The Hatch-Waxman Act expedites the process by which generic drug manufacturers can obtain approval from the Food and Drug Administration (“FDA”) to market generic drugs, and allows generic drug manufacturers to produce and market brand-name drugs for...
Hatch-Waxman Act
(LIIBULLETIN preview (pre-2014))
Issue
Does federal law governing claims against generic pharmaceutical products preempt state law design-defect claims against the makers of those products?
top
FactsIn December of 2004, Karen Bartlett’s doctor prescribed her Clinoril for...
(LIIBULLETIN preview (pre-2014))
Oral argument: Mar. 30, 2011
Appealed from: United States Court of Appeals for the Eighth Circuit (Nov. 27, 2009); United States Court of Appeals for the Fifth Circuit (Jan. 8, 2010)
DRUGS, FAILURE-TO-WARN,...