Ethicon Sarl v Gill

[2021] FCAFC 29

FEDERAL COURT OF AUSTRALIA

Ethicon Sàrl v Gill [2021] FCAFC 29  

File number:

NSD 391 of 2020

Judgment of:

JAGOT, MURPHY AND LEE JJ

Date of judgment:

5 March 2021

Catchwords:

CONSUMER LAW - defective goods - urogynaecological medical devices - whether primary judge erred in finding safety of devices not such as persons generally were entitled to expect - whether primary judge erred in finding devices not of merchantable or acceptable quality, or not reasonably fit for purpose within meaning of Trade Practices Act 1974 (Cth) or the Australian Consumer Law - whether primary judge erred in finding respondents’ damage caused by defect

CONSUMER LAW - misleading or deceptive conduct - information in connection with devices, instructions for use and marketing - whether primary judge erred in finding appellants engaged in misleading or deceptive conduct - whether primary judge erred in finding third respondent’s damage caused by misleading or deceptive conduct

NEGLIGENCE - medical devices - duty of care - whether primary judge erred in finding appellants breached duty of care - inadequate pre-market and post-market evaluations of safety of devices - inadequate warnings of material risks of devices - standard of care - breach - regulatory environment - causation - onus of proof - application of ss 5C and 5D of the Civil Liability Act 2002 (WA) and ss 51 and 52 of the Wrongs Act 1958 (Vic)

LIMITATION OF ACTIONS - whether primary judge erred in finding that first and third respondents’ claims in negligence were not statute barred - onus of proof - application of Limitation Act 1935 (WA) and ss 39(3) and (4) of Limitation Act 2005 (WA)

OTHER RELIEF - whether primary judge erred in granting injunction enjoining appellants from supplying, distributing, marketing or promoting devices in Australia without warning or advice

Legislation:

Civil Liability Act 2002 (WA)

Competition and Consumer Act 2010 (Cth)

Evidence Act 1995 (Cth)

Federal Court of Australia Act 1976 (Cth)

Judiciary Act 1903 (Cth)

Limitation Act 1935 (WA)

Limitation Act 2005 (WA)

Therapeutic Goods Act 1989 (Cth)

Trade Practices Act1974 (Cth)

Trade Practices Amendment Bill 1992 (Cth)

Trade Practices Amendment (Personal Injuries and Death) Act 2004 (No 2) (Cth)

Trade Practices Amendment (Australian Consumer Law) Act (No. 2) 2010 (Cth)

Wrongs Act 1958 (Vic)

Federal Court Rules 2011 (Cth)

Therapeutic Goods (Medical Devices) Regulations 2002 (Cth)

Explanatory Memorandum, Trade Practices Amendment Bill 1992 (Cth)

Federal Food, Drug and Cosmetic Act 1938 (US)

Federal Rules of Civil Procedure (US)

Cases cited:

A v National Blood Authority [2001] 3 All ER 289

Aldi Foods Pty Ltd v Moroccanoil Israel Ltd [2018] FCAFC 93; (2018) 261 FCR 301

Amaca Pty Ltd v Hannell [2007] WASCA 158; (2007) 34 WAR 109

AstraZeneca Pty Ltd v GlaxoSmithKline Australia Pty Ltd [2005] FCA 1645

Australian Competition and Consumer Commission v 4WD Systems Pty Ltd [2003] FCA 850; (2003) 200 ALR 491

Australian Executor Trustees (SA) Limited v Kerr [2021] NSWCA 5

Axon v Axon [1937] HCA 80; (1937) 59 CLR 395

Banque Commerciale SA en Liquidation v Akhil Holdings Ltd [1990] HCA 11; (1990) 169 CLR 279

Bennett v Minister of Community Welfare [1992] HCA 27; (1992) 176 CLR 408

Betfair Pty Ltd v Racing New South Wales and Anor [2010] FCAFC 133; (2010) 189 FCR 356

Black v Lipovac (by his next friend Lipovac) [1998] FCA 699; (1998) 217 ALR 365

BMW Australia Limited v Australian Competition and Consumer Commission [2004] FCAFC 167; (2004) 207 ALR 452

Branir v Owston Nominees (No 2) [2001] FCA 1833; (2001) 117 FCR 424

Butcher v Lachlan Elder Realty Pty Ltd [2004] HCA 60; (2004) 218 CLR 592

Campbell v Backoffice Investments Pty Ltd [2009] HCA 25; (2009) 238 CLR 304

Carey-Hazellv Getz Bros & Co (Aust) Pty Ltd [2004] FCA 853; (2004) ATPR 42-014

Chappel v Hart [1998] HCA 55; (1998) 195 CLR 232

Commercial Union Assurance Co of Australia Ltd v Ferrcom Pty Ltd (1991) 22 NSWLR 389

Commonwealth v McLean [1996] NSWSC 657; (1996) 41 NSWLR 389

Dyczynski v Gibson [2020] FCAFC 120; (2020) 381 ALR 1

Ethicon Sàrlv Gill [2018] FCAFC 137; (2018) 264 FCR 394

Femcare Ltd v Bright [2000] FCA 512; (2000) 100 FCR 331

Forrest v Australian Securities and Investments Commission [2012] HCA 39; (2012) 247 CLR 486

Fox v Percy [2003] HCA 22; (2003) 214 CLR 118

Gill v Ethicon SÀRL [2018] FCA 470

Gill v Ethicon Sàrl(No 3) [2019] FCA 587; (2019) 369 ALR 175

Gill v Ethicon Sàrl (No 5) [2019] FCA 1905

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

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

Graham Barclay Oysters Pty Ltd v Ryan [2002] HCA 54; (2002) 211 CLR 540

Hollis v Dow Corning Ltd [1995] 4 SCR 634

Hunt & Hunt Lawyers v Mitchell Morgan Nominees Pty Limited [2013] HCA 10; (2013) 247 CLR 613

ICI Australia Operations Pty Ltd v Trade Practices Commission [1992] FCA 707; (1992) 38 FCR 248

Jones v Dunkel [1959] HCA 8; (1959) 101 CLR 298

Lee v Lee [2019] HCA 28; (2019) 266 CLR 129

March v E & MH Stramare Pty Ltd [1991] HCA 12; (1991) 171 CLR 506

McLean v Tedman [1984] HCA 60; (1984) 155 CLR 306

Merck Sharp & Dohme (Australia) Pty Ltd v Peterson [2009] FCAFC 26; (2009) 355 ALR 20

Merck Sharp & Dohme (Australia) Pty Ltd v Peterson [2011] FCAFC 128; (2011) 196 FCR 145

Naxakis v Western General Hospital [1999] HCA 22; (1999) 197 CLR 269

Parkdale Custom Built Furniture Pty Ltd v Puxu Pty Ltd (1982) 149 CLR 191

Peterson v Merck Sharpe & Dohme (Aust) Pty Ltd [2010] FCA 180; (2010) 184 FCR 1

Pilato v Metropolitan Water Sewerage & Drainage Board  (1959) 76 WN (NSW) 364

Precision Plastics Pty Limited v Demir (1975) 132 CLR 362

Purkess v Crittenden [1965] HCA 34; (1965) 114 CLR 164

Rogers v Whitaker [1992] HCA 58; (1992) 175 CLR 479

Rosenberg v Percival [2001] HCA 18; (2001) 205 CLR 434

Rural Press Ltd v Australian Competition and Consumer Commission [2003] HCA 75; (2003) 216 CLR 53

Scope Machinery Pty Ltd v Ross [2009] WASCA 100

State Rail Authority of New South Wales v Earthline Constructions Pty Limited (in liq) [1999] HCA 3; (1999) 160 ALR 588

Strong v Woolworths Ltd [2012] HCA 5; (2012) 246 CLR 182

Taco Company of Australia Inc v Taco Bell Pty Ltd [1982] FCA 170; (1982) 42 ALR 177

Timbercorp Finance Pty Ltd (in liquidation) v Collins [2016] HCA 44; (2016) 259 CLR 212

Trade Practices Commission v Mobil Oil Australia Ltd [1984] FCA 403; (1984) 4 FCR 296

Vairy v Wyong Shire Council [2005] HCA 62; (2005) 223 CLR 422

Vale v Sutherland [2009] HCA 26; (2009) 237 CLR 638

Wallace v Kam [2013] HCA 19; (2013) 250 CLR 375

Wilkes v DePuy International Ltd [2016] EWHC 3096 (QB); [2017] 3 All ER 589

Wyong Shire Council v Shirt [1980] HCA 12; (1980) 146 CLR 40

Young PW, Declaratory Orders (2nd ed, Butterworths, 1984)

Division:

General Division

Registry:

New South Wales

National Practice Area:

Commercial and Corporations

Sub-area:

Regulator and Consumer Protection

Number of paragraphs:

928

Dates of hearing:

1-9 February 2021

Counsel for the Appellants:

B Walker SC with K Morgan and D Wong

Solicitor for the Appellants:

Clayton Utz

Counsel for the Respondents:

A Bannon SC with A Naylor, C Colquhoun and Z Hillman

Solicitor for the Respondents:

Shine Lawyers

ORDERS

NSD 391 of 2020

BETWEEN:

ETHICON SÀRL

First Appellant

ETHICON INC

Second Appellant

JOHNSON & JOHNSON MEDICAL PTY LIMITED ACN 000 160 403

Third Appellant

AND:

KATHRYN GILL

First Respondent

DIANE DAWSON

Second Respondent

ANN SANDERS

Third Respondent

ORDER MADE BY:	JAGOT, MURPHY AND LEE JJ
DATE OF ORDER:	5 MARCH 2021

THE COURT ORDERS THAT:

1.Subject to order 2, the appeal be dismissed.

2.By 4pm on 19 March 2021 the parties provide:

(a)any competing submissions as to the costs of the appeal;

(b)an agreed or competing form of order addressing the issue referred to in [812] to [818] of the reasons of the Full Court (s 33ZB order); and

(c)any submissions, limited to five pages, relied upon by to support any dispute as to the appropriate costs order and form of s 33ZB order (with any such dispute to be thereafter resolved by the Full Court on the papers).

