FEDERAL COURT OF AUSTRALIA

Gill v Ethicon Sárl (No 8) [2020] FCA 771

ORDERS

THE COURT ORDERS THAT:

1.    Order 2 made on 6 March 2020 be varied by the deletion of the struck-through number and words and the insertion of the underlined words as indicated below:

Pursuant to s 232 of the Australian Consumer Law, being Schedule 2 to the Competition and Consumer Act 2010 (Cth), after 20 March 30 June 2020 the respondents may not supply, distribute, market or promote any of the medical devices identified in Schedule B to these orders anywhere in Australia without including in the patient information leaflets and any promotional material relating to those devices advice in the following terms or to the following effect:

PROLENE mesh is designed to, and will invariably elicit in all patients, an acute inflammatory reaction followed by a chronic inflammatory response. The chronic inflammatory response will result in continuously regenerating scar tissue within and surrounding the implant for as long as the implant remains in the body. The scar tissue will cause the mesh to contract to some degree in all patients. It is not possible to predict the severity of the chronic inflammatory response in any individual patient. In some patients the chronic inflammatory response will have adverse effects. It is not possible to identify in advance the patients who will experience those effects, although some patients are at greater risk than others. At-risk patients include healthy patients. Complications might also occur in patients without any known risk factors.

The severity of a patient’s chronic inflammatory response can be affected by physical activity and mechanical loading of the pelvic floor. It can also be affected by conditions which affect the immune response and healing, such as autoimmune and connective tissue disorders. The mechanical forces in the pelvic floor may influence the compatibility and function of the implant.

The adverse events which may result include:

 (a)    infection;

(b)    erosion of the mesh into the vaginal canal resulting in infection which may be difficult to treat, cause offensive vaginal discharge and pain;

(c)    erosion of the mesh into surrounding organs such as the bladder, urethra or rectum which may cause pain and damage those organs;

 (d)    damage to nerves in the scar tissue surrounding the implant or elsewhere;

(e)    punctures or lacerations of vessels, nerves, structures or organs, including the bladder, urethra or bowel, which may require surgical repair;

  (f)    chronic pain, which may be severe and chronic;

(g)    pain with sexual intercourse (dyspareunia), which may be severe and may become chronic;

(h)    loss of sexual function (apareunia), which may be ongoing and may not resolve in some patients;

(i)    leg weakness and other neuromuscular problems which may include acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area;

(j)    de novo urge urinary incontinence or recurrent recurrence of stress urinary incontinence;

 (k)    difficulty voiding; and

  (l)    vaginal discharge.

Adverse events may occur years after implantation. The risk will endure for as long as the implant remains in the patient.

Each of these events may occur regardless of the skill of the surgeon.

While the true incidence of these complications is unknown, they are not rare.

One or more revision surgeries may be necessary to treat the adverse reactions associated with PROLENE Mesh. Revision surgeries may not resolve complications and are associated with a risk of adverse reactions. PROLENE Mesh is a permanent implant that integrates into the tissue. In cases in which the PROLENE Mesh needs to be removed in part or whole, significant dissection may be required.

Removal of the implant in whole or in part will not necessarily alleviate the patient’s symptoms. Removal of part of the implant can be difficult. Removal of the whole of the implant may be practically impossible. Surgery to remove the whole or part of an implant can result in further scarring and tissue damage which, in turn, may have adverse outcomes including severe chronic pain which may not be able to be satisfactorily treated. Surgery to remove the whole or part of the implant may also result in recurrence of stress urinary incontinence.

Removal of the eroded mesh will not necessarily prevent further erosions or other adverse events.

2.    The interlocutory application filed by the respondents on 17 April 2020 and amended on 25 May 2020 otherwise be dismissed with costs.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT

KATZMANN J:

1    This is a representative proceeding in which I held that the respondents contravened the Trade Practices Act 1974 (Cth) and the Australian Consumer Law by, amongst other things, supplying defective goods within the meaning of that legislation and making misleading or deceptive statements in relation to them. I also found that the respondents breached their duty of care to the applicants who received some of those goods. See Gill v Ethicon Sàrl (No 5) [2019] FCA 1905 (the principal judgment). The goods in question are implantable medical devices made from treated polypropylene and indicated for the treatment of either pelvic organ prolapse (POP devices) or stress urinary incontinence (SUI devices). None of the POP devices has been sold in Australia for some time and none can now be sold since they have been removed from the Australian Register of Therapeutic Goods (ARTG). All but one is no longer manufactured. The SUI devices, however, continue to be manufactured and all but one is still sold in Australia. Those devices currently available for sale in Australia are Gynecare Tension-free Vaginal Tape System (TVT), Gynecare TVT Obturator System (TVT-O), Gynecare TVT Exact Continence System (TVT Exact) and Gynecare TVT Abbrevo Continence System (TVT Abbrevo). They are manufactured by Ethicon Sàrl, a Swiss corporation, and imported, promoted and distributed in Australia by a related company, Johnson & Johnson Medical Pty Limited (JJM).

2    An appeal from the principal judgment was filed on 3 April 2020.

3    This is an application brought by the respondents to vary one of two injunctions I imposed on 6 March 2020. The effect of that injunction was to restrain the respondents from supplying, distributing, marketing or promoting any of the four SUI devices listed above without including in patient information leaflets and promotional material relating to those devices certain information or advice about some significant complications about which no or no adequate warnings had previously been given (the Advice). The injunction in question was order 2 of the orders made that day (Order 2). Order 2 was in the following terms:

Pursuant to s 232 of the Australian Consumer Law, being Schedule 2 to the Competition and Consumer Act 2010 (Cth), after 20 March 2020 the respondents may not supply, distribute, market or promote any of the medical devices identified in Schedule B to these orders anywhere in Australia without including in the patient information leaflets and any promotional material relating to those devices advice in the following terms or to the following effect:

Prolene mesh is designed to, and will invariably elicit in all patients, an acute inflammatory reaction followed by a chronic inflammatory response. The chronic inflammatory response will result in continuously regenerating scar tissue within and surrounding the implant for as long as the implant remains in the body. The scar tissue will cause the mesh to contract to some degree in all patients. It is not possible to predict the severity of the chronic inflammatory response in any individual patient. In some patients the chronic inflammatory response will have adverse effects. It is not possible to identify in advance the patients who will experience those effects, although some patients are at greater risk than others. At-risk patients include healthy patients. The severity of a patient’s chronic inflammatory response can be affected by physical activity and mechanical loading of the pelvic floor. It can also be affected by conditions which affect the immune response and healing, such as autoimmune and connective tissue disorders. The mechanical forces in the pelvic floor may influence the compatibility and function of the implant.

