Ethicon Sarl v Gill

Case [2021] FCAFC 29

FEDERAL COURT OF AUSTRALIA

Ethicon Sàrl v Gill [2021] FCAFC 29  

File number: NSD 391 of 2020
Judgment of: JAGOT, MURPHY AND LEE JJ
Date of judgment: 5 March 2021
Catchwords:

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

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

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

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

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

Civil Liability Act 2002 (WA)

Competition and Consumer Act 2010 (Cth)

Evidence Act 1995 (Cth)

Federal Court of Australia Act 1976 (Cth)

Judiciary Act 1903 (Cth)

Limitation Act 1935 (WA)

Limitation Act 2005 (WA)

Therapeutic Goods Act 1989 (Cth)

Trade Practices Act1974 (Cth)

Trade Practices Amendment Bill 1992 (Cth)

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

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

Wrongs Act 1958 (Vic)

Federal Court Rules 2011 (Cth)

Therapeutic Goods (Medical Devices) Regulations 2002 (Cth)

Explanatory Memorandum, Trade Practices Amendment Bill 1992 (Cth)

Federal Food, Drug and Cosmetic Act 1938 (US)

Federal Rules of Civil Procedure (US)
Cases cited:

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

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

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

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

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

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

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

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AGLC
Ethicon Sarl v Gill [2021] FCAFC 29
Case
[2021] FCAFC 29
Decision Date

CaseChat Overview and Summary

Ethicon Sarl v Gill involved a class action brought by three women against the manufacturer of urogynaecological medical devices. The respondents alleged that the devices were defective, that the appellants were negligent, and that the appellants engaged in misleading or deceptive conduct. The case was heard in the Federal Court of Australia. The primary judge found in favour of the respondents, and the appellants appealed the decision.

The legal issues in the appeal included whether the primary judge erred in finding that the devices were defective, not of merchantable or acceptable quality, or not reasonably fit for purpose. The court also had to determine whether the primary judge erred in finding that the respondents' damages were caused by the defects. Additionally, the court considered whether the primary judge erred in finding that the appellants engaged in misleading or deceptive conduct and that the respondents' damages were caused by such conduct. The court also examined whether the primary judge erred in finding that the appellants breached their duty of care by providing inadequate warnings of the risks associated with the devices. Finally, the court had to decide whether the primary judge erred in granting an injunction enjoining the appellants from supplying, distributing, marketing, or promoting the devices in Australia without a warning or advice.

The Full Court of the Federal Court dismissed the appeal. The court found that the primary judge did not err in finding that the devices were defective, not of merchantable or acceptable quality, or not reasonably fit for purpose. The court also found that the primary judge did not err in finding that the respondents' damages were caused by the defects. The court held that the primary judge did not err in finding that the appellants engaged in misleading or deceptive conduct and that the respondents' damages were caused by such conduct. The court found that the primary judge did not err in finding that the appellants breached their duty of care by providing inadequate warnings of the risks associated with the devices. Finally, the court found that the primary judge did not err in granting an injunction enjoining the appellants from supplying, distributing, marketing, or promoting the devices in Australia without a warning or advice.

The appeal was dismissed, subject to the parties providing competing submissions as to the costs of the appeal, an agreed or competing form of order addressing the issue referred to in [812] to [818] of the reasons of the Full Court, and any submissions, limited to five pages, relied upon by the parties to support any dispute as to the appropriate costs order and form of s 33ZB order. The Full Court resolved any such dispute on the papers.

Orders

Orders of the court

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

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

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

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

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

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

1 THE APPEAL

[1]

1.1 The proceedings before the primary judge

[1]

1.2 The issues in the appeal

[4]

1.2.1 Defects

[8]

1.2.2 Negligence

[12]

1.2.3 Misleadingor deceptive conduct

[19]

1.2.4 Limitation periods

[22]

1.2.5 Injunction

[24]

1.3 Summary of conclusions

[26]

2 KEY ASPECTS OF THE PROCEEDINGS BELOW

[27]

3 KEY FINDINGS OF THE PRIMARY JUDGE

[62]

3.1 The representative respondents - overview

[63]

3.1.1 Mrs Gill

[63]

3.1.2 Mrs Dawson

[69]

