NEWS OF INTEREST top

1. Kuneva Calls for More Work with U.S. and China
2. The Baby Bottle Controversy
3. Intertek Launches Safety Tested Mark for Toys

1. Kuneva Calls for More Work with U.S. and China

EU Consumer Commissioner Meglena Kuneva March 14 called for further product safety cooperation with the U.S. and China. In a speech marking EU Consumer Day, she placed emphasis on the EU’s efforts with China, including a project called the RAPEX-China Application. Begun in 2006, the program involves Chinese product safety officials using EU RAPEX reports to investigate problems with products made in their nation. Last fall, Kuneva made similar calls for cooperation with the U.S. and China. The Europeans have memoranda of understanding with both nations targeting information sharing and other cooperation to improve product safety.

Kuneva also pointed to EU Internal efforts to improve its product safety system, especially related to toys, explaining,” Since last summer, we have made it clear that we will make no compromise on safety. The numerous recalls of toys have put our current safety and surveillance system in the spotlight. In response, we have carried out a thorough review of this system.” She was referring to an EU “stocktaking” of its rules begun in December. One result of that effort was a member state vote to require warnings on magnetic toys about the risks of ingesting magnets. That proposal still needs final scrutiny by the European Parliament and College of Commissioners before adoption. Meanwhile, the EU standards group CEN is looking at other magnet standards for toys, and the EU Enterprise and Industry Directorate General has proposed broad changes to EU toy rules.

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2. The Baby Bottle Controversy

Unless you’ve been living under a rock for the past few months, you’ve probably heard about a recent study called “Baby’s Toxic Bottle” put together by a coalition of activist groups which has parents questioning the safety of polycarbonate plastic and the chemical in it, Bisphenol-A or BPA.

The Juvenile Products Manufacturers Association (JPMA), which represents the leading manufacturers of baby bottles in the United States, stands by the scientific research indicating that plastic baby bottles are safe.

Many parents are afraid of microwaving plastic or feeding their infants with a plastic baby bottle because of their concerns over the “toxic chemicals” contained in plastic. But those reports have been based on the research of a very small subset of scientists, whose work is now being called into question by independent toxicologists and regulatory agencies around the world.

There is irrefutable data available on the safety of BPA, a material used to make tough, shatter-resistant polycarbonate plastic baby bottles. Definitive studies and scientific reviews supporting its safety have been conducted by the U.S. Food and Drug Administration, Harvard University, the National Toxicology Program, the European Food Safety Authority, the German Federal Institute for Risk Analysis, and the Japanese National Institute of Advanced Industrial Science and Technology.

In spite of this strong scientific support, misinformation about polycarbonate baby bottles continues to circulate, and as a result, is needlessly scaring parents and caregivers away from a trusted and safe product. Several new studies provide additional strong support for the safe use of polycarbonate bottles:

• TNO, a prominent Dutch research organization, subjected eighteen different brands of polycarbonate baby bottles sold in Europe to a series of tests to determine the level of BPA that migrates under real-life microwave heating or sterilizing conditions. The study determined that microwave heating has no effect on migration of BPA from polycarbonate bottles and indicates that microwave heating can be safely used to warm contents of a polycarbonate bottle or to sterilize the bottles. Migration levels measured in this and earlier studies using other modes of heating are all well below science-based safety standards set by government agencies.
• Researchers from the Norwegian Food Safety Authority and the Official Food Control Authority of the Canton of Zürich, Switzerland recently conducted a very comprehensive set of experiments designed to assess whether any real-life dishwashing condition, “even rather improbable conditions and scenarios,” could lead to BPA levels above safety standards. They concluded “that even under extreme conditions and scenarios the amount of BPA released from polycarbonate baby bottles is clearly below the TDI [Tolerable Daily Intake; a European science-based safety standard] for babies.”
• Toxicologist Calvin Willhite from the California Environmental Protection Agency recently completed a two-year BPA risk assessment on his own time with NSF International, a not-for-profit, public health and safety company. He reviewed more than 4,000 studies on BPA, carefully analyzing the scientific data and determining a more current “safe number” for humans, what’s known as a reference dose. The independent analysis, published in February’s Journal of Toxicology and Environmental Health, showed very small amounts of BPA leaching into bottles under extreme conditions, when they were heated to 176 degrees for 24 hours. The study concluded that “the concentration that’s in there is infinitesimal, and it’s at least 500 and closer to a thousand times less than what you can calculate from the most rigorous studies” available.

Found in a wide variety of products, lightweight and shatter-resistant polycarbonate plastic has been the material of choice in baby bottles for decades. From baby bottles and food packaging, to bicycle helmets and eyeglass lenses, as well as incubators and components of many life-saving medical devices, polycarbonate plastic makes everyday lives better and safer.

