Gill v Ethicon Sàrl (No 5)
[2019] FCA 1905
•21 November 2019
FEDERAL COURT OF AUSTRALIA
Gill v Ethicon Sàrl (No 5) [2019] FCA 1905
File number: NSD 1590 of 2012 Judge: KATZMANN J Date of judgment: 21 November 2019 Catchwords: CONSUMER LAW — representative action — nine urogynaecological medical devices made from polypropylene intended for permanent implantation in the female pelvis — where manufactured by foreign corporations and supplied by local corporation in the same corporate group — where neither foreign corporation had a place of business in Australia but impugned conduct took place in Australia, whether foreign corporations can be found liable for contraventions of the Trade Practices Act 1974 (Cth) and the Australian Consumer Law — whether conduct of foreign corporations was “in trade or commerce” — whether foreign corporations were carrying on business in Australia
CONSUMER LAW — defective goods — whether at the time medical devices were supplied by the manufacturer they had a “defect” within the meaning of s 75AC of the Trade Practices Act 1974 (Cth) or 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” — relevant circumstances — meaning of “the time they were supplied by the manufacturer” — “learned intermediary” doctrine — significance of supply of devices through “learned intermediaries” (here, surgeons or physicians) — where respondents failed to warn doctors or patients of certain risks or potential complications of which they were aware — extent of obligation to warn — where some warnings were misleading — whether manufacturers excused from liability with respect to risks or potential complications that should be known to medical practitioners or which they are able to discover for themselves — significance of CE marking — relevance of state of scientific knowledge at time of supply — whether state of scientific or technical knowledge at time of supply not such as to enable defects to be discovered — whether devices unfit for the purpose for which they were supplied or of unmerchantable quality — whether each applicant suffered injuries because of defect in device she received or by reason that device not reasonably fit for the purpose for which it was supplied — proper approach to determination of causation in defective goods claim — causal connection required by s 75AD(c)
CONSUMER LAW — misleading or deceptive conduct — medical devices — whether product information published by one or other respondent misleading or deceptive or likely to mislead or deceive consumers of medical devices about the safety and/or efficacy of the devices — whether loss or damage by conduct
NEGLIGENCE — product liability — medical devices — duty of care — content of duty owed by foreign manufacturers and local supplier to end users of medical devices — where known risk of significant injury, whether respondents breached their duties of care by failing to adequately evaluate the safety of the devices before and/or after they were released to market — extent of obligation to warn where products supplied through “learned intermediaries” — whether product information insufficient to inform consumers of potential risks
EVIDENCE — where Civil Liability Act 2002 (WA) renders inadmissible evidence of injured person as to what she would have done if tortfeasor had not been at fault, whether evidence of this nature nonetheless admissible in a court exercising federal jurisdiction — whether s 5C(3) of the Civil Liability Act picked up by Judiciary Act 1903 (Cth)
PRACTICE AND PROCEDURE — representative proceeding — consumer class action — where respondents’ conduct with respect to multiple products is impugned — whether applicants were capable of representing group members who had been supplied with different products
LIMITATION OF ACTIONS — Trade Practices Act 1974 (Cth), ss 74J, 75AO — burden of proof — times that causes of action arose — whether certain actions statute-barred — effect of long-stop provisions in ss 74J(3) and 75AO(2) — whether Limitation Act 1935 (WA) or Limitation Act 2005 (WA) applied to claim by applicant implanted with device before commencement of 2005 Act — whether common law actions statute-barred — whether leave should be granted to extend the periods of limitation
PRACTICE AND PROCEDURE — whether respondent required to plead that action statute-barred under ss 74J(3) and 75AO(2) — whether provisions were in fact pleaded when only raised against group members and not against applicant
DAMAGES — calculations of life expectancy — discount for vicissitudes — whether discounts for the ordinary vicissitudes of life should be made to damages for future out-of-pocket expenses or care/services — whether s 5D of the Civil Liability Act 2002 (WA) and s 52 of Wrongs Act1958 (Vic) disturb principles in Watts v Rake (1960) 108 CLR 158 and Purkess v Crittenden (1965) 114 CLR 164 — whether under Trade Practices Act 1974 (Cth) and Wrongs Act 1958 (Vic) a 5% multiplier or discount rate applies to future out-of-pocket expenses and care/services or only to future economic loss — whether future services should be compensated at commercial rates
OTHER RELIEF — whether injunctive relief appropriate or of any utility — whether declaratory relief should be granted
Legislation: Acts Interpretation Act 1901 (Cth) ss 13, 18A
Australian Consumer Law (Sch 2 of the Competition and Consumer Act 2010 (Cth)) ss 3, 7, 18, 55, 137C, 138, 142, 143, 232
Civil Aviation (Carriers’ Liability) Act 1959 (Cth) s 34
Competition and Consumer Act 2010 (Cth) ss 4B, 5
Competition and Consumer Amendment (Competition Policy Review) Act 2017 (Cth) Sch 14 Pt 1
Evidence Act 1995 (Cth) ss 56, 60
Federal Court of Australia Act 1976 (Cth) ss 33A, 33C, 33D, 37M, Pt IVA
Judiciary Act 1903 (Cth) s 79
Motor Accidents Act 1988 (NSW) s 72(2)
Therapeutic Goods Act 1989 (Cth) ss 3, 41BD, 41BE, 41BG, 41CA, 41FC, 41FD, 41FH, 41FN, 41FO, 41GK, Pt 4–11 Div 3
Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth)
Trade Practices Act 1974 (Cth) ss 4B, 4, 5, 52, 74A, 74B, 74D, 74J, 75AA, 75AC, 75AD, 75AK, 75AR, 75AO, 82, 87F, 87G, 87H, 87Y, 87Z
Trade Practices Amendment Act 1978 (Cth)
Trade Practices Amendment Act (No 1) 2001 (Cth), Sch 1 cl 21(2)
Trade Practices Amendment (Australian Consumer Law) Act (No. 2) 2010 (Cth) Item 6 Sch 7
Trade Practices Amendment (Personal Injuries and Death) Act 2006 (Cth)
Trade Practices Amendment (Personal Injuries and Death) Act 2004 (No 2) (Cth) ss 74J, 75AO, Sch 1 cl 11
Trade Practices Revision Act 1986 (Cth) s 8
Veterans’ Entitlements Act 1986 (Cth) s 70
Federal Court Rules 2011 (Cth) rr 16.08, 16.42, 23.11, 23.13
Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) regs 1.6, 5.3, 5.6, 5.7, 10.4, Sch 1, Sch 2
Civil Law (Wrongs) Act 2002 (ACT) s 43(2)
Civil Liability Act 2002 (NSW) ss 5B, 5C, 5D, 5E
Civil Liability Act 2004 (Qld) s 9(2)
Civil Liability Act 1936 (SA) s 32(2)
Civil Liability Act 2002 (Tas) s 11(2)
Civil Liability Act 2002 (WA) ss 5B, 5C, 5D, 14
Limitation Act 1969 (NSW) Pt 2 Div 6, Pt 3 Div 4
Limitation Act 1935 (WA) s 38
Limitation Act 2005 (WA) ss 4, 6, 14, 39, 44, 55, 79
Limitations of Actions Act 1936 (SA) s 36(1)
Limitation of Actions Act 1958 (Vic) s 5
Limitation Legislation Amendment and Repeal Act 2005 (WA) s 4
Supreme Court Act 1935 (WA) s 32(2)
Supreme Court Act 1986 (Vic) Pt 4A
Wrongs Act1958 (Vic) ss 28B, 28F, 28G, 28H, 28HAAB, 28I, 28IA, 28LACA, 28LE, 28LF, 48, 49, 51, 52
Wrongs Amendment Act 2015 (Vic) s 6
Wrongs and Other Acts (Law of Negligence) Act 2003 (Vic)
Consumer Protection Act 1987 (UK) ss 2(1), 3(1), 4(1)(e), 11A
Limitation Act 1980 (UK) ss 11, 14
Federal Food, Drug, and Cosmetic Act (Title 21 of the US Code) §§ 510(k), 522
European Council Directive 85/374/EEC of 25 July 1985
European Council Directive 93/42/EEC of 14 June 1993
European Council Directive 2007/47/EC of 5 September 2007
Explanatory Memorandum, Federal Court of Australia Amendment Bill 1991 (Cth)
Explanatory Memorandum, Limitation Bill 2005 (WA)
Explanatory Memorandum, Therapeutic Goods Amendment (Medical Devices) Bill 2002
Explanatory Memorandum, Trade Practices Amendment Bill 1992 (Cth)
Explanatory Memorandum, Trade Practices Amendment (Australian Consumer Law) Bill (No 2) 2010 (Cth)
Explanatory Memorandum, Trade Practices Amendment (Personal Injuries and Death) Bill (No. 2) 2004
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Dates of hearing: 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
1‑22 February 2018
Date of last submissions: 15 March 2019 Registry: New South Wales Division: General Division National Practice Area: Commercial and Corporations Sub-area: Regulator and Consumer Protection Category: Catchwords Number of paragraphs: 5,827 Counsel for the Applicants: Mr AJL Bannon SC
Dr DE Graham SC
Mr A Naylor
Ms J Taylor
Mr C Colquhoun
Ms Z Hillman
Solicitor for the Applicants: Shine Lawyers Counsel for the Respondents: Mr SG Finch SC
Ms KC Morgan SC
Ms CO Gleeson
Mr DTW Wong
Solicitor for the Respondents: Clayton Utz
ORDERS
NSD 1590 of 2012 BETWEEN: KATHRYN GILL
First Applicant
DIANE DAWSON
Second Applicant
ANN SANDERS
Third Applicant
AND: ETHICON SÀRL
First Respondent
ETHICON INC.
Second Respondent
JOHNSON & JOHNSON MEDICAL PTY LTD (ACN 000 160 403)
Third Respondent
JUDGE:
KATZMANN J
DATE OF ORDER:
21 november 2019
THE COURT ORDERS THAT:
1.By 20 December 2019, each applicant is to notify the respondents and the Court of her election as to whether she will accept an award of damages under the relevant provisions of the Trade Practices Act 1974 (Cth) or at common law, as modified by the statutory scheme, if any, that operates in the State in which she lives.
2.By 14 February 2020, the parties bring in short minutes giving effect to these reasons.
3.In the event that the parties are unable to agree on the form of orders or all of the orders, including the form of the common questions and the answers to them for the purposes of s 33ZB of the Federal Court of Australia Act 1976 (Cth), a timetable for the filing and exchange of submissions be forwarded to chambers by 17 January 2020, with a view to a hearing in the week commencing 10 February 2020.
4.Liberty to apply be granted on two (2) days’ notice.
Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.
REASONS FOR JUDGMENT
Table of contents
PART I: INTRODUCTION
[1]
PART II: OVERVIEW OF THE PROCEEDING
[13]
The applicants’ claims
[13]
The history of the proceeding
[18]
The evidence
[21]
The conduct of the trial
[35]
PART III: THE HISTORY AND DEVELOPMENT OF THE ETHICON DEVICES
[38]
The use of synthetic mesh and polypropylene in surgery
[39]
Stress urinary incontinence and its treatments
[43]
Traditional treatments for stress urinary incontinence
[50]
The development of midurethral synthetic slings
[63]
The SUI devices
[71]
The mesh used in the SUI devices
[73]
TVT
[80]
TVT-O
[89]
TVT Secur
[93]
TVT Exact
[102]
TVT Abbrevo
[104]
Pelvic organ prolapse and its treatments
[107]
Traditional treatments for pelvic organ prolapse
[118]
The POP devices
[131]
The meshes used in the POP devices
[134]
Gynemesh PS
[137]
Prolift
[142]
Prolift+M
[162]
Prosima
[168]
PART IV: THE RISKS POSED BY THE USE OF THE ETHICON DEVICES
[183]
The pleaded complications
[184]
The nature of the pleaded complications and the circumstances in which they can arise
[198]
Complications directly associated with the use of mesh
[213]
Erosion
[214]
Pain
[227]
Reoperation or revision surgery
[244]
Risks attributable to the recommended techniques for implantation
[258]
The significance of surgical training and the learning curve
[266]
The significance of the immune response and other patient-specific factors
[278]
PART V: BIOCOMPATIBILITY ISSUES
[299]
Some preliminary observations
[299]
Some reflections on the witnesses
[301]
The nature and extent of the dispute
[326]
Biocompatibility
[330]
The foreign body reaction
[341]
The work of the Aachen Group
[363]
The opinions of Professors Klosterhalfen and Klinge about the Ethicon devices
[390]
The attack on the Aachen Group’s pelvis data pool
[406]
The question of pore size
[450]
Bridging fibrosis
[520]
Mesh contraction or shrinkage
[538]
“Mechanical mismatch”
[611]
Nerve damage and pain
[672]
Oxidation or oxidative degradation
[685]
Does Prolene oxidise in vivo?
[693]
Did the applicants prove that oxidation of Prolene had any significant effect?
[780]
Conclusion
[787]
PART VI: THE PERFORMANCE OF THE DEVICES
[788]
The epidemiological and statistical evidence
[791]
The nature of the evidence
[791]
The qualifications of the witnesses
[793]
The utility of the evidence
[801]
Some general observations about assessing complication rates
[807]
Studies relevant to complications arising from the SUI devices
[878]
The Nordic multicentre studies
[879]
The Ward Hilton RCT
[913]
The Cochrane reviews
[961]
The Novara and Fusco meta-analyses
[991]
The Morling study
[1016]
The 2004 Cochrane review
[1021]
Studies relevant to complications arising from the POP devices
[1024]
The 2006 HAS evaluation
[1025]
The 2007 Cochrane review
[1026]
The NICE guidance
[1030]
The 2010 Cochrane review
[1032]
The Altman RCT
[1037]
The 2013 Cochrane review
[1074]
The 2016 Cochrane reviews
[1080]
The Morling study
[1116]
The PROSPECT study
[1122]
The prevalence of the pleaded complications
[1133]
SUI devices
[1143]
Erosion, extrusion, exposure
[1143]
Infection
[1152]
Chronic pain
[1156]
Dyspareunia and apareunia
[1169]
Reoperation or revision surgery
[1175]
Difficulties with voiding
[1178]
De novo or recurrent urinary incontinence
[1184]
Damage to surrounding organs, nerves, ligaments, tissue and blood vessels
[1193]
Leg weakness
[1200]
Offensive discharge, haemorrhage and psychiatric injury
[1203]
POP devices
[1206]
Erosion, extrusion, exposure
[1206]
Infection
[1217]
Chronic pain
[1221]
Dyspareunia and apareunia
[1227]
Reoperation or revision surgery
[1235]
Mesh removal or excision surgery due to erosion
[1239]
Difficulties with voiding and defecating
[1241]
De novo urinary incontinence
[1243]
Offensive discharge
[1246]
Recurrence of pelvic organ prolapse
[1248]
Damage to surrounding organs, nerves, ligaments, tissue and blood vessels
[1253]
Haemorrhage
[1256]
Leg weakness
[1260]
Psychiatric injury
[1263]
Gynemesh PS used abdominally in vault repair
[1264]
The expert evidence on comparative outcomes
[1284]
PART VII: THE REGULATORY FRAMEWORK
[1337]
Introduction
[1337]
The witnesses
[1345]
The respondents’ arguments on the utility of the regulatory expert evidence
[1354]
Regulation of medical devices in Australia
[1364]
Application for inclusion of a medical device on the ARTG
[1375]
The requirements for medical devices cleared for sale in Europe
[1389]
The CE mark
[1389]
The essential requirements
[1403]
The technical file
[1411]
Clinical evaluation
[1413]
Equivalence
[1443]
Clinical investigations
[1449]
The notified body and conformity assessments
[1452]
Post-market surveillance and testing
[1459]
Cancellation of an ARTG entry
[1474]
Overview of the evidence from the regulatory experts on the respondents’ compliance with regulatory requirements
[1476]
Dr Allman’s evidence
[1480]
Ms Holland’s evidence
[1496]
Dr Pence’s evidence
[1534]
PART VIII: DEVELOPMENT AND PRE-MARKET EVALUATION OF THE DEVICES
[1548]
The SUI devices
[1554]
TVT
[1554]
TVT-O
[1613]
TVT Secur
[1656]
TVT Exact
[1701]
TVT Abbrevo
[1715]
The POP devices
[1735]
Background
[1735]
Gynemesh PS
[1746]
Prolift
[1785]
Prolift+M
[1873]
Prosima
[1912]
PART IX: POST-MARKET EVALUATION OF THE DEVICES
[1956]
Introduction
[1956]
Monitoring of complaints made to the respondents
[1973]
Reports to regulatory authorities of adverse events
[1978]
BSI audits
[2008]
The SUI devices
[2019]
TVT
[2019]
TVT-O
[2159]
TVT Secur
[2168]
TVT Abbrevo and TVT Exact
[2202]
The POP devices
[2204]
Gynemesh PS
[2204]
Prolift
[2289]
Prolift+M
[2339]
Prosima
[2417]
PART X: REMOVAL OF SOME OF THE ETHICON DEVICES FROM THE MARKET AND THE ARTG
[2445]
The FDA alerts
[2448]
The § 522 notices
[2469]
The decisions made by JJM and the TGA
[2492]
PART XI: INFORMATION PROVIDED BY THE RESPONDENTS ABOUT THE ETHICON DEVICES
[2560]
Instructions for use
[2561]
IFUs for the SUI devices
[2586]
TVT
[2588]
TVT-O
[2604]
TVT Secur
[2610]
TVT Exact
[2614]
TVT Abbrevo
[2618]
Dr Pence’s assessment
[2622]
IFUs for the POP devices
[2629]
Gynemesh PS
[2630]
Prolift
[2637]
Prolift+M
[2639]
Prosima
[2641]
Dr Pence’s assessment
[2645]
Intervention by the regulators
[2656]
The FDA
[2656]
Health Canada
[2668]
The TGA
[2676]
Professional training
[2682]
Marketing
[2706]
The respondents’ strategy
[2708]
Promotional activities
[2717]
Product brochures
[2718]
Brochures for the SUI devices
[2719]
Patient brochures
[2730]
Surgeon brochures
[2748]
Brochures for the POP devices
[2759]
Patient brochures
[2763]
Surgeon brochures
[2778]
The use of key opinion leaders
[2798]
Website advertising
[2800]
The use of preceptors and the preceptor training program
[2805]
The adequacy of the respondents’ warnings and other information it provided
[2810]
Adequacy of warnings and other information provided about the SUI devices
[2812]
Chronic inflammatory reaction of the tissues surrounding or attached to the tape
[2814]
Erosion
[2836]
Infection
[2848]
Chronic pain
[2863]
Dyspareunia and apareunia
[2876]
Heightened inflammatory response in patients with autoimmune disorders
[2880]
Reoperation and revision surgery
[2890]
The difficulty or impossibility of removing mesh
[2900]
Difficulties with voiding
[2906]
De novo and recurrent urinary incontinence
[2912]
Offensive discharge
[2919]
Damage to surrounding organs, nerves, ligaments, tissue and blood vessels
[2923]
Haemorrhage
[2927]
Leg weakness
[2931]
Psychiatric injury
[2932]
The absence of any or any adequate clinical or other evaluation of the risks
[2933]
Adequacy of warnings and other information provided about the POP devices
[2940]
Chronic inflammatory reaction
[2946]
Erosion
[2949]
Infection
[2958]
Chronic pain
[2966]
Dyspareunia and apareunia
[2973]
Heightened inflammatory response in patients with autoimmune disorders
[2975]
Reoperation and revision surgery
[2987]
The difficulty or impossibility of removing a device
[2991]
Difficulties with voiding
[2995]
Difficulties with defaecating
[2999]
De novo and recurrent urinary incontinence
[3000]
Offensive discharge
[3003]
Recurrence of POP
[3005]
Damage to surrounding organs, nerves, ligaments, tissue and blood vessels
[3008]
Haemorrhage
[3015]
Leg weakness
[3016]
Psychiatric injury
[3017]
The absence of any or any adequate clinical or other evaluation of the risks
[3018]
Conclusion
[3029]
PART XII: PRELIMINARY ISSUES RAISED BY THE APPLICANTS’ CLAIMS
[3036]
Representation
[3037]
The effect of the amendments to the group definition
[3051]
Identifying the common questions
[3057]
Allegedly fatal gaps in the evidence
[3061]
TVT Abbrevo
[3068]
TVT Secur
[3075]
TVT Exact
[3093]
Prolift+M
[3099]
Prosima
[3106]
PART XIII: THE APPLICANTS’ STATUTORY CLAIMS
[3113]
Some general matters
[3113]
The relevant legislation
[3113]
To whom are the obligations owed?
[3116]
Upon whom are the obligations imposed?
[3117]
How far do the obligations extend?
[3122]
Do the obligations extend to overseas corporations without a place of business in Australia?
[3124]
Were Ethicon Sàrl and Ethicon Inc. carrying on business in Australia?
[3132]
The allegations
[3151]
Defective goods
[3161]
What must be proved?