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

1         THE APPEAL	[1]
1.1      The proceedings before the primary judge	[1]
1.2      The issues in the appeal	[4]
1.2.1    Defects	[8]
1.2.2    Negligence	[12]
1.2.3    Misleadingor deceptive conduct	[19]
1.2.4    Limitation periods	[22]
1.2.5    Injunction	[24]
1.3      Summary of conclusions	[26]
2         KEY ASPECTS OF THE PROCEEDINGS BELOW	[27]
3         KEY FINDINGS OF THE PRIMARY JUDGE	[62]
3.1      The representative respondents - overview	[63]
3.1.1    Mrs Gill	[63]
3.1.2    Mrs Dawson	[69]
3.1.3    Mrs Sanders	[74]
3.2      The relevant conditions	[76]
3.2.1    Stress urinary incontinence	[76]
3.2.2    Pelvic organ prolapse	[81]
3.3      The devices	[86]
3.3.1    The SUI devices	[91]
3.3.2    The POP devices	[96]
3.4      Risks associated with mesh implantation	[100]
3.5      Biocompatibility	[113]
3.6      The performance of the devices	[136]
3.6.1    The evidence	[136]
3.6.2    Complication rates	[137]
3.6.3    SUI devices	[145]
3.6.4    POP devices	[152]
3.6.5    Gynemesh PS used abdominally in vault repair	[158]
3.7      Comparative outcomes	[159]
3.8      Regulatory requirements	[162]
3.9      Development and pre-market evaluations	[179]
3.9.1    SUI devices	[180]
3.9.1.1       TVT	[180]
3.9.1.2       TVT-O	[185]
3.9.1.3       TVT Secur	[187]
3.9.1.4       TVT Exact	[192]
3.9.1.5       TVT Abbrevo	[194]
3.9.2    POP devices	[196]
3.9.2.1       Gynemesh PS	[196]
3.9.2.2       Prolift	[199]
3.9.2.3       Prolift+M	[203]
3.9.2.4       Prosima	[206]
3.10     Post-market evaluation of the devices	[208]
3.10.1  General	[208]
3.10.2  Complaints	[212]
3.10.3  BSI audits	[219]
3.11     Removal of some devices from the market	[225]
3.12     Information the appellants provided about the devices	[234]
3.13     Statutory claims	[250]
3.13.1  Defect	[250]
3.13.2  Misleading and deceptive conduct	[275]
3.14     Negligence	[278]
3.14.1  Duty and breach	[278]
3.14.2  Causation – negligence	[292]
3.14.2.1     General	[292]
3.14.2.2     Mrs Gill	[295]
3.14.2.3     Mrs Dawson	[304]
3.14.2.4     Mrs Sanders	[308]
3.15     Limitation issues	[312]
3.15.1  Mrs Gill	[312]
3.15.2  Mrs Sanders	[327]
3.16     Damages and compensation	[334]
3.16.1  General	[334]
3.16.2  Mrs Gill	[335]
3.16.3  Mrs Dawson	[342]
3.16.4  Mrs Sanders	[354]
3.17     Other observations	[365]
4         OVERARCHING OBSERVATIONS	[366]
4.1      Appellants’ submissions	[366]
4.2      All surgery involves risks	[378]
4.3      Knowledge of pelvic surgeons	[387]
4.3.1    Preliminary observations	[387]
4.3.2    The relevant state of knowledge	[424]
4.3.2.1       Chronic inflammation	[433]
4.3.2.2       Extrusion or erosion of the mesh into surrounding organs, including the vaginal wall, bladder or urethra	[435]
4.3.2.3       Infection	[439]
4.3.2.4       Chronic pain	[442]
4.3.2.5       Dyspareunia and/or apareunia (avoidance of sexual intercourse)	[444]
4.3.2.6       Difficulty voiding	[446]
4.3.2.7       Offensive vaginal discharge	[448]
4.3.2.8       De novo or recurrent urinary incontinence	[449]
4.3.2.9       Damage to surrounding organs, nerves, ligaments, tissue and/or blood vessels	[451]
4.3.2.10     Haemorrhage	[453]
4.3.2.11     Leg weakness	[454]
4.3.2.12     Reoperation or revision surgery associated with complications	[455]
4.3.2.13     Psychiatric injury	[457]
4.3.2.14     Recurrence of prolapse	[458]
4.3.2.15     Difficulty of removing devices	[459]
4.3.3    The forensic contest	[462]
4.3.4    RANZCOG position statements	[464]
4.3.5    The IFUs	[466]
4.3.6    Patient brochures	[470]
4.3.7    Medical publications	[475]
4.3.8    The appellants’ conduct	[477]
4.3.9    Conclusions	[478]
4.4      Clinical consensus?	[479]
4.5      The evidence of the pelvic surgeons and other “non-clinical” experts	[496]
4.6      The appellants’ concession about clinical significance of the pleaded complications	[540]
4.7      Drugs v implants?	[552]
4.8      Causation	[553]
5         DEFECTIVE DEVICES (GROUNDS 1 AND 2 AND NOTICE OF CONTENTION)	[556]
5.1      Overview	[556]
5.2      The appellants’ submissions	[560]
5.3      Relevant principles	[578]
5.4      Discussion	[612]
6         MERCHANTABLE/ACCEPTABLE QUALITY AND FITNESS FOR PURPOSE (GROUND 3)	[697]
7         NEGLIGENCE – FAILURE TO WARN (GROUND 5)	[699]
7.1      Primary judge’s conclusions	[699]
7.2      Appellants’ submissions	[700]
7.3      Discussion	[706]
8         NEGLIGENCE – PRE-MARKET AND POST-MARKET TESTING (GROUNDS 6, 7 AND 8)	[744]
8.1      Primary judge’s conclusions	[744]
8.2      Appellants’ submissions	[745]
8.3      Discussion	[749]
9         MISLEADING OR DECEPTIVE CONDUCT – BEYOND THE PLEADED CASE (GROUND 12)	[774]
9.1      Appellants’ submissions	[774]
9.2      Discussion	[777]
10       MISLEADING OR DECEPTIVE CONDUCT – FURTHER ALLEGED ERRORS (GROUND 13)	[789]
10.1     Appellants’ submissions	[789]
10.2     Discussion	[793]
11       CAUSATION – NEGLIGENCE (GROUNDS 9, 10 AND 11)	[819]
11.1     Overview	[819]
11.2     Appellants’ submissions	[822]
11.3     Discussion	[829]
12       CAUSATION – CONSUMER LAW CLAIMS (GROUNDS 4 AND 14)	[870]
12.1     Appellants’ submissions	[870]
12.1.1  Mrs Gill	[871]
12.1.2  Mrs Dawson	[874]
12.1.3  Mrs Sanders	[877]
12.2     Discussion	[881]
12.2.1  Misleading and deceptive conduct	[883]
12.2.2  The other statutory claims and causation	[887]
13       LIMITATION PERIODS (GROUNDS 15 AND 16)	[893]
13.1     Mrs Sanders – extension of time (ground 16(a))	[894]
13.2     Mrs Gill and Mrs Sanders – extensions of time (grounds 15 and 16(b))	[897]
14       INJUNCTION (GROUND 17)	[908]
14.1     Appellants’ submissions	[908]
14.2     Discussion	[913]
15       CONCLUSION	[928]

REASONS FOR JUDGMENT

THE COURT:

1.               THE APPEAL

1.1             The proceedings before the primary judge

1. In Gill v Ethicon Sàrl (No 5) [2019] FCA 1905 (TJ) the primary judge held the appellants (the respondents in the proceedings below) liable for damages in connection with the supply of nine medical devices in Australia (the devices). Five of the devices were intended for use in the treatment of female stress urinary incontinence (SUI). They are known as 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), and are together referred to as the SUI devices. The other four devices were intended for use in the treatment of female pelvic organ prolapse (POP). They are known as 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), and are together referred to as the POP devices.

2. The respondents to the appeal (the applicants in the proceedings below) succeeded on all the pleaded causes of action. The three representative applicants in the class action (the respondents to the appeal), Kathryn Gill, Diane Dawson, and Ann Sanders, were awarded damages for loss and injury caused to them by the device with which they had been implanted. Mrs Gill had POP and was implanted with a Prolift device on 12 January 2007. Mrs Dawson also had POP and was implanted with Gynemesh PS on 8 May 2009. Mrs Sanders suffered from SUI and was implanted with TVT on 12 March 2001.

3. In Gill v Ethicon Sàrl (No 6) [2020] FCA 279 (RJ) the primary judge quantified the damages payable to the representative applicants ($1,276,113 to Mrs Gill, $555,555 to Mrs Dawson and $757,372 to Mrs Sanders), answered common questions in the proceedings, and granted an injunction (the Injunction). The common questions and the answers to them are set out in Schedule A. The Injunction is set out in Schedule B. The Injunction relates to the four SUI devices which remain on the market. None of the POP devices is currently on the Australian Register of Therapeutic Goods (ARTG) so that those devices can no longer be sold in Australia. One of the SUI devices, TVT Secur, was also removed from the ARTG and has not been sold in Australia since 2008.

   1.2             The issues in the appeal

4. The appellants (also referred to as Ethicon below, where it is not necessary to distinguish between them) challenge the trial judgment in which the primary judge held them liable for contraventions of the Trade Practices Act1974 (Cth) (the TPA) and Sch 2 to the Competition and Consumer Act 2010 (Cth) (the CCA), the Australian Consumer Law (the ACL) and for negligence.

5. The primary judge held the appellants liable for contraventions of:

   ·s 75AD of the TPA in that the devices were supplied with a “defect” and s 138 of the ACL because they were supplied with “a safety defect”;

   ·s 74D of the TPA in that the devices were not of merchantable quality and did not comply with the guarantee given by s 54 of the ACL in that they were not of acceptable quality;

   ·s 74B of the TPA in that the devices were not reasonably fit for the particular purpose for which they were acquired by the group members and not fit for the disclosed purpose under s 55 of the ACL; and

   ·s 52 of the TPA and s 18 of the ACL in that the information the respondents released in connection with the devices, including the instructions for use accompanying the devices (the IFUs), and the way in which they were marketed and promoted was misleading or deceptive or likely to mislead or deceive consumers: TJ [15].

6. Insofar as the common law claims for negligence are concerned, the primary judge held the appellants liable for breaching their duty of care to Mrs Gill, Mrs Dawson and Mrs Sanders by:

   ·failing to undertake any, or any adequate, clinical or other evaluation of the devices before releasing them in Australia;

   ·failing to conduct any, or any adequate, evaluation of safety and effectiveness of the devices after their release in Australia; and

   ·failing to inform them, their treating doctors, and/or the hospitals in which the treatments were administered, of the inadequate evaluations about, and the risks of, or susceptibilities to, complications of the kinds from which they suffered: TJ [16].

7. The appellants contend that the primary judge erred on 17 grounds as follows.

   1.2.1Defects

8. Ground 1: the primary judge erred (including at TJ [3458], [3496], [3499]) in finding that the safety of each of the nine devices was not such as persons generally were entitled to expect because the primary judge:

   (1)did not properly consider or give sufficient weight to the evidence of the pelvic surgeons in relation to clinical considerations and the different safety profiles of each of the devices, and their safety profiles relative to other surgical and nonsurgical alternatives;

   (2)preferred the evidence of non-clinical experts and relied on the findings about the appellants’ awareness (including relevant clinical significance) of the pleaded complications; and

   (3)did not properly consider or give sufficient weight to the differences between the five SUI devices and the four POP devices (comprising the three pelvic floor repair systems and Gynemesh PS).

   Had this evidence been properly considered, the primary judge would not have concluded that each of the devices had a defect or a safety defect because that evidence established, when viewed in the context of clinical considerations, the benefit-risk profile for each device was such as persons generally were entitled to expect.

1. Ground 2: the primary judge erred:

   (1)in using the conclusions of non-compliance with the requirements for Conformité Européenne marking (CE marking or the CE Mark) to find that (at TJ [3458], [3496], [3499]) the safety of each of the devices was not such as persons generally were entitled to expect because:

   (a)the case pleaded, particularised or advanced by the respondents was not based on the CE Mark or any representation said to be made by the CE Mark; and/or

   (b)using conclusions of non-compliance with the requirements for CE marking was inconsistent with the primary judge’s finding that most surgeons would not have any appreciation of the path of regulatory clearance for medical devices (TJ [3250]); and/or

   (c)the primary judge had no evidence as to any Australian surgeon’s or patient’s understanding or appreciation of the CE Mark and made no relevant finding (other than at TJ [3250]) as to a person’s understanding or appreciation of the CE Mark; and/or

   (d)contrary to the primary judge’s finding (at TJ [3270], [3272]) the CE Mark and clearance for sale was not a representation in Australia that the devices met “regulatory requirements and standards”, and

   (2)in the alternative, in placing too much weight (at TJ [3272]) on the conclusion of any non-compliance with the requirements for CE marking in finding that each device had a defect or a safety defect within the meaning of the TPA or the ACL.

2. Ground 3: as a consequence of grounds 1 and/or 2 above, the primary judge erred in finding that each of the devices was not of merchantable or acceptable quality, or was not reasonably fit for purpose within the meaning of the TPA or the ACL.

3. Ground 4: as a consequence of grounds 1 and/or 2 above, the primary judge erred in finding that:

   (1)because Mrs Gill suffered damage caused by her Prolift, she suffered damage caused by the defect, because it was not of merchantable quality, or because it was not reasonably fit for purpose (TJ [3544], [4428], [4429]);

   (2)because Mrs Dawson suffered damage caused by her Gynemesh PS, she suffered damage caused by the defect, because it was not of merchantable quality, or because it was not reasonably fit for purpose (TJ [3544], [4498]); and

   (3)because Mrs Sanders suffered damage caused by her TVT, she suffered damage caused by the defect, because it was not of merchantable quality, or because it was not reasonably fit for purpose (TJ [3544], [4517]).

   1.2.2Negligence

4. Ground 5: the primary judge erred (including at TJ [3878]) in finding that the appellants breached their duty of care to warn in respect of each device because the primary judge:

   (1)did not properly consider or give sufficient weight to the evidence of the pelvic surgeons in relation to clinical considerations and the different safety profiles of each of the devices, and their safety profiles relative to other surgical and nonsurgical alternatives; and

   (2)preferred the evidence of non-clinical experts and relied on the findings about the appellants’ awareness (including relevant clinical significance) of the pleaded complications; and

   (3)did not properly consider or give sufficient weight to the differences between the five SUI devices and the four POP devices (comprising the three pelvic floor repair systems and Gynemesh PS).

   Had this evidence been properly considered, the primary judge would not have concluded that the appellants breached their duty of care to warn in respect of each device because that evidence established, when viewed in the context of clinical considerations, that the warnings provided in connection with each device were reasonable and appropriate in the circumstances.

5. Ground 6: the primary judge erred in finding that the first appellant and second appellant breached their duty of care to take reasonable care to avoid injury to patients by finding that the appellants’ pre-market and post-market evaluations of each of the devices was deficient in circumstances where (see TJ [3699]):

   (1)the respondents did not advance a case that the regulatory environment informs the first appellant’s and second appellant’s obligations; and

   (2)the respondents did not advance a case as to how any non-compliance with the regulatory environment has relevantly affected the appellants’ obligations.

6. Ground 7: the primary judge erred in finding that the first appellant and second appellant breached their duty to take reasonable care to avoid injury to patients by finding that their pre-market evaluation of each of the devices was deficient (common question and answer 15; TJ [3762]) because:

   (1)the evidence did not establish:

   (a)the first appellant’s and second appellant’s engagement with any regulator was insufficient;

   (b)the first appellant’s and second appellant’s risk analyses and design validation studies were insufficient;

   (c)the first appellant and second appellant did not satisfy the European Council Directive 93/42/EEC issued on 14 June 1993 and amended from time to time thereafter (European Directive) (TJ [3688]-[3689]); and

   (d)the first appellant and second appellant did not have enough evidence to obtain CE marking for each of the devices (TJ [3687]); and

   (2)the evidence did establish that the first appellant and second appellant appropriately and reasonably relied on studies conducted on, and experience associated with, the use of polypropylene and polypropylene-based meshes in the body, as well as the surgical technique and benefit-risk profile of earlier Ethicon devices before each device was supplied in Australia.

7. Ground 8: the primary judge erred in finding that the first appellant and second appellant breached their duty to take reasonable care to avoid injury to patients by finding that their post-market evaluation of each of the devices was deficient (TJ [3776]-[3778], [3784], [3794]; common question and answer 16) because:

   (1)the evidence did not establish:

   (a)the first appellant’s and second appellant’s post-market evaluation on the devices, both in terms of clinical studies and ongoing review of the scientific literature was deficient;

   (b)the first appellant’s and second appellant’s complaint handling and event reporting to regulatory authorities was deficient;

   (c)the first appellant’s and second appellant’s responses to enquiries raised by regulators was deficient; and

   (2)as a consequence of the matters outlined at ground 5 above, the evidence did establish that the adverse events (including the impact of those events on patients) and the warnings accompanying each of the devices were reasonable and appropriate in the circumstances.

8. Ground 9: the primary judge erred in finding that, but for the first appellant’s and second appellant’s allegedly negligent pre-market and post-market evaluations:

   (1)none of the devices would have been on the Australian market at any time (common question and answer 19(a));

   (2)no group member would have received a device and suffered damage from its implantation (common question and answer 19(b)); and

   (3)Mrs Gill (at TJ [4445]-[4446]), Mrs Dawson (at TJ [4502]) and Mrs Sanders (at TJ [4521]) would not have suffered their injuries because the evidence does not establish that:

   (a)registration in Australia would have been withheld for each device had the first appellant and second appellant disclosed certain facts about the testing process for each device; or

   (b)withholding or withdrawing each device from the market was the only course reasonably open to the first appellant, second appellant, and any regulator.

9. Ground 10: the primary judge erred in finding that:

   (1)Mrs Gill’s injuries were caused by the appellants’ pre-market and post-market evaluations (TJ [4445]-[4446]) because the primary judge failed properly to apply ss 5C and 5D of the Civil Liability Act 2002 (WA) (the CLA) and reversed the onus of proof;

   (2)Mrs Dawson’s injuries were caused by the appellants’ pre-market and post-market evaluations (TJ [4502]) because the primary judge failed properly to apply ss 51 and 52 of the Wrongs Act 1958 (Vic) (the Wrongs Act) and reversed the onus of proof; and

   (3)Mrs Sanders’ injuries were caused by the appellants’ pre-market and post-market evaluations (TJ [4521]) because the primary judge failed properly to apply ss 5C and 5D of the CLA or the common law and reversed the onus of proof.

10. Ground 11: the primary judge erred in finding that:

    (1)Mrs Gill’s injuries were caused by deficiencies in the appellants’ warnings accompanying Prolift (including at TJ [4492], [4496]) because the primary judge failed properly to apply ss 5C and 5D of the CLA and reversed the onus of proof;

    (2)Mrs Dawson’s injuries were caused by deficiencies in the appellants’ warnings accompanying Gynemesh PS (including at TJ [4508], [4514]-[4515]) because the primary judge failed properly to apply ss 51 and 52 of the Wrongs Act and reversed the onus of proof; and

    (3)Mrs Sanders’ injuries were caused by deficiencies in the appellants’ warnings accompanying TVT (including at TJ [4530], [4556], [4558]) because the primary judge failed properly to apply ss 5C and 5D of the CLA or the common law and reversed the onus of proof.

    1.2.3Misleadingor deceptive conduct

11. Ground 12: the primary judge erred in finding that the appellants engaged in misleading or deceptive conduct (see TJ [3604]-[3607], common question and answer 22) in relation to a case not pleaded, particularised or advanced by the respondents.

12. Ground 13: the primary judge erred in finding that the appellants engaged in misleading or deceptive conduct because:

    (1)the primary judge:

    (a)did not properly consider or give sufficient weight to the evidence of the pelvic surgeons in relation to clinical considerations and the different safety profiles of each of the devices, and their safety profiles relative to other surgical and non-surgical alternatives;

    (b)preferred the evidence of non-clinical experts and relied on the findings about the appellants’ awareness (including relevant clinical significance) of the pleaded complications; and

    (c)did not properly consider or give sufficient weight to the differences between the five SUI devices and the four POP devices (comprising the three pelvic floor repair systems and Gynemesh PS).

    Had this evidence been properly considered, the primary judge would not have concluded that the appellants engaged in misleading or deceptive conduct in respect of each device because that evidence established, when viewed in the context of clinical considerations, that the conduct of the appellants in respect of each device (including the information provided in connection with each device) was not misleading:

    (2)the evidence did not otherwise establish the surrounding facts and circumstances of the supply of each device in Australia, including by medical practitioners to potential patients in each relevant period (TJ [3581], [3584], [3586], [3591]-[3592], [3594]-[3600], [3602], [3604]-[3605], common question and answer 22).

13. Ground 14: the primary judge erred in finding that, because Mrs Sanders suffered damage caused by her TVT, she suffered damage caused by the misleading or deceptive conduct (TJ [4560]) because the evidence does not establish that:

    (1)Dr O’Neill, Dr Giele and/or Dr Taylor would have provided different advice, including a different or additional warning (TJ [4530], [4558]); and/or

    (2)Mrs Sanders would not have undergone surgery to implant her TVT (TJ [4556]).

    1.2.4Limitation periods

14. Ground 15: the primary judge erred in finding that Mrs Gill’s claim in negligence was not statute barred by failing properly to apply ss 39(3) and (4) of the Limitation Act 2005 (WA) (the 2005 Limitation Act) by reversing the onus of proof (TJ [4831]).

15. Ground 16: the primary judge erred in finding that Mrs Sanders’ claim in negligence was not statute barred by:

    (1)applying the 2005 Limitation Act (rather than the Limitation Act 1935 (WA) (the 1935 Limitation Act)) and granting Mrs Sanders an extension of time under ss 39(3) and (4), by:

    (a)failing to place sufficient weight on the contemporaneous medical records (TJ [4840]); and

    (b)finding that the first symptom or other manifestation of personal injury (beyond de minimis) occurred in 2007 or 2008 (at TJ [4853]).

