Hatch-Waxman and Defective Generic Drug Labels: The Disjunction Between Federal Drug Safety Law and State Warning Defect Law (Part I)
Consider the following hypothetical. A drug company develops and patents a pharmaceutical to sell under brand-name. It secures FDA approval and enjoys its patent monopoly for many years. But after that patent monopoly expires, generic brand-makers flood into the market and undercut the brand-name’s price. Pharmacists substitute the generic for the brand name. The label […]