Turner v Bayer Australia Ltd
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•10 December 2024
IN THE SUPREME COURT OF VICTORIA Not Restricted AT MELBOURNE
COMMON LAW DIVISION
GROUP PROCEEDINGS LIST
S ECI 2019 02916
PATRICE SARAH TURNER Plaintiff v BAYER AUSTRALIA LTD (ACN 000 138 714) & ORS Defendants
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JUDGE:
KEOGH J
WHERE HELD:
Melbourne
DATE OF HEARING:
11–14, 17–21, 24, 26–28 April, 1–4, 8–12, 23–25, 29–31 May, 1–2, 5–9, 13–16, 19–23, 27–28, 30 June, 21, 28, 31 July, 1–4 August 2023
DATE OF JUDGMENT:
10 December 2024
CASE MAY BE CITED AS:
Turner v Bayer Australia Ltd
MEDIUM NEUTRAL CITATION:
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REPRESENTATIVE ACTION — Implantable medical device — Contraceptive device made from metal alloys and PET fibre — Device designed to incite inflammatory response in fallopian tube to cause development of fibrosis resulting in tubal occlusion and sterilisation — Whether the device had an inherent defect in that it caused ongoing chronic inflammation in a not insignificant number of women, resulting in adverse events of chronic pelvic pain and abnormal uterine bleeding — General causation not established — Plaintiff’s symptoms likely caused by adenomyosis — Whether there were risks that the device could migrate, be expulsed, break or fragment, corrode, fatigue, perforate organs and/or leach nickel or other metals resulting in new or increased pain, new or increased menstrual bleeding and/or damage to internal organs — Whether resolution of any adverse event associated with the device was likely to require surgical removal of uterus or fallopian tubes — Some risks established — Degree and magnitude of proven risks.
CONSUMER LAW — Whether devices 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 — Significance of supply of devices via gynaecologists — Whether defendants failed to warn doctors or patients of certain risks or potential complications and the gravity of complications — Whether state of scientific or technical knowledge at time of supply not such as to enable defects to be discovered — Ethicon Sàrl v Gill (2021) 288 FCR 338 — Merck Sharp & Dohme (Australia) Pty Ltd v Peterson (2011) 196 FCR 145— Adequate warnings and information given about established risks — Goods not defective.
CONSUMER LAW — Whether devices not of ‘merchantable quality’ within the meaning of s 74D of the Trade Practices Act 1974 (Cth) or ‘acceptable quality’ within the meaning of s 54 of the Australian Consumer Law — Expectations of reasonable consumer of medical device — Medtel Pty Ltd v Courtney (2003) 130 FCR 182 — Lack of merchantable quality not established.
CONSUMER LAW — Where goods manufactured by foreign defendants in same corporate group and supplied by local corporations — Where foreign defendants had no place of business in Australia but impugned conduct took place in Australia — Whether foreign defendants can be found liable for contraventions of the Trade Practices Act 1974 (Cth) and the Australian Consumer Law — Whether certain conduct of foreign defendants was ‘in trade or commerce’ — Whether foreign defendants were carrying on business in Australia.
NEGLIGENCE — Duty of care — Content of duty owed by manufacturers and suppliers to end users of medical devices — Whether defendants were negligent in development, design and marketing of device — Extent of obligation to warn where products supplied through ‘learned intermediaries’ — Whether product information and warnings insufficient to inform consumers of potential risks — Wrongs Act 1958 (Vic), s 48 — Gill v Ethicon Sàrl (No 5) [2019] FCA 1905 — Merck Sharp & Dohme (Australia) Pty Ltd v Peterson (2011) 196 FCR 145— Plaintiff failed to establish breach of duty owed by defendants.
LIMITATION OF ACTIONS — Whether certain actions statute-barred — Effect of long-stop provisions — Trade Practices Act 1974 (Cth), ss 74J, 75AO — Trade Practices Amendment (Personal Injuries and Death) Act (No 2) 2004 (Cth) ss 87F, 87G, 87H — Statutory claims of group members in respect of supply of devices before 13 July 2004 statute-barred — Statutory claims of group members in respect of devices supplied between 13 July 2004 and 28 June 2007 expired.
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APPEARANCES:
Counsel Solicitors For the Plaintiff F Forsyth KC and F Ryan SC with E Levine and M Guo Slater & Gordon For the Defendants D Collins KC and B Walker SC with K Brazenor, D Wong and J Teng Clayton Utz TABLE OF CONTENTS
I.INTRODUCTION........................................................................... 10
II.ANATOMY OF THE UTERUS AND FALLOPIAN TUBES... 17
III.ESSURE............................................................................................. 23
IV.PARTIES........................................................................................... 25
Plaintiff........................................................................................................ 25
Group members......................................................................................... 25
Defendants.................................................................................................. 26
First defendant – Bayer Australia Ltd (‘Bayer Australia’)......... 26
Second defendant – Bayer AG....................................................... 26
Third defendant – Bayer HealthCare............................................ 27
Fourth defendant – Bayer Essure................................................... 27
Fifth defendant – Gytech Pty Ltd (‘Gytech’)................................ 28
Sixth defendant – Australian Medical & Scientific Ltd (‘AMSL’)................................................................................................. 28
V.PLEADED CLAIMS........................................................................ 29
Inherent defects.......................................................................................... 29
Failure defects............................................................................................ 30
Adverse events........................................................................................... 32
Removal limitation.................................................................................... 32
Injuries......................................................................................................... 33
Marketing conduct.................................................................................... 35
Statutory claims......................................................................................... 36
Negligence.................................................................................................. 37
VI.PLEADED DEFENCES.................................................................. 38
Limitation periods..................................................................................... 39
State of scientific knowledge.................................................................... 39
Safety defects did not exist at the time of supply................................. 40
Significant injury........................................................................................ 41
VII.WITNESSES..................................................................................... 41
Lay witnesses............................................................................................. 41
Turner................................................................................................ 41
Defendants........................................................................................ 42
Expert witnesses........................................................................................ 43
Turner gynaecology......................................................................... 44
Gynaecology..................................................................................... 45
Pathology........................................................................................... 46
Immunology..................................................................................... 51
Biomaterials...................................................................................... 52
Clinical data...................................................................................... 56
Regulatory......................................................................................... 57
Remaining experts........................................................................... 58
VIII.GYNAECOLOGICAL CONDITIONS........................................ 58
Pelvic pain and dysmenorrhea................................................................ 59
Abnormal uterine bleeding and menorrhagia...................................... 63
IX.CONTRACEPTION........................................................................ 64
X.HISTORY OF ESSURE.................................................................. 67
Pre-market testing and clinical studies.................................................. 67
Non-clinical laboratory testing...................................................... 67
Animal studies.................................................................................. 68
Biocompatibility studies.................................................................. 68
Pre-market clinical studies.............................................................. 69
Corrosion testing.............................................................................. 80
Regulatory approval................................................................................. 82
Pre-market approval application to the FDA.............................. 82
Regulatory approval outside the United States........................... 89
Essure supply in Australia....................................................................... 91
Post-Market clinical studies..................................................................... 91
Phase II study 5-year follow-up..................................................... 91
Pivotal trial five-year follow-up..................................................... 96
Newly trained physicians study final reports........................... 101
Subsequent clinical trials........................................................................ 104
SUCCES II clinical trial.................................................................. 104
Transvaginal ultrasound clinical study...................................... 107
NovaSure endometrial ablation clinical trial............................. 109
522 study.......................................................................................... 111
Post-market surveillance and risk management................................. 111
Essure annual PMA reports.......................................................... 112
Essure clinical evaluation reports................................................ 113
Periodic post-market surveillance reports................................. 113
Risk analysis reports...................................................................... 113
Bayer management review meetings.......................................... 114
Increased medical reporting and concerns about Essure.................. 114
Social media.................................................................................... 114
Medical device reporting in the US............................................. 115
Increase in Medical device reports.............................................. 115
ARGUS database............................................................................ 117
2015 FDA review............................................................................ 120
ANSM report.................................................................................. 123
Regulatory concerns from 2014 to 2017...................................... 124
Global product discontinuance............................................................. 136
Jones v Dunkel inferences............................................................... 137
Post-discontinuance clinical evaluation............................................... 140
2019 Metals Advisory Committee meeting................................ 141
XI.PHYSIOLOGICAL RESPONSE TO ESSURE IMPLANTATION......................................................................................... 142
The immune system................................................................................ 143
Wound healing......................................................................................... 146
Chronic wound........................................................................................ 150
Foreign body response............................................................................ 152
Biocompatibility....................................................................................... 155
Literature relied on by experts..................................................... 161
Key definitions......................................................................................... 164
Acute inflammation....................................................................... 164
Chronic inflammation................................................................... 167
Persistent chronic inflammation.................................................. 175
Pro-inflammatory response.......................................................... 176
Inflammatory cell infiltrate........................................................... 176
Inflammatory cells......................................................................... 177
Acute inflammatory cells and chronic inflammatory cells...... 178
Scientific literature relevant to definitions................................. 179
XII.HISTOLOGY.................................................................................. 183
Histology of the uterus and fallopian tubes........................................ 183
Uterus............................................................................................... 183
Fallopian tubes............................................................................... 187
Essure histological studies..................................................................... 189
Twelve-week rabbit study............................................................ 194
Twenty-six week rabbit study...................................................... 196
Pre-hysterectomy study and Valle 2001..................................... 197
Hysterectomy data from annual PMA reports.......................... 230
Essure 505 Study............................................................................ 239
Maassen 2018.................................................................................. 241
Rubin 2020....................................................................................... 250
Banet 2020........................................................................................ 252
Hoogendam 2020........................................................................... 261
Catinon 2022................................................................................... 267
Further expert evidence.......................................................................... 272
Submissions on Essure histological evidence..................................... 274
Turner.............................................................................................. 274
Defendants...................................................................................... 276
Analysis..................................................................................................... 278
XIII.CORROSION................................................................................. 281
Essure composition................................................................................. 284
316LVM stainless steel................................................................... 286
Nitinol.............................................................................................. 286
Tin-Silver solder............................................................................. 287
Key definitions......................................................................................... 287
Leach. ............................................................................................... 287
Corrosion......................................................................................... 287
Galvanic corrosion......................................................................... 288
Metal release................................................................................... 288
Local toxicity................................................................................... 288
Delayed-type hypersensitivity reaction...................................... 289
Corrosion tests......................................................................................... 290
Immersion bench test..................................................................... 290
Potentiodynamic cyclic polarisation test.................................... 290
Relevant standards for implantable devices........................................ 291
ASTM F2129.................................................................................... 292
ASTM F3306.................................................................................... 293
ISO-10993......................................................................................... 293
FDA 2015a and 2019e.................................................................... 293
Acceptable metal ion release rates............................................... 294
Expert evidence on corrosion testing................................................... 295
Acceptance criteria......................................................................... 295
Chrzanowski................................................................................... 295
Eiselstein.......................................................................................... 296
Conceptus corrosion tests....................................................................... 298
Corrosion bench test...................................................................... 299
Potentiodynamic test..................................................................... 308
Essure corrosion studies......................................................................... 313
Parant 2020...................................................................................... 313
Parant 2022...................................................................................... 314
Catinon 2020................................................................................... 316
Catinon 2022................................................................................... 318
Aslan 2022....................................................................................... 319
Goodwin 2023................................................................................. 322
Further expert evidence on Essure corrosion studies............... 326
Submissions on Essure corrosion studies............................................ 336
Turner.............................................................................................. 336
Defendants...................................................................................... 338
Analysis..................................................................................................... 342
XIV.OTHER PROPOSED MECHANISMS CAUSING ONGOING CHRONIC INFLAMMATION.................................................................. 345
Micro-movements causing ongoing mechanical injury..................... 346
Vulnerability of the fallopian tube and uterus to incomplete wound healing............................................................................................. 351
Scar-free wound healing of the uterus and fallopian tube................ 355
Hypoxic state of the uterus and fallopian tube................................... 359
XV.EPIDEMIOLOGY.......................................................................... 362
Key terms.................................................................................................. 364
Null hypothesis.............................................................................. 366
Non-inferiority margin.................................................................. 366
Statistical power............................................................................. 367
Significance..................................................................................... 367
Bias.... ............................................................................................... 368
Hierarchy of epidemiological evidence in medical research............ 369
Experiments.................................................................................... 370
Randomised controlled trials....................................................... 370
Cohort studies................................................................................. 371
Unadjusted comparisons.............................................................. 371
Propensity score matching............................................................ 371
Systematic reviews, meta-analysis and data pooling............... 373
Fixed effect analysis....................................................................... 374
Random effects analysis................................................................ 374
Essure comparative studies.................................................................... 376
Conover 2015.................................................................................. 376
Perkins 2016.................................................................................... 381
Carney 2017..................................................................................... 384
Bouillon 2018................................................................................... 387
Steward 2018................................................................................... 390
Gariepy 2022................................................................................... 395
522 study.......................................................................................... 398
Retrospective Analyses................................................................. 403
Utility of Essure comparative studies................................................... 405
As-Sanie’s analysis......................................................................... 405
Gebski’s pooled analysis............................................................... 417
Criticisms of Gebski’s pooled analysis....................................... 424
No Essure RCT............................................................................... 436
Submissions on epidemiological evidence.......................................... 442
Turner.............................................................................................. 442
Defendants...................................................................................... 449
Analysis..................................................................................................... 454
RCT... ............................................................................................... 454
Gebski’s pooled analysis............................................................... 457
522 study.......................................................................................... 459
Essure comparative studies.......................................................... 460
XVI.CAUSATION STUDIES.............................................................. 464
Pelvic pain................................................................................................. 465
Chene 2019...................................................................................... 465
Francini 2021................................................................................... 466
Eychenne 2021................................................................................ 468
Chauhan 2021................................................................................. 469
Beckwith 2008................................................................................. 473
Clark 2017........................................................................................ 474
Casey 2016....................................................................................... 475
Van Limburg Stirum 2020............................................................. 476
Maassen 2018.................................................................................. 478
Banet 2020........................................................................................ 480
Rubin 2020....................................................................................... 481
Catinon 2022................................................................................... 482
Abnormal uterine bleeding.................................................................... 483
XVII.CLINICAL EXPERIENCE............................................................ 487
XVIII.CAUSATION................................................................................. 490
Principles and authorities....................................................................... 490
Submissions.............................................................................................. 501
Turner.............................................................................................. 501
Defendants...................................................................................... 507
Analysis..................................................................................................... 511
CPP and dysmenorrhea................................................................ 511
AUB... ............................................................................................... 517
Fatigue, breakage and fragmentation......................................... 518
Migration and expulsion............................................................... 523
Perforation....................................................................................... 529
Corrosion and allergic/hypersensitivity reaction..................... 533
Removal limitation......................................................................... 539
XIX.TURNER’S CASE.......................................................................... 540
History, tests and treatment................................................................... 541
Expert evidence on Turner’s diagnosis................................................ 550
Adenomyosis.................................................................................. 551
PCOS. ............................................................................................... 563
Expert evidence on causation of Turner’s symptoms........................ 566
Submissions.............................................................................................. 568
Turner.............................................................................................. 568
Defendants...................................................................................... 571
Analysis..................................................................................................... 575
When did Turner’s gynaecological symptoms develop?......... 575
Cause of Turner’s symptoms........................................................ 580
Warnings in Turner’s case............................................................ 594
Assessment of damages................................................................ 601
XX.WARNINGS................................................................................... 604
Essure product information................................................................... 604
Instructions for use.................................................................................. 605
Australian IFU distribution.......................................................... 607
IFU content...................................................................................... 610
Physician Training Manuals.................................................................. 620
PTM distribution............................................................................ 620
PTM content.................................................................................... 621
Essure device training programs........................................................... 626
Patient information brochures............................................................... 637
PIB distribution.............................................................................. 637
PIB content...................................................................................... 639
Webpages.................................................................................................. 646
‘Informed Consent Protocols’ during the clinical trial period.......... 649
Submissions.............................................................................................. 653
Turner.............................................................................................. 653
Defendants...................................................................................... 657
Analysis..................................................................................................... 659
Ongoing chronic inflammation causing CPP, dysmenorrhea or AUB...................................................................................... 662
Pain and bleeding disturbance..................................................... 663
Migration and expulsion............................................................... 664
Breakage, fragmentation and fatigue.......................................... 666
Corrosion......................................................................................... 666
Perforation....................................................................................... 667
Damage to internal organs............................................................ 669
Removal limitation......................................................................... 669
Clinical trial period........................................................................ 670
XXI.POST-MARKET SURVEILLANCE........................................... 671
Submissions.............................................................................................. 679
Turner.............................................................................................. 679
Defendants...................................................................................... 679
Analysis........................................................................................... 680
XXII.LIMITATION PERIODS............................................................. 681
XXIII.STATUTORY CLAIMS................................................................ 683
Application of the TPA and ACL to the defendants.......................... 684
Clinical trial period........................................................................ 684
Extra-territorial application.......................................................... 686
Defendants as ‘manufacturers’.............................................................. 696
Bayer Australia............................................................................... 698
Bayer AG......................................................................................... 700
Bayer HealthCare........................................................................... 701
Bayer Essure.................................................................................... 702
Gytech.............................................................................................. 702
AMSL............................................................................................... 702
Supply in trade or commerce................................................................. 702
Defect claim.............................................................................................. 703
Principles and authorities............................................................. 704
Submissions.................................................................................... 710
Analysis........................................................................................... 714
Merchantable Quality claim................................................................... 716
Principles and authorities............................................................. 717
Submissions.................................................................................... 718
Analysis........................................................................................... 720
XXIV.NEGLIGENCE............................................................................... 720
Duty........................................................................................................... 721
Breach........................................................................................................ 728
XXV.ANSWERS TO COMMON QUESTIONS............................... 736
GLOSSARY
KEY TERMS
ASOC
Amended Statement of Claim dated 23 December 2022
CPP
Chronic pelvic pain
AUB
Abnormal uterine bleeding
PET
Polyethylene terephthalate
PIB
Patient information brochure
IFU
Instructions for use
PTM
Physician training manual
FDA
United States Food and Drug Administration
TGA
Australian Therapeutic Goods Administration
ARTG
Australian Register of Therapeutic Goods
NSAI
National Standards Authority of Ireland
ANSM
French National Agency for Medicines and Health Products Safety
PMN
Polymorphonuclear cells
PMA
Post-market approval
PMS
Post-market surveillance
MDR
Medical device report
JER
Joint expert report
DTHR
Delayed-type hypersensitivity reaction
RCT
Randomised controlled trial
PID
Pelvic inflammatory disease
IUD
Intrauterine device
PCOS
Polycystic ovarian syndrome
HSG
Hysterosalpingogram
OCP
Oral contraceptive pill
LEGISLATION
TPA
Trade Practices Act 1974 (Cth)
ACL
Australian Consumer Law
TG Act
Therapeutic Goods Act 1989 (Cth)
Wrongs Act
Wrongs Act 1958 (Vic)
CCA
Competition and Consumer Act 2010 (Cth)
Evidence Act
Evidence Act 2008 (Vic)
TP Amendment Act
Trade Practices Amendment (Personal Injuries and Death) Act (No 2) 2004 (Cth)
TABLE OF SCHEDULES
1
Results of Conceptus biocompatibility studies
2
Plaintiff’s re-operation aide memoire
3
IFU aide memoire
4
PTM aide memoire
5
PTM training overview diagram
HIS HONOUR:
I. INTRODUCTION
1 This proceeding concerns Essure, a permanent contraceptive device that was commercially supplied to women in Australia between 2001 and August 2017 as an alternative to laparoscopic tubal sterilisation.
2 Essure is a spring-like device that consists of inner and outer metal coils with PET fibres located in between. During the implantation procedure, it is hysteroscopically inserted into a woman’s fallopian tube. The outer coil is released and expands to press against the inner walls of the fallopian tube, holding the device in place. Features of the device including the PET fibres and expanded outer coil incited a localised inflammatory foreign body response in the fallopian tube in order to cause fibrosis resulting in tubal occlusion and sterilisation.
