Sandoval v. PharmaCare US, Inc.

145 F. Supp. 3d 986, 2015 U.S. Dist. LEXIS 157108, 2015 WL 7351512
CourtDistrict Court, S.D. California
DecidedSeptember 30, 2015
DocketCASE NO. 15-cv-0738-H-JLB
StatusPublished
Cited by10 cases

This text of 145 F. Supp. 3d 986 (Sandoval v. PharmaCare US, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Sandoval v. PharmaCare US, Inc., 145 F. Supp. 3d 986, 2015 U.S. Dist. LEXIS 157108, 2015 WL 7351512 (S.D. Cal. 2015).

Opinion

ORDER DENYING MOTION TO DISMISS AND STRIKE

MARILYN L. HUFF, District Judge, UNITED STATES DISTRICT COURT

On June 25, 2015, Defendant Pharma-Care US, Inc. filed a motion to dismiss and [990]*990strike portions of Plaintiff John Sandoval’s first amended complaint. (Doc. No. 11.) Plaintiff opposed the motion on September 14, 2015. (Doc, No. 13.) Defendant replied on September 21, 2015. (Doc. No. 14.) The Court took the matter under submission on September 23, 2015, pursuant to Local Civil Rule 7.1(d)(1). (Doc. No. 16.) For the reasons set forth below, the Court denies Defendant’s motion.

Background

This case is a putative nationwide consumer class action regarding Defendant’s over-the-counter product IntenseX. Plaintiff filed the initial complaint on April 3, 2015.- (Doc. No. 1.) He filed the operative first amended complaint (“FAC”) on June 11, 2015. (Doc. No. 9.) This Court has jurisdiction under the Class Action Fairness Act, 28 U.S.C. § 1332(d)(2). (Id. ¶ 1.)

Plaintiff seeks to litigate on behalf of all persons in' the United States who bought IntenseX primarily for personal, family, or household use and not for resale since January 1, 2004. (Id. ¶87.) He alleges causes of action for unlawful, unfair, and fraudulent business practices under California’s Unfair Competition Law (“UCL”), Cal. Bus. & Prof. Code § 17200 et seq.; violation of California’s False Advertising Law (“FAL”), Cal. Bus. & Prof. Code § 17500 et seq.; violation of California’s Consumer Legal Remedies Act (“CLRA”), Cal. Civ. Code § 1750 et seq.; breach of express warranty; breach of the implied warranty of merchantability; and violation of the federal Magnuson-Moss Warranty Act (“MMWA”), 15 U.S.C. § 2301 et seq. (FAC ¶¶ 99-146.)

According to Plaintiff, the name “Inten-seX” implies that the product will enable intense sex. (Id, ¶ 22.) The label contains the following statements: “Sexual Power and Performance,” “IntenseX is designed to intensify your endurance, stamina, and sexual performance,” “This fast acting formula quickly dissolves in the body releasing an energy packed blend of potent herbal extracts,” “Achieve peak performance to maximize the experience when you want it most,” “Laboratory Quality Tested,” “Proprietary Stamina Blend,” and “Produced using the highest manufacturing standards.” (Id. ¶¶ 23-25, 77.) The ingredients are calcium, guaraña, muirá puama, catuaba, ginkgo biloba, avena sativa, cor-dyceps, ashwaganda, tribulus terrestris, American ginseng, Korean ginseng, ginger, cinnamon, nutmeg, and cayenne. (Id. ¶ 28.)

The IntenseX website features pictures of amorous couples and claims the product “WORKS SO FAST YOU MAY NOT MAKE IT HOME,” and the “FAST ACTING FORMULA ... is the. only formula that works within minutes giving you the powerful energy you need to make a ‘long lasting1 impression.” (Id. ¶ 70.) The website asserts, regarding ginseng: “Use if you suffer from coldness, rheumatism, colds and flu, frigidity and impotence.” (Id. ¶56.) The website also states that “Empirical evidence suggests tribulus may help impotence in men and diminished libido in both sexes.” (Id. ¶ 57.)

