FEDERAL COURT OF AUSTRALIA

Gill v Ethicon Sàrl (No 6) [2020] FCA 279

ORDERS

THE COURT ORDERS THAT:

Common questions

1.    The common questions raised in the proceedings be answered in the terms set out in Schedule A to these orders.

Injunctive relief

2.    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.

3.    Pursuant to s 232 of the Australian Consumer Law, being Schedule 2 to the Competition and Consumer Act 2010 (Cth), after 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 instructions for use the above advice or advice to the same effect.

Appeal period

4.    Pursuant to r 36.03(b) of the Federal Court Rules 2011 (Cth), any notice of appeal from the judgment pronounced on 21 November 2019 and these or earlier orders must be filed by 3 April 2020.

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

Schedule A

Definitions

Australian Consumer Law means Schedule 2 of the Competition and Consumer Act.

CE mark means Conformité Européenne mark applied as a declaration by a manufacturer that its product conforms to the requirements of the European Council Directive 93/42/EEC issued on 14 June 1993 as amended from time to time.

Competition and Consumer Act means the Competition and Consumer Act 2010 (Cth).

Ethicon devices means the SUI devices and the POP devices.

Group members means the group members as defined in para 1(b) of the Fifth Further Amended Statement of Claim.

JJM means Johnson & Johnson Medical Pty Limited.

Manufacturers means the first and second respondents, Ethicon Sàrl and Ethicon, Inc.

POP means pelvic organ prolapse.

POP devices means the medical devices used for the treatment of pelvic organ prolapse known by the trade names Gynecare Gynemesh Prolene Soft (Gynemesh PS), Gynecare Prolift Pelvic Floor Repair System (Prolift), Gynecare Prolift+M Pelvic Floor Repair System (Prolift+M) and Gynecare Prosima Pelvic Floor Repair System (Prosima).

SUI means stress urinary incontinence.

SUI devices means the medical devices used for the treatment of stress urinary incontinence known by the trade names Gynecare Tension-free Vaginal Tape System (TVT), Gynecare TVT Obturator System (TVT-O), Gynecare TVT Secur System (TVT Secur), Gynecare TVT Exact Continence System (TVT Exact) and Gynecare TVT Abbrevo Continence System (TVT Abbrevo).

Trade Practices Act means the Trade Practices Act 1974 (Cth).

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The purpose for which the Ethicon devices were acquired

Q1:    What was the purpose for which the POP devices were acquired?

A:    The POP devices were acquired for the purpose of treating pelvic organ prolapse in women and, more particularly, for the purpose of treating the condition more effectively, or at least as effectively as other surgical interventions, and with fewer risks to safety.

Q2:    What was the purpose for which the SUI devices were acquired?

A:    The SUI devices were acquired for the purpose of treating stress urinary incontinence in women and, more particularly, for the purpose of treating the condition more effectively, or at least as effectively as other surgical interventions, and with fewer risks to safety.

Complications that can be caused by the Ethicon devices?

Q3:    Can the Ethicon devices cause the following complications

(a)    a chronic inflammatory reaction of the tissues surrounding the implanted device, also known as a foreign body response, which is affected by conditions which affect the immune response and healing, including autoimmune and connective tissue disorders;

(b)    extrusion or erosion of the mesh into surrounding organs, including the vaginal wall, bladder or urethra;

(c)    infection;

(d)    chronic pain;

(e)    dyspareunia and/or apareunia;

(f)    difficulty voiding;

(g)    offensive vaginal discharge;

(h)    de novo or recurrent urinary incontinence;

(i)    damage to surrounding organs, nerves, ligaments, tissue and/or blood vessels;

(j)    haemorrhage;

(k)    leg weakness;

(l)    psychiatric injury;

(m)    the need for reoperation or revision surgery associated with complications;

(n)    the need to remove the implanted device or part of the implanted device; and

(o)    complications associated with the removal of the implanted device or part of the implanted device, which might prove difficult or impossible, including aggravation of existing complications?

A:    Yes.

Q4:    Can the POP devices also cause the following complications:

(a)    difficulty defecating; and

(b)    recurrence of prolapse?

A:        Yes.

Q5:    Are each of the complications referred to in questions 3 and 4 clinically significant?

A:    Yes.

Q6:    Are the complications confined to the transvaginal use of mesh?

A:    No, they extend to mesh implanted transabdominally.

Q7:    Can the complications occur many years after implantation?

A:    Yes.

Q8:    Is it necessary for group members to prove the mechanism by which the Ethicon devices caused the complications they suffered as a result of implantation of those devices?

A:    No.

Biocompatibility issues

Q9:    Can the pores of the mesh used in the Ethicon devices deform and collapse under mechanical load?

A:    Yes.

Q10:    Does deformation and collapse of the pores of the mesh used in the Ethicon devices cause bridging fibrosis or fibrotic bridging?

A:    Yes.

Q11:    Is bridging fibrosis of clinical significance?

A:    Yes. It can cause or contribute to contraction of the mesh which, in turn, can cause complications such as mesh exposure, erosion, chronic pain and dyspareunia.

Negligence

Q12:    Did the respondents owe a duty of care to group members?

A:    Yes. The respondents owed a duty to take reasonable care to avoid injury to consumers.

Q13:    Did the manufacturers owe the group members a duty to take reasonable care in the design, testing, evaluation, supply, and marketing of the Ethicon devices?

A:    Yes.

Q14:    Did JJM owe the group members a duty to take reasonable care in the supply and marketing of the Ethicon devices?

A:    Yes.

Q15:    Did the manufacturers breach their duty of care to the group members by failing to undertake adequate pre-market evaluations of the safety and efficacy of the Ethicon devices?

A:    Yes.

Q16:    Did the manufacturers breach their duty of care to the group members by failing to undertake adequate post-market evaluations of the safety and efficacy of the Ethicon devices?

A:    Yes.

Q17:    During the period from the time of first supply in Australia of each of the Ethicon devices until 4 July 2017, did the respondents breach their duty of care to group members by failing to provide any adequate information, advice or warnings about the above-mentioned complications and the absence of any adequate clinical or other evaluation of the risks?

A:    Yes, throughout the period, except that they did not breach their duty of care by failing to warn of the risk of psychiatric injury.

Q18:    In what respects was the information, advice or warnings provided by the respondents about the complications inadequate?

