Gill v Ethicon Sarl (No 5)

• Jurisdiction: Australia Federal only
• Judge: KATZMANN J
• Judgment Date: 21 November 2019
• Neutral Citation: [2019] FCA 1905
• Court: Federal Court

FEDERAL COURT OF AUSTRALIA

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

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...