Evaluation of product liability and risk for a product manufactured outside the United States is complex and nuanced. A necessary threshold consideration is the relationship between the non-U.S. manufacturer and its U.S. distributor. That relationship will impact numerous litigation-related issues for both parties, including jurisdiction, scope of defense and indemnification obligations, discovery, and collection of judgments.

Imagine a scenario where a product manufactured outside of the United States allegedly injures someone in the United States […]

The Food, Drug, and Cosmetic Act (FDCA or the Act) governs safety, efficacy, and labeling over drugs, cosmetics, dietary supplements, medical devices, and other consumer products. 21 U.S.C. § 393(b). The FDCA grants the Food and Drug Administration (FDA) the primary power to enforce the Act (id. § 393(a)), including whether drugs, cosmetics, dietary supplements, and medical device manufacturers properly label their products to avoid misleading their customers. See, e.g., id. §§ 343, 352, 362, 387c. The FDCA expressly precludes […]