Federal Court of Australia
Federal Court of Australia Secretary, Department of Health v Medtronic Australasia Pty Ltd [2024] FCA 1096 File number(s): NSD 883 of 2021
Judgment of: NEEDHAM J
Date of judgment: 19 September 2024
Catchwords: HEALTH LAW – Therapeutic goods – Requirement to register therapeutic goods for use in humans on the Australian Register of Therapeutic Goods – Where composite parts of the registered therapeutic good were supplied separately – Where the respondent admits that this constitutes a contravention of the Therapeutic Goods Act 1989 (Cth) STATUTORY INTERPRETATION - Imposition of civil penalty under the Therapeutic Goods Act 1989 (Cth) – Whether the Court must be satisfied of the specific section of the Therapeutic Goods Act 1989 (Cth) which has been contravened – Discussion of relevant principles – Agreed statement of facts – Whether contraventions can be considered collectively as a course of conduct or individually as a separate contravening supply
Evidence Act 1995 (Cth) s 191 Legislation: Federal Court of Australia Act 1976 (Cth) ss 37M(1), 43 Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) Pt 3, Sch 1 Therapeutic Goods Act 1989 (Cth) ss 3, 7, 9A, 15A, 19D(1), 41BD, 412BF, 41MIB(1), 42Y, 42Y(1), 42Y(2), 42Y(3), Pt 3 Sch 1
ACCC v Cement Australia Pty Ltd [2017] FCAFC 159; (2017) FCR 312 Australian Building and Construction Commissioner v Pattinson (2022) 274 CLR 450 Australian Competition and Consumer Commission v Coles Supermarkets Australia Pty Ltd [2014] FCA 1405 Australian Competition and Consumer Commission v Reckitt Benckiser (Australia) Pty Ltd (2016) 340 ALR 25 Commonwealth v Director, Fair Work Building Industry Inspectorate (2015) 258 CLR 482 Cases cited: Construction, Forestry, Mining and Energy Union v Cahill (2010) 269 ALR 1 Flight Centre Limited v Australian Competition and Consumer Commission (No 2) [2018] FCAFC 53 Secretary, Dept of Health and Ageing v Export Corporation (Australia) Pty Ltd [2012] FCA 42 Thomson Australian Holdings Pty Ltd v Trade Practices Commission (1981) 148 CLR 150 viagogo AG v ACCC [2022] FCAFC 87 Volkswagen Aktiengesellschaft v ACC (2021) 284 FCR 24
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