FEDERAL COURT OF AUSTRALIA

Ethicon Sàrl v Gill [2021] FCAFC 29

ORDERS

THE COURT ORDERS THAT:

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

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

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

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

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

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

REASONS FOR JUDGMENT

THE COURT:

1.    THE APPEAL

1.1    The proceedings before the primary judge

1    In Gill v Ethicon Sàrl (No 5) [2019] FCA 1905 (TJ) the primary judge held the appellants (the respondents in the proceedings below) liable for damages in connection with the supply of nine medical devices in Australia (the devices). Five of the devices were intended for use in the treatment of female stress urinary incontinence (SUI). They are known as Gynecare Tension-free Vaginal Tape System (TVT), Gynecare TVT Obturator System (TVT-O), Gynecare TVT Secur System (TVT Secur), Gynecare TVT Exact Continence System (TVT Exact) and Gynecare TVT Abbrevo Continence System (TVT Abbrevo), and are together referred to as the SUI devices. The other four devices were intended for use in the treatment of female pelvic organ prolapse (POP). They are known as Gynecare Gynemesh Prolene Soft (Gynemesh PS), Gynecare Prolift Pelvic Floor Repair System (Prolift), Gynecare Prolift+M Pelvic Floor Repair System (Prolift+M) and Gynecare Prosima Pelvic Floor Repair System (Prosima), and are together referred to as the POP devices.

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

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

1.2    The issues in the appeal

4    The appellants (also referred to as Ethicon below, where it is not necessary to distinguish between them) challenge the trial judgment in which the primary judge held them liable for contraventions of the Trade Practices Act 1974 (Cth) (the TPA) and Sch 2 to the Competition and Consumer Act 2010 (Cth) (the CCA), the Australian Consumer Law (the ACL) and for negligence.

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

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

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

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

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

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

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

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

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

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

1.2.1    Defects

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

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

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

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

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

9    Ground 2: the primary judge erred:

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

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

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

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

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

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

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

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

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

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

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

1.2.2    Negligence

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

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

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

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

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

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

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

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

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

(1)    the evidence did not establish:

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

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

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

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

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

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

(1)    the evidence did not establish:

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

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

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

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

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

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

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

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

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

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

17    Ground 10: the primary judge erred in finding that:

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

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

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

18    Ground 11: the primary judge erred in finding that:

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

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

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

1.2.3    Misleading or deceptive conduct

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

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

(1)    the primary judge:

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

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

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

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

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

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

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

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

1.2.4    Limitation periods

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

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

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

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

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

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

1.2.5    Injunction

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

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

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

25    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

26    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

27    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].

28    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.

29    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].

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

31    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].

32    The appellants (the respondents below) called evidence from:

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

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

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

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

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

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

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

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

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

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

    infection;

    chronic pain;

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

    difficulty voiding;

    offensive vaginal discharge;

    de novo or recurrent urinary incontinence;

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

    haemorrhage;

    leg weakness;

    reoperation or revision surgery associated with complications; and

    psychiatric injury: TJ [184].

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

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

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

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

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

43    However, as the primary judge recorded:

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

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

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

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

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

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

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

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

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

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

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

52    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.

53    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.

54    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.

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

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

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

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

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

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

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

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

3.    KEY FINDINGS OF THE PRIMARY JUDGE

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

3.1    The representative respondents - overview

3.1.1    Mrs Gill

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

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

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

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

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

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

3.1.2    Mrs Dawson

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

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

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

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

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

3.1.3    Mrs Sanders

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

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

3.2    The relevant conditions

3.2.1    Stress urinary incontinence

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

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

78    Traditional surgical treatments for SUI include:

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

(2)    needle suspension procedures;

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

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

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

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

3.2.2    Pelvic organ prolapse

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

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

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

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

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

3.3    The devices

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

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

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

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

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

3.3.1    The SUI devices

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

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

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

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

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

3.3.2    The POP devices

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

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

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

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

3.4    Risks associated with mesh implantation

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

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

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

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

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

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

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

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

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

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

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

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

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

3.5    Biocompatibility

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

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

115    For a permanent implant, like each of the devices, the foreign body response endures for the duration of the time the implant remains in the body: TJ [345].

116    The foreign body reaction can vary in intensity, and the intensity of the foreign body reaction, more particularly the extent of the inflammatory response, correlates with the extent of the fibrosis (scarring): TJ [347].

117    Until relatively recently, in the IFUs issued for all the devices the foreign body reaction was described as “transitory”: TJ [352]. However, the appellants knew that as long as the implant remains in the body, the foreign body or inflammatory response to polypropylene implants, including the devices in question, is not “transient” or “transitory” but chronic and permanent. Indeed, this was an intended outcome, as some fibrosis (scarring) is required to enable the device to adhere to the tissue and remain in place: TJ [353].

118    The respondents proved that the foreign body reaction is clinically significant and can cause many, if not all, of the pleaded complications: TJ [354].

119    The evidence establishes that every woman implanted with a device could suffer from all of the pleaded complications: TJ [405].

120    The appellants accepted that pore size is a critical component of the biocompatibility of any mesh used in the body: TJ [450]. The changes in pore size in vivo that occurs with the devices is significant: TJ [787(1)].

121    Bridging fibrosis can occur following implantation of all of the devices: TJ [533], [787(4)]. Bridging fibrosis is where the fibrous tissue around one filament comes in contact with the fibrous tissue around the next one: TJ [526]. The filling out of the distance between fibres by scar tissue forms a rigid “scar/mesh compound” or “scar plate”, which leads to a number of complications including loss of elasticity and pain associated with the rigidity, shrinkage or contraction of the mesh, mesh erosion, nerve entrapment, bacterial encasement, chronic pain and dyspareunia: TJ [521]. Bridging fibrosis is of clinical significance: TJ [537] and [787(4)].

122    “Mesh contraction” or “mesh shrinkage” is a complication of the use of polypropylene meshes. It involves a reduction in the surface area originally covered by the mesh brought about by the retraction of the fibrotic tissues around the mesh: TJ [538].

123    The evidence establishes that contraction has clinical significance: TJ [564]. The appellants’ records show that they accepted that contraction was clinically significant: TJ [576]. The appellants’ submissions to the contrary were inconsistent with their own documents, the opinions of the TVM Group (a group of experts who were developing a standardised technique for the surgical management of POP with mesh via a vaginal approach and attempting to better understand the mechanism of vaginal erosion which was associated with the use of synthetic materials in order to reduce its occurrence), and the position of the FDA: TJ [593]. Polypropylene mesh, including those meshes used in the devices, contracts in the way Professors Klinge, Klosterhalfen and Deprest explained, and contraction of the mesh has clinical significance. It can increase the risk of recurrence of the condition which it was designed to arrest and it can cause a number of complications such as mesh exposure/erosion and chronic pain, including at rest and with sexual intercourse: TJ [610], [787(5)].

124    It is inappropriate to transfer results of experimental studies on polypropylene fibres or sutures to polypropylene meshes: TJ [631]. A suture is a single fibre with only one compartment (loop). All the meshes in question consist of a considerably larger amount of foreign material and multiple compartments (pores). Consequently, the nature and extent of the reaction to a mesh implant will be different from the nature and extent of the reaction to a suture or sutures: TJ [633].

125    Hernia mesh is used as a flat mesh in largely tension-free conditions whereas the pelvic floor is an area subject to a great deal of stress and strain: TJ [634].

126    The clinical studies conducted by the Aachen Group confirmed that the more foreign body implanted or surface area covered, the greater the degree of inflammation: TJ [635].

127    The effect of polypropylene mesh on tissue differs according to the environment in which it is implanted: TJ [636].

128    The mesh cannot expand or contract and, in order to function properly, several organs in the pelvis need to expand and contract. The mobility and function of the anterior abdominal wall, on the other hand, are much more limited: TJ [637].

129    The devices are designed to be implanted superficially under sensitive mucosa and can easily erode through the mucosa. In contrast, erosions of hernia meshes are rare: TJ [637]. There is some evidence that the appellants recognised this: TJ [638].

130    Hernia repair meshes are only in direct contact with the abdominal fascia. Pelvic meshes, on the other hand, are placed in an environment with a wide range of soft tissues, including smooth and striated muscle, various kinds of connective tissue, and specialised organs: TJ [647].

131    The vagina is regarded as a “clean-contaminated” field. When polypropylene is implanted transvaginally, it is seeded with bacteria which contribute to infection and inflammation in the tissues: TJ [648]. There is no dispute and no doubt on the evidence that the mesh can both cause an infection and exacerbate an existing infection: TJ [652].

132    In numerous other respects the environment of the pelvic floor is very different from the wall of the abdomen or, for that matter, the groin: TJ [653]. The female genital area has a much higher nerve density in comparison with the anterior abdominal wall and the groin: TJ [660]. There are several sensory nerves in the female pelvis, including the pudendal nerve. The chance of mesh coming into contact with sensory nerves is high, particularly if it moves or erodes: TJ [681]. It is uncontentious that all the devices may cause pain, including chronic pain, and that there are various mechanisms that may be responsible for it: TJ [684].

133    There was a vastly higher rate of mesh exposure/erosion with vaginal implants compared to abdominal wall implants: TJ [660]. Accordingly:

(1)    erosion through the vaginal mucosa is one of the most common complications of implantation with polypropylene mesh but it is rare to encounter mesh erosion through abdominal skin or into internal organs with hernia mesh: TJ [664];

(2)    chronic pain is a complication of both hernia and vaginal mesh. The differences are mainly in the distribution and pattern of radiation. Since the arms of the POP devices and the ends of the SUI devices cross many structures in the pelvis, “pain distribution can involve areas from suprapubic to vaginal, introital, deep pelvic/vaginal, obturator/hip/groin, and into the buttock”. Pain can also radiate into the medial thigh: TJ [665];

(3)    with hernia mesh, pain on intercourse can occur in cases of mesh migration into the spermatic cord, but dyspareunia is more prevalent as a complication of vaginal mesh: TJ [666];

(4)    urinary obstruction is a complication “almost unique to vaginal implants”: TJ [667];

(5)    other de novo urinary symptoms, such as overactive bladder and urge incontinence, are much more frequent for vaginal mesh implants: TJ [668]; and

(6)    mesh excision is much more problematic in the case of vaginal implants as it is difficult to readily access the obturator and other “deep parts”. In addition, removal of mesh that has migrated into the bladder or rectum poses a risk of fistulas: TJ [669].

134    Polypropylene is subject to oxidation: TJ [685]. The IFUs provided with all the devices, however, stated that Prolene is not subject to degradation or weakening by the action of tissue enzymes: TJ [686]. It is because polypropylene is subject to oxidation that the appellants added antioxidants to it in the manufacture of Prolene (and Prolene Soft): TJ [691]. The weight of evidence indicates that polypropylene is subject to oxidation in vivo despite the addition of antioxidants during the manufacturing process: TJ [693]. Ethicon’s own scientists concluded that Prolene is subject to oxidative degradation in vivo: TJ [713]. Polypropylene, including Prolene, undergoes oxidation in vivo and the antioxidants added to the polypropylene during the manufacturing process, do not provide permanent protection from the risk of degradation: TJ [779].

135    When Prolene undergoes oxidation in vivo this is reflected in the surface cracking detected by Professor Kosterhalfen and Dr Iakovlev and others using scanning electron microscopy. When this occurs it may lead to an increase in inflammation and scar tissue formation but it has not been proved that when Prolene does oxidise in vivo it has any clinically significant effect and, in particular, that it causes a significant reduction in the tensile strength of the polymer: TJ [786].

3.6    The performance of the devices

3.6.1    The evidence

136    Witnesses who were pelvic floor surgeons but who lacked epidemiological or statistical expertise placed weight on study findings which were not statistically significant or which drew heavily on studies that were affected by one or more kinds of bias: TJ [805]. Ethicon’s contention that the Court should (invariably) prefer the evidence of pelvic surgeons to evidence of the epidemiologists and biostatisticians in assessing how the published literature should be interpreted and applied is rejected: TJ [806].

3.6.2    Complication rates

137    The primary judge applied the following descriptions taken from the Royal College of Obstetricians and Gynaecologists: TJ [808].

138    Inappropriate placement is not the sole cause of exposure or erosion. Bunching and folding may also occur as a result of the scar tissue contracting around the mesh: TJ [836].

139    For the Prolift procedure, as counsel for the appellants conceded in closing argument, the evidence shows that, even in the most experienced hands, complications, including mesh erosion and exposure, will still occur: TJ [837].

140    It was common ground that mesh-related adverse events may occur years after vaginal mesh surgery: TJ [839].

141    The weight of the evidence makes it tolerably clear that many, if not all, of the complications associated with incontinence surgery using polypropylene mesh, including all the SUI devices, were at least in part attributable to the mesh. Even Ethicon accepted as much. The Nilsson et al (2013) (Nilsson C et al, “Seventeen years’ follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence” (2013) 24(8) Int Urogynecol J 1265–1269 (ETH.MESH.19876896)) results were exceptional; the study’s findings could not be generalised to other patient and surgeon populations where the same exclusion criteria were not employed, less skilled surgeons were involved, and all other conditions were not equal. In any case the study population was a small one: TJ [912].

142    The Morling study (Morling R et al, “Adverse events after first, single, mesh and non-mesh surgical procedures for stress urinary incontinence and pelvic organ prolapse in Scotland, 1997-2016: a population based cohort study” (2016) The Lancet 1–12 (SHI.MESH.00024517)) is significant, not least because it cast doubt over the widespread perception that the risk of recurrence of POP following native tissue procedures is high: TJ [1121].

143    The evidence indicates that the following complications are common after surgery with the SUI devices (that is, occurring in 1% to 10% of patients):

    mesh exposure/extrusion/erosion;

    recurrent urinary tract infections;

    chronic pain;

    dyspareunia;

    difficulty voiding;

    de novo urinary incontinence;

    recurrence of stress urinary incontinence;

    bladder perforations (with retropubic slings) (uncommon but not rare with transobturator slings); and

    reoperation or revision surgery associated with complications: TJ [1139].

144    After surgery with the POP devices, these complication rates were higher: TJ [1140].

3.6.3    SUI devices

145    Erosion is common to all the SUI devices, but most of these erosions are cases of vaginal exposure: TJ [1151].

146    The evidence does not allow for a definitive conclusion to be reached on the incidence of chronic pain after implantation of an SUI device. Having regard to the findings in the various reviews and studies discussed above, however, the incidence appears to be between 1% and 10%. It is therefore common, and not rare as Dr Hinoul and others have claimed: TJ [1167].

147    Dyspareunia and apareunia following implantation of the SUI devices is likely to be common: TJ [1174].

148    Reoperation or revision surgery is likely to be common following implantation with the SUI devices: TJ [1177].

149    Voiding difficulties are not uncommon after implantation with the SUI devices: TJ [1183].

150    De novo or recurrent urinary incontinence is a common outcome of surgery using the SUI devices, but unlikely to be any more frequent than it is after traditional surgery: TJ [1192].

151    Bladder and vaginal perforations are common after implantation with the retropubic SUI devices and uncommon after implantation with the transobturator SUI devices. The evidence is insufficient to enable a finding about the incidence of damage to other surrounding organs or vessels or to nerves, ligaments, tissue and blood vessels: TJ [1199].

3.6.4    POP devices

152    On any view of the matter, erosion, at least in the sense of exposure, is at least common after transvaginal implantation of any and all of the devices: TJ [1216].

153    Whatever the true rate of chronic pain for the POP devices, it does not appear to be rare, is likely to be higher than experienced by women who received only an SUI device, and the highest rates are likely to occur following multiple-compartment repair using synthetic polypropylene mesh, including Prolene Soft: TJ [1226].

154    De novo dyspareunia and apareunia are likely to be common after implantation of the POP devices: TJ [1234].

155    De novo SUI is also common after mesh surgery: TJ [1243].

156    While recurrence of POP after native tissue repair is a given, permanent mesh repair does not prevent it. Indeed, the evidence indicates that it is common after both kinds of repair: TJ [1248].

157    Injury to the bladder appears to be more common with mesh surgery than native tissue repair: TJ [1253].

3.6.5    Gynemesh PS used abdominally in vault repair

158    It therefore seems that mesh erosion is a common outcome of sacrocolpopexy but in the short to medium term the rates are lower than they are after transvaginal implantation: TJ [1269].

3.7    Comparative outcomes

159    The two hypotheses considered were TJ [1285]:

(1)    treatment of stress urinary incontinence with the SUI devices causes equivalent or fewer complications than surgical treatment of stress urinary incontinence using the alternative treatments (the safety hypothesis); and

(2)    treatment of stress urinary incontinence with the SUI devices causes an equivalent or better outcome than surgical treatment of stress urinary incontinence using the alternative treatments (the efficacy hypothesis),

Where the alternative treatments identified were open colposuspension, laparoscopic colposuspension and fascial sling repair.

(Original emphasis).

160    Neither in October 1999, when TVT was first supplied in Australia, nor at any time thereafter were any of the SUI devices proven to be safer or more effective in the long-term than the alternative treatments: TJ [1336].

161    Neither in July 2003 when Gynemesh PS was first supplied in Australia nor at any time thereafter were any of the POP devices proven to be safer or more effective in the long-term than the alternative treatments: TJ [1336].

3.8    Regulatory requirements

162    The evidence of Dr Allman, Ms Holland and Dr Pence is accepted: TJ [1353].

163    Each of the devices is a medical device within the meaning of the Therapeutic Goods Act 1989 (Cth) (TG Act), s 41BD: TJ [1367].

164    At all material times JJM was the Australian sponsor of the devices, s 3 TG Act: TJ [1368].

165    Ethicon Sàrl and Ethicon Inc. were the manufacturers of the devices: TJ [1479].

166    TVT-O, TVT Abbrevo, and TVT Exact were all included in the same ARTG registration as TVT on the basis that they were the same kind of device. Similarly, the Prolift+M and Prosima devices were included in the same entry as Prolift. Gynemesh PS had a separate entry, as did TVT Secur, with its unique classification as a class III device: TJ [1377].

167    In order to secure registration on the ARTG for these devices (save for TVT) JJM, as the Australian sponsor, had to make an application under s 41FC of the TG Act, certifying the following relevant matters set out in s 41FD (TJ [1378]):

(1)    that the device is correctly classified according to the medical device classifications;

(2)    that it complies with the essential principles established under the TG Act and set out in Sch 1 of the MDR [the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) (Medical Devices Regulations or MDR)];

(3)    that appropriate “conformity assessment procedures” or other comparable procedures have been applied to devices of that kind;

(4)    that either the sponsor has sufficient information to substantiate compliance with (b) and (c) above, or that the sponsor has procedures in place, including a written agreement with the manufacturer, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and

(5)    that particular advertising requirements have been complied with.

168    The Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Community (EC Mutual Recognition Agreement) came into force on 1 January 1999. It committed Australia to recognising conformity assessment results, like testing and certification, performed by the European Union’s designated conformity assessment bodies. It covered a wide range of goods including medical devices: TJ [1389].

169    Apart from class III medical devices, at the time the devices were entered onto the ARTG, products that had received a “CE” marking were accepted for registration without the TGA conducting any independent assessment of their safety or efficacy and without the need for the manufacturer to demonstrate that independent pre-market testing of their safety and efficacy had been carried out. “CE” is an acronym for Conformité Européenne (meaning “European Conformity”). All the sponsor needed to do in order to have the devices registered on the ARTG was to produce the CE certificates: TJ [1391].

170    The presence of the CE Mark on a medical device constitutes a representation that the device conforms to the requirements of the particular European directive which applied to that type of product at the time of certification and thereafter and is an indication to the world at large that it may lawfully be sold in all member states of the European Union: TJ [1392].

171    Each of the devices carries a CE Mark. The mark was placed on TVT in 1997 (the evidence does not reveal the precise date but it is likely to have been in about November or late October), TVT-O in December 2003, TVT Secur on 4 May 2006, TVT Exact in June 2010, TVT Abbrevo in September 2010, Gynemesh PS on 20 March 2003, Prolift on 2 March 2005, Prolift+M on 18 March 2008, and Prosima on 12 April 2007: TJ [1398].

172    TVT was listed on the ARTG on 21 July 1998, TVT Secur on 18 October 2006, Gynemesh PS on 26 May 2003, and Prolift on 30 March 2005: TJ [1399].

173    With the exception of TVT Secur, each of the devices was classified as a class IIb device as each was a surgically invasive and implantable medical devices intended for long-term use. TVT Secur was classified as a class III device because of the Vicryl and PDS fleece which were designed to be wholly absorbed by the patient’s body: TJ [1400].

174    The European Directive required a critical evaluation of the relevant scientific literature relating to the safety, performance, design characteristics and intended purpose of the device where the device is demonstrated to be equivalent to the device to which the data relates and the data adequately demonstrate compliance with the relevant essential requirements or a critical evaluation of the results of all clinical investigations made or a critical evaluation of both the relevant scientific literature and clinical investigations: TJ [1413]. For implantable devices and devices in class III, however, clinical investigations were mandatory unless it was “duly justified to rely on existing clinical data”: TJ [1414].

175    Ethicon adopted the “literature” route for all devices. When clinical investigations were not undertaken the decision to rely on existing clinical data was not always “duly justified”. When clinical investigations were undertaken, Ethicon rarely waited for them to be completed before applying the CE Mark and did not critically evaluate them. The clinical evaluation reports for all the devices revealed a distinct lack of critical evaluation of the studies on which they relied and the literature to which they referred. Some of them disclosed no evaluation at all. In addition, in some instances the literature to which the data related and upon which the reports relied concerned devices that were not demonstrated to be equivalent to the device in question: TJ [1415].

176    Although Ethicon had procedures in place that were intended to meet regulatory requirements for obtaining CE marking for each of the devices, it did not in fact have adequate clinical evidence and therefore did not have sufficient justification to affix a CE Mark to any of them. Ethicon did not comply with the steps that a reasonable manufacturer would undertake to ensure that it was appropriate for the devices to maintain their CE marking once released onto the market: TJ [1480].

177    Ethicon did not adhere at any time to European Union or United States industry requirements and regulatory standards in any of the following areas: design validation; evaluation of complaints; management responsibility or risk management. During the development of both the SUI and the POP devices, no overarching, cohesive risk management system was in place. Ethicon’s design validation process was flawed because it did not adequately represent the population of surgeons using the devices and feedback from surgeons was not fully evaluated or implemented: TJ [1501].

178    Certain information required to be included in the IFUs of all devices was not provided. There were significant deficiencies with respect to the information provided about potential complications, adverse reactions, and warnings. A significant and extensive amount of information regarding the safety of the devices was omitted from the various IFUs. Ethicon’s failure to include the required information in the IFUs was contrary to the essential principles/requirements with which Ethicon had certified compliance as part of the process of obtaining registration of the devices on the ARTG: TJ [1540].

3.9    Development and pre-market evaluations

179    There is no disagreement that any clinical experience with Prolene sutures and mesh should be considered when evaluating future devices of the same material. However, the evaluation should not have solely relied on prior history of similar devices for safety and effectiveness due to the new indication and use in pelvic floor repair versus the abdominal wall (hernia). What was not considered in these risk assessments was the impact of polypropylene mesh on anatomical location with respect to differing biomechanical properties (erosion/adhesion risk), microbiological flora (infection risk), as well as inflammatory response: TJ [1551].

3.9.1    SUI devices

3.9.1.1    TVT

180    Ethicon did not wait for the long-term results or for more widespread use before releasing TVT to the market. Dr Hinoul conceded as much in cross-examination. TVT was released in Europe in 1997, before the one year results of the Nordic multi-centre study had been published, and well before any long term results were available. At that point in time Ulmsten et al (1996) (Ulmsten U et al, “An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence” (1996) 7(2) Int Urogynecol J Pelvic Floor Dysfunct 81-85 (ETH.MESH.19935677)) was the only published article on the use of transvaginal tape using Prolene mesh. It was cleared for sale in the United States in January 1998: TJ [1573]-[1575].

181    If Dr Hinoul intended to represent that Ethicon carried out a thorough analysis of the similarities and differences between the two products (ProteGen and TVT), I cannot agree. The technical file, which he referenced, does contain a table which compared the two products. What it does not contain, however, is any assessment and demonstration of the significance these might have on safety and performance. If ProteGen were indeed substantially equivalent to TVT, then one might also reasonably have expected that the literature review in the clinical evaluation report would refer to, and critically analyse, the literature on ProteGen. Yet it did not: TJ [1577]. Further:

(1)    Dr Hinoul went on to say that ProteGen was recalled in 1999 after many patients experienced complications, though he did not say what these complications were. I was not taken to any evidence to indicate that the experience with ProteGen triggered a review by Ethicon of TVT, as one might have expected of a reasonably prudent manufacturer: TJ [1578];

(2)    Dr Allman’s opinion, which was not challenged, was that the two devices did not meet the European definition of equivalence: TJ [1580]; and

(3)    as Dr Allman observed, it is logically difficult to sustain an argument that the safety and performance of ProteGen could be used to define the safety and performance of TVT: TJ [1580].

182    It was common ground that there had been no comparative, let alone randomised controlled trials, assessing the safety and efficacy of TVT at the time of its launch in Australia in 1999: TJ [1600].

183    The clinical evaluation conducted by Ethicon was not sufficient to justify CE marking for TVT. Ethicon should have conducted “Ethicon-controlled” clinical investigations before CE marking was obtained or instituted post-market clinical follow-up studies at the time of CE marking: TJ [1601].

184    Ethicon’s risk assessments of the TVT device were manifestly inadequate: TJ [1602]. Ethicon had not complied with the requirements for quality management systems for the design of a medical device. The design history and technical files from 1999 and 2000 disclosed that critical documentation regarding the TVT system design and associated processes were missing: TJ [1606]. A design Failure Mode and Effect Analysis (dFMEA) was not created until 2000-2002, three and five years after the CE Mark was applied to TVT and two and four years after it was first sold in Australia: TJ [1607]. This retrospective dFMEA was not credible: TJ [1608].

3.9.1.2    TVT-O

185    TVT-O was launched worldwide on 22 December 2003 and was first supplied in Australia in March 2004: TJ [1654].

186    The launch was the result of Ethicon cutting corners including by compromising on safety evaluation: TJ [1655].

3.9.1.3    TVT Secur

187    Ethicon’s comparison of TVT Secur, which utilises different materials and has a different size, shape factor, and surgical approach, with TVT, was not a valid method to determine a specification for the TVT Secur: TJ [1666]. It is true that the indications of use were the same as the currently marketed TVT mesh products but there were significant differences between the devices in material, construction, and dimensions. Supplementary submissions filed by the appellants on 20 June 2018 acknowledged as much: TJ [1688]. The data from TVT and TVT-O “could not appropriately be leveraged to accept the risks associated with [TVT Secur]”: TJ [1692].

188    The documents relating to the dFMEA for TVT Secur did not fully comply with either Ethicon’s own procedural requirements or industry standards: TJ [1671].

189    The design validation for TVT Secur did not represent the simulated use conditions and led to false confidence in the performance of the device in the hands of inexperienced users without the benefit of one-on-one training by the design team: TJ [1678]-[1679].

190    The 2006 clinical evaluation report (CER) also declared that TVT Secur was a safe device, effective for treatment of stress urinary incontinence, and that additional clinical studies were unnecessary before the product was released to the market. These conclusions were unjustified and the report itself was insufficient to support CE marking. It was illogical to rely on safety and performance data from predicate devices when TVT Secur was designed to be different from, and an improvement on, those devices: TJ [1695].

191    In all likelihood the failure to recommend or conduct clinical studies, let alone a randomised controlled trial, before the device was launched, whether overseas or in Australia, was attributable to marketing considerations: TJ [1700].

3.9.1.4    TVT Exact

192    No studies or clinical trials of TVT Exact were undertaken before market launch in Australia in July 2010: TJ [1701].

193    Reliance on the TVT data was unjustified since the procedure used with TVT Exact was different in that it involved one less cystoscopy. A conclusion that review of safety and efficacy data for TVT was sufficient to assess TVT Exact would require a more critical assessment of the differences between the devices and the impact, both good and bad, on clinical use: TJ [1712].

3.9.1.5    TVT Abbrevo

194    The conclusion of the CER was unjustified by the clinical evidence presented and the report did not satisfy the European regulatory requirements for clinical evaluation: TJ [1731]. Ethicon should have conducted clinical investigations of TVT Abbrevo, with clearly defined acceptance criteria before CE marking or considered post-market clinical follow-up studies: TJ [1732].

195    By October 2010, when TVT Abbrevo was launched in Australia, no further clinical trials of the device had been conducted: TJ [1734].

3.9.2    POP devices

3.9.2.1    Gynemesh PS

196    In the technical file for Gynemesh PS no consideration was apparently given to the change in indication (from treatment for hernias in the abdominal wall to repair of POPs). At the very least, the new indication should have been addressed in the risk evaluation. In fact, the new indication was not “addressed as significant” in any of the submission files, despite the vast differences between Prolene sutures, hernia mesh, and Gynemesh PS: TJ [1751].

197    The 2002 Gynemesh PS CER and the material to which it referred did not represent a sufficient and adequate basis on which to come to a conclusion that the use of the mesh for the indication identified was safe and efficacious: TJ [1755]. Dr Weisberg signed this CER without independently reviewing the literature upon which it was based: TJ [1770]. The CER failed to advert to the essential requirements of the European Directive and it also failed to conform to them (the Essential Requirements): TJ [1776]. The conclusion that its use appeared to be safe and efficacious for pelvic floor repair was not justified and the CER was insufficient to justify CE marking of Gynemesh PS: TJ [1777].

198    A clinical study was begun before the CER was signed but the appellants did not wait for the results before applying for CE marking: TJ [1783].

3.9.2.2    Prolift

199    The conclusions of the CER for the Prolift were not justified as “[n]o clinical evidence was presented to demonstrate the safety and performance of the mesh under the normal conditions of use of the complete PROLIFT device”: TJ [1835].

200    The Prolift CER was “incoherent” and suffered from the same problems as the CER on Gynemesh PS: TJ [1848]. While Dr Hinoul conceded in cross-examination that the CER was inadequate to justify the product’s safety as a stand-alone document he steadfastly, and for no good reason, refused to concede that the statement about the absence of reports of tissue contraction in the Gynemesh clinical evaluation was misleading: TJ [1849]. Dr Hinoul contended that “[t]his risk assessment corresponds to the risk/benefit analyses I have performed”. In light of the numerous problems with the Prolift CER, if Dr Hinoul’s contention is an accurate representation of the nature of his risk/benefit analyses, it only serves to undermine those analyses: TJ [1852].

201    Prolift was first supplied in Europe in January 2005 and approved for sale in the United States in March 2005. Prolift was first supplied in Australia in June that year: TJ [1856]. As Ethicon frankly admitted in its “Prolift+M Clinical Strategy” finalised on 6 September 2007, Prolift was launched without clinical evidence. This is consistent with Dr Allman’s view that the information disclosed in the 2005 CER for Prolift was inadequate to justify CE marking: TJ [1857].

202    Special training of the intended user was necessary for implantation of the Prolift but he Prolift IFU merely stated that training on the use of the Prolift system was “recommended and available”: TJ [1869].

3.9.2.3    Prolift+M

203    No clinical studies of Prolift+M were carried out before the device was placed on the market. Prolift+M was cleared for supply on the basis of Ethicon’s claim, which proved to be false, that it was equivalent to other Ethicon devices that were already on the market TJ [1883].

204    The Prolift+M CER assumed that Prolift+M was an equivalent device to Prolift, which was made from Prolene Soft whilst at the same time asserting that Prolift+M, which used Gynemesh M, was designed to be an improvement on Prolift. They were not equivalent devices and there was no justification for using the literature route to certification: TJ [1904].

205    Given the design differences between Prolift and Prolift+M, a more rigorous argument, with clinical data, was needed to conclude that the risk/benefit ratio was acceptable. The CER did not meet the requirements of the European Directive or the European Commission guidelines on the evaluation of clinical data, April 2003 (MEDDEV 2.7.1). Its conclusions were not justified by the data presented, and it was insufficient to justify CE marking: TJ [1911].

3.9.2.4    Prosima

206    Ethicon’s clinical strategy for Prosima reflected a misunderstanding of European regulatory requirements. Clinical data were necessary to comply with the requirements for CE marking: TJ [1914].

207    The appellants were prepared to affix the CE Mark and release the Prosima device to the market before the additional clinical studies Carey et al said were necessary to establish the safety and efficacy of the device had been conducted (Carey M et al “Vaginal surgery for pelvic organ prolapse using mesh and a vaginal support device” (2008) 115(3) BJOG 391–397 (ETH.MESH.00154197)) and notwithstanding the conclusion of the Maher et al Cochrane review (Maher C et al, “Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse” The Cochrane Collaboration (John Wiley & Sons Ltd, 2016) (SHI.MESH.00005748)): TJ [1940].

3.10    Post-market evaluation of the devices

3.10.1    General

208    The appellants were obliged to undertake post-market surveillance and evaluation of the safety and efficacy of the devices: TJ [1956].

209    Ethicon displayed a poor understanding of the European regulatory requirements for clinical evaluation and post-market surveillance: TJ [1960].

210    Ethicon’s post-market clinical evaluations were neither regular nor rigorous and, not until 2012 at the earliest, could they be described as detailed: TJ [1970].

211    The CERs were deficient in numerous respects, review of complaints and adverse events was unsatisfactory, and the conclusions drawn from them largely unjustified: TJ [1971].

3.10.2    Complaints

212    The appellants received numerous complaints about the devices: TJ [1973].

213    There was under-reporting of events in practice, and the incidence of events derived from the Manufacturer and User Facility Device Experience (MAUDE) database was unreliable: TJ [1979].

214    Ethicon had a practice of dismissing (and determining not to report) complaints on the basis that they were the subject of adequate warnings in the IFUs, even though that was not the case, and Ethicon would then proceed to feed back into its clinical evaluation process low adverse event rates as evidence of the safety of its products: TJ [1980].

215    Dr Pence provided 29 examples of complaints received by Ethicon in relation to its SUI devices which, in her opinion, were reportable but were not submitted to the FDA as medical device reports (note: the primary judge accepted Dr Pence’s evidence – see above). Many of Ethicon’s explanations were disingenuous and led to under-reporting of adverse events. A reasonably prudent manufacturer would have performed due diligence to follow-up some of these events to determine if there were any longer-term sequelae: TJ [1984]. Dr Pence undertook a similar exercise in respect of the complaints received for the POP devices. She reviewed 116 reports that were determined to be non-reportable, and provided a number of examples of events that she considered should have been reported: TJ [1990].

216    Similarly, on numerous occasions, Ethicon determined that adverse events were not reportable to the UK regulator, the UK Medicines and Healthcare products Regulatory Agency (MHRA): TJ [1996].

217    Ethicon’s approach to complaints reporting limited the capacity of the regulatory authorities to adequately determine the safety of the devices: TJ [2004].

218    The appellants’ internal documents showed that they recognised that inadequate reporting was an issue: TJ [2005].

3.10.3    BSI audits

219    The British Standards Institute (BSI) prepared 9 audit reports for the appellants: TJ [2008]. In June 2008, BSI found serious deficiencies in post-market surveillance with respect to Gynemesh PS, Prolift+M and Prosima: TJ [2009].

220    In June 2009, BSI’s findings were raised to major non-conformity status after Ethicon’s Corrective Action Plan (CAP) was rejected because it contained “insufficient information for Post Market surveillance feeding into Risk and Clinical, as well as insufficient details on implementation dates”: TJ [2010].

221    With respect to all files, BSI noted that the risk management report only appeared to have been completed on the basis of complaints, only addressed design/application risks, and did not consider process risks or other post-market surveillance activities: TJ [2011].

222    BSI also found that none of the CERs was consistent with the requirements of MEDDEV 2.7.1 for clear description of search methodology, clear exclusion data, citation of weighting methods, details of specific analysis of each cited paper, demonstration of equivalence, clear link to post-market surveillance, and because there was insufficient justification for the lack of post-market follow-up: TJ [2012].

223    In an audit in September 2012, BSI discovered that none of the risk management files had been finalised in accordance with the previous CAP, few of the CERs had been updated as required by another CAP, and the updated implementation plans indicated that completion may take three years, well-beyond the original or extended timelines: TJ [2013].

224    BSI’s assessments were based on sampling. Accordingly, it is reasonable to infer that the non-conformities were not confined to the audited files and were more likely than not equally applicable to Ethicon’s evaluations and risk assessments for the other devices: TJ [2018].

3.11    Removal of some devices from the market

225    None of the POP devices is presently for sale in Australia, the United States or Europe. Neither is TVT Secur. These devices have been removed from the ARTG: TJ [2445].

226    The FDA issued an alert to doctors on 20 October 2008 entitled “FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence”: TJ [2448]-[2449].

227    On 13 July 2011, the FDA issued an “update” to its 2008 alert. Its stated purpose was to alert health care providers and patients alike, both actual and prospective, that the problem was more serious than the 2008 report might have suggested: TJ [2452].

228    On 3 January 2012, the FDA issued notices to Ethicon under § 522 of the Federal Food, Drug and Cosmetic Act 1938 (US): TJ [2469]. The FDA informed Ethicon that each of Gynemesh PS, Prolift, Prolift+M, Prosima and TVT Secur was subject to post-market surveillance under § 522 because they were class II devices the failure of which “would be reasonably likely to cause mesh erosion (i.e. organ perforation), severe pain, and fistula formation, which would meet the definition of ‘serious adverse health consequences’ at 21 C.F.R. § 822.3(j)”, and also because the devices were intended to be implanted in the body for more than one year: TJ [2470]. The FDA ordered Ethicon to submit a plan addressing a number of questions: TJ [2471]. Ethicon had no inclination to conduct either of the studies recommended in by the FDA: TJ [2472].

229    On 1 February 2012 Ethicon submitted “study plans” for Prolift and Prolift+M, Gynemesh PS, Prosima, and TVT Secur. In early April 2012, the FDA informed Ethicon that it did not accept its proposals: TJ [2474].

230    On 2 May 2012 Ethicon wrote to the FDA to inform it that Ethicon would “stop commercializing” (that is to say, stop selling) TVT Secur and had no intention of resuming sales in the future: TJ [2484]. Letters in like terms were sent on 9 May 2012 seeking a similar indulgence in relation to the § 522 orders for the POP devices, informing the FDA that Ethicon would stop the sale of Prosima, Prolift and Prolift+M within 120 days and had no intention of resuming sales in the future: TJ [2485]. On 9 July 2012, the FDA agreed to Ethicon’s request to conditionally suspend the § 522 orders: TJ [2488].

231    More likely than not, Ethicon realised it could not satisfy either the market or the FDA that, with respect to the transvaginal use of Gynemesh PS, the mesh kits, or TVT Secur, the benefits outweighed the risks: TJ [2491].

232    A hold was put on supply of the TVT Secur device in Australia in March 2008 and the ARTG registration for it was cancelled in June 2012: TJ [2493].

233    On 28 November 2017 the TGA decided to remove from the ARTG all transvaginal mesh products used in the treatment of POP. In its media release issued the same day the TGA explained that the decision was taken following its review of the most recent published international studies and an examination of the clinical evidence for each such product included in the ARTG and supplied in Australia. It concluded that “the benefits of using transvaginal mesh products in the treatment of POP do not outweigh the risks these products pose to patients”: TJ [2559].

3.12    Information the appellants provided about the devices

234    In Australia, a medical device must be sold accompanied by an IFU document subject to some immaterial exceptions: TJ [2561].

235    IFUs for each of the devices were prepared by Ethicon Inc. and distributed across the world, including Australia, in the boxes in which the devices were sold, other than the original IFU for TVT where the IFU was prepared by Medscand Medical AB which Ethicon subsequently purchased: TJ [1559] and [2562].

236    The IFU is “an essential component of medical devices”, “the cornerstone of risk management”, and “the primary tool for communication between the manufacturer and the clinician about the particular device”: TJ [2563].

237    Twenty-five IFUs for the SUI devices were admitted into evidence. The IFUs were in use in Australia from 1999 to at least 2015: TJ [2586].

238    A reasonable manufacturer of medical devices in the position of Ethicon should have warned of risks which were not included in the IFUs for the SUI devices: TJ [2625]. Based on information Ethicon knew or should have known, the IFUs for all the SUI devices were, and remained, incomplete and certain warnings should have been given in the IFUs at the time those devices were available for sale. The IFUs for all the SUI devices were deficient: TJ [2627]-[2628].

239    Fourteen IFUs for the POP devices were tendered: TJ [2629].

240    Based on the information known by, or knowable to, Ethicon the warnings in the POP devices were incomplete. Failing to include them meant that surgeons were denied the full scope of the safety information necessary to weigh the potential risks and benefits of implanting the device and to fully inform patients of the potential risks to get their consent. A reasonable manufacturer would have warned surgeons (and hence, patients) of those risks: TJ [2645].

241    The warnings and precautions section of each of the IFUs for the POP devices were incomplete. Warnings in certain terms should have been included in all IFUs for the POP devices at all times: TJ [2654].

242    The appellants did not provide training to all surgeons who used the POP devices or take reasonable steps to ensure that the training they did provide adequately equipped those who received it with the skills and information to conduct the operations with minimal risk of injury: TJ [2705].

243    The appellants acknowledged that no surgeon brochures or presentations regarding Prolift contained relevant warnings and the IFU was the only material provided for surgeons that included relevant warnings: TJ [2779].

244    There were numerous deficiencies in the warnings and other information provided by the appellants about the safety and efficacy of the devices to patients and surgeons: TJ [2810] and [2811].

245    The obligation to inform users of the risks in the use of the devices was far more extensive than Dr Hinoul acknowledged and the appellants consistently failed to discharge it. Informing users of a risk requires informing users of the probability and severity of harm, and how that risk was established, not just informing users of a possible harm. None of the warnings or other information provided by the respondents satisfied this requirement. The appellants did provide warnings about some risks but the warnings they gave did not extend to all known risks or to all the pleaded complications. No information was provided about the probability of the risks and next to no information about their severity. Nor did the appellants disclose the manner in which the risks were established. Warnings and other information provided by the appellants about all the devices were deficient: TJ [3031]-[3034].