3.1.3 Mrs Sanders

[74]

3.2 The relevant conditions

[76]

3.2.1 Stress urinary incontinence

[76]

3.2.2 Pelvic organ prolapse

[81]

3.3 The devices

[86]

3.3.1 The SUI devices

[91]

3.3.2 The POP devices

[96]

3.4 Risks associated with mesh implantation

[100]

3.5 Biocompatibility

[113]

3.6 The performance of the devices

[136]

3.6.1 The evidence

[136]

3.6.2 Complication rates

[137]

3.6.3 SUI devices

[145]

3.6.4 POP devices

[152]

3.6.5 Gynemesh PS used abdominally in vault repair

[158]

3.7 Comparative outcomes

[159]

3.8 Regulatory requirements

[162]

3.9 Development and pre-market evaluations

[179]

3.9.1 SUI devices

[180]

3.9.1.1 TVT

[180]

3.9.1.2 TVT-O

[185]

3.9.1.3 TVT Secur

[187]

3.9.1.4 TVT Exact

[192]

3.9.1.5 TVT Abbrevo

[194]

3.9.2 POP devices

[196]

3.9.2.1 Gynemesh PS

[196]

3.9.2.2 Prolift

[199]

3.9.2.3 Prolift+M

[203]

3.9.2.4 Prosima

[206]

3.10 Post-market evaluation of the devices

[208]

3.10.1 General

[208]

3.10.2 Complaints

[212]

3.10.3 BSI audits

[219]

3.11 Removal of some devices from the market

[225]

3.12 Information the appellants provided about the devices

[234]

3.13 Statutory claims

[250]

3.13.1 Defect

[250]

3.13.2 Misleading and deceptive conduct

[275]

3.14 Negligence

[278]

3.14.1 Duty and breach

[278]

3.14.2 Causation – negligence

[292]

3.14.2.1 General

[292]

3.14.2.2 Mrs Gill

[295]

3.14.2.3 Mrs Dawson

[304]

3.14.2.4 Mrs Sanders

[308]

3.15 Limitation issues

[312]

3.15.1 Mrs Gill

[312]

3.15.2 Mrs Sanders

[327]

3.16 Damages and compensation

[334]

3.16.1 General

[334]

3.16.2 Mrs Gill

[335]

3.16.3 Mrs Dawson

[342]

3.16.4 Mrs Sanders

[354]

3.17 Other observations

[365]

4 OVERARCHING OBSERVATIONS

[366]

4.1 Appellants’ submissions

[366]

4.2 All surgery involves risks

[378]

4.3 Knowledge of pelvic surgeons

[387]

4.3.1 Preliminary observations

[387]

4.3.2 The relevant state of knowledge

[424]

4.3.2.1 Chronic inflammation

[433]

4.3.2.2 Extrusion or erosion of the mesh into surrounding organs, including the vaginal wall, bladder or urethra

[435]

4.3.2.3 Infection

[439]

4.3.2.4 Chronic pain

[442]

4.3.2.5 Dyspareunia and/or apareunia (avoidance of sexual intercourse)

[444]

4.3.2.6 Difficulty voiding

[446]

4.3.2.7 Offensive vaginal discharge

[448]

4.3.2.8 De novo or recurrent urinary incontinence

[449]

4.3.2.9 Damage to surrounding organs, nerves, ligaments, tissue and/or blood vessels

[451]

4.3.2.10 Haemorrhage

[453]

4.3.2.11 Leg weakness

[454]

4.3.2.12 Reoperation or revision surgery associated with complications

[455]

4.3.2.13 Psychiatric injury

[457]

4.3.2.14 Recurrence of prolapse

[458]

4.3.2.15 Difficulty of removing devices

[459]

4.3.3 The forensic contest

[462]

4.3.4 RANZCOG position statements

[464]

4.3.5 The IFUs

[466]

4.3.6 Patient brochures

[470]

4.3.7 Medical publications

[475]

4.3.8 The appellants’ conduct

[477]

4.3.9 Conclusions

[478]

4.4 Clinical consensus?

[479]

4.5 The evidence of the pelvic surgeons and other “non-clinical” experts

[496]

4.6 The appellants’ concession about clinical significance of the pleaded complications

[540]

