Ethicon Sarl v Gill

• Jurisdiction: Australia Federal only
• Court: Federal Court
• Judgment Date: 05 March 2021
• Neutral Citation: [2021] FCAFC 29
• Date: 05 March 2021

FEDERAL COURT OF AUSTRALIA

Ethicon Sàrl v Gill [2021] FCAFC 29

File number:	NSD 391 of 2020
Judgment of:	JAGOT, MURPHY AND LEE JJ
Date of judgment:	5 March 2021
Catchwords:	CONSUMER LAW - defective goods - urogynaecological medical devices - whether primary judge erred in finding safety of devices not such as persons generally were entitled to expect - whether primary judge erred in finding devices not of merchantable or acceptable quality, or not reasonably fit for purpose within meaning of Trade Practices Act 1974 (Cth) or the Australian Consumer Law - whether primary judge erred in finding respondents’ damage caused by defect ; CONSUMER LAW - misleading or deceptive conduct - information in connection with devices, instructions for use and marketing - whether primary judge erred in finding appellants engaged in misleading or deceptive conduct - whether primary judge erred in finding third respondent’s damage caused by misleading or deceptive conduct ; NEGLIGENCE - medical devices - duty of care - whether primary judge erred in finding appellants breached duty of care - inadequate pre-market and post-market evaluations of safety of devices - inadequate warnings of material risks of devices - standard of care - breach - regulatory environment - causation - onus of proof - application of ss 5C and 5D of the Civil Liability Act 2002 (WA) and ss 51 and 52 of the Wrongs Act 1958 (Vic) ; LIMITATION OF ACTIONS - whether primary judge erred in finding that first and third respondents’ claims in negligence were not statute barred - onus of proof - application of Limitation Act 1935 (WA) and ss 39(3) and (4) of Limitation Act 2005 (WA) ; OTHER RELIEF - whether primary judge erred in granting injunction enjoining appellants from supplying, distributing, marketing or promoting devices in Australia without warning or advice
Legislation:	Civil Liability Act 2002 (WA) Competition and Consumer Act 2010 (Cth) Evidence Act 1995 (Cth) Federal Court of Australia Act 1976 (Cth) Judiciary Act 1903 (Cth) Limitation Act 1935 (WA) Limitation Act 2005 (WA) Therapeutic Goods Act 1989 (Cth) Trade Practices Act 1974 (Cth) Trade Practices Amendment Bill 1992 (Cth) Trade Practices Amendment (Personal Injuries and Death) Act 2004 (No 2) (Cth) Trade Practices Amendment (Australian Consumer Law) Act (No. 2) 2010 (Cth) Wrongs Act 1958 (Vic) ; Federal Court Rules 2011 (Cth) Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) ; Explanatory Memorandum, Trade Practices Amendment Bill 1992 (Cth) ; Federal Food, Drug and Cosmetic Act 1938 (US) Federal Rules of Civil Procedure (US)
Cases cited:	A v National Blood Authority [2001] 3 All ER 289 Aldi Foods Pty Ltd v Moroccanoil Israel Ltd [2018] FCAFC 93; (2018) 261 FCR 301 Amaca Pty Ltd v Hannell [2007] WASCA 158; (2007) 34 WAR 109 AstraZeneca Pty Ltd v GlaxoSmithKline Australia Pty Ltd [2005] FCA 1645 Australian Competition and Consumer Commission v 4WD Systems Pty Ltd [2003] FCA 850; (2003) 200 ALR 491 Australian Executor Trustees (SA) Limited v Kerr [2021] NSWCA 5 Axon v Axon [1937] HCA 80; (1937) 59 CLR 395 Banque Commerciale SA en Liquidation v Akhil Holdings Ltd [1990] HCA 11; (1990) 169 CLR 279 Bennett v Minister of Community Welfare [1992] HCA 27; (1992) 176 CLR 408 Betfair Pty Ltd v Racing New South Wales and Anor [2010] FCAFC 133; (2010) 189 FCR 356 Black v Lipovac (by his