Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



This article was originally published in The Tan Sheet

Executive Summary

FOREIGN-LANGUAGE WARNINGS ON OTCs NOT LEGALLY REQUIRED, COURT RULES in a Dec. 9 decision on Ramirez v. Plough. In deciding whether Schering-Plough could be held liable for not marketing its St. Joseph Aspirin for Children with Reye syndrome warnings in Spanish, the California Supreme Court concluded that "manufacturers of nonprescription drugs have no presently existing legal duty, within the tog law system, to include foreign-language warnings with their packaging materials." The original complaint was filed in Stanislaus County (California) Superior Court in 1989 on behalf of Jorge Ramirez, an eight-year-old child who contracted Reye syndrome as an infant after his mother, who spoke only Spanish, administered St. Joseph Aspirin for Children. The plaintiff charged that Schering-Plough had a duty to warn about the risk of Reye syndrome in Spanish. In March 1991, the superior court granted summary judgment in favor of Schering-Plough, stating that the company had no duty to warn consumers of product risks in any language other than English. After an appeal by the plaintiff, the Court of Appeals for the Fifth District of California in Fresno overturned the superior court's decision in October 1992. Schering-Plough subsequently petitioned the California Supreme Court in December 1992 to review the case. Amicus briefs were filed with the Supreme Court on behalf of Schering-Plough by the Nonprescription Drug Manufacturers Association and the Cosmetic, Toiletry and Fragrance Association; a group of health care and civil rights advocacy groups filed an amicus brief in favor of the plaintiff ("The Tan Sheet" May 24, p. 15). The California Supreme Court based its decision on the fact that "both state and federal law now require warnings in English but not in any other language." Therefore, a "manufacturer may not be held liable for failing to label" an OTC drug with "warnings in a language other than English." The court referred to several statutes where the state legislature defined situations under which a foreign language must be used. "These statutes demonstrate that the legislature is able and willing to define circumstances in which foreign-language communications should be mandated," the court said. "Given the existence of a statute expressly requiting that package warnings on nonprescription drugs be in English, we think it reasonable to infer that the legislature has deliberately chosen not to require that manufacturers also include warnings in foreign languages," according to the court document. The same inference "is warranted on the federal level," the court continued, referring to FDA regulations that "abundantly demonstrate its sensitivity to the issue of foreign language labeling, and yet . . . do not require it." Presumably, the agency "has concluded that despite the obvious advantages of multilingual package warnings, the associated problems and costs are such that at present, warnings should be mandated only in English," the court stated. The court agreed with arguments made by NDMA that "the burden of including warnings in so many different languages would be onerous, would add to the costs and environmental burdens of the packaging, and at some point might prove ineffective or even counter-productive if the warning inserts became so large and cumbersome that a user could not easily find the warning in his or her own language." The court speculated that a legislative body considering the "utility of foreign-language label warnings for nonprescription medications would no doubt gather pertinent data on a variety of subjects, including the space limitations on nonprescription drug labels and packages, the volume of information that must be conveyed, the relative risks posed by the misuse of particular medications, the cost to the manufacturer of translating and printing warnings in languages other than English, [and] the cost to the consumer of multilingual package warnings in terms of higher prices for, or reduced availability of products." The decision notes that other "pertinent questions" regarding foreign-language warnings include "the feasibility of targeted distribution of products with bilingual or multilingual packaging, the number of persons likely to benefit from warnings in a particular language, and the extent to which nonprescription drug manufacturers as a group have used foreign-language advertisements to promote sales of their products." In a statement on the Dec. 9 decision, Schering-Plough said that it "believes that the court correctly recognized the importance of the FDA regulatory process in determining if there should be any deviation from present English language labeling requirements for nonprescription drugs."

You may also be interested in...

People In Brief

Perrigo promotes in pricing, planning

In Brief

Combe sells most of its OTC brands

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts