Opinion
Previously published at 9 Cal.App.4th 1895
Certified for Partial Publication
Pursuant to California Rules of Court, rule 976.1, this opinion is certified for publication with the exception of part III.
Retired judge of the Kern County Superior Court sitting under assignment by the Chairperson of the Judicial Council.
As Modified on Denial of Rehearing Oct. 30, 1992.
Review Granted Dec. 31, 1992.
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COUNSEL
Robert L. Davis, Leonard & Lyde, Chico, for plaintiff and appellant.
Charles F. Preuss, Kevin G. McCurdy, Bronson, Bronson & McKinnon, San Francisco, Harold D. Murry, Jr., Clifford & Warnke, and Katherine D. McManus, Howrey & Simon, Washington, D.C., for defendant and respondent.
OPINION
THAXTER, Associate Justice.
Jorge Ramirez, a minor, by his guardian ad litem Rosa Rivera, appeals from a summary judgment in favor of Plough, Inc. Appellant
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sued Plough alleging negligence, product liability and fraud. The action sought damages for injuries sustained in March of 1986 when Jorge, who was then four months old, contracted Reye's Syndrome after ingesting St. Joseph Aspirin for Children (SJAC). Plough marketed and distributed SJAC.
Papers submitted in support of and in opposition to the motion for summary judgment reflect some conflicts in the facts. Because this is an appeal from a summary judgment, we resolve those conflicts in favor of the nonmoving party, appellant. (Chesney v. Gresham (1976) 64 Cal.App.3d 120, 125, 134 Cal.Rptr. 238.
Reye's Syndrome is a serious disease of unknown cause characterized by severe vomiting, lethargy, or irritability which may progress to delirium or coma. The disease generally strikes children or teenagers who are recovering from a mild respiratory tract infection, influenza, chicken pox, or other viral illness. The mortality rate of the disease is high, and permanent brain damage occurs in many cases. As a result of contracting Reye's Syndrome, appellant suffered catastrophic injuries including quadriplegia, blindness, and profound mental retardation.
In the early 1980's, there was significant scientific debate concerning the cause of Reye's Syndrome. Several state studies suggested a statistical association between the ingestion of aspirin and the disease. In December 1982, the federal government acknowledged the debate. After considering the state studies and their critics, the federal government rejected a proposal which would require a warning label and instead, undertook an independent study. Apparently, Plough participated in efforts to influence government officials and agencies to reject the label proposal which Plough considered premature.
In December 1985, the Food and Drug Administration (FDA) requested that aspirin manufacturers voluntarily place a label on aspirin products warning consumers of the possible association between aspirin and Reye's Syndrome. Plough voluntarily complied and began including a warning and insert in SJAC packaging. On June 5, 1986, the Reye's Syndrome warning became mandatory.
For a more comprehensive discussion of the historical events leading to the mandatory warning requirement, see American Home Products Corp. v. Johnson & Johnson (S.D.N.Y.1987) 672 F.Supp. 135.
In March 1986, SJAC labeling bore the following warning:
"WARNING: Reye Syndrome is a rare but serious disease which can follow flu or chicken pox in children and teenagers. While the cause of Reye Syndrome is unknown, some reports claim aspirin may increase the risk of developing this disease. Consult doctor before use in children or teenagers with flu or chicken pox."
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In addition, the SJAC package insert included the following statement:
"The symptoms of Reye Syndrome can include persistent vomiting, sleepiness and lethargy, violent headaches, unusual behavior, including disorientation, combativeness and delirium. If any of these symptoms occur, especially following chicken pox or flu, call your doctor immediately, even if your child has not taken any medication. REYE SYNDROME IS SERIOUS, SO EARLY DETECTION AND TREATMENT ARE VITAL."
Rosa Rivera purchased SJAC on March 12, 1986, and administered it to appellant who was suffering from what appeared to be a cold or upper respiratory infection. She gave appellant the aspirin without reading the directions or warnings appearing on the SJAC packaging. The packaging was in English and Ms. Rivera can speak and understand only Spanish. She did not seek to have the directions or warnings translated from English to Spanish, even though members of her household spoke English.
The trial court granted Plough's motion for summary judgment on the grounds that "there is no duty to warn in a foreign language and there is no [causal] relationship between plaintiff's injury and defendant's activities." Before granting that motion the court issued a protective order preventing appellant from discovering evidence regarding Plough's activities in petitioning government agencies and officials. Appellant claims the court erred in both rulings.
DISCUSSION
I. Standard of Review.
The purpose of the summary judgment procedure is to penetrate evasive language and adept pleading and to ascertain the existence or absence of triable issues. (Tresemer v. Barke (1978) 86 Cal.App.3d 656, 668, 150 Cal.Rptr. 384.) Summary judgment is also intended to prevent the unnecessary expense of spurious and meritless litigation and needless trials. (McCreery v. Eli Lilly & Co. (1978) 87 Cal.App.3d 77, 81, 150 Cal.Rptr. 730.) Summary judgment is properly granted only when the evidence in support of the moving party establishes there is no issue of fact to be tried and the moving party is entitled to judgment as a matter of law. (Code Civ.Proc., § 437c; Mann v. Cracchiolo (1985) 38 Cal.3d 18, 35, 210 Cal.Rptr. 762, ; Lipson v. Superior Court (1982) 31 Cal.3d 362, 374, 182 Cal.Rptr. 629, .)
On appeal, review is limited to the facts presented to the trial court. The appellate court must independently review the record to determine
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whether the moving party is entitled to judgment as a matter of law. (Onciano v. Golden Palace Restaurant, Inc. (1990) 219 Cal.App.3d 385, 391, 268 Cal.Rptr. 96; Brooks v. Eugene Burger Management Corp. (1989) 215 Cal.App.3d 1611, 1618, 264 Cal.Rptr. 756; AARTS Productions, Inc. v. Crocker National Bank (1986) 179 Cal.App.3d 1061, 1064, 225 Cal.Rptr. 203.)
II. The Adequacy of the Warning Is a Jury Question Involving Disputed Issues of Fact.
The trial court granted summary judgment for Plough stating "there is no duty to warn in a foreign language and there is no [causal] relationship between the plaintiff's injury and defendant's activities." Appellant argues everyone has a general duty to exercise ordinary care pursuant to Civil Code section 1714. Therefore, the issue is not whether Plough had a duty to warn but whether its failure to warn in Spanish constitutes a failure to exercise ordinary care under the circumstances (because the injury is foreseeable) and whether the warning given was adequate. This, he argues, is a question of fact for the jury.
There is confusion about the interplay between the concept of foreseeability and the concept of duty. The Supreme Court has explained the relationship between the two as follows:
"The confusion may stem, at least in part, from the fact that the 'foreseeability' concept plays a variety of roles in tort doctrine generally; in some contexts it is a question of fact for the jury, whereas in other contexts it is part of the calculus to which a court looks in defining the boundaries of 'duty.'
"The question of 'duty' is decided by the court, not the jury. [Citations omitted.] As this court has explained, 'duty' is not an immutable fact of nature ' "but only an expression of the sum total of those considerations of policy which lead the law to say the particular plaintiff is entitled to protection." ' [Citations omitted.]" (Ballard v. Uribe (1986) 41 Cal.3d 564, 572, fn. 6, 224 Cal.Rptr. 664, .)
The factors to be considered in determining whether a duty exists include the foreseeability of harm to the plaintiff, the degree of certainty that the plaintiff suffered injury, the closeness of the connection between the defendant's conduct and the injury suffered, the moral blame attached to the conduct, the policy of preventing future harm, the extent of the burden to the defendant, and the consequences to the community of imposing a duty to
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exercise care with resulting liability for breach. (Ballard v. Uribe, supra, 41 Cal.3d at p. 572, fn. 6, 224 Cal.Rptr. 664, .)
The California Legislature has imposed on manufacturers of drugs a duty to warn "in such manner and form as are necessary for the protection of users." (Health & Saf.Code, § 26638.) So has the federal government. (21 U.S.C. § 352.) The courts in California have balanced the above listed factors and confirmed what the executive and legislative branches have stated in statute and regulation: manufacturers of drugs--prescription and over-the-counter--must warn consumers of known risks or hazards associated with the intended use of their products. Manufacturers are also required to instruct as to proper usage and dosage. (Brown v. Superior Court (1988) 44 Cal.3d 1049, 245 Cal.Rptr. 412, ; Finn v. G.D. Searle & Co. (1984) 35 Cal.3d 691, 699-700, 200 Cal.Rptr. 870, ; Rodriguez v. Superior Court (1990) 221 Cal.App.3d 1371, 1374-1375, 271 Cal.Rptr. 114.)
