Kanter v. Warner-Lambert Co.

• Decision Date: 25 June 2002
• Docket Number: No. A094975.,A094975.
• Citation: 122 Cal.Rptr.2d 72,99 Cal.App.4th 780
• Court: California Court of Appeals Court of Appeals
• Parties: Susan KANTER et al., Plaintiffs and Appellants, v. WARNER-LAMBERT COMPANY et al., Defendants and Respondents.

122 Cal.Rptr.2d 72

99 Cal.App.4th 780

Susan KANTER et al., Plaintiffs and Appellants, v. WARNER-LAMBERT COMPANY et al., Defendants and Respondents.

No. A094975.

Court of Appeal, First District, Division 1.

June 25, 2002.

Review Denied October 2, 2002.

Zelle, Hofmann, Voelbel, Mason & Gette, LLP, Daniel S. Mason, Esq., Joseph W. Bell, Esq. Dan Zoloth Dorfman, Esq., San Francisco, Gordon-Creed, Kelley, Holl & Sugerman, LLP, Kevin J. Holl, Esq., Jeremy Sugerman, Esq., San Francisco, Attorneys for Appellants.

Kaye Scholer, LLP, Jeffrey S. Gordon, Esq., Los Angeles, David Klingsberg, Esq., Thomas A. Smart, Esq., Richard A. DeSevo, Esq., Attorneys for Respondents, Warner-Lambert Co. and Pfizer Inc.

Sedgwick, Detert, Moran & Arnold, Michael F. Healy, Esq., Wayne A. Wolff,

Esq., San Francisco, Attorneys for Respondent, Care Technologies, Inc.

MARGULIES, J.

Plaintiffs Susan Kanter and Sharlon Plunk sued defendants Warner-Lambert Company, Pfizer Inc., and Care Technologies, Inc., the manufacturers of NIX, RID, and CLEAR, over-the-counter drugs for the treatment of head lice. Framed as a class action, the complaint alleged that the product labels contain false and misleading statements about the effectiveness of the drugs. The complaint contained several state law claims, including breach of express warranty and false advertising, and a claim for breach of written warranty under the federal Magnuson-Moss Warranty Act. Plaintiffs sought refunds of the purchase price of the drugs, an order banning their sale in their current formulations or requiring their relabeling, and other related relief.

The question in this appeal is not whether the allegations of plaintiffs' complaint have merit, but whether their claims are preempted by federal law. The trial court granted summary judgment for defendants on the ground that the claims were expressly preempted by title 21 of the United States Code section 379r(a), a provision of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L.No. 105-115 (Nov. 21, 1997) 111 Stat. 2296). We agree with the trial court and affirm the judgment.

FACTUAL AND PROCEDURAL BACKGROUND

A. Approval of New Drugs by the Food and Drug Administration

Familiarity with the procedures of the federal Food and Drug Administration (FDA) for approving the marketing of drugs is a prerequisite to an understanding of the facts, issues, and arguments in this appeal. Under the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 301 et seq.), a drug manufacturer is prohibited from marketing a new drug unless the FDA has approved the drug as both safe and effective for its intended use.¹ (§ 355(a); see generally Weinberger v. Hynson, Westcott & Dunning (1973) 412 U.S. 609, 612-613, 93 S.Ct. 2469, 37 L.Ed.2d 207.)

A manufacturer seeking approval of a new drug must submit a detailed new drug application in accordance with the requirements of the FDCA and related regulations promulgated by the FDA. (§§ 355(b)(1); 21 C.F.R §§ 314.1-314.3, 314.50 (2001).) Among other information, a new drug application must include "substantial evidence" that the drug is safe and effective, meaning "evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof." (§ 355(d); see 21 C.F.R. § 314.126 (2001) [explaining characteristics of "adequate and well-controlled study"].)

A new drug application must also include "specimens" of the labeling proposed for the drug. (§ 355(b)(1)(F); see 21 C.F.R. §§ 314.50(c)(2)(i) (2001) [application must include proposed text of labeling], 201 et seq. (2001) [general labeling provisions].) If the FDA determines that the labeling of a new drug is false or misleading in any particular, the drug is deemed "misbranded." Whether labeling is false or misleading depends not only on its stated or suggested representations, but also on the extent to which it fails to reveal any material facts. (§§ 352(a), 321(n).) The application will be refused if the FDA determines that the labeling is false or misleading in any particular, if the application contains an untrue statement of a material fact, or if the proposed labeling does not comply with the requirements established in the regulations. (§ 355(d)(7); 21 C.F.R. § 314.125(b)(6), (7), (8) (2001).)