[3161]
The applicants’ case
[3197]
The comparative evidence
[3203]
The relevance of the physician/surgeon intermediary
[3210]
What might reasonably be expected to be done with or in relation to the devices?
[3253]
The manner in which and the purposes for which the devices were marketed
[3259]
The use of any mark in relation to the devices
[3269]
Instructions and warnings: some general observations
[3273]
The time the devices were supplied by the manufacturer
[3347]
What level of safety are persons generally entitled to expect?
[3360]
Was the safety of each device less than persons generally are entitled to expect?
[3378]
The SUI devices
[3382]
Conclusion in respect of the SUI devices
[3458]
The POP devices
[3459]
Conclusion in respect of the POP devices
[3496]
The defence under s 75AK(1)(c)
[3501]
Conclusion
[3515]
Unfitness for purpose and unmerchantable quality
[3518]
The legal framework: unfitness for purpose
[3519]
The legal framework: unmerchantable quality
[3528]
Conclusion
[3544]
Misleading or deceptive conduct
[3545]
What must be proved?
[3545]
What is the conduct complained of?
[3561]
Was the conduct complained of misleading or deceptive?
[3581]
PART XIV: THE APPLICANTS’ CLAIMS IN NEGLIGENCE
[3608]
The elements of the cause of action
[3609]
The applicable law
[3610]
The allegations
[3613]
The manufacturers’ duty of care
[3624]
The supplier’s duty of care
[3628]
The dispute
[3645]
The standard of care
[3646]
Breach of duty
[3653]
Did the respondents breach their duty of care to the applicants?
[3672]
Was the risk of injury foreseeable?
[3673]
What was a reasonable response to the risk?
[3675]
First alleged breach: inadequate pre-market evaluation
[3680]
Overview of the arguments and some general findings
[3680]
The SUI devices
[3716]
TVT
[3726]
TVT-O
[3730]
TVT Secur
[3736]
TVT Exact
[3742]
TVT Abbrevo
[3743]
The POP devices
[3744]
Gynemesh PS
[3746]
Prolift
[3750]
Prolift+M
[3756]
Prosima
[3759]
Was the pre-market evaluation of any of the Ethicon devices insufficient to discharge the manufacturers’ duty of care?
[3762]
Second alleged breach: inadequate post-market evaluation
[3775]
The arguments
[3776]
The devices in general
[3784]
The SUI devices
[3797]
The POP devices
[3808]
Was the post-market evaluation insufficient to discharge the manufacturers’ duty of care?
[3826]
Third alleged breach: failing to provide adequate warnings and other relevant information
[3828]
The nature and purpose of the duty to warn
[3830]
Did reasonable care require warnings about the pleaded complications and/or the other matters?
[3836]
To whom should the warnings and other information have been provided?
[3849]
Did reasonable care require warnings about all the pleaded complications and/or the other matters?
[3850]
Was the information supplied by the respondents insufficient to discharge their duty of care?
[3875]
Conclusion
[3879]
PART XV: THE APPLICANTS’ CIRCUMSTANCES
[3885]
Kathryn Gill
[3885]
Background and medical history
[3885]
Education and employment history
[3896]
The prolapses
[3899]
The implant surgery
[3919]
The aftermath of the prolapse surgery
[3921]
First mesh exposure
[3941]
Second mesh exposure
[3955]
Third mesh exposure
[3987]
Recurrence of prolapse
[4017]
Fourth mesh exposure
[4052]
Current position
[4063]
Diane Dawson
[4070]
Background and medical history
[4070]
Education and employment
[4080]
First prolapse
[4081]
First prolapse repair
[4083]
The aftermath of the first prolapse repair
[4084]
Pre-injury condition
[4090]
The recurrence of prolapse
[4092]
The implant surgery
[4097]
The aftermath of the implant surgery
[4100]
Injury
[4105]
First mesh exposure and excision surgery
[4112]
Second mesh exposure and excision surgery
[4150]
Fourth mesh exposure and excision surgery
[4155]
Fifth revision surgery
[4191]
Current position
[4198]
Ann Sanders
[4228]
Background
[4228]
Education and employment history
[4231]
Urinary incontinence
[4233]
The implant surgery
[4235]
The aftermath of the implant surgery
[4237]
Injury
[4240]
Mesh exposure/erosion
[4247]
Mesh excision surgery
[4263]
The aftermath of the excision surgery
[4270]
Current position
[4344]
PART XVI: CAUSATION
[4357]
The legal approach to causation
[4358]
Causation in negligence
[4362]
Causation under the Trade Practices Act
[4371]
The respondents’ general arguments
[4412]
Mrs Gill
[4428]
Did Mrs Gill suffer injury caused by a defect in Prolift Total?
[4428]
Did Mrs Gill suffer damage caused by the respondents’ negligence?
[4431]
The first and second negligence claims: inadequate evaluation of Prolift Total
[4438]
The third negligence claim: failure to provide adequate warnings and other information
[4448]
Mrs Dawson
[4498]
Did Mrs Dawson suffer injury caused by a defect in Gynemesh?
[4498]
Did Mrs Dawson suffer damage caused by the respondents’ negligence?
[4500]
The first and second negligence claims: inadequate evaluation of Gynemesh PS
[4502]
The third negligence claim: failure to provide adequate warnings and other information
[4503]
Mrs Sanders
[4516]
Did Mrs Sanders suffer injury caused by a defect in TVT?
[4516]
Did Mrs Sanders suffer damage caused by the respondents' negligence?
[4518]
The first and second negligence cases: inadequate evaluation of TVT
[4518]
The third negligence claim: failure to provide adequate warnings and other information
[4522]
Did Mrs Sanders suffer damage by the misleading conduct of the respondents?
[4559]
PART XVII: THE LIMITATIONS QUESTIONS
[4562]
The claims under the Trade Practices Act
[4563]
The relevant provisions
[4563]
Contraventions before July 2004
[4564]
Contraventions after July 2004
[4567]
The burden of proof
[4595]
Kathryn Gill
[4605]
The respondents’ argument
[4609]
When did Mrs Gill first know that she had sustained an injury? When should she first have known?
[4611]
When did Mrs Gill first know or when should she have known that the injury was significant enough to justify bringing an action?
[4631]
When did Mrs Gill first know that her injury was attributable to a contravention of the TPA? When should she first have known?
[4635]
Ann Sanders
[4668]
The long-stop point
[4674]
Sections 74J(1) and 75AO(1)
[4729]
The defence under s 82
[4761]
The defence under s 87F
[4774]
The negligence claims
[4778]
The relevant legislation
[4779]
Kathryn Gill
[4788]
Is the action statute-barred?
[4788]
Should leave be granted to extend the period of limitation?
[4807]
Ann Sanders
[4833]
Is the action statute-barred?
[4833]
Should the limitation period be extended?
[4857]
PART XVIII: DAMAGES AND COMPENSATION
[4864]
The negligence claims
[4864]
Which law applies?
[4864]
Damages at common law
[4868]
General damages
[4869]
Economic loss
[4878]
Contingencies or vicissitudes
[4881]
Out-of-pocket expenses
[4882]
Gratuitous care and/or services
[4883]
Legislative reforms
[4889]
Some issues of principle affecting all claims
[4894]
Calculation of life expectancy
[4895]
Discounting damages for the vicissitudes of life
[4896]
Discounting damages for other reasons
[4906]
Mrs Gill’s damages
[4916]
The claim
[4916]
The extent of the damage
[4918]
Chronic inflammatory reaction
[4921]
Recurrent prolapses
[4927]
Development of a bulky, fibroid, acutely anterverted uterus
[4932]
Chronic pelvic pain, dyspareunia, coccygeal, low back pain, severe pain on defaecation
[4938]
Bowel and gastrointestinal symptoms
[4984]
Psychiatric injuries
[5004]
Urinary symptoms
[5028]
Tightness in the mesh arms
[5037]
Conclusion
[5048]
Non-economic or non-pecuniary loss
[5050]
Past economic loss
[5070]
Past out-of-pocket expenses
[5121]
Past care and services
[5122]
Interest
[5123]
Future economic loss
[5132]
Loss of superannuation benefits
[5144]
Future domestic assistance
[5151]
Future out-of-pocket expenses
[5234]
Mrs Dawson’s damages
[5336]
The extent of the injuries
[5336]
Chronic inflammatory reaction
[5340]
Pudendal neuropathy
[5345]
Rigid vagina
[5355]
The urinary symptoms
[5357]
Chronic pain syndrome
[5365]
Psychiatric disorders
[5372]
Coccydynia
[5404]
Apareunia
[5424]
Bowel symptoms
[5432]
Depressive symptoms
[5443]
Chronic pelvic pain
[5445]
Conclusion
[5459]
Non-economic loss
[5462]
Past economic loss
[5478]
Past loss of superannuation
[5497]
Past out-of-pocket expenses
[5498]
Past domestic care and assistance
[5499]
Interest
[5502]
Future loss of earning capacity
[5504]
Loss of superannuation benefits
[5514]
Future domestic assistance
[5515]
Future out of pocket expenses
[5551]
Mrs Sanders’ damages
[5601]
The extent of the injuries
[5601]
Chronic inflammation
[5609]
Scarification of the urethra, perivaginal tissue and/or bladder
[5614]
Erosion into the bladder and urethra
[5617]
Squamous metaplasia of the trigone
[5623]
Urinary tract infections, detrusor instability, low compliance bladder, urethral instability
[5625]
Flatal incontinence and constipation
[5653]
Chronic pain, dyspareunia, and apareunia
[5655]
Adjustment disorder
[5674]
Conclusion
[5676]
General damages
[5678]
Economic loss
[5691]
Past out-of-pocket expenses
[5692]
Past care and assistance
[5693]
Interest
[5694]
Future domestic assistance
[5698]
Future out-of-pocket expenses
[5745]
Therapy and interventions
[5747]
Future equipment
[5773]
Future travel
[5793]
PART XIX: OTHER RELIEF
[5800]
Declaratory relief
[5800]
Injunctive relief
[5808]
PART XX: DISPOSITION
[5824]
KATZMANN J:
PART I: INTRODUCTION
This is a representative action concerning nine medical devices, all made using knitted polypropylene, a thermoplastic polymer. The devices were designed to be surgically implanted in women to alleviate either stress urinary incontinence or pelvic organ prolapse. The action calls into question the safety of those devices. Its outcome will affect thousands of women who were implanted with any of the devices in Australia and who suffered any complications caused by those devices at any time before 4 July 2017. A number of the final orders that will be made in the proceedings will bind all such women except for those who have exercised their rights to opt out of the action.