Tort liability for failure to warn may arise under either negligence or strict liability theories. Negligent failure to warn requires a showing that a manufacturer did not warn of a particular risk for reasons which fell below the acceptable standard of care, that is, what a reasonable manufacturer would have known and would have warned about. Strict liability requires only a showing that the manufacturer did not adequately warn of a risk known or knowable in light of the available information at the time of manufacture and distribution. (Anderson v. Owens-Corning Fiberglas Corp. (1991) 53 Cal.3d 987, 1002-1003, 281 Cal.Rptr. 528, .) Under either theory, the adequacy of the warning is a key determination. A warning is inadequate when it is not given in a manner likely to reach those to whom harm is reasonably foreseeable. (Prosser & Keeton, Torts (5th ed. 1984) § 96, pp. 685-686.) Whether the warning is adequate is usually a question of fact. (Jackson v. Deft, Inc. (1990) 223 Cal.App.3d 1305, 1320, 273 Cal.Rptr. 214; Miles Laboratories, Inc. v. Superior Court (1982) 133 Cal.App.3d 587, 596, 184 Cal.Rptr. 98; Stanley Industries, Inc. v. W.M. Barr & Co., Inc. (S.D.Fla.1992) 784 F.Supp. 1570, 1575; see also, Anderson v. Owens-Corning Fiberglas Corp., supra, 53 Cal.3d at pp. 1002-1003, 281 Cal.Rptr. 528, ; Gonzales v. Carmenita Ford Truck Sales, Inc. (1987) 192 Cal.App.3d 1143, 1148-1149, 238 Cal.Rptr. 18; Rosburg v. Minnesota Mining & Mfg. Co. (1986) 181 Cal.App.3d 726, 734, 226 Cal.Rptr. 299; Perfetti v. McGhan Medical (1983) 99 N.M. 645, 650-651 ; Cavers v. Cushman Motor Sales, Inc. (1979) 95 Cal.App.3d 338, 347-350, 157 Cal.Rptr. 142; contra, Temple v. Velcro USA, Inc. (1983) 148 Cal.App.3d 1090, 1094-1095, 196 Cal.Rptr. 531 .)
It is undisputed SJAC was marketed and intended for the treatment of minor aches and pains associated with colds, flu, and minor viral illnesses.
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The SJAC box promised "... fast, effective relief of fever and minor aches and pains of colds." Both parties accept the premise that Plough had a duty to warn consumers that the intended use of SJAC after a viral infection or chicken pox could lead to Reye's Syndrome, an illness with serious, possibly fatal, consequences. In March 1986, federal regulations requiring a Reye's Syndrome warning had been promulgated and were final, although not yet effective. The FDA had previously solicited voluntary labeling. In response to the request for voluntary labeling, Plough started packaging SJAC with explicit warnings of the risks of Reye's Syndrome. The scientific community had already confirmed and documented the relationship between Reye's Syndrome and the use of aspirin after a viral illness. There is no doubt Plough had a duty to warn of the Reye's Syndrome risk.
The question thus is whether the warning given only in English was adequate under the circumstances. Respondent argues that as a matter of law it has no duty to place foreign-language warnings on products manufactured to be sold in the United States and that holding manufacturers liable for failing to do so would violate public policy.
The California Constitution now provides that English is the state's official language. (Cal. Const., art. III, § 6, added by initiative, Gen.Elec. (Nov. 4, 1986).) Respondent argues that because English is recognized by virtue of this constitutional provision as the common language of the state and because the Legislature and officials of the state are required to ensure English remains the common language, public policy negates any duty of manufacturers to label in a language other than English. Respondent also argues this policy is evident in that there is no statutory duty to warn in a language other than English. Health and Safety Code section 25900 mandates that all warnings be printed in English and no other statute requires printing in another language. Federal regulations also require warnings be in English. (21 C.F.R. § 201.15 (1991).)
Respondent cites several cases including Guerrero v. Carleson (1973) 9 Cal.3d 808, 109 Cal.Rptr. 201, and Castro v. State of California (1970) 2 Cal.3d 223, 85 Cal.Rptr. 20, , which hold government does not have a duty to make itself understood to non-English speakers. Although both Guerrero and Castro discuss the difficulty non-English speakers may have undertaking routine daily tasks and note the interest in allowing these difficulties to provide repeated incentives either to learn English or develop a reliance on bilingual translators, neither case addresses the duty of manufacturers to warn in a foreign language against known risks under circumstances which lead a reasonable person to give such warning.
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While the constitutional, statutory, regulatory, and judicial authorities relied on by respondent may reflect a public policy recognizing the status of English as an official language, nothing compels the conclusion that a manufacturer of a dangerous or defective product is immunized from liability when an English-only warning does not adequately inform non-English literate persons likely to use the product.
