FEDERAL COURT OF AUSTRALIA
Gill v Ethicon Sàrl (No 6) [2020] FCA 279
File number(s): NSD 1590 of 2012 Judge(s): KATZMANN J Date of judgment: 6 March 2020 Catchwords: CONSUMER LAW — representative action — nine urogynaecological medical devices made with polypropylene intended for permanent implantation in the female pelvis
PRACTICE AND PROCEDURE — representative action — answers to common issues/questions
RELIEF — injunctive relief — where information and warnings given by respondents about risks of injury from implantation of medical devices found to be inadequate and misleading or deceptive and proposed injunction would prevent respondents from supplying, distributing, marketing or promoting any medical devices without including in the instructions for use for each device and any promotional material relating to it a suitable warning — where proposed injunction unlikely to benefit group members and where changes made to instructions for use after hearing of action, whether injunctive relief should be granted — where recent amendments to Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) require certain information about risks and other matters to be included in cards and leaflets to be sent to surgeons and patients, whether proposed injunction should extend to inclusion of proposed warning in instructions for use of those devices where devices are manufactured overseas and supplied with identical instructions for use throughout the world
Legislation: Australian Consumer Law (Sch 2 of the Competition and Consumer Act 2010 (Cth)) ss 232, 235
Federal Court of Australia Act 1976 (Cth) s 33H(1)(c)
Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) sch 1 cls 13A.1, 13A.2, 13A.3, 13A.4
Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017 (Cth)
Cases cited: Bright v Femcare Limited [2002] FCAFC 243; 195 ALR 574
Gill v Ethicon SÁRL [2018] FCA 470
Gill v Ethicon Sàrl (No 5) [2019] FCA 1905
Date of hearing: 3 March 2020 Date of last submissions: 5 March 2020 Registry: New South Wales Division: General Division National Practice Area: Commercial and Corporations Sub-area: Regulator and Consumer Protection Category: Catchwords Number of paragraphs: 50 Counsel for the Applicants: Mr AJL Bannon SC
Dr DE Graham SC
Mr A Naylor
Ms Z Hillman
Solicitor for the Applicants: Shine Lawyers Counsel for the Respondents: Ms KC Morgan SC
Mr DTW Wong
Solicitor for the Respondents: Clayton Utz ORDERS
NSD 1590 of 2012 BETWEEN: KATHRYN GILL
First Applicant
DIANE DAWSON
Second Applicant
ANN SANDERS
Third Applicant
AND: ETHICON SARL
First Respondent
ETHICON, INC
Second Respondent
JOHNSON & JOHNSON MEDICAL PTY LIMITED ACN 000 160 403
Third Respondent
JUDGE:
KATZMANN J
DATE OF ORDER:
6 MARCH 2020
THE COURT ORDERS THAT:
Common questions
1.The common questions raised in the proceedings be answered in the terms set out in Schedule A to these orders.
Injunctive relief
2.Pursuant to s 232 of the Australian Consumer Law, being Schedule 2 to the Competition and Consumer Act 2010 (Cth), after 20 March 2020 the respondents may not supply, distribute, market or promote any of the medical devices identified in Schedule B to these orders anywhere in Australia…
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- Case
- [2020] FCA 279
- Decision Date
CaseChat Overview and Summary
The court held that the information and warnings provided by the respondents were inadequate and misleading or deceptive. The respondents failed to adequately disclose the risks associated with the chronic inflammatory response, the potential for severe complications, and the lack of predictability of adverse effects in patients. The court further ruled that the proposed injunction, which required the inclusion of a specific warning in the instructions for use and promotional material, would be effective in preventing misleading conduct. However, the court also noted that recent amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) required certain information to be included in cards and leaflets to be sent to surgeons and patients. Consequently, the court decided to limit the injunction to the inclusion of the proposed warning in the instructions for use of the devices, considering that the devices were manufactured overseas and supplied with identical instructions worldwide.
The final orders of the court mandated that the respondents could not supply, distribute, market, or promote any of the specified medical devices without including the required warnings in the patient information leaflets and instructions for use. The court set deadlines for filing notices of appeal and specified the definition of terms used in the orders. The injunction was to take effect after a certain period, providing the respondents time to comply with the new requirements. The court's decision aimed to ensure that women were adequately informed of the risks associated with the implantation of these medical devices, thereby protecting consumer rights and safety.
Orders
Orders of the court
Common questions
1. The common questions raised in the proceedings be answered in the terms set out in Schedule A to these orders.
Injunctive relief
2. Pursuant to s 232 of the Australian Consumer Law, being Schedule 2 to the Competition and Consumer Act 2010 (Cth), after 20 March 2020 the respondents may not supply, distribute, market or promote any of the medical devices identified in Schedule B to these orders anywhere in Australia without including in the patient information leaflets and any promotional material relating to those devices advice in the following terms or to the following effect:
Prolene mesh is designed to, and will invariably elicit in all patients, an acute inflammatory reaction followed by a chronic inflammatory response. The chronic inflammatory response will result in continuously regenerating scar tissue within and surrounding the implant for as long as the implant remains in the body. The scar tissue will cause the mesh to contract to some degree in all patients. It is not possible to predict the severity of the chronic inflammatory response in any individual patient. In some patients the chronic inflammatory response will have adverse effects. It is not possible to identify in advance the patients who will experience those effects, although some patients are at greater risk than others. At-risk patients include healthy patients. The severity of a patient’s chronic inflammatory response can be affected by physical activity and mechanical loading of the pelvic floor. It can also be affected by conditions which affect the immune response and healing, such as autoimmune and connective tissue disorders. The mechanical forces in the pelvic floor may influence the compatibility and function of the implant.
The adverse events which may result include:
(a) infection;
(b) erosion of the mesh into the vaginal canal resulting in infection which may be difficult to treat, cause offensive vaginal discharge and pain;
(c) erosion of the mesh into surrounding organs such as the bladder, urethra or rectum which may cause pain and damage those organs;
(d) damage to nerves in the scar tissue surrounding the implant or elsewhere;
(e) chronic pain, which may be severe;
(f) dyspareunia, which may be severe and may become chronic;
(g) apareunia;
(h) leg weakness;
(i) de novo or recurrent urinary incontinence;
(j) difficulty voiding; and
(k) vaginal discharge.
Adverse events may occur years after implantation. The risk will endure for as long as the implant remains in the patient.
Each of these events may occur regardless of the skill of the surgeon.
While the true incidence of these complications is unknown, they are not rare.
Removal of the implant in whole or in part will not necessarily alleviate the patient’s symptoms. Removal of part of the implant can be difficult. Removal of the whole of the implant may be practically impossible. Surgery to remove the whole or part of an implant can result in further scarring and tissue damage which, in turn, may have adverse outcomes including severe chronic pain which may not be able to be satisfactorily treated. Surgery to remove the whole or part of the implant may also result in recurrence of stress urinary incontinence.
Removal of the eroded mesh will not necessarily prevent further erosions or other adverse events.
3. Pursuant to s 232 of the Australian Consumer Law, being Schedule 2 to the Competition and Consumer Act 2010 (Cth), after 30 June 2020 the respondents may not supply, distribute, market or promote any of the medical devices identified in Schedule B to these orders anywhere in Australia without including in the instructions for use the above advice or advice to the same effect.
Appeal period
4. Pursuant to r 36.03(b) of the Federal Court Rules 2011 (Cth), any notice of appeal from the judgment pronounced on 21 November 2019 and these or earlier orders must be filed by 3 April 2020.
Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.
Schedule A
Definitions
Australian Consumer Law means Schedule 2 of the Competition and Consumer Act.
CE mark means Conformité Européenne mark applied as a declaration by a manufacturer that its product conforms to the requirements of the European Council Directive 93/42/EEC issued on 14 June 1993 as amended from time to time.
Competition and Consumer Act means the Competition and Consumer Act 2010 (Cth).
Ethicon devices means the SUI devices and the POP devices.
Group members means the group members as defined in para 1(b) of the Fifth Further Amended Statement of Claim.
JJM means Johnson & Johnson Medical Pty Limited.
Manufacturers means the first and second respondents, Ethicon Sàrl and Ethicon, Inc.
POP means pelvic organ prolapse.
POP devices means the medical devices used for the treatment of pelvic organ prolapse known by the trade names Gynecare Gynemesh Prolene Soft (Gynemesh PS), Gynecare Prolift Pelvic Floor Repair System (Prolift), Gynecare Prolift+M Pelvic Floor Repair System (Prolift+M) and Gynecare Prosima Pelvic Floor Repair System (Prosima).
SUI means stress urinary incontinence.
SUI devices means the medical devices used for the treatment of stress urinary incontinence known by the trade names Gynecare Tension-free Vaginal Tape System (TVT), Gynecare TVT Obturator System (TVT-O), Gynecare TVT Secur System (TVT Secur), Gynecare TVT Exact Continence System (TVT Exact) and Gynecare TVT Abbrevo Continence System (TVT Abbrevo).
Trade Practices Act means the Trade Practices Act 1974 (Cth).
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The purpose for which the Ethicon devices were acquired
Q1: What was the purpose for which the POP devices were acquired?
A: The POP devices were acquired for the purpose of treating pelvic organ prolapse in women and, more particularly, for the purpose of treating the condition more effectively, or at least as effectively as other surgical interventions, and with fewer risks to safety.
Q2: What was the purpose for which the SUI devices were acquired?
A: The SUI devices were acquired for the purpose of treating stress urinary incontinence in women and, more particularly, for the purpose of treating the condition more effectively, or at least as effectively as other surgical interventions, and with fewer risks to safety.
Complications that can be caused by the Ethicon devices?
Q3: Can the Ethicon devices cause the following complications
(a) a chronic inflammatory reaction of the tissues surrounding the implanted device, also known as a foreign body response, which is affected by conditions which affect the immune response and healing, including autoimmune and connective tissue disorders;
(b) extrusion or erosion of the mesh into surrounding organs, including the vaginal wall, bladder or urethra;
(c) infection;
(d) chronic pain;
(e) dyspareunia and/or apareunia;
(f) difficulty voiding;
(g) offensive vaginal discharge;
(h) de novo or recurrent urinary incontinence;
(i) damage to surrounding organs, nerves, ligaments, tissue and/or blood vessels;
(j) haemorrhage;
(k) leg weakness;
(l) psychiatric injury;
(m) the need for reoperation or revision surgery associated with complications;
(n) the need to remove the implanted device or part of the implanted device; and
(o) complications associated with the removal of the implanted device or part of the implanted device, which might prove difficult or impossible, including aggravation of existing complications?
A: Yes.
Q4: Can the POP devices also cause the following complications:
(a) difficulty defecating; and
(b) recurrence of prolapse?
A: Yes.
Q5: Are each of the complications referred to in questions 3 and 4 clinically significant?
A: Yes.
Q6: Are the complications confined to the transvaginal use of mesh?
A: No, they extend to mesh implanted transabdominally.
Q7: Can the complications occur many years after implantation?
A: Yes.
Q8: Is it necessary for group members to prove the mechanism by which the Ethicon devices caused the complications they suffered as a result of implantation of those devices?
A: No.
Biocompatibility issues
Q9: Can the pores of the mesh used in the Ethicon devices deform and collapse under mechanical load?
A: Yes.
Q10: Does deformation and collapse of the pores of the mesh used in the Ethicon devices cause bridging fibrosis or fibrotic bridging?
A: Yes.
Q11: Is bridging fibrosis of clinical significance?
A: Yes. It can cause or contribute to contraction of the mesh which, in turn, can cause complications such as mesh exposure, erosion, chronic pain and dyspareunia.
Negligence
Q12: Did the respondents owe a duty of care to group members?
A: Yes. The respondents owed a duty to take reasonable care to avoid injury to consumers.
Q13: Did the manufacturers owe the group members a duty to take reasonable care in the design, testing, evaluation, supply, and marketing of the Ethicon devices?
A: Yes.
Q14: Did JJM owe the group members a duty to take reasonable care in the supply and marketing of the Ethicon devices?
A: Yes.
Q15: Did the manufacturers breach their duty of care to the group members by failing to undertake adequate pre-market evaluations of the safety and efficacy of the Ethicon devices?