The adverse events which may result include:

(a)    infection;

(b)    erosion of the mesh into the vaginal canal resulting in infection which may be difficult to treat, cause offensive vaginal discharge and pain;

(c)    erosion of the mesh into surrounding organs such as the bladder, urethra or rectum which may cause pain and damage those organs;

(d)    damage to nerves in the scar tissue surrounding the implant or elsewhere;

(e)    chronic pain, which may be severe;

(f)    dyspareunia, which may be severe and may become chronic;

(g)    apareunia;

(h)    leg weakness;

(i)    de novo or recurrent urinary incontinence;

(j)    difficulty voiding; and

(k)    vaginal discharge.

Adverse events may occur years after implantation. The risk will endure for as long as the implant remains in the patient.

Each of these events may occur regardless of the skill of the surgeon.

While the true incidence of these complications is unknown, they are not rare.

Removal of the implant in whole or in part will not necessarily alleviate the patient’s symptoms. Removal of part of the implant can be difficult. Removal of the whole of the implant may be practically impossible. Surgery to remove the whole or part of an implant can result in further scarring and tissue damage which, in turn, may have adverse outcomes including severe chronic pain which may not be able to be satisfactorily treated. Surgery to remove the whole or part of the implant may also result in recurrence of stress urinary incontinence.

Removal of the eroded mesh will not necessarily prevent further erosions or other adverse events.

4    Schedule B was a list of the SUI devices still supplied in Australia. “Patient information leaflets” are relatively new in Australia. In the principal judgment I referred to patient brochures produced by the respondents. These were largely marketing tools. “Patient information leaflets” are documents which are required by Australian law to be supplied with implantable medical devices like the SUI devices. The requirement was introduced through amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) (Medical Devices Regulations or Regulations) which came into force on 1 December 2018. Clause 13A of Schedule 1 of the Regulations specifies the information which must be included in the leaflets. That includes information regarding any undesirable side-effects that could be caused by the use of a device. Since 1 December 2019 patient information leaflets and patient implant cards must be supplied with any urogynaecological mesh devices already included in the ARTG because of an application made before 1 December 2018.

5    On 18 March 2020 the respondents filed an interlocutory application seeking to have the time for compliance with Order 2 extended from 20 March until 20 April 2020. I acceded to their application and made orders, in accordance with their request, the same day.

6    In an affidavit filed in support of that interlocutory application, Colin Loveday, the solicitor with carriage of the matter on behalf of the respondents, deposed that, at the time the injunction was granted, the respondents considered that 14 days was “an appropriate estimate of the time required for compliance”. But he said, and I accepted, that they had not taken into account what, if any, impact COVID-19 might have had on JJM’s day-to-day business operations.

7    On 17 April 2020 a second interlocutory application was filed. An amended application was sent to my chambers on 22 May 2020 and I gave leave at the hearing on 25 May 2020 for the respondents to file the amended application. From now on I shall refer to this application as the “application”. By the time the application was filed, the respondents had filed a notice of appeal which, amongst other things, I was informed, seeks to have the injunction set aside. In the application, the respondents apply for the following orders:

1.    The date for compliance with Order 2 made on 6 March 2020 be extended to the date of determination of this interlocutory application.

2.     Pursuant to r 39.05(d) of the Federal Court Rules 2011 (Cth), Order 2 made on 6 March 2020 be varied by replacing the “advice” with the following:

All polypropylene mesh is designed to, and will elicit in all patients, a foreign body reaction which involves a period of acute inflammation, followed by a permanent foreign body response involving remodelling and an inflammation process which provides support to weakened support structures.

The foreign body response will result in continuously regenerating scar tissue within and surrounding the implant for as long as the implant remains in the body. The scar tissue will cause the mesh to contract to some degree in all patients.

It is not possible to predict the severity of the chronic inflammatory response in any individual patient. In some patients the chronic inflammatory response will have adverse effects. It is not possible to identify in advance the patients who will experience those effects, although some patients are at greater risk than others. Complications might also appear in patients without any known risk factors.

The severity of a patient’s chronic inflammatory response can be affected by physical activity and mechanical loading of the pelvic floor. It can also be affected by patient-specific factors such as autoimmune and connective tissue disorders. The mechanical forces in the pelvic floor may influence the compatibility and function of the implant.

The adverse events which may result include:

(a)     Punctures or lacerations of vessels, nerves, structures or organs, including the bladder, urethra or bowel, may occur and may require surgical repair.

(b)    Local irritation at the wound site may occur.

(c)     As with any implant, a foreign body response will occur, the extent of which may differ. This response could result in extrusion, erosion, exposure, fistula formation and/or chronic inflammation, the severity of which is unpredictable, or other adverse reactions, which may be ongoing.

(d)     Fistula formation, acute and chronic inflammation and ongoing risk of mesh extrusion, exposure, or erosion into the vagina or other structures or organs (such as bladder, urethra or rectum), which may be difficult to treat and result in consequent pain. Mesh extrusion, exposure, or erosion into the vagina may also cause offensive vaginal discharge.

(e)     As with all surgical procedures and the implantation of foreign bodies, there is a risk of infection and PROLENE Mesh may potentiate an existing infection.

(f)     Pain - which may be severe and chronic.