The medical devices used for the treatment of stress urinary incontinence which are the subject of this action are known by the trade names Gynecare Tension-free Vaginal Tape System (TVT), Gynecare TVT Obturator System (TVT-O), Gynecare TVT Secur System (TVT Secur), Gynecare TVT Exact Continence System (TVT Exact) and Gynecare TVT Abbrevo Continence System (TVT Abbrevo). When I refer to them collectively in this judgment, I use the shorthand expression “the SUI devices”.
The medical devices used for the treatment of pelvic organ prolapse which are the subject of this action are known by the trade names Gynecare Gynemesh Prolene Soft (Gynemesh PS), Gynecare Prolift Pelvic Floor Repair System (Prolift), Gynecare Prolift+M Pelvic Floor Repair System (Prolift+M) and Gynecare Prosima Pelvic Floor Repair System (Prosima). I refer to them collectively as “the POP devices”.
When I refer to the SUI devices as well as the POP devices, I call them “the Ethicon devices”.
In a nutshell, the applicants’ case is that all the Ethicon devices cause a number of potentially serious complications but the respondents were so driven by commercial interests that they neglected to undertake the investigations reasonably necessary to inform themselves and the community of the extent, if not also the nature, of the risks posed by the devices and to take appropriate or sufficient remedial action. To the extent that they were aware, they failed to make adequate disclosure. As the applicants put it in their opening submissions:
[A]t all times from the development of the first TVT products, to the commencement of proceedings, the Respondents were motivated by a sales-driven culture, with an emphasis on the perceived urgent need to get products to doctors before competitors. There was a focus on profit and maintaining market share, without adequate focus on safety, efficacy and potential complications. In the race to sell as many products as possible, the Respondents failed to undertake proper or adequate evaluations or [disclose] known complications and risks. [1]
[1] SBM.010.001.0001 at 0015
Since the commencement of this proceeding, all the POP devices have been removed from the market but, with the exception of TVT Secur, all the SUI devices are still available for sale.[2]
[2] AID.010.002.0001_8
The devices in question were made by two foreign companies: the first respondent, Ethicon Sàrl (Société Anonyme à Responsabilité Limitée or Limited Liability Company) and; the second respondent, Ethicon Inc., both members of the Johnson & Johnson group of companies.
Ethicon Sàrl is a Swiss corporation and the manufacturer of a variety of polypropylene implantable medical devices, including all but one of the devices the subject of this litigation. Ethicon Inc. is an American corporation and the manufacturer of the remaining one, Gynemesh PS.[3] It was also involved in the marketing of all the relevant devices through its Gynecare division. Ethicon Inc. is a subsidiary of Johnson & Johnson, an American public company, listed on the New York Stock Exchange. Ethicon Sàrl is a subsidiary of another Swiss company but the ultimate parent company is Johnson & Johnson. In these circumstances, unless it is necessary for a particular reason to distinguish between them, I will generally refer to both Ethicon companies simply as “Ethicon”.
[3] CRT.500.007.0001
Ethicon Sàrl and Ethicon Inc. supplied the Ethicon devices to the third respondent, a related Australian company, Johnson & Johnson Medical Pty Limited (JJM). JJM promoted and supplied the Ethicon devices to Australian hospitals and doctors.
The respondents were represented by the same lawyers and, through their senior counsel, made it clear that no point would be taken that the knowledge of one of the companies in the group was not shared by another.[4]
[4] T6039–40 (TRA.500.076.0001 at 0003‑0004)
According to statements made on the Australian Register of Therapeutic Goods (ARTG), the purpose of each of the SUI devices is to, by way of a sling, treat stress urinary incontinence and female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.[5] 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”.[6]
[5] ETH.MESH.08219161; ETH.MESH.08219150; MSC.010.170.0001
[6] ETH.MESH.08219159; ETH.MESH.08219144
The devices were promoted as effective in restoring normal anatomy and sexual function, as not subject to degradation or weakening by tissue enzymes, and as having high patient satisfaction. Instructions for use (IFU) supplied with the devices warned of some possible adverse reactions and contraindications. Yet, a number of potential complications, known to the respondents from the time the devices were first supplied, were not disclosed and those that were disclosed were often minimised. Some of the potential complications could occur with any form of pelvic surgery. Others were unique to implantable synthetic mesh devices.
PART II: OVERVIEW OF THE PROCEEDING
The applicants’ claims
This action is brought under Pt IVA of the Federal Court of Australia Act 1976 (Cth) (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 Ethicon devices during the relevant period. I was informed at the beginning of the trial that there are some 700 registered group members but as the class is an open one, and more than 90,000 Ethicon devices have been supplied in Australia,[7] it is highly likely that there are many more.
[7] T2 (TRA.500.001.0001_2 at 0002_2)
The three applicants are Kathryn Gill, Diane Dawson, and Ann Sanders. Mrs Gill had pelvic organ prolapse and was implanted with a Prolift device on 12 January 2007. Mrs Dawson also had pelvic organ prolapse and was implanted with Gynemesh PS on 8 May 2009. Mrs Sanders suffered from stress urinary incontinence and was implanted with TVT on 12 March 2001.[8]
[8] T69 (TRA.500.001.0001_2 at 0069_2)
The applicants allege that the respondents contravened various provisions of the Trade Practices Act1974 (Cth) (TPA) and the Competition and Consumer Act 2010 (Cth) (CCA). The statutory claims are based on:
·s 74B of the Trade Practices Act, because it is alleged that the Ethicon 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 Sch 2 to the Competition and Consumer Act — the Australian Consumer Law (ACL);
·s 74D of the Trade Practices Act, because it is alleged that the Ethicon 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 75AD of the Trade Practices Act in that the Ethicon devices were allegedly supplied with a “defect” and s 138 of the ACL because they were allegedly supplied with “a safety defect”; and
·s 52 of the Trade Practices Act and s 18 of the ACL in that the information the respondents released in connection with the Ethicon devices, including the IFUs accompanying the products, and the way in which they were marketed and promoted was misleading or deceptive or likely to mislead or deceive consumers.
The applicants also allege that the respondents are liable to the applicants in negligence for:
·failing to undertake any, or any adequate, clinical or other evaluation of the Ethicon devices before releasing them in Australia;
·failing to conduct any, or any adequate, evaluation of safety and effectiveness of the Ethicon 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.
The respondents deny liability and, in the cases of Mrs Gill and Mrs Sanders, they contend that, in any event, their actions are statute-barred.
The history of the proceeding
An Originating Application and Statement of Claim were filed on 15 October 2012 naming a single applicant, Mrs Julie Davis. On 6 April 2016, by orders of the Court, Mrs Gill, Mrs Dawson, and Mrs Sanders were substituted for Mrs Davis, and two sub-groups were created, one referred to in the pleading as the “Mesh Sub-Group”, mesh being a reference to the POP devices, the other as the “Tape Sub-Group”, tape being a reference to the SUI devices.
The trial commenced at the beginning of July 2017 and did not conclude until the end of February 2018. Evidence was adduced from 48 witnesses, 35 of whom gave oral evidence. Of the 48 witnesses, 37 were experts hailing from nine different disciplines. Each witness gave evidence individually, as my proposal that experts in the same discipline prepare joint reports and give concurrent evidence was opposed by both parties. Extensive written and oral submissions were made.
More than 5,500 documents were tendered, running to over 164,000 pages. Mercifully, the trial was conducted electronically, which, to some extent, eased the burden on the Court.
The evidence
Each of the applicants gave evidence on affidavit and was cross-examined. Affidavits were also read from their husbands, only one of whom, Steven Gill, was required for cross‑examination.
The applicants adduced evidence from four urogynaecologists. They were Andrew Korda, Wael Agur, Jerry Blaivas, and Michael Thomas Margolis. Professor Korda is an Australian. Dr Agur practises in Scotland and was described by one of the respondents’ experts as an opinion leader in Great Britain.[9] Professor Blaivas and Assistant Professor Margolis hail from the United States. Urogynaecology, I should explain, is a surgical subspecialty of urology and gynaecology, which involves the diagnosis and treatment of female pelvic floor disorders.[10]
[9] Collinet at 22 (EXP.020.005.0001_4 at 0022_4)
[10] Korda 1 at 5 (EXP.010.078.0001_3 at 0006_3)
After the respondents had indicated they would not be calling him, the applicants tendered a report prepared for the respondents by Malcolm Frazer, another urogynaecologist.
The applicants also tendered reports and read affidavits from a number of other expert witnesses in a range of disciplines. They included the following people who, unless otherwise indicated, are based in Australia: Bilal Chughtai, a urologist, from the United States; Uwe Klinge, a general surgeon and biomaterials researcher who lives in Belgium; Bernd Klosterhalfen from Germany and Vladimir Iakovlev from Canada, both pathologists; two biomechanical engineers, Russell Dunn and Scott Guelcher from the United States; four regulatory experts, Derrick Beech, Bryan Allman from the United Kingdom, Peggy Pence and Anne Holland from the United States; three epidemiologists, Howard Hu from Canada, Cara Krulewitch from the United States, and Mark Woodward; Ian Gordon, a biostatistician; two colorectal surgeons, Alan Meagher and Anthony Eyers; Patricia Jungfer, a psychiatrist; Joseph Slesenger, a specialist in occupational medicine; and Lindy Williams and Timothy Walsh, both occupational therapists.
Of these witnesses, only Dr Beech, Professor Woodward, Ms Williams, and Mr Walsh were not required for cross-examination.
Affidavits were also read from Robyn Leake, an obstetrician and gynaecologist who treated Mrs Gill for a number of years, 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.
The respondents adduced evidence from six urogynaecologists: Piet Hinoul from the United States, Pierre Collinet from France, Jan Deprest from Belgium, Alan Lam, Jan-Paul Roovers from the Netherlands, and Anna Rosamilia; an engineer, Steven McLean from the United States; Paul Santerre, a professor of biomaterials from Canada; Thomas Wright, a pathologist from the United States; three psychiatrists, Lisa Brown, Anthony Samuels, and Rosalie Wilcox; and an occupational therapist, Susan Borthwick. All of these witnesses, except Dr Wilcox, were required for cross‑examination.
Dr Hinoul was the only witness from any of the three respondents to give evidence. Dr Hinoul is a urogynaecologist born in Belgium and educated in the United States, Belgium, and the Netherlands. 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.[11] He gave evidence about the Ethicon devices and their development and Ethicon’s conduct. Some of that evidence was based on company records. Not all of it concerned matters of fact.
