Gill v Ethicon Sárl (No 8)

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FEDERAL COURT OF AUSTRALIA

Gill v Ethicon Sárl (No 8) [2020] FCA 771

File number: NSD 1590 of 2012
Judge: KATZMANN J
Date of judgment: 5 June 2020
Catchwords: PRACTICE AND PROCEDURE — application to vary injunction and for stay of injunction in the alternative
Legislation:

Competition and Consumer Act 2010 (Cth), s 235

Federal Court Rules 2011 (Cth) r 39.05(d)

Cases cited:

Alexander v Cambridge Credit Corporation Ltd (receivers appointed) (1985) 2 NSWLR 685

Australian Competition and Consumer Commission v True Alliance Trading Pty Ltd (formerly, Reebok Australia Pty Ltd) (No 2) [2017] FCA 990

Australian Securities and Investments Commission v ActiveSuper Pty Ltd (No 4) [2013] FCA 318

Bryant v Commonwealth Bank of Australia (1996) 70 ALJR 306; 90 LGERA 126; 134 ALR 460

ICI Australia Operations Pty Ltd v Trade Practices Commission (1992) 38 FCR 248

New South Wales Bar Association v Stevens [2003] NSWCA 95; 52 ATR 602

Phillip Morris (Australia) Pty Ltd v Nixon [1999] FCA 1281

Powerflex Services Pty Ltd v Data Access Corporation (1996) 67 FCR 65

Red Bull Australia Pty Ltd v Sydneywide Distributors Pty Limited t/as Sydneywide Bottlers Australia [2001] FCA 1750

Date of hearing: 25 May 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: 73
Counsel for the Applicants: Mr AJL Bannon SC with Ms Z Hillman
Solicitor for the Applicants: Shine Lawyers
Counsel for the Respondents: Ms T Wong SC with Mr R Pietriche
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 SÁRL

First Respondent

ETHICON, INC.

Second Respondent

JOHNSON & JOHNSON MEDICAL PTY LIMITED (ACN 000 160 400)

Third Respondent

JUDGE:

KATZMANN J

DATE OF ORDER:

5 JUNE 2020

THE COURT ORDERS THAT:

1.Order 2 made on 6 March 2020 be varied by the deletion of the struck-through number and words and the insertion of the underlined words as indicated below:

Pursuant to s 232 of the Australian Consumer Law, being Schedule 2 to the Competition and Consumer Act 2010 (Cth), after 20 March 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 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…

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Details
Case
[2020] FCA 771
Decision Date

CaseChat Overview and Summary

In Gill v Ethicon Sàrl (No 8), the respondents, Ethicon Sàrl and Johnson & Johnson Medical Pty Limited, sought to vary an injunction and obtain a stay of the injunction. The injunction, which was imposed by the court on 6 March 2020, required the respondents to include specific information in patient information leaflets and promotional material for certain medical devices. The injunction was part of a broader representative proceeding where the court found the respondents had contravened consumer protection laws by supplying defective goods and making misleading statements about those goods. The medical devices in question were implantable polypropylene mesh devices used to treat pelvic organ prolapse and stress urinary incontinence.

The legal issues before the court were whether to vary the injunction to extend the deadline for compliance and to modify the required information in the patient leaflets, and whether to stay the injunction pending the outcome of an appeal against the principal judgment. The respondents argued that the injunction was overly broad, potentially harmful to patients, and that the information required to be included was misleading. They sought a variation to provide more time for compliance and to refine the information provided to patients. The applicants opposed the application, arguing that the injunction was necessary to protect consumers and that the proposed changes would undermine its effectiveness.

The court considered the urgency of the need to protect consumers, the potential harm of the injunction, and the respondents' ability to comply with the injunction. The court found that while the injunction was necessary to protect consumers, there was merit in extending the deadline to allow the respondents more time to implement the changes. The court also found that the proposed changes to the information were reasonable and did not undermine the effectiveness of the injunction. The court dismissed the application for a stay of the injunction, finding that the appeal did not raise substantial questions of law warranting a stay.

The court varied the injunction to extend the deadline for compliance and to modify the information required in the patient information leaflets and promotional material. The injunction was amended to require the inclusion of additional information about the risks and potential complications associated with the medical devices. The court dismissed the application for a stay of the injunction with costs.

Orders

Orders of the court

1. Order 2 made on 6 March 2020 be varied by the deletion of the struck-through number and words and the insertion of the underlined words as indicated below:

Pursuant to s 232 of the Australian Consumer Law, being Schedule 2 to the Competition and Consumer Act 2010 (Cth), after 20 March 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 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. Complications might also occur in patients without any known risk factors.

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) punctures or lacerations of vessels, nerves, structures or organs, including the bladder, urethra or bowel, which may require surgical repair;

(f) chronic pain, which may be severe and chronic;

(g) pain with sexual intercourse (dyspareunia), which may be severe and may become chronic;

(h) loss of sexual function (apareunia), which may be ongoing and may not resolve in some patients;

(i) leg weakness and other neuromuscular problems which may include acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area;

(j) de novo urge urinary incontinence or recurrent recurrence of stress urinary incontinence;

(k) difficulty voiding; and

(l) 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.

One or more revision surgeries may be necessary to treat the adverse reactions associated with PROLENE Mesh. Revision surgeries may not resolve complications and are associated with a risk of adverse reactions. PROLENE Mesh is a permanent implant that integrates into the tissue. In cases in which the PROLENE Mesh needs to be removed in part or whole, significant dissection may be required.

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.

2. The interlocutory application filed by the respondents on 17 April 2020 and amended on 25 May 2020 otherwise be dismissed with costs.

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

Background

Background to the litigation

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Evidence

Evidence Before The Court

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Decision

Reasons for decision

This is a representative proceeding in which I held that the respondents contravened the Trade Practices Act 1974 (Cth) and the Australian Consumer Law by, amongst other things, supplying defective goods within the meaning of that legislation and making misleading or deceptive statements in relation to them. I also found that the respondents breached their duty of care to the applicants who received some of those goods. See Gill v Ethicon Sàrl (No 5) [2019] FCA 1905 (the principal judgment). The goods in question are implantable medical devices made from treated polypropylene and indicated for the treatment of either pelvic organ prolapse (POP devices) or stress urinary incontinence (SUI devices). None of the POP devices has been sold in Australia for some time and none can now be sold since they have been removed from the Australian Register of Therapeutic Goods (ARTG). All but one is no longer manufactured. The SUI devices, however, continue to be manufactured and all but one is still sold in Australia. Those devices currently available for sale in Australia are Gynecare Tension-free Vaginal Tape System (TVT), Gynecare TVT Obturator System (TVT-O), Gynecare TVT Exact Continence System (TVT Exact) and Gynecare TVT Abbrevo Continence System (TVT Abbrevo). They are manufactured by Ethicon Sàrl, a Swiss corporation, and imported, promoted and distributed in Australia by a related company, Johnson & Johnson Medical Pty Limited (JJM). An appeal from the principal judgment was filed on 3 April 2020. This is an application brought by the respondents to vary one of two injunctions I imposed on 6 March 2020. The effect of that injunction was to restrain the respondents from supplying, distributing, marketing or promoting any of the four SUI devices listed above without including in patient information leaflets and promotional material relating to those devices certain information or advice about some significant complications about which no or no adequate warnings had previously been given (the Advice). The injunction in question was order 2 of the orders made that day (Order 2). Order 2 was in the following terms: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.

Ratio Decidendi

Legal Principle Established

Full text does not contain this section.