A design-defect theory: Which product-liability theory most directly fits a flaw inherent in the design?
A systematic flaw inherent in the device's design is a design defect under product-liability law.
The question
A medical-imaging AI marketed as a diagnostic device systematically misses a class of tumors because of how its detection logic was designed. Patients harmed by missed diagnoses sue. Which product-liability theory most directly fits a flaw inherent in the design?
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- A manufacturing-defect theory, alleging that a single deployed copy diverged from the maker's validated production design build.Almost right but wrong: a manufacturing defect is unit-specific, not a systematic design flaw.
- A failure-to-warn theory resting only on the vendor omitting a written warning about the device's retail price.Wrong: price disclosure is not a safety warning and is unrelated to product-liability harm.
- A design-defect theory, alleging the diagnostic logic was unreasonably unsafe as designed for its intended clinical use. ✓Correct: a systematic flaw inherent in the design across all units is a design defect.
- A pure economic-loss theory, alleging the hospital simply overpaid for a device that merely underperformed in use.Wrong: patient injury is physical harm, not pure economic loss from an underperforming purchase.
The trap
Calling a systematic, design-level flaw a manufacturing defect, which by definition affects only individual units. How to remember it
A systematic flaw inherent in the device's design is a design defect under product-liability law.
How many of these would you get right?
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Every answer, right and wrong, comes with its own explanation.