to the Rosen report.
I found for the plaintiff in relation to the following paragraph in which Rosen addressed the outcome of tubal ligation:
Post-operative changes in menstrual patterns or volume are usually attributed to cessation of use of the oral contraceptive pill OCP after a tubal ligation.
It is unclear whether Rosen meant attributed or attributable. If it is the former, it is unclear by whom, in what circumstances, and for what reason. If it is the latter, there is no reasoned basis for the opinion.
Many of the plaintiff’s remaining objections relate to Rosen’s evidence about the consultation with women seeking contraceptive options. The questions addressed to Rosen and his answers may make it difficult to determine the extent to which his evidence relates to the manner in which he conducted his own practice as a gynaecologist, to his knowledge of the way in which other gynaecologists practiced, to training he received in relation to the Essure device, or possibly to a standard of care that can reasonably be expected of a person with the specialised training, skill and experience of a gynaecologist. For example, question 3 simply asks that Rosen ‘[d]escribe the consultation process or processes undertaken with patients seeking contraceptive options’. Rosen’s answer to question 3 includes the following paragraphs:
3.1.6Patient considerations in relation to contraceptive options and the Essure consultation process
The consultation and discussions are guided by the patient and takes into consideration such factors as[:]
a.Patient age and desire for future fertility
b.Previous obstetric history
c.Previous surgical history
d.Other health considerations that may preclude certain options e.g., history of oestrogen-based malignancy would preclude use of the OCP, previous surgical adhesions may make laparoscopy more challenging and riskier to the patient (see 5.1.2).
3.1.7Some patients will exclude various options because of previous bad reaction to medication or similar side-effects, desire not to have a device within their uterus, need for rapid return to full activity and of course the decision that they do not desire further pregnancy regardless of the situation.
3.1.8Patients are provided with relevant documentation which may take the form of RANZCOG pamphlets on contraception and sterilization, referral to a practitioner’s website with information about certain procedures and other relevant websites. After considering all the permutations noted above and depending on the desires of the individual patient, a decision is made on a form of contraception or a further consultation scheduled after the patient has had further time to digest the information and make an informed decision.
3.1.9In my practice, because of my history with the procedure and association with teaching the process, many patients arrived to see me with a referral for the Essure procedure and had made their own research into the procedure, and having done their own research, they requested a referral from their General Practitioner or their regular Gynaecologist who did not perform the Essure procedure, to see me for the Essure procedure, a decision having been made ahead of the consultation and reiterated during our consultation.
3.1.10In my practice. patients would then be consented for the Essure procedure. A glass vial containing a single Essure device was shown by me to the patient and it was explained that, once deployed, the “metal” coils would expand within the fallopian tube and the white (PET) fibres within the coils would allow a benign growth of her own tissue across the tube over the next 3 months at which time, pending a satisfactory X-Ray, she could rely on the device for permanent contraception.
3.1.11In certain cases, as discussed below (5.1.5) and the Physician training manual and intraoperative situation may arise whereby insertion of the Essure devices in both fallopian tubes may not be possible, due to difficulties with access or visualization of the fallopian tube openings. Such a possibility would be discussed as part of my routine consent process for Essure, and in order to preempt such an occurrence, a patient may wish to allow the surgeon to proceed to laparoscopic tubal ligation so that she is guaranteed a sterilization procedure. The option to proceed to Laparoscopic tubal ligation would then be included on the consent form at the time of initial consent.
3.1.12Procedural details regarding anaesthesia, post-operative discomfort and analgesia, cycle timing to maximize visibility at the time of hysteroscopy and 3- month follow-up were then discussed prior to signing of the consent form and booking of surgery.
On the face of his report Rosen may be qualified to give evidence about each of the above matters. He can say how he conducted his own practice, and probably how some other gynaecologists practiced, although how far this knowledge extends is uncertain. He trained gynaecologists in the Essure procedure. He is a senior, experienced gynaecologist who may be qualified to express an opinion about reasonable gynaecological practice.