(g)     Temporary or chronic voiding dysfunction (or difficulty voiding) or urinary retention/obstruction independent from that caused by overcorrection or urethral hypermobility, i.e. too much tension applied to the tape, or from misplacement of the sling or placing the sling too tightly.

(h)     Pain with intercourse, (dyspareunia) and loss of sexual function (apareunia), which may be ongoing and may not resolve in some patients.

(i)     Excessive contraction or shrinkage of the tissue surrounding the mesh, and vaginal scarring from causes which include, but are not limited to, chronic inflammation and mesh exposure.

(j)     Neuromuscular problems, including acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area, and leg weakness, may occur.

(k)     Do novo urge urinary incontinence or recurrence of stress urinary incontinence.

(l)     Bleeding including hemorrhage, or hematoma.

One or more revision surgeries may be necessary to treat these adverse reactions. Revision surgeries may not resolve complications and are associated with a risk of adverse reactions. PROLENE Mesh is a permanent implant that integrates into the tissue. In cases in which the PROLENE Mesh needs to be removed in part or whole, significant dissection may be required.

Adverse events may occur years after implantation. The risk will endure for as long as the implant remains in the patient.

Each of these events may occur regardless of the skill of the surgeon.

While the true incidence of these complications is unknown, they are not rare.

Removal of the implant in whole or in part will not necessarily alleviate the patient’s symptoms.

Removal of part of the implant can be difficult. Removal of the whole of the implant may be practically impossible. Surgery to remove the whole or part of an implant can result in further scarring and tissue damage which, in turn, may have adverse outcomes including severe chronic pain which may not be able to be satisfactorily treated. Surgery to remove the whole or part of the implant may also result in recurrence of stress urinary incontinence.

Removal of the eroded mesh will not necessarily prevent further erosions or other adverse events.

3.     Further or in the alternative to order 2 of this interlocutory application, pursuant to r 36.08(2) of the Federal Court Rules 2011 (Cth), Order 2 made on 6 March 2020 be stayed until the determination of the appeal filed on 3 April 2020, being Proceedings NSD391/2020 (Ethicon Sarl & Ors v Kathryn Gill & Ors).

4.    In the event that the Court makes order 2 of this interlocutory application but does not make order 3 of this interlocutory application, the date for compliance with Order 2 made on 6 March 2020 (as varied) be extended to a date being 7 days after the date of determination of this interlocutory application.

 5.    Such other orders as the Court sees fit.

 6.    Liberty to apply on 3 days’ notice.

8    The application was supported by two further affidavits from Mr Loveday, filed on 17 April and 1 May 2020, and which have since been sworn.

9    The applicants consented to ground 1 but opposed the making of the other proposed orders. In the pious hope that they might be able to reach agreement I directed that the parties confer. But that was not to be. On 7 May 2020 I made orders listing the application for hearing and fixed a timetable for the filing and exchange of submissions.

10    On 21 May 2020 affidavits were filed on behalf of the applicants in opposition to the application. One was from Paris Maree Hamrey, the other from Janice Mary Saddler, both solicitors with Shine Lawyers, who represent the applicants.

11    The day the respondents’ submissions were due to be filed, they requested a 24-hour extension, which I granted. The day they filed their submissions they also filed a further affidavit. This was an affidavit, yet to be affirmed or sworn, from Dr Giovanni Antonio Tommaselli, Ethicon’s Medical Director, “Life Cycle Management”, who lives in Naples, Italy. I gather from his affidavit that he is the Medical Director with responsibility for the SUI devices. It also appears from his curriculum vitae that he is an obstetrician and gynaecologist. Dr Tommaselli purported to explain the reasons for the proposed variations to the injunction.

12    In their written submissions the respondents contended that they brought the application “as a matter of necessity”. They went on to say:

Relevant to this Application, the dispute between the parties in these proceedings concerned the warnings that ought to have been given by the Respondents with respect to the adverse events which might eventuate following implantation of the SUI Devices. That dispute – and indeed resolution of the common questions and answers in March 2020 – did not encompass any separate debate with respect to the precise wording of any warning or advice which the Respondents would be required, by way of permanent injunction, to give in future distribution of those devices to non-group members.

(Original emphasis.)

13    Later in their submissions, the respondents asserted that “the form and content of the injunction proposed to be granted was first disclosed to the parties in the [principal judgment] on 21 November 2019”.

14    I emphatically reject the notion, implicit in these submissions, that this is the first opportunity the respondents have had to be heard on the form of the injunction.

15    It is true that the parties were not given advanced warning of the precise form the injunction would take. That is unremarkable. With some omissions, however, the injunction I granted was similar in terms to the injunction the applicants sought in their fifth amended originating application filed pursuant to leave granted, on 9 April 2018, and included in their interlocutory application, filed on 14 March 2018. Amongst other things, in that interlocutory application, the applicants sought leave to amend the originating application to seek an injunction restraining the respondents from supplying, distributing, marketing or promoting the devices without providing what they referred to as a “Proper Warning”: Gill v Ethicon SÁRL [2018] FCA 470 (Gill No 1). The “Proper Warning” was first flagged with the respondents more than 21 months before the publication of the principal judgment in November 2019. At a hearing on 9 February 2018 the applicants’ lead counsel, Mr Bannon SC, handed up a document by the same name which was given the Bates number CRT.010.021.0001. That document is Annexure A to Gill No 1, which was published on 9 April 2018. In Gill No 1 I indicated that I would give the respondents leave to make further submissions, amongst other things, relating to injunctive relief, and directed that those submissions be filed by 31 May 2018. The respondents later obtained an extension of time and filed submissions on 18 June 2018. For some obscure reason, they chose to use this opportunity merely to repeat the submissions they made on the interlocutory application and which I had rejected in Gill No 1. They did not engage at all with the contents of the “Proper Warning”. Thus, the only reason there was no debate about the content of the injunction was because the respondents elected not to enter into one. Presumably this was a forensic decision. They had ample opportunity to persuade the Court that, if an injunction were to be granted, it should not be in the form the applicants proposed and to advance its current formulation.

