Ramirez v. Plough, Inc., No. S029777

• Court: United States State Supreme Court (California)
• Writing for the Court: KENNARD; LUCAS; MOSK
• Citation: 6 Cal.4th 539,863 P.2d 167,25 Cal.Rptr.2d 97
• Parties: , 863 P.2d 167, 62 USLW 2383, Prod.Liab.Rep. (CCH) P 13,740, 27 A.L.R.5th 899 Jorge RAMIREZ, a Minor, etc., Plaintiff and Appellant, v. PLOUGH, INC., Defendant and Respondent
• Decision Date: 09 December 1993
• Docket Number: No. S029777

Page 97

25 Cal.Rptr.2d 97 6 Cal.4th 539, 863 P.2d 167, 62 USLW 2383, Prod.Liab.Rep. (CCH) P 13,740, 27 A.L.R.5th 899 Jorge RAMIREZ, a Minor, etc., Plaintiff and Appellant,
v.
PLOUGH, INC., Defendant and Respondent. No. S029777. Supreme Court of California Dec. 9, 1993.
Rehearing Denied Feb. 24, 1994.

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[6 Cal.4th 542] [863 P.2d 168] Leonard & Lyde and Robert L. Davis, Chico, for plaintiff and appellant.

Edward M. Chen, San Francisco, Robin S. Toma, Paul L. Hoffman, Mark D. Rosenbaum, Esteban Lizardo, Los Angeles, Arthur H. Bryant, Anne W. Bloom, Washington, D.C., Joseph R. Grodin, San Francisco, Kazan, McClain, Edises & Simon and Dianna Lyons, Oakland, as amici curiae on behalf of plaintiff and appellant.

Preuss, Walker & Shanagher, Charles F. Preuss, Bronson, Bronson & McKinnon, Kevin G. McCurdy, Jose H. Garcia, San Francisco, Clifford & Warnke, Washington, D.C., Howrey & Simon, Harold D. Murry, Jr., and Katherine D. McManus, Washington, DC, for defendant and respondent.

Harvey M. Grossman, Los Angeles, Daniel F. O'Keefe, Jr., Eve E. Bachrach, Covington & Burling, Bruce N. Kuhlik, Lars Noah, Washington, DC, Landels, Ripley & Diamond, Sanford Svetcov, San Francisco, and Fred J. Hiestand, Sacramento, as amici curiae on behalf of defendant and respondent.

KENNARD, Justice.

We granted review in this case to determine whether a manufacturer of nonprescription drugs may incur tort liability for distributing its products with warnings in English only. Recognizing the importance of uniformity and predictability in this sensitive area of the law, we conclude that the rule for tort liability should conform to state and federal statutory and administrative law. Because both state and federal law now require warnings in English but not in any other language, we further conclude that a manufacturer may not be held liable in tort for failing to label a nonprescription drug with warnings in a language other than English.

I

Plaintiff Jorge Ramirez, a minor, sued defendant Plough, Inc., alleging that he contracted Reye's syndrome as a result of ingesting a nonprescription drug, St. Joseph Aspirin for Children (SJAC), that was manufactured and distributed by defendant. Plaintiff sought compensatory and punitive damages on theories of negligence, products liability, and fraud. The trial court granted summary judgment for defendant. On plaintiff's appeal, the Court of Appeal reversed, 15 Cal.App.4th 1110, 12 Cal.Rptr.2d 423.

Viewing the appellate record in light of the standard of review for summary judgments (Code Civ.Proc., § 437c; Molko v. [863 P.2d 169] Holy Spirit

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Ass'n [6 Cal.4th 543] 1988) 46 Cal.3d 1092, 1107, 252 Cal.Rptr. 122, 762 P.2d 46), we determine the relevant facts to be these:

In March 1986, when he was less than four months old, plaintiff exhibited symptoms of a cold or similar upper respiratory infection. To relieve these symptoms, plaintiff's mother gave him SJAC. Although the product label stated that the dosage for a child under two years old was "as directed by doctor," plaintiff's mother did not consult a doctor before using SJAC to treat plaintiff's condition. Over a two-day period, plaintiff's mother gave him three SJAC tablets. Then, on March 15, plaintiff's mother took him to a hospital. There, the doctor advised her to administer Dimetapp or Pedialyte (nonprescription medications that do not contain aspirin), but she disregarded the advice and continued to treat plaintiff with SJAC.

Plaintiff thereafter developed Reye's syndrome, resulting in severe neurological damage, including cortical blindness, spastic quadriplegia, and mental retardation.