3 After the birth of her third child, the plaintiff Patrice Turner sought out options for permanent contraception. Essure was one of the options she discussed with her gynaecologist. Turner understood that Essure implantation was a day procedure, was less intrusive and had a faster recovery time than tubal ligation. She chose to proceed with Essure.
4 Turner returned to normal health a few days after the procedure was performed. However, within a few years she began to experience abnormal uterine bleeding (‘AUB’) and pelvic pain. Turner’s menstrual bleeding became much heavier and lasted for longer. She also began to suffer sharp and debilitating pelvic pain, and constant heavy and dull pain in a band around her lower abdomen and back. Turner’s symptoms worsened over time.
5 Almost five years after having Essure implanted, Turner consulted a gynaecologist who advised her to have a hysterectomy. By that time Turner was suffering severe pelvic pain and regular heavy menstrual bleeding. After Turner’s hysterectomy, the debilitating symptoms she had been experiencing resolved. Turner was 32 years old when she had hysterectomy surgery.
6 Turner brings this representative proceeding on her own behalf and on behalf of all women who had Essure implanted and allegedly suffered harm as a result. She relies on three causes of action. First, Turner alleges that Essure had a defect within the meaning of s 75AC of the TPA and/or a safety defect within the meaning of s 9 of the ACL, giving rise to a cause of action under s 138 of the ACL (‘Defect claim’). The defendants raised the statutory ‘state of scientific knowledge’ defence to the Defect claim. Second, she alleges that Essure was not of merchantable quality within the meaning of s 74D of the TPA and/or not of acceptable quality within the meaning of s 54 of the ACL, giving rise to a cause of action under s 271 of the ACL (‘Merchantable Quality claim’). Third, Turner alleges that the third defendant, Bayer HealthCare LLC (‘Bayer HealthCare’) and the fourth defendant, Bayer Essure Inc (‘Bayer Essure’) were each negligent in the design, development, manufacture, supply and distribution of Essure in Australia. Further, Turner alleges that all of the defendants apart from the second defendant Bayer Aktiengesellschaft (’Bayer AG’), were negligent in failing to provide adequate warnings about the device defects and associated risks to women’s health, and in failing to ensure that information disclosing the defects and risks was made available to women who already had Essure implanted (‘negligence claims’).
7 There were three important features of the case that were critical to the determination of the claims Turner made.
8 Turner alleged, as the first and principal limb of her case, that in a not insignificant number of women Essure caused ongoing chronic inflammation that resulted in chronic pelvic pain (‘CPP’) and AUB (‘inherent defects’). Turner argued that unlike other implanted biomedical devices, Essure was designed to promote an inflammatory response in order to create scar tissue. She alleged there was an inherent risk that Essure would cause ongoing chronic inflammation in some women because of its fundamentally problematic design, and because of certain features of the fallopian tube environment and adjacent uterus. Turner alleged that in some cases, the corrosion of metal ions and particles from the device would likely cause or contribute to the chronic inflammatory response. Turner relied on expert evidence that ongoing chronic inflammation caused by Essure could result in women experiencing CPP, dysmenorrhea and/or AUB. She said this meant that many healthy young women who chose Essure as a permanent contraceptive option suffered severe symptoms that could only be resolved by major surgery involving removal of the fallopian tubes or uterus (‘removal limitation’). The defendants argued that the foreign body response to Essure devices resolved normally and that there was no evidence that Essure could cause ongoing chronic inflammation resulting in CPP, dysmenorrhea or AUB.
9 The following categories of evidence were critical to the determination of whether, as a question of general causation, Essure can cause ongoing chronic inflammation resulting in CPP, dysmenorrhea or AUB. The first is clinical studies which report histologic assessment of fallopian tube tissue from women who had Essure devices surgically removed. Turner argued that the histologic assessments showed ongoing chronic inflammation that would be associated with adverse health outcomes in fallopian tube tissue caused by Essure devices in a not insignificant proportion of women. The defendants argued that the histologic assessments were evidence of a normal foreign body response to Essure, and that in most or all cases the assessments reported the mere presence of certain types of immune cells. The defendants argued the histological studies were not evidence that Essure can cause ongoing chronic inflammation that is pathologic and injurious to health.
10 The second category is corrosion studies. Turner argued that the studies showed that the Essure device corroded in vivo, resulting in significant accumulation of metal ions and particles in adjacent fallopian tube tissue. She argued that the accumulated metal ions and particles were likely to be a cause of ongoing chronic inflammation in some women. The defendants argued that the rate of Essure corrosion in vivo decreased over time. They accepted there was a risk that metal ions from a device could cause an allergic hypersensitivity reaction in some women, which could be associated with an ongoing inflammatory response. They argued that hypersensitivity reactions were extremely rare, the subject of an adequate warning, and amenable to treatment. The defendants argued that Turner had not established that corrosion occurred at a rate or to a degree that was unsafe, or that corrosion was a likely cause of ongoing chronic inflammation.
11 The third category is evidence of the biological plausibility of mechanisms that Turner argued explained how Essure could cause ongoing chronic inflammation leading to CPP, dysmenorrhea and AUB. Turner relied on what she submitted was compelling scientific opinion evidence of biological causal mechanisms provided by the expert witnesses she called. The defendants submitted that the expert evidence of causal mechanisms relied on by Turner amounted to no more than ‘brainstormed’ hypotheses which were hotly contested by their own expert witnesses. Further, the defendants argued that even if the biological explanations advanced by Turner were found to be plausible, they were not sufficient to establish that Essure was a cause of CPP and AUB, in the face of contrary evidence including epidemiological studies and the results of extensive testing conducted before and after Essure was placed on the market.
12 The fourth category is epidemiological studies examining the possibility of a relationship between Essure and adverse events including CPP and AUB, using laparoscopic tubal sterilisation as a comparator (‘comparative studies’). The outcomes of these comparative studies do not show any increase in the rate of CPP and AUB for women who underwent hysteroscopic sterilisation (principally by use of Essure) compared to women who underwent laparoscopic sterilisation. Turner argued that high quality biostatistical studies of Essure should have but had not been undertaken and that the comparative studies were of inferior design and poor quality, meaning very little weight could be attributed to the available epidemiological evidence.
13 The defendants made two points in response. First, the defendants argued that consistent with the approach taken in legal authority and in scientific analysis, epidemiological evidence was critical to consideration of the possible causal connection between an exposure such as by implantation of Essure and the adverse outcomes under consideration. The defendants submitted that Turner’s attempt to prove general causation without relying on epidemiological evidence was novel. Second, the defendants argued that the comparative studies, which examine the experiences of over 100,000 women, show that Essure is not associated with an increase in the incidence of CPP or AUB. The defendants submitted that the most probable explanation is that the rates of CPP and AUB identified in those studies reflect the background rates of those conditions experienced by women of reproductive age. The defendants argued that it logically follows from the outcomes of the comparative studies that Turner had not established an association, let alone a causal relationship, between Essure and CPP or AUB.
14 The fifth category is clinical evidence. The evidence of gynaecologists who had treated women for CPP, dysmenorrhea and AUB did not support a causal connection between Essure and these conditions. There is no evidence that laboratory tests for the presence of pathological chronic inflammation in women who had Essure devices implanted had been administered. The histological assessment in Turner’s case did not report the presence of chronic inflammation in her fallopian tubes. Turner’s medical records do not indicate that her treaters had a clinical suspicion of pathologic chronic inflammation. Turner’s treating surgeon, who was not called to give evidence, diagnosed adenomyosis as the cause of her gynaecological symptoms.
15 The final category is evidence of the prevalence and range of causes of CPP and AUB in women. CPP and AUB commonly affect women of reproductive age. There is a broad range of potential causes of both disorders. Diagnosis is complex and causation is often multifactorial. It is not uncommon that no causal pathology is identified. This context is relevant to Turner’s attempt to attribute causation of CPP and AUB to Essure.
16 For the detailed reasons that follow I have largely accepted the defendants’ submissions. I have concluded that the biostatistical evidence weighs heavily against causation, and represents a very significant barrier to Turner proving general causation. The evidence supporting general causation in the histological and corrosion studies, and the expert evidence of biologically plausible causal mechanisms is far from compelling. The clinical evidence does not support general causation. In relation to the first limb of Turner’s case, I am not satisfied that she has established that Essure can cause ongoing chronic inflammation in some women resulting in CPP, dysmenorrhea and/or AUB.
17 The second feature of Turner’s case was her allegation that, following implantation, there were risks that an Essure device would migrate into the peritoneal cavity; be expulsed from the fallopian tube; break or fragment; corrode; fatigue; perforate the fallopian tube, uterus or other organs such as the bowel; and/or leach nickel or other metals into the body of the recipient (‘failure defects’). Turner alleged that eventuation of one or more of these risks could result in new pain or increased pain including dysmenorrhea, new or increased menorrhagia and/or damage to internal organs.
18 The defendants accepted that there were risks of migration, expulsion, perforation and metal leaching that may be associated with adverse health outcomes. They argued that these risks were associated with many biomedical devices and surgical procedures, that the degree of risk was low, that the magnitude of an adverse health outcome if a risk eventuated was likely to be small, and that the risks were the subject of adequate warnings. The defendants argued that the only evidence of the devices breaking or fragmenting was in the process of surgical implantation or removal, and that Turner had not proven a risk that Essure devices could corrode or fatigue resulting in them breaking or fragmenting in vivo.
19 The third feature of Turner’s case was her allegation that the defendants distributed patient information brochures (‘PIBs’) and published webpages about Essure which did not adequately disclose the risks of adverse events and outcomes Essure could cause. The defendants accepted they did not provide a warning that Essure could cause ongoing chronic inflammation resulting in CPP, dysmenorrhea or AUB because they said that risk did not exist. They argued that the warnings and information they provided about Essure included the content of training programs for gynaecologists who performed the Essure procedure, physician training manuals (‘PTMs’) provided to gynaecologists, and Instructions For Use (‘IFUs’) supplied with Essure devices. They argued that this material adequately disclosed risks that were associated with Essure, and that Turner had not demonstrated any relevant deficiency in the information provided about the device.
20 There was a risk that an Essure device could migrate, be expulsed from the fallopian tube, perforate organs, corrode, and leach nickel or other metals into the body. I conclude that in most cases, the degree and magnitude of these risks were small and that they were often associated with placement or removal of the device. I do not accept that there was a risk that Essure could break, fragment or fatigue once implanted in the body.
21 I have again largely accepted the defendants arguments. I have concluded that the defendants provided adequate warnings of the established Essure risks in the PTMs and IFUs. It was reasonable to expect that treating gynaecologists would provide information and warnings about the established risks to their patients based upon their own specialist skill, expertise and experience and the information provided by the defendants. The PIBs and webpages relied on by Turner did not represent the entirety of the information and warnings about the Essure risks provided by the defendants and available to women considering undergoing the Essure procedure.
22 For the reasons that follow, I have concluded that the three claims made by Turner have failed.
II. ANATOMY OF THE UTERUS AND FALLOPIAN TUBES
23 The uterus is an inverted pear-shaped muscular organ of the female reproductive system, located in the middle of the pelvis in the space between the bladder and the rectum.[1] A circular narrowing in the inferior portion of the uterus divides it in two. The upper part is called the uterine corpus (body of the uterus). The lower part is called the uterine cervix (cervix), and is a tubular structure that connects the endometrial cavity and the vagina. The cervix, uterine corpus, fallopian tubes and ovaries together form the female upper genital tract (shown in the following diagram).[2]
[1]Lam at 19 [2.4] (EXP.001.002.0006).
[2]As-Sanie at 11 [33] (EXP.001.002.0005).
24 The uterus has three main layers. The outer layer that forms the surface of the organ facing the peritoneal cavity is the serosa or perimetrium. The thick muscular wall of the uterus is the myometrium. The inner layer of the uterus is the endometrium, where embryos normally implant and develop when a pregnancy occurs.[3] The endometrium itself is divided into three layers: the thin surface layer called the epithelium; the functionalis or ‘functional’ layer, which contains glands that are most responsive to the hormones estrogen and progesterone during the menstrual cycle and is completely shed during menstruation; and the less responsive basalis or ‘basal’ layer located between the functionalis and myometrium.[4]
[3]Robertson at 64 [238] (EXP.001.001.0127).
[4]Murdock at 10 [14] (EXP.001.002.0008).
25 The epithelium consists of a single layer of epithelial cells. It provides a degree of protection from infectious organisms but is soft, easily damaged and does not protect against chemical agents or trauma.[5]
[5]Robertson at 64-5 [238] (EXP.001.001.0127).
26 The hormonal response of the functionalis results in transient changes to its physical structure, cellular composition and function over the course of the menstrual cycle. Each month, estrogen stimulates the dynamic growth and proliferation of the functionalis, followed by degeneration and shedding in response to progesterone. The cycle of menstruation then regeneration, represented in the following diagram, is unique to the uterus.[6]
Glands in the functionalis become progressively more secretory in the second half of the menstrual cycle, delivering fluids into the endometrial cavity to support an embryo that may have formed in the event of conception. If conception has not occurred the endometrial layer will undergo a phase of senescence, with cells beginning to die and be progressively lost as menstrual fluid.[7]
[6]Ibid at 65 [242].
[7]T2674-5 (TRA.500.029.0001 at 0020_28-0021_3).
27 The myometrium has robust contractile action that is most important for labour and birth, but also promotes shedding and expulsion of endometrial tissue during menstruation. This can cause menstrual cramping and pain that should not occur to the level that interferes with normal daily functions.[8]
[8]Robertson at 66 [243] (EXP.001.001.0127).
28 The two fallopian tubes arise from the body of the uterus and provide the connection between the uterus and each ovary.
29 The fallopian tube has four segments. The funnel-shaped infundibulum is the distal end of the tube that opens into the peritoneal cavity adjacent to the ovary. Attached to the distal end of the infundibulum are fimbria, which are finger-like mucosal projections which project over the medial surface of the ovary. The ampulla is the longest segment of the fallopian tube. Fertilisation usually takes place within the lumen of the ampulla.[9] The final two segments of the fallopian tube are the isthmus which is about 2–3 cm long, followed by the intramural region (also known as interstitial region or SUTJ) which is approximately 1 cm long and connects the fallopian tube and the uterus.[10]
[9]As-Sanie at 12 [38] (EXP.001.002.0005)
[10]Robertson at 78 (EXP.001.001.0127); As-Sanie at 12 (EXP.001.002.0005).
30 The fallopian tube has three layers: an outer serosa layer, a middle smooth muscle layer and an inner mucosal layer comprised of lamina propria (a thin layer of connective tissue) covered by a single columnar epithelial lining.
31 The features and dimensions of different segments of the tube vary relative to the role played in transporting ova, sperm and early embryos; conception; and early embryo development.[11] A diagrammatic illustration of conception in the fallopian tube and implantation of the embryo in the uterus follows:[12]
[11]Robertson at 74 [276] (EXP.001.001.0127)
[12]Ibid at 232.
32 The external diameter of the fallopian tube and the internal diameter of the lumen progressively reduce along its length as it approaches the uterus. The ampulla has large numbers of branching folds that appear in cross-section as a labyrinth of finger-like projections with little space between them. The folds are less highly branched and numerous in the isthmus, and less again in the intramural region.[13] These features are demonstrated in the following figure:[14]
Figure 2. Normal fallopian tube anatomy and the microscopic findings at each segment. All histologic images are at 10x, low magnification except the second isthmus image, which is at 20x, medium magnification. The intramural cross section demonstrates a fallopian tube lumen with surrounding uterine smooth muscle (myometrium). The first cross section of isthmus is surrounded by the fallopian tube muscular wall (myosalpinx), which is composed of 3 layers 1) an inner longitudinal layer, 2) a circular layer 3) an outer longitudinal layer. The second cross section of isthmus shows a thick-walled muscle layer. Note the expanded lumen with more plica (longitudinal branching folds) compared to the first cross section of isthmus. The ampulla has a thin-walled muscular area and an expanded lumen with normal plicae. The fimbriated end has numerous finger-like projections, each covered with a single layer of epithelium.
The narrowing of the lumen of the fallopian tube is necessary to allow the inner walls to form contact with the embryo and propel it towards the uterus.[15]
[13]Ibid at 74 [278].
[14]Murdock at 8 (EXP.001.002.0008).
[15]Robertson at 74 (EXP.001.001.0127).
33 The transport of ova and embryos in the direction of the uterus is mediated by delicate cilia (fine hair-like structures) on the surface of the fimbriae in specialised cells of the tubal epithelium. These cilia cells beat in the direction of the uterus, creating a current that transports the ovum towards the site of fertilisation.[16] Peristaltic activity in the tubal muscular layer propels sperm against the current of the cilia from the uterine end of the fallopian tube into the ampulla, where fertilisation of the ovum takes place.[17]
[16]Ibid at 75 [281].
[17]Ibid at 75.
34 Any surgical procedure that prevents transport of the ovum, sperm and/or early embryo along the fallopian tube by occluding, interrupting or removing a segment or the entirety of both tubes is a method of permanent sterilisation.[18]
[18]As-Sanie at 13 [39] (EXP.001.002.0005).
III. ESSURE
35 Essure was developed as an alternative to tubal ligation. Each Essure device is comprised of:
(a) a 316L stainless steel inner coil;
(b) a chromium doped nitinol (nickel/titanium) dynamically expanding outer coil;
(c) PET fibres attached to the inner coil;
(d) a ball tip at the distal end of the inner coil, composed of either silver-tin solder or remelted 316L stainless steel;[19]
[19]SBM.001.001.0004 at 11 [19].
(e) a platinum/iridium half band at the proximal end of the outer coil; and
(f) a platinum/iridium positioning marker attached to the inner coil.[20]
[20]BAY-ESSURE-0004422; BAY-ESSURE-0004934.
36 Each device was delivered hysteroscopically into the fallopian tube in a wound down configuration, attached to a delivery wire, constrained by a release catheter and sheathed by a flexible, hydrophilically coated delivery catheter. In the wound down configuration, an Essure device was approximately 4 cm in length and 0.8 mm in diameter. The delivery catheter extended only to the joint between the inner and outer coil. The unsheathed ball tip acted as a guidewire to cannulate the fallopian tube. The platinum/iridium half band and positioning marker acted as a visual guide for the physician to determine the correct depth of insertion into the fallopian tube. Once released, the device expanded to an approximate diameter of 2.0 mm to acutely anchor itself into the fallopian tube, with a number of outer coils trailing into the uterus. A drawing of the Essure device and the internal delivery components is shown below:
37 The Essure insertion procedure was designed to be performed without the need for incisions. In Australia, the Essure procedure was performed under anaesthetic in an operating theatre setting by a gynaecologist.[21]
[21]Rosen (EXP.001.002.0002); T2636 (TRA.500.028.0001_2 at 0099_10).
38 The intended placement of the Essure insert in the fallopian tube and uterine cavity is shown in the following diagram:[22]
[22]PLE.001.002.0001 at 9.
39 The PET fibres were intended to promote an inflammatory response resulting in fibrotic tissue ingrowth that secured the device in place and occluded the fallopian tube lumen, resulting in permanent sterilisation.
IV. PARTIES
Plaintiff
40 Turner was born in 1986. She has three children. In September 2013 after the birth of her youngest child, Turner underwent hysteroscopic implantation of Essure into each of her fallopian tubes. Turner had hysterectomy surgery resulting in explantation of the devices on 25 June 2018.
Group members
41 Turner brings this proceeding on behalf of all women who had Essure devices implanted at any time on or before 31 December 2018, and who have suffered harm as a result.
42 Essure was at all times manufactured overseas and imported into Australia. From the late 1990s, some Essure devices were supplied for clinical trials conducted in Australia that involved implantation into participating women. The defendants admitted that Essure devices were commercially supplied in Australia from about 2001 to 28 August 2017 (‘commercial supply period’).
