 ሁለተኛው ለሠራተኛው ደኅንነት ወይም ጤንነት የሚያሠጋና ሊደርስ የተቃረበ አደጋ መኖሩን አሠሪው እያወቀ የመከላከያ ዕርምጃ ካልወሰደ ነው።
(2)  the patient when the manufacturer knows or has reason to know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.