Intel · Mass Tort Glossary

Adverse Event

A harmful outcome reported in connection with the use of a drug, medical device, or product. Adverse event data from the FDA's FAERS database is a primary input in causation analysis for pharmaceutical mass torts. A disproportionate reporting ratio (PRR or ROR) above threshold is a key early signal for emerging tort viability.

Related terms

Bradford Hill CriteriaFAERS (FDA Adverse Event Reporting System)PRR (Proportional Reporting Ratio)

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