A:    Save as indicated below, the respondents failed to disclose or make adequate disclosure of the following matters:

(a)    that the mesh used in the Ethicon devices was designed to, and would invariably elicit in patients, an acute inflammatory reaction followed by a chronic inflammatory response;

(b)    that in some patients the chronic inflammatory response will have adverse effects;

(c)    that it is not possible to predict which patients will be adversely affected but they include healthy patients;

(d)    that the severity of a patient’s chronic inflammatory response can be affected by conditions which affect the immune response and healing, such as autoimmune and connective tissue disorders;

(e)    that the severity of a patient’s chronic inflammatory response can be affected by physical activity and mechanical loading of the pelvic floor;

(f)    that the mechanical forces in the pelvic floor may influence the compatibility and function of the implant;

(g)    that the adverse effects of the chronic inflammatory response in some patients include:

(i)    infection, rather than merely the potentiation of infection;

(ii)    that erosion of the mesh into the vaginal canal could cause infection which might be difficult to treat and cause offensive vaginal discharge and pain;

(iii)    that erosion of the mesh into surrounding organs, such as the bladder, urethra or rectum, could cause pain and damage those organs;

(iv)    damage to nerves in the scar tissue surrounding the implant or elsewhere (except for Gynemesh PS from 16 March 2013, Prolift from 1 October 2009, and Prolift+M from 12 December 2008);

(v)    chronic pain, which may be severe;

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

(vii)    apareunia;

(viii)    leg weakness;

(ix)    de novo or recurrent incontinence (except TVT from 7 October 2015, TVT-O from 22 September 2015, TVT Abbrevo from 24 September 2015, TVT Exact from 18 September 2015, Gynemesh PS from 16 March 2013, Prolift from 1 October 2009, Prolift+M from 12 December 2008);

(x)    difficulty voiding (except for TVT from 7 October 2015, TVT-O from 22 September 2015, TVT Abbrevo from 24 September 2015, TVT Exact from 18 September 2015, Gynemesh PS from 16 March 2013, Prolift from 1 October 2009, Prolift+M from 12 December 2008);

(xii)    vaginal discharge (except TVT from 7 October 2015, TVT-O from 22 September 2015, TVT Abbrevo from 24 September 2015, TVT Exact from 18 September 2015, Gynemesh PS from 3 April 2015); and

(xiii)    (in the case of the POP devices only) recurrent prolapse (except for Gynemesh PS from 16 March 2013, Prolift from 1 October 2009, and Prolift+M from 12 December 2008) and pain on defaecation;

(h)    that the adverse events may occur years after implantation and the risk will endure for as long as the implant remains in the body;

(i)    that the adverse events may occur regardless of the skill of the surgeon;

(j)    that the true incidence of the adverse events is unknown but they are not rare;

(k)    that removal of the implant in whole or in part will not necessarily alleviate the patient’s symptoms;

(l)    that removal of part of an implant can be difficult and removal of the whole may be practically impossible;

(m)    that mesh removal surgery 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;

(n)    that surgery to remove the whole or part of an implanted SUI device can result in recurrence of stress urinary incontinence;

(o)    that surgery to remove the whole or part of an implanted POP device can result in recurrence of pelvic organ prolapse; and

(p)    that removal of eroded mesh will not necessarily prevent further erosions or other adverse events.

Q19:    But for the respondents’ negligent pre-market evaluations:

(a)    would any of the Ethicon devices have been on the Australian market at any time?

A:    No.

(b)    would any group member have received an Ethicon device and suffered damage from its implantation?

A:    No.

The statutory causes of action

Q20:    Do the causes of action under the Trade Practices Act or the Australian Consumer Law apply to Ethicon Sàrl and Ethicon, Inc. even though they are incorporated overseas and neither has a place of business in Australia?

A:    Yes.

Misleading or deceptive conduct

Q21:    Between the first supply in Australia of the Ethicon devices and 4 July 2017 was the respondents’ conduct in marketing the Ethicon devices misleading or deceptive or likely to mislead within the meaning of s 52 of the Trade Practices Act or s 18 of the Australian Consumer Law?

A:    Yes.

Q22:    Why was the respondents’ conduct misleading or deceptive or likely to mislead or deceive?

Throughout the period from the first supply in Australia of the Ethicon devices to 4 July 2017, the respondents falsely represented that the inflammatory reaction generated by implantation was transitory rather than permanent and possible rather than certain, and exaggerated the benefits of the devices and minimised the risks associated with implantation.

Defective goods

Q23:    Did the POP devices or any of them have a defect within the meaning of s 75AC of the Trade Practices Act and a safety defect within the meaning of s 9 of the Australian Consumer Law in that their safety was not such as persons generally are entitled to expect?

A:    Yes, all of them. The safety of those devices was not such as persons generally are entitled to expect because they exposed women to significant risks of injury against which inadequate precautions were taken and in respect of which misleading representations were made. The mesh kits were only ever suitable for use in the context of a clinical trial and then only with appropriate warnings about the nature and extent of the complications.

Q24:    Did the SUI devices or any of them have a defect within the meaning of s 75AC of the Trade Practices Act and a safety defect within the meaning of s 9 of the Australian Consumer Law in that their safety was not such as persons generally are entitled to expect?

A:    Yes, all of them because, taking into account all the relevant circumstances, including the way in which and the purposes for which they were marketed, the use of the CE mark in relation to them, the deficiencies in the warnings and other information supplied by the respondents they exposed women to significant risks of injury against which inadequate precautions were taken and in respect of which misleading representations were made.

Q25:    Which of the respondents is liable to compensate a group member who can prove she suffered an injury because of a defect, or safety defect, in a POP device?

A:    Ethicon Sàrl and JJM are jointly and severally liable to compensate group members who suffered an injury because of a defect, or safety defect, in Prolift, Prolift+M or Prosima. Ethicon, Inc and JJM are jointly and severally liable to compensate group members who suffered an injury because of a defect, or safety defect, in Gynemesh PS.

Q26:    Which of the respondents is liable to compensate a group member who can prove she suffered an injury because of a defect, or safety defect, in a SUI device?

A:     Ethicon Sàrl and JJM are jointly and severally liable to compensate group members who suffered an injury because of a defect, or safety defect, in any of the SUI devices.

Q27:    Did the respondents establish a state of the art defence within s 75AK(1)(c) of the Trade Practices Act or s 142(c) of the Australian Consumer Law?

A:    No.

Unfitness for purpose and unmerchantable quality

Q28:    Were the POP devices reasonably fit for the purpose for which they were acquired?

A:    No.

Q29:    Were the SUI devices reasonably fit for the purpose for which they were acquired?

A:    No.

Q30:    Were the POP devices not as fit for the purpose for which goods of that kind are commonly bought as it is reasonable to expect having regard to all relevant circumstances?

A:    No.

Q31:    Were the SUI devices not as fit for the purpose for which goods of that kind are commonly bought as it is reasonable to expect having regard to all relevant circumstances?

A:     No.

Schedule B

REASONS FOR JUDGMENT

1    Judgment in this matter was published on 21 November 2019: Gill v Ethicon Sàrl (No 5) [2019] FCA 1905. The judgment concerned nine medical devices sold in Australia by the third respondent, Johnson & Johnson Medical Pty Ltd (JJM) and manufactured by one or other of the first respondent, Ethicon Sàrl, or second respondent, Ethicon, Inc. In that judgment, which I shall call “the principal judgment”, I referred to those devices collectively as “the Ethicon devices”. Five of the devices were intended for use in the treatment of female stress urinary incontinence. They are known by the trade names Gynecare Tension-free Vaginal Tape System (TVT), Gynecare TVT Obturator System (TVT-O), Gynecare TVT Secur System (TVT Secur), Gynecare TVT Exact Continence System (TVT Exact) and Gynecare TVT Abbrevo Continence System (TVT Abbrevo). I referred to them collectively as “the SUI devices”. The remaining four devices were intended for use in the treatment of pelvic organ prolapse in women. Those devices were known by the trade names Gynecare Gynemesh Prolene Soft (Gynemesh PS), Gynecare Prolift Pelvic Floor Repair System (Prolift), Gynecare Prolift+M Pelvic Floor Repair System (Prolift+M) and Gynecare Prosima Pelvic Floor Repair System (Prosima). I referred to them collectively as “the POP devices”. In this judgment, I intend to use the abbreviations used in the principal judgment. None of the POP devices is currently on the Australian Register of Therapeutic Goods (ARTG) and consequently is no longer able to be sold in Australia. TVT Secur was also removed from the ARTG before judgment was published.

2    The applicants succeeded on all the pleaded causes of action. Damages were assessed, but the final arithmetical calculations were left to the parties, who were ordered to bring in short minutes giving effect to the reasons by 14 February 2020, a deadline which was extended by consent. The applicants were also ordered to notify the Court by 20 December 2019 whether they elected to receive damages under the Trade Practices Act 1974 (Cth) or at common law. On that day, the applicants informed the Court that they elected to receive damages at common law and the parties later agreed on the amounts. In their originating application (as amended) the applicants also sought declaratory and injunctive relief. In the principal judgment I declined to grant a declaration in the terms the applicants sought but gave them an opportunity to settle with the respondents on a suitable form of words, based on my reasons. Since then, however, I have heard nothing further on the subject. I will proceed, therefore, on the basis that a claim for declaratory relief is no longer pressed.

3    Two matters remain in dispute. One is the form of the common questions, which has been a festering sore since the respondents were served with the originating application, and how they should be answered. The other is whether the Court should grant injunctive relief. This was not an open question when the principal judgment was published. I decided that injunctive relief should be granted and I also determined the form of the injunction. But the respondents now seek to revisit the matter.

The common questions and answers

4    In a representative proceeding, questions of law or fact common to the claims of the group members are required to be specified in the application commencing the proceeding or a document filed in support of such an application: Federal Court of Australia Act 1976 (Cth), s 33H(1)(c). Lindgren J observed in Bright v Femcare Limited [2002] FCAFC 243; 195 ALR 574 at [14] that the purpose of this provision “is to elicit the identity of questions, the answering of which in the representative party’s claim can be expected also to perform the useful purpose of answering them in the claims of the represented parties”.

5    According to the respondents’ written submissions, on 20 December 2019, the applicants served on respondents a set of 34 questions and answers. I have not seen that document. The document the applicants filed, following the programming orders made at the time of publication of the principal judgment, contained some 72 questions and answers. I had trouble with a number of those questions and the answers to them. A number of the questions seemed to me to be unnecessary, some of the answers unnecessarily detailed. Some were not comprehensible without reading the judgment. Some were inflammatory. Some were confusing. Some took opinions I had reached after considering all the evidence and incorporated them in the questions, such as “did the Ethicon respondents have a flawed design validation process” (question 63), “did the Ethicon respondents take the TVT-O device to market with unseemly haste (question 65)”; and “was the pre-market evaluation for Gynemesh PS woeful in that …(question 67)”? Since the Act requires that common issues be identified at the outset of the proceeding, it is singularly inappropriate to incorporate in the questions any of the Court’s opinions.

6    The respondents submitted, in effect, that the applicants’ proposed questions were at odds with the principles outlined by Lindgren J in Bright. But the respondents give his Honour’s remarks more work than was intended. His Honour was dealing with a statement which, as he pointed out at [13] did not even specify the common questions:

The claim gives rise to substantial common issues of law and fact including the issues raised by the allegations contained in each of paras 9, 10, 15 to 39, 40, 42 to 45, 47 to 50, 52 to 5 , 60 to 63, 64 to 67, 94 to 145, 146(a), 147, 148, 149, 151, 152, 154, 155, 157 and 158.

7    Whether an issue is common to some or all of the group members is not determined by whether it is necessary to include it in the list of common questions and answers. It is determined by whether it is an issue of fact or law in the proceeding and whether its answer can be expected to perform a useful purpose in the claims of the group members. Simply put, it is an issue, which is not peculiar to the case of a representative party (an applicant) but is common to the representative party and the group or sub-groups of the group. If including a question will reduce the risk of future disputes in the determination of the claims of group members and the incurring of unnecessary costs, then it will serve this purpose.

8    The respondents submitted that certain questions included by the applicants, which they described as “supplementary adjectival issues”, were inappropriate for inclusion. They contended that these questions were “of such a level of granularity [that] they are not common”. They insisted that such questions were “not of the nature of common questions that will assist a later group member in their litigation”.

9    I do not accept the submission. The degree of granularity with which the questions are cast cannot affect whether they are common to the group members.

10    At the outset of the hearing, the applicants abandoned a number of their proposed questions, including 63, 65 and 67. After I raised my other concerns, the applicants did not press for the inclusion of other questions and some of them were revised, as were the answers. The final revisions took heed of a number of my concerns and some, but not all, of the respondents’ objections. A copy of their most recent version (the applicants’ final revised list) appears in Appendix A to these reasons. Not all of the revisions were called for. One, for example, was the insertion of “indirectly” before “psychiatric injury” in question 3 which asked whether the Ethicon devices can cause certain listed complications. The adverb is unnecessary and its insertion is apt to confuse, since some of the other complications, such as chronic pain, can also be caused indirectly.