Plough's argument that public policy absolutely precludes liability for failing to warn in a foreign language is seriously undercut by federal regulations. In announcing its final rule continuing and revising the required Reye's Syndrome warning statement, the FDA specifically addressed the foreign-language issue:
"... Although in the 50 states all required labeling must appear in English, the regulations do not preclude the distribution of labeling in a language other than English, in a special format, or in Braille along with the conventional English language labeling. FDA encourages the preparation of labeling to meet the needs of non-English speaking or special user populations so long as such labeling fully complies with agency regulations." (53 Fed.Reg. 21633, 21636 (June 9, 1988).)
In addition, a federal regulation mandates that when a drug label contains any representation in a foreign language, all warnings and other information required by law shall also be given in that language. (21 C.F.R. § 201.15(c)(2) (1991).) This regulation is not directly applicable here because there is no showing that any of the SJAC label used Spanish, but it demonstrates that public policy does not forbid requiring warnings in languages other than English when appropriate.
We presume that the duty to warn also reflects a public policy, one designed to benefit consumers by reducing risks and protecting individual autonomy in decision-making. (Prosser & Keeton, Torts, op. cit. supra, § 96, pp. 685-686.) Plough has not offered any persuasive reasons for concluding as a matter of law that the "English as official language" public policy should, under all circumstances, override the consumer-protection public policy.
Although we have not been directed to any California cases on point, we note several decisions from other jurisdictions acknowledging language difficulties are part of a negligence analysis. (See Exxon Corp. v. Roberts (Tex.Civ.App.1986) 724 S.W.2d 863, 867 [employer was negligent in failing to make sure two crews docking an offshore oil rig could communicate with one another]; Campos v. Firestone Tire & Rubber Co. (1984) 98 N.J. 198 [485 A.2d 305, 310] [in view of existence of many in work force who do not read English, warnings in form of symbols might have been
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appropriate]; Wackenhut Corp. v. Canty (Fla.1978) 359 So.2d 430 [security guard did not speak English, communication problems led to customer's injury]; Cepeda v. Cumberland Engineering Co., Inc. (1978) 76 N.J. 152 [386 A.2d 816, 839] [dissenting justice argues employee's inability to read or speak English important factor] overruled on other grounds in Suter v. San Angelo Foundry & Mach. Co. (1979) 81 N.J. 150 [406 A.2d 140]; Delgadillo v. Tex-Con Util. Contractors, Inc. (Tex.Civ.App.1975) 526 S.W.2d 208 [in wrongful death action, fact that Spanish-speaking workers given safety instructions in Spanish a factor] disapproved on other grounds in Burk Royalty Co. v. Walls (Tex.1981) 616 S.W.2d 911, 913-922; Hubbard-Hall Chemical Company v. Silverman (1st Cir.1965) 340 F.2d 402, 405 [manufacturer of parathion should have foreseen use by non-English speaking farm workers; poison symbols or hieroglyphics might be required for adequate instructions and warnings].) At least one treatise has recognized manufacturers may be required to warn in a language other than English if some users are not likely to understand English. (5 Harper, James & Gray, Law of Torts (2d ed. 1986) § 28.7 p. 377, fn. 23.)
Two cases from other jurisdictions involve circumstances similar to those present here.
In Fernandez v. N.Y. City Health & Hosp. Corp. (1987) 129 A.D.2d 554 [514 N.Y.S.2d 49] a non-English speaking patient was given Clinitest tablets by a physician. The tablets were not for ingestion but were for use by the patient in testing his urine at home. Because of the language difficulty, the patient did not understand the instructions given and took the tablets orally, causing internal burns. The plaintiff argued the defendants had a duty to provide adequate instructions and warnings in Spanish. The case was decided on a procedural issue (setting aside a default) and thus the precise question raised in this case was not reached.
The second case is Stanley Industries, Inc. v. W.M. Barr & Co., Inc., supra, 784 F.Supp. 1570. W.M. Barr & Co. manufactured Kleanstrip Boiled Linseed Oil which was used by the Stanley employees to oil a cutting table. A fire started, caused by spontaneous combustion of the rags used in oiling the table. The two employees using the product were Hispanic. One could not read or comprehend English and the other could read English words but had difficulty understanding their meaning. Kleanstrip's English language label warned of the danger of spontaneous combustion. Stanley claimed the product was defective because the warning did not adequately alert non-English-reading users of the danger.
The court denied Barr's motion for summary judgment, holding that in light of Barr's advertising in Miami's Hispanic media and the nature of the
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product, genuine issues of material fact were presented regarding the warning's adequacy. It was for the jury to decide if Barr should have reasonably foreseen use of the product by non-English speaking individuals, and, if so, whether the warning, to be adequate, should have included language other than English or pictorial warning symbols. (784 F.Supp. at p. 1576.)
As the party moving for summary judgment, Plough carried the burden of conclusively proving an affirmative defense to every cause of action or conclusively disproving at least one essential element of each cause. (Chevron U.S.A., Inc. v. Superior Court (1992) 4 Cal.App.4th 544, 548, 5 Cal.Rptr.2d 674.) Plough would be entitled to summary judgment on the negligence cause if it conclusively proved it used "reasonable care to give warning of the dangerous condition of the product or of facts which make it likely to be dangerous to those whom the supplier should expect to use the product or be endangered by its probable use ...." (BAJI No. 9.20, emphasis added.)
We have not found any opinion discussing whether in strict liability cases the adequacy of a warning, as opposed to the duty to warn, is tested by the reasonable care standard or some other standard. Because we conclude that Plough did not demonstrate its entitlement to summary judgment on the negligence cause, we do not decide what standard applies to the warning's adequacy in the strict liability cause.
Plough's evidence showed that over 148 foreign languages are spoken in the United States and over 23 million Americans speak a language other than English in their homes. That evidence plainly does not prove that Plough used reasonable care in giving an English-only warning. Plough, then, resorts to arguing that the burden on manufacturers and society of requiring additional warnings is so "staggering" that the courts should preclude liability as a matter of law. We are not persuaded.
Certainly the burden and costs of giving foreign-language warnings is one factor for consideration in determining whether a manufacturer acted reasonably in using only English. The importance of that factor may vary from case to case depending upon other circumstances, such as the nature of the product, marketing efforts directed to segments of the population unlikely to be English-literate, and the actual and relative size of the consumer market which could reasonably be expected to speak or read only a certain foreign language. Plough presented no evidence from which we can gauge the extent of the burden under the facts of this case.
The plaintiff submitted evidence that Plough knew Hispanics were an important part of the market for SJAC and that Hispanics often maintain their first language rather than learn English. SJAC was advertised in the Spanish media, both radio and television. That evidence raises material questions of fact concerning the foreseeability of purchase by a Hispanic not literate in English and the reasonableness of not giving a Spanish-language warning. If Plough has evidence conclusively showing that it would have been unreasonable to give its label warning in Spanish because of the burden, it did not present that evidence below.
Given the triable issues of material fact, if we accepted Plough's arguments in this case in effect we would be holding that failure to warn in a foreign language is not negligence, regardless of the circumstances. Such a sweeping grant of immunity should come from the legislative branch of government, not the judicial. In deciding that Plough did not establish its right to judgment as a matter of law, we do not hold that manufacturers are required to warn in languages other than English simply because it may be foreseeable that non-English literate persons are likely to use their products. Our decision merely recognizes that under some circumstances the standard of due care may require such warning.
Respondent further argues it has complied with all statutory and regulatory requirements and therefore no additional responsibility may be imposed. However, compliance with applicable regulation does not preclude liability on a negligence or strict liability theory. (Stevens v. Parke, Davis & Co. (1973) 9 Cal.3d 51, 65, 107 Cal.Rptr. 45, .) As the court noted in Hubbard-Hall Chemical Company v. Silverman, supra, 340 F.2d 402, 405, compliance with federal labeling requirements merely establishes compliance with congressional concerns. Federal compliance does not necessarily comport with the standard of due care imposed under state common law. (Ibid.; see also Cipollone v. Liggett Group, Inc. (1992) 505 U.S. 504, 112 S.Ct. 2608, 120 L.Ed.2d 407 [cigarette manufacturers liable under state tort law even though complying with federal warning requirements].)
Plough also argued to the trial court that inadequacy of its Reye's Syndrome warning could not have been a causative factor in appellant's injuries because his mother did not read and rely on the warning. The trial court apparently agreed. The court's ruling, however, is based on the premise that an English-only warning is adequate as a matter of law. We have concluded that the premise is unsound. Thus, the causation basis for the court's ruling also falls.
Because the evidence shows triable issues of material fact and because Plough did not establish its immunity from liability as a matter of law, its motion for summary judgment should have been denied.
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III. Appellant Has Not Shown the Trial Court Abused Its Discretion in Granting the Protective Order.
See footnote *, ante.
DISPOSITION
Judgment reversed. Costs to appellant.
MARTIN, Acting P.J., and BIANCHI, J., Assigned, * concur.