Legal perspectives in causality assessment.
An overview is presented of how drug experience reports most often fit in a product liability lawsuit. The three major areas include (a) the duty to warm; (b) the failure to report adverse reactions as required by regulations; and (c) the requirement to warn of unknown side effects. Recommendations for establishing a company program designed to prevent product liability are also given.
D004348:Drug Labeling / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007880:Legislation, Drug; D011358:Product Surveillance, Postmarketing / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration