Re-Structuring Application Of The Consumer Expectations Standard - Strict Product Liability And Medical Device Failure

Abstract

This thesis investigates the issue of excessive uncertainty in applying the consumer expectations standard in strict product liability cases involving medical device failure. Drawing on negligence literature, it conducts a doctrinal analysis that uncovers significant inconsistencies and a lack of structure in how courts treat comparable factual material across similar cases. Building on these findings, the thesis proposes a novel theoretical framework designed to enhance the predictability of strict product liability applications in this context. This framework adopts a two-step approach: first, it advocates for a more structured method to judicial fact-selection and evaluation by incorporating international medical device safety guidelines, such as those from the International Medical Device Regulators Forum and International Safety Organisation standards. Second, it integrates normative guidance from Aristotle's virtue ethics to provide decision-makers with a more principled and transparent basis for applying the consumer expectations test. This research addresses a critical gap in existing scholarship by responding to calls from scholars like Twerski, Geistfeld, Viscusi, and Masterman for a more tailored and structured approach to strict product liability in specific product categories. The proposed framework shows significant promise for enhancing predictability and clarifying the relationship between factual material and the consumer expectations test when applied to cases of medical device failure. Show more