The duty to warn and instruct is a significant duty both in the United States and in countries within the European Union. Under U.S. product liability law and the new EU Directives, significant liability can result if a manufacturer or product seller fails to adequately communicate appropriate safety information to purchasers and users of its products.
Given the significant number of languages spoken and read in the United States and Europe, developing a method to effectively communicate safety information to readers of product labels and instruction manuals is an important consideration. Adequate safety communications that are not effectively communicated to foreseeable users may be considered defective. However, the law does not require labels in a language other than English and providing labels in other languages may be risky.
This article will describe the relevant law in the United States, including recent decisions and recent commentaries addressing a manufacturer's duty to include multilingual and pictorial warnings , and provide recommendations to manufacturers about using multilingual labels. In addition, relevant aspects of some of the EU Directives as well as some U.S. and European technical standards will be discussed.
U.S. Case Law
The two main ways to effectively communicate to illiterate or non-English reading product users is by use of their mother tongue or by use of commonly understood pictorials or symbols on the label. In the United States, the common law provides little guidance on the question of when foreign languages or illustrated safety communications are appropriate or required. In fact, there have been very few cases discussing the necessity to communicate to product users in the United States who do not read English or are illiterate.
Many years ago, a U.S. federal appellate court set forth two essential characteristics of a legally adequate warning:
- It must be in such a form that it could reasonably be expected to catch the attention of a reasonably prudent man in the circumstances of its use; and
- the content of the warning must be of such a nature as to be comprehensible to the average user and to convey a fair indication of the nature and extent of the danger to the mind of a reasonably prudent person. See Spruill v. Boyle-Midway, Incorporated, 308 F.2d 79 (4th Cir. 1962).
Given that definition, can manufacturers always assume that the "average user" is literate in English? Certainly, when considering different parts of the country, the practical answer is "No." For example, the Census Bureau has found that, in New York City, 4l% of residents age 5 or older speak a foreign language in their homes. Nearly half of those 4l% said that they do not speak English very well. In Miami, nearly 75% of the residents speak a language other than English at home with 76% of those saying that they do not speak English very well.
In addition, experts suggest that nearly 150 foreign languages are spoken in the United States, and over 23 million Americans speak a language other than English in their homes. In 1990, social scientists estimated that there were 23 million functionally illiterate English-speaking Americans in the United States and that this number is growing by approximately 2.3 million people per year. Lastly, these experts estimate that there are another 35 to 45 million Americans who are marginally illiterate, meaning that they are unable to understand many basic messages conveyed by the English language.
Given these statistics, it would be possible for a product manufacturer to identify locations where its product will be sold and distributed in which a large number of product users do not speak or even read English very well. Even without such statistics, product manufacturers should be able to identify generally where their products will be sold and anticipate the level of education and reading comprehension that might exist in part of the "average user" population. Foreseeing the user population is easy in a number of large cities. Trying to communicate with those so-called 'average users' in their language, however, is much more difficult.
Problems abound in getting the "right" product to the right user population, selecting the correct foreign language, dealing with total or partial illiterates, and even if these problems are solved, getting the users to read and understand the information presented. But first, let's examine what the courts are saying in this area.
Despite the existence of many non-English reading or speaking and illiterate U.S. residents, there have been very few legal opinions which have discussed the requirement to provide safety communications in anything other than English. Recently, two courts have ruled on this issue.
On February 11, 1992, the U.S. District Court for the Southern District of Florida issued a ruling in Stanley Industries, Inc. v. W.M. Barr & Co., Inc., 784 F.Supp. 1570 (S.D. Fla. 1992). In that case, plaintiff alleged that a fire, which occurred in plaintiff's facility, was caused by the spontaneous combustion of rags soaked in defendant's linseed oil. The linseed oil was being used by two employees who were brothers from Nicaragua and whose primary language was Spanish.
Plaintiff sued the manufacturer of the linseed oil and the retailer, Home Depot, Inc., for negligent failure to warn, strict liability and breach of warranty of fitness for a particular purpose. The defendant manufacturer filed a motion for summary judgment on the negligent failure to warn count.
The plaintiff's response to defendant's motion for summary judgment alleged that because the language on the back of the product label was in English only and contained no pictographs or symbols, it was therefore inadequate. It further alleged that the label did not fairly, appropriately and comprehensively warn Spanish speaking, monolingual product users of the dangers likely to be encountered with the product's use.
The key fact in this case was that both defendants arranged to jointly and cooperatively advertise, promote and market products in the Miami area. Home Depot regularly and actively advertised in the Miami market on Hispanic television and radio and in newspapers. Home Depot also marketed a number of its products with bilingual instructions.
After reviewing the few prior cases discussing the subject of multilingual warnings or universally accepted pictographs or symbols, the court held that it was for the jury to decide whether the defendants could have reasonably foreseen that the linseed oil would be used by persons such as the plaintiff's Nicaraguan, Spanish-speaking unskilled laborers.
The court also held that the jury must decide whether a warning should at least contain universally accepted precautionary symbols. Lastly, the court held that it was the jury's decision whether a warning, to be adequate, must contain words in a language other than English or warning symbols.
In addition to denying defendant's motion for summary judgment, the court added that it did not intend to advance any position on the merits of the case nor did its decision foreclose affirmative defenses such as comparative negligence or intervening cause.
In a subsequent trial in November 1993, the jury returned a verdict in favor of Home Depot. Since the only defect claimed by the plaintiff was an inadequate warning, it can be assumed that the jury felt it unnecessary to warn the plaintiff's employees in Spanish or by use of pictorials or symbols even if the defendant retailer advertised in Spanish.
Interestingly, three days before the jury verdict, Home Depot sent a letter to its suppliers asking that Spanish be included on all warning labels and instructions accompanying products sold to Home Depot. Presumably, Home Depot, as a preventive measure, decided to warn and instruct in Spanish regardless of whether it won or lost this case.
This illustrates the difference between counseling from a preventive (i.e., product safety) as opposed to from a litigation standpoint. A litigator may say that, based on this case, there appears to be no duty to warn in any language other than Spanish. However, having a good defense to a lawsuit may not be the best result when considering product safety and liability prevention. Because the goal is to provide a reasonably safe product, a manufacturer may decide to exceed any enunciated or anticipated legal requirements in the hope that accidents will be prevented.
In the second major opinion on this issue, the California Supreme Court ruled, on December 9, 1993, that a manufacturer may not be held liable in tort for labeling a non-prescription drug solely in English. In Ramirez v. Plough, Inc., 25 Cal. Rptr. 2d 97 (1993), the court ruled on the adequacy of English-only warnings regarding Reye's syndrome on aspirin purchased by the plaintiff's mother who could not read English but was literate in Spanish.
The California Court of Appeals, previously had held (12 Cal. Rptr.2d 423) that the adequacy of warnings was normally one of fact and an issue for the jury. The pertinent facts this court considered were that the aspirin was advertised to and used by non-English-literate Hispanics and that the manufacturer presented no evidence as to the cost of Spanish-language labeling and the reasonableness of the manufacturer's conduct in not labeling in Spanish. The manufacturer appealed the case to the California Supreme Court.
The California Supreme Court reversed, affirming summary judgment for the manufacturer. The court held that the plaintiff's cause of action for inadequate warnings was preempted by federal and state regulations regarding warning requirements. Thus, the court held that as a matter of law, a manufacturer could not be held liable for failure to include foreign language warnings when the product's warnings and labels complied with federal and state regulations.
The court relied on the lack of statutory authority from the California State Legislature requiring anything other than English labels on non-prescription drugs. It inferred that the Legislature had ". . . deliberately chosen not to require that manufacturers also include warnings in foreign languages."
In addition, the U.S. Food and Drug Administration has issued numerous regulations concerning information required in labeling non-prescription drugs. The FDA regulations require only that manufacturers provide English labeling for all non-prescription drugs except those distributed in Puerto Rico or a territory where the predominant language is other than English.
Other courts have discussed this issue. In 1965, in Hubbard-Hall Chemical Company v. Silverman, 340 F.2d 402 (1st Cir. 1965), the U.S. Court of Appeals considered a label for Parathion dust which was in English with no pictorial. The court held that the jury could have reasonably believed that the manufacturer should have foreseen that its dangerous product would be used by persons like the plaintiffs who had limited education and reading ability and that a warning without pictorials or other comparable symbols could be inadequate. Thus, if it is foreseeable that product users cannot read, then safety communications should contain symbols or pictographs that adequately communicate safety information to those users.
Another early major case considering this issue was Campos v. Firestone Tire & Rubber Company, 98 N.J. 198, 485 A.2d 305 (1984). The plaintiff in this case immigrated to the United States in 1971 from Portugal. The accident, which occurred in 1978, involved the explosion of a truck tire rim and tire while being mounted. The manufacturer provided various warnings and instructions in English. However, the plaintiff could not read or write Portuguese or English.
The plaintiff won in the trial court on a failure to warn theory, and the judgment was appealed. In addition to holding that the manufacturer had a responsibility to warn of what was arguably an obvious hazard, the New Jersey Supreme Court also stated that:
In view of the unskilled or semi-skilled nature of the work and the existence of many in the work force who do not read English, warnings in the form of symbols might have been appropriate, since the employee's 'ability to take care of himself' was limited.
These four cases discussed above all hold that the jury will generally decide whether a label is adequate in the circumstances of an individual case. There is enough language in these cases, however, to suggest that if a manufacturer is selling a product in areas where the average user likely will not speak English or possibly not read at all, it should consider including at least a pictorial or symbol which identifies the hazard, and, possibly, a word message in a foreign language.
U.S. Labeling Standards
In 1991, the American National Standards Institute published voluntary consensus standards, referred to as ANSI Z535, concerning product safety labeling. In these newly issued standards, pictographs, pictorials or symbols are not required, but are acceptable. One of the subparts, ANSI Z535.3, provides criteria for safety symbols to be used in safety signs and labels in the United States. The introduction to ANSI Z535.3 states:
The U.S. population is multi-ethnic, highly mobile, and derived from a multiplicity of social and educational backgrounds, with different reading skills and word comprehension. These factors complicate the effectiveness of word-only signs. Effective safety symbols have demonstrated their ability to provide critical information for accident prevention and for personal protection.
In addition, a related subpart, ANSI Z535.4, provides guidelines for developing safety signs and labels. While this subpart does allow for, but not require, the inclusion of pictorials and symbols, it does not contain acceptable formats for bilingual labels nor does it even discuss when it might be appropriate to have bilingual labels. Despite this, an unofficial, but widely used label system created by FMC Corporation, does contain a suggested format for bilingual labels.
Despite the lack of general consensus standards requiring foreign language labeling, some product sellers, such as Home Depot, are requiring bilingual or even trilingual (English, Spanish and French) labels and instructions. These requirements may arise out of safety or liability concerns or merely be a reaction to NAFTA. Trilingual labels and other identification information would allow a manufacturer to sell anywhere in North America without changing its labeling. To the extent that this trend grows, the "state of the art" may be raised despite the lack of clear judicial or legislative guidance or requirements.
In addition, some government agencies may require manufacturers who fall under their jurisdiction to attach bilingual or pictorial labels to their products. For example, in 1994, the Consumer Product Safety Commission issued a notice of proposed rulemaking that would require, in part, a Spanish safety message or a pictogram be included on packages of charcoal to clarify the dangers of burning charcoal indoors because of carbon monoxide fumes. The basis for the Spanish message or pictogram comes from CPSC data which indicates that 80 of 137 victims were members of ethnic minorities, and more than one-half of these were Hispanic.
