The proliferation of direct-to-consumer (DTC) genetic testing poses new regulatory challenges as genetic testing and information, once within the exclusive domain of medical institutions, has migrated into the private commercial sector. The FDA’s traditional “protective” medical device...

This book chapter explores how common law (state or federal) tort law evolves to fill regulatory voids. Particularly in areas that pose emerging, and incompletely understood, health and safety risks, common law tort liability holds out the potential for a dynamic regulatory response, one that...