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Gill v Ethicon Sàrl (No 5)

Gill v Ethicon Sàrl (No 5)

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FEDERAL COURT OF AUSTRALIA
Gill v Ethicon Sàrl (No 5) [2019] FCA 1905

File number: NSD 1590 of 2012

Judge: KATZMANN J

Date of judgment: 21 November 2019

Catchwords:
CONSUMER LAW — representative action — nine urogynaecological medical devices made from polypropylene intended for permanent implantation in the female pelvis — where manufactured by foreign corporations and supplied by local corporation in the same corporate group — where neither foreign corporation had a place of business in Australia but impugned conduct took place in Australia, whether foreign corporations can be found liable for contraventions of the Trade Practices Act 1974 (Cth) and the Australian Consumer Law — whether conduct of foreign corporations was “in trade or commerce” — whether foreign corporations were carrying on business in Australia

CONSUMER LAW — defective goods — whether at the time medical devices were supplied by the manufacturer they had a “defect” within the meaning of s 75AC of the Trade Practices Act 1974 (Cth) or a “safety defect” within the meaning of s 9 of the Australian Consumer Law in that “their safety [was] not such as persons generally are entitled to expect” — relevant circumstances — meaning of “the time they were supplied by the manufacturer” — “learned intermediary” doctrine — significance of supply of devices through “learned intermediaries” (here, surgeons or physicians) — where respondents failed to warn doctors or patients of certain risks or potential complications of which they were aware — extent of obligation to warn — where some warnings were misleading — whether manufacturers excused from liability with respect to risks or potential complications that should be known to medical practitioners or which they are able to discover for themselves — significance of CE marking — relevance of state of scientific knowledge at time of supply — whether state of scientific or technical knowledge at time of supply not such as to enable defects to be discovered — whether devices unfit for the purpose for which they were supplied or of unmerchantable quality — whether each applicant suffered injuries because of defect in device she received or by reason that device not reasonably fit for the purpose for which it was supplied — proper approach to determination of causation in defective goods claim — causal connection required by s 75AD(c)

CONSUMER LAW — misleading or deceptive conduct — medical devices — whether product information published by one or other respondent misleading or deceptive or likely to mislead or deceive consumers of medical devices about the safety and/or efficacy of the devices — whether loss or damage by conduct

NEGLIGENCE — product liability — medical devices — duty of care — content of duty owed by foreign manufacturers and local supplier to end users of medical devices — where known risk of significant injury, whether respondents breached their duties of care by failing to adequately evaluate the safety of the devices before and/or after they were released to market — extent of obligation to warn where products supplied through…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

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Details

Case: [2019] FCA 1905
Decision Date: 21 November 2019

CaseChat Overview and Summary

The case of Gill v Ethicon Sàrl (No 5) involved multiple applicants who had been implanted with medical devices manufactured by Ethicon Sàrl and related entities, alleging that the devices were defective and that the respondents engaged in misleading or deceptive conduct. The dispute was heard in the Federal Court of Australia, where the applicants sought damages and other relief against Ethicon Sàrl and related corporations for the alleged contraventions of the Trade Practices Act 1974 (Cth) and the Australian Consumer Law, as well as claims of negligence.

The court was tasked with determining several legal issues, including whether the foreign corporations could be held liable under Australian consumer law, the definition of "defect" in the context of the supplied medical devices, the obligations of the respondents to warn of known risks, and the extent of the duty of care owed by the manufacturers. Additionally, the court needed to address issues of causation, the admissibility of certain evidence under state and federal laws, and the appropriateness of injunctive and declaratory relief.

The Federal Court found that the foreign corporations could indeed be liable under Australian law as their conduct occurred in Australia and was part of their business activities. The court held that the medical devices were defective as their safety was not as expected by the general public, despite the "learned intermediary" doctrine. The respondents were found to have breached their duty of care by not adequately warning of the known risks associated with the devices. The court also ruled on the admissibility of certain evidence, the appropriate calculation of damages, and the applicability of limitation periods to the claims.

In conclusion, the court ordered the applicants to elect between statutory and common law damages by a specified date, mandated the preparation of minutes reflecting the court's reasons, and set a timetable for further proceedings should the parties be unable to agree on the form of orders. The court also granted liberty to apply for further orders as needed.

Orders

Orders of the court

1. By 20 December 2019, each applicant is to notify the respondents and the Court of her election as to whether she will accept an award of damages under the relevant provisions of the Trade Practices Act 1974 (Cth) or at common law, as modified by the statutory scheme, if any, that operates in the State in which she lives.

2. By 14 February 2020, the parties bring in short minutes giving effect to these reasons.

3. In the event that the parties are unable to agree on the form of orders or all of the orders, including the form of the common questions and the answers to them for the purposes of s 33ZB of the Federal Court of Australia Act 1976 (Cth), a timetable for the filing and exchange of submissions be forwarded to chambers by 17 January 2020, with a view to a hearing in the week commencing 10 February 2020.

