Consumers or Patients? Medical Device Recipients under Australian Law Straddle Two Worlds

Julia Symons, Marco Rizzi

Research output: Contribution to journalArticlepeer-review

Abstract

This article analyses the status of medical device recipients under Australian law. The 2021 Gill v Ethicon Sàrl litigation in the Federal Court of Australia has recently brought the issue to the fore. Moving from the Court’s findings and expanding on key underpinning issues, the article dissects the specific vulnerability of medical device recipients and explores the under-researched distinction between patients and consumers under Australian law. The analysis spans the regulatory landscape for medical devices prior to marketing approval, the statutory protections and causes of actions available to consumers under the Australian Consumer Law, and the safeguards for patients developed under medical law (and particularly medical negligence). In addition to offering doctrinal clarifications, the article provides a discussion of the key policy considerations that frame the various regimes. The findings reveal that patients and consumers share characteristics, but their legal protections differ in terms of focus and objectives. Medical device recipients straddle both worlds, requiring the highest levels of care and disclosure.
Original languageEnglish
Pages (from-to)572-592
Number of pages21
JournalJournal of Law and Medicine
Volume30
Issue number3
Publication statusPublished - 2023

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