Ramirez v. Plough, Inc.
863 P.2d 167, 6 Cal. 4th 539 (1993)
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Rule of Law:
A manufacturer of nonprescription drugs has no common law tort duty to include warnings in languages other than English on its product packaging. The standard of care is defined by federal and state statutes and regulations, which require warnings only in English.
Facts:
- In March 1986, Jorge Ramirez, a minor less than four months old, exhibited symptoms of a cold.
- His mother, who was literate only in Spanish, gave him St. Joseph Aspirin for Children (SJAC), a nonprescription drug manufactured by Plough, Inc.
- The SJAC package contained warnings in English regarding the association between aspirin and Reye's syndrome but did not contain warnings in Spanish.
- The mother could not read the English warning and did not ask anyone in her household who could read English to translate it for her.
- After ingesting the SJAC, Ramirez developed Reye's syndrome, resulting in severe and permanent neurological damage.
- Plough, Inc. knew that Hispanics were a significant market for its product and had advertised SJAC in Spanish.
- Ramirez's mother had never seen or heard any of Plough's advertising for SJAC in either English or Spanish.
Procedural Posture:
- Jorge Ramirez sued Plough, Inc. in a California trial court, asserting claims for negligence, products liability, and fraud.
- Plough, Inc. filed a motion for summary judgment.
- The trial court granted summary judgment in favor of Plough, Inc., finding no duty to warn in a foreign language.
- Ramirez, the plaintiff, appealed the trial court's decision to the Court of Appeal.
- The Court of Appeal reversed the summary judgment, concluding that the adequacy of the warning was a triable issue of fact for a jury.
- Plough, Inc., the defendant, sought review from the Supreme Court of California.
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Issue:
Does a manufacturer of nonprescription drugs have a duty in tort to provide warnings in a foreign language on its product packaging when it is foreseeable that the product will be used by consumers who cannot read English?
Opinions:
Majority - Kennard, J.
No. A manufacturer's duty to warn is satisfied by complying with the applicable federal and state laws that mandate warnings in English only. The court concluded that defining the circumstances under which foreign-language warnings should be required is a complex policy determination best left to legislative and administrative bodies, not courts on a case-by-case basis. These bodies are better equipped to weigh the costs, benefits, and practicalities of multilingual warnings. To ensure uniformity and predictability in this highly regulated area, the court adopted the existing legislative and administrative standard of care, which requires English-language warnings but does not mandate warnings in any other language. The court also noted a lack of causation, as the plaintiff's mother did not read or have the English warnings translated.
Concurring - Mosk, J.
No. The justice concurred with the majority's conclusion but wrote separately to emphasize that tort liability might arise if a manufacturer's foreign-language advertising is materially misleading as to a product's risks. He argued that if a company promotes a drug's benefits in a foreign language without also providing risk information in a manner reasonably calculated to reach non-English-literate consumers, a jury could potentially find the manufacturer liable. This specific issue was not present in this case because there was no evidence regarding the content of the Spanish-language advertisements.
Analysis:
This decision establishes a significant 'safe harbor' for manufacturers of nonprescription drugs, shielding them from tort liability so long as they comply with existing federal and state labeling regulations. By refusing to impose a common law duty to warn in foreign languages, the court prioritized regulatory uniformity and deference to legislative bodies over a fact-specific 'reasonableness' standard that could vary by jury. The ruling shifts the responsibility for enacting multilingual warning requirements from the judiciary to the legislature and agencies like the FDA. The concurrence, however, leaves open a potential avenue for future liability based on the content of foreign-language advertising, suggesting that manufacturers cannot promote a product's benefits in one language while providing critical risk information only in another without potential legal consequences.
