The Phenergan whose label had been approved by FDA caused a patient amputated. Heated debats on the preemption issues between FDA and State Tort Court, and about government supervision and drug infringement remedy were under way. According to the CBE regulation, there was no preemption issue, however, the arguement concerning that played an important role in the study on relationship not only between Federal Food, Drug & Cosmetic Act and State Tort Law, but also between government supervision and infringement remedy.