JPMA is committed to educating the juvenile product industry and the public about the safety of polycarbonate baby bottles. To that end, JPMA has established a Web site, www.babybottle.org, as a resource for anyone looking to learn more about the safety of plastic baby bottles. For more information on the safety of juvenile products, please visit: www.jpma.org.

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3. Intertek Launches Safety Tested Mark for Toys

Intertek, a global leader in safety and quality assurance services, introduced a safety tested certification program and mark for toys to global manufacturers, importers, and retailers in March 2008. This certification program was strategically developed in direct response to global customer demands for a means to communicate the safety of toys to consumers and includes a branded trust mark to promote safety as an intrinsic part of every client’s value proposition.

Intertek’s toy tested certification program takes a product-focused approach to intricately ensure that strict attention is paid to both design defects and manufacturing defects. While many of the 2007 recalls resulted from manufacturing defects, design defects continue to be the root cause for over 75% of all recalls. Intertek’s certification program includes detailed Design Hazard Analysis® and uses extensive testing and open-market surveillance to ensure clients can incorporate product safety, as well as avoid manufacturing risk.

With an international reputation as a leading independent third party certifier across many industries and products, Intertek pays particular attention to possible new mandatory third party certification requirements. Importantly, Intertek’s safety tested certification program was designed to be both adaptable and scalable to changes in US and international requirements.

This certification program is efficient, cost effective, and can be implemented immediately, and exclusively through Intertek, the accredited, third-party global leader in consumer product testing, inspection, and certification.

About Intertek
Intertek is a leading provider of quality and safety solutions serving a wide range of industries around the world. From auditing and inspection to testing, quality assurance and certification, Intertek people are dedicated to adding value to customers' products and processes, supporting their success in the global marketplace. Intertek has the expertise, resources and global reach to support its customers through its network of more than 1,000 laboratories and offices and over 21,000 people in 110 countries around the world.

Contacts
For further information, please contact
Julie Naujokas, Communications Manager
Telephone: +1 630 623 6062
Julie.naujokas@intertek.com

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SPECIAL ARTICLES top

• Insurance Coverage for Lawsuits Seeking Funding for Medical Monitoring Programs
  By Barry Buchman
• The Duty to Warn Illiterate or Non-English-Reading Product Users
  By Kenneth Ross

Insurance Coverage for Lawsuits Seeking Funding for Medical Monitoring Programs
By Barry Buchman

I. BACKGROUND
As some in the media have noted, the recent upsurge in lawsuits stemming from recalls of toys believed to contain lead paint have put a spotlight on a recurring legal debate – whether courts should recognize the right of consumers to bring “medical monitoring” lawsuits.¹ Medical monitoring lawsuits have been the subject of debate in the tort system because the lawsuits typically do not allege any present physical injury to the plaintiffs; rather, these lawsuits typically seek to compel defendants to pay for the cost of providing medical testing to individuals, often children, who allegedly have been exposed to dangerous levels of lead or other toxic substances.² The stated purpose of such testing is to allow early detection of any illnesses that subsequently may be caused by that exposure. Consistent with this model, recent medical monitoring class actions against Mattel and other toy companies seek to compel the companies to pay for blood tests to determine if children have elevated levels of lead in their systems.³

Medical monitoring claims are not unique to products containing lead paint. Claimants have used medical monitoring suits in the context of asbestos, environmental pollution, alleged radiation from cell phones, and recalled products such as Vioxx, Fen-Phen, Avandia, and Moistureloc contact lens solution.⁴

Aside from the debate over their validity in the tort system, medical monitoring lawsuits also give rise to a related, and equally important, issue for companies that are named in the lawsuits – whether the companies can recover insurance proceeds, under their comprehensive general liability (CGL) insurance policies, for defense costs and any ultimate liabilities associated with the lawsuits. In the past, insurance companies have argued that there is no coverage for medical monitoring lawsuits because the lawsuits do not seek “damages” because of “bodily injury” within the meaning of standard-form CGL policies. In support of this position, the insurance industry has relied on the fact that medical monitoring lawsuits typically do not allege any present physical injury. As discussed below, courts that have addressed this issue have not been receptive to the insurance industry’s position.

II. INSURANCE COVERAGE ISSUES
A. Basic Insuring Agreements In CGL Policies And Principles of Interpretation
Typical CGL policies promise that the insurance company will “pay those sums that the insured becomes legally obligated to pay ‘as damages’ because of ‘bodily injury’ or ‘property damage’ to which this insurance applies.” “Bodily injury” typically is defined as “bodily injury, sickness or disease sustained by a person, including death resulting from any of these at any time.” This language is the source of insurance companies’ obligation to pay settlements reached by, or judgments entered against, policyholders in underlying tort suits. This obligation often is referred to as the “duty to indemnify.”