    (2)in the alternative, failing properly to apply ss 39(3) and (4) of 2005 Limitation Act by reversing the onus of proof (TJ [4861]).

    1.2.5Injunction

16. Ground 17: the primary judge erred in granting the Injunction (at TJ [5822], RJ [50]) enjoining the appellants from supplying, distributing, marketing or promoting any of the SUI devices (other than TVT Secur) anywhere in Australia without including a warning or advice in the terms set out in orders 2 and 3 of the orders of 6 March 2020 in the patient information leaflets, instructions for use or any promotional material because:

    (1)there was no evidence before the Court as to the knowledge of treating surgeons or persons generally as at 21 November 2019 (the date reasons were published in the trial judgment) or 6 March 2020 (the date reasons were published in RJ and the Injunction ordered); and/or

    (2)the Injunction was ordered in the absence of hearing from the Therapeutic Goods Administration (embodied by the Commonwealth) (the TGA) despite it being the entity having the expertise and statutory responsibility for regulating the provision of medical devices (and the warnings and advice provided in relation to medical devices) in Australia.

17. The respondents filed a notice of contention to the effect that, if the primary judge’s conclusion in relation to the existence of a defect/safety defect in any product the subject of the proceeding below relied on the Court’s findings of non-compliance with the requirements for CE marking, then the primary judge’s conclusion as to defect should be upheld for each product on the basis of those of the primary judge’s findings other than non-compliance with CE marking requirements.

    1.3             Summary of conclusions

18. We have decided that the appeal must be dismissed, subject to us being satisfied it is appropriate to vary the order by which the primary judge’s findings are binding on group members and providing greater specificity to the answer to common question 22. Our reasons follow.

    2.               KEY ASPECTS OF THE PROCEEDINGS BELOW

19. As the primary judge recorded, the proceedings were brought under Pt IVA of the Federal Court of Australia Act 1976 (Cth) (the FCA Act) by three applicants, both on their own behalf and on behalf of other women who claim to have suffered complications from the implantation of one or other of the devices during the relevant period. The class of applicants is open and more than 90,000 of the devices have been supplied in Australia: TJ [13].

20. The hearing began in July 2017 and ended in February 2018 involving hearing days on 4-14, 19-20, 24-28 July 2017, 2, 9-17, 21-23, 30-31 August 2017, 4, 12-19, 28-29 September 2017, 3-12, 16-26 October 2017, 1-8, 14-16, 20-24, 29 November 2017, 29-31 January 2018 and 1-22 February 2018.

21. Evidence was adduced from 48 witnesses, 35 of whom gave oral evidence. Of the 48 witnesses, 37 were experts from nine different disciplines: TJ [19]. More than 5,500 documents were tendered, running to over 164,000 pages: TJ [20].

22. Mrs Gill, Mrs Dawson and Mrs Sanders, and each of their husbands gave evidence: TJ [21].

23. The respondents (the applicants below) also called evidence from:

    (1)four urogynaecologists (a surgical subspecialty of urology and gynaecology, which involves the diagnosis and treatment of female pelvic floor disorders) – Andrew Korda, Wael Agur, Jerry Blaivas, and Michael Thomas Margolis: TJ [22]. They also tendered a report from a urogynaecologist on whom the appellants (the respondents below) proposed to rely – Malcolm Frazer: TJ [23];

    (2)Bilal Chughtai, a urologist, Uwe Klinge, a general surgeon and biomaterials researcher, Bernd Klosterhalfen and Vladimir Iakovlev, pathologists, Russell Dunn and Scott Guelcher, biomechanical engineers, Derrick Beech, Bryan Allman, Peggy Pence and Anne Holland, regulatory experts, Howard Hu, Cara Krulewitch, and Mark Woodward, epidemiologists, Ian Gordon, a biostatistician, Alan Meagher and Anthony Eyers, colorectal surgeons, Patricia Jungfer, a psychiatrist, Joseph Slesenger, a specialist in occupational medicine, and Lindy Williams and Timothy Walsh, occupational therapists: TJ [24]; and

    (3)Robyn Leake, an obstetrician and gynaecologist who treated Mrs Gill, James Swan, an obstetrician and gynaecologist who treated Mrs Dawson, and Sandra McNeill, an obstetrician and gynaecologist who assisted in the operation in which Mrs Sanders was implanted with TVT: TJ [26].

24. The appellants (the respondents below) called evidence from:

    (1)six urogynaecologists – Piet Hinoul, Pierre Collinet, Jan Deprest, Alan Lam, Jan-Paul Roovers, and Anna Rosamilia; and

    (2)Steven McLean, an engineer, Paul Santerre, a professor of biomaterials, Thomas Wright, a pathologist, Lisa Brown, Anthony Samuels and Rosalie Wilcox, psychiatrists, and Susan Borthwick, an occupational therapist: TJ [27].

25. Dr Hinoul was the only witness from the appellants to give evidence. He holds a PhD in bio-medical sciences from the University of Amsterdam. Since June 2014 he has held the position of Vice President – Medical Affairs at Ethicon Inc., based in Somerville, New Jersey, USA: TJ [28]. Dr Hinoul joined Ethicon in 2008, when he was appointed Director of Medical Affairs – Europe, Middle East and Africa (Women’s Health and Urology), based in Paris, France. As Director of Medical Affairs, Dr Hinoul was responsible for Ethicon’s pelvic floor repair and incontinence repair products: TJ [29]. In December 2010 Dr Hinoul became the Worldwide Director of Medical Affairs (Women’s Health and Urology) for Ethicon Inc., based in Somerville, New Jersey. In June 2012 his responsibilities increased to cover other aspects of the Ethicon business and from April 2013, until his promotion to Vice-President – Medical Affairs, he held the position of Worldwide Director of Medical Affairs (Ethicon Endo-Surgery (Energy Franchise)): TJ [30].

26. The primary judge made adverse credit findings against Dr Hinoul. She said:

    Dr Hinoul presented as a company spokesman. His affidavit was lengthy (363 pages) but not full and frank. It cast Ethicon’s conduct in the most favourable light. In cross-examination, Dr Hinoul was inclined not to give responsive answers to potentially uncomfortable questions and tended to be evasive where direct answers would not suit the respondents’ interests. At times he steadfastly defended the indefensible: TJ [31].

27. A key figure in the development of the devices, Dr Axel Arnaud, remains with Ethicon. He was a predecessor of Dr Hinoul as Ethicon’s Director of Medical Affairs. He investigated the TVT procedure in 1996 and TVT-O in 2002 and was a moving force in the development of the POP devices. He was not called to give evidence. No explanation for his failure to give evidence was provided. Nor was any explanation given for the fact that other Directors of Medical Affairs at Ethicon were not called to give evidence: TJ [32].

28. The primary judge also made adverse credit findings against a number of the other witnesses called by the appellants, Professor Wright (TJ [305]-[309]), Professor Santerre (TJ [310]-[313]), Professor Deprest (TJ [314]-[323]) and, to a lesser extent, Dr MacLean (TJ [324]-[325]).

29. The respondents pleaded that the SUI devices could cause the following complications (called the Tape Complications):

    ·a chronic inflammatory reaction of the tissues surrounding or attached to the implants;

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

    ·infection;

    ·chronic pain;

    ·dyspareunia and/or apareunia (avoidance of sexual intercourse);

    ·difficulty voiding;

    ·offensive vaginal discharge;

    ·de novo or recurrent urinary incontinence;

    ·damage to surrounding organs, nerves, ligaments, tissue and/or blood vessels;

    ·haemorrhage;

    ·leg weakness;

    ·reoperation or revision surgery associated with complications; and

    ·psychiatric injury: TJ [184].

1. The respondents alleged that the POP devices could cause the same complications and also cause difficulty defecating and recurrence of prolapse (called the Mesh Complications): TJ [185].

2. The respondents also alleged that the devices were difficult, if not impossible, to remove safely from patients suffering from one or more of the pleaded complications, that one or more surgical procedures might be required, and that removal carried the risk of new complications or of aggravating existing complications. These were referred to as the “Tape Removal Complications” (for SUI devices) and the “Mesh Removal Complications” (for POP devices), as the case may be: TJ [187].

3. After the hearing, the respondents applied for and were granted leave to amend their pleadings to add an allegation that the appellants failed to give any or any sufficient information or warning that the chronic inflammatory response to the implants could be affected by conditions which affect the immune response and healing, including autoimmune and connective tissue disorders: see Gill v Ethicon Sàrl [2018] FCA 470 at [81]-[107]: TJ [196].

4. The primary judge referred to these complications together as the pleaded complications: TJ [197].

5. The appellants pleaded that “all surgical procedures present risks”. They also pleaded that non-absorbable polypropylene mesh, which formed a component of each of the POP and SUI devices, was designed to allow for an inflammatory response that is necessary for tissue ingrowth. They otherwise denied the existence of the pleaded complications: TJ [188]. They did not plead that either pelvic surgeons generally or the particular treating surgeons of the representative respondents were aware at all relevant times of the pleaded complications.

6. However, as the primary judge recorded:

   189In cross-examination, Dr Hinoul acknowledged that, from the time each of the devices was first supplied anywhere in the world, Ethicon knew of its potential to cause each of the pleaded complications. He conceded that, from the time of first supply, Ethicon was aware that a foreign body reaction to surrounding tissue would create a scar, that the mesh could be subjected to a contracting force applied by surrounding scar tissue, that the response of the host tissue was variable, and that any significant degree of contraction could lead to pain as could the scarring itself. Furthermore, he admitted that from that time Ethicon knew that there was a risk of mesh exposure and extrusion into the vaginal canal or another organ, that mesh exposure or extrusion could be difficult to treat, and that it could cause pain or discomfort. He also admitted that at the date of first supply Ethicon knew that both mesh erosion or extrusion and pain could occur many years after any of the devices had been implanted. Moreover, he admitted that Ethicon knew at that time that implantation carried a lifelong risk of erosion and pain, as well as risks of: dyspareunia and, as a consequence, apareunia; difficulty voiding; difficulty defecating; offensive discharge; leg weakness; and damage to surrounding organs, ligaments, tissues, and blood vessels.

   190Dr Hinoul also conceded that Ethicon knew at that time that both acute and chronic pain could be caused by each of the devices, that chronic pain could be very damaging and debilitating, indeed “life altering”, and that multiple operations might be necessary to attempt to alleviate the pain. He agreed that the mesh could be difficult, if not impossible, to remove safely or without complications and that, in the case of Prolift, it could be disastrous. He said that Prolift could be removed safely but admitted that there was always a risk in so doing of causing damage to surrounding structures. He also admitted that, at the time each of the Ethicon devices was launched, Ethicon knew that, in the event of complications, the original condition (stress urinary incontinence or pelvic organ prolapse) could recur.

