DeLarosa v. Boiron, Inc., Case No. 8:10–CV–1569–JST (CWx).

Decision Date25 July 2011
Docket NumberCase No. 8:10–CV–1569–JST (CWx).
PartiesGina DELAROSA, Plaintiff, v. BOIRON, INC., Defendant.
CourtU.S. District Court — Central District of California

OPINION TEXT STARTS HERE

Ryan M. Ferrell, Call Jensen & Ferrell, Scott J. Ferrell, Newport Trial Group, Newport Beach, CA, for Plaintiff.

Patton Boggs LLP, Newark, NJ, Christina Guerola Sarchio, Patton Boggs LLP, Washington, DC, Gary A. Pemberton, John Mark Jennings, Shulman Hodges and Bastian LLP, Irvine, CA, for Defendant.

ORDER DENYING DEFENDANT'S MOTION FOR JUDGMENT ON THE PLEADINGS

JOSEPHINE STATON TUCKER, District Judge.

Plaintiff Gina Delarosa, individually and on behalf of all others similarly situated, filed this action in California state court, alleging that Defendant Boiron, Inc.1 defrauded Californians by claiming that a tablet called “Children's Coldcalm” would provide relief from sneezing, runny nose, nasal congestion, sinus pain, headaches, and sore throat. (Doc. 1, Ex. 2.) Defendant removed the case pursuant to diversity as set forth under 28 U.S.C. § 1332(a), and pursuant to the Class Action Fairness Act, 28 U.S.C. § 1332(d)(2). (Doc. 1 at 3–4.) On January 21, 2011, Defendant filed this Motion for Judgment on the Pleadings, arguing that Plaintiff's claims are preempted by federal law and that Plaintiff fails to state a claim upon which relief can be granted. (Doc. 27–1.) For the reasons set forth below, the Court DENIES Defendant's Motion.

I. Legal Standard

A motion for judgment on the pleadings under Federal Rule of Civil Procedure 12(c) is “functionally identical” to a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6); therefore, the same legal standard applies to both motions. Dworkin v. Hustler Magazine, Inc., 867 F.2d 1188, 1192 (9th Cir.1989). Dismissal of a complaint for failure to state a claim is not proper where a plaintiff has alleged “enough facts to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). When evaluating a Rule 12(b)(6) motion, the Court must accept as true all allegations of material facts that are in the complaint, and must construe all inferences in the light most favorable to the non-moving party. Moyo v. Gomez, 32 F.3d 1382, 1384 (9th Cir.1994). Judgment on the pleadings is therefore appropriate only “when the moving party clearly establishes on the face of the pleadings that no material issue of fact remains to be resolved and that it is entitled to judgment as a matter of law.” Enron Oil Trading & Transp. Co. v. Walbrook Ins. Co., 132 F.3d 526, 529 (9th Cir.1997) (citation omitted).

II. BackgroundA. The Parties

Defendant Boiron, Inc. is the manufacturer and distributor of Children's Coldcalm (“Coldcalm”). (Doc. 1, Ex. 2, Compl. ¶ 2.) Coldcalm belongs to a class of medicine known as “natural” or “homeopathic,” and is described as such on its packaging. ( Id. ¶ 11; id. Ex. 2.) The homeopathic ingredients in Coldcalm include various flowers, vegetables, insects, metals, and poison. ( Id. ¶ 17.) Defendant advertises on the outside of the package that Coldcalm will relieve symptoms of the common cold, including: sneezing, runny nose, nasal congestion, sinus pain, headaches, and sore throat. ( Id. ¶ 7.)

Plaintiff Gina Delarosa read Defendant's advertisements on the outside of the Coldcalm package and read about Coldcalm on a website. ( Id. ¶ 8; id. Exs. 1, 2.) After reading that Coldcalm relieved cold symptoms, Plaintiff purchased Coldcalm, and her family used the drug as directed. ( Id. ¶ 8.) Plaintiff's family did not obtain the advertised relief from the common cold, nor did they receive any benefits from using Coldcalm. ( Id.) Plaintiff filed a Complaint alleging three claims: (1) violation of the California Legal Remedies Act (“CLRA”); (2) common-law fraud; and (3) violation of the California Unfair Competition Law (“UCL”). ( Id. ¶¶ 29–46.) Plaintiff seeks to represent persons located within California who purchased Coldcalm for personal use at any time during the four years preceding the filing of the Complaint. ( Id. ¶ 22.) Plaintiff requests all available legal and equitable remedies. ( Id. at 11.)

B. Regulatory Framework for Over–The–Counter Drugs

Congress enacted the Federal Food, Drug, and Cosmetic Act (“FDCA”), ch. 675, 52 Stat. 1040, as amended, 21 U.S.C. § 301 et seq. in 1938, after Congress “became increasingly concerned about unsafe drugs and fraudulent marketing.” Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 1198–99, 173 L.Ed.2d 51 (2009). Among other things, Congress prohibited the sale of adulterated or misbranded drugs, and required manufacturers to apply to the U.S. Food and Drug Administration (“FDA”) for premarket approval of new drugs. 21 U.S.C. § 331. The FDCA defines “drug” to include articles, like Coldcalm, that are recognized in the official Homœopathic Pharmacopœia of the United States (“HPUS”) and includes both prescription and over-the-counter (“OTC”) drugs.2 21 U.S.C. § 321(g)(1). Although homeopathic OTC drugs appear to be treated as a subset of OTC drugs by the FDCA and its various regulations, the way in which they are evaluated and tested by the FDA differs markedly from the ways in which non-homeopathic OTC drugs are evaluated.

1. Regulation of Non-homeopathic OTC Drugs

The FDA evaluates whether non-homeopathic OTC drugs are safe, effective and not misbranded using a drug monograph system created by the FDA. See 21 C.F.R. §§ 330.1, 330.10. In drafting the monographs, the FDA divided the non-homeopathic OTC drugs into drug categories, such as antacids, laxatives, antidiarrheal products, emetics, antiemetics, antiperspirants, etc. Id. § 330.5. Each category of drugs was then assigned an advisory review panel of qualified experts who were appointed by the Commissioner of the FDA. Id. § 330.10(a). The advisory review panels were tasked with evaluating the safety and effectiveness of the non-homeopathic OTC drugs, reviewing the drugs' labeling, and advising the Commissioner on the promulgation of monographs establishing conditions under which non-homeopathic OTC drugs listed within each monograph are generally recognized as safe, effective, and not misbranded. Id. § 330.10(a). To that end, the panels reviewed clinical studies, explanations from manufacturers as to why clinical studies may not exist, reports of documented side effects, as well as other pertinent information. See id. § 330.10. Based on each panel's recommendations, the Commissioner engaged in a notice and comment period; the Commissioner published a proposed monograph, received comments and sometimes further data, and ultimately published a final monograph that established the conditions under which a non-homeopathic OTC drug is safe, effective, and not misbranded. Id. Although any interested person may petition for the amendment or repeal of any monograph pursuant to 21 C.F.R. § 10.30, a non-homeopathic OTC drug which fails to conform to its applicable monograph after the date the final monograph became effective is liable to regulatory action. See id. § 330.10(a)(12), (b).

A manufacturer seeking approval of a new non-homeopathic OTC drug must submit a detailed new drug application in accordance with the requirements of the FDCA and related regulations promulgated by the FDA. 21 U.S.C. § 355(b)(1); 21 C.F.R. §§ 314.1–314.3, 314.50. A new drug application must include:

[E]vidence 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.

21 U.S.C. § 355. Similarly, after the FDA approves a new drug application, any change in the drug's labeling requires a supplement to the application, and further approval by the FDA, either before or after the change. 21 C.F.R. §§ 314.70(b), (c), 314.71.

2. Quasi–Regulation of Homeopathic OTC Drugs

Unlike non-homeopathic OTC drugs, homeopathic OTC drugs, including the Coldcalm product at issue here, are not evaluated by the FDA at all. The FDA defines a homeopathic drug as any drug labeled as being homeopathic that is also listed in the HPUS, an addendum, or its supplements. See 21 U.S.C. § 321(g)(1)(A); FDA, Inspections, Compliance, Enforcement, and Criminal Investigations, Compliance Policy Guides § 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed” (CPG § 400.400), available at http:// www. fda. gov/ ICECI/ Compliance Manuals/ Compliance Policy Guidance Manual/ ucm 074360. htm. 3 According to the FDA, the HPUS is [a] compilation of standards for source, composition, and preparation of homeopathic drugs. The HPUS contains monographs of drug ingredients used in homeopathic treatment.” CPG § 400.400. Although the HPUS describes how these ingredients are prepared for homeopathic use, it does not list the drugs as fit to treat specific symptoms, ailments, or conditions. (Compl. ¶ 14.) Instead, the HPUS allows the practitioner or manufacturer to set forth the substance's indications for use. ( Id.)

Drug substances are included in the HPUS after having been subjected to “provings.” ( Id.) “Provings,” conducted in the 1800's and early 1900's, established what types of symptoms resulted from the use of a homeopathic substance in a healthy person. ( Id. ¶ 13.) Use of homeopathic remedies relies on the “law of similars,” i.e., “a notion that the symptoms of disease, ailment or condition can be cured by extremely small amounts of substances that produce similar symptoms in healthy people when administered in large amounts.” ( Id. ¶ 14.) See CPG § 400.400 (“The practice of homeopathy is based on the belief that disease symptoms can be cured by small...

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