Despite the fact that many of the individuals in the target population are Hispanic, the Commission opted to require a warning pictogram rather than requiring a warning in Spanish, because the Commission determined that the pictorial message would more effectively communicate the warning to a larger number of the target population with less confusion. According to the clinical psychologist who administered the Commission's test comparing the effectiveness of pictorial and written warnings, and who works with low-income Hispanics, "many in the target population are unable to read either English or Spanish. Therefore, a safety message in Spanish instead of a pictogram would not necessarily reach those Hispanics who do not read English." Under these circumstances, a pictorial warning signal may be more effective because the pictorial will communicate effectively to both literate and non-literate Spanish speakers, non-literate English speakers and non-English speaking persons not in the targeted Hispanic community.
Conclusion for U.S. Sales
With a few narrow exceptions, neither U.S. law nor voluntary consensus technical standards specifically require that foreign languages, symbols or pictorials be used on safety labels that are attached to products, even when those products are clearly being sold in non-English speaking or reading areas in the United States. Despite this, the easiest way to present safety information in such areas is to include comprehensible or generally accepted pictorials or symbols that at least portray the type of hazard and possibly the consequences of encountering it. Many such pictorials and symbols exist today and more are being developed and even tested on focus groups consisting of expected user populations.
However, before including foreign languages on their products, manufacturers should be careful. First, although a manufacturer may have no legal duty to provide foreign language labels, § 323 of the Restatement (Second) of Torts imposes a duty to act non-negligently on persons who voluntarily undertake to "render services to another which he should recognize as necessary for the other person." Hence, a manufacturer may run some risk of liability if it voluntarily chooses to include foreign language labels on their products and these labels contain inadequate information or are not effectively communicated. Likewise, a manufacturer who voluntarily chooses to include one foreign language on its label may be liable for its failure to include warnings in other languages. Similarly, one commentator has argued that manufacturers who advertise in the non-English media assume a duty to warn the targeted population in the consumer's primary language.
Second, there is no assurance that product users in the U.S. will be able to read the foreign language. In fact, they may be illiterate in all languages as was the case with Mr. Campos and with the target audience for charcoal. Also, including other languages on a safety label tends to clutter the label and could diminish the effectiveness of the entire label, especially the English message. Lastly, if one foreign language is selected, another significant part of the user population that reads one of the other 150 languages used in the United States may be neglected.
When Spanish is the second language, one option is to have two signal words on the label. ANSI standards provide for the use of the signal words "DANGER", "WARNING" and "CAUTION." Warning labels usually use only one signal word. However, a manufacturer could still comply with the standard and place two signal words, one in English and one in Spanish, on the label, and then include a pictorial or symbol. The remainder of the label could be in English. The result might be that non-English reading or illiterate users could at least understand the type of hazard and possibly the consequences of not avoiding it. Then, if they are unable to read the English message on the label, they could ask their supervisor or a co-worker to translate. Although pictorial warnings are desirable because they are simplistic, one commentator has argued that pictorial warning symbols, because of their simplicity, may not be desirable because of the possibility of omitting needed information.
Another option is when the manufacturer does not know what foreign language may be appropriate, it could provide English labels, including symbols or pictorials, with the product and offer labels in other languages to retailers or employers. The practical burden (although probably not the legal burden) could be shifted to the sellers or employers to decide if another language is required for safe use of this product. These entities could then specifically request foreign language labels from the manufacturer. For non-prescription drugs, maybe all that would be appropriate is a Spanish (or other language) label or possibly just a safety notice at the point of sale in the retail store. For linseed oil or machinery, foreign language labels that take the place of or are, in addition to, the English labels might be in order.
A similar alternative suggested by one commentator is that manufacturers could supply retailers in areas with a significant number of non-English speaking customers with a pamphlet or leaflet providing the warning information that the customer could request when purchasing the product. One potential problem, however, with this alternative is that customers are likely not to know or comprehend the danger associated with many products and would not therefore, know of the need to request the warning information. Another alternative suggested by the same commentator is to include a toll-free customer information number on the label of the product alerting the consumer that they can call the toll-free number to receive warning information.
Since the retailer or employer knows its customers or product users better than the manufacturer, maybe the decision as to the appropriate course of action properly resides with them. While it may not be possible, as a legal matter, to delegate the duty to warn to the retailer or employer, it may be appropriate try to do so as a preventive law and product safety question.
