On September 19, 2014, a federal district judge allowed a consumer class action to proceed against the marketer and seller of an over-the-counter “male enhancement product,” finding that the plaintiff adequately pled facts to support false advertising and unfair competition claims under California law.  See Dorsