Dowhal v. SmithKline Beecham Consumer, S109306.

• Decision Date: 15 April 2004
• Docket Number: No. S109306.,S109306.
• Court: California Supreme Court
• Parties: Paul DOWHAL, Plaintiff and Appellant, v. SMITHKLINE BEECHAM CONSUMER HEALTHCARE et al., Defendants and Respondents.

12 Cal.Rptr.3d 262

88 P.3d 1

32 Cal.4th 910

Paul DOWHAL, Plaintiff and Appellant, v. SMITHKLINE BEECHAM CONSUMER HEALTHCARE et al., Defendants and Respondents.

No. S109306.

Supreme Court of California

April 15, 2004.

Lexington Law Group, Eric S. Somers, Mark N. Todzo, San Francisco, Todd E. Robins and Howard J. Hirsch, Orange, for Plaintiff and Appellant.

Bill Lockyer, Attorney General, Manuel M. Medeiros, State Solicitor General, Richard M. Frank, Chief Assistant Attorney General, Theodora Berger, Assistant Attorney General, Craig C. Thompson, Edward G. Weil, Dennis Ragen and Susan S. Fiering, Deputy Attorneys General, for the People as Amicus Curiae on behalf of Plaintiff and Appellant.

Environmental Law Foundation, James R. Wheaton, Oakland, Iryna A. Kwasny; Public Citizen Litigation Group, Allison M. Zieve and Brian Wolfman, Washington, DC, for Public Citizen as Amicus Curiae on behalf of Plaintiff and Appellant.

Morrison & Foerster, James P. Bennett, Michèle B. Corash, Maria Chedid and Brooks M. Beard, San Francisco, for Defendants and Respondents GlaxoSmithKlineConsumer Healthcare, Alza Corp., Aventis Pharmaceuticals, Inc., Costco Wholesale Corp., Lucky Stores, Inc., Rite Aid Corp., Safeway Inc., and Walgreen Co.

Livingston & Mattesich Law Group, Livingston & Mattesich Law Corporation, Gene Livingston and Matthew J. Goldman, Sacramento, for Defendant and Respondent McNeil Consumer Products Company.

Crosby, Heafey, Roach & May, Reed Smith Crosby Heafey, John E. Dittoe, Oakland and Paul D. Fogel for Defendant and Respondent Pharmacia & Upjohn Company.

Covington & Burling, Steven J. Rosenbaum, Washington, DC and Darren D. Cooke for the Consumer Healthcare Products Association, the Cosmetic Toiletry and Fragrance Association, the Grocery Manufacturers of America and the Pharmaceutical Research and Manufacturers of America as Amici Curiae on behalf of Defendants and Respondents.

Catherine I. Hanson, Astrid Meghrigian, San Francisco and Hans P. Lee for California Medical Association as Amicus Curiae on behalf of Defendants and Respondents.

Robert D. McCallum, Jr., and Peter D. Keisler, Assistant Attorneys General, David W. Shapiro and Kevin V. Ryan, United States Attorneys, Barbara L. Herwig, Douglas Letter, Peter R. Maier, Washington, DC; Daniel E. Troy, Lynn Whipkey Mehler and Heidi P. Forster, Rockville, MD, for United States of America as Amicus Curiae on behalf of Defendants and Respondents.

KENNARD, Acting C.J.

Plaintiff filed this action to challenge the failure of defendants to place health warnings mandated by California's Proposition 65 on products containing nicotine sold over the counter as aids to stop smoking. The trial court granted summary judgment to defendants, ruling that in this setting the requirements of Proposition 65 were impliedly preempted by the federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 301 et seq.). The Court of Appeal reversed; we granted review.

We conclude: (1) Notwithstanding language in the FDCA exempting Proposition 65 from the preemptive effect of the federal act, when the warning mandated by California law directly conflicts with the one that the federal Food and Drug Administration (FDA) requires, the federal requirement prevails; (2) this is a case of direct conflict; and (3) the FDA has authority to prohibit use of the Proposition 65 warning, even though that warning is literally truthful, if the FDA concludes that it would have the effect of misleading consumers. We therefore reverse the judgment of the Court of Appeal.

I. FACTUAL AND PROCEDURAL BACKGROUND

On November 4, 1986, the voters of this state enacted Proposition 65 as an initiative measure. Proposition 65 added section 25249.6 to the Health and Safety Code: "No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause ... reproductive toxicity without first giving clear and reasonable warning to such individual...." This provision does not apply, however, to "[a]n exposure for which federal law governs warning in a manner that preempts state authority." (Health & Saf.Code, § 25249.10.)

The regulations adopted to implement Health and Safety Code section 25249.6 state that the required warning "must clearly communicate that the chemical in question is known to the state to cause ... birth defects or other reproductive harm." (Cal.Code Regs., tit. 22, § 12601, subd. (a).) The regulations also describe optional "safe harbor" warnings that are deemed to be clear and reasonable. (Id., § 12601, subd. (b).) One of the "safe harbor" warnings reads: "WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm." (Id., § 12601, subd. (b)(4)(B).) The warning may be communicated through product labeling, point-of-sale signs, or public advertising. (Id., § 12601, subd. (b)(1)(A)-(C).)

On April 1, 1990, the State of California listed nicotine as a chemical known to cause reproductive toxicity. (Cal.Code Regs., tit. 22, § 12000(c).) This listing was based on the then current determination by the FDA that because of the dangerous consequences of fetal nicotine exposure, nicotine delivery products should be rated in "Category X" — not for use by pregnant women.¹ Consequently, to conform to Proposition 65, defendants' products must carry a warning that "this product contains nicotine, a chemical known to the state of California to cause reproductive harm," or words to that effect.

The FDA, however, has never permitted defendants to use the Proposition 65 warning. The FDA's currently approved warning does not state that nicotine can cause reproductive harm. It requires the product label to state: "If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known." The difference between the two warnings is the focus of this case.

The FDCA prohibits a drug manufacturer from marketing a new drug unless the FDA has approved the drug as both safe and effective for its intended use. (21 U.S.C. § 355.) In addition to scientific and experimental data, a new drug application must include a proposed label. (21 U.S.C. § 355(b)(1)(F).) If the FDA determines that the labeling is false or misleading in any way, the drug is deemed "misbranded," and the FDA will reject the application for approval of the drug. (21 U.S.C. § 352(a).) Once an application has been approved, any change in the labeling requires a supplement to the application and approval by the FDA, either before or after the change. (21 C.F.R. §§ 314.70, 314.71 (2003).)

The issue here is whether California's Proposition 65 requirements are preempted by the FDA regulation, or preserved by the savings clause, section 379r(d)(2), of the Food and Drug Administration Modernization Act of 1997 (Modernization Act) (Pub.L. No. 105-115 (Nov. 21, 1997) 111 Stat. 2296). Section 379r(a) establishes the preemptive effective of federal regulation; it states in part: "[N]o State or political subdivision of a State may establish or continue in effect any requirement — [¶].... (2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter...." The Modernization Act, however, contained a savings clause designed specifically to preserve Proposition 65. It provides: "This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997." (21 U.S.C. § 379r(d)(2).) Proposition 65 is the only state enactment that falls within the savings clause.

Defendants here manufacture, market, and distribute products, such as gum and patches, that are designed to help people quit smoking through nicotine replacement therapy (NRT).² Originally, the products were available only by prescription. In 1993, defendants sought FDA approval to sell them over the counter. Defendants' application presented a complex labeling issue because the products contain nicotine, a substance that if taken by a pregnant woman could cause harm to the fetus. On the other hand, the purpose of the products is to help individuals stop smoking, and smoking is even more dangerous to the fetus, because it may deliver more nicotine than the NRT products, and also exposes the smoker to carbon monoxide and other harmful chemicals. As the chairman of the FDA's Nonprescription Drugs Advisory Committee stated: "This is one of the few instances where we have a product that has come before this committee that I would like lots of people to use, that I think we are underusing.... [¶] So we want to make sure that we are not introducing barriers that would prevent people from using them, and what is worse, somebody continuing to smoke or not calling their physician and talking with him.... [¶] I think, at least as I am interpreting the sense of the committee is that let's be real careful on something we want people to use more of that we don't introduce barriers that would reduce their willingness to use the product." (FDA Nonprescription Drugs Advisory Meeting (Apr. 19, 1996), pp. 169-170.)

Partly in an effort to balance these competing concerns, the products underwent an unusually long approval process. As of 1996, the labels for the original Nicorette, Nicoderm, and Nicotrol prescription products carried a required warning: "Nicotine in any form may cause harm to your unborn baby." (This is the warning required for prescription drugs containing nicotine in 1996.) But when the FDA approved over-the-counter sales in 1996, the FDA advised defendants that their products could carry the following pregnancy warning: "Nicotine can increase your baby's heart rate; ... if you are pregnant or...