Defendants
First defendant – Bayer Australia Ltd (‘Bayer Australia’)
43 Bayer Australia is an Australian corporation in the Bayer group of companies which was the registered sponsor of Essure on the ARTG under the TG Act from 29 January 2018 to 9 February 2018. Bayer Australia admitted that its name was included on some material published in Australia regarding Essure between 1 July 2013 and August 2017.[23] What further role, if any, Bayer Australia played in relation to Essure was in issue. Turner alleged that Bayer Australia was a ‘manufacturer’ of Essure within the meaning of s 7 of the ACL. Bayer Australia submitted that it did not supply Essure in Australia and was not a manufacturer of Essure for the purposes of the ACL.
[23]PLE.500.001.0008 at [7](c).
Second defendant – Bayer AG
44 Bayer AG is a corporation registered in Germany. It has no place of business or registered office in Australia.
45 Bayer AG is the owner of the following trademarks numbered 1950359, 242139, 242143 and 1188965:
From around 1 July 2013 to August 2017, one or more of these trademarks appeared on some material published in Australia regarding Essure. Turner submitted the evidence established that Bayer AG was a manufacturer of Essure under the ACL from 5 June 2013. Bayer AG submitted that because of the extra-territorial provisions of the ACL, the legislation did not apply to it; and that in any event, it was not a manufacturer of Essure within the meaning of the ACL and did not supply the device in Australia.
Third defendant – Bayer HealthCare
46 Bayer HealthCare is an indirect subsidiary of Bayer AG and is a limited liability company registered in Delaware in the US.
47 Bayer HealthCare admitted that:
(a) it was responsible for the design and development of Essure from around 5 June 2013 to 1 January 2016;
(b) it was responsible for limited manufacturing and assembly of Essure from around 1 July 2013 to 1 January 2016;
(c) it supplied Essure for importation into, and distribution in, Australia from around 1 July 2013 to 31 May 2017;
(d) from around 1 July 2013 to August 2017, some material published in Australia regarding Essure included the name of Bayer HealthCare; and
(e) it was the registered manufacturer of Essure on the ARTG from around May 2014 to 9 February 2018.[24]
[24]Ibid at [9].
Bayer HealthCare admitted that it was a manufacturer of Essure in accordance with the TPA and ACL from 5 June 2013 until about 9 February 2018.[25] However, it denied that it came within the extra-territorial jurisdiction of the TPA and ACL and argued that the statutory provisions Turner relied on did not apply to it.
[25]Ibid at [9](e)(ii).
Fourth defendant – Bayer Essure
48 Bayer Essure is a company registered in Delaware in the US.
49 From 1992 to 25 October 2013, Bayer Essure was named Conceptus Inc (‘Conceptus’). On 5 June 2013, Conceptus was acquired by a wholly owned subsidiary of Bayer HealthCare. On 25 October 2013, Conceptus changed its name to Bayer Essure Inc.
50 During the period from December 1999 to around 1 July 2013, Bayer Essure (as Conceptus) designed, developed and manufactured Essure and supplied the device for importation to Australia.[26] Bayer Essure admitted that from about 1999 to about 2014 it:
[26]Ibid at [10](c).
(a) owned the trademark ‘Conceptus’ and the Conceptus logo; and
(b) was listed on the ARTG as the manufacturer of Essure.[27]
[27]Ibid at [10](d).
51 Bayer Essure admitted that it was a manufacturer of Essure from about 1999 to about 1 May 2014 within the meaning of s 74A of the TPA and s 7 of the ACL.[28] Bayer Essure denied that it was a manufacturer of Essure under the ACL at any time from 1 May 2014. Further, Bayer Essure denied that it came within the extra-territorial jurisdiction of the TPA or ACL.
[28]Ibid at [10](e).
Fifth defendant – Gytech Pty Ltd (‘Gytech’)
52 Gytech was the importer and the exclusive distributor of Essure in Australia, and the registered sponsor of the device on the ARTG, from 19 August 2010 to 31 December 2014. Gytech admitted it was a manufacturer of Essure for the purposes of the TPA and ACL during this period.[29]
[29]SBM.500.001.0003_2 at 105 [8.4].
Sixth defendant – Australian Medical & Scientific Ltd (‘AMSL’)
53 AMSL is incorporated in New Zealand and registered in Australia as a foreign company. From around 23 January 2015 to 28 January 2018, AMSL was the registered sponsor of Essure on the ARTG. From 1 January 2015 to around 31 May 2017, AMSL was the importer and sole distributor of Essure in Australia. From 2015 to 2017, AMSL promoted and marketed Essure in Australia and the AMSL name appeared on material relating to Essure during this time. AMSL admitted it was a manufacturer of Essure within the meaning of s 7 of the ACL from 1 January 2015 to 1 August 2017.[30]
[30]PLE.500.001.0008 at [12](d).
V. PLEADED CLAIMS
54 Turner alleged that Essure was defective, and that this resulted in the risk of women who had the devices implanted suffering from adverse events and injuries. She alleged that the defendants failed to disclose the existence of the defects and the risk of adverse events in the marketing material they published. These allegations were the foundation of each of the claims advanced by Turner.
Inherent defects
55 In paragraph [18] of her amended statement of claim (‘ASOC’), Turner alleged that by reason of its design and method of operation, Essure:
a.disrupted the inner layers of the uterine horn and/or the fallopian tubes;
b.caused initial acute inflammation in the fallopian tubes and/or endometrium;
c.caused ongoing chronic inflammation in the fallopian tubes and/or endometrium; and/or
d.incited a foreign body response to the Essure Insert in the fallopian tubes and/or endometrium and/or uterine cavity.[31]
In her final submissions, Turner clarified that the matters alleged in sub-paragraphs (a), (b) and (d) above were not relied on as separate defects, but were part of the explanation for why Essure caused chronic inflammation in some women. A central issue at trial was whether Turner had established the allegation in (c) above.
[31]PLE.001.002.0001 at [18].
56 Turner alleged that an ongoing chronic inflammatory response to Essure occurred in some women implanted with the device by reason of:
(i)the acute inflammatory response not resolving;
(ii)limited biocompatibility in the constituent materials of the Essure Insert hindering the physiological healing process following acute inflammation;
(iii)lack of surface functionalisation of the Essure Insert;
(iv)the metal and synthetic components of the Essure Insert including the mixing of metals of different electrochemical potential;
(v)corrosion and metal ion release;
(vi)micromovements causing ongoing mechanical injury in the tissue of the fallopian tube;
(vii)the Essure Insert not resorbing in the body;
(viii)the Essure Insert not promoting a functional integration with host tissues;
(ix)the propensity of female reproductive tissue and organs towards a pro-inflammatory response; and/or
(x)the interaction of the female reproductive tissue with the Essure Insert as a foreign body and the elicitation of the foreign body response.[32]
[32]AID.001.001.0002 at 18–19.
57 The defendants agreed that Essure was designed to disrupt the inner layers of the fallopian tube upon insertion, cause acute inflammation and incite a foreign body response. They said that this was a necessary part of the process leading to development of fibrotic scar tissue to occlude the fallopian tube. However, the defendants denied that Essure caused an ongoing chronic inflammatory response as alleged.
Failure defects
58 In paragraph [19] of the ASOC, Turner pleaded that there was a risk that following implantation, an Essure device:
a.would:
i.migrate, including into the abdominal cavity;
ii.be expulsed from the fallopian tube and/or uterus;
iii.break or fragment;
iv.corrode;
v.fatigue; and/or
b.would perforate the fallopian tube, uterus or other organs such as the bowel; and/or
c.would:
i.leach nickel or other metals into the body of the recipient; …[33]
[33]PLE.001.002.0001 at [19].
59 The defendants agreed that unsatisfactory location of the device during implantation could be associated with migration, expulsion or perforation of the fallopian tube, uterus or bowel in some patients. They said that nickel alloys were commonly used in medical devices, and that nickel may be released at low levels from an Essure device following implantation. They said that during the commercial supply period, publications were made available to doctors and patients in Australia regarding Essure that contained information and risk warnings about matters including the following:
(i)the fact that all medical procedures and implantable devices carry risks and that there were risks associated with implantation and use of the Essure Device; and
(ii)risks that may be associated with implantation, use and/or removal of the Essure Device included:
A.movement of the Essure Insert such as migration or expulsion from the fallopian tube;
B.breakage or fragmentation of the Essure Insert during removal;
C.perforation of or damage to internal organs such as the uterus during implantation or as a result of unsatisfactory location of the Essure Insert during the implantation process;
D.an allergic reaction to nickel-titanium;
E.pain; and
F.bleeding.[34]
[34]PLE.500.001.0008 at [19](c)(i)-(ii).
60 The defendants accepted that an Essure device may corrode in vivo. However, they denied that there was a risk that a device might break or fragment because of corrosion or fatigue, or that this could result in migration, expulsion, perforation or injury.
61 The defendants argued that the degree and magnitude of the admitted risks were small.
Adverse events
62 Turner alleged in paragraph [20] of the ASOC that, by reason of any one or more of the inherent defects and/or the failure defects, there was a risk that an Essure insert would cause:
a.pain or increased pain, including serious, chronic and/or recurring pain;
b.new, increased or worsened menorrhagia (heavy menstrual bleeding);
c.new, increased or worsened dysmenorrhoea (intense uterine cramping and pain); and/or
d.damage to internal organs.[35]
(‘adverse events’).
[35]PLE.001.002.0001 at [20].
63 Turner principally relied on ongoing chronic inflammation as the cause of the adverse events in (a), (b) and (c) above. At trial, those adverse events were described broadly as CPP, dysmenorrhea and AUB. The risk of the adverse event in (d) was alleged to arise from perforation, migration, breakage or fragmentation of the device and to result in pain and bleeding.
64 The defendants denied there was a risk that Essure could cause ongoing pathologic chronic inflammation resulting in CPP or AUB.
65 The defendants relied on the information and warnings they had made available to doctors and patients in Australia regarding the risk of adverse events associated with Essure.
Removal limitation
66 It was not in dispute that Essure was designed to anchor in a woman’s fallopian tube after insertion and quickly become embedded in fibrotic tissue.