4.7 Drugs v implants?

[552]

4.8 Causation

[553]

5 DEFECTIVE DEVICES (GROUNDS 1 AND 2 AND NOTICE OF CONTENTION)

[556]

5.1 Overview

[556]

5.2 The appellants’ submissions

[560]

5.3 Relevant principles

[578]

5.4 Discussion

[612]

6 MERCHANTABLE/ACCEPTABLE QUALITY AND FITNESS FOR PURPOSE (GROUND 3)

[697]

7 NEGLIGENCE – FAILURE TO WARN (GROUND 5)

[699]

7.1 Primary judge’s conclusions

[699]

7.2 Appellants’ submissions

[700]

7.3 Discussion

[706]

8 NEGLIGENCE – PRE-MARKET AND POST-MARKET TESTING (GROUNDS 6, 7 AND 8)

[744]

8.1 Primary judge’s conclusions

[744]

8.2 Appellants’ submissions

[745]

8.3 Discussion

[749]

9 MISLEADING OR DECEPTIVE CONDUCT – BEYOND THE PLEADED CASE (GROUND 12)

[774]

9.1 Appellants’ submissions

[774]

9.2 Discussion

[777]

10 MISLEADING OR DECEPTIVE CONDUCT – FURTHER ALLEGED ERRORS (GROUND 13)

[789]

10.1 Appellants’ submissions

[789]

10.2 Discussion

[793]

11 CAUSATION – NEGLIGENCE (GROUNDS 9, 10 AND 11)

[819]

11.1 Overview

[819]

11.2 Appellants’ submissions

[822]

11.3 Discussion

[829]

12 CAUSATION – CONSUMER LAW CLAIMS (GROUNDS 4 AND 14)

[870]

12.1 Appellants’ submissions

[870]

12.1.1 Mrs Gill

[871]

12.1.2 Mrs Dawson

[874]

12.1.3 Mrs Sanders

[877]

12.2 Discussion

[881]

12.2.1 Misleading and deceptive conduct

[883]

12.2.2 The other statutory claims and causation

[887]

13 LIMITATION PERIODS (GROUNDS 15 AND 16)

[893]

13.1 Mrs Sanders – extension of time (ground 16(a))

[894]

13.2 Mrs Gill and Mrs Sanders – extensions of time (grounds 15 and 16(b))

[897]

14 INJUNCTION (GROUND 17)

[908]

14.1 Appellants’ submissions

[908]

14.2 Discussion

[913]

15 CONCLUSION

[928]

Background

Background to the litigation

Full text does not contain this section.

Evidence

Evidence Before The Court

This volte-face forced upon the appellants by a witness telling the truth in cross-examination was described by senior counsel for the respondents, not unfairly, as an adventitious attempt to try to extract a plausible defence from a case that until the eleventh hour had been premised on a theory of the case that had become untenable. Reduced to its core, the argument put in final submissions below (and on appeal) was essentially a focus on s 140(1) of the Evidence Act 1995 (Cth) (Evidence Act) and, more specifically, on the notion, as Sir Owen Dixon emphasised, that a party bearing the onus will not succeed unless the whole of the evidence establishes a “reasonable satisfaction” on the preponderance of probabilities such as to sustain the relevant issue (Axon v Axon [1937] HCA 80; (1937) 59 CLR 395 at 403, 407), and the “facts proved must form a reasonable basis for a definite conclusion affirmatively drawn of the truth of which the tribunal of fact may reasonably be satisfied”: Jones v Dunkel [1959] HCA 8; (1959) 101 CLR 298 at 305. The second observation is connected to the first. The hearing below was both very long and hard fought. Of the 48 witnesses, 37 were experts giving opinion evidence in nine broadly distinguishable areas of specialised knowledge. Unlike in most complex class actions, there were no orders for concurrent evidence of experts after the conclusion of the lay evidence, nor was any dispute of a scientific or technical nature made the subject of inquiry and report. Another feature was that by the consent of the parties, the hearing was unusually structured. According to senior counsel for the respondents (that is, the applicants) who appeared below, lay affidavits by the representative respondents (applicants) were read but cross-examination was deferred. Then the experts called on behalf of the respondents (applicants) gave evidence. Dr Hinoul thereafter gave his highly significant and (from the perspective of the appellants) damaging lay evidence. None of this is meant as a criticism of the primary judge who was presented with this unique way of doing things by the parties who, no doubt, were required to work around the availability of a large number of busy professionals. But it is worth mentioning, because when it comes to drawing any inference about the respondents’ failure to call witnesses in chief or the failure to adduce certain evidence in chief from witnesses who were called, it is necessary to bear in mind the case was a very different one before, as compared to after, the cross-examination of Dr Hinoul. The third observation involves a reiteration of the statements in Gill v Ethicon Sàrl(No 3) [2019] FCA 587; (2019) 369 ALR 175 at [3]-[15]. That is, there was a regrettable failure of the parties to identify with precision, in advance, the precise issues to be determined at the hearing. Indeed confusion about what was resolved and the consequences of setting aside the impugned findings of fact and law by the primary judge remained, up until the oral hearing of this appeal, and complicated any questions of relief.