Typical CGL policies also promise that the insurance company will “defend any suit against the insured seeking damages on account of such injury or property damage, even if any of the allegations of the suit are groundless, false or fraudulent.” This language is the source of insurance companies’ obligation to pay defense costs incurred by companies defending underlying tort suits. This obligation often is referred to as the “duty to defend.”

The duty to defend is even broader than the duty to indemnify. The duty to defend extends to groundless, false, or fraudulent lawsuits; thus, an insurance company must defend its policyholder whenever the underlying allegations raise any possibility that bodily injury occurred, even if the proof later adduced establishes that there was no actual injury.⁵ Courts resolve any doubts in this regard in favor of finding a duty to defend.⁶

The duty to indemnify turns on the findings of the jury or the court in the underlying lawsuit. If the jury or other fact finder in the underlying action awards damages against the policyholder based upon a finding of bodily injury, the policyholder is not required to independently prove, or to admit, that bodily injury did in fact occur in order to obtain indemnification from its insurer.⁷ A contrary rule would create an impossible Catch-22 for the policyholder: to obtain indemnity coverage, the policyholder would be required to concede its liability for underlying claims. Policyholders, therefore, may obtain indemnification by showing that a settlement or judgment against them was the result of claims that, based on the evidence in the underlying lawsuits, fall within the provisions of their CGL policies.

B. Application To Medical Monitoring Lawsuits
Courts that have addressed the issue of insurance coverage for medical monitoring lawsuits generally have sided with policyholders and ruled that CGL policies cover these lawsuits. For example, in a case addressing the very issue of coverage for lead paint claims, a court ruled in 2002 that a medical monitoring class action alleged “damages” due to “bodily injury” within the meaning of standard CGL policies.⁸ The court ruled in favor of coverage even though the medical monitoring complaint stated that it was not seeking recovery for any present injuries:

The [insurance companies] are obligated to defend any lead-related claim that potentially triggers one or more of their policies even though: . . . the claims seek to recover medical monitoring costs even in the absence of present injury . . . .⁹

Other courts have reached similar conclusions in the context of litigation over environmental contamination. These courts held that the particular medical monitoring lawsuits at issue, which alleged an increased risk of disease due to the contamination, alleged “bodily injury” within the meaning of CGL policies. The courts, therefore, held that the insurance companies had a duty to defend the lawsuits.¹⁰

Most of the above-referenced cases focused primarily on whether the underlying medical monitoring suits alleged “bodily injury” within the meaning of CGL policies, and not on whether they sought “damages” within the meaning of such policies.

Two groups of cases, however, support the proposition that medical monitoring costs qualify as “damages” under CGL policies. First, several courts addressing medical monitoring lawsuits in the tort system have held that these lawsuits seek damages, rather than injunctive or other equitable relief.¹¹ Second, courts in insurance coverage cases have held that any payment of money to address injury or damage constitutes “damages,” even if the court in the underlying litigation fashions or characterizes the remedy as an equitable one.¹²

The most pertinent example of the latter group of cases comes from class action litigation over alleged radiation from handheld cell phones. These cases have involved efforts to compel defendants to pay for the costs of supplying headsets to the class members, allegedly to minimize the risk of future harm (just like medical monitoring programs). Courts have held that these costs are “damages” within the meaning of CGL policies.¹³ In ruling that the costs of headsets are “damages” (because of “bodily injury”), one court even analogized such costs to the costs of medical monitoring programs; the court noted that headset programs and medical monitoring programs both allegedly seek to prevent, or at least minimize, future harm.¹⁴

Accordingly, insurance companies should not be able to avoid their obligation to cover medical monitoring lawsuits on the basis that the lawsuits do not seek “damages” on account of “bodily injury” within the meaning of CGL policies.

C. Interaction With Defense of Underlying Suits
It is important to note that, by pursuing coverage under their CGL policies, companies are not conceding that medical monitoring lawsuits in fact constitute valid, personal injury claims in the tort system. Conversely, for similar reasons, companies are not precluded from pursuing coverage based on the fact that, in the context of underlying tort litigation, they appropriately argue that medical monitoring lawsuits are not compensable claims, due to the lack of present physical injury.