First described by the Australian pathologist Douglas Reye in 1963, Reye's syndrome occurs in children and teenagers during or while recovering from a mild respiratory tract infection, flu, chicken pox, or other viral illness. The disease is characterized by severe vomiting and irritability or lethargy, which may progress to delirium and coma. In 1982, the Centers for Disease Control estimated that Reye's syndrome affected 600 to 1200 children and teenagers in this country each year. ¹ (47 Fed.Reg. 57,886 (Dec. 28, 1982).) The disease is fatal in 20 to 30 percent of cases, with many of the survivors sustaining permanent brain damage. The cause of Reye's syndrome was unknown in 1986 (and apparently remains unknown), but by the early 1980's several studies had shown an association between ingestion of aspirin during a viral illness, such as chicken pox or influenza, and the subsequent development of Reye's syndrome. These studies prompted the United States Food and Drug Administration (FDA) to propose a labeling requirement for aspirin products warning of the dangers of Reye's syndrome. (See 50 Fed.Reg. 51,400 (Dec. 17, 1985).) The FDA published a regulation to this effect on March 7, 1986. (51 Fed.Reg. 8,180.) Unless extended, the regulation was to expire two years after its effective date. (Id. at p. 8182.) In 1988, the FDA revised the required warning to state explicitly that Reye's syndrome is reported to be associated with aspirin use, and it made the regulation permanent. (53 Fed.Reg. 21,633 (June 9, 1988).)

Even before the federal regulation became mandatory, packages of SJAC displayed this warning: "Warning: Reye Syndrome is a rare but serious [6 Cal.4th 544] 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." The package insert contained the same warning, together with this 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."

These warnings were printed in English on the label of the SJAC that plaintiff's mother purchased in March 1986. At that time, plaintiff's mother, who was born in Mexico, was literate only in Spanish. Because she could not read English, she was unable to read the warnings on the SJAC label and package insert. Yet she did not ask anyone to translate the label or package insert into Spanish, even though other members of her household could have done so. Plaintiff's mother had never heard, [863 P.2d 170] seen, or relied upon

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any advertising for SJAC in either English or Spanish. In Mexico, she had taken aspirin for headaches, both as a child and as an adult, and a friend had recommended SJAC.

Plaintiff, by and through his mother as guardian ad litem, filed suit against defendant in August 1989, alleging causes of action for fraud, negligence, and product liability, all premised on the theory of failure to warn about the dangers of Reye's syndrome.

The charging allegation as to negligence was that defendant "failed to warn" that aspirin "caused or contributed to the development of Reye Syndrome in children suffering from the flu, chicken-pox and other viral illnesses." As to fraud, the complaint charged that defendant falsely represented that SJAC "was safe to administer to children with the flu, chickenpox and other viral illnesses," and that defendant concealed the fact that "aspirin causes or contributes to the development of Reyes [sic] Syndrome in children with the flu, chickenpox or other viral illness." As to products liability, the complaint alleged that the SJAC plaintiff ingested was defective when it left defendant's control and that the product's reasonably foreseeable use involved a substantial and not readily apparent danger of which defendant failed to adequately warn.

Defendant moved for summary judgment, submitting uncontradicted evidence of the facts as stated above. Defendant argued that it was under no [6 Cal.4th 545] duty to label SJAC with Spanish language warnings, that the English language label warnings were adequate, and that the adequacy of the English warnings was ultimately inconsequential in this case because plaintiff's mother did not read the warnings or have them translated for her. On the motion for summary judgment, the parties agreed that over 148 languages are spoken in the United States. Plaintiff adduced evidence that defendant realized that Hispanics, many of whom have not learned English, constituted an important segment of the market for SJAC, and that defendant had acted on this knowledge by using Spanish language advertisements for SJAC in Los Angeles and New York. ²

The court granted summary judgment. In its order granting the motion, the court stated that there was "no duty to warn in a foreign language" and no causal relationship between plaintiff's injury and defendant's activities. Plaintiff appealed from the judgment for defendant.

The Court of Appeal reversed. It reasoned that although the question of duty is an issue for the court, the existence of a duty to warn here was undisputed, the actual dispute being as to the adequacy of the warning given. The court noted that the adequacy of a product warning is normally a question of fact, and that a defendant moving for summary judgment has the burden of proving an affirmative defense or the nonexistence of an element of the plaintiff's cause of action. Given the evidence of defendant's knowledge that SJAC was being used by non-English-literate Hispanics, and the lack of evidence as to the costs of Spanish language[863 P.2d 171] labeling, the reasonableness of defendant's conduct in

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not labeling SJAC with a Spanish language warning was, the court concluded, a triable issue of fact. ³

6 Cal.4th 546

II

A

Defendant concedes, as it must, that a manufacturer of nonprescription drugs has a duty to warn...