Dowhal v. Smithkline Beecham Consumer
| Decision Date | 12 July 2002 |
| Docket Number | No. A094460.,A094460. |
| Citation | 100 Cal.App.4th 8,122 Cal.Rptr.2d 246 |
| Court | California Court of Appeals Court of Appeals |
| Parties | Paul A. DOWHAL, Plaintiff and Appellant, v. SMITHKLINE BEECHAM CONSUMER HEALTHCARE, etc., et al., Defendants and Respondents. |
General, David W. Shapiro, United States Attorney, Douglass Letter, Peter R. Maier, Department of Justice, Amicus Curiae on behalf of defendants and respondents.
Appellant filed an action challenging the failure of respondents to place health warnings mandated by California's Proposition 65 on their nicotine delivery products, marketed over-the-counter as aids to stop smoking. The trial court granted summary judgment to respondents ruling that certain aspects of Proposition 65 are impliedly preempted by the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 301 et seq.). Because the FDCA contains a provision that expressly exempts Proposition 65 from federal preemption, we will reverse the trial court's judgment.
Respondents in this action manufacture, market, and distribute over-the-counter products, such as gum and patches, that are designed to help people quit smoking through nicotine replacement therapy (the products).1
Originally, the products were available only by prescription. However in 1993, respondents sought Federal Food and Drug Administration (FDA) approval to sell them over the counter.
One aspect of the approval process involved labeling. The FDCA includes strict labeling rules, stating that a product is deemed to be misbranded if "its labeling is false or misleading in any particular...." (21 U.S.C. § 352, subd. (a).) Respondents' application presented a complex labeling issue because the products contain nicotine, a substance recognized by the State of California to cause reproductive toxicity. (See 22 Cal.Code Regs., tit. 22, (Regs.) § 12000, subd. (c).) On the other hand, FDA officials recognized that the purpose of the products is to help individuals stop smoking, a public health goal that should not be frustrated by overwarning. As the chairman of the FDA's nonprescription drugs advisory committee stated,
Partly in an effort to balance these competing concerns, the products underwent an unusually long approval process. At the conclusion of that process, the FDA approved the products for sale subject to specific labeling requirements. In each instance, the FDA mandated that the products carry the following pregnancy warning: "Nicotine can increase your baby's heart rate; ... if you are pregnant or nursing a baby, seek the advice of a health professional before using this product."2 In the course of processing supplemental new drug applications in the years that followed, the FDA told respondents they "must use," "should ... use," or to "please use," the FDA approved pregnancy warning, and that "[m]arketing the product with [labeling] that is not identical to the approved labeling text ... may render the product misbranded and an unapproved new drug."
Proposition 65 was approved by the voters of this state as an initiative on November 4, 1986. As is relevant here, it added section 25249.6 to the Health and Safety Code which states, "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...." The regulations adopted to implement Proposition 65 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." (Regs., § 12601, subd. (a).) The regulations also describe optional safe harbor warnings that are deemed to be clear and reasonable. (Regs., § 12601, subd. (b).) One of those warning states as follows, "WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm." (Regs., § 12601, subd. (b)(4)(B).) Finally, the regulations state that the warning may be accomplished in several ways including product labeling, store signs, and public advertising. (Regs., § 12601, subds.(b)(1)(A) through (b)(1)(C).)
In January 1997, respondent McNeil asked the FDA for permission to change the label for its product Nicotrol, to add the Proposition 65 safe harbor warning that we have quoted. The FDA denied the request telling McNeil it "[m]ust use the labeling that was approved at the time of ... approval."
Later that same year, the United States Congress enacted the Food and Drug Administration Modernization Act of 1997 (Modernization Act of 1997). (See 111 Stat. 2296.) The Modernization Act of 1997 added a new section to the FDCA, 21 United States Code section 379r. Subdivision (a) of section 379r states, in part, Section 379r also includes a narrowly focused saving clause which states, "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, subd. (d)(2).)
In August 1999, appellant, acting on behalf of the public, filed the complaint that is at issue in the present appeal. The complaint names respondents as defendants and contains two causes of action. First, appellant alleged respondents violated Health and Safety Code section 25249.6 because they placed products that contained nicotine into the "stream of commerce" without providing an adequate pregnancy warning as is required by Proposition 65. Second, appellant alleged those same acts (failing to provide an adequate Proposition 65 pregnancy warning) constituted an unfair business practice within the meaning of Business and Professions Code section 17200 et seq. Appellant asked the court to issue an injunction precluding respondents from offering their products for sale in California without providing an adequate Proposition 65 warning.
In November 1999, while the complaint was pending, the FDA granted permission to Novartis Consumer Health Care, Inc. (Novartis), to sell a smoking cessation product called Habitrol. Although Habitrol contains nicotine and is similar in active ingredients, indication for use, and method of administration to the products at issue in this case, Habitrol carried a different FDA approved pregnancy warning. The Habitrol warning stated as follows, "Nicotine, whether from smoking or medication, can harm your baby." Novartis is not a party to this litigation.
When respondent SmithKline learned about the Habitrol pregnancy warning, it asked the FDA about its own warning. The FDA responded that it was "reviewing its position as it relates to the warnings of nicotine products concerning pregnancy and breast feeding."
In May 2000, respondents SmithKline and McNeil each wrote to the FDA, again pointing out that Habitrol carried a different pregnancy warning. Respondents also noted they were being sued by appellant who was alleging their warning was inadequate. In June 2000, the FDA responded to SmithKline that although it was reviewing its position on the pregnancy warning, SmithKline should continue to "use the current warning."
On July 11, 2000, counsel for SmithKline wrote to the FDA seeking confirmation about the pregnancy warning that was required. The FDA responded by letter 10 days later, stating that the products "must" carry the pregnancy warning that had been specified when they were approved.
In March 2001, the FDA sent a letter to SmithKline stating that even though Habitrol carried a different warning, the instructions concerning respondents' products remained unchanged. ...
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