   191Ultimately, then, there was no dispute that all of the complications could be caused by implantation of the Ethicon devices. What is more, lead counsel for the respondents, Mr Finch SC, told the Court in closing argument that the respondents accepted that each of the pleaded complications was clinically significant.

7. This last statement is a reference to the fact that in closing submissions senior counsel for the appellants conceded that each of the pleaded complications, if one of them occurred, was clinically significant in terms of incidence and consequence. The appellants now dispute the extent of the concession but, for the reasons we later explain, we consider the appellants made that concession in clear terms.

8. The appellants’ concession, prompted by Dr Hinoul’s oral evidence, was important to the primary judge’s process of reasoning: TJ [192], [198], [280]-[281], [300], [1134], [1540], [2839], [2990], [3063], [3362], [3405].

9. Dr Hinoul, it should be noted, gave evidence after all of the respondents’ experts (excluding experts in respect of issues of quantification of damages) gave evidence.

10. Three observations should be made about these events immediately, as they partly explain the nature of the challenges to the reasoning of the primary judge and how those challenges should be assessed.

11. The first observation represents the way the appellants’ defence evolved. The case advanced by the respondents since this case began (as long as nine years ago) involved two fundamental and connected propositions: (a) the factual contention that each of the devices caused the pleaded complications, and (b) the factual and legal contention that the appellants should have warned of the risks of the pleaded complications, but failed to do so as required.

12. As noted above, the response was straightforward – the appellants pleaded that all surgery presents risks, but otherwise expressly denied that the devices caused the pleaded complications: defence at [23] and [45]. Consistently with this approach – and obviously enough, given the denial – the appellants did not suggest that pelvic surgeons knew of the risk of the pleaded complications (notwithstanding they did state their expectation of the nature of the risks that would be the subject of warning by surgeons in their defence at [18(c)] and [40(c)]).

13. These opposed positions as to the existence or otherwise of the pleaded complications marked out the primary forensic battleground in the many years leading up to the hearing and during much of the hearing. A vast array of expert evidence was marshalled to support each position. Lay evidence was also filed, including 363 pages of narrative affirmed by Dr Hinoul. No-one reading that long, dense and carefully constructed affidavit would have understood from it the true position, which was only revealed when Dr Hinoul was cross-examined. As it turned out, not only did the pleaded complications exist, but at all relevant times they were known by the appellants to exist. Moreover, they were all clinically significant.

14. It is important to remember this history when one comes to the way the appellants now advance their case. With what can only be described as considerable forensic dexterity, the appellants now suggest that the pleaded complications were known to pelvic surgeons generally, such that the respondents did not establish that it was necessary for them to warn pelvic surgeons about them or that, at the least, the respondents had not proved that the pleaded complications were not known to pelvic surgeons generally, with the same consequence.

15. This volte-face forced upon the appellants by a witness telling the truth in cross-examination was described by senior counsel for the respondents, not unfairly, as an adventitious attempt to try to extract a plausible defence from a case that until the eleventh hour had been premised on a theory of the case that had become untenable. Reduced to its core, the argument put in final submissions below (and on appeal) was essentially a focus on s 140(1) of the Evidence Act 1995 (Cth) (Evidence Act) and, more specifically, on the notion, as Sir Owen Dixon emphasised, that a party bearing the onus will not succeed unless the whole of the evidence establishes a “reasonable satisfaction” on the preponderance of probabilities such as to sustain the relevant issue (Axon v Axon [1937] HCA 80; (1937) 59 CLR 395 at 403, 407), and the “facts proved must form a reasonable basis for a definite conclusion affirmatively drawn of the truth of which the tribunal of fact may reasonably be satisfied”: Jones v Dunkel [1959] HCA 8; (1959) 101 CLR 298 at 305.

16. The second observation is connected to the first. The hearing below was both very long and hard fought. Of the 48 witnesses, 37 were experts giving opinion evidence in nine broadly distinguishable areas of specialised knowledge. Unlike in most complex class actions, there were no orders for concurrent evidence of experts after the conclusion of the lay evidence, nor was any dispute of a scientific or technical nature made the subject of inquiry and report. Another feature was that by the consent of the parties, the hearing was unusually structured. According to senior counsel for the respondents (that is, the applicants) who appeared below, lay affidavits by the representative respondents (applicants) were read but cross-examination was deferred. Then the experts called on behalf of the respondents (applicants) gave evidence. Dr Hinoul thereafter gave his highly significant and (from the perspective of the appellants) damaging lay evidence. None of this is meant as a criticism of the primary judge who was presented with this unique way of doing things by the parties who, no doubt, were required to work around the availability of a large number of busy professionals. But it is worth mentioning, because when it comes to drawing any inference about the respondents’ failure to call witnesses in chief or the failure to adduce certain evidence in chief from witnesses who were called, it is necessary to bear in mind the case was a very different one before, as compared to after, the cross-examination of Dr Hinoul.

17. The third observation involves a reiteration of the statements in Gill v Ethicon Sàrl(No 3) [2019] FCA 587; (2019) 369 ALR 175 at [3]-[15]. That is, there was a regrettable failure of the parties to identify with precision, in advance, the precise issues to be determined at the hearing. Indeed confusion about what was resolved and the consequences of setting aside the impugned findings of fact and law by the primary judge remained, up until the oral hearing of this appeal, and complicated any questions of relief.

18. The binding of class members to a determination of the court or a settlement approved by the court is foundational to the operation of a class action regime. A Federal Court in the United States is required, by Rule 23 of the Federal Rules of Civil Procedure (US), to designate those persons whom the court finds to be members of the class, so as to identify the claimants potentially bound by the outcome of the court’s determination or any settlement: see r 23(c)(3). In a proceeding governed by Pt IVA of the FCA Act, effectively the same result is arrived at by reason of the operation of s 33ZB. This provides that a judgment given in a class action must describe or otherwise identify the group members affected by it and binds all such persons other than any person who has opted-out. This provision creates its own kind of “statutory estoppel”: Timbercorp Finance Pty Ltd (in liquidation) v Collins [2016] HCA 44; (2016) 259 CLR 212 at [52]-[53] per French CJ, Kiefel, Keane and Nettle JJ. It was described by the Full Court in Femcare Ltd v Bright [2000] FCA 512; (2000) 100 FCR 331 at [25] per Black CJ, Sackville and Emmett JJ as, in one sense, the “pivotal provision” in Pt IVA.

19. A routine misconception is that the common questions specified in the originating application or supporting documentation define the common questions for the balance of the proceeding. This cannot be the case. For one thing, issues which are common may narrow considerably upon a joinder of issue by way of pleadings. Similarly, issues which are common to the claims may arise by way of a positive averment made in a subsequent pleading, whether it be a defence, a reply, a rejoinder or so on. Further common issues of fact may arise upon the filing of lay or expert affidavit evidence.

20. By whatever means common questions arise, what is critical for the orderly conduct of a Pt IVA proceeding is that prior to an initial trial starting there is specificity in what common questions are being determined. In Merck Sharp & Dohme (Australia) Pty Ltd v Peterson [2009] FCAFC 26; (2009) 355 ALR 20 at [6], the Full Court explained that at the conclusion of an initial trial, the court should pronounce formal orders regarding the common questions, perhaps by way of formal declarations or answers to questions.

21. In the early stages of Pt IVA litigation, the discipline of identifying the issues to be determined at an initial trial had not developed. Significant controversy often arose following the delivery of a judgment (as it did here), with the parties parsing the judgment trying to divine which of the findings amounted to the determination of a common issue of law or fact. The accumulated experience of this Court in having to deal with the needless controversy that such a course involved was the impetus for ensuring that prior to an initial trial there was no such confusion.

22. Nowadays, a “Merck order” is made, almost always wholly or largely by consent, which identifies that at an initial trial the whole of the claim of the applicant or some other group representatives are determined, together with a list of questions identified in a schedule to the order. These questions reflect common issues or issues of commonality the answers to which, following judgment, can be the subject of s 33ZB orders (thus identifying the metes and bounds of the statutory estoppel).

23. Unfortunately, in this proceeding, the primary judge was provided with what was said to be an agreed statement of the common questions, but no order was made. Senior counsel for the respondents (the applicants below) started the hearing in July 2017 apparently on the basis of a perceived consensus as to the common questions, but was apparently disabused of his misapprehension over five months later when a document was provided by the appellants (SBM.020.002.0003) which stated that, as to the “self-styled…agreed statement of the common questions” filed on 12 July 2017, there:

    …is no agreement between the parties that the questions are common. There is also no agreement that the questions can be answered in a meaningful and sensible way.

24. Precisely why this occurred is difficult to discern. Although the appellants’ failure to speak out in a timely way about the lack of consensus is particularly troubling, both sides share some responsibility for an order not being made at the outset of the initial trial making it clear (either by way of agreement or determination) what precisely was being decided. But whatever else is unclear, this lack of clarity ought not to be a course repeated in any complex Pt IVA proceeding in the future.

    3.               KEY FINDINGS OF THE PRIMARY JUDGE

25. The summary below includes only those facts where it should be concluded from the primary judge’s reasons for judgment as a whole that the primary judge was satisfied about the fact to the requisite civil standard of proof. It includes findings which the primary judge made by accepting the evidence of an expert or experts and identifying that evidence. The summary below does not identify the expert who provided the opinion which supported the finding except where it is necessary to do so. The summary mainly consists of direct quotes from the primary judge’s reasons. Accordingly, first person references in the summary are to the primary judge. Further, to avoid confusion, the primary judge’s references to the respondents as quoted or referred to below have been amended to refer instead to the appellants.

    3.1             The representative respondents - overview

    3.1.1Mrs Gill

26. Mrs Gill was born in 1970: TJ [3885]. She has psoriasis, an autoimmune condition: TJ [3888].

27. After her second child Mrs Gill suffered a vaginal prolapse in 2004: TJ [3900]. She developed urge incontinence and pain with intercourse and constipation: TJ [3901]. Her symptoms increased. She needed to insert her fingers into her vagina and push her vaginal wall backwards to defecate. Her sexual relationship with her husband deteriorated significantly: TJ [3910].