First, as noted above, regardless of the merits of an underlying lawsuit, companies are entitled to coverage for their defense costs in that suit, i.e., even if the underlying suit turns out to be “groundless, false, or fraudulent,” because the duty to defend is broader than the duty to indemnify. Thus, courts have broadly interpreted the terms “bodily injury” and “damages,” as used in CGL policies, to afford coverage when evaluating the duty to defend, even though the underlying claimant ultimately may be unable to prove injury or damages.¹⁵ Courts also, therefore, have recognized that insurance companies cannot predicate a denial of their duty to defend on an issue to be litigated in the underlying lawsuit.¹⁶ Instead, insurance companies should defend their insured, pursuing their coverage defenses later.¹⁷

Second, as also noted above, if medical monitoring claimants do succeed in imposing liability against a policyholder, insurance companies cannot rehash those liability issues in the context of a dispute over insurance coverage. Thus, in such a situation, a company should not have to take positions in the coverage case that claimants could use against the company in future underlying tort litigation.

III. CONCLUSION
Contrary to insurance company assertions, CGL policies typically cover medical monitoring lawsuits absent an applicable exclusion. The coverage that these policies provide for medical monitoring suits and other lawsuits arising out of product recalls can be an extremely valuable corporate asset. In addition to an aggressive defense, companies should keep their insurance assets in mind as another potential tool to minimize the adverse financial impact of such lawsuits.

Barry I. Buchman is counsel in the Insurance Coverage Practice at Dickstein Shapiro LLP. He may be reached at buchmanb@dicksteinshapiro.com.

1 See Kimberly Atkins, Parents out for blood [tests]: Medical monitoring suits filed against Mattel, Lawyers USA, Sept. 24, 2007; Amir Efrati, Toy Recalls May Push ‘Medical Monitoring’ Debate: Suits Seek Funds To Test Children Before Injuries Show, Wall St. J., Aug. 20, 2007, at A7.

2 See Atkins, supra note 1; Efrati, supra note 1; see also Victoria Davis Lockard & Colin K. Kelly, Another Medical Monitoring “Lead” Balloon, For The Defense 80, 83 (Dec. 2007).

3 See Atkins, supra note 1; Efrati, supra note 1.

4 See Atkins, supra note 1; see also Michael Booth, Merck Attacks Ruling That Let Users of Vioxx Sue for Medical Monitoring, N.J.L.J. (Oct. 24, 2007); Complaint Seeks Certification of Avandia Class for Injury,Refund, Medical Monitoring, Mealey’s Litig. Rep. Class Actions (Aug. 2, 2007); Contact Lens Solution MDL Assigned To Judge Norton In South Carolina Court, Mealey’s Litig. Rep. Class Actions (Sept. 7, 2006).
Because of the many variations in policy language, this white paper does not address all of the issues. This white paper also does not replace, and should not be relied on instead of, legal advice based on the specific policy language involved and an insured’s particular situation. However, it does provide a starting point and is intended to be an aid in considering what sometimes is a maze of factual and legal issues. This white paper may be considered advertising in some states.

5 See NL Indus. v. Commercial Union Ins. Co., 926 F. Supp. 446, 454 (D.N.J. 1996); Sherwin-WilliamsCo. v. Certain Underwriters at Lloyd’s London, 813 F. Supp. 576, 582-83 (N.D. Ohio 1993); A-HPlating, Inc. v. Am. Nat’l Fire Ins. Co., 57 Cal. App. 4th 427, 442-43, 67 Cal. Rptr. 2d 113 (1997).

6 See NL Indus., 926 F. Supp. at 454; Sherwin-Williams, 813 F. Supp. at 583.

7 See U.S. Gypsum Co. v. Admiral Ins. Co., 643 N.E.2d 1226, 1242-44 (Ill. App. Ct. 1994); Dayton Indep. Sch. Dist. v. Nat’l Gypsum Co., 682 F. Supp. 1403, 1406-07 (E.D. Tex. 1988), rev’d on jurisdictional grounds sub nom. W.R. Grace & Co. v. Cont’l Cas. Co., 896 F.2d 865 (5th Cir. 1990).

8 See Millennium Chems. Inc. v. Lumbermens Mut. Cas. Co., No. 411388, slip op. at 39 (Ohio Ct. Com. Pl. May 8, 2002) (“Millennium Chems.”), reprinted in Mealey’s Litig. Rep.: Ins. at A-1 (May 21, 2002).

9 See Order of Partial Summary Judgment dated August 20, 2002, in Millennium Chems., F(8)(a)(ii). A copy of this Order is on file with the author, who was one of the attorneys for the policyholder in this case.