A: Yes.
Q16: Did the manufacturers breach their duty of care to the group members by failing to undertake adequate post-market evaluations of the safety and efficacy of the Ethicon devices?
A: Yes.
Q17: During the period from the time of first supply in Australia of each of the Ethicon devices until 4 July 2017, did the respondents breach their duty of care to group members by failing to provide any adequate information, advice or warnings about the above-mentioned complications and the absence of any adequate clinical or other evaluation of the risks?
A: Yes, throughout the period, except that they did not breach their duty of care by failing to warn of the risk of psychiatric injury.
Q18: In what respects was the information, advice or warnings provided by the respondents about the complications inadequate?
A: Save as indicated below, the respondents failed to disclose or make adequate disclosure of the following matters:
(a) that the mesh used in the Ethicon devices was designed to, and would invariably elicit in patients, an acute inflammatory reaction followed by a chronic inflammatory response;
(b) that in some patients the chronic inflammatory response will have adverse effects;
(c) that it is not possible to predict which patients will be adversely affected but they include healthy patients;
(d) that the severity of a patient’s chronic inflammatory response can be affected by conditions which affect the immune response and healing, such as autoimmune and connective tissue disorders;
(e) that the severity of a patient’s chronic inflammatory response can be affected by physical activity and mechanical loading of the pelvic floor;
(f) that the mechanical forces in the pelvic floor may influence the compatibility and function of the implant;
(g) that the adverse effects of the chronic inflammatory response in some patients include:
(i) infection, rather than merely the potentiation of infection;
(ii) that erosion of the mesh into the vaginal canal could cause infection which might be difficult to treat and cause offensive vaginal discharge and pain;
(iii) that erosion of the mesh into surrounding organs, such as the bladder, urethra or rectum, could cause pain and damage those organs;
(iv) damage to nerves in the scar tissue surrounding the implant or elsewhere (except for Gynemesh PS from 16 March 2013, Prolift from 1 October 2009, and Prolift+M from 12 December 2008);
(v) chronic pain, which may be severe;
(vi) dyspareunia, which may be severe and become chronic;
(vii) apareunia;
(viii) leg weakness;
(ix) de novo or recurrent incontinence (except TVT from 7 October 2015, TVT-O from 22 September 2015, TVT Abbrevo from 24 September 2015, TVT Exact from 18 September 2015, Gynemesh PS from 16 March 2013, Prolift from 1 October 2009, Prolift+M from 12 December 2008);
(x) difficulty voiding (except for TVT from 7 October 2015, TVT-O from 22 September 2015, TVT Abbrevo from 24 September 2015, TVT Exact from 18 September 2015, Gynemesh PS from 16 March 2013, Prolift from 1 October 2009, Prolift+M from 12 December 2008);
(xii) vaginal discharge (except TVT from 7 October 2015, TVT-O from 22 September 2015, TVT Abbrevo from 24 September 2015, TVT Exact from 18 September 2015, Gynemesh PS from 3 April 2015); and
(xiii) (in the case of the POP devices only) recurrent prolapse (except for Gynemesh PS from 16 March 2013, Prolift from 1 October 2009, and Prolift+M from 12 December 2008) and pain on defaecation;
(h) that the adverse events may occur years after implantation and the risk will endure for as long as the implant remains in the body;
(i) that the adverse events may occur regardless of the skill of the surgeon;
(j) that the true incidence of the adverse events is unknown but they are not rare;
(k) that removal of the implant in whole or in part will not necessarily alleviate the patient’s symptoms;
(l) that removal of part of an implant can be difficult and removal of the whole may be practically impossible;
(m) that mesh removal surgery can result in further scarring and tissue damage which, in turn, may have adverse outcomes, including severe chronic pain which may not be able to be satisfactorily treated;
(n) that surgery to remove the whole or part of an implanted SUI device can result in recurrence of stress urinary incontinence;
(o) that surgery to remove the whole or part of an implanted POP device can result in recurrence of pelvic organ prolapse; and
(p) that removal of eroded mesh will not necessarily prevent further erosions or other adverse events.
