## Facts

- Jorge Ramirez, an infant under four months old, developed cold-like symptoms in March 1986.
- His mother administered St. Joseph Aspirin for Children (SJAC), an over-the-counter aspirin product manufactured by Plough, Inc.
- The SJAC label provided dosing directions, including that dosing for children under two years was “as directed by doctor,” but the mother did not consult a doctor before giving SJAC.
- The label contained an English-language warning about the association between aspirin use in children with viral illness and Reye’s syndrome, consistent with FDA labeling requirements at the time.
- The mother was literate only in Spanish, did not read the English warnings, did not obtain a translation, and relied on a friend’s recommendation.
- After the child was hospitalized, a physician prescribed non-aspirin medications; the mother continued administering SJAC despite that advice.
- The child developed Reye’s syndrome and suffered severe neurological injury.
- Ramirez sued for negligence, strict products liability (failure to warn), and fraud, alleging the warning was inadequate because it was only in English and because it did not sufficiently warn against use for cold-like symptoms.
- The trial court granted summary judgment for Plough; the Court of Appeal reversed; the California Supreme Court granted review.

## Issues

1. Whether a nonprescription drug manufacturer may be held liable in tort for providing English-only package warnings when state and federal law require warnings in English and do not require foreign-language warnings.
2. Whether any alleged inadequacy in the substance of the English warning could be a legal cause of injury where the consumer did not read the label or obtain a translation.

## Decision

- The California Supreme Court reversed the Court of Appeal and reinstated summary judgment for Plough.
- The court held that a manufacturer of nonprescription drugs cannot be held liable for failing to provide package warnings in a language other than English when governing state and federal requirements call for English labeling.
- The court also held that, even assuming a defect in the English warning’s content, causation failed because the child’s mother neither read nor translated the label, so any omission could not have affected her conduct.
- The court limited its holding to failure-to-warn claims premised on the absence of foreign-language package warnings and noted potential liability could exist for materially misleading foreign-language advertising that induces reliance by consumers unable to read accurate English package warnings.

## Legal Principles

- In heavily regulated areas such as over-the-counter drug labeling, tort duties regarding warning language generally track applicable statutory and administrative requirements.
- Where state and federal law require English-language warnings and do not mandate additional languages, tort law does not impose a separate duty to add foreign-language package warnings.
- Failure-to-warn liability requires causation; if the relevant consumer did not read the warning and did not obtain a translation, alleged deficiencies in the warning’s content typically cannot be the legal cause of the injury.
- The absence of a judicially imposed translation duty for package labeling does not necessarily preclude liability based on separate, materially misleading foreign-language marketing that causes detrimental reliance.

## Conclusion

The court held that English-only warnings on an over-the-counter drug label, when consistent with state and federal regulatory requirements, do not support tort liability for failure to provide Spanish-language warnings, and that any alleged inadequacy in the English warning could not have caused injury where the consumer never read or translated the label.


Ramirez v. Plough, Inc., 6 Cal. 4th 539 (Cal. 1993)