[11] Hinoul at [16] (LAY.020.001.0001_4 at 0007_4])
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.[12] According to Dr Hinoul, the Director of Medical Affairs is responsible for “generating evidence for new medical devices”, “for ensuring that there is sufficient evidence to enable products to be released onto the market” and for products that are already on the market, and for “monitoring the literature and the various studies involving the products”.[13] The Director of Medical Affairs is also responsible for assessing their risks and benefits. As Director of Medical Affairs, Dr Hinoul said that he was responsible for Ethicon’s pelvic floor repair and incontinence repair products. His duties included undertaking risk/benefit analyses of devices, drafting clinical evaluation reports, assessing clinical literature, presenting at panel meetings, and reviewing adverse events. He also contributed to various Ethicon documents which required “medical input”. They included IFUs supplied with the devices, patient brochures, marketing, design verification, and professional education materials.[14]
[12] Hinoul at [19(f)] (LAY.020.001.0001_4 at 0009_4)
[13] Hinoul at [18] (LAY.020.001.0001_4 at 0007_4)
[14] Hinoul at [19(f)] (LAY.020.001.0001_4 at 0009_4)
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)).[15]
[15] Hinoul at [19(g)‑(i)] (LAY.020.001.0001_4 at 0009_4)
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.
Of the Medical Affairs Directors who preceded him, only his immediate predecessor, Dr Axel Arnaud,[16] remains with Ethicon.[17] Dr Arnaud was a key figure in the development and post‑market surveillance of a number, if not all, of the Ethicon devices. In particular, he investigated the TVT procedure in 1996 and TVT-O in 2002 and was a moving force in the development of the POP devices. No explanation was provided to the Court for his absence nor for the absence of the other Medical Affairs Directors. Presumably the respondents were content to rely solely on their reports, despite the criticisms made of them by the applicants’ experts and others.
[16] ETH.MESH.03913758
[17] Hinoul at [19(f)] (LAY.020.001.0001_4 at 0009_4)
The rest of the evidence consisted of documents. One legacy of the parties’ approach to tendering documents is that documents referenced by multiple witnesses or submissions were tendered multiple times. Sometimes the same document was tendered by both parties. Sometimes the same document was tendered multiple times by the same party. The result was that one document might have two or more document identification (ID) numbers. Rather than refer to multiple document ID numbers for the same documents, I have elected to use one only, and where a document is mentioned more than once in these reasons, I have endeavoured to refer to the document by the same ID number throughout. No significance should be attached to the choice of ID tender number. Moreover, a source cited in a footnote should not be regarded as the only source upon which I relied to form the view expressed in the relevant sentence or paragraph. The ID numbers have been included in the footnotes to assist the parties to identify source material. They are otherwise of no consequence.
In a case of this magnitude, it is impossible to refer to all the evidence and it is unnecessary to do so. My failure to refer to any particular item of evidence, however, ought not to be taken as an indication that I have not considered it. Having regard to the length of the judgment and the connection between the subject-matter of its various parts, a degree of repetition is unavoidable. Indeed, it is often necessary. I have tried to keep repetition to a minimum, although some readers may consider that I did not try hard enough.
The conduct of the trial
At this point I also wish to make some remarks about the conduct of the trial. An extraordinary amount of work goes into a trial of this size and nature and the stakes are high. No doubt these pressures take their toll on lawyers and their clients. Despite these pressures, and notwithstanding the zealous prosecution of their clients’ interests, counsel conducted the trial with a good deal of equanimity and courtesy. This made the herculean task that confronted me far less daunting and much more tolerable than it might otherwise have been. For that, I am truly grateful.
On the other hand, the case could certainly have been conducted with greater efficiency.
It is questionable, for example, whether it was necessary for the applicants to plead so many causes of action. The applicants’ pleadings were convoluted and, owing to cumbersome cross-referencing, often difficult to follow. The parties quarrelled about points upon which they should have been able to reach agreement. Insufficient judgment was exercised about the number of experts that should be retained in each discipline, the way in which the evidence should be elicited, and the documents that should be tendered. Sources for some submissions were not always provided, which meant that I had to trawl through the evidence to find them for myself. I appreciate that the litigation was a substantial logistical exercise and that it is easy to be wise after the event. I do hope, however, that when the dust settles, both sides reflect on what could have been done better, as I have done.
PART III: THE HISTORY AND DEVELOPMENT OF THE ETHICON DEVICES
Despite some sharp and often irreconcilable differences of opinion, there was a good deal of common ground. Unless otherwise indicated, my account of the facts is based on agreed facts, and evidence which was not contradicted or challenged.
The use of synthetic mesh and polypropylene in surgery
Prolene is a polypropylene resin first made by Ethicon in the 1960s.[18] Subject to certain conditions, it was approved by the Food and Drug Administration (FDA) in the United States in April 1969 for use in non‑absorbable surgical sutures.[19] Ethicon Inc. had sought approval for its product as a new “drug”. Strict conditions had to be satisfied before approval could be given. Ethicon was required to submit detailed reports of preclinical investigations, including studies on laboratory animals. In order for an animal study to be considered appropriate, proper attention had to be given to the conditions of use recommended in the proposed labelling, including whether the “drug” was intended for short or long-term administration.[20] Ethicon conducted studies of tissue reactions to the sutures in rats, rabbits, and dogs. It conducted studies of the tensile strength of the sutures when implanted in rats. Ethicon was also required to submit reports of all clinical testing and all information relating to the evaluation of the safety and effectiveness of the sutures.[21] After approval had been granted, Ethicon continued to test its sutures and submitted quarterly reports to the FDA.[22]
[18] Hinoul at [217] (LAY.020.001.0001_4 at 0088_4)
[19] ETH.MESH.09625725 at 5731
[20] ETH.MESH.09625725 at 5818
[21] Respondents’ written closing submissions (RWS) ch 7 at [12] (SBM.020.002.0108 at 0112)
[22] RWS ch 7 at [15]–[24] (SBM.020.002.0108 at 0119)
Prolene sutures continue to be widely used, including in pelvic reconstructive surgery. Dr Hinoul described them as “functional, safe and effective”.[23] The applicants did not suggest otherwise.
[23] Hinoul at [218] (LAY.020.001.0001_4 at 0088_4)
Synthetic mesh was first used in the repair of hernias in the abdominal wall. Francis Usher was the pioneer. In 1958 he published on the use of synthetic mesh in six dogs to reinforce the abdominal wall and close the abdominal wall and thoracic tissue defects. Dr Usher initially used a woven material made of polyester but rapidly changed to a knitted fabric made of a high-density polyethylene known as Marlex.[24] Marlex became increasingly stiff after implantation and at times caused considerable local wound complications, seroma formation, infection, and “stiff belly”.[25] At some later point in time, another polymer, polypropylene, was used in the manufacture of Marlex.
[24] Usher F et al, “Marlex Mesh, a New Plastic Mesh for Replacing Tissue Defects” (1959) 78 AMA Arch Surg 138–145 (SHI.MESH.00033484)
[25] Klinge at [41]-[43] (LAY.010.022.0001_2 at 0008_2)
In the early 1970s, Ethicon developed Prolene sutures into a knitted flat mesh[26] and, in 1997, into a three-dimensional form known as the “Prolene Hernia System”.[27] Ethicon conducted a good deal of research on Prolene sutures, both before and after it had obtained regulatory approval for their use. But the Prolene Hernia System was cleared for sale on the back of the approval for Prolene sutures, based on their supposed “substantial equivalence”. The first of the Ethicon 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.
[26] Hinoul [226] (LAY.020.001.0001_4 at 0091_4)
[27] Klinge at [48] (LAY.010.022.0001_2 at 0011_2); see also Hinoul at [226]–[228] (LAY.020.001.0001_4 at 0091_4)
Stress urinary incontinence and its treatments
Stress urinary incontinence is the involuntary leakage of urine during activities such as coughing, sneezing, lifting, laughing or exercising.[28] It is to be contrasted with urge urinary incontinence which is involuntary leakage of urine accompanied by a compelling urge or need to urinate.[29] For completeness, overactive bladder is a symptom complex characterised by urgency (the compelling need to urinate), usually with urinary frequency and nocturia (rising at night to urinate) and, sometimes, with urge incontinence.[30] Mixed urinary incontinence is a combination of stress urinary incontinence and urge urinary incontinence.[31]
[28] CRT.500.007.0001; AWS ch 3 (SBM.010.005.0125_2); RWS ch 3 and 4 (SBM.020.026.0001)
[29] T581 (TRA.500.007.0001_2 at 0073_2)
[30] T582 (TRA.500.007.0001_2 at 0074_2)
[31] T583 (TRA.500.007.0001_2 at 0075_2)
The only symptom of stress urinary incontinence is leakage of urine during activities accompanied by increased abdominal pressure like coughing, sneezing, lifting, running, and various other forms of physical exercise. It does not affect any aspect of the anatomy. It affects the quality of the sufferer’s life. It is undoubtedly distressing. But it is never life-threatening.
The urethra (the duct or tube extending from the bladder down to the wall of the upper vagina through which urine is carried out of the body) and the bladder are supported by pelvic floor muscles, which contract during coughing, sneezing and exercise to prevent leakage of urine.
Whereas urge incontinence is a “bladder problem”, caused by involuntary contraction of the detrusor muscle), stress urinary incontinence is a “sphincter problem”.[32] The urinary sphincter is an arrangement of muscles situated closest to the bladder. Ordinarily, voluntary urination causes the sphincter to relax and the detrusor muscle (the smooth muscle in the wall of the bladder) to squeeze or contract, resulting in the expulsion of urine from the bladder down the urethra and out of the body. Weakness in the muscles or damage to the bladder neck support can result in leakage.
[32] T582 (TRA.500.007.0001_2 at 0074_2)
There are two types of stress urinary incontinence: urethral hypermobility and intrinsic sphincter deficiency. Urethral hypermobility describes the situation in which the urethra has moved outside the pelvis and activities such as coughing or sneezing (known as Valsalva activities) put added pressure on the bladder, causing leakage. Intrinsic sphincter deficiency simply refers to weak urethral sphincter muscles or poor urethral closure function.[33]
[33] Applicants’ written closing submissions (AWS) ch 3 at [6] (SBM.010.005.0125_2 at 0126_2); CRT.010.001.0001_2
Risk factors include pregnancy and vaginal birth and other conditions which cause an increase in abdominal pressure, such as obesity, chronic cough, chronic heavy lifting and constipation.
Treatment is always elective.
Traditional treatments for stress urinary incontinence
There are surgical and non-surgical options.
Non-surgical (or conservative) treatments include general lifestyle changes, pelvic floor exercises, and the use of continence devices such as a pessary. Conservative treatments are not always successful. Some women experience alleviation of their symptoms; some do not and elect to have surgery.
Traditional surgical treatment options include:
(1)Burch colposuspension, named after Dr John Burch who first described it in 1961,[34] 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.[35]
[34] SHI.MESH.00013425
[35] Blaivas 1 at 8 (EXP.010.026.0001_3 at 0010_3); Hinoul at [48] (LAY.020.001.0001_4 at 0020_4)
In Australia, at least until the late 1990s, the Burch colposuspension was described as “the gold standard” surgical treatment for stress urinary incontinence. Associate Professor Rosamilia said that it had an 85% cure rate at five years, although she did not cite a source.[36]
[36] Rosamilia 1 at 7 (EXP.020.026.0001_3 at 0009_3)
The Burch colposuspension is performed either through abdominal incision (open abdominal surgery) or laparoscopically (keyhole surgery) in which the retropubic space (the space between the pubic bone and the bladder) is dissected and the neck of the bladder is elevated (or suspended) by sutures passed through the Cooper’s ligament, which borders the femoral ring, and attached to the pubic bone.[37] The effect on the anatomy is to prevent or minimise descent of the proximal urethra during increases in abdominal pressure and to create a sling of tissue against which the urethra is compressed;[38]
[37] Hinoul at [49(b)(ii)] (LAY.020.001.0001_4 at 0021_4); Rosamilia 1 at 6 (EXP.020.026.0001_3 at 0008_3)
[38] Blaivas 1 at 8 (EXP.010.026.0001_3 at 0010_3)
The object of autologous slings is to cause the urethra to hit against something during a Valsalva activity so that the urethra momentarily shuts off. A Valsalva manoeuvre, named after an Italian anatomist, Antonio Valsalva, is the action of attempting to exhale with a closed mouth and nostrils. It increases pressure in the middle ear and chest and is used as a means of equalising pressure in the ears.[39] The slings are placed under the neck of the bladder and are commonly referred to as “pubovaginal slings”.
[39] Oxford Concise Medical Dictionary (Oxford University Press, 8th ed, 2010) at 767
The autologous fascial sling procedure was first described in 1907.[40] Although it was a mode of treatment favoured by Professor Blaivas, it never achieved widespread popularity, because of its high complication rates, particularly in inexperienced hands.[41] The complications with which it was associated included increased rates of urinary tract infection, urge incontinence, voiding dysfunction, erosion, and, occasionally, the need for surgical revision to improve voiding.[42] It is not in dispute that the complications include continued incontinence, voiding dysfunction, urinary retention, pain, and dyspareunia (pain with sexual intercourse).[43] Historically, the procedure was reserved for cases of intrinsic sphincter deficiency or prior surgical failure but there was evidence that it was an effective treatment for all types of stress incontinence with acceptable “long-term” efficacy.[44] In 1998, Chaikin et al published the results of a prospective and retrospective study of 251 women with all types of stress incontinence who underwent pubovaginal fascial sling surgery by a single surgeon, and were followed up after a median period of three years (with a range of one to 15 years). Chaikin et al (1998) claimed that they had “demonstrated that the procedure [could] be performed in a reproducible fashion with minimal morbidity”.[45] They said that postoperative urinary retention should be minimal if the sling is not tied with excessive tension. They acknowledged, however, that persistent and de novo urge incontinence remained “a vexing problem”. In cross‑examination, Professor Blaivas, who was a co-author of the Chaikin article, suggested that in 1998 a five year follow-up would have been considered “long term”, although he would not consider it to be long term now.[46]
[40] PUB.MESH.00001204; although see ETH.MESH.09917864 at 7866
[41] ETH.MESH.09917864 at 7866; T592–93 (TRA.500.007.0001_2 at 0084_2)
[42] PUB.MESH.00001204 at 1204; see also ETH.MESH.09917864 at 7866
[43] T713 (TRA.500.008.0001_2 at 0102_2); PUB.MESH.00009395 at 9408
[44] Chaikin D, Rosenthal J and Blaivas J, “Pubovaginal fascial sling for all types of stress urinary incontinence: Long-term analysis” (1998) 160 J Urol 1312-1316 (ETH.MESH.09917864)
[45] Ibid at 1316 (ETH.MESH.09917864 at 7868)
[46] T599 (TRA.500.007.0001_2 at 0091_2)
The SUI devices are midurethral slings. Midurethral slings may be surgically implanted in a number of ways. They may pass under the midurethra, run behind the pubic bone through the retropubic space (the cavity between the urethra and the muscles above it, the rectus muscles and the peritoneum) and exit above the pubic bone. This type of sling is known as a retropubic sling. Then there are those which are also placed under the midurethra but, unlike the retropubic slings, they pass through the obturator space and exit in the groin. They are called transobturator slings.
There are also single-incision slings, sometimes called “mini-slings”, which also pass under the midurethra, but are typically shorter in length than the multi-incision midurethral slings, and can be placed via either the retropubic or the transobturator route.
Despite the variety of approaches and materials used, it is widely accepted that all these slings should be placed under “minimal tension” to prevent the development of additional voiding dysfunction, such as obstruction with incomplete voiding.[47]
[47] Barone W, Abramowitch S and Moalli P, “Host Response to Biomaterials for Pelvic Floor Reconstruction” in Host Response to Biomaterials (Elsevier Inc, 2015) at 386 (SHI.MESH.00044785 at 4796)
Every one of these surgical treatment options is attended by risks, although the nature and extent of the risks vary from procedure to procedure. The complications associated with the Burch colposuspension, for example, include urinary tract infection, urinary retention, urethral obstruction, de novo overactive bladder, haematuria, neurologic symptoms, pelvic pain, dyspareunia, and death. The most common complications associated with the other traditional forms of surgery are voiding dysfunction and urethral and urinary retention. They are managed conservatively with either intermittent self-catheterisation or an indwelling catheter. Refractory pain, that is pain that is resistant to treatment, is exceedingly rare after any of these procedures.[48] The complications of treatment with the SUI devices are discussed below.
[48] AWS Ch 3 at [16]–[17] (SBM.010.005.0125_2 at 0128); Blaivas 1 at 9–11 (EXP.010.026.0001_3 at 0011–13)
Regardless of the nature of the surgery, clinical outcomes appear to be worse for patients who have had previous surgery for stress urinary incontinence.[49]
[49] T713 (TRA.500.008.0001_2 at 0102_2)
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.
The development of midurethral synthetic slings
As I have noted, the SUI devices are midurethral slings. The object of midurethral and pubovaginal slings is similar, but, unlike pubovaginal slings, midurethral slings are placed under the midurethra. Presumably for this reason, they are sometimes referred to as “suburethral slings”. The SUI devices are designed to be inserted without tension.
Tension-free vaginal tape was the brainchild of an Australian pelvic floor surgeon, Peter Petros. Its story begins in 1986 with two unrelated observations, which I gather were made by Dr Petros. The first was that a haemostat (an instrument for preventing blood flow by compression of a blood vessel) applied immediately behind the pubic symphysis (the immovable joint between the pubic bones in the centre of the pelvis), at the level of the midurethra, controlled urine loss on coughing. The second was that, on implantation, polytetrafluoroethylene (PTFE, such as Teflon) tape created a collagenous tissue reaction around it. These observations generated two hypotheses: that a loose pubourethral ligament causes stress urinary incontinence and that a tape implanted in the exact position of the damaged pubourethral ligament would create a collagenous “neoligament” to reinforce it, restoring function and continence.[50]
[50] Hinoul at [347] (LAY.020.001.0001_4 at 0134_4); Petros P, “Creating a gold standard surgical device: scientific discoveries leading to TVT and beyond” (2015) Int Urogynecol J (PUB.MESH.00001886)
Dr Petros began animal studies at the Royal Perth Hospital in 1987 using a tape made from Mersilene, a polyester material produced by Ethicon.[51] The tape was inserted in the vaginal cavities of 13 dogs for periods from six to 12 weeks. Apart from a sticky yellow vaginal discharge, there were apparently no “ill effects”.
[51] Petros P, “Creating a gold standard surgical device: scientific discoveries leading to TVT and beyond” (2015) Int Urogynecol J (PUB.MESH.00001886 at 1887); see also Iglesia C, Fenner D and Brubaker L, “The use of mesh in gynecologic surgery” (1997) 8 Int Urogynecol J 105–115 (ETH.MESH.00155061)
Human studies began over the following two years and continued into the 1990s. Between 1998 and 1999, 30 women underwent a “combined intravaginal sling and tuck” procedure, which involved creating an artificial pubourethral ligament and tightening the suburethral vagina. At the end of six weeks, all patients remained continent.[52] Within two weeks of the tape being removed, however, 50% of the patients reported recurrent incontinence.[53]
[52] Hinoul at [349] (LAY.020.001.0001_4 at 0135_4); Petros P and Ulmsten U, “The combined intravaginal sling and tuck operation. An ambulatory procedure for stress and urge incontinence” (1990) 69 Acta Obstet Gynecol Scand 53–59 (PUB.MESH.00000185)
[53] Hinoul at [349] (LAY.020.001.0001_4 at 0135_4); Petros P and Ulmsten U, “The combined intravaginal sling and tuck operation. An ambulatory procedure for stress and urge incontinence” (1990) 69 Acta Obstet Gynecol Scand 53–59 (PUB.MESH.00000185)
In the early 1990s, doctors from the Department of Obstetrics and Gynaecology at the University Hospital in Uppsala, Sweden, developed a technique for treating female urinary incontinence under local anaesthetic. Their objective was to restore the pubourethral ligament and the suburethral vaginal hammock. The technique was described in a paper by Professor Ulmsten and Dr Petros entitled “Intravaginal Slingplasty (IVS): an ambulatory surgical procedure for treatment of female urinary incontinence” published in 1995. [54] It involved placing under the urethra a tape-like strip of mesh in a U-shape sling formation using a specially designed instrument referred to as a “tunneller” introduced through paraurethrally dissected canals. The technique was used on 50 patients and drew on previous experimental and clinical studies. Thirty-eight of the 50 patients suffered from genuine stress incontinence, objectively verified, and 12 had symptoms and signs of both urge and stress incontinence. The mesh used was Mersilene (in 37 patients), Goretex (in five), Teflon (in six), and Lyodura (in two). Patients were evaluated post-operatively at intervals of one month, six months, and one to two years.[55]
[54] Ulmsten U and Petros P, “Intravaginal Slingplasty (IVS): an ambulatory surgical procedure for treatment of female urinary incontinence”(1995) 29 Scand J Urol Nephrol 75–82 (ETH.MESH.01271090)
[55] Ibid at 78 (ETH.MESH.01271090 at 1093)
The work of Ulmsten and Petros appears to have been driven by the prevalence of urinary leakage in post-menopausal women and the fact that the surgical treatment was generally extensive and required general anaesthesia. Ulmsten and Petros considered that there was “a strong need for more precise and simple ambulatory surgical methods to treat female urinary incontinence”. They specified the following criteria for these procedures:
(1)the type of defect causing the patient’s leakage must be defined and described in the work-up, as should the manner in which surgery can restore the dysfunction;
(2)the procedure should allow the patient to return to work shortly after the operation;
(3)the operation should be carried out under local anaesthesia, enabling the patient’s cooperation during the procedure and reducing costs and the number of services otherwise required; and
(4)both subjective and objective evaluation of the patient should be carried out, “recognizing her symptoms and the quality of life situation both before and after the operation”.[56]
[56] Ibid at 75 (ETH.MESH.01271090 at 1091)
On the other hand, Mrs Sanders did give evidence that she had trouble lifting and that she avoids chores requiring lifting. She also told Ms Williams she could only lift very light weights and Ms Borthwick accepted as much.[4575] I do not accept the respondents’ submission that Mrs Sanders’ unrelated co-morbidities would have interfered with her ability to do these tasks in any event.