16    The background of the present application is explained in the respondents’ written submissions by reference to what they referred to as “two developments of relevance”.

17    The first is said to be the filing of the notice of appeal. The appeal has been provisionally listed for hearing in the first week of February next year. The respondents submitted that the present application “must be considered in the context of the pending appeal”. They explained:

Specifically, the respondents maintain the position that, if they succeed in the appeal on all relevant grounds, they would not be required to implement the amendments to the PIL [patient information leaflet] envisaged by Order 2 in order to continue distributing the SUI Devices in Australia. That notwithstanding, it is still the case that the respondents will be undertaking a continuous process of review and revision of the PILs and IFUs [Instructions For Use] (as they would in any case), particularly in light of changing regulatory regimes in Australia and the European Union. That the Respondents are seeking to ensure that Order 2 — and indeed the Court’s findings upon which Order 2 is predicated — can be appropriately accommodated in this revision process properly recognises the fact that the Court’s orders and findings are final unless subsequently set aside on appeal. The Respondents’ proposed variations to the advice must therefore be understood through that lens, and not as a concession with respect to the issues to be raised on appeal.

18    The second “development of relevance” is said to be a review by the Therapeutic Goods Administration (TGA) of the patient information leaflet for the SUI devices.

19    An annexure to Mr Loveday’s affidavit of 1 May 2020 reveals that on 27 November 2019 JJM, as the “sponsor” of the SUI devices within the meaning of that term in the Therapeutic Goods Act 1989 (Cth), was requested to provide their patient information leaflets for the SUI devices to the TGA for evaluation. As I explained in the principal judgment, a “sponsor” includes a person responsible for importing the goods into Australia or arranging for another person to manufacture the goods for supply in Australia (or elsewhere). The TGA’s evaluation report, annexed to the affidavit, was sent to JJM by email on 24 April 2020. It raised numerous concerns about deficiencies in the safety information in the single patient information leaflet for the SUI devices. In the covering email, after referring to the attached evaluation, Katie Burns, of the Devices Post-Market Reforms and Reviews Section of the Medical Devices Surveillance Branch, relevantly stated (without alteration):

We acknowledge that some of the actions required will have already been updated due to Judge Katzmann’s ruling, some of the actions include updating the list of known adverse events. However, the other feedback provided will need to be taken into consideration.

Could you please provide a timeline in which the required changes will be implemented?

Please provide the timeline by COB 11 May 2020.

20    By 19 May 2020, however, the affidavit from Ms Hamrey indicates that no action had been taken to update the patient information leaflet for the SUI devices because the version available on the JJM website was no different from the version annexed to Mr Loveday’s affidavit of 1 May 2020, which predated the injunction and was the subject of the evaluation by the TGA. Moreover, although that leaflet was produced after the publication of the principal judgment, it paid no attention to its findings.

21    Dr Tommaselli’s evidence was that JJM is in the process of considering the evaluation and expects to provide a “further update” by 10 June 2020 addressing the steps it proposes to take.

22    The evidence is silent on when, or even whether, JJM informed the TGA that it had sought an extension of time to comply with Order 2 and had not yet complied with it. Dr Tommaselli annexed to his affidavit an email from Rebecca Gaudin, JJM’s Director of Regulatory Affairs, sent to Ms Burns on 11 May 2020. In that email Ms Gaudin wrote:

As referenced in your evaluation, on 6 March 2020 the Federal Court of Australia, made an order requiring JJM to include certain warnings in our PIL. As you know, that order is currently stayed pending further orders of the Court. An application has now been made to the Court to vary the 6 March orders that affect the contents of the PIL. We anticipate this application will be heard in late May 2020 and determined shortly after.

23    The statement made in the second sentence was not an accurate summary of the position. On 1 May 2020 I ordered that the “date for compliance with Order 2 made on 6 March 2020 be extended to the date of determination of the interlocutory application filed on 17 April 2020”. Order 2 was not “stayed pending further orders of the Court.”

24    The TGA evaluation report stated that the patient information leaflet had been assessed for compliance against the requirements of Sch 1 cl 13A of the Medical Devices Regulations and that my findings had also been included in the assessment. It contained a link, to the principal judgment and the terms of Order 2 were also extracted in full. In a summary of the findings the TGA relevantly stated (without alteration) that:

[T]he PILs submitted for assessment:

•    Do not adequately address serious adverse outcomes and the types of adverse outcomes.

•    Are insufficient in their current state to provide the level of information regarding patient warnings, of which are a mandatory inclusion for all PILs.

•    Do not contain sufficient information pertaining to the device and the procedure.

25    The report noted (also without alteration) that, amongst other things, to demonstrate compliance with cl 13A:

•    The PIL should include the following information (or similar): “Whilst the surgery is intended to be permanent, the life expectancy of the mesh is unpredictable. This is due to the possibility of the mesh migrating, eroding and integrating into surrounding tissue(s), which may lead to complications. Whilst the device itself may remain functional, complications (such as scarring and tissue), may cause symptoms (such as pain) which may become severe and chronic and subsequently result in the need to remove the mesh”. As the mesh integrates into surrounding tissue, removal of the mesh in its entirety is extremely difficulty and in some cases, practically impossible.” (Or similar effect).

•    The above should be followed by a statement in bold text that reads, “Please carefully consider this information and warning prior to providing consent to the procedure”.

26    The report went on to remind JJM that:

8.    As per EP [Essential Principle] 13A.3 (3)(4)(b), a PIL must include information regarding any undesirable side effects that could be caused by the use of the device. Clearer and more comprehensive information within the “What are the risks?” section should be provided, as the current information is insufficient and further, the formatting is incoherent. This section of the PIL holds critical information pertaining to potential health outcomes and it is therefore imperative that this section is presented in a clear and informative manner (in line with EP 13A.3 (4)). As the current formatting and content stands, the paragraph contains a list of non-specific and ambiguous symptoms. The TGA would like to remind the sponsor that it is mandatory to include warnings and risks associated with the device in the PIL.

27    The report continued:

To demonstrate compliance with EP 13A.3(4)(b),

•    The PIL should contain a list (dot points) and not a paragraph of individual risks and each individual risk should be accompanied by additional information that provides context surrounding each risk. An example is “inflammation”. There is nil reference to or explanation of the inflammatory process including acute and or chronic states of inflammation and where the inflammation might occur. We recommend the sponsor elaborate on the risk “inflammation” as it is too broad and ambiguous.

•    The clinical assessor has suggested the sponsor categorise the information into risks associated with general surgery, risks associated with surgery for SUI and risks associated with the mesh itself.

9.    Further to point 8 and in line with EP 13A.3 (3)(4)(b) and EP 13A.3 (4), clearer information within the “Complications Associated with Synthetic Mesh to Treat SUI” section should be provided. Information within this section is information that concerns undesirable side effects that may be caused by the device and the information must be written in a way that is readily understood by patients.

To demonstrate compliance with EP 13A.3(3)(4)(b),

•    The PIL should contain a list (dot points) and not a paragraph of complications and it would be expected that the sponsor elaborate on each of the complications listed. For example, the PIL states that mesh erosion can cause “pain and additional problems”. Simply stating “additional problems” is unacceptable. We recommend the sponsor list mesh erosion as one single dot point and provide further explanation and context surrounding what is meant by “additional problems”. For example, we recommend the inclusion of complications that may result due to mesh erosion, such as an infection. In line with EP 13A.3 (3)(7)(b), a PIL should also provide information regarding symptoms that could indicate that the device is malfunctioning. For example, if an infection is a complication that can result due to mesh erosion, then the symptoms of an infection should be listed, for example, pain and fever.

•    The PIL should comprehensively list all of the known risks and complications associated with synthetic mesh and not just some. Therefore, the PIL should include the following:

•    Chronic pain in the pelvis, lower back, hip and thigh, or a combination of these

•    Becoming aware of the mesh during intercourse or experiencing pain during sex for the woman or her partner

•    Vaginal bleeding

•    Being able to feel the mesh in the vagina or having pain or a prickly feeling

•    Having blood in the urine due to erosion of the mesh into the bladder or urethra (urine tube)

•    Obstruction of the urethra causing bladder symptoms such as retention (being unable to urinate when your bladder is full), incontinence, urge incontinence (sudden and strong need to urinate) and poor urinary flow

•    Recurrent urinary or vaginal infection

•    A 'foreign body response' (wound breakdown, extrusion, erosion, exposure, fistula formation and/or inflammation)

•    Difficulty with bladder emptying may require reoperation

•    Removal of part, or all, of the sling may be necessary in the case of a complication such as the mesh affecting the vaginal wall and becoming exposed or eroding into the bladder or urethra. Complete removal may be difficult or impossible and multiple surgeries may be needed

•    The PIL should state the following, “Women who suffer severe complications may experience significant personal and mental wellbeing effects”.

…

To demonstrate compliance with EP 13A.3(2)(b),

•    The PIL should include all relevant contraindications; the PIL currently states pregnancy but no others.

•    We note that within the section “Who is a candidate for treatment?”, two dot points relating to warnings (pregnancy and smoking). In conveying information which is easy to read and of which is coherent, we recommend transferring these dot points to the “Contraindications” section of the PIL. These dot points meet the definition of contraindications in that they are specific situations in which the procedure should not be performed.

14.    It is mandatory to include any warnings and risks associated with the device, in the PIL. In some cases, removal of the mesh device may be required. Removal of the device in its entirety is difficult and near impossible, therefore, the PIL should adequately explain this. The TGA would consider such information a very serious warning and information that a patient has the right to be made aware of prior to consenting to undergoing the procedure.

To demonstrate compliance with EP13A.3(4)(b),

•    The PIL should explicitly state that removal of the device in its entirety is difficult and in some cases almost impossible. The PIL currently refers to the removal of mesh in two different sections of the PIL. Removal is first referred to in the “Complications Associated with Synthetic Mesh to Treat SUI” and secondly within the “Adverse reactions” section. Both references to the removal of the mesh should be followed by a warning that removal is extremely difficult and in some cases, impossible.

…

28    It is difficult to understand how the TGA’s evaluation report assists the respondents’ application particularly since it seems from Ms Burns’ email of 24 April 2020 that the TGA (at that point at least) was labouring under the mistaken assumption that the respondents was in the process of complying with Order 2.

29    To a large extent, the application to vary the injunction is misconceived. Part of the motivation for it appeared to be concern that, if they did not use the precise words of the Advice, the respondents would be in breach of the injunction and at risk of contempt. That is not so, as the plain words of the order make clear. Otherwise, the application seeks to involve the Court in a drafting or “wordsmithing” exercise, as the applicants put it.

30    In their submissions, the respondents noted that the variations they propose “may require further revision and amendment as a result of the TGA’s assessment” which rather begs the question as to why the application was made. The respondents went on to say that the changes they propose “do not involve a substantive alteration to the [A]dvice, nor do they reframe the [A]dvice in such a fashion so as to detract from the clarity, effect or gravity of the warnings which it is intended to convey”. Rather, they contended, the variations are primarily concerned with “improving its precision and completeness”.

31    I find these submissions difficult to accept. Indeed, I regard them as disingenuous. The Advice was not intended to be complete or comprehensive — far from it. That would have been obvious to the respondents from the reasons for judgment. Its purpose was to ensure that prospective recipients of the SUI devices were informed about potential complications of which the respondents had given no or no adequate warning and its formulation reflected the way the case was pleaded and argued. That is why “hispareunia” (pain to the patient’s husband or male sexual partner during sexual intercourse), for example, a recognised risk of implantation of the devices, was not included in the Advice as an adverse event, although it was not mentioned in the respondents’ instructions for use or brochures. It was not included because it was not one of the complications the applicants alleged should have been the subject of a warning, although others might well think otherwise. And if the respondents genuinely desired that the injunction be varied in order that the Advice was complete, they presumably would have included the additional matters identified by the TGA in its evaluation report. Further, while in some respects the proposed changes did not substantively alter the Advice, in certain respects they did, such as in the case of infection, although the respondents retreated from that position and, in the case of dyspareunia, they tended to detract from the gravity of the warning.

32    After the hearing of the application on 25 May 2020, the respondents agreed to modify their request in a number of respects. Instead of what appears in their amended interlocutory application, they proposed the following variation to the first three paragraphs of the Advice:

Prolene All polypropylene mesh, including PROLENE mesh, is designed to, and will invariably elicit in all patients, an acute inflammatory a foreign body reaction which involves a period of acute inflammation followed by a permanent foreign body (chronic inflammatory) response, which involves remodelling and an inflammation process which is intended to provide support to weakened support structures.

The foreign body chronic inflammatory response will result in continuously regenerating scar tissue within and surrounding the implant for as long as the implant remains in the body. The scar tissue will cause the mesh to contract to some degree in all patients. It is not possible to predict the severity of the chronic inflammatory response in any individual patient. In some patients the chronic inflammatory response will have adverse effects. It is not possible to identify in advance the patients who will experience those effects, although some patients are at greater risk than others. At-risk patients include healthy patients. Complications might also appear in patients without any known risk factors.

The severity of a patient’s chronic inflammatory response can be affected by physical activity and mechanical loading of the pelvic floor. It can also be affected by conditions which affect the immune response and healing, patient-specific factors such as autoimmune and connective tissue disorders. The mechanical forces in the pelvic floor may influence the compatibility and function of the implant.

33    They also restored the list of adverse events in the Advice but proposed the following changes:

(1)    adding “punctures or lacerations of vessels, nerves, structures or organs, including the bladder, urethra or bowel which may require surgical repair” after “damage to nerves in the scar tissue surrounding the implant or elsewhere”, which they had previously sought to remove;

(2)    substituting for “chronic pain, which may be severe” “pain – which may be severe and chronic”;

(3)    substituting for “dyspareunia, which may be severe and may become chronic” “pain with sexual intercourse (dyspareunia), which may be ongoing and may not resolve in some patients”;

(4)    replacing “apareunia” with “loss of sexual function (apareunia), which may be ongoing and may not resolve in some patients”;

(5)    adding to “leg weakness” “and other neuromuscular problems which may include acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area”; and

(6)    deleting “or recurrent” after the words “de novo” and adding before “urinary incontinence” “urge urinary incontinence or recurrence of stress”.

34    The final proposed variation would seek to retain the paragraph appearing in the application commencing with the words “[o]ne or more revision surgeries may be necessary to treat the adverse reactions associated with PROLENE Mesh…” but moving it below the paragraph beginning “[a]dverse events may occur years after implantation…”.

35    Otherwise, the terms of the Advice would be unchanged.

36    The applicants agreed to all except the amendments to the first paragraph; the addition of the words “foreign body” before “chronic” in the first sentence of the second paragraph; the addition of the word “also” after “might” in the last sentence of the second paragraph; the deletion of the words “conditions which affect the immune response and healing” in the second sentence of the third paragraph; and the variation to the warnings concerning dyspareunia and apareunia. There also appeared to be a slight difference of opinion between the parties about the manner in which the warning about pain should be expressed, with the applicants proposing “pain – which may include severe pain and/or chronic pain” instead of “pain – which may be severe and chronic”, a distinction, I venture to suggest, without a difference.

37    There is no doubt that I have the power to vary the injunction. The power is expressly conferred by r 39.05(d) of the Federal Court Rules 2011 (Cth) and s 235 of the Australian Consumer Law. See also ICI Australia Operations Pty Ltd v Trade Practices Commission (1992) 38 FCR 248 at 266. In that case, which was concerned with s 80(3) of the Trade Practices Act, the predecessor to s 235 of the ACL, Gummow J said:

[Section] 80 (3) authorises the court to rescind or vary not only an interim injunction but a final injunction. Such an order may become spent by reason of the temporal or other criteria specified in it for its operation (eg the duration of a patent). A subsequent change in the law in aid of which the injunction was granted or supervening impossibility of performance required by a mandatory order, may provide special cases. But in other respects it remains a question under the general law as to when a final injunction may be discharged otherwise than by consent. However, the generality of the circumstances in which an injunction may be granted under s 80 made it highly expedient for the Parliament to place beyond doubt the power of the court to rescind or vary both interim and final injunctions.

38    The variations the respondents seek do not fall within any of the categories mentioned by Gummow J in the above-mentioned passage. I do not suggest, however, that those categories are exhaustive. Plainly, though, the power to vary a final injunction should not be exercised without good reason.

39    Speaking of r 39.05(f), which entitles the court to vary or set aside a judgment or order after it has been entered if the party in whose favour it was made consents, McKerracher J said that the power should be exercised “with caution and in exceptional circumstances”, having regard to “the overarching principle of the finality of litigation”: Australian Competition and Consumer Commission v True Alliance Trading Pty Ltd (formerly, Reebok Australia Pty Ltd) (No 2) [2017] FCA 990 at [12] (McKerracher J), citing Australian Securities and Investments Commission v ActiveSuper Pty Ltd (No 4) [2013] FCA 318 at [6] per Gordon J. These principles apply equally, however, to r 39.05 generally. The respondents did not suggest otherwise. ActiveSuper, for example, concerned, amongst other things, an application to vary an interlocutory injunction made in the absence of a party.

40    The respondents have not made out a case for variation of Order 2. Nothing in the material advanced in support of the application provides a proper basis for it. Certainly, they have not pointed to any exceptional circumstances which would justify it.