10 See Burt Rigid Box, Inc. v. Travelers Prop. Cas. Corp., 126 F. Supp. 2d 596, 637 (W.D.N.Y. 2001) (individuals who lived or worked near contaminated landfill alleged “bodily injury” by alleging increased risk of future disease), aff’d in part, rev’d in part on other grounds, 302 F.3d 83 (2d Cir. 2002); Techalloy Co. v. Reliance Ins. Co., 487 A.2d 820, 822, 826 (Pa. Super. Ct. 1984) (insurance company obligated to defend medical monitoring class action arising out of allegedly reckless dumping and storage of dangerous chemical). In the one case that rejected coverage for a medical monitoring lawsuit, the tort complaint did not allege that the recalled product either caused a present injury or even that it may have caused an injury. See HPF, L.L.C. v. Gen. Star Indem. Co., 788 N.E.2d 753, 757 (Ill. App. Ct. 2003). Thus, unlike the other cases cited, there was no allegation of an increased risk of injury. See id. at 757-58.

11 See, e.g., Zinser v. Accufix Research Inst., Inc., 253 F.3d 1180 (9th Cir. 2001); Dhamer v. Bristol-Myers Squibb Co., 183 F.R.D. 520 (N.D. Ill. 1998); Hurt v. Phila. Hous. Auth., 151 F.R.D. 555 (E.D. Pa. 1993).

12 See, e.g., Helena Chem. Co. v. Allianz Underwriters Ins. Co., 594 S.E.2d 455, 457-59 (S.C. 2004); Bausch & Lomb Inc. v. Utica Mut. Ins. Co., 625 A.2d 1021, 1032-33 (Md. 1993) (“The reasonably prudent layperson does not cut nice distinctions between the remedies offered at law and in equity.”); AIU Ins. Co. v. Superior Court, 799 P.2d 1253, 1267-68 (Cal. 1990); Hazen Paper Co. v. U.S. Fid. & Guar.Co., 555 N.E.2d 576, 583 (Mass. 1990); Minn. Mining & Mfg. Co. v. Travelers Indem. Co., 457 N.W.2d 175, 179-80 (Minn. 1990).

13 See VoiceStream Wireless Corp. v. Fed. Ins. Co., 112 F. App’x 553, 556 (9th Cir. 2004); N. Ins. Co. v. Balt. Bus. Commc’ns, Inc., 68 F. App’x 414, 419 (4th Cir. 2003); Ericsson, Inc. v. St. Paul Fire & Marine Ins. Co., 423 F. Supp. 2d 587, 593-94 (N.D. Tex. 2006); Samsung Elecs. Am., Inc. v. Fed. Ins. Co., 202 S.W.3d 372, 382-83 (Tex. App. 2006); Nokia, Inc. v. Zurich Am. Ins. Co., 202 S.W.3d 384, 390-91 (Tex. App. 2006); Motorola, Inc. v. Associated Indem. Corp., 878 So. 2d 824, 835 (La. Ct. App. 2004).

14 See Motorola, 878 So. 2d at 831-34.

15 See Burt Rigid Box, 126 F. Supp. 2d at 637; Techalloy, 487 A.2d at 822, 826.

16 See, e.g., County of San Bernardino v. Pac. Indem. Co., 56 Cal. App. 4th 666, 686, 65 Cal. Rptr. 2d 657 (1997) (an insurance company cannot “properly avoid its duty to defend by relying upon a coverage defense related to a critical issue in the underlying lawsuits.”).
17 In appropriate circumstances, a company may even be able to stay coverage litigation pending
resolution of the underlying litigation. As the California Supreme Court has explained, “To eliminate the risk of inconsistent factual determinations that could prejudice the insured, a stay of the declaratory relief action pending resolution of the third party suit is appropriate when the coverage question turns on facts to be litigated in the underlying action.” Montrose Chem. Corp. v. Superior Court, 6 Cal. 4th 287, 301, 24 Cal. Rptr. 2d 467 (1993) (citations omitted).

This article was previously published by Dickstein Shapiro LLP, © 2008 Dickstein Shapiro LLP. All Rights Reserved.

Mr. Buchman would like to thank his colleague Kirk Pasich for his contributions to this article.

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The Duty to Warn Illiterate or Non-English-Reading Product Users
By Kenneth Ross

The duty to warn and instruct is a significant duty in the United States. Under U.S. product liability law, 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 the significant number of people who are illiterate in English or in all languages, 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 arguably be considered defective.

This article will describe the relevant law and technical standards in the United States and provide recommendations to manufacturers about using multi-lingual labels and pictorials.

The Number of Illiterates and Non-English Reading Residents in the U.S.
The Census Bureau, in its 2006 American Community Survey, found that approximately 20 percent of the U.S. population, or 56 million people, speak a language other than English. And, of that number, 44 percent, or 24.6 million, speak English less than “very well.”