246    In summary, the primary judge found in respect of the SUI devices that the IFUs were inadequate because, amongst other things:

(1)    the first IFU for TVT (the Medscand IFU) omitted any mention of the risk of erosion, exposure or contraction of the mesh: TJ [3276];

(2)    the first reference to “implant contraction” in an IFU for a device, which included the SUI devices, did not appear until the 11 January 2005 Prolift IFU: TJ [3276];

(3)    the IFUs for the SUI devices warned against using the devices in women with urinary tract infections and advised that “as with all foreign bodies Prolene mesh may potentiate an existing infection”. But until 2015 none of them warned that the mesh could actually cause infection: TJ [3277];

(4)    the first reference to potential difficulties with mesh removal did not appear in any IFU until 3 April 2015 when they were mentioned for the first time in the Gynemesh PS IFU: TJ [3278];

(5)    a number of other complications associated with the implantation of the devices and known to the appellants at all relevant times, were not included in the IFUs until 2013, some not until 2015; some were never included: TJ [3279];

(6)    in respect of permanent foreign body responses following the surgical implantation of mesh, the representations contained in all IFUs for the SUI devices until September or October 2015 which claimed that such responses were “transitory” were misleading, because it was liable to lead the reader to believe that there is no possibility of a permanent or long-lasting abnormal foreign body response, which was consistent with the appellants’ internal position that the foreign body responses were not transitory at all: TJ [3282]-[3286];

(7)    inaccurately and in a manner which was apt to mislead the reader, the IFUs represented that the inflammatory reaction elicited in the tissues is transient. Although immediate or acute post-operative inflammation due to implantation may resolve within days or weeks, the inflammatory foreign body reaction around the implants can persist for years; having been told that a minimal and transient inflammatory response to the mesh could occur, persons generally are entitled to expect no more severe or enduring a reaction: TJ [3293] and [3295];

(8)    though the clinical significance of degradation and weakening of mesh was controversial, the IFUs all contained an incorrect representation that mesh is not subject to degradation or weakening by the action of tissue enzymes: TJ [3298];

(9)    the description in the IFUs for, among others, all the SUI devices includes the sentence: “[t]his material, when used as a suture, has been reported to be non-reactive …”. The primary judge found this was unjustified because the tissue reactions between mesh and sutures were not comparable and that the statement could lull readers into a false sense of security: TJ [3299];

(10)    the description of the devices in the IFUs for TVT, TVT-O, TVT Secur, included the representation that the mesh has “elasticity in both directions” or a “bi-directional elastic property [which] allows adaptation to various stresses encountered in the body”. The primary judge accepted that there was no scientific data to justify these statements. Moreover, her Honour found that whatever elastic properties the devices possessed, they were not adapted to the stresses of the female pelvis: TJ [3300]-[3301]; and

(11)    some of the IFUs for TVT, TVT Secur, TVT Exact, contained a statement to the effect that if the implant is used in contaminated areas it must only be with the understanding that subsequent infection may require its removal. The primary judge found that the statement was misleading in that it indicated that removal would only be required in the case of infection and it was deficient in that it did not advert to the difficulties of removal or to the fact that removal might not alleviate pain. Moreover, none of the IFUs provided any instruction on the method of removal: TJ [3307].

247    The primary judge made the following findings about the marketing of the SUI devices:

(1)    the marketing strategy targeted surgeons which it divided and classified as “Community Practitioner”; “Practice Driven”; “Technical Innovator” and “Clinical Innovator”: TJ [2708];

(2)    the appellants particularly targeted the “Practice Driven Physician” who was focussed on profitability and efficiency;

(3)    the appellants’ group sales representatives visited surgeons to convince them to use its mesh for (at least) prolapse surgery: TJ [2717];

(4)    the appellants produced two kinds of product brochures: brochures directed to patients and brochures targeted at surgeons. Both kinds were integral to the appellants’ marketing strategy: TJ [3261];

(5)    a brochure was produced for “the TVT family of products” which represented that the products had benefits including “no late onset adverse events”; “no tape erosion” and “no tissue reactions”; this was “not a true reflection of the information in Ethicon’s possession.”: TJ [2719] and [2721];

(6)    the patient brochures for the SUI devices contained representations that told “a story of simple fixes for [stress urinary incontinence] that would restore the patient to a life free from social embarrassment and inhibition.” They tended to minimise the significance of any accompanying warning: TJ [2730];

(7)    a 2004 patient brochure for the TVT family of products made no suggestion that long term complications could arise, and created the impression that with the exception of lower urinary tract obstruction, any complications would be short lived: TJ [2741];

(8)    the 2010 TVT family of products patient brochure in response to the question “What are the risks?” said (see: TJ [2743]):

All medical procedures present risks. Although rare, complications include difficulty urinating, injury to blood vessels of the pelvic sidewall and abdominal wall, and bladder and bowel injury. For a complete description of risks, see the adverse events section of the attached product information.

(9)    the adverse events section of the attached product information said (see TJ [2744]):

Punctures or lacerations or injury to vessels, nerves, bladder, urethra, or bowel may occur during instrument passage and may require surgical repair.

Improper placement of the TVT device may result in incomplete or no relief from urinary incontinence or may cause urinary tract obstruction.

The primary judge found that this was misleading because it represented that adverse reactions only occur because of intraoperative surgical error, and it omitted mention of mesh erosion, exposure, contraction and the potential consequences. There was no acknowledgment of the possibility of long-term complications: TJ [2745];

(10)    the 2013 brochure was updated to include (see TJ [2746):

Transitory local irritation at the wound site and a transitory foreign body response may occur. The response could result in extrusion, erosion, fistula formation and inflammation.

(11)    the brochures directed at surgeons emphasised the benefits of the SUI devices over those manufactured by the appellants’ competitors, though they were more muted in tone than the patient brochures they paid little attention to the potential risks: TJ [2748]; and

(12)    in respect of a brochure for the TVT Secur, the respondents represented that the product had (see: TJ [2751]):

•    Low incidence of serious reported complications (<0.03%)

•    Low retention rate (<3%)

•    No reported urethral erosions in multiple clinical studies of 50+ patients.

248    In summary, the primary judge found in respect of the POP devices that the IFUs were inadequate because, amongst other things:

(1)    the first reference to the “implant contraction” in an IFU for any device did not appear until the 11 January 2005 Prolift IFU: TJ [3276];

(2)    the first reference to potential difficulties with mesh removal did not appear in any IFU until 3 April 2015 when they were mentioned for the first time in the Gynemesh PS IFU. By then, however, all the other POP devices were no longer sold or manufactured: TJ [3278];

(3)    a number of other complications associated with the implantation of the devices and known to the appellants at all relevant times, were not included in the IFUs until 2013, some not until 2015. Some were never included: TJ [3279];

(4)    inaccurately and in a manner which was apt to mislead the reader, the IFUs represented that the inflammatory reaction elicited in the tissues is transient. Although immediate or acute post-operative inflammation due to implantation may resolve within days or weeks, the inflammatory foreign body reaction around the implants can persist for years; having been told that a minimal and transient inflammatory response to the mesh could occur, persons generally are entitled to expect no more severe or enduring a reaction: TJ [3293] and [3295];

(5)    the representation in the IFUs for the POP devices that “[t]he mesh remains soft and pliable” is misleading, given the evidence about contraction and the development of a solid mass in the area of the implanted mesh: TJ [3296];

(6)    the unqualified statement [in the IFUs for the POP devices] that “normal wound healing is not noticeably impaired” was also misleading: TJ [3297];

(7)    though the clinical significance of degradation and weakening of mesh was controversial, the IFUs all contained an incorrect representation that mesh is not subject to degradation or weakening by the action of tissue enzymes: TJ [3298];

