Who Is the Foreseeable User?: Manufacturers’ Duty to Warn Multilingual Users

by Abbie Maier*

More than 350 languages are spoken in United States homes. In certain U.S. cities, Spanish speakers represent the majority of the population. In New York City and Houston, almost half of the people speak a language other than English at home, and in Los Angeles, the majority of the population speak languages at home other than English. Despite the high concentration of non-native English speakers in pockets of the United States, manufacturers are under virtually no obligation to provide warnings in alternate languages. A broad overview of relevant case law reveals that courts are sometimes sympathetic to illiterate or foreign-tongued plaintiffs, but that they are unwilling to extend a duty any further than to require pictorial warnings. Reform to FDA regulations should focus on expanding the duty to warn in multiple languages. Additionally,  to better protect users who cannot adequately read product warnings, and to avoid costly litigation, manufacturers’ best practices should include clear symbols of serious product dangers.

I. Applicable Restatement Provisions

Generally, the Third Restatement of Torts: Products Liability § 2(c) governs warning failures.[1] It provides that a product is defective due to inadequate warnings “when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable instructions or warnings . . . and the omission of the instructions or warnings renders the product not reasonably safe.”[2] The Restatement gives no discernible guidance on the issue of multilingual warnings. Yet, the drafters of the Restatement were apparently aware of litigation concerning warning inadequacy due to failure to warn in alternative languages.[3] No comment to the Restatement expressly discusses non-English speakers.

II. Illustrative Case Law Considering the Multilingual User

a. Stanley: A Court Brave Enough to Impose Liability

There is a surprisingly sparse amount of litigation surrounding the existence of a duty to warn in multiple languages. Stanley Industries, Inc. v. W.M. Barr & Co. (“Stanley”) is the most prominent example of a court willing to impose liability on a seller who failed to warn in a language other than English. In Stanley, Plaintiff alleged that two of its employees, brothers from Nicaragua who marginally understood English, were injured in a fire caused by the spontaneous combustion of rags soaked in linseed oil manufactured and sold by Defendants.[4] Although it contained no symbols, the label unambiguously warned of spontaneous combustion in English.[5] The Court held that “the alleged inadequacy . . . caused the product users to be unable to read the label on the can.”[6] Other courts have been historically unwilling to impose any duty to warn in multiple languages; the Court in Stanley perhaps found liability where other courts have not because the facts were particularly egregious—the Defendants intentionally marketed products towards Hispanic communities while simultaneously refusing to warn in Spanish.[7] Accordingly, some courts evade imposing a duty to warn in additional languages by distinguishing cases from Stanley’s highly particularized facts. For example, in Martinez, there was no indication that Defendants “intended to target Spanish-speaking populations or reasonably expected that its [product] would be sold to or used by Spanish speakers.”[8]

b. Ramirez, Medina, and Farias: The Standard Bar Against Liability

A trio of cases (Ramirez, Medina, and Farias) stand for the more common position that manufacturers are rarely liable for failure to warn in a language other than English. In Ramirez, the four-month-old child Plaintiff contracted Reye’s syndrome after his mother administered aspirin to him.[9] The product in this case clearly warned users about Reye’s Syndrome in English,[10] but the California Supreme Court refused to impose a duty to warn beyond that defined by legislative or agency action.[11] Although the FDA encourages labeling that meets the needs of non-English speakers, the FDA only mandates labeling in English, unless the product is distributed solely in a territory with a predominant language other than English.[12] California law similarly required only English warnings.[13]

Similarly, in Medina, the entire case depended on whether Defendants “were legally obligated to furnish Spanish warnings and instructions.”[14] The Court here expressly disagreed with and declined to follow Stanley.[15] In justifying this decision, the Court recognized that Stanley is an isolated case and in the fifteen years between the Stanley and Medina decisions, not one Florida case followed Stanley’s holding.[16]

In 2010, in the same jurisdiction as Stanley, the Farias Court declined to impose liability on Defendant for failure to warn in Spanish.[17] There, based on pictures on the product box that depicted individuals using a heater in a garage and in a warehouse, Plaintiff concluded that inside use was safe and she purchased two heaters.[18] Indoor use caused Plaintiff’s home to catch on fire.[19] Although many of the facts aligned with those in Stanley, the Farias Court noted that here, Plaintiff “made no effort to understand the instructions contained with the manual.”[20] Additionally, nothing in the record indicated that Defendant purposefully directed its sales towards Spanish speakers, making any reliance on Stanley “misplaced.”[21] More fundamentally, the Court cited Medina for the proposition that Florida law imposes no duty to provide bilingual warnings on consumer products.[22] Farias was not the proper case for progress in the realm of multilingual warning liability; the Court’s hands were somewhat tied because it feared diverging from the duty already explicitly recognized by Florida courts.[23] Both the lack of proximate cause from Ms. Faria’s willful ignorance of the warnings and precedent created by Medina necessitated the Court’s decision. Overall, non-English speaking plaintiffs’ ability to recover for injuries resulting from failures to warn in their primary languages looks grim.

