Pink Sheet is part of the Business Intelligence Division 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

UsernamePublicRestriction
UsernamePublicRestriction

SCHERING-PLOUGH's ENGLISH LANGUAGE REYE SYNDROME WARNING FOR ST. JOSEPH

This article was originally published in The Tan Sheet

Executive Summary

SCHERING-PLOUGH's ENGLISH LANGUAGE REYE SYNDROME WARNING FOR ST. JOSEPH Children's Aspirin is being challenged by a coalition of health care and civil rights advocacy groups in a May 17 amicus brief to the California Supreme Court. The coalition charges that Schering-Plough was negligent in warning a Spanish-speaking consumer of the risk of Reye syndrome associated with St. Joseph Aspirin for Children in a manner comprehensible to the consumer. The group is arguing that the case, Ramirez v. Plough, merits a jury trial. The complaint was filed in Stanislaus County (California) Superior Court in August 1989 on behalf of Jorge Ramirez, an eight year-old child who contracted Reye syndrome after consuming St. Joseph Aspirin for Children when he was an infant; Ramirez is quadriplegic, blind and mentally impaired as a result of the Reye syndrome, according to court documents. The plaintiff argued that Ramirez' mother, who spoke only Spanish, was not adequately cautioned about the risks of Reye syndrome by Schering-Plough's English warning statement. In March 1991, the superior court granted summary judgment in favor of Schering-Plough that declared that the firm had no duty to warn consumers in Spanish; the case therefore was not taken to a jury. Following 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 then petitioned the California Supreme Court on Dec. 31, 1992 to review the case, a request that was granted by the high court. The California Supreme Court has not yet set a date to hear the case. In the May 17 brief, the coalition asserted that "the court of appeal properly characterized the issue in this case as whether Plough's English-only warning was adequate, not whether Plough had a duty to warn in Spanish." "Properly viewed," the group contended, "the question here is whether Plough satisfied its duty to Jorge Ramirez and his family to use ordinary care in warning about the risk of Reye syndrome, not, as Plough would have it, whether it had a duty to warn in Spanish." The coalition includes Public Citizen's Health Research Group, Trial Lawyers for Public Justice, ACLU Foundation of Southern California, ACLU Foundation of Northern California and the Mexican American Legal Defense and Educational Fund. The coalition contends that "whether Plough exercised ordinary care in fulfilling [its] duty by providing a warning solely in English . . . pertains to [the company's] standard of conduct (i.e., the adequacy of its warning)." The brief maintains that Schering-Plough "knew of the substantial Latino population which routinely used [the company's] product with the expectation it was safe, knew that many within that population could not read or understand English, and had specifically targeted that population for its marketing." The firm "not only knew its children's aspirin was popular among Spanish-speaking persons not literate in English, but it actually advertised in Spanish in their communities," the brief asserts. The appeals court thus "properly concluded that Plough's failure to provide a warning in a manner comprehensible to Jorge Ramirez' Spanish-speaking mother raises a factual question as to the adequacy of the warning, an issue on which Plough is not entitled to summary judgment," the coalition maintained. Schering-Plough has argued that foreign language warnings are not feasible given: the large number of languages spoken in the U.S.; the limitations imposed by product packaging; and the prohibitive cost of translating and printing warnings in a variety of languages, according to court documents. However, according to the coalition, "those burdens are grossly exaggerated and do not excuse a manufacturer from liability where there is a significant risk of serious injury to a large community," which in this case is "the largest of all non-English speaking groups both within California and the nation." The coalition suggested that "even a one-word phrase such as "WARNING! AVISO! followed by the text of a warning in English would have been better than nothing." The industry also could devise a "universal pictograph or symbol to alert consumers to the warning, in order to have the warning translated," the brief contends. In addition, since Schering-Plough "knew that its product sold well in Spanish stores," the document notes, "it could have easily provided the stores through which it marketed its product with signs which warned of the dangers of Reye syndrome in Spanish." Such efforts "would substantially diminish the risk of injury and thus of lawsuits," the coalition contended. Schering-Plough maintained in a statement that "providing appropriate warnings in English is sufficient and that manufacturers should not have to include warnings in all of the 143 or more languages spoken by potential U.S. consumers." The firm added that "providing such warnings would impose" an "unreasonable burden on manufacturers" who market products nationwide. In a Feb. 22 brief filed in the California Supreme Court, Schering-Plough asserted that the Stanislaus County "trial court correctly found that an OTC drug manufacturer cannot be held liable under California law for providing warnings and directions in English and not in other languages." Since the firm "had no duty to warn in Spanish, and since there is no causal relationship between Plough's English language warnings and plaintiff's alleged use of Plough's" St. Joseph Aspirin for Children, "summary judgment was correct." The appeals court "erroneously reversed and remanded the decision of the trial court," Schering-Plough contended, and "this court should reinstate the judgment of the trial court." Schering-Plough said it expects the California Supreme Court to schedule a hearing on the case "later this year." Among parties that filed amicus briefs on behalf of the firm were the Cosmetic, Toiletry and Fragrance Association and the Nonprescription Drug Manufacturers Association. NDMA argued in an April 23 brief that multilingual labeling would be "physically impossible to satisfy on the packages of many products. Even if there were room to include such labeling, it would compromise the readability of product labels," the association said. "In any form, multilingual labeling also could detract from the information and warnings required under federal law" and would be burdensome for manufacturers. FDA does not require OTC labeling to appear in any foreign language, NDMA added.
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS081477

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

Cancel