The state of knowledge of gynaecologists about the Essure device and what constituted reasonable gynaecological practice in respect to the devices as a contraceptive option will be in issue at trial. Evidence about each of the above matters may be probative of those issues. Further, the level of experience as a gynaecologist and his role as an Essure device trainer may be relevant to consideration of what the general cohort of gynaecologists knew or did not know about the pleaded inherent and failure defects, risk of adverse events and removal limitation.[11] Reduced weight may be ascribed to Rosen’s evidence to the extent the subject matter remains unclear. However, I conclude the evidence is relevant.
[11]See for example observations in Ethicon Sarl v Gill (2021) 288 FCR 338, [387]-[423] (Jagot, Murphy and Lee JJ).
I deal with some of the plaintiff’s specific objections in the following paragraphs.
The plaintiff complains that Rosen is not qualified to give opinions about patient behaviour set out in two paragraphs of his report. In the first Rosen said:
3.0When a patient seeks referral to a specialist gynaecologist for discussion regarding contraceptive options, they would usually seek advice from their general practitioner and obtain appropriate referral. In some cases, the patient has researched various options themselves and requests a direct referral to a particular gynaecologist for a specific contraceptive option.
In this paragraph Rosen is simply describing his experience of the way that patients come to see him. The second paragraph is a response to the following question: ‘For a patient who had decided on permanent female contraception, describe the factors which were relevant when deciding upon tubal ligation versus the Essure Device.’ In his answer Rosen describes the factors that are relevant from his perspective as a gynaecologist. He does not purport to give an opinion about patient behaviour in either paragraph.
In his report, Rosen said a physician would consider certain matters to be relevant when advising a patient about contraceptive options and whether the Essure device was suitable. The plaintiff objects on the ground of relevance because Rosen’s evidence concerns ‘what a hypothetical physician might do’, and because there is no factual basis for the generalised opinion that any physician would give a patient certain advice. Read in context Rosen is describing the matters that, as a gynaecologist, he considers are relevant information for a patient, and why. Rosen makes some reference to information contained in a PTM, and to what he does in his own practice. The evidence satisfies the test for relevance.
In the section of Rosen’s report responding to the expert witness report of Korda, Rosen said that if, after discussion of the relevant risks and benefits of the Essure procedure and laparoscopic tubal ligation a patient wished to proceed with the latter, ‘she would be consented for the laparoscopic procedure, or further discussion regarding alternative forms of contraception as discussed in detail within my report above (3.1).’ The plaintiff objects on grounds of relevance, basis, speculations and expertise. It seems likely Rosen is describing his own practice. On that basis none of the grounds for objection are made out.
Commenting on Korda’s opinion that a gynaecologist would fund the risks associated with the Essure device unacceptable. Rosen said:
… based on my training in the procedure and extensive experience with the Essure procedure, I did not find the risks of the Essure procedure in any way unacceptable and indeed I believed it provided my patients with an effective, minimally invasive and safe surgical option for permanent non-hormonal birth control. I found those risks acceptable when compared to the alternative of laparoscopic tubal ligation and other forms of reversible contraception.
The plaintiff objected on relevance and basis grounds. Rosen’s Essure training, his belief in the safety of the device, his knowledge of relevant risks and the information he therefore gave to patients are relevant to facts in issue in the proceeding. His opinion appears to be based on his training in and experience of the Essure device. Further, this evidence responds directly to parts of Korda’s report, and is further considered by Korda in his reply reports. The evidence is admissible.
Rosen said in his report that it is unreasonable to attribute every case of vaginal discharge, heavier menstrual loss and chronic pelvic pain to the systemic effects of a localised inflammatory response. The plaintiff objected on the ground that Rosen said he did not have expertise to comment on inflammatory responses. Read in context Rosen’s opinion is that in some cases the symptoms referred to have a gynaecological explanation. That opinion is within his field of expertise.
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