The Census Bureau also estimated the number of “linguistically isolated” households in the U.S.; meaning that all members of the household 14 years and over have at least some difficulty with English. For Spanish speaking households, 27.6 percent are considered isolated. For Asian and Pacific Island languages, 27.4 percent of the households are isolated.

Concerning illiteracy, the U.S. Department of Education, in 2003, performed A National Assessment of Adult Literacy, updating the last assessment performed in 1992. In particular, the assessment estimated illiteracy in “prose literacy” and “document literacy.” The Department of Education estimated that 11 million people were “nonliterate” in English. And, they concluded that, among adults who spoke Spanish or Spanish and another non-English language before starting school, 61 percent had “Below Basic” skills in prose literacy and 49 percent were “Below Basic” in document literacy.

Given these statistics, it is arguable that manufacturers should be providing safety information in some way other than just in English. While foreseeing the non-English reading and illiterate user population is easy, trying to communicate with those so-called “average users” is much more difficult. Problems abound in getting the “right” product to the right user population, selecting the correct foreign language or pictorial, 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 us examine what the courts are saying in this area.

U.S. Case Law
The two main ways to communicate effectively to illiterate or non-English reading product users is by use of their mother tongue or by use of commonly understood pictorials. However, U.S. common law provides little guidance on when foreign languages or safety pictorials or symbols 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: (l) it must be in such a form that it could reasonably be expected to catch the attention of a reasonably prudent person in the circumstances of its use; and (2) 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 assume that the “average user” is literate in English? Based on the statistics above, the answer is certainly “no.”

Despite the existence of many non-English reading or speaking and illiterate U.S. residents, there have been very few significant legal opinions that have considered the issue of whether safety communications in anything other than English should be required. Several court rulings on this issue show the difficulty the courts have had in rendering clear decisions and providing guidance on this issue.

In 1992, the U.S. District Court for the Southern District of Florida issued a significant ruling in Stanley Industries, Inc. v. W.M. Barr & Co., Inc., 784 F. Supp. 1570 (S.D. Fla. 1992). In that case, the plaintiff alleged that a fire, which occurred in the plaintiff’s facility, was caused by the spontaneous combustion of rags soaked in the defendant’s linseed oil. The linseed oil was being used by two employees who were brothers from Nicaragua and whose primary language was Spanish.

The 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 the defendant’s motion for summary judgment argued that because the language on the back of the product label was in English only and contained no pictorials, it was 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, jointly and cooperatively, to 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 Hispanic newspapers. Home Depot also marketed a number of its products with bilingual instructions.

After reviewing the few prior cases discussing the subject of multi-lingual warnings or universally accepted pictorials or symbols, the court denied the motion for summary judgment and 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 plaintiffs.

The court also held that the jury must decide whether a warning should at least contain universally accepted precautionary pictorials. Lastly, the court held that it was for the jury to decide whether a warning, to be adequate, must contain words in a language other than English or must contain pictorials.

In addition to denying the 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. Until recently, as discussed below, the Stanley Industries case had not been followed or rejected by another court in Florida.

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 for the defendants to warn the plaintiff’s employees in Spanish or by use of pictorials, even if the defendant retailer advertised in Spanish.

Interestingly, many people have interpreted the judge’s ruling in Stanley to mean that pictorials and Spanish were necessary in this situation. That is not the holding of the court and the fact that the jury subsequently ruled in favor of Home Depot supports the view that such communications were not necessary in this case.

It should also be noted that three days before the jury verdict in 1993, Home Depot sent a letter to many of 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 that its suppliers should warn and instruct in Spanish, regardless of the outcome of this case.

In the second major opinion on this issue, the California Supreme Court ruled in 1993 that a manufacturer might 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 had held 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.” And, they believed that requiring a language other than English “…is a matter of public policy for consideration by the appropriate legislative bodies and not by the Courts.” Since this ruling, the Ramirez case has never been overruled in California or cited negatively by any court.

Another early major case considering this issue was Campos v. Firestone Tire & Rubber Company, 98 N.J. 198, 485 A.2d 305 (1984), superseded by statute as stated in Dewey v. R.J. Reynolds Tobacco Co. v. Silverman, 577 A.2d 1239, 1253 (N.J. 1990). 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.

Most recently, the federal district court in Orlando considered the efficacy of the Stanley Industries decision from 1992. The plaintiff argued in Medina v. Louisville Ladder and Home Depot, U.S.A., Inc., 496 F. Supp. 2d 1324 (2007), that the ladder was defective because it lacked warnings and instructions in Spanish and that the defendants were negligent in failing to include them in that language. They relied on the Stanley Industries case to support their allegations. The defendants filed a motion for summary judgment.

