He's Just a Little Bit Dead. Would you side with Denny or Madison and why? If you think it's a close call legally, what ethical principles guide your decision? Use the law below, as well as the principles discussed in the ethics module, to support your position. Here is the law: Adverse Event (21 CFR 312.32(a)) Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An adverse event (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug and does not imply any judgment about causality. Suspected Adverse Reaction (21 CFR 312.32(a)) Suspected adverse reaction means any adverse event for which there is a reasonable possibility that the drug caused the adverse event. For the purposes of Investigational New Drug safety reporting, 'reasonable possibility' means there is evidence to suggest a causal relationship between the drug and the adverse event. A suspected adverse reaction implies a lesser degree of certainty about causality than adverse reaction, which means any adverse event caused by a drug. Within the reporting requirement FDA makes clear the meaning of reasonable possibility by providing the following examples of types of evidence that would suggest a causal relationship between the drug and the adverse event. A single occurrence of an event that is uncommon and known to be strongly associated with drug exposure (e.g., angioedema) One or more occurrences of an event that is not commonly associated with drug exposure, but is otherwise uncommon in the population exposed to the drug (e.g., tendon rupture) An aggregate analysis of specific events observed in a clinical trial that indicates those events occur more frequently in the drug treatment group than in a concurrent or historical control group