The U.S. Supreme Court is presently considering whether federal law pre-empts state design-defect claims targeting generic pharmaceutical products. Just two years ago, the court insulated generic-drug manufacturers from state-law failure-to-warn claims. It seems doubtful that any of the justices in that majority will treat this case differently, and, thus, generic drugmakers may soon enjoy a new immunity.
Background
A complex federal regulatory scheme creates uniform guidelines for the manufacturing, marketing and sale of prescription drugs. To promote safety in the prescription drug market, Congress enacted the federal Food, Drug and Cosmetic Act (FDCA) and, years later, the Drug Price Competition and Patent Term Restoration Act of 1984 (part of the Hatch-Waxman amendments to the FDCA). While these pieces of legislation contain a Byzantine series of express directives, they are also silent on important questions.
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