67 Turner alleged that a woman who experienced an adverse event associated with Essure would be unable to resolve the adverse event without abdominal surgery to remove the insert. This removal surgery would likely involve a salpingectomy or hysterectomy. Turner relied on the removal limitation as being relevant to the magnitude of the risk of an adverse event.
68 The defendants admitted that Essure was designed to promote tissue ingrowth and long-term anchoring, and might require salpingectomy or hysterectomy to effect its removal if a patient experienced an adverse event. They alleged that information and risk warnings made available to doctors and patients regarding Essure included:
A.the fact that all medical procedures and implantable devices carry risks and that there were risks associated with implantation and use of the Essure Device;
B.the Essure Device procedure was permanent and not reversible;
C.removal of the Essure Insert may require surgery; and
D.if surgical removal of the Essure Insert was required, a salpingectomy or hysterectomy might be required[.][36]
[36]PLE.500.001.0008 at [21](d)(ii).
Injuries
69 Turner pleaded that:
…[b]y reason of one or more of the Inherent Defects, the Failure Defects and/or the Removal Limitation and/or the occurrence of one or more of the Adverse Events, the Plaintiff and group members suffered injuries as a result of implantation of the Essure Insert.[37]
[37]PLE.001.002.0001 at [23].
70 The particulars of injuries allegedly resulting from the inherent defects include:
(iv) By reason of the Inherent Defects and/or the Removal Limitation, some Group Members suffered the following injuries (GM Implantation Injuries):
…
B.the development of acute and then chronic or persistent chronic inflammation in the fallopian tubes and/or endometrium; and
C.associated symptoms or conditions of pain (including pelvic or abdominal pain o[r] cramping) and/or abnormal uterine bleeding, and/or menstrual abnormalities, (including exacerbation of any of the above), some with resulting sexual dysfunction, and/or psychological conditions or symptoms;
D.in some cases requiring:
1.hysterectomy (with or without bilateral or unilateral salpingectomy and with or without oophorectomy);
2.salpingectomy (bilateral or unilateral, with or without oophorectomy and/or corneal resection)[.] [38]
[38]AID.001.001.0002 at 36–38.
71 Turner particularised injuries resulting from the failure defects as follows:
(vii) By reason of the Failure Defects, in some Group Members the Essure Device migrated, was expulsed from the fallopian tube or uterus, broke or fragmented, corroded, fatigued and/or leached nickel or other metals into the body of the recipient.
(viii) By reason of the matters in the previous subparagraph, some Group Members suffered:
A.disruption of tissue;
B.acute inflammation;
C.chronic or persistent chronic inflammation; and/or
D.damage to internal organs; and/or
E.associated symptoms or conditions of pain (including abdominal, pelvic pain and cramping) and/or bleeding (including menstrual abnormalities) (including exacerbation of any of the above), some with resulting sexual dysfunction, and/or psychological conditions or symptoms;
F.in some cases requiring:
1.hysterectomy (with or without bilateral or unilateral salpingectomy and with or without oophorectomy)
2.salpingectomy (bilateral or unilateral, with or without oophorectomy and/or corneal resection);
3.surgery to investigate the cause of symptoms or conditions;
4.other surgery to excise the device from the body; and/or
5.removal of other organs or part of an organ.[39]
[39]Ibid at 39–40.
72 The defendants’ case was that there were known or expected risks associated with implantation of a biomedical device such as Essure; that they communicated information and warnings about those risks in published material made available to doctors and potential recipients of Essure; and that the degree and magnitude of the risks were small.
Marketing conduct
73 Turner alleged that between 1999 and 2018, the defendants published PIBs and webpages about Essure which were directed to potential recipients of the device (‘marketing material’). Turner alleged:
The Marketing Material did not or did not adequately disclose the existence of the Inherent Defects, the Failure Defects, the risk of Adverse Events, and/or the Removal Limitation (the Marketing Conduct).
Particulars
(i)The Marketing Material did not contain express references to the Inherent Defects, the Failure Defects, the risk Adverse Events and/or the Removal Limitation.
(ii)To the extent that the Marketing Material made any references to any one or more of the Inherent Defects, the Failure Defects, the Adverse Events and/or the Removal Limitation, any risks were downplayed and/or were represented as rare and/or temporary.
(iii)The general impression given by the Marketing Material was that the Essure Device was safe, gentle and had a low impact on the body.
(iv)There was no or no adequate reference to the Essure Insert operating as an intrauterine device nor to any increased risks associated with the Essure Device and any pain or bleeding conditions. [40]
…
[40]PLE.001.002.0001 at [25].
74 The defendants responded that Essure was supplied to women via their treating gynaecologist, and that publications they made available to gynaecologists and women regarding Essure disclosed the risks associated with implantation of the device. The publications relied on by the defendants were the PIBs, IFUs contained in the boxes in which Essure was supplied, and PTMs provided to doctors as part of training for the Essure procedure. The defendants alleged that prior to performing the Essure procedure the gynaecologist would, as a matter of course, have consulted with the patient, synthesised information relevant to the patient’s needs, provided information and advice about Essure, and made recommendations as to the most appropriate contraceptive option for the patient. The defendants alleged that in those circumstances, it was reasonable for them to expect that a patient undergoing the Essure procedure would be informed by their doctor of the risks and benefits associated with alternative contraceptive options, including Essure.
75 The defendants’ response to the risks associated with Essure alleged by Turner dictated the central matters in issue at trial. As stated above, the defendants accepted that some of the alleged risks existed. The defendants argued that context relevant to consideration of the accepted risks included the following: every contraceptive option carries risks; all medical procedures and implantable devices carry risks; information and warnings were made available to doctors and patients in Australia regarding the risks; it was reasonable to expect that doctors would inform their patients about the comparative risks and benefits of Essure; and the magnitude and degree of the accepted risks was small.
76 The defendants understandably took a different approach to the pleaded risks which they argued did not exist. The defendants accepted that they did not provide information or warnings to doctors or patients about the risk that Essure could cause ongoing pathologic chronic inflammation resulting in CPP or AUB, because they denied that risk existed. The most significant issue at trial was whether Turner had established the existence, degree and magnitude of this alleged risk.
2256 Second, if Hoogendam 2020 was accepted as a case where the risk of harm proposed by Turner eventuated, it would stand alone as the only example identified in all of the evidence. In those circumstances, Turner would have established no more than that there was a rare risk of ongoing chronic inflammation resulting in adverse health outcomes associated with Essure that was no different than with any other biomedical device. As Badylak said, there will be cases like that in Hoogendam 2020 with any medical device. In those circumstances, I would have found that Turner had not established that the risk was ‘not insignificant’.[2277]
[2277]Ultra Thoroughbred Racing Pty Ltd v Those Certain Underwriters [2011] VSC 589 at [285] (J Forrest J).
2257 Third, reasonableness must be assessed in the context of all of the steps taken by Bayer Essure (as Conceptus) and other Bayer entities, both pre- and post-FDA approval, in relation to the design, development, safety assessments and monitoring of Essure.
2258 Fourth, relevant context also includes the process of approval of Essure for commercial supply and the ongoing regulatory oversight by the FDA, TGA and other regulatory bodies set out in Chapter X of these reasons.
2259 Fifth, I take into account the training, information and warnings provided by the defendants to gynaecologists who were approved to perform the Essure procedure, set out in Chapter XX of these reasons.
2260 Sixth, it was reasonable for the defendants to expect that gynaecologists consulting with women who were considering permanent sterilisation and the Essure procedure would warn their patients about potential risks associated with the device and relevant contraindications. That would include gynaecologists warning patients about inherent risks associated with implantation of biomedical devices. Turner did not lead evidence to show that a rare outcome such as that in Hoogendam 2020, being the eventuation of a risk associated with implantation of any biomedical device, was outside the knowledge of gynaecologists who performed the Essure procedure.
2261 Seventh, there was clearly social utility in providing women a choice for permanent sterilisation which enjoyed some advantages compared to the available alternatives on a risk-benefit analysis.
2262 Eighth, the burden of taking precautions on the design failure case advanced by Turner was very considerable. Turner’s case was, in effect, that Essure was ‘a bad idea from the start’ and that the device should never have been commercially supplied. Turner submitted that Essure ‘was poorly conceived and poorly designed and should not have been put on the market without proper long-term safety testing’.[2278] The extensive process undertaken to design and obtain approval for commercial supply of Essure is set out in these reasons. I infer that the cost of re-conceiving and re-designing Essure in order to minimise the risk of an outcome like in Hoogendam 2020 would have been very considerable.
[2278]T41 (TRA.500.001.0001_2 at 0042_19).
2263 I conclude that even if the case reported by Hoogendam 2020 was accepted as being an eventuation of the risk of harm identified by Turner, a reasonable person in the position of Bayer Essure or Bayer HealthCare would not have taken the precaution of reconceptualising and re-designing Essure.
2264 For similar reasons, had I found causation in relation to Hoogendam 2020, I would conclude that Turner had failed to establish breach on her ‘failure to warn/failure to inform’ case. While the burden on the defendants of taking precautions on that case would have been lower, it is not clear what further warning or information should have been provided to take account of the rare occurrence described in Hoogendam 2020. It is also unclear why a warning framed to take account of that possible eventuation of the risk would be more effective than the information already provided by the defendants in the training, PTMs, IFUs and PIBs, considered in the context of the skill of doctors who performed the Essure procedure and the duties they owed to their patients. Turner did not call Weatherill or any other gynaecologist who had performed the Essure procedure in Australia. Turner has not established that Bayer Essure, Bayer HealthCare, Gytech or AMSL breached their duty of care to group members by failing to give a warning or information about the possibility of a Hoogendam 2020 outcome.
2265 To establish the probability of harm, Turner relied on the following evidence. First was Robertson’s opinion that Essure would cause persistent chronic inflammation in a small but not insignificant proportion of women; that persistent chronic inflammation has a ‘very high likelihood’ of triggering or exacerbating CPP;[2279] and that she expected it to cause AUB in a not insignificant proportion of women.[2280] Robertson based her opinion on her theories as to biological plausibility and the findings of chronic inflammation recorded in the Essure histological studies.[2281] She said the adverse events recorded in the MAUDE database and the outcomes of the causation studies aligned with and corroborated her opinion.[2282]
[2279]Robertson at 118 (EXP.001.002.0015_2).
[2280]Robertson at 181 (EXP.001.001.0127_2).
[2281]Ibid at 14.
[2282]Ibid at 171–181.
2266 Second was Korda’s opinion that Essure ‘often’ caused pain and increased or worsened heavy menstrual bleeding, dysmenorrhea and damage to internal organs.[2283]
[2283]Korda (EXP.001.001.0025).
2267 Third, Turner submitted that the 2015 FDA report[2284] prepared for the 2015 OGDAP meeting which summarised the reports of adverse events and information from the ARGUS database[2285] was ‘further evidence of the prevalence of the harms associated with the device’ for which she contended. Turner submitted that the 2023 interim results of the 522 study, ‘while not conclusive of incidence of Adverse Events[,] further [support] a finding that the incidence is not insignificant’.[2286]
[2284]BAY-EDPA-0934554.
[2285]TUR.002.001.0067_2.
[2286]SBM.001.001.0004 at 319 [1072].
2268 Had I found that there was a risk that Essure would cause ongoing chronic inflammation resulting in CPP and AUB in some women, Turner’s submissions and the evidence upon which she relied could not form the basis of a positive conclusion as to the degree of that risk. The quantifications expressed by Robertson in terms of ‘not insignificant proportion of women’ and ‘very high likelihood’ are based largely, if not entirely, on her theories of biological plausibility. There is no path of reasoning from any quantitative evidence identified by Robertson that makes her expression of opinion meaningful. Attribution of causation must be considered in the context that complaints of CPP and AUB are common in reproductive age women, that there are a large range of potential causes of those complaints, a number of which are themselves common, and that frequently no pathological cause is found for symptoms of CPP and AUB. In this context, the mere fact that complaints of this nature are frequently recorded in the MAUDE database, the 2015 FDA report and the ARGUS database means nothing in terms of attributing causation.
2269 The opinions of Robertson and Korda about the probability of harm are untethered to any quantitative evidence or clinical evidence of instances in which the identified harm has eventuated and is causally linked to Essure. In the circumstances, I attribute little weight to these opinions about the probability of harm.
2270 The defendants admit that Essure did cause some of the pleaded ‘failure defects’ and ‘adverse events’. It is not reasonable to expect that a biomedical device such as Essure will be risk free. The established risks were the subject of adequate warnings by the defendants, and were in the nature of adverse outcomes that surgeons would expect to be associated with implantable devices and procedures such as the Essure procedure. Turner has not established that Bayer’s design, testing or manufacture of the device was in some way deficient such that it fell below the reasonable standard of care. Reasonableness did not require that Bayer Essure, Bayer HealthCare, Gytech or AMSL provide further information or warnings to group members about those risks, or take any other step as a precaution against evaluation of a risk.
2271 I conclude that Turner has failed to establish any breach of the duty owed to her and group members by Bayer Essure, Bayer HealthCare, Gytech and/or AMSL.
XXV. ANSWERS TO COMMON QUESTIONS
Question 1: Over what time period was the Essure Device supplied in Australia and by which Defendants?
Bayer Essure supplied Essure from about 1999 to about 1 July 2013. Bayer HealthCare supplied Essure from about 1 July 2013 to 28 August 2017. Gytech supplied Essure from 19 Augst 2010 to 31 December 2014. AMSL supplied Essure from 1 January 2015 to around 28 August 2017.
Question 2: Were the Essure Devices goods within the meaning of sections 4 and 74A(2) of the Trade Practices Act and section 2 of the Australian Consumer Law?
Yes.
Question 3: Which, if any, of the Defendants were ‘manufacturers’ of the Essure Device within the meaning of section 74A of the Trade Practices Act and/or section 7 of the Australian Consumer Law (and, if any, during what time periods)?
Bayer HealthCare from 5 June 2013 to 9 February 2018. Bayer Essure from about 1999 to about 1 May 2014. Gytech between 19 August 2010 and 31 December 2014. AMSL between 1 January 2015 and 28 August 2017.
Question 4: Which, if any, of the Defendants promoted and marketed the Essure Device in Australia (and, if any, during what time periods)?
Bayer Essure from about 1999 to 2014. Bayer HealthCare from about July 2013 to 28 August 2017. Gytech from 19 August 2010 to 31 December 2014. AMSL from 1 January 2015 to 28 August 2017.
Question 5: Which, if any, of Bayer Australia Ltd, Gytech Pty Ltd and/or AMSL were a ‘sponsor’ of the Essure Device for the purposes of the Therapeutic Goods Act (and, if any, during what time period)?
Bayer Australia from about 29 January 2018 until 9 February 2018. Gytech from 19 August 2010 to 31 December 2014. AMSL from around 23 January 2015 to 28 January 2018.
Question 6: Was the Essure Device supplied for importation into Australia and, if so, by whom and during what time periods?
Yes. Bayer Essure from about 1999 to 1 July 2013. Bayer HealthCare from about 1 July 2013 to about August 2017.
Was the supply of the Essure Device into Australia:
(a)for resupply to consumers; and
(b)in trade or commerce between Australia and places outside of Australia;
and, if so, by whom and during what time periods?
(a) Yes, (b) Yes. Essure was supplied by Bayer Essure, and then Bayer HealthCare, to various Australian suppliers, including Gytech and AMSL, for distribution in Australia from around 1997 to 1 August 2017.
Was the Essure Device imported into and supplied to treating hospitals or doctors (the Intermediary Suppliers) for resupply to consumers and, if so, by whom and during what time periods?
Yes. Bepen Pty Ltd between about 1 December 1999 and about 6 November 2000. Conceptus (Australia) Pty Ltd between about 6 November 2000 and about January 2005. N Stenning & Co Pty Ltd between about January 2005 and about August 2010. Gytech between about August 2010 and about January 2015. AMSL between about January 2015 and August 2017.
Was the supply of the Essure Device to Intermediary Suppliers and to the Plaintiff and Group Members in trade or commerce in Australia?
Yes.
Question 7: In respect of the Essure Device micro-insert (the Essure Insert):
(a) Was it comprised of any (and if so, which) of the following?
(i)A 316L stainless steel ‘inner coil’;
(ii) A chromium-doped nitinol (nickel titanium alloy) ‘outer coil’;
(iii) Polyethylene terephthalate fibres;
(iv) “platinum-iridium bands and bump”;
(v) silver-tin solder?
(b) Was it a spring-like device that:
(i) was wound down, in the disposable delivery system, to approximately 4 cm in length and 0.8 mm in diameter;
(ii) expanded, once deployed, to approximately 2.0 mm in diameter?
(c) Was a cross-section of the chromium- doped nitinol (nickel-titanium alloy) ‘outer coil’ of the micro-insert “rectangular with sharp corners”?
(a) Yes, (b) Yes, (c) No.
Question 8: Was the purpose of the Essure Device:
(a) to prevent pregnancy through implantation of a mechanical insert that could be left permanently in the body; or
(b) to provide patients with permanent birth control (contraception) by bilateral occlusion of the fallopian tubes?
Yes to both.
Question 9: Is the Essure Device designed to operate in any (and if so, which) of the following ways:
(a) via its initial presence, by triggering an acute inflammatory response in the fallopian tubes and/or endometrium?
(b) via its continued presence, by triggering a foreign body response in the fallopian tubes and/or endometrium?
(c) by disrupting the soft tissue in the walls of the fallopian tube once anchored?
(d) via its continued presence, by triggering a chronic inflammatory response in the fallopian tubes and/or endometrium?
(e) via the acute inflammatory response and/or chronic inflammatory response and/or foreign body response, by resulting in tissue in-growth into the coils of the Essure Insert and around the PET fibres?
(f) to the extent that the answer to the previous question is ‘yes’, by occluding the fallopian tube in which the Essure device was located?
(g) to the extent that the answer to the previous question is ‘yes’, by preventing pregnancy?
(h) by operating as an intrauterine device?
(a) Yes in the fallopian tubes, no in the endometrium, (b) Yes in the fallopian tubes, no in the endometrium, (c) Yes, (d) Yes in the fallopian tube, no in the endometrium, (e) Yes, (f) Yes, (g) Yes, (h) No.
Question 10: By reason of any of the matters alleged in ASOC to [17], did the Essure Insert cause any of the following:
(a) Disruption of the inner layers of the uterine horn and/or the fallopian tubes?
(b) Initial acute inflammation in the fallopian tubes and/or endometrium?
(c) Ongoing chronic inflammation in the fallopian tubes and/or endometrium?
(d) A foreign body response in the fallopian tubes and/or endometrium and/or uterine cavity?
(the Inherent Defects).
(a) Yes in the fallopian tubes, no in the uterine horn, (b) Yes in the fallopian tubes, no in the endometrium, (c) Yes in the fallopian tubes, no in the endometrium, (d) Yes in the fallopian tubes, no in the endometrium, no in the uterine cavity.
Question 11: By reason of any of the matters alleged in ASOC to [17], was there a risk that the design and composition of the Essure Insert would, following implantation, do any of the following:
(a) migrate;
(b) be expulsed from the fallopian tube and/or uterus;
(c) break or fragment;
(d) corrode;
(e) fatigue;
(f) perforate the fallopian tube, uterus or other organs such as the bowel;
(g) leach nickel or other metals into the body of the recipient;
(the Failure Defects).
(a) Yes, (b) Yes, (c) Yes, in the context of implantation or explantation of the device, (d) Yes, (e) No, (f) Yes, (g) Yes.
Question 12: To the extent that they are made out, did any one of the Failure Defects and/or the Inherent Defects (including in any combination) give rise to a risk that the Essure Insert would:
(a) cause or exacerbate pelvic pain (including dysmenorrhea, being intense uterine cramping and pain);
(b) cause or exacerbate serious continuing chronic and/or recurring pain;
(c) cause or exacerbate menorrhagia (being heavy menstrual bleeding);
(d) cause damage to internal organs;
(the Adverse Events).
(a) Yes, (b) No, (c) No, (d) Yes.