Plaintiff alleges that he bought IntenseX for $9.99 about fourteen months ago in California.. (Id. ¶ 75.) When deciding to buy the product, he relied on the label and believed IntenseX had powerful aphrodisiac qualities that would improve his sexual power and performance. (Id. ¶¶ 77-78.) But the product did not deliver the promised benefits. (Id. ¶ 79.) Moreover, he asserts, there is no evidence that the ingredients provide the claimed benefits, and consuming random herbs and extracts is potentially dangerous, which is an unfair and unreasonable risk considering that the product provides no benefits. (Id. ¶¶ 45, 79.)

Plaintiff supports his claims with several reports. According to New York Univer-[991]*991shy’s Langone Medical Center, there is no real evidence that herbs offer any benefits for increasing sexual performance or desire, and there are no reliable; scientific studies to establish that ginkgo biloba improves sexual function. (Id. ¶¶ 32-33.) In fact, at least two studies have shown that ginkgo failed to improve sexual function to any greater extent than placebo. (Id. ¶ 34.) According to another article, ginkgo biloba has been proven to be ineffective in improving, sexual function. (Id. ¶35.) And, according to a third article, evidence supporting a role for muirá puama in sexual health is limited, and its widespread use in supplements, for sexual health is not supported. (Id. ¶ 36.) The third article also reports that the effect of tribulus ter-restris on human sexual response has not been well documented, guidelines and dosages are not clear, and the reason for its use in supplements purporting to provide sexual benefits is not strongly supported on the basis of scientific evidence. (Id. ¶ 37.) Plaintiff asserts further that avena sativa, guaraña, ginger, nutmeg, cinnamon, and cayenne also do not support sexual function. (Id. ¶¶ 38-44.)

Plaintiff makes three core claims about IntenseX. First, he claims that IntenseX is misbranded because the product label and website make “disease” claims that cause reasonable consumers to believe the product can treat premature ejaculation, erectile dysfunction, and diminished libido. (Id. ¶¶ 63.) Hence, plaintiff claims, Inten-seX violates FDA regulation 21 C.F.R. § 101.93, which regulates the claims manufacturers can make on supplement labels, as well as California’s Sherman Food, Drug, and Cosmetic Law (“Sherman Law”), Cal, Health & Safety Code § 109875 et seq., which incorporates the FDA’s labeling regulations. (Id. ¶¶ 63-66, 102-03.) In turn, Plaintiff alleges that these violations are “unlawful” conduct within the meaning of the UCL. (Id. ¶¶ 101-03.)

Second, Plaintiff claims that IntenseX is misbranded because it is marketed for use as. an aphrodisiac. (Id. ¶¶ 58-62, 102.) The FDA has determined that any product that is promoted for use as an aphrodisiac is a “new drug” that requires premarket approval. See 21 C.F.R. § 310.528(b). Because Defendant does not have new-drug approval for IntenseX, Plaintiff asserts, the product is misbranded, in violation of FDA regulations, the Sherman Law, and the unlawful prong of the UCL. (FAC ¶¶ 101-03.)

. Third, Plaintiff alleges that the IntenseX labeling and advertising is false and misleading because IntenseX is incapable of delivering the áphrodisiac and sexual-health benefits it promises. (Id. ¶¶ 26-57.) He. claims that the-product is thus mis-branded under the Food, Drug, and Cosmetic Act (“FPCA”), the labeling violates California false-advertising laws and the Sherman Law, and these violations are unlawful conduct under the UCL. (Id. ¶¶ 101-03.) ..

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Cite This Page — Counsel Stack

Bluebook (online)
145 F. Supp. 3d 986, 2015 U.S. Dist. LEXIS 157108, 2015 WL 7351512, Counsel Stack Legal Research, https://law.counselstack.com/opinion/sandoval-v-pharmacare-us-inc-casd-2015.