41    There is no need to add to the Advice “punctures or lacerations of vessels, nerves, structures or organs …”. The respondents admitted as much in their submissions, observing that their inclusion “does not necessarily require the Court’s sanction (and indeed may be the subject of further refinement following completion of the TGA’s review)”. Nevertheless, since the applicants agreed to the addition, I am prepared to vary the Advice to include it.

42    The fact that I referred to “dyspareunia” and “apareunia”, the medical terms for pain on sexual intercourse and the absence of sexual intercourse, does not require a variation of the Advice. The respondents were well aware of the meaning of these terms and I expected them to convey the advice in the patient information leaflets in a way patients would understand, hence the reference in the order to “words to that effect”. I am nonetheless content to amend the Advice to spell out their meaning and to add to the entry concerning apareunia, “which may be ongoing and may not resolve in some patients”. I am also content to add the reference to “other neuromuscular problems …” after “leg weakness” in the list of adverse events and to clarify the “de novo or recurrent urinary incontinence” item, although it does not seem necessary. Nor do I have any difficulty with the variation of “chronic pain, which may be severe” to “pain, which may be severe and chronic”, although once again, an amendment is unnecessary. I see the force, however, of the respondents’ proposal to replace the sentence “At-risk patients include healthy patients” with “Complications might also appear in patients without any known risk factors”. I am also content to include the paragraph beginning “[o]ne or more revision surgeries may be necessary …”.

43    But I cannot countenance the omission of “severe” from the reference to dyspareunia even though, as the respondents contended, there is a separate warning that pain may be severe. To omit “severe” from the entry for “dyspareunia”, would tend to dilute the message. It seems likely this was the respondents’ purpose. Further, unless the respondents are seeking to minimise the significance of dyspareunia as an adverse effect of implantation of an SUI device, which they implicitly denied in their submissions, I do not understand why they have removed the statement that dyspareunia may become chronic, replacing “chronic” with “ongoing”. The words are not synonymous. “Chronic” means lasting a long time, lingering, inveterate. “Ongoing” simply means continuing. Besides, “chronic” is retained in the items dealing with both pain simpliciter and “pain in the groin, thigh, leg, pelvic and/or abdominal area”.

44    Nor do I regard the reference to “patient-specific factors” as an entirely suitable synonym for “conditions which affect the immune response and healing”. This is not to say that the respondents should not advise patients of so-called patient-specific factors, including such other factors as are not captured by the Advice. Rather, the reference to “conditions which affect the immune response and healing” directs attention to the range of factors of this kind.

45    I am ambivalent about the proposed change to the first paragraph of the Advice. I accept that “invariably” is redundant and should be deleted. But I see no need to vary the injunction to accommodate the other suggested changes. The Court is concerned with the mesh used in the SUI devices, known by the trade name PROLENE, not with polypropylene mesh in general. The reference to a foreign body reaction or response, which the respondents want to add to the first and second paragraphs, is unlikely to enhance the patients’ understanding of the inflammatory process. In their submissions the respondents professed concern to ensure that “harmony” is achieved between the Court’s orders and “the regulatory regime for the SUI [d]evices in Australia”. I find this difficult to accept since the respondents do not ask the Court to incorporate in the injunction all the omissions from the Patient Information Leaflet which the TGA drew to their attention. In any event, there is no dissonance whatsoever between the terms of the injunction and the Australian regulatory regime or between the contents of the Advice and the matters identified by the TGA in its evaluation report. The additional matters identified by the TGA are not at odds with the Advice.

46    Since I have refused to vary the injunction in precisely the manner the respondents sought, I now need to deal with their stay application on the assumption that it is pressed.

47    The principles relating to a stay of orders pending an appeal are well-established.

48    First, while special circumstances are not required and the Court has a broad discretion, the judgment is not to be treated as provisional. The Court starts with the premise that the successful party is entitled to its benefit and to the presumption that it is correct. Consequently, an applicant for a stay carries the burden of establishing that a stay is appropriate. See, for example, Alexander v Cambridge Credit Corporation Ltd (receivers appointed) (1985) 2 NSWLR 685 (CA) at 693–695; Powerflex Services Pty Ltd v Data Access Corporation (1996) 67 FCR 65 (FC) at 66 (Burchett J).

49    Second, the burden is not discharged merely by the filing of an appeal or an application for leave to appeal: Alexander at 694.

50    Third, a stay should not be granted unless the appeal is at least arguable, but “the existence of an arguable case on appeal does not of itself justify the granting of a stay”: Red Bull Australia Pty Ltd v Sydneywide Distributors Pty Limited t/as Sydneywide Bottlers Australia [2001] FCA 1750 at [6] (Hely J).

51    Fourth, in the exercise of the discretion, the Court will weigh up such factors as the balance of convenience and the competing rights of the parties, including, in particular, whether prejudice will be caused by the grant or the withholding of a stay. If there is a risk that the appeal would be rendered nugatory if a stay is not granted in the event that an appeal is successful, this will be a substantial factor in favour of granting a stay. See Alexander at 693–695; Phillip Morris (Australia) Pty Ltd v Nixon [1999] FCA 1281 (FC) at [17].

52    The respondents conceded that the appeal would not be rendered nugatory if a stay were refused. They argued that a stay was appropriate for other reasons, which I will deal with in the order in which they appear in their submissions.

53    The first is the so-called “state of regulatory flux” in which they currently find themselves. There is no state of regulatory flux. The new regulations were made on 14 December 2017, before the application for the injunction was made, and came into force nearly a year before the principal judgment was delivered. It is nonsense to suggest, as the respondents did, that many of the TGA’s recommendations are not directly compatible or consistent with the Advice. Certainly the TGA did not say so. Its point was that it was not enough just to include the information in the Advice. Nor is it necessary, as the respondents contended, or even desirable for the respondents to make further applications to the Court “to validate” revisions to the patient information leaflet so that they comply with Order 2.