28. Mrs Gill was implanted with a POP device, Prolift Total, in January 2007 when she was 36: TJ [3919]. Her post-surgical pain never resolved: TJ [3921]. It was becoming painful for her to defecate and she became ill in February 2007: TJ [3923]-[3925]. She had a post-surgical infection and was hospitalised: TJ [3928]. On release from hospital in March she was still in pain, very tired, and could not have sex: TJ [3931]. She did not improve and needed help with daily tasks: TJ [3935]. She continued to suffer pain which she said was of three types (a constant, aching pain in the region of her coccyx which she rated at 6 out of 10 in severity, sporadic severe pain akin to period pain with coughing or on sudden movements rated at 8 or 9 out of 10, and “terrible” pain on defecation, fluctuating in intensity but with a difficult bowel movement rating around 9 out of 10 in severity): TJ [3936]. She had non-menstrual vaginal bleeding: TJ [3937]. She spent a lot of time sleeping and just lying in bed as even sitting in a chair was a problem: TJ [3938]. Sex was impossible: TJ [3939].

29. By June 2007 she had mesh erosion into her vagina: TJ [3942]-[3943]. She had her first mesh excision surgery in September 2007: TJ [3949]. Her pain continued. She was diagnosed with depression in March 2008: TJ [3953]. She resumed sexual intercourse but had dyspareunia. By May 2008 she had another mesh erosion into the vagina: TJ [3955]. In June 2008 she had her second mesh excision surgery in which part of the mesh was removed to relieve her pain: TJ [3959]. Her symptoms improved: TJ [3965]-[3966]. She remained stable until mid-2013 apart from heavy period and associated treatment: TJ [3967]-[3970]. Her depression worsened after her husband had an accident in 2010: TJ [3972]-[3974].

30. In mid-2013 Mrs Gill could feel something sharp and lumpy in her vagina. Pain and bleeding with intercourse occurred. Bowel movements again became painful and she had some urge incontinence: TJ [3987]. She had her third mesh excision surgery in August 2013: TJ [3997]. Afterwards she continued to have pain including a new pain originating in her lower right pelvic area and travelling down the front of her right groin and leg: TJ [3999].

31. In December 2015 or January 2016 Mrs Gill’s prolapse recurred: TJ [4017]. Examination in July 2017 disclosed that the right Alcock canal (also known as the pudendal canal) was exquisitely tender and that residual mesh was palpable to a few millimetres above the canal and about one centimetre caudal from the ischial spine: TJ [4054]. An examination in January 2018 disclosed “tender +++on [right] anterior wall/apex where mesh fibres are exposed”: TJ [4060]. Mrs Gill continues to suffer serious and chronic pain, faecal urgency and flatal and faecal incontinence, aggravation of her depression and an anxiety disorder, and recurrent prolapse all of which the primary judge found was caused by the device with which she was implanted: TJ [4063], [5049]. Her revision surgeries were also caused by the device: TJ [4916]-[4918]. Sexual intercourse has ceased due to pain: TJ [4063].

    3.1.2Mrs Dawson

32. Mrs Dawson was born in 1959: TJ [4070]. She suffered from POP: TJ [4081]. She had prolapse repair surgery and a hysterectomy in 2001: TJ [4082]-[4083]. By 2003 she had a problem with painful sexual intercourse: TJ [4086]. She had surgery in 2004 for adhesions and cyst removal: TJ [4087]-[4089]. Post-surgery she and her husband resumed sexual intercourse on average once every one to two weeks: TJ [4091].

1. In 2008 she developed mild pain in her lower back, bottom and pelvis after prolonged sitting. By 2009 the pain had worsened. Her bowel function deteriorated. She needed to digitate and push her vagina back to defecate. She experienced urge incontinence: TJ [4092]. She had superficial dyspareunia. She had symptoms of recurrent prolapse: TJ [4094].

2. She was implanted with the POP device, Gynemesh PS, in May 2009 (when she was 50): TJ [4097]. A review in June 2009 indicated excellent results from the surgery: TJ [4103]. Shortly after, however, she began to experience terrible (10 out of 10) pain which she had never experienced before inside and across her bottom, as well as pain down her legs and inside her vagina. Her bowel problems returned. Sexual intercourse was painful. She could not tolerate sitting for any long period. Coping with the pain for the rest of her life felt unimaginable: TJ [4105]. She saw a number of doctors about the pain: TJ [4107], [4111]. She had a local steroid injection to deal with the pain in her sacro-coccygeal joint in July 2009: TJ [4114]. The injection did not work: TJ [4115]. In August 2009 examination of the coccyx externally caused “exquisite discomfort”: TJ [4117]. She continued to see doctors. Examination in September 2009 revealed a 1 x 6mm erosion in the mid anterior vaginal wall: TJ [4120]. Medications for neuropathic pain did not resolve the issue: TJ [4127].

3. In October 2009 Mrs Dawson had mesh excision surgery of an area of mesh erosion of 2mm x 1cm: TJ [4123]. Her bottom remained painful affecting her ability to sit: TJ [4125]. She continued to see doctors and take medication, but the pelvic pain was ongoing: TJ [4129]. In 2012 examination showed she had SUI, severe dyspareunia, detrusor instability (associated with urge incontinence), inability to defecate without digital support, and persistent leg and buttock pain: TJ [4131]. Medications were prescribed to re-oestroganise her vagina and reduce the detrusor instability: TJ [4132]. She obtained some relief: TJ [4133]. By March 2013 she still had apareunia, was now complaining of pain with a full rectum, continued to experience difficulty initiating and completing defecation, and her buttock pain had returned: TJ [4134]. In January 2014 she had her second mesh excision surgery: TJ [4141]. She experienced some improvement: TJ [4143]. Sexual intercourse remained impossible, however: TJ [4145]. Mesh erosion issues continued: TJ [4148]. In May 2015 she had her third mesh excision surgery: TJ [4151]. By July 2015 Mrs Dawson was again experiencing pain in her bottom and back passage: TJ [4156]. Further mesh exposure was discovered: TJ [4157]. The pain continued making it very difficult for her to sit: TJ [4161]. She had her fourth mesh excision surgery in October 2015: TJ [4164]. By her examination in March 2016 her pain was much worse, she had difficulty sitting and walking for long periods, and had to strain to defecate: TJ [4168]. In June 2016 she was examined by Professor Korda who “confirmed a narrowed introitus and a contracted, narrowed vagina with a fibrosis around the left anterior and left posterior portion of the vagina. Her vagina was rigid, not pliable, and only admitted one finger. A tender remnant of the mesh was palpable on both the anterior and posterior walls. The right ischiorectal fossa was tender and she indicated that this was the spot where she had to push in order to complete defaecation”: TJ [4170], [4172]. By March 2017 she was in a great deal of pain. She said she was “hardly able to walk or sit and “had a bulge coming outside of [her] bottom”, which she sometimes had to push in order to defecate and which “felt like touching a balloon”: TJ [4192]. She had surgery to divide her vaginal scar tissue which was caused by the initial mesh insertion and subsequent mesh erosion revision surgeries: TJ [4191]-[4193]. The relief given by this surgery was short-lived: TJ [4216].

4. Mrs Dawson had not been able to have successful intercourse since the implant surgery: TJ [4208]. Since the operation in 2009 she had had intercourse with her husband five, possibly six times. She said that it felt like someone was cutting her inside and she would scream with pain. When Mr and Mrs Dawson attempted to have sexual intercourse on about 18 September 2017 she experienced knife-like pain pushing up and down inside her vagina and pain radiating down the right leg and a burning and pulling sensation under her right buttock. The next day she spent a great deal of time on the toilet with increasing rectal mucus. As a result of the pain she vowed never to have intercourse with her husband again: TJ [4221]. She has continuing pain in the nature of a burning sensation in the top of her legs and underneath her buttocks, a needle-like sensation inside her bottom, and a burning pain in and around her vagina: TJ [4216]. Her bottom and pelvis continue to ache after a day’s work. She reduced her work to four days a week and did not know how she would manage work in the future: TJ [4217]. She was depressed at the significant changes in her life since the implant surgery: TJ [4227]. Each of her revision surgeries was caused by the device with which she was implanted: TJ [5336]-[5337]. The primary judge also found that the device caused Mrs Dawson’s pudendal neuropathy, chronic pain syndrome, coccygeal pain, chronic and severe pelvic pain, and apareunia, and also aggravated her pre-existing defecation disorder: TJ [5354]-[5461].

   3.1.3Mrs Sanders

5. Mrs Sanders was born in 1946: TJ [4228]. She was implanted with an SUI device, TVT, on 12 March 2001 (when she was 54) to treat her SUI: TJ [4235]-[4236]. The surgery effectively treated her SUI and she recovered well and remained well until 2007: TJ [4237]-[4239]. In 2007 she experienced discomfort urinating: TJ [4240]. In 2008 she found sexual intercourse painful. So did her husband who could feel something sharp in her vagina: TJ [4241]. She also developed constant groin pain: TJ [4242]. In 2008 to 2009 she experienced a sharp pain in her vagina which could radiate down her legs which adversely affected her quality of life: TJ [4243]. In 2010 her urinary symptoms increased and she had to regularly take antibiotics. She had also started to take regular painkillers: TJ [4244]-[4246]. The vaginal pain caused her to see a doctor in January 2011 and mesh exposure in the vagina was discovered. By this time she felt that she could not cope with the pain and was relieved to be told she needed to have the mesh excised: TJ [4247]-[4259]. She had mesh excision surgery on 8 August 2011: TJ [4263]. Only part of the mesh could be removed. She was told she might need more surgery: TJ [4268].

6. After the mesh excision surgery, her symptoms of painful, difficult and frequent urination and leakage continued: TJ [4270]. These symptoms got worse and the dull pain and sharp pain returned: TJ [4272]-[4273]. She continued to be prescribed antibiotics: TJ [4274]-[4278]. She developed hip pain for which she had hip replacement surgery in 2016: TJ [4327]. The hip surgery resolved her hip pain: TJ [4330]. She also developed shoulder pain due to previous shoulder injuries: TJ [4333]-[4335]. Mrs Sanders continues to experience severe pain in her groin and vagina and throughout her pelvis: TJ [4345]. She continues to take an antibiotic tablet every day, as well as two paracetamol (Panadol) and two ibuprofen (Advil) tablets every night: TJ [4344]. She was and continues to be troubled by incontinence and has no bladder control: TJ [4346]. She and her husband have not had sex since 2008 because intercourse is painful for her: TJ [4350]. She has been both anxious and depressed and grieves for the life she once enjoyed: TJ [4354]. Her prognosis is uncertain as she has incipient vaginal mesh erosion: TJ [4356]. The device caused her revision surgeries and scarring of her vagina. It also caused her adjustment disorder with mixed anxiety and depressed mood: TJ [5606]. The device caused her overactive bladder symptoms of urgency and frequency, her dyspareunia, apareunia, and chronic pelvic pain: TJ [5676].

   3.2             The relevant conditions

   3.2.1Stress urinary incontinence

7. SUI is the involuntary leakage of urine during activities such as coughing, sneezing, lifting, laughing or exercising: TJ [43]. The condition affects the sufferer’s quality of life but is never life-threatening: TJ [44]. Treatment is always elective: TJ [49].