Question 13: Once the Essure insert is anchored into the fallopian tube(s):
(a) was it designed to be removed;
(b) was it unlikely to be able to be removed without surgery; and
(c) could it likely only be removed by:
(i) a salpingectomy; Or
(ii) a hysterectomy?
(a) No, (b) Yes, (c) Yes.
In the event that a woman experienced Adverse Events or other complications associated with the Essure Insert, would she be unable to resolve the Adverse Events or other complications through removal of the Essure Insert without abdominal surgery and likely the removal of one or more organs (the Removal Limitation)?
Yes.
Question 14: What information was provided about risks associated with the Essure Device, during what time periods and was this information provided to:
(a) recipients of the Essure Device in Australia (consumers); and/or
(b) users of the Essure Device in Australia (healthcare practitioners and healthcare institutions);
and if so, by which Defendants?
(a) Consumers:
(i) Fifteen PIBs were published in Australia during the commercial supply period.
(ii) Webpages were published in Australia during the commercial supply period.
(iii) Information conveyed by gynaecologists in consultation with consumers.
(iv) Informed consent protocols were used as part of clinical trials conducted from about 1997.
(b) Healthcare practitioners and institutions:
(i) Eleven IFUs were distributed to gynaecologists in Australia in the period March 2001 to October 2017.
(ii) At least three PTMs were distributed to physicians in Australia during the period 2000 to 28 August 2017.
(iii) Training was provided to gynaecologists during the commercial supply period.
The clinical trial protocols were provided by Bayer Essure. The PIBs, IFUs, PTMs and physician training programs were provided to the Australian distributors by Bayer Essure from about 1999 to 1 July 2013, and by Bayer HealthCare from 1 July 2013 to 28 August 2017. It is unclear which entity published the webpages. Gytech and AMSL provided the PIBs, IFUs, PTMs and the training to gynaecologists from 19 August 2010 to 31 December 2014, and 1 January 2015 to 28 August 2017 respectively.
Question 15: Were the Plaintiff and Group Members each ‘consumers’ within the meaning of section 4B of the Trade Practices Act and/or section 3 of the Australian Consumer Law?
No for those group members who received Essure as part of the clinical trials. Otherwise yes.
Question 16: Were the Essure Devices:
(a) not of ‘merchantable quality’ within the meaning of section 74D(1) and 74D(3) of the Trade Practices Act; and/or
(b) not of ‘acceptable quality’ within the meaning of sub-sections 54 (2) and (3) of the Australian Consumer Law;
by reason of any or all of the Inherent Defects, the Failure Defects, the risk of Adverse Events and/or the Removal Limitation?
No.
Question 17: Did the Essure Device have:
(a) a ‘defect’ within the meaning of s 75AC of the Trade Practices Act; and/or
(b) a ‘safety defect’ within the meaning of section 9 of the Australian Consumer Law;
by reason of any or all of the:
(c) Inherent Defects, the Failure Defects, the risk of Adverse Events and/or the Removal Limitation; and/or
(d) relevant matters identified in s 9(2) of the Australian Consumer Law or s 75AC(2) of the Trade Practices Act?
No.
If the answer to any part of this question is “yes”, for what time period was this the case?
Not necessary to answer.
Question 18: Having regard to the answers to the preceding question, are any of the Defendants (and if so, which and in respect of which defects / safety defects, and for what time periods) not liable for damages to the Plaintiff and/or Group Members pursuant to the statutory causes of action alleged against them under s 75AC of the Trade Practices Act 1974, and/or s 9 of the Australian Consumer Law, because of the defences in:
(a) s 75AK(1)(a) of the Trade Practices Act and/or s 142(a) of the Australian Consumer Law, that any defect or safety defect in the Essure Device did not exist at the time when it was supplied by its actual manufacturer;
(b) s 75AK(1)(c) of the Trade Practices Act and/or s 142(c) of the Australian Consumer Law, that the state of scientific or technical knowledge at the time when the Essure Device was supplied by its manufacturer was not such as to enable that defect or safety defect to be discovered?
Not necessary to answer.
Question 19: Was it reasonably foreseeable (and if so, to which Defendant/s, and during which time period/s) that loss or damage would be suffered by the Plaintiff and Group Members as a result of the Inherent Defects, the Failure Defects, the risk of Adverse Events and/or the Removal Limitation?
(a) Inherent defects – No, (b) Failure defects – Yes, in relation to perforation, migration, expulsion, corrosion and leaching to the extent of delayed type hypersensitivity reaction to nickel, and breakage and fragmentation in the process of surgical removal. No, in relation to the other failure defects, (c) Risk of adverse events – Yes, to the extent that pain or increased pain, altered bleeding, and damage to internal organs may be associated with incidents of expulsion, migration, perforation, breakage and fragmentation with surgical removal or DTHR to nickel, (d) Removal limitation – Yes.
Question 20: Was it reasonably foreseeable (and if so, to which Defendant/s, and during which time period/s) that:
(a) Individuals who were considering a procedure to implant the Essure Device or Devices may suffer harm arising from the Essure Device or Devices if they were not warned (or not adequately warned) about the Inherent Defects, the Failure Defects, the risk of Adverse Events and the Removal Limitation; and/or
(b) Individuals who had a procedure to implant the Essure Device or Devices may suffer harm (or further harm) arising from the Essure Device or Devices if information disclosing the Inherent Defects, Failure Defects and/or the risk of Adverse Events was not made available to those individuals?
(a) Yes, to the extent the risks existed.
(i) For Bayer Essure from at least 1 December 1999.
(ii) For Bayer HealthCare from at least 1 July 2013.
(iii) For Gytech from 19 August 2010.
(iv) For AMSL from 1 January 2015.
(b) No.
Question 21: Did any one or more of the Defendants know or ought they to have known that the Essure Device had the Inherent Defects, the Failure Defects, the risk of Adverse Events and/or the Removal Limitation (and if so who and in what time periods?)
Yes, to the extent the risks existed.
(a) For Bayer Essure from at least 1999.
(b) For Bayer HealthCare from at least 1 July 2013.
(c) For Gytech from 19 August 2010.
(d) For AMSL from 1 January 2015.
Question 22: In the period between about 1999 and about 2018, what duty did Bayer Essure Inc owe to the Plaintiff and each Group Member?
As a manufacturer, Bayer Essure owed a duty to take reasonable care to avoid reasonably foreseeable risks of harm to the users of Essure, which included the plaintiff and group members.
Question 23: In the period between about 2014 and about 2018, what duty did Bayer Healthcare LLC owe to the Plaintiff and each Group Member?
As a manufacturer, Bayer HealthCare owed a duty to take reasonable care to avoid reasonably foreseeable risks of harm to the users of Essure, which included the plaintiff and group members.
Question 24: In the period from about 2010 onwards, what duty did Gytech Pty Ltd owe to the Plaintiff and each Group Member?
Gytech owed a duty to take reasonable care to avoid injury to the users of Essure, which included the plaintiff and group members.
Question 25: In the period from about 2015 onwards, what duty did Australasian Medical and Scientific Limited owe to the Plaintiff and each Group Member?
AMSL owed a duty to take reasonable care to avoid injury to the users of Essure, including the plaintiff and group members.
Question 26: In the period from about 2014 onwards, what duty did Bayer Australia Limited owe to the Plaintiff and each Group Member?
None.
Question 27: If any duty is identified in the answers to questions 35-36, did Bayer Essure Inc and/or Bayer Healthcare LLC breach and if so on and from what dates did they breach that duty in:
(a) designing, developing, manufacturing; and/or
(b) distributing in Australia and supplying for sale in Australia,
the Essure Device with the Inherent Defects, the Failure Defects, the risk of Adverse events and the Removal Limitation?
No.
Question 28: If any duty is identified in the answers to questions 35-39, did Bayer Essure Inc, Bayer Healthcare LLC, Gytech Pty Ltd, Australasian Medical and Scientific Limited and/or Bayer Australia Ltd breach and if so on and from what dates did they breach that duty in:
(a) promoting or marketing the Essure Device without warning or adequate warning of the Inherent Defects, the Failure Defects, the risk of Adverse Events and/or the Removal Limitation; and/or
(b) failing to make available to the Plaintiff and Group Members who had already received the Essure Device information disclosing the Inherent Defects, Failure Defects and/or the risk of Adverse Events?
No.
Question 29: Are the claims of group members under s 74D of the Trade Practices Act who had their devices supplied on a date between 13 July 2004 and 28 June 2007 statute barred under s 74J(3), 87F(1)(b), 87H(1) of the Trade Practices Act, unless they obtain an extension of the long-stop period under s 87H(1)(b)?
Yes.
Are the claims of group members under s 75AD of the Trade Practices Act who had their devices supplied on a date between 13 July 2004 and 28 June 2007 statute barred under s 75AO and 87F(1)(b), 87H(1) of the Trade Practices Act, unless they obtain an extension of the long-stop period under s 87H(1)(b)?
Yes.
Are the claims of group members under s 74D of the Trade Practices Act who had their devices supplied on a date before 13 July 2004 statute barred under s 74J(3)?
No, but they are subject to the defence in s 74J(3).
Are the claims of group members under s 75AD of the Trade Practices Act who had their devices supplied on a date before 13 July 2004 statute barred under s 75AO(2)?
Yes.
Question 30: Did Bayer Essure Inc and/or Bayer Healthcare Inc design, develop and/or manufacture the Essure Device and, if so, during what time periods?
Yes. Bayer HealthCare designed, developed and manufactured Essure from around 5 June 2013. Bayer Essure, as Conceptus, designed, developed and manufactured Essure from 1997 to 1 May 2014.
Question 31: Did Bayer Australia, Bayer Essure, Bayer HealthCare LLC, Gytech and/or AMSL (and if so which) make available to the Plaintiff and Group Members who had already received the Essure Device information disclosing the Inherent Defects, the Failure Defects and/or the risk of Adverse Events and, if so, when?
Yes. On 30 August 2017, AMSL in consultation with the TGA issued a hazard alert referring to symptoms including chronic bleeding, perforation, migration and the requirement for abdominal surgery or hysterectomy for device removal.
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