next friend Lipovac) [1998] FCA 699; (1998) 217 ALR 365 BMW Australia Limited v Australian Competition and Consumer Commission [2004] FCAFC 167; (2004) 207 ALR 452 Branir v Owston Nominees (No 2) [2001] FCA 1833; (2001) 117 FCR 424 Butcher v Lachlan Elder Realty Pty Ltd [2004] HCA 60; (2004) 218 CLR 592 Campbell v Backoffice Investments Pty Ltd [2009] HCA 25; (2009) 238 CLR 304 Carey-Hazell v Getz Bros & Co (Aust) Pty Ltd [2004] FCA 853; (2004) ATPR 42-014 Chappel v Hart [1998] HCA 55; (1998) 195 CLR 232 Commercial Union Assurance Co of Australia Ltd v Ferrcom Pty Ltd (1991) 22 NSWLR 389 Commonwealth v McLean [1996] NSWSC 657; (1996) 41 NSWLR 389 Dyczynski v Gibson [2020] FCAFC 120; (2020) 381 ALR 1 Ethicon Sàrl v Gill [2018] FCAFC 137; (2018) 264 FCR 394 Femcare Ltd v Bright [2000] FCA 512; (2000) 100 FCR 331 Forrest v Australian Securities and Investments Commission [2012] HCA 39; (2012) 247 CLR 486 Fox v Percy [2003] HCA 22; (2003) 214 CLR 118 Gill v Ethicon SÀRL [2018] FCA 470 Gill v Ethicon Sàrl (No 3) [2019] FCA 587; (2019) 369 ALR 175 Gill v Ethicon Sàrl (No 5) [2019] FCA 1905 Gill v Ethicon Sàrl (No 6) [2020] FCA 279 Gill v Ethicon Sàrl (No 8) [2020] FCA 771 Graham Barclay Oysters Pty Ltd v Ryan [2002] HCA 54; (2002) 211 CLR 540 Hollis v Dow Corning Ltd [1995] 4 SCR 634 Hunt & Hunt Lawyers v Mitchell Morgan Nominees Pty Limited [2013] HCA 10; (2013) 247 CLR 613 ICI Australia Operations Pty Ltd v Trade Practices Commission [1992] FCA 707; (1992) 38 FCR 248 Jones v Dunkel [1959] HCA 8; (1959) 101 CLR 298 Lee v Lee [2019] HCA 28; (2019) 266 CLR 129 March v E & MH Stramare Pty Ltd [1991] HCA 12; (1991) 171 CLR 506 McLean v Tedman [1984] HCA 60; (1984) 155 CLR 306 Merck Sharp & Dohme (Australia) Pty Ltd v Peterson [2009] FCAFC 26; (2009) 355 ALR 20 Merck Sharp & Dohme (Australia) Pty Ltd v Peterson [2011] FCAFC 128; (2011) 196 FCR 145 Naxakis v Western General Hospital [1999] HCA 22; (1999) 197 CLR 269 Parkdale Custom Built Furniture Pty Ltd v Puxu Pty Ltd (1982) 149 CLR 191 Peterson v Merck Sharpe & Dohme (Aust) Pty Ltd [2010] FCA 180; (2010) 184 FCR 1 Pilato v Metropolitan Water Sewerage & Drainage Board (1959) 76 WN (NSW) 364 Precision Plastics Pty Limited v Demir (1975) 132 CLR 362 Purkess v Crittenden [1965] HCA 34; (1965) 114 CLR 164 Rogers v Whitaker [1992] HCA 58; (1992) 175 CLR 479 Rosenberg v Percival [2001] HCA 18; (2001) 205 CLR 434 Rural Press Ltd v Australian Competition and Consumer Commission [2003] HCA 75; (2003) 216 CLR 53 Scope Machinery Pty Ltd v Ross [2009] WASCA 100 State Rail Authority of New South Wales v Earthline Constructions Pty Limited (in liq) [1999] HCA 3; (1999) 160 ALR 588 Strong v Woolworths Ltd [2012] HCA 5; (2012) 246 CLR 182 Taco Company of Australia Inc v Taco Bell Pty Ltd [1982] FCA 170; (1982) 42 ALR 177 Timbercorp Finance Pty Ltd (in liquidation) v Collins [2016] HCA 44; (2016) 259 CLR 212 Trade Practices Commission v Mobil Oil Australia Ltd [1984] FCA 403; (1984) 4 FCR 296 Vairy v Wyong Shire Council [2005] HCA 62; (2005) 223 CLR 422 Vale v Sutherland [2009] HCA 26; (2009) 237 CLR 638 Wallace v Kam [2013] HCA 19; (2013) 250 CLR 375 Wilkes v DePuy International Ltd [2016] EWHC 3096 (QB); [2017] 3 All ER 589 Wyong Shire Council v Shirt [1980] HCA 12; (1980) 146 CLR 40
	Young PW, Declaratory Orders (2nd ed, Butterworths, 1984)
Division:	General Division
Registry:	New South Wales
National Practice Area:	Commercial and Corporations
Sub-area:	Regulator and Consumer Protection

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