III. FDA Regulation Suggests Pictorial Warnings

Although the FDA’s authority only extends to a limited category of products, the FDA provides a potential source of standards for manufacturers to warn in other languages or in symbols. Since courts seem unwilling to provide greater protection for non-English speakers and illiterate users, perhaps advocacy for greater tort law protection should focus on legislative and agency action. As the Ramirez Court noted: “Defining the circumstances under which warnings or other information should be provided in a language other than English is a task for which legislative and administrative bodies are particularly well-suited.”[24]

Currently, the FDA only requires manufacturers to warn in English.[25] The FDA permits manufacturers to use a territory’s primary language instead of English.[26] However, if manufacturers separately decide to include “any representation in a foreign language,” they must match any English representations in those languages as well. Manufacturers would violate FDA regulations by including a single word or phrase in Spanish when there are longer English warnings. Together, these provisions likely disincentivize manufacturers from warning in any foreign language. Manufacturers who choose to include any foreign-language warnings are actually assuming greater liability.

On the subject of pictorial warnings, the FDA promulgated a rule in 2016 permitting the use of symbols absent explanatory text for medical devices if certain requirements are met. One of these requirements is the inclusion of a “symbols glossary.” The motivation behind this rule is to harmonize U.S. standards with international ones as the world becomes increasingly globalized. Additionally, the FDA found that use of stand-alone symbols would reduce design costs for manufacturers because its standards are more consistent with foreign market labeling.

IV. Ideal Versus Practical Solutions: Warning in Multiple Languages or with Symbols?

a. Adopting FDA Regulations that Impose Wider Duties to Warn in Multiple Languages

The multicultural makeup of the U.S. should render multilingual users foreseeable. Thus, for example, professor Keith Sealing argues that U.S. manufacturers should be held liable for not warning in Spanish when the product is sold to regions with dense Hispanic populations, the product is marketed towards Hispanic people, and when the product is used in industries with large portions of Hispanic workers. To protect multilingual users, the FDA should expand manufacturers’ duty to warn in other languages in line with Professor Sealing’s criteria.

b. Recommendation for the Time Being: Manufacturers Should Include Pictorial Warnings

Courts are weary of extending liability beyond pictorial warnings to avoid burdening manufacturers with the “onerous” obligation to warn in multiple languages and of cluttering warning content beyond what will be read.[27] The FDA’s own current emphasis on the value of symbols reflects that the most realistic protection for these users will be found in pictorial warnings. Therefore, until courts or the FDA are willing to reform the duty to warn, manufacturers should still use pictorial warnings when its products are likely to end up in non-English speakers’ or illiterate users’ hands. As the global economy continues to be increasingly intertwined, many manufacturers will benefit from using warnings that better serve their multinational customers. In addition to protecting its multilingual users, manufacturers can avoid costly litigation and harmful press resulting from user injuries.

*Abbie Maier, University of Minnesota Law School Class of 2023, JLI Vol. 40 Note & Comment Editor

[1] Restatement (Third) of Torts: Products Liability § 2(c) (1997).

[2] Id.

[3]  “The reporters of the Third Restatement . . . cited to [Ramirez] in the context of a discussion of compliance with legislation or regulations as non-conclusive on the issue of product defectiveness.”

[4] Stanley Industries, Inc. v. W.M. Barr & Co., 784 F. Supp. 1570, 1572 (S.D. Fla. 1992).

[5] Id.

[6] Id. at 1574.

[7] Id. at 1573.

[8] Martinez v. Triad Controls, Inc., 593 F. Supp. 2d 741, 764 (E.D. Pa. 2009).

[9] Ramirez v. Plough, Inc., 863 P.2d 167, 168 (Cal. 1993).

[10] Id. at 169.

[11] Id. at 168.

[12] Id. at 173.

[13] Id. at 174.

[14] Medina v. Louisville Ladder, Inc., 496 F. Supp. 2d 1324, 1326 (M.D. Fla. 2007).

[15] Id. at 1329.

[16] Id.

[17] Farias v. Mr. Heater, Inc., 757 F. Supp. 2d 1284, 1287 (S.D. Fla. 2010).

[18] Id.

[19] Id. at 1288.

[20] Id. at 1290.

[21] Id. at 1292.

[22] Id. at 1291.

[23] Id.

[24] Ramirez v. Plough, Inc., 863 P.2d 167, 174 (Cal. 1993).

[25] 21 C.F.R. § 101.15.

[26] Id.

[27] Ramirez, 863 P.2d at 175–76.