11    One of my concerns was that several questions in the applicants’ list were subsumed within other questions. They included questions relating to the biocompatibility and performance of the devices and regulatory clearance. The respondents baulked at the inclusion of questions relating to “biocompatibility issues” when the immediately preceding question, to which a negative answer was given, was whether it was necessary for group members to prove the mechanism by which the Ethicon devices caused the complications they suffered as a result of implantation of those devices. On the face of things, the respondents’ point was well-made.

12    During the course of the hearing, however, it became clear that some of the applicants’ questions had been drafted with a view to avoiding argument in the individual claims of group members about some of the issues which have already been determined and which could affect those claims. The applicants submitted that the questions relating to biocompatibility were intended to pre-empt a dispute which could otherwise arise in the determination of causation in individual cases where a group member has a condition which could be caused by an Ethicon device but could equally be caused by something else. Chronic pain is an obvious example. They argued that including these questions and answers might assist in the resolution of such issues.

13    I am not persuaded that the inclusion of the disputed questions will necessarily assist in the resolution of those issues.

14    Be that as it may, it seems to me that, irrespective of whether it is strictly necessary to do so, it would be prudent to include some of the disputed questions. Those questions are 16–19 of the applicant’s final revised list. After all, as their position on injunctive relief demonstrates, the respondents do not lack the appetite to reopen old wounds.

15    On the other hand, I am not satisfied that questions 5 and 6, 11–15 or 20–22 of the applicants’ revised list are appropriate. They are either irrelevant to the determination of the individual claims of group members or subsumed by the later questions relating to liability. Nor am I satisfied that, to the extent that they are not picked up by other questions, the questions relating to regulatory clearance of the devices (questions 23–25) or the performance of the devices (questions 26–30) can serve any relevant purpose.

16    Furthermore, I am not satisfied that question 44 is appropriate.

17    The respondents objected to the reference to “de novo” urinary incontinence in question 3(h) because the chapeau to the question refers to “the Ethicon devices”, which includes the SUI devices. I do not understand this objection. There is no reference to “stress urinary incontinence” in the question and there are several kinds of urinary incontinence. Besides, one of the pleaded complications relating to the SUI devices was “de novo or recurrent urinary incontinence” and Dr Piet Hinoul, who was the only representative of the respondents to give evidence, admitted that the respondents knew that the SUI devices could cause that complication.

18    Question 8, to which the respondents also took objection, asks whether the complications can occur many years after implantation. That question should remain. It could be relevant to the limitation defences that have been foreshadowed.

19    The respondents additionally objected to questions 38 and 43 and, if question 38 were included to one particular part of the answer.

20    The objection to part of the answer to question 38 is well-founded. The preamble to the warning is incomprehensible. In any case, I do not consider that question 38 is the right question. In my opinion, the question that should have been asked is: “In what respects was the information, advice or warnings provided by the respondents inadequate to discharge their duty of care?” In the event that group members have to prove that their injuries were caused by the respondents’ failure to provide adequate warnings, the common questions and answers should identify those respects in which the information provided by the respondents was wanting.

21    Similarly, I reject the respondents’ objection to question 43, which asks in what way the respondents’ conduct was misleading or deceptive or likely to mislead or deceive. In order to recover damages arising out of that conduct, group members who may have a claim for damages for misleading or deceptive conduct will need to show a causal connection between their injuries and the conduct. How are they to do so unless they know at least the nature of that conduct? That said, I accept the respondents’ submission that the question should be limited by reference to the period covered by the proceeding, that is, until 4 July 2017.

22    Having considered the arguments advanced by the parties, I am satisfied that the common questions are those I have included in Schedule A to the orders and the answers are as I have recorded them there.

The damages awards

23    After the hearing on 3 March 2020, I made orders for judgment in the damages’ claims of the three applicants. The applicants had proposed that various amounts for the heads of damage also be included in the orders. I regarded that as inappropriate. But as they are not all recorded in the principal judgment, it is necessary that they be recorded here.

24    The parties agreed that damages for the first applicant, Kathryn Gill, should be awarded in the sum of $1,276,113, made up as follows:

25    The parties agreed that the second applicant, Diane Dawson, should be awarded damages in the sum of $555,555, made up as follows:

26    The parties agreed that the third applicant, Ann Sanders, should be awarded damages in the sum of $757,372, made up as follows:

27    At the end of the hearing on 3 March 2020 I made orders for judgment in favour of the three applications in the agreed sums.

The proposed injunction

28    The respondents opposed the grant of injunctive relief. Their arguments are set out at [5813] of the principal judgment. They were first advanced early in 2018 when 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 a warning in terms proposed by the applicants and which the applicants described as “the proper warning”, which are included in [5803] of the principal judgment. I rejected them all on both occasions. While I did not embrace the terms of the so-called proper warning, I did say that I considered it appropriate to enjoin the respondents from supplying, distributing, marketing or promoting any of the SUI devices still on the ARTG without including in the instructions for use (IFU) for each of those devices and any promotional material relating to those devices or warning in the terms or to the following effect:

The 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 foreign body 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 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.

29    The contents of the warning contain information which ultimately proved to be to uncontroversial. Yet, much of the information was not disclosed adequately or at all to doctors or patients either in the IFUs or brochures ostensibly produced for the assistance of surgeons and patients.

30    The orders made on 21 November 2019 did not envisage that the respondents would have another opportunity to argue their case. Yet they sought to take advantage of the fact that final orders have not been made in order to do so. To this end, they relied on an affidavit of Sheena Louise McKie sworn on 28 February 2020, to which a number of documents are exhibited. Ms McKie is a Special Counsel employed by Clayton Utz, the respondents’ lawyers.

31    Ms McKie’s evidence discloses that, since the hearing of the action, new IFUs were issued for the relevant devices. Copies were annexed to her affidavit. Those documents indicate a release date of 12 December 2019. The evidence is silent as to what prompted Ethicon to produce new IFUs. Ms McKie did not identify what, if any, amendments had been made to the previous IFUs or compare them to the 2015 versions that were tendered in evidence. It appears, however, that some amendments have been made to the adverse reactions sections, which pick up some, but by no means all of the previously undisclosed complications.

32    Ms McKie’s affidavit also reveals that in 2017 amendments were made to the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) (Regulations) by the Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017 (Cth). Those amendments came into force on 1 December 2018, after the hearing had concluded but while judgment was reserved. If they were relevant, it is difficult to understand why they were not drawn to my attention well before the publication of judgment.

33    At all events, the effect of the amendments is that a patient implant card and a patient information leaflet must be provided with all implantable medical devices except for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors: Sch 1 cl 13A.1.

34    Clause 13A.2 of Schedule 1 provides that a patient implant card must contain the following information: the name of the device; the model of the device; the batch code, lot number or serial number of the device; the unique device identifier (if any); and the name, address and website of the manufacturer.

35    Clause 13A.3 provides that a patient information leaflet must be written in a way that is readily understood by patients and it must include information identifying the device and its intended purpose, information explaining how to use the device safely, and other information of about the device that the manufacturer considers would be useful for patients. Subclause 13.A(3) requires that, in particular, the leaflet must include the information mentioned in the following table:

36    Clause 13A.4 provides that the information required to be included in a patient implant card or patient information leaflet must be in English, may also be in any other language, may include diagrams or drawings, and any number, letter, symbol, or letter or number in a symbol, used in a patient implant card or patient information leaflet must be both legible and at least 1mm high.

37    The purpose of these materials, according to the guidance brochure issued by the TGA in August 2019, is to assist patients to:

    understand the medical device, both before and after surgery;

    have “informed consent conversations” with their health professionals; and

    report any adverse effects associated with their implanted medical device.

38    The guidance brochure emphasises that “[p]atient information leaflets and cards are not intended for advertorial or promotional purposes” and provides advice to manufacturers and sponsors of medical devices about the way to reduce the risk of content being considered promotional. That advice includes only presenting information in a factual and balanced manner and not including information about different therapeutic options in a way that implies that the medical device implant is the best option.

39    On or about 28 November 2019 JJM sent letters to surgeons who are current users of the SUI devices setting out information about the patient information leaflet and patient information card and stating that the TGA had requested that, from 1 December 2019, all urogynaecological mesh products have available a patient information leaflet and a patient implant card. Amongst other things, the letter advises that patient information leaflets will be made available to patients on the JJM website and asks surgeons to guide their patients to the leaflet. Physical cards have also been sent to each facility where SUI devices are currently implanted. The JJM patient information leaflet for the SUI devices is behind tab 5 of the exhibit to Ms McKie’s affidavit.

40    The respondents maintained their objection to the making of an injunction, reiterating their earlier submissions. They argued that the injunction does not operate to the benefit of the group members and would require the ongoing supervision of the Court. They described an injunction as “a blunt and inflexible remedy in circumstances such as these”. They submitted that “[t]o set in place a rigid requirement for the content of any notice, as the Applicants seek to do through this injunction, would be to remove the flexibility which would otherwise exist for the Respondents (and potentially the Therapeutic Goods Administration) to update the contents of any notice to reflect necessary changes in medical best practice and advances in scientific knowledge”. They further submitted that it was necessary to consider both the need for, and content of, any injunction in the light of any change of circumstances, including changes in the knowledge of treating surgeons and members of the public. They submitted that, with the passage of time, the information about the SUI devices has changed and that the Court should take into account amendments to the IFUs made since the principal judgment was published, which have not been the subject of expert evidence, and patient information leaflets and cards, which have been supplied with the devices since 1 December 2019. In the event that the Court was still minded to grant injunctive relief, they urged the Court not to extend the injunction to the contents of the IFUs since they are used throughout the world and to accept the provision of a warning through patient information would achieve the same purpose without requiring the respondents to engage with numerous regulatory authorities that they require amendments to “the Court’s preferred wording”.

41    The respondents’ opposition to the injunction is understandable. It would doubtless be inconvenient to amend the IFUs, particularly when the last amendments were made only recently. But I am not persuaded by their arguments.

42    First, the injunction may not benefit group members, but that is not its purpose. As I have said repeatedly, injunctive relief need not be of any benefit to those who bring legal proceedings or to those for whose benefit legal proceedings are brought: Gill v Ethicon SÁRL [2018] FCA 470 at [78]–[79], extracted at [5820] of the principal judgment. Since the point seems to have fallen on deaf ears, I will make it again. The point is that injunctive relief for a contravention of the Trade Practices Act or the Australian Consumer Law serves a public purpose. That purpose includes the prevention and deterrence of undesirable, indeed, unlawful trade practices.

43    Second, the amendments to the IFUs exhibited to Ms McKie’s affidavit have not been tracked to show the extent of any changes to the most recent IFUs that were in evidence. At a glance, however, it is apparent that they continue to suffer from some of the vices I identified in my reasons for judgment. They do not make it clear, for example, that the mesh used in the devices can cause infection, not merely “potentiate” an existing infection. They warn of the possibility of “transitory local irritation at the wound site” when the evidence was that all the SUI devices generate a chronic inflammatory response. They do not draw attention to the risk that the response may be worse for patients with autoimmune, connective tissue and like disorders. They do not warn of the potential for late onset complications or the difficulties associated with removal of the implants. The deficiencies of the IFUs and other publications discussed in the principal judgment would not have come as a surprise to the respondents. The evidence disclosed that Ethicon was aware of all the risks against which the applicants alleged inadequate warnings had been given at the time all the Ethicon devices were taken to market. The provision of the patient cards is beside the point. They are silent on the risks associated with the use of the devices. The patient information leaflet is an improvement on the information provided in the patient brochures tendered in the proceeding. But it does not go far enough.

44    Third, the respondents did not explain, and I am unable to see, how the injunction would interfere with the ability of the respondents to “update the contents of any notice to reflect necessary changes in medical best practice and advances in scientific knowledge”. Nor did the respondents explain, and I am unable to see, how the injunction could interfere with the work of the TGA.

45    Fourth, the warning I proposed is consistent with the requirements of the Medical Device Regulations. The order I proposed would allow for some flexibility in that it would not bind the respondents to the precise words of the warning; words to the same effect would suffice.

46    Fifth, I reject the submission that it would be sufficient for the warning to be included in information provided directly to patients. The patient information leaflets, like the patient brochures tendered during the trial, reproduce parts of the IFU dealing with warnings, contraindications, patient factors and adverse reactions. The information in the IFU should be consistent with the information in the documents supplied to patients. As the applicants submitted, otherwise there is a danger of mixed messages.

47    Sixth, the basis for the submission that including the information the subject of the proposed injunction in the IFUs would require the respondents “to engage with numerous regulatory authorities” was Ms McKie’s evidence that, since the IFUs are used throughout the world, amending them in foreign jurisdictions may require consultation and approval by regulatory authorities, which may involve a significant period of time. This evidence was little more than speculation. Besides, the injunction only apples to the supply, distribution, marketing or promotion of the relevant SUI devices in Australia and does not require changes to IFUs supplied elsewhere.

