Although in most cases a pharmaceutical foreign language translation of a product’s warning label is required when the manufacturer knows that non-English speakers are likely to use the product, there are exceptions. For instance, courts have held that a manufacturer may be under no duty to provide a foreign language translation of warning labels when specific regulations prescribe the warnings and do not require warnings in a language other than English.
For example, in Ramirez v. Plough, Inc., 6 Cal. 4th 539, 863 P.2d 167 (1994) the infant plaintiff developed Reye’s Syndrome after his Spanish-speaking mother gave him aspirin manufactured by the defendant. The California Supreme Court, on appeal, held that FDA regulations – which preempted the field of warning labels for non-prescription drugs – required labeling only in English (except for products marketed solely in Puerto Rico or a territory where the predominant language is not English).
Further, the court noted that legislative and administrative bodies were better suited to decide whether foreign language translations of warning labels should be required in this context.