(8)    the description in the IFUs for all the devices except for Prolift+M includes the sentence: “[t]his material, when used as a suture, has been reported to be non-reactive …”. The primary judge found this was unjustified because the tissue reactions between mesh and sutures were not comparable and that the statement could lull readers into a false sense of security: TJ [3299];

(9)    the description of the devices in the IFUs for Gynemesh PS, Prolift, and Prosima also includes the representation that the mesh has “elasticity in both directions” or a “bi-directional elastic property [which] allows adaptation to various stresses encountered in the body”. The primary judge accepted that there was no scientific data to justify these statements. Moreover, her Honour found that whatever elastic properties the devices possessed, they were not adapted to the stresses of the female pelvis: TJ [3300]-[3301];

(10)    the IFUs for Gynemesh PS, Prolift and Prosima stated that “[t]he mesh affords excellent strength, durability, and surgical adaptability …” when the evidence was to the contrary: TJ [3302];

(11)    the Gynemesh PS IFU also represented that Gynemesh PS has “sufficient porosity for necessary tissue ingrowth”. This representation was misleading because the type of tissue ingrowth was not a type of tissue ingrowth that avoided complications: TJ [3303];

(12)    it was misleading to describe Gynemesh PS as a mesh “…knitted into a unique design that results in a mesh that is approximately 50% more flexible than standard PROLENE mesh” because it is capable of causing the reader to erroneously think that Gynemesh PS was designed for the specific purpose of prolapse repair in women when it is in fact a mesh designed for use in the abdominal wall rebadged for pelvic use as Gynemesh PS: TJ [3304]; and

(13)    some of the IFUs for Gynemesh PS, Prosima and Prolift+M contained a statement to the effect that if the implant is used in contaminated areas it must only be with the understanding that subsequent infection may require its removal. The primary judge found that the statement was misleading in that it indicated that removal would only be required in the case of infection and it was deficient in that it did not advert to the difficulties of removal or to the fact that removal might not alleviate pain. Moreover, none of the IFUs provided any instruction on the method of removal: TJ [3307].

249    The primary judge made the following findings about the marketing of the POP devices:

(1)    a surgeon brochure for Gynemesh PS contained misleading representations including that the product was “[a]n inert synthetic mesh” and that it “conforms to the anatomy and lies flat” when it was likely that the appellants knew from the work of Professors Klinge and Klosterhalfen that meshes were not inert: TJ [2759]-[2760];

(2)    as Gynemesh PS was Prolene Soft Mesh and manufactured for abdominal hernia repairs, there was no sound foundation for the representations that Gynemesh PS conformed to the anatomy of the pelvic floor, that it lies flat, and that it did not harbour bacteria: TJ [2761];

(3)    a 2005 patient brochure for Prolift informed patients that mesh was “a soft synthetic material specially designed for placement through the vagina to support pelvic organs that have ‘dropped out’ of their normal position (prolapsed)”, yet this was not correct as the mesh was “not ‘specifically designed’” for the Prolift application and “[t]his statement is unsupportable from … a design history standpoint.”” This brochure also contained the following representations regarding what the product could do:

It allows for the restoration of sexual function by restoring normal vaginal anatomy.

Using this new surgical procedure there is often no need to perform a hysterectomy if the uterus itself is not diseased.

The 2005 brochure did not warn patients that they might experience a great deal more pain than with traditional surgery or that the pain could be chronic and resistant to treatment: TJ [2764]-[2766];

(4)    the same patient brochure included a section on risks that said:

All surgical procedures present some risks. Although rare, complications associated with the procedure include injury to blood vessels of the pelvis, nerve damage, difficulty urinating, bladder and bowel injury. There is also a small risk of the mesh material becoming exposed into the vaginal canal.

The primary judge found that the warning created the impression that the nominated risks, with the exception of the risk of mesh exposure, were risks which could occur with traditional pelvic surgery. It also understated the risks: TJ [2767]-[2769];

(5)    the respondents acknowledged that no surgeon brochures or presentations regarding Prolift contained relevant warnings and the IFU was the only material provided that contained relevant warnings: TJ [2779];

(6)    the Prolift +M brochure from 2010 was promoted as being a device suitable for all surgeons of varying skill levels: TJ [2780];

(7)    brochures for Prosima omitted reference to the randomised trial conducted by its inventor, Dr Marcus Carey, which demonstrated that the product produced no better results that native tissue colporrhaphy: TJ [2783]; and

(8)    the Prosima brochures all directed the reader to the IFUs “for complete contraindications, warnings, precautions, and adverse reactions”. The primary judge found that this was a clear message from the manufacturer that surgeons need look no further than the IFUs for information on those matters: TJ [2797].

3.13    Statutory claims

3.13.1    Defect

250    At all relevant times Ethicon Sàrl and Ethicon Inc. were “manufacturers” under the TPA and ACL, at least because they manufactured the devices and used their brand name in relation to them, and JJM was a deemed “manufacturer” because it imported the devices into Australia: TJ [3121].

251    The statutory causes of action apply to Ethicon Sàrl and Ethicon Inc. even though they are incorporated overseas and neither has a place of business in Australia: TJ [3124] and [3125].

252    The relevant conduct of Ethicon Sàrl and Ethicon Inc. was in trade or commerce: TJ [3131].

253    In any event, at all relevant times both Ethicon Sàrl and Ethicon Inc. were carrying on business in Australia: TJ [3132].

254    The mere fact that the CE marking was affixed to the devices did not prove that the devices met the regulatory requirements and standards. All the CE marking proved was that the manufacturer asserted and represented that a device met those requirements and that the steps taken to meet the requirements of the European Directive had occurred: TJ [3270].

255    It is reasonable for the public to expect that a medical device which carries CE marking has been cleared for sale and meets the regulatory requirements and standards of the European Directive and, relatedly, the requirements of the TGA. If it does not, it is unlikely to have the safety persons generally are entitled to expect. An isolated episode of non-compliance or an insignificant infraction may not matter. Repeated and systematic non-compliance, however, certainly does: TJ [3272].

256    At all relevant times none of the SUI devices met the level of safety persons generally were entitled to expect: TJ [3413].

257    Many of the representations the appellants made about the SUI devices were misleading: TJ [3418].

258    Having regard to the nature and extent of the risks associated with all the devices, the deficiencies of the appellants’ warnings and the other information they provided, the repeated failure to comply with the requirements for CE marking, and the way in which the devices were marketed, at no relevant time was the safety of any of the SUI devices such as persons generally were entitled to expect. Accordingly, each SUI device had a “defect” or “a safety defect” within the meaning of the TPA and the ACL respectively: TJ [3458].

259    The information provided in the IFUs for all the POP devices was deficient in numerous respects from the first iteration to the last: TJ [3464].

260    While amendments were made to the IFUs from time to time, they did not adequately capture either the true nature or extent of the adverse events that could arise from implantation with the devices or the categories of patients for whom surgery using those devices was contraindicated: TJ [3465].

261    There was a wealth of evidence to indicate that the POP devices were never safe for general use in the wide range of patients for whom they were indicated and promoted: TJ [3470].

262    Despite Ethicon’s repeated unqualified representations to the regulators that all the devices were safe and efficacious and despite the indications in the IFUs, not even Dr Hinoul could justify the unrestricted use of the POP devices: TJ [3494].

263    None of the POP devices satisfied all the requirements for CE marking at any relevant time: TJ [3495].