Decision

Reasons for decision

The respondents filed a notice of contention to the effect that, if the primary judge’s conclusion in relation to the existence of a defect/safety defect in any product the subject of the proceeding below relied on the Court’s findings of non-compliance with the requirements for CE marking, then the primary judge’s conclusion as to defect should be upheld for each product on the basis of those of the primary judge’s findings other than non-compliance with CE marking requirements.1.3 Summary of conclusions We have decided that the appeal must be dismissed, subject to us being satisfied it is appropriate to vary the order by which the primary judge’s findings are binding on group members and providing greater specificity to the answer to common question 22. Our reasons follow.2. KEY ASPECTS OF THE PROCEEDINGS BELOW As the primary judge recorded, the proceedings were brought under Pt IVA of the Federal Court of Australia Act 1976 (Cth) (the FCA Act) by three applicants, both on their own behalf and on behalf of other women who claim to have suffered complications from the implantation of one or other of the devices during the relevant period. The class of applicants is open and more than 90,000 of the devices have been supplied in Australia: TJ [13]. The hearing began in July 2017 and ended in February 2018 involving hearing days on 4-14, 19-20, 24-28 July 2017, 2, 9-17, 21-23, 30-31 August 2017, 4, 12-19, 28-29 September 2017, 3-12, 16-26 October 2017, 1-8, 14-16, 20-24, 29 November 2017, 29-31 January 2018 and 1-22 February 2018. Evidence was adduced from 48 witnesses, 35 of whom gave oral evidence. Of the 48 witnesses, 37 were experts from nine different disciplines: TJ [19]. More than 5,500 documents were tendered, running to over 164,000 pages: TJ [20]. Mrs Gill, Mrs Dawson and Mrs Sanders, and each of their husbands gave evidence: TJ [21]. The respondents (the applicants below) also called evidence from:(1)four urogynaecologists (a surgical subspecialty of urology and gynaecology, which involves the diagnosis and treatment of female pelvic floor disorders) – Andrew Korda, Wael Agur, Jerry Blaivas, and Michael Thomas Margolis: TJ [22]. They also tendered a report from a urogynaecologist on whom the appellants (the respondents below) proposed to rely – Malcolm Frazer: TJ [23];(2)Bilal Chughtai, a urologist, Uwe Klinge, a general surgeon and biomaterials researcher, Bernd Klosterhalfen and Vladimir Iakovlev, pathologists, Russell Dunn and Scott Guelcher, biomechanical engineers, Derrick Beech, Bryan Allman, Peggy Pence and Anne Holland, regulatory experts, Howard Hu, Cara Krulewitch, and Mark Woodward, epidemiologists, Ian Gordon, a biostatistician, Alan Meagher and Anthony Eyers, colorectal surgeons, Patricia Jungfer, a psychiatrist, Joseph Slesenger, a specialist in occupational medicine, and Lindy Williams and Timothy Walsh, occupational therapists: TJ [24]; and(3)Robyn Leake, an obstetrician and gynaecologist who treated Mrs Gill, James Swan, an obstetrician and gynaecologist who treated Mrs Dawson, and Sandra McNeill, an obstetrician and gynaecologist who assisted in the operation in which Mrs Sanders was implanted with TVT: TJ [26].

Ratio Decidendi

Legal Principle Established

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