In June 2007, the court considered the Stanley Industries opinion and declined to follow it. The court stated that Stanley Industries is “isolated precedent” and that in 15 years from the date of the opinion, no Florida case, state or federal, had concluded that bilingual warnings and instructions may be necessary under Florida law. The court said that there is no indication that Florida law imposes a duty to provide bilingual labels on consumer products and the court was unwilling to extend the law that far. On that basis, the court granted the defendant’s motion for summary judgment. This is a significant ruling since no defendant wants to have a jury decide such an issue and defendants would prefer to have it decided in their favor as a matter of law. (DRI members Rasch Brown and Eugene Terk of Frilot L.L.C. represented Louisville Ladder in this case.)

With the exception of the Medina case, the other cases discussed above and most all of the other rulings on this issue hold that the jury will generally decide whether a label is adequate based on the circumstances of an individual case. Even so, there is enough language in these cases 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 at least consider including a pictorial that identifies the hazard, and, possibly, include a word message in a foreign language.

Therefore, as of today, while the common law in general does not require a label to include a foreign language or even pictorials in order for it to meet the duty to warn and instruct, manufacturers should not rest easy and assume that the law will not change. It is very possible that some court or jury might rule in the future that a foreign language or pictorial is necessary in certain situations.

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 standards, pictorials are not required, but are acceptable. And, while multi-lingual label formats are shown, there is no requirement or discussion of when it is appropriate to add a foreign language to any particular safety sign.

One of the subparts, ANSI Z535.3, pro-vides criteria for symbols or pictorials to be used in safety labels in the United States. The introduction to ANSI Z535.3- 2006 states:

The U.S. population is multi-ethnic, highly mobile, and derived from a multiplicity of social and educational back-grounds, 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. Labels with safety symbols can promote greater and more rapid communication of the safety message, and therefore, greater safety for the general population.

In addition, a related subpart, ANSI Z535.4, provides guidelines for developing safety labels. This subpart does not require the inclusion of pictorials or symbols, but it does encourage their use whenever practical. It also provides, in an unofficial annex, acceptable formats for multi-lingual labels, all of which include pictorials, but the subpart does not provide any guidance on when to include foreign languages. On that issue, the standard says:

The selection of additional languages for product safety signs is an extremely complex issue. Experts suggest that nearly 150 languages are spoken in the United States and over 23 million Americans speak a language other than English in their homes.

A 2007 revision to ANSI Z535.4 allows labels that have only pictorials and no words. This change basically acknowledges the labeling standards promulgated by the International Organization for Standardization (ISO) and could allow a manufacturer to comply both with ISO and ANSI standards with one set of pictorial only labels. This revision made no changes concerning multi-lingual safety labels.

And, lastly, a new subpart, ANSI Z535.6, was issued in 2006 for instructions. This standard does not contain any discussion of multi-lingual manuals, although it does provide guidance on how to incorporate pictorials used on safety labels into the text of the instructions. Therefore, the main safety label standard in the U.S. does not require multi-lingual labels and provides no guidance on when or where they may be appropriate.

Retailer and Government Actions
Despite the fact that the common law and voluntary standards do not require foreign language safety labeling, some manufacturers are including bilingual or even trilingual (English, Spanish and French) labels and instructions with their products. This may arise out of safety or liability concerns or merely is a reaction to sales patterns as a result of NAFTA or customer demands.

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, legislative or voluntary standard guidance or requirements.

In addition, some government agencies have required manufacturers who fall under their jurisdiction to attach bilingual or pictorial labels to some of their products. For example, in 1994, the U.S. Consumer Product Safety Commission issued a notice of proposed rulemaking that would require, in part, a Spanish safety message or a pictorial be included on packages of charcoal to clarify the dangers of burning charcoal indoors because of carbon monoxide fumes. The basis for requiring the Spanish message came from CPSC data that indicated that 80 of 137 victims were members of ethnic minorities, and more than half of these were Hispanic.

However, despite the fact that many of the individuals in the target population were Hispanic, the Commission opted to require only a pictorial along with the English message, 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 pictorial would not necessarily reach those Hispanics who do not read English.”

Under these circumstances, a pictorial warning was deemed to be more appropriate because the pictorial would 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. Another example of government action is when the California legislature adopted a law requiring five-gallon buckets sold in California to have a bilingual label with a pictorial.

There may be other specific examples of government agencies or even standards groups requiring or recommending foreign language labels, but it is limited and has not resulted in a broad legal or practical requirement. Therefore, manufacturers and prod-uct sellers still have great flexibility as to how to meet their duty to warn and instruct.

What to Do for U.S. Sales
As discussed above, 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.

Based on that, one could argue that there appears to be no duty to warn in any language other than English. 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 or retailer may decide to exceed any enunciated or anticipated legal or technical requirements in the hope that accidents will be prevented.

The easiest way to present safety information where you are concerned about non-English reading or illiterate product users is to include comprehensible or generally accepted pictorials that at least portray the type of hazard and possibly the consequences of encountering it.

Many such pictorials and symbols exist today, more are being developed, and some have been tested on focus groups consisting of expected user populations. One problem, however, with some pictorials is that they cannot communicate the probability of an incident occurring and/or how to avoid the hazard, messages that are required by the law and standards. Thus, full reliance on a pictorial to transmit the entire message may be risky in the event of an accident.

In addition, one of the leading safety organizations in the world, the British Department of Trade and Industry, said about pictorials:

Pictograms are not the language free answer to written safety warnings. There is no clear objective evidence to suggest that they have any significant effect on ultimate compliance with safety warnings on products. Therefore the desire to decrease text information on packaging due to the internationalisation of markets must not take the route of language free pictorial warnings unless they have been proven to be effective across all the relevant cultures.

Therefore, where you are in doubt as to the efficacy of the pictorial, the best approach is either to add words that assist the pictorial in more fully and clearly communicating the message or test the pictorial on expected user populations to confirm that they are comprehensible and adequate. However, testing has its risks, too, since the results may confirm that a certain pictorial does not communicate the necessary message, and, therefore, should not be used without words.

Considering foreign languages, manufacturers should be careful before put-ting them in labels on their products and in their instructions. A manufacturer may run some risk of liability if it voluntarily chooses to include foreign language labels on its products and these labels contain inadequate information or are not effectively communicated. This is particularly true in the case of illiterates.

Likewise, a manufacturer who voluntarily chooses to include one foreign language on its label may be criticized for its failure to include other languages. If one foreign language is selected, another significant part of the user population that reads one of the over 150 other languages used in the United States may be neglected. For example, in Minnesota, there are several non-Spanish foreign language newspapers and television stations for the Somali and Hmong population. Do warnings have to be provided in these languages for products sold in Minnesota? I don’t think so.

Another reason to be careful is that 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. And, lastly, if the label is in a foreign language, the manufacturer should arguably also provide an instruction manual in the same foreign language that it provides on the safety label or the message is incomplete.

If the manufacturer decides to add some Spanish, but doesn’t want to make it fully bilingual, one option is to have two signal words (e.g., WARNING in English and Spanish) and a pictorial on the label that at least clearly shows the hazard. The remainder of the label would be in English. Another option is to include one sentence in the foreign language describing the hazard and telling the reader to consult with their supervisor to find out how to avoid it. In either case, the 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 someone who reads English to translate. Also, in this situation, the label could include a reference to the company website that could include safety in-formation in a variety of foreign languages. Presumably this safety information will al-ready be translated for manuals shipped with products sold in foreign countries.

When the manufacturer does not know what foreign language may be appropriate for a given situation, it could provide English labels, including pictorials, with the product and offer to provide labels in other languages to product sellers or employers. The practical burden (although probably not the legal burden) could be shifted to the product sellers or employers to decide if another language is required for safe use of the product. These entities could then specifically request foreign language labels and manuals from the manufacturer. While this approach might be appropriate for some industrial equipment and other products used by workers, it isn’t practical for most consumer products.

One alternative that has been suggested is that manufacturers could offer to provide, to retailers in areas with a significant number of non-English speaking customers, a pamphlet or leaflet providing the safety information in the foreign language of the customers. Another alternative suggested is to include a toll-free customer information number on the label of the product informing consumers that they can call the toll-free number to receive safety information in a foreign language.

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 others, it may be appropriate to allow those more familiar with product users’ language skills to assist in more effectively communicating the safety message to enhance safe product use.

Conclusion
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 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.

There are risks no matter what course of action a manufacturer takes if the plaintiff is illiterate or only reads a foreign language and the safety information does not fully transmit the necessary information to that product user. Therefore, a manufacturer should make a risk assessment of which strategy to take and whether it will be defensible if challenged.

A manufacturer’s goal in this area is to communicate safety information adequately 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 communicate all necessary safety information adequately to all foreseeable product users. Nevertheless, attention to this issue can help minimize future liability in the United States as well as provide a better quality product that is safer and easier to use.

Kenneth Ross is of Counsel in the Minneapolis office of Bowman and Brooke LLP. Mr. Ross can be reached at (952) 933-1195 or kenrossesq@comcast.net.

An earlier version of this article appeared in the Fall 2007 issue of Strictly Speaking, the newsletter of DRI’s Product Liability Committee.

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