After a new drug application has been approved, any change in the labeling requires a supplement to an application and approval by the FDA, either before or after the change. (21 C.F.R. §§ 314.70(b), (c), 314.71 (2001).) Furthermore, the FDA has the power to withdraw its approval of a drug for reasons related to its safety or effectiveness, including a determination by that agency on the basis of new evidence that the drug does not have the effect represented or suggested on its labeling or that the labeling is false and misleading in any particular. (§ 355(e); 21 C.F.R. § 314.150(a)(2)(iii), (iv), (b)(3) (2001).)

The FDCA expressly prohibits the manufacture and distribution of any misbranded drug (§ 331(a), (b), (c), (g), (k)), and it authorizes the United States to bring enforcement actions seeking injunctive relief and civil or criminal penalties. (§§ 332-334.) But it does not create a private cause of action for violation of its provisions. (§ 337(a); In re Orthopedic Bone Screw Products (3rd Cir.1999) 193 F.3d 781, 788.)

B. Monographs for Over-the-Counter Drugs

The FDA has adopted another system for evaluating whether the hundreds of thousands of over-the-counter drugs available to consumers are safe, effective, and not misbranded. Under the over-the-counter drug monograph system, the FDA appoints advisory review panels of qualified experts to evaluate the safety and effectiveness of over-the-counter drugs, to review their labeling, and to advise on the promulgation of monographs establishing conditions under which particular categories of over-the-counter drugs can be marketed.² (21 C.F.R. §§ 330.1, 330.10(a) (2001); id., § 330.14(a) (2002); see generally Weinberger v. Bentex Pharmaceuticals, Inc. (1973) 412 U.S. 645, 650-651, 93 S.Ct. 2488, 37 L.Ed.2d 235; Cutler v. Hayes (D.C.Cir.1987) 818 F.2d 879, 882-884.) The FDA publishes proposed and tentative final monographs for public review and comment, and eventually promulgates a final monograph in the form of regulations in the Code of Federal Regulations. Those regulations establish conditions under which a category of over-the-counter drugs is recognized as safe and effective and not misbranded. (21 C.F.R. § 330.10 (2001); see Cutler v. Hayes, supra, at p. 884.)

An over-the-counter drug is generally recognized as safe and effective and not misbranded if it meets each condition in the regulations governing such drugs and in any applicable monograph. (21 C.F.R. § 330.1 (2001).) The regulations for all over-the-counter drugs include labeling requirements. Under the heading "Uses," the label must "contain the labeling describing the `Indications' that have been established in an applicable [over-the-counter] drug monograph or alternative truthful and nonmisleading statements describing only those indications for use that have been established in an applicable monograph...." (21 C.F.R. § 330.1(c)(2) (2001).) Another general regulation provides that the labeling of over-the-counter drugs must be "clear and truthful in all respects and may not be false or misleading in any particular." Labeling must state intended uses and results, directions for proper use, and warnings against unsafe use, side effects, and adverse reactions "in such terms as to render them likely to be read and understood by the ordinary individual, including individuals of low comprehension, under customary conditions of purchase and use." (21 C.F.R. § 330.10(a)(4)(v) (2001).)

Under the regulations, "[a]ny product which fails to conform to an applicable monograph after its effective date is liable to regulatory action." (21 C.F.R. § 330.10(b) (2001).)

C. FDA Approval of NIX

Defendant Warner-Lambert Company (Warner-Lambert) manufactures NIX, now marketed as an over-the-counter product for the treatment of head lice. In 1986, the FDA approved a new drug application for NIX to be sold as a prescription drug. The description section of the approved labeling for the product described NIX as "a topical pediculicide and ovicide for the treatment of infestation with Pediculus humanus var. capitis (the head louse) and its nits (eggs)." The indications and usage section of that label stated: "Nix is indicated for the single-application treatment of infestation with Pediculus humanus var. capitis (the head louse) and its nits (eggs)."

In 1990, the FDA approved a new drug application allowing the sale of NIX as an over-the-counter product. The indications section of the approved labeling stated: "For the treatment of head lice." The product benefits section of that label stated in part: "Nix Creme Rinse kills lice and their unhatched eggs with only one application. Nix protects against head lice reinfestation for a full 14 days." The directions section of the label stated in pertinent part: "A single application is sufficient. Retreatment is required in less than 1% of patients. If live lice are observed seven days or more after the first application of this product, a second treatment should be given." The approved label for the front panel of the package stated:

"One Application

"Kills Lice & Their Eggs

"Prevents Reinfestation"

For the entire period covered by plaintiffs' complaint, the FDA-approved labeling for NIX stated that the product was indicated "[f]or the treatment of head lice" and that the...