Q19: But for the respondents’ negligent pre-market evaluations:
(a) would any of the Ethicon devices have been on the Australian market at any time?
A: No.
(b) would any group member have received an Ethicon device and suffered damage from its implantation?
A: No.
The statutory causes of action
Q20: Do the causes of action under the Trade Practices Act or the Australian Consumer Law apply to Ethicon Sàrl and Ethicon, Inc. even though they are incorporated overseas and neither has a place of business in Australia?
A: Yes.
Misleading or deceptive conduct
Q21: Between the first supply in Australia of the Ethicon devices and 4 July 2017 was the respondents’ conduct in marketing the Ethicon devices misleading or deceptive or likely to mislead within the meaning of s 52 of the Trade Practices Act or s 18 of the Australian Consumer Law?
A: Yes.
Q22: Why was the respondents’ conduct misleading or deceptive or likely to mislead or deceive?
Throughout the period from the first supply in Australia of the Ethicon devices to 4 July 2017, the respondents falsely represented that the inflammatory reaction generated by implantation was transitory rather than permanent and possible rather than certain, and exaggerated the benefits of the devices and minimised the risks associated with implantation.
Defective goods
Q23: Did the POP devices or any of them have a defect within the meaning of s 75AC of the Trade Practices Act and a safety defect within the meaning of s 9 of the Australian Consumer Law in that their safety was not such as persons generally are entitled to expect?
A: Yes, all of them. The safety of those devices was not such as persons generally are entitled to expect because they exposed women to significant risks of injury against which inadequate precautions were taken and in respect of which misleading representations were made. The mesh kits were only ever suitable for use in the context of a clinical trial and then only with appropriate warnings about the nature and extent of the complications.
Q24: Did the SUI devices or any of them have a defect within the meaning of s 75AC of the Trade Practices Act and a safety defect within the meaning of s 9 of the Australian Consumer Law in that their safety was not such as persons generally are entitled to expect?
A: Yes, all of them because, taking into account all the relevant circumstances, including the way in which and the purposes for which they were marketed, the use of the CE mark in relation to them, the deficiencies in the warnings and other information supplied by the respondents they exposed women to significant risks of injury against which inadequate precautions were taken and in respect of which misleading representations were made.
Q25: Which of the respondents is liable to compensate a group member who can prove she suffered an injury because of a defect, or safety defect, in a POP device?
A: Ethicon Sàrl and JJM are jointly and severally liable to compensate group members who suffered an injury because of a defect, or safety defect, in Prolift, Prolift+M or Prosima. Ethicon, Inc and JJM are jointly and severally liable to compensate group members who suffered an injury because of a defect, or safety defect, in Gynemesh PS.
Q26: Which of the respondents is liable to compensate a group member who can prove she suffered an injury because of a defect, or safety defect, in a SUI device?
A: Ethicon Sàrl and JJM are jointly and severally liable to compensate group members who suffered an injury because of a defect, or safety defect, in any of the SUI devices.
Q27: Did the respondents establish a state of the art defence within s 75AK(1)(c) of the Trade Practices Act or s 142(c) of the Australian Consumer Law?
A: No.
Unfitness for purpose and unmerchantable quality
Q28: Were the POP devices reasonably fit for the purpose for which they were acquired?
A: No.
Q29: Were the SUI devices reasonably fit for the purpose for which they were acquired?
A: No.
Q30: Were the POP devices not as fit for the purpose for which goods of that kind are commonly bought as it is reasonable to expect having regard to all relevant circumstances?
A: No.
Q31: Were the SUI devices not as fit for the purpose for which goods of that kind are commonly bought as it is reasonable to expect having regard to all relevant circumstances?
A: No.
Schedule B
Product name
ARTG no.
Gynecare Tension-free Vaginal Tape System (TVT)
supplied under 99193
Gynecare TVT Obturator System
supplied under 99193
Gynecare TVT Exact Continence System
supplied under 99193
Gynecare TVT Abbrevo Continence System
supplied under 99193
Background
Background to the litigation
Full text does not contain this section.
Evidence
Evidence Before The Court
Full text does not contain this section.
Decision
Reasons for decision
Ratio Decidendi
Legal Principle Established
Full text does not contain this section.