48    In any event, Ms McKie did not suggest that, even if this were necessary, it would be unduly burdensome. Her only concern was the time it might take. Regardless of whether consultation and approval is required I appreciate that amending the IFUs is likely to take some time but allowance can be made for that in the order.

49    For the sake of clarity, the terms of the warning should be amended to replace “chronic foreign body response” with “chronic inflammatory response” in line 6 of the warning.

50    It follows that I am not disposed to resile from my decision to grant injunctive relief or, save for the above amendments, to vary the terms of the proposed injunction. But I will allow time to facilitate compliance. If, at any time in the future, the respondents can satisfy the Court that there is no longer any utility in the injunction, they may make an application under s 235 to discharge it.

Associate:

Dated:    6 March 2020

Appendix A

APPLICANTS’ DRAFT STATEMENT OF COMMON QUESTIONS AND ANSWERS

(AS AT 3 MARCH 2020)

DEFINITIONS

Australian Consumer Law means Schedule 2 of the Competition and Consumer Act.

CE mark means Conformité Européenne mark applied as a declaration by a manufacturer that its product conforms to the requirements of the European Council Directive 93/42/EEC issued on 14 June 1993 as amended from time to time.

Competition and Consumer Act means the Competition and Consumer Act 2010 (Cth)

Ethicon Devices means the SUI Devices and the POP Devices.

group members means the "Group Members" as defined in paragraph 1(b) of the Fifth Further Amended Statement of Claim.

POP means pelvic organ prolapse.

POP Devices means the medical devices used for the treatment of pelvic organ prolapse known by the trade names Gynecare Gynemesh Prolene Soft (Gynemesh PS), Gynecare Prolift Pelvic Floor Repair System (Prolift), Gynecare Prolift+M Pelvic Floor Repair System (Prolift+M) and Gynecare Prosima Pelvic Floor Repair System (Prosima).

SUI means stress urinary incontinence.

SUI Devices means the medical devices used for the treatment of stress urinary incontinence known by the trade names Gynecare Tension-free Vaginal Tape System (TVT), Gynecare TVT Obturator System (TVT-O), Gynecare TVT Secur System (TVT Secur), Gynecare TVT Exact Continence System (TVT Exact) and Gynecare TVT Abbrevo Continence System (TVT Abbrevo).

Trade Practices Act means the Trade Practices Act 1974 (Cth).

THE PURPOSE OF THE ETHICON DEVICES

The purpose of the POP Devices

1.    What was the purpose of the POP Devices?

The POP Devices were acquired for the purpose of treating pelvic organ prolapse.

The purpose of the SUI Devices

2.    What was the purpose of the SUI Devices?

The SUI Devices were acquired for the purpose of treating stress urinary incontinence.

COMPLICATIONS THAT COULD BE CAUSED BY THE ETHICON DEVICES

3.    Can the Ethicon Devices cause the following complications:

(a)    a chronic inflammatory reaction of the tissues surrounding the implanted device;

(b)    extrusion or erosion of the mesh into surrounding organs, including the vaginal wall, bladder or urethra;

(c)    infection;

(d)    chronic pain;

(e)    dyspareunia and/or apareunia;

(f)    difficulty voiding;

(g)    offensive vaginal discharge;

(h)    de novo or recurrent urinary incontinence;

(i)    damage to surrounding organs, nerves, ligaments, tissue and/or blood vessels;

(j)    haemorrhage;

(k)    leg weakness;

(l)    indirectly, psychiatric injury;

(m)    reoperation or revision surgery associated with complications;

(n)    the need to remove the implanted device or part of the implanted device;

(o)    complications associated with the removal of the implanted device or part of the implanted device (which removal might prove difficult or impossible) including aggravation of existing complications; and

(p)    that the chronic inflammatory response to the implanted device is affected by conditions which affect the immune response and healing, including autoimmune and connective tissue disorders?

Yes.

3A    Additionally, can the Mesh Implants cause the following complications:

(a)    de novo or recurrent urinary incontinence;

(b)    difficulty voiding and in addition, or alternatively, difficulty defecating; and

(c)    recurrence of prolapse?

Yes.

4.    Are each of the complications referred to in questions 3 and 3A clinically significant?

Yes.

5.    What is the magnitude of the risk of each of the complications referred to in questions 3 and 3A occurring?

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

6.    What is the potential seriousness of the complications if they materialise?

The complications can be serious.

7.    Are the complications confined to the transvaginal use of mesh?

No, they extend to mesh used transabdominally.

8.    Can the complications occur many years after implantation?

Yes.

9.    From the time of their first supply anywhere in the world, did the respondents know that each of the Ethicon Devices could cause each of the complications referred to in question 3?

Yes.

MECHANISM OF THE COMPLICATIONS

10.    Is it necessary for group members to prove the mechanism by which the Ethicon Devices caused the complications which they suffered as a result of their Ethicon Devices?

No.

BIOCOMPATIBILITY ISSUES

11.    What type of foreign body or inflammatory response is caused by the Ethicon Devices?

A foreign body or inflammatory response that is neither transient nor mild nor a mere possibility, but permanent and chronic, lasting as long as the device is in the body.

12.    Is some chronic foreign body or inflammatory response an intended outcome of implantation of the Ethicon Devices so as to create a desired level of fibrosis?

Yes.    

13.    Can the chronic foreign body response or inflammatory response to the Ethicon Devices be greater than necessary to create the desired level of fibrosis.

Yes.

14.    Can the foreign body reaction to the implantation of the Ethicon Devices be clinically significant?

Yes.

15.    Can the foreign body reaction to the implantation of the Ethicon Devices cause any of the complications other than chronic inflammation?

Yes.

16.    Do the pores of the mesh used in the Ethicon Devices deform and collapse under mechanical load?

Yes.

17.    Does deformation and collapse of the pores of the mesh used in the Ethicon Devices result in complications of fibrotic bridging, scar plate formation and/or excessive scarring?

Yes.

18.    Is fibrotic bridging of clinical significance?

Yes. It can lead to increased mesh shrinkage, mesh contraction, mesh bunching and decreased mobility of repaired tissue.

19.    Is mesh shrinkage or contraction of clinical significance?

Yes. It can cause several of the complications referred to in question 3 including mesh exposure, erosion and chronic pain including dyspareunia.

