Ethicon Sàrl v Gill [2021] FCAFC 29 (05 March 2021) (Jagot, Murphy and Lee JJ)


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