[4575] Williams 2 at 7 (EXP.010.252.0001_2 at 0010_2); T5525 (TRA.500.068.0001 at 0044)
Taking all relevant considerations into account, I would allow $1,500 for aids.
Future travel
In their submissions the applicants also made a claim on Mrs Sanders’ behalf for the annual cost of upgrading from an economy class to a business class ticket for a return flight from Perth to London Heathrow presumably so that she could visit her daughters in greater comfort than an economy class seat would permit. The claim, which totals $4,695 per year and translates to $90.28, per week and, on the applicants’ calculation $65,759.95 in total, was not included in the statement of particulars.
No provision for this significant expense was made in Ms Williams’ first report or in the appendix in which the various recommendations were costed. The claim was supported, however, by evidence elicited from Ms Williams in her supplementary report in response to direct questioning. Ms Borthwick considered that business class air travel was unwarranted. She said that Mrs Sanders’ standing tolerance was of concern, especially when she had to wait for long periods in airport terminals or at customs but airport assistance, which is free, would take care of this. But Ms Borthwick overlooked the evidence that Mrs Sanders also has trouble sitting.
In her first affidavit, Mrs Sanders deposed that she cannot sit for long periods because it gives her a stabbing pain in her vagina, especially when sitting on a hard chair.[4576] She also reportedly told Ms Williams that she was very concerned about the prolonged sitting on the long haul flight to the United Kingdom and that she was unsure whether she could tolerate the flight.
[4576] Sanders 1 at [105] (LAY.010.005.0001 at 0022)
Nevertheless, for the following reasons I am not persuaded that she has made out a case for the cost of an upgrade to business class.
First, the question was not addressed in the medical evidence.
In her first affidavit Mrs Sanders discussed travelling overseas since 2008 including to Canada and the United Kingdom. She said that she did not enjoy the Canadian trip as much as she had hoped because of the pain and that she had trouble “getting around the UK”. She did not say, however, that the long plane trip was problematic, perhaps because unlike in a car, it is possible to move around on a plane.
Besides, Mrs Sanders would still have to sit for a prolonged period in business class. True it is, she could fully recline her seat in business class. But if, as she apparently told Ms Williams, she derives no relief from changing her position, the capacity to recline the seat would make no significant difference. Further, she reportedly told Ms Borthwick that, for their forthcoming trip to the UK, she and her husband had selected seats towards the rear of the aircraft with a space which allowed for better adjustment of posture and would not disturb others as she often rises to go to the toilet.
PART XIX: OTHER RELIEF
Declaratory relief
In any civil proceeding in its original jurisdiction, the Court has the power to make binding declarations of right: FCA Act, s 21(1). In a representative proceeding the Court is expressly empowered to make declarations of liability: FCA Act, s 33Z(1).
In their written closing submissions the applicants submitted that declarations should be made that:
(a)each of the devices had a defect;
(b)each of the devices was not of merchantable quality;
(c)each of the devices was not reasonably fit for the purpose for which it was acquired;
(d)the respondents breached their duty of care by failing to undertake adequate pre-market and post-market evaluation of the devices and also by failing to issue adequate warnings about the risks associated with their use; and
(e)the respondents engaged in misleading conduct both by providing limited warnings and in failing to provide adequate warnings in relation to those risks.
The declarations sought in the originating application were of this nature.
In their interlocutory application filed after the conclusion of the hearing, however, the applicants applied for leave to amend the originating application to also seek declarations that by, marketing, promoting, distributing and supplying the devices without providing “the proper warning set out in CRT.010.021.0001” Ethicon engaged in conduct that was misleading or deceptive or was likely to mislead or deceive the group members. “The proper warning” was in the following terms:
The implant is designed to and will elicit an acute inflammatory reaction followed by a chronic inflammatory response in all patients. The chronic inflammatory response will result in continuously regenerating scar tissue within and surrounding the implant for as long as the implant is in the body. The scar tissue will cause the implant to contract to some degree in all patients. It is not possible to predict the severity of the chronic inflammatory response of any individual patient. There is a risk that in some patients the severity of the chronic inflammatory response will result in adverse outcomes. That risk is not rare. It is not possible to identify in advance the patients who will have that response. 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 may be affected by conditions which affect the immune response and healing, including autoimmune and connective tissue disorders. The mechanical forces in the pelvic floor are unknown and may influence the compatibility and function of the implant. The adverse events which may result are:
(a)by reason of excessive contraction of the implant or otherwise, severe chronic pain with potentially life altering consequences with or without psychiatric injury;
(b)damage to or entrapment of nerves in the scar tissue surrounding the implant or otherwise, resulting in severe chronic pain with potentially life altering consequences with or without psychiatric injury;
(c)by reason of excessive contraction of the implant or otherwise, de novo dyspareunia including severe chronic dyspareunia and consequently apareunia;
(d)erosion or extrusion of the implant into the vaginal canal resulting in infection of the tissue surrounding the non-exposed part of the implant which may be difficult to treat resulting in offensive vaginal discharge;
(e)erosion or extrusion of the implant into the vaginal canal resulting in pain suffered by the patient or her sexual partner or both;
(f)erosion or extrusion of the implant into surrounding organs such as the bladder, urethra or rectum with the risk of damage to those organs and pain;
(g)by reason of excessive contraction of the implant or otherwise, difficulty voiding or defecating;
(h)by reason of excessive contraction of the implant or otherwise, de novo stress or urge incontinence,
(i)infection.
Each of the risks may eventuate regardless of the skill of the surgeon. They are not rare. If any of those adverse events eventuate, they will likely persist for so long as the implant remains in the patient. Removal of the implant in whole or in part will not necessarily alleviate the patient’s condition. 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 resulting in adverse outcomes including severe chronic pain which may not be able to be treated.
Surgery to remove the whole or part of the implant may result in recurrence of the original condition the mesh was designed to treat.
Surgery to remove the whole or part of the implant may make remedying the original condition of the patient which the implant was designed to alleviate more difficult to treat.
Successful treatment of erosion by excision will not necessarily prevent further erosion or other future adverse outcomes.
Whether the implant is or remains inert for the remainder of a patient’s life is unknown. The implant is made from polypropylene. It is known that polypropylene undergoes oxidative degradation in vivo. Degradation may affect the mechanical properties of the implant and the severity of the chronic inflammatory response to it.
Use of the implant may result in fraying and fragmentation of the implant or the release of polypropylene particles which may affect the severity of the chronic inflammatory response to the implant.
The adverse outcomes may not materialise until years after implantation and the risk of the adverse outcomes are life-long risks for so long as the implant remains in the patient.
Insufficient clinical testing of the implant has been undertaken to determine the safety of the implant and its long-term effectiveness.
The long-term safety of the implant has not been studied and is unknown.
The long-term efficacy of the implant has not been studied and is unknown.
Whether the safety and efficacy of the implant is the same as or better than non-mesh treatment alternatives has not yet been established.
The Court’s discretion is very broad. In general, however, a declaration will not be made unless the question to which it relates is real, rather than hypothetical; the person raising it has a real interest in doing so; and there is a proper contradictor, that is, someone who has a true interest in opposing the declaration: Forster v Jododex Australia Pty Limited (1972) 127 CLR 421 at 437–438 (Gibbs J).
It was not suggested, that these conditions were not satisfied in the present case. Rather, the respondents contended that the declarations sought by the applicants lacked utility. They accepted that declarations may be appropriate where it is established that the respondent intends to take action that will amount to a contravention of a law or an infringement of a duty or where the proceeding involves a matter of public interest and the circumstances call for the Court to mark its disapproval of the contravening conduct. They argued, however, that this was not such a case. In the event that the Court was of the view that declaratory relief were appropriate, they submitted that the form of the declarations will depend on the Court’s findings and should therefore await the Court’s determination of the common issues.[4577]
[4577] SBM.020.002.0359 at 0360
Declaratory relief is appropriate. The proceeding unquestionably involves a matter of public interest. Proceedings brought under the TPA are concerned with the protection of the public. Declarations can mark the Court’s disapproval of the contravening conduct. Damages are merely compensatory. Declarations may have a deterrent effect, if not on the respondents, then on others in an analogous position: Australian Competition and Consumer Commission v Murray Goulburn Co-Operative Co Limited [2018] FCA 1964 at [15] (Beach J). There is no reason why, if declarations about the contravening conduct were to be made, declarations should not also be made about the negligent conduct.
I see no point, however, in declarations that the various devices have a defect or are not of merchantable quality or fit for the purpose for which they are acquired. Without identifying the reasons the devices were defective, declarations in the form in which they appear in the originating application would be meaningless. Unlike the form of declaration made by Edelman J in ACCC v Reckitt Benckiser (No 4), it could scarcely be said that the proposed form in the present case was “closely tailored” to the contravening conduct. Based on my findings, however, the parties should be able to agree on an appropriate form.
Injunctive relief
The applicants also sought an injunction pursuant to s 80 of the TPA or s 232 of the ACL restraining the respondents from supplying, distributing, marketing or promoting the devices without providing the proper warning. Leave to amend the originating application to seek that injunction was granted over the respondents’ opposition on 9 April 2018: see Gill v Ethicon SÁRL [2018] FCA 470.
Section 80 is inapplicable. The effect of the transitional provisions in the Trade Practices Amendment (Australian Consumer Law) Act (No. 2) 2010 (Cth) is that any proceedings for an injunction under or in relation to the TPA that were commenced but not concluded before 1 January 2011 are taken, after that date, to be proceedings under s 232 of the ACL: see Sch 7 item 6(2).
Section 232 relevantly provides that:
(1)A court may grant an injunction, in such terms as the court considers appropriate, if the court is satisfied that a person has engaged … in conduct that constitutes or would constitute:
(a) a contravention of a provision of Chapter 2, 3 or 4;
…
(2)The court may grant the injunction in application by the regulator or any other person.
…
(4)The power of the court to grant an injunction under subsection (1) restraining a person from engaging in conduct may be exercised:
(a)whether or not it appears to the court that the person intends to engage again, or to continue to engage, in conduct of a kind referred to in that subsection;
(b)whether or not the person has previously engaged in conduct of that kind; and
(c)whether or not there is an imminent danger of substantial damage to any other person if the person engages in conduct of that kind.
(5)Without limiting subsection (1), the court may grant an injunction under that subsection restraining a person from carrying on a business or supplying goods or services (whether or not a part of, or incidental to, the carrying on of another business):
(a) for a specified period: or
(b) except on specified terms and conditions.
…
Chapter 2 includes the prohibition against engaging in misleading or deceptive conduct (s 18 of the ACL, formerly s 52 of the TPA), while chapter 3 includes the guarantees that goods are of acceptable quality (s 54, formerly 74D of the TPA) and fit for the disclosed purpose (s 55, formerly s 74B of the TPA), and also the liability to pay compensation for injuries caused by goods with a safety defect (s 138, formerly s 74AD of the TPA).
It is trite to observe that the power conferred on the Court by s 232, like that of its predecessor, s 80 of the TPA, is extremely broad. Nevertheless, besides being appropriate in its terms, the proposed injunction should be enforceable, any breach should be detectable, and there must be utility in the making the order. An injunction will not be appropriate in its terms if, on its face, it operates over a range of conduct which includes conduct falling outside the relationship required by the section: ICI Australia Operations Pty Ltd v Trade Practices Commission (1992) 38 FCR 248 at 267 (Gummow J). That relationship is between the contraventions of the ACL and the respondent’s or respondents’ conduct.
The respondents opposed the injunction the applicants sought. Their arguments were advanced in opposition to the applicants’ interlocutory application. Although I indicated in my reasons for judgment when granting leave to amend that I would give the respondents the opportunity to supplement those arguments were they to seek it, they never applied to do so. The respondents’ arguments, as I laid out in Gill (No 1), were as follows:
(a)the proposed form of injunction purports to usurp the role of the TGA in regulating the provision of medical devices in Australia;
(b)if relief is pressed, the Commonwealth would have been a necessary party and should have been joined at the outset;
(c)the TGA is better placed to supervise the content of warnings necessary to accompany the sale of a medical device and is already doing so;
(d)the form and content of the proposed warning is a “lawyers’ construct based on the applicants’ pleaded case” and should not be the basis on which sales of the devices are permitted;
(e)it would be futile to grant the application because the pre-conditions for the making of the order have not been established and, in the context of a detailed regulatory regime enforced by the TGA, the injunction could not be said to have “the character of enforcing present compliance or inducing future compliance”: Truth About Motorways Pty Limited v Macquarie Infrastructure Investment Management Limited (2000) 200 CLR 591 at [79]–[80] (Gummow J), adopted by the Full Court in Australian Competition and Consumer Commission v Dataline.Net.Au Pty Ltd(In liq) (2007) 161 FCR 513 at [98] (Moore, Dowsett and Greenwood JJ); and
(f)the proposed relief would not be for the benefit of the applicants or the group members, actual or prospective.
None of these arguments has merit.
With respect to the first two arguments, I maintain what I said my interlocutory judgment at [76]:
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”.
As for the third argument, the 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.
As for the fourth argument, it is true that the proposed warning has been crafted by lawyers but that, of itself, is no basis for refusing relief. It is difficult to conceive of any injunction that is not the work of lawyers.
Turning to the fifth argument, the only relevant precondition to the exercise of the power is that the Court is satisfied that the respondents (or one or more of them) engaged in conduct that constitutes or would constitute a contravention of a provision of Chapter 2, 3 or 4 of the ACL. Having regard to my findings on the statutory causes of action, this precondition is satisfied. The Court has the power to grant an injunction. The only question is whether it should exercise that power to make an order in the terms proposed. The quote from Truth About Motorways is selective. This is the full context of Gummow J’s observation with the substantive omissions emphasised:
In many cases, the remedy sought under s 80 for a prohibitory injunction would have the character of enforcing present compliance or inducing future compliance with the norm of conduct imposed by s 52.
In any case, I do not accept that the proposed order does not have “the character of enforcing present compliance or inducing future compliance”.
Finally, as I said in Gill (No 1) at [78]–[79], injunctive relief need not be of benefit to the applicants or the group members:
78As the Hon Dyson Heydon AO observes in his commentary on the Act (published by Thomson Reuters) at [280.230], the words “any other person” mean what they say. In Phelps v Western Mining Corporation Ltd (1978) 20 ALR 183; 33 FLR 327 the Full Court of this Court rejected an argument that only persons who are affected by a contravention of Pt V of the Trade Practices Act (the consumer protection provisions now contained in the ACL) could seek relief under s 80, holding that the words were to be given an unlimited ambit. An applicant need have no direct or special interest in the proceeding. A competitor of an alleged contravener, for example, may seek injunctive relief. The High Court endorsed this position in Truth About Motorways. See, for example, at [13]–[15] (Gleeson CJ and McHugh J). In any case, the applicants have a direct and special interest in the present proceeding.
79The enforcement of the Competition and Consumer Act through relief of this kind serves a public purpose. That purpose includes prevention and deterrence of undesirable trade practices. The public interest may justify the making of an injunction to restrain contravening conduct even in circumstances where the applicants have no personal interest and, as Toohey J observed in Trade Practices Commission v Mobil Oil Australia Ltd (1984) 4 FCR 296 at 300, even when the contravener is unlikely to engage in the offending conduct again. The power may be exercised in order “to mark the court’s disapproval” of the contravener’s conduct: ibid. Contrary to the respondents’ position, the TGA is not the sole guardian of the public interest when it comes to medical devices.
It remains for me to consider whether the terms of the proposed injunction are appropriate.
Having regard to my findings, the proposed injunction would not operate over a range of conduct which includes conduct falling outside the relationship required by the section. It would be enforceable. Moreover, any breach would be detectable. The respondents did not suggest otherwise. But it is too prescriptive. In addition, parts of it are inappropriate, particularly those parts which refer to safety and efficacy studies of the devices. Although they would have been appropriate when the devices were launched, I am not satisfied that they are appropriate now. Furthermore, the “proper warning” included the risk of pain to the patient’s sexual partner when no such complaint was included in the applicants’ pleading and “difficulty defaecating” when that risk was only pleaded in the case of the POP devices. With suitable modifications, however, I consider that it would be appropriate to enjoin the respondents from supplying, distributing, marketing or promoting any of the SUI devices still on the ARTG without including in the IFU for each of those devices and any promotional material relating to those devices a warning in the following terms or to the following effect:
The mesh is designed to, and will invariably elicit in all patients, an acute inflammatory reaction followed by a chronic inflammatory response. The chronic inflammatory response will result in continuously regenerating scar tissue within and surrounding the implant for as long as the implant remains in the body. The scar tissue will cause the mesh to contract to some degree in all patients. It is not possible to predict the severity of the chronic foreign body response in any individual patient. In some patients the chronic inflammatory response will have adverse effects. It is not possible to identify in advance the patients who will experience those effects, although some patients are at greater risk than others. At-risk patients include healthy patients. The severity of a patient’s chronic inflammatory response can be affected by physical activity and mechanical loading of the pelvic floor. It can also be affected by conditions which affect the immune response and healing, such as autoimmune and connective tissue disorders. The mechanical forces in the pelvic floor may influence the compatibility and function of the implant.
The adverse events which may result include:
(a)infection;
(b)erosion of the mesh into the vaginal canal resulting in infection which may be difficult to treat, cause offensive vaginal discharge and pain;
(c)erosion of the mesh into surrounding organs such as the bladder, urethra or rectum which may cause pain and damage those organs;
(d)damage to nerves in the scar tissue surrounding the implant or elsewhere;
(e)chronic pain, which may be severe;
(f)dyspareunia, which may be severe and may become chronic;
(g)apareunia;
(h)leg weakness;
(i)de novo or recurrent incontinence;
(j)difficulty voiding; and
(k)vaginal discharge.
Adverse events may occur years after implantation. The risk will endure for as long as the implant remains in the patient.
Each of these events may occur regardless of the skill of the surgeon.
While the true incidence of these complications is unknown, they are not rare.
Removal of the implant in whole or in part will not necessarily alleviate the patient’s symptoms. Removal of part of the implant can be difficult. Removal of the whole of the implant may be practically impossible. Surgery to remove the whole or part of an implant can result in further scarring and tissue damage which, in turn, may have adverse outcomes including severe chronic pain which may not be able to be satisfactorily treated. Surgery to remove the whole or part of the implant may also result in recurrence of stress urinary incontinence.
Removal of the eroded mesh will not necessarily prevent further erosions or other adverse events.
Since all of the POP devices have been removed from the market and are no longer on the ARTG, I am not satisfied that there is any utility in extending the injunction to, or making a similar injunction with respect to, those devices.
PART XX: DISPOSITION
The parties should bring in short minutes of order giving effect to these reasons by 14 February 2020. Those orders should include both orders with respect to the disposition of the applicants’ claims and those required by s 33ZB of the FCA Act. The length of time I have allowed takes into account the length of the judgment and the impending summer holiday period. I encourage the parties, however, not to wait until the last moment but to do their best to ensure that orders can be made as soon as possible.
By 20 December 2019 I require each of the applicants to notify the respondents and the Court whether she elects to receive damages in accordance with the relevant provisions of the TPA or at common law, as modified by local legislation where applicable.
In the event that the parties are unable to agree on the form of the orders or all the orders, including the form of the common questions and the answers to them for the purpose of the s 33ZB orders, a timetable for the filing and exchange of submissions should be forwarded to my chambers by 17 January 2020, with a view to a hearing in the week commencing 10 February 2020.
I will grant liberty to apply on two days’ notice.
I certify that the preceding five thousand, eight hundred and twenty‑seven (5,827) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Katzmann. Associate:
Dated: 21 November 2019
women (Review)” The Cochrane Collaboration (John Wiley & Sons Ltd, 2009) (ETH.MESH.04558879)
women (Review)” The Cochrane Collaboration (John Wiley & Sons Ltd, 2009) at 1 (ETH.MESH.04558879 at 8885)
(Review)” (John Wiley & Sons Ltd, 2017) (PUB.MESH.00011228)
(Review)” (John Wiley & Sons Ltd, 2017) at 1 (PUB.MESH.00011228 at 1231)
operative procedures: a randomized study” (2015) 10 Open Med 311–317 (PUB.MESH.00001868)
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