For sales of products in Europe, the manufacturer must consider the new product liability and product safety-related laws and standards. While neither the Strict Liability Directive nor the General Product Safety Directive contain any specific language requirements for warnings and instructions, the Product Safety Directive does contain language that should be considered.
Manufacturers are required to place only safe products on the market. Safe products do not present any risk or only minimum risks compatible with the product's use taking into account, among other things, the labeling and instructions. In addition, the manufacturer must "provide consumers with the relevant information to enable them to assess the risks inherent in a product . . . where such risks are not immediately obvious without adequate warnings . . ." (Article 3, subpart 2) Arguably, warnings that do not adequately communicate hazards to the foreseeable users by words and pictures do not comply with these requirements.
In addition, the Machinery Safety Directive contains language requirements and these may place a great burden on manufacturers. The Machinery Safety Directive states that warnings "should preferably use readily understandable pictograms and/or be drawn up in one of the languages of the country in which the machinery is to be used, accompanied, on request, by the languages understood by the operators." (Annex 1, Section 1.7.2). This means that manufacturers may be required to draft their warnings in two or more languages.
According to the Machinery Safety Directive, instructions must be drafted in one of the languages of the country in which the machinery is to be used. (Annex l, Section l.7.4, Subpart (b)). Curiously, for maintenance instructions used by specialized personnel, these only need to be created in one of the official EU languages, either French or English.
In addition to the various Directives, some of the European technical standards may contain guidance on the types of languages that could be incorporated into warnings and instructions on products sold in the European Union. For example, a recently approved standard on safety signs and safety pictorials for tractors, agriculture and forestry machinery, and powered lawn and garden equipment, discusses multilingual messages and symbols. This standard, referred to as ISO/CD ll684, provides for labels similar to those under ANSI Z535, but states that such safety signs should contain a signal word or text message in the language of the country where the product is sold.
The standard includes an alternative format for safety signs without text. These safety signs contain two pictorials -- one describing the hazard and the other one depicting how the hazard can be avoided. In the event a no-text safety sign is used, the manufacturer must include either a special four-language safety sign that instructs the operator to consult the operator's manual for an explanation of the safety signs applicable to that product or a special no-text safety sign symbolically requesting that the operator's manual be read. Therefore, it is possible to create safety labels without words.
This, of course, does not apply to the instructions. For instructions, the manufacturer must print word messages, corresponding to the no-text safety signs, in the operator's manual in the "appropriate" language. The appropriate language is defined in the standard. Products sold or used in Central Europe, for example, must carry the message in English, German, French and Dutch. Other languages are required for other regions within Europe.
The approach taken in ISO 11684 is expected to be duplicated in other ISO standards. For example, ISO 9244, relating to earth moving machinery, is proceeding through the approval process and is expected to be approved soon. It incorporates the label and instruction requirements of ISO 11684, although it deletes pictorials not related to earth moving machinery.
Some U.S. manufacturers are selling their products in Europe with no-text safety labels. Some of these manufacturers would like to see no-text safety labels allowed in the U.S. so that one set of labels will be compliant for both the U.S. and Europe. This harmonization of the labeling standards is desirable but will not happen for the foreseeable future. No-text labels cannot transmit enough of the information required by U.S. law.
The legal and technical requirements for providing adequate safety communications to those who do not read or speak English are evolving. Manufacturers who are creating safety communications for sales in the United States and in Europe must keep track of these requirements and trends and try to comply with or exceed them as they exist today or might exist in the foreseeable future.
To further complicate matters, product liability laws have been recently adopted in Japan and China and presumably labeling standards or requirements will also be established in the near future.
A manufacturer's goal in this area is to adequately communicate safety information to foreseeable users, no matter where they are located. It is not too difficult to anticipate that people may not read or speak the English language. It is much more difficult, if not impossible, to adequately communicate all necessary safety information to all foreseeable product users. Nevertheless, attention to this issue can help minimize future liability in the United States, Europe and elsewhere as well as provide a better quality product that is safer and easier to use.