20.    Does the mesh used in the Ethicon Devices cause pain? If so, is the pain attributable to nerve entrapment?

The mesh used in all of the Ethicon Devices causes pain. It is unnecessary to determine the mechanism which may be responsible for it.

21.    Does Prolene mesh oxidise in vivo?

Yes.

22.    Does oxidisation of Prolene mesh in vivo have clinical significance?

There is insufficient evidence to establish that oxidisation in vivo is clinically significant.

REGULATORY CLEARANCE OF THE DEVICES

23.    Does the entry of the Ethicon Devices on the Australian Register of Therapeutic Goods, or the fact that the Ethicon Devices bore the “CE mark”, demonstrate that the products met applicable regulatory standards?

No.

24.    Was the “CE marking” of any of the Ethicon devices justified at the time the marks were applied or at any time thereafter?

No.

25.    If there was no “CE marking”, would the Ethicon devices have been supplied in Australia?

No.

PERFORMANCE OF THE DEVICES

26.    Were the techniques designed by the Respondents for transvaginal implantation of the Ethicon Devices able to be reproduced consistently?

No.

27.    Have the SUI Devices ever been shown to be safer or more effective in the long-term than alternative non-mesh treatments?

No.

28.    Have the POP Devices ever been shown to be safer or more effective in the long-term than alternative non-mesh treatments?

No.

29.    Were the POP Devices ever safe for general use in the wide range of patients for whom they were indicated and promoted?

No.

30.    Were the POP Devices (except for Gynemesh PS) ever suitable for use outside the context of a clinical trial in which participants were provided with appropriate warnings about the nature and extent of the potential complications?

No.

NEGLIGENCE

Duty of Care

31.    Did the respondents owe a duty of care to group members?

Yes, the respondents owed a duty to take reasonable care to avoid injury to consumers.

32.    Did the manufacturers of the Ethicon Devices (Ethicon Sàrl and Ethicon Inc.) owe the group members in Australia a duty to take reasonable care in the design, testing, evaluation, supply and marketing of those of the Ethicon Devices they manufactured?

Yes.

33.    Did the supplier of the Ethicon Devices (Johnson & Johnson Medical Pty Limited) owe the group members in Australia a duty to take reasonable care in the supply and marketing of the Ethicon Devices?

Yes.

34.    What was the scope or content of the respondents’ duty of care in relation to the supply and marketing of the Ethicon devices?

(a)    To warn of reasonably foreseeable risks.

(b)    To provide accurate information about the performance and safety of the Ethicon devices, including warnings about potential complications and contraindications.

(c)    To take into account the possibility that medical practitioners might fail to inform a patient of the relevant risks associated with the use of the Ethicon Devices unless those risks were specifically drawn to their attention by the respondents.

(d)    To warn of risks of which they were aware even if the users of the devices (physicians and hospitals) either knew of them already or had at their disposal other sources from which they could have acquired the information.

(e)    To provide guidance about how to manage the potential risks arising from implantation with all of their meshes, regardless of what they might surmise physicians knew, should have known, or could have learned from other sources or by other means.

(f)    To warn of the heightened risk of adverse reactions for patients with autoimmune disorders or whose immune systems were suppressed for other reasons.

(g)    To notify doctors and hospitals of changes of significance made to an IFU, especially a change to the adverse events section.

(h)    For the Ethicon respondents, a continuing duty to evaluate the safety of the Ethicon Devices and keep abreast of information about the nature and extent of potential complications and to convey that information to users of the devices.

(i)    To inform doctors and prospective patients of any shortcomings of its clinical evidence or evaluations.

Breach

Pre-market Evaluation

35.    Did Ethicon Sàrl and Ethicon Inc. breach their duty of care in Australia by failing to undertake adequate pre-market evaluations of the safety and efficacy of the Ethicon Devices?

Yes.

Post-market Evaluation

36.    Did Ethicon Sàrl and Ethicon Inc. breach their duty of care in Australia by failing to undertake adequate post-market evaluations of the Ethicon Devices from the time of their supply?

Yes.

Information

37.    For the period from the date of first supply of any of the Ethicon Devices in Australia up to 4 July 2017, did the respondents breach their duty of care to Group Members by failing to provide adequate warnings as to the risks associated with the implantation of those devices?

Yes.

38.    What warnings and other information should the respondents have provided from the time of first supply of the Ethicon Devices?

The Respondents ought to have warned of the absence or limitations of available clinical studies and the shortcomings of their own clinical evaluations of the Ethicon Devices.

In the event that the Ethicon Devices were released on the market (which the applicants dispute), then a warning to the following effect should have been provided:

WARNING

The mesh used in this device 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 mesh is not inert. 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 foreign body 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 surrounding organs, nerves, ligaments, tissue and/or blood vessels;

(e)    haemorrhage;

(f)    leg weakness;

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

(h)    chronic pain, which may be severe;

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

(j)    apareunia;

(k)    leg weakness;

(l)    de novo or recurrent incontinence;

(m)    difficulty voiding;

(n)    offensive vaginal discharge;

(o)    in relation to the POP Devices, difficulty defaecating;

(p)    in relation to the POP Devices, recurrence of POP; and

(q)    reoperation or revision surgery associated with complications.

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.

The long-term safety and effectiveness of the device has not been established. In relation to the POP Devices (except Gynemesh PS), they are not suitable for use outside the context of a clinical trial in which participants are provided with appropriate warnings about the nature and extent of the adverse reactions described above.

39.    To whom should the warnings or other information have been provided?

Warnings should have been provided (both with the Ethicon Devices and in material promoting the Ethicon Devices) to prospective users, including the applicants, group members, their treating surgeons or physicians and the hospitals to which the Ethicon Devices were distributed.

General Causation

40.    But for the respondents’ negligent pre-market evaluations:

(a)    Would any of the Ethicon devices have been on the Australian market at any time?

No.

(b)    Would any group members have received an Ethicon device and suffered damage from its implantation?

No.

APPLICATION OF THE STATUTORY CAUSES OF ACTION TO THE RESPONDENTS THAT ARE INCORPORATED OVERSEAS

41.    Do the statutory causes of action (being claims of misleading or deceptive conduct and product liability claims) apply to Ethicon Sàrl and Ethicon Inc. even though those respondents are incorporated overseas and neither has a place of business in Australia?

Yes.

MISLEADING OR DECEPTIVE CONDUCT

42.    Since the Ethicon Devices were or have been available on the Australian market, was the respondents’ conduct, in marketing the Ethicon Devices, conduct that was misleading or deceptive or likely to mislead or deceive within the meaning of s 52 of the Trade Practices Act or s 18 of the Australian Consumer Law?

Yes.

43.    In what way was the respondents’ conduct misleading or deceptive or likely to mislead or deceive?

At all relevant times, the information in the IFUs and the brochures the respondents provided to patients and surgeons about the Ethicon Devices omitted warnings of the complications associated with the devices and the limits to the evaluation of them. The respondents also failed to provide information about the gravity of the risks that attached to the devices.

Contrary to statements in the IFUs supplied with the Ethicon Devices, once implanted, they were not inert and the inflammatory reaction they caused was certain to occur and was not transient.

DEFECTIVE GOODS

44.    Is it sufficient for a group member to establish that she has suffered an injury caused by reason of an Ethicon Device being a defective product for the purposes of s 75AD(c) if she establishes that her injury is a complication that has been found to result from implantation of an Ethicon Device?

Yes.

POP Devices

45.    Were the POP Devices defective within the meaning of ss 75AC and 75AD of the Trade Practices Act and did they have a safety defect within the meaning of ss 9 and 138 of the Australian Consumer Law?

Yes.

Each of the POP Devices was defective by reason that:

(a)    each of the POP Devices exposed women to significant risks of injury against which inadequate warnings were given and in respect of which misleading representations were made;

(b)    the respondents were not candid with the public about the risks of, and contraindications for, use of the POP Devices or the limitations of the available data;

(c)    the respondents represented that the benefits of using the POP Devices outweighed the risks for women with any level of prolapse when the evidence did not support that;

(d)    none of the POP Devices was the subject of an adequately powered clinical trial, before each of them was released to market;

(e)    the respondents represented that the devices met the essential requirements for CE marking when the material upon which they relied to affix and maintain the CE mark was insufficient to satisfy those requirements; and

(f)    in respect of the mesh kits only (Prolift, Prolift+M and Prosima), on balance, the mesh kits were only ever suitable for use in the context of a clinical trial and then only with appropriate warnings about the nature and extent of the potential complications;

(g)    in respect of Gynemesh PS only:

(i)    its implantation exposed women to the risk of significant injury;

(ii)    the warnings given by the respondents were insufficient to protect users from those risks;

(iii)    the information supplied with and about the device was liable to lull users into a false sense of security; and

(iv)    information accompanying the sale of Gynemesh PS, after the limitation was made to the indication for use on and from 16 March 2013, was still insufficient to put users on notice of the true nature and extent of the risks.

(h)    In relation to the Prolift devices — they had a defect in that the safety of Prolift had not been demonstrated at the time that it was taken to market because it had not been the subject of adequately powered randomised controlled trials.

46.    Which of the respondents is liable if any applicant or group member proves that they have suffered injury because of the defect, or safety defect, in a POP Device?

(a)    Ethicon Sàrl (as the manufacturer and supplier of Prolift, Prolift +M and Prosima) and JJM (as the deemed manufacturer and supplier of Prolift, Prolift +M and Prosima) are jointly and severally liable to compensate any applicant or group member for the amount of loss or damage suffered because of the defect or safety defect in those devices.

(b)    Ethicon Inc. (as the manufacturer and supplier of Gynemesh PS), and JJM (as the deemed manufacturer and supplier of Gynemesh PS) are jointly and severally liable to compensate any applicant or group member for the amount of loss or damage suffered because of the defect or safety defect in that device.

SUI Devices

47.    Were the SUI Devices defective within the meaning of s 75AC of the Trade Practices Act and did they have a safety defect within the meaning of s 9 of the Australian Consumer Law?

Yes. Each of the SUI Devices was defective by reason of:

(a)    the nature and extent of the risks associated with each of the SUI Devices;

(b)    the deficiencies of the respondents' warnings and other information they provided;

(c)    the repeated failure to comply with the requirements for CE marking; and

(d)    the way in which each of the SUI Devices was marketed.

48.    Which of the respondents is liable if any applicant or group member proves that they have suffered injury because of the defect, or safety defect, in an SUI Device?

Ethicon Sàrl (as the manufacturer and supplier), and JJM (as the deemed manufacturer and supplier), of the SUI Devices are therefore jointly and severally liable to compensate any applicant or group member for the amount of loss or damage suffered because of the defect or safety defect.

Availability of a State-of-the-art Defence

49.    Did the respondents established a defence within the meaning of s 75AK(1)(c) of the Trade Practices Act of s 142(c) of the Australian Consumer Law?

No.

UNFITNESS FOR PURPOSE AND UNMERCHANTABLE QUALITY

POP Devices – Lack of fitness for purpose

50.    Were the POP Devices reasonably fit for the purpose identified in answer to question 1 within the meaning of s 74B of the Trade Practices Act or s 55 of the Australian Consumer Law?

No. The POP Devices were not fit for purpose within the meaning of s 74B of the Trade Practices Act or s 55 of the Australian Consumer Law for the same reasons that the POP Devices were defective or had a safety defect.

SUI Devices – Lack of fitness for purpose

51.    Were the SUI Devices reasonably fit for the purpose identified in answer to question 2 within the meaning of s 74B of the Trade Practices Act or s 55 of the Australian Consumer Law?

No. The SUI Devices were not fit for purpose within the meaning of s 74B of the Trade Practices Act or s 55 of the Australian Consumer Law for the same reasons that the SUI Devices were defective or had a safety defect.

POP Devices – Not of merchantable quality or acceptable quality

52.    Were the POP Devices not of merchantable quality, within the meaning of s 74D of the Trade Practices Act, or acceptable quality, within the meaning of s 54 of the Australian Consumer Law, in that they were not as fit for the purpose for which goods of that kind are commonly bought as it is reasonable to expect having regard to all relevant circumstances?

Yes. The POP Devices were not of merchantable or acceptable quality within the meaning of s 74D of the Trade Practices Act or s 54 of the Australian Consumer Law, respectively, for the same reasons that the POP Devices were defective or had a safety defect.

SUI Devices – Not of merchantable quality or acceptable quality

53.    Were the SUI Devices not of merchantable quality, within the meaning of s 74D of the Trade Practices Act, or acceptable quality, within the meaning of s 54 of the Australian Consumer Law, in that they were not as fit for the purpose for which goods of that kind are commonly bought as it is reasonable to expect having regard to all relevant circumstances?

Yes. The SUI Devices were not of merchantable or acceptable quality within the meaning of s 74D of the Trade Practices Act or s 54 of the Australian Consumer Law, respectively, for the same reasons that the SUI Devices were defective or had a safety defect.