8. Non-surgical treatments for SUI, which are not always successful, include general lifestyle changes, pelvic floor exercises, and the use of continence devices such as a pessary: TJ [51].

9. Traditional surgical treatments for SUI include:

   (1)Burch colposuspension which is used to correct urodynamic stress incontinence;

   (2)needle suspension procedures;

   (3)sling procedures using either the patient’s own connective tissue (fascia) (known as autologous slings) or foreign graft material; and

   (4)use of urethral bulking agents, involving injection of a variety of different substances around the bladder neck and into the urethral sphincter, to thicken the urethral wall so as to provide greater urethral resistance during increases in abdominal pressure: TJ [52].

10. All of the surgical treatment options for SUI are attended by risks, although the nature and extent of the risks vary from procedure to procedure: TJ [60].

11. It is common ground that, before deciding on the most appropriate course or method of treatment, a treating surgeon would consult with the patient, obtain her medical and surgical history, and assess her clinical needs: TJ [62].

    3.2.2Pelvic organ prolapse

12. POP is the downward displacement of a pelvic organ, which, in the case of a woman means the uterus, the different vaginal compartments or neighbouring organs such as the bladder, rectum or bowel: TJ [107]. In a prolapse of the anterior compartment of the vagina, either the bladder or uterus (or, in the absence of a uterus the vaginal vault) bulges into the front wall of the vagina. This is referred to as a cystocoele or urethrocoele. In a posterior compartment prolapse, the rectum (the lower part of the large bowel) or part of the small intestine bulges into the upper part of the back wall of the vagina. The former is known as a rectocoele and the latter as an enterocoele: TJ [109].

13. Prolapse can affect sexual function and cause dyspareunia, inability to penetrate the vagina due to obstruction, vaginal laxity, and loss of libido: TJ [116]. It is not a life-threatening condition but can drastically affect a woman’s quality of life: TJ [117].

14. Non-surgical treatments for POP include lifestyle interventions, pessaries and pelvic physiotherapy, as well as the use of vaginal oestrogen in post-menopausal women, avoidance of constipation and chronic cough, and training the pelvic floor muscles: TJ [119].

15. Traditional surgical treatments for POP include reconstructive surgery and vaginal closure or removal surgery (also known as obliterative procedures): TJ [120]. Surgery which uses the patient’s own tissue is commonly referred to as “native tissue repair”: TJ [127].

16. All surgical treatment options for POP are associated with risks, although the evidence indicates that complications from native tissue repair are generally short-lived and treatable: TJ [130].

    3.3             The devices

17. The first appellant (Ethicon Sàrl, a Swiss corporation) made all of the devices but for Gynemesh PS which was made by the second appellant (Ethicon Inc., an American corporation): TJ [8]. The first and second appellants supplied the devices to the third appellant, a related Australian company, Johnson & Johnson Medical Pty Limited (JJM). JJM promoted and supplied the devices to Australian hospitals and doctors: TJ [9].

18. According to statements made on the ARTG, the purpose of each of the SUI devices was to treat SUI and female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The purpose of the POP devices was to provide “tissue reinforcement and long-lasting stabilisation of fascial structures of the pelvic floor in vaginal wall prolapses”: TJ [11].

19. The devices are all made using a knitted polypropylene, a thermoplastic polymer: TJ [1].

20. Prolene, a polypropylene resin, has been widely used in sutures which the primary judge accepted to be “functional, safe and effective”: TJ [40].

21. In the early 1970s, Ethicon developed Prolene sutures into a knitted flat mesh and, in 1997, into a three-dimensional form known as the “Prolene Hernia System”. The first of the devices was cleared for sale on the back of the regulatory approval of Prolene sutures and, in part, because of its supposed “substantial equivalence” to the Prolene Hernia System, despite the differences in design, use, anatomy, and site-specific considerations: TJ [42].

    3.3.1The SUI devices

22. TVT gained regulatory approval in Europe in 1997 and was cleared by the United States Food and Drug Administration (the FDA) on 28 January 1998. On 21 July 1998 it was approved by the TGA as a class IIB device for supply in Australia. It was first sold here in October 1999: TJ [85].

23. TVT-O received regulatory approval in Europe and the United States in December 2003. It was first supplied in Australia in March 2004: TJ [92]. It remains on the market in Australia.

24. TVT Secur was cleared for sale in the United States on 28 November 2005 and in Europe on 4 May 2006. It was launched in Australia in April 2007, but sales were halted in March 2008 and its registration was cancelled by the TGA in June 2012: TJ [100].

25. TVT Exact was released to the Australian market in July 2010: TJ [103]. It remains on the market in Australia.

26. TVT Abbrevo gained regulatory clearance in the United States on 1 July 2010, and in Europe in September 2010. It was first supplied in Australia in October 2010: TJ [104]. It remains on the market in Australia.

    3.3.2The POP devices

27. Gynemesh PS received regulatory clearance in the United States on 8 January 2002, in Europe on 20 March 2003, and in Australia on 26 May 2003. It was first supplied to the Australian market in July 2003: TJ [137]. On 16 March 2013 the indication for use of Gynemesh PS was narrowed to “a bridging material for apical vaginal and uterine prolapse where surgical treatment (laparotomy or laparoscopic approach) is warranted”. In other words, it was no longer indicated for transvaginal use but only for prolapse repair using an abdominal approach: TJ [140]. On 17 August 2017, JJM notified the TGA that it would be discontinuing Gynemesh effective immediately and on 22 August 2017 the TGA cancelled its entry on the ARTG: TJ [141].

28. Prolift was cleared for sale in Europe on 2 March 2005, around the same time in the United States, and in Australia on 30 March 2005. It was supplied in Australia in and from June 2005 until 15 August 2012. Registration was cancelled by the TGA on 21 April 2015: TJ [142].

29. Prolift+M obtained regulatory clearance in Europe on 18 March 2008, in the United States on 15 May 2008, and was first supplied in Australia in December 2009. Registration was cancelled by the TGA on 21 April 2015: TJ [162] and [168].

30. Prosima was first supplied in Australia in April 2010. It was not supplied after 15 August 2012 and, along with the other mesh kits (that is, the POP devices), the TGA cancelled its registration on 21 April 2015: TJ [168].

    3.4             Risks associated with mesh implantation

31. As noted, the appellants ultimately conceded that all of the pleaded complications could be caused by implantation of the devices, they knew of the potential to cause each of the pleaded complications from the time of first supply of a device, and each of the pleaded complications was clinically significant: TJ [191].

32. Mesh can extrude or “erode” into the bladder, urethra and vaginal canal: TJ [214]. This can occur immediately, soon after surgery or years later: TJ [216]. Exposure may have serious consequences. Since the vagina is never free of organisms (bacteria), once the mesh is exposed or erodes, the vagina “inevitably” becomes infected and the nidus (focus) of the infection is virtually impossible to treat because antibiotics have great difficulty penetrating through the mesh. Chronic inflammation is the result of exposed mesh and exposure may also aggravate chronic inflammation, particularly when bacteria colonise the exposed mesh: TJ [223].

33. Pain can be both more severe and more enduring after repair with procedures involving the use of mesh than after procedures which do not: TJ [228]. In contrast with native tissue repair, pain after mesh repair can arise well after surgery, sometimes years later: TJ [232]. All the devices may cause pain, including chronic pain, and there are various mechanisms that may be responsible for it: TJ [787(6)].

34. The mesh is difficult, if not impossible, to remove entirely as it is or becomes integrated in the connective tissue, and removal surgery may not relieve pain: TJ [246].

35. All meshes used in the devices must be inserted without tension. However, achieving the requisite amount of tension is not easy and even the most experienced surgeons can occasionally fail. If the mesh tension is too tight each complication is more likely to occur: TJ [263] and [264].

36. In the implantation of the SUI devices, the retropubic space is vulnerable to damage. Major vascular injury can occur and is potentially fatal. Haemorrhage can be “dramatic” and is difficult to manage: TJ [258]. Bladder perforation is a well-recognised risk of the retropubic procedures: TJ [259]. Obstructive voiding symptoms (including, rarely, retention) can also occur, possibly in association with a “higher than desirable tension”: TJ [260].

37. The implantation of the POP devices may involve injuries to the bladder, urethra, rectum and pelvic nerves: TJ [262].

38. There is no good evidence that the surgical learning curve accounts to any significant extent for “the inherent mesh complications”: TJ [270].

39. Transvaginal mesh kits like Prolift were “notoriously difficult for a surgeon to get right every time” even for a surgeon skilled in prolapse surgery: TJ [272].

40. Tension was the critical factor in the success of Prolift and if implants were put in too tightly patients often experienced pain and dyspareunia: TJ [272]. However, mesh may become too tight because of variations in the patient’s response to it: TJ [273]. The Prolift technique involved “a blind approach”, which made it difficult to determine whether or not there would be sufficient or excessive tension after the operation was complete: TJ [275].

41. The development of a haematoma after mesh implantation can become a far greater problem than a haematoma after native tissue repair because of healing difficulties in the presence of mesh: TJ [274].

42. Immunocompromised patients were at particular risk of harm from the chronic inflammatory response and the appellants either knew or ought to have known that was so at least from the time the very first device was launched. The proposition that this was not a matter of clinical significance must be rejected: TJ [281].

43. The immune response to any foreign material has been described as “complex, dynamic, and patient specific”. It was uncontroversial that the individual host response is unpredictable. The evidence established that a heightened chronic inflammatory response to implantation with non-absorbable polypropylene may occur in patients who have autoimmune disorders or have been using immune-suppressants for a long time and that the appellants knew this at the time the first of the devices was released to the market: TJ [282].

    3.5             Biocompatibility

44. The biomechanical properties of the mesh and mesh stiffness in particular are amongst the main reasons for the post-surgery complications of mesh implantation: TJ [299].

45. When a biomaterial such as polypropylene is implanted in the body, it provokes an inflammatory response in the host tissue. This inflammatory response is known as the “foreign body reaction” or “foreign body response”. It causes a layer of scar tissue to form around the implant or the pores of the implant, which is weaker and more rigid than normal healthy tissue: TJ [341]. In a foreign body reaction the inflammatory cells may persist for years, even decades, becoming “a chronic inflammatory response”: TJ [345].