4. Liberty to apply be granted on two (2) days’ notice.

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

More than 5,500 documents were tendered, running to over 164,000 pages. Mercifully, the trial was conducted electronically, which, to some extent, eased the burden on the Court.The evidence Each of the applicants gave evidence on affidavit and was cross-examined. Affidavits were also read from their husbands, only one of whom, Steven Gill, was required for cross‑examination. The applicants adduced evidence from four urogynaecologists. They were Andrew Korda, Wael Agur, Jerry Blaivas, and Michael Thomas Margolis. Professor Korda is an Australian. Dr Agur practises in Scotland and was described by one of the respondents’ experts as an opinion leader in Great Britain.[9] Professor Blaivas and Assistant Professor Margolis hail from the United States. Urogynaecology, I should explain, is a surgical subspecialty of urology and gynaecology, which involves the diagnosis and treatment of female pelvic floor disorders.[10][9] Collinet at 22 (EXP.020.005.0001_4 at 0022_4)[10] Korda 1 at 5 (EXP.010.078.0001_3 at 0006_3) After the respondents had indicated they would not be calling him, the applicants tendered a report prepared for the respondents by Malcolm Frazer, another urogynaecologist. The applicants also tendered reports and read affidavits from a number of other expert witnesses in a range of disciplines. They included the following people who, unless otherwise indicated, are based in Australia: Bilal Chughtai, a urologist, from the United States; Uwe Klinge, a general surgeon and biomaterials researcher who lives in Belgium; Bernd Klosterhalfen from Germany and Vladimir Iakovlev from Canada, both pathologists; two biomechanical engineers, Russell Dunn and Scott Guelcher from the United States; four regulatory experts, Derrick Beech, Bryan Allman from the United Kingdom, Peggy Pence and Anne Holland from the United States; three epidemiologists, Howard Hu from Canada, Cara Krulewitch from the United States, and Mark Woodward; Ian Gordon, a biostatistician; two colorectal surgeons, Alan Meagher and Anthony Eyers; Patricia Jungfer, a psychiatrist; Joseph Slesenger, a specialist in occupational medicine; and Lindy Williams and Timothy Walsh, both occupational therapists. Of these witnesses, only Dr Beech, Professor Woodward, Ms Williams, and Mr Walsh were not required for cross-examination. Affidavits were also read from Robyn Leake, an obstetrician and gynaecologist who treated Mrs Gill for a number of years, 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. The respondents adduced evidence from six urogynaecologists: Piet Hinoul from the United States, Pierre Collinet from France, Jan Deprest from Belgium, Alan Lam, Jan-Paul Roovers from the Netherlands, and Anna Rosamilia; an engineer, Steven McLean from the United States; Paul Santerre, a professor of biomaterials from Canada; Thomas Wright, a pathologist from the United States; three psychiatrists, Lisa Brown, Anthony Samuels, and Rosalie Wilcox; and an occupational therapist, Susan Borthwick. All of these witnesses, except Dr Wilcox, were required for cross‑examination.

Decision

Reasons for decision

Full text does not contain this section.

Ratio Decidendi

Legal Principle Established

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File number:	NSD 1590 of 2012
Judge:	KATZMANN J
Date of judgment:	21 November 2019
Catchwords:	CONSUMER LAW — representative action — nine urogynaecological medical devices made from polypropylene intended for permanent implantation in the female pelvis — where manufactured by foreign corporations and supplied by local corporation in the same corporate group — where neither foreign corporation had a place of business in Australia but impugned conduct took place in Australia, whether foreign corporations can be found liable for contraventions of the Trade Practices Act 1974 (Cth) and the Australian Consumer Law — whether conduct of foreign corporations was “in trade or commerce” — whether foreign corporations were carrying on business in Australia CONSUMER LAW — defective goods — whether at the time medical devices were supplied by the manufacturer they had a “defect” within the meaning of s 75AC of the Trade Practices Act 1974 (Cth) or a “safety defect” within the meaning of s 9 of the Australian Consumer Law in that “their safety [was] not such as persons generally are entitled to expect” — relevant circumstances — meaning of “the time they were supplied by the manufacturer” — “learned intermediary” doctrine — significance of supply of devices through “learned intermediaries” (here, surgeons or physicians) — where respondents failed to warn doctors or patients of certain risks or potential complications of which they were aware — extent of obligation to warn — where some warnings were misleading — whether manufacturers excused from liability with respect to risks or potential complications that should be known to medical practitioners or which they are able to discover for themselves — significance of CE marking — relevance of state of scientific knowledge at time of supply — whether state of scientific or technical knowledge at time of supply not such as to enable defects to be discovered — whether devices unfit for the purpose for which they were supplied or of unmerchantable quality — whether each applicant suffered injuries because of defect in device she received or by reason that device not reasonably fit for the purpose for which it was supplied — proper approach to determination of causation in defective goods claim — causal connection required by s 75AD(c) CONSUMER LAW — misleading or deceptive conduct — medical devices — whether product information published by one or other respondent misleading or deceptive or likely to mislead or deceive consumers of medical devices about the safety and/or efficacy of the devices — whether loss or damage by conduct NEGLIGENCE — product liability — medical devices — duty of care — content of duty owed by foreign manufacturers and local supplier to end users of medical devices — where known risk of significant injury, whether respondents breached their duties of care by failing to adequately evaluate the safety of the devices before and/or after they were released to market — extent of obligation to warn where products supplied through…