food and drug law

(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?

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Facts

In December of 2004, Karen Bartlett’s doctor prescribed her Clinoril for...

(LIIBULLETIN preview)

In 2010 Congress passed the Patient Protection and Affordable Care Act which enacted the Biologics Price Competition and Innovation Act (“BPCIA”). Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1351 (Fed. Cir. 2015). Under the BPCIA, when a manufacturer...