1. As to the want of party point, according to the appellants at AS [114]:

   …the injunction was ordered in the absence of information about the position of the TGA. The TGA is the regulatory authority with responsibility for administering the TG Act and, as such, is charged by Parliament to oversee and manage a national regime “relating to the quality, safety, efficacy and timely availability of therapeutic goods” that are used in Australia (s 4(1)(a)). It follows that the attitude of the TGA, having regard to its expertise and responsibility, is necessarily a relevant consideration in determining the necessity and utility of a proposed warning, as well as the contents of that warning. The approach of the primary judge, however, was to accept that the TGA may be better placed to supervise the contents of the warnings (see TJ, [5816]), but ultimately to ignore the basis of that finding (that it is because of the TGA’s expertise and responsibility that they are better placed) and the logical consequence of that finding (that it is appropriate to hear from the TGA before warnings are to be mandated) by proceeding to make the Injunction.

   14.2           Discussion

2. In order to deal with these two points, it is necessary to pay regard to the nature of the power that was exercised by the primary judge in granting the Injunction. Section 232 of the ACL provides (as did s 80 of the TPA) that a statutory injunction may be granted whether or not it appears to the Court that the person enjoined intends to engage again, or to continue to engage, in contravening conduct: see ss 232(1) and (4) of the ACL and ss 80(1) and (4) of the TPA.

3. The inaptness of uncritically relying upon principles attending the grant of final injunctive relief in equity is evident from the Full Court’s reasons in ICI Australia Operations Pty Ltd v Trade Practices Commission [1992] FCA 707; (1992) 38 FCR 248 per Lockhart, Gummow and French JJ. As Lockhart J (with whom French J generally agreed) explained at 256, the statutory power is novel in that if the condition precedent to the exercise of the power to grant injunctive relief was satisfied, the Court would be given “the widest possible injunctive powers, devoid of traditional constraints, though the power must be exercised judicially and sensibly”. His Honour continued at 256-257:

   Injunctions are traditionally employed to restrain repetition of conduct. A statutory provision that enables an injunction to be granted to prevent the commission of conduct that has never been done before and is not likely to be done again is a statutory enlargement of traditional equitable principles. But this is because traditional doctrine surrounding the grant of injunctive relief was developed primarily for the protection of private proprietary rights. Public interest injunctions are different... These are legislative enactments of matters vital to the presence of free competition and enterprise and a just society. This does not mean that the traditional equitable doctrines are irrelevant. For example, it must be relevant to consider questions of repetition of conduct or whether it has ever occurred before or whether imminent substantial damage is likely: but the absence of any one or more of these elements is not fatal to the grant of an injunction...

4. Further, the width of the power was noted by Gummow J at 267:

   [The relevant statutory provisions] provide that the power of the court to grant prohibitory and mandatory injunctions may be exercised in circumstances where, under the general law, there ordinarily would be a good answer to an application for injunctive relief. There may have been no previous infraction of the law, there may be no threat of any infraction or further infraction of the law, and there may be no imminent danger of substantial damage by the act or omission of the defendant.

5. Although the discretion must be exercised judicially and for a proper purpose, it is clear that such a proper purpose may extend to marking the court’s disapproval of the conduct of the contravenor: see Trade Practices Commission v Mobil Oil Australia Ltd [1984] FCA 403; (1984) 4 FCR 296 at 300 per Toohey J and Australian Competition and Consumer Commission v 4WD Systems Pty Ltd [2003] FCA 850; (2003) 200 ALR 491 at [212] per Selway J.

6. Both in writing and at the oral hearing of the appeal, the submissions made by the appellants as to utility tended to range more broadly than the relevant ground of appeal as to a want of evidence as to knowledge of surgeons or others at particular dates. For completeness it is necessary to deal with these submissions.

7. The wide power to grant relief below was enlivened by the findings that the appellants had contravened chapters 2 and 3 of the ACL. The assertion of the appellants that the primary judge erred because there was no evidence that the proposed warnings “could and would be effective” sits unhappily with reality of the width of the statutory power being exercised. To accept, like on an application for final injunctive relief in equity, that the moving party must demonstrate a particular level of utility in granting relief, would have the effect of attenuating the width of the power. More particularly, the supposed added hurdle of a demonstrated level of practical utility or effectiveness is in tension with the express terms of s 232(4)(a) and (c) which provide that an injunction can be granted whether or not it appears that the person intends to engage in the contravening conduct again and whether or not there is an imminent danger of substantial damage. This is not to say effectiveness or utility were not proper discretionary considerations in determining whether relief should be granted – they clearly were. But an absence of particular evidence that the proposed warnings gave a level of satisfaction of “effectiveness” or of knowledge of particular matters at particular dates was not in itself fatal to relief being granted.

8. What must be recalled is that prior to the Injunction being made, the parties had an opportunity of putting on any evidence they wished to adduce as to effectiveness and her Honour obviously considered the relief she granted to be utile. In this regard, the primary judge received and considered evidence after the initial trial as to new, amended IFUs which were issued for the relevant devices: RJ [31]. After having found that contrary to applicable statutory norms information, including information “which ultimately proved to be uncontroversial” had not been disclosed (RJ [29]), the new, amended IFUs were found to contain the vice of not “go[ing] far enough” in not disclosing “all of the previously undisclosed complications”: RJ [31] and [43]. The primary judge emphasised that injunctive relief for a contravention of the TPA or the ACL serves a public purpose, including “the prevention and deterrence of undesirable, indeed, unlawful trade practices”: RJ [42]. She further considered and dismissed the submission that the Injunction would interfere with the work of the TGA: RJ [44].

9. Specifically, contrary to the appellants’ suggestion that the Injunction was issued by the primary judge based on her Honour’s finding of a failure to warn as at 4 July 2017 (AS [112]), as noted above, the Injunction was issued after the appellants were given the opportunity of adducing further evidence as to the content of the IFUs which were proposed to accompany those of the devices which remained on the market in Australia as at December 2019, and those IFUs were found to be deficient: RJ [30]-[31]. Indeed, the appellants had two attempts at resisting the relief and there was no fetter on them adducing such evidence as they wished to rely upon going to the exercise of her Honour’s broad discretion. The primary judge was satisfied on the basis of all the evidence adduced and her findings as to contravening conduct that the Injunction served a proper purpose, was in the public interest, and was an appropriate remedial response to the contravening conduct. No error in granting the Injunction because of a want of particular evidence or as to an absence of utility is established.

10. It should be noted further that the suggestion (at AS [113]), which again went beyond the grounds of appeal, that the mandated warning ought not to include the complications associated with use of the devices in women with autoimmune conditions must be rejected. This is because, as the respondents correctly submitted, this matter was put in issue prior to judgment and the appellants accepted that such patients are at heightened risk.

11. It was the want of party point that received most focus at the hearing of the appeal. The appellants put this in writing as a contention that the Injunction could not issue absent evidence from the TGA (AS [114]), but the ground of appeal was somewhat different: it was contended the error was that the Injunction “was ordered in the absence of hearing from the TGA” (emphasis added). The only way of the TGA being heard was if it was made a party or allowed to intervene. No application was made for intervention (nor was it suggested) and the notion it was a necessary party does not withstand analysis. Section 232(2) of the ACL expressly provides that an injunction may be obtained on application by a regulator “or any other person”. If the argument that the Court was required to hear from the TGA was correct, it would seem the relevant regulator of activity governed by norms found to be breached would need to be heard before relief by way of a statutory injunction regulating the conduct of a contravenor could be made. That proposition only need be stated to be rejected in circumstances where persons other than the regulator are expressly given standing to seek relief in non-regulatory proceedings. In some cases it may be appropriate to hear from a regulator as an intervener, but it is a different matter entirely to accept that the discretion to grant statutory relief by way of an injunction would miscarry if such a course was not taken.

12. Assuming, despite the way ground 17 was expressed, the argument encompassed an allegation of error relating to a want of evidence from the TGA, the argument still has fundamental difficulties. As noted above, given each party was able to adduce evidence from the TGA, why should the failure of the moving party to adduce evidence from persons within the TGA be fatal in circumstances where the primary judge was affirmatively satisfied that the Injunction would not interfere with the work of the TGA? The appellants did not explain why it was the case that the Injunction could not be granted unless the moving party adduced evidence that the TGA was somehow content with the proposed order.

13. The appellants submitted that the attitude of the TGA, having regard to its expertise and responsibility, “is necessarily a relevant consideration in determining the necessity and utility of a proposed warning, as well as the contents of that warning”: AS [114]. But as explained above, her Honour did consider the position of the TGA. As the primary judge explained (TJ [5815]-[5816]):

    I maintain what I said [in an earlier interlocutory judgment]:

    The contentions that the job of regulating the sale of the products should be left to the regulator and that any such order could not be made without adding the regulator as a party are spurious. The TGA does not have an exclusive role in protecting the safety of consumers. As Selway J observed in Australian Competition and Consumer Commission v 4WD Systems Pty Ltd [2003] FCA 850; (2003) 200 ALR 491; (2003) 59 IPR 435 at [217], “[t]he purpose of an appropriately drafted injunction may be merely to reinforce to the market place that the restrained behaviour is unacceptable”…

    [T]he TGA might well be better placed to supervise the content of warnings, but the evidence indicates that it did nothing about them until after Ethicon stopped manufacturing and selling the POP devices and TVT Secur was no longer sold in Australia. Not even the FDA alerts were sufficient to prompt an investigation before then. Besides, I have found that not even the most recent IFUs are adequate to protect women from the risks to which the SUI devices still on the ARTG expose them.

14. Although it again travelled beyond the grounds of appeal, for completeness, reference should also be made to the oral submission made by the appellants on appeal at T99.15-19:

    Our point simply is that her Honour has given plainly insufficient weight to the fact that these orders have a judge who is not, with respect, a regulator of the kind that the Parliament intends, to lay down a regime which, presumably, could only be adjusted by indefinite possibilities of liberty to apply, which in itself is a mark of an invidious exercise of a discretion.

15. This submission ought to be rejected. Parliament provided the remedial response of a statutory injunction for the public purpose of preventing and deterring contravening conduct in trade and commerce. If there is a need for adjustment of the Injunction because of any regulatory imperatives or other change of circumstances (including that the Injunction became, for some reason, unworkable), the Parliament also provided a mechanism, by s 235 of the ACL, by which a private party or a regulator can seek to vary or discharge an injunction granted under s 232.

16. No error has been demonstrated in the exercise of the primary judge’s discretion to order the Injunction.

    15.             CONCLUSION

17. For the reasons given the appeal should be dismissed save and except for the requirement to provide a proper answer to common question 22. The parties will be given the opportunity to make further submissions in that regard.

I certify that the preceding nine hundred and twenty-eight (928) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justices Jagot, Murphy and Lee.

Associate:

Dated:       5 March 2021

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

2Pursuant 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.

3Pursuant 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.

Schedule B

Product name	ARTG no.
Gynecare Tension-free Vaginal Tape System (TVT)	supplied under 99193
Gynecare TVT Obturator System	supplied under 99193
Gynecare TVT Exact Continence System	supplied under 99193
Gynecare TVT Abbrevo Continence System	supplied under 99193