54    The second reason the respondents submitted a stay was appropriate was the lack of prejudice to the applicants. But that is beside the point, since the injunction serves a public purpose, which is protective, and includes the prevention and deterrence of undesirable trade practices.

55    The respondents also argued the Court’s concern, to ensure that prospective patients are given sufficient warning of the risks associated with the SUI devices, carries “limited weight” given the current restrictions on elective surgery due to the COVID-19 pandemic. The evidence in support of the argument was in Mr Loveday’s 17 April affidavit. At that point in time, all non-urgent elective surgery had been temporarily suspended. Since then, however, those restrictions are being progressively relaxed.

56    The respondents also relied on the fact that the patient information leaflet is not the only source of information on “implants in the nature of the SUI devices”. They submitted that surgeons regularly use guidance documents prepared by the Australian Commission on Safety and Quality in Health Care (ACSQHC) and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) to ensure that patients are able to provide fully informed consent to implantation of the SUI devices. To the extent that elective incontinence surgery is available during the pandemic, they argued that “there is no reason to doubt the effectiveness of the wealth of information already available to patients and the proficiency of the medical professionals responsible for carrying out such procedures to ensure proper warnings are given”.

57    There are a number of problems with these submissions.

58    First, the injunction relates to information to be provided directly to patients.

59    Second, for this reason the fact that other sources of information are available is immaterial.

60    Third, the statements by professional bodies like RANZCOG do not adequately address the matters the subject of the injunction. As the applicants submitted, the picture painted in the documents upon which the respondent relied is “dangerously incomplete”. The RANZCOG brochure entitled “Stress Urinary Incontinence”, published in July 2018, exhibited to Mr Loveday’s 17 April affidavit, is a good example. It minimises the significance of erosion. It makes no mention of the risks of infection associated with erosion, damage to nerves in scar tissue, or dyspareunia. Nor does it mention the risk to women with conditions affecting the immune response and healing. It describes surgery to excise or remove exposed mesh as “a minor procedure” and fails to point out the difficulties and possible consequences associated with removal or the potential for multiple revision surgeries. This is the sum total of its advice on the potential consequences of erosion:

In some cases, the erosion occurs with no symptoms, but it may cause bleeding, discomfort or awareness by either or both partners during sexual activity. A tender or exposed area can be managed with the use of oestrogen cream, or may require a minor procedure to excise or remove the exposed mesh. For every 100 women who have this procedure, 1 or 2 will have this complication.

61    Videos on the RANZCOG website, exhibited to Ms Saddler’s affidavit, are similarly deficient.

62    None of this material adverts to the risk of late onset complications, apart from a cursory reference in one of the videos to erosion sometimes occurring “years later”, or to the fact that the risk will endure for as long as the implant remains in the body.

63    The guide on Treatment Options for Stress Urinary Incontinence published by the ACSQHC, dated May 2018, following the recommendations of the report of the Senate inquiry into the number of women in Australia who have undergone transvaginal implants and related matters, is admittedly more informative and presents a more comprehensive list of complications. Unlike the Advice, however, this guide does not include a statement to the effect that while the true incidence of the complications is unknown, they are not rare. Further, while the Commission references “discomfort with intercourse”, the guide does not make it clear that it can be severe or chronic.

64    In any case, the mere fact that there are differences between the nominated source materials underscores the need for the injunction.

65    It is not as though the respondents deny the accuracy of the matters covered by the Advice. To the contrary, their own evidence demonstrated that the complications with which it is concerned could arise with all the devices. Prospective users are entitled to know the truth from the horse’s mouth, that is to say, from those who know more about the devices than anyone: the manufacturer and supplier. They should not be placed in the position of having to decide which organisation’s advice is correct.

66    The third reason the respondents offered in support of the stay is that, absent the variations they sought, “there is a real risk that, should the warnings [they give] in the PIL be constrained by the terms or content of [o]rder 2”, they may experience “reputational damage to the detriment of its market share and the future economic viability of the manufacture and distribution of the SUI devices”. The only thing they point to is the reference to PROLENE, rather than polypropylene mesh in general, in the opening paragraph of the Advice. They claimed that success on the appeal would not necessarily remedy this “reputational damage”. I am unpersuaded that reputational damage could occur merely because the respondents are required to inform patients of the way their mesh is designed to operate, particularly when, as they say, it is no different in this respect from other polypropylene meshes. The injunction would not prevent the respondents from making that point.

67    The fourth and final reason advanced in support of the stay is that the grounds of appeal are reasonably arguable.

68    While certain grounds of appeal were identified by number in the submissions, they were not otherwise described with any particularity and the notice of appeal itself was not put before the Court. It is, however, apparent that the respondents intend to argue that the injunction should not have been imposed. I was informed that they intend to renew the arguments they raised both at the time the applicants applied for leave to amend to seek injunctive relief and in final submissions, arguments I considered baseless. Be that as it may, I am prepared to assume that the grounds of appeal are reasonably arguable.

69    But the respondents have not discharged their burden of demonstrating that a stay is appropriate. Not only would the appeal not be rendered nugatory without it but there is also no probative evidence to suggest that the respondents would suffer any real prejudice if a stay were refused.

70    Furthermore, as this is a case involving consumer protection laws designed to protect the public, the public interest militates against the grant of a stay, and the public interest is entitled to significant weight: see, for example, Bryant v Commonwealth Bank of Australia (1996) 70 ALJR 306 at 309; 90 LGERA 126 at 131; 134 ALR 460 at 464 (Kirby J); New South Wales Bar Association v Stevens [2003] NSWCA 95; 52 ATR 602 at [103]–[104] (Spigelman CJ, Meagher and Sheller JJA agreeing).

71    It follows that, as Hely J put it in Red Bull at [20], the presumption that the applicants are entitled to the benefit of the judgment has not been displaced. I therefore refuse to grant the respondents a stay of the injunction but I will give them until 30 June 2020 to comply.

72    The respondents should pay the applicants’ costs.

73    There will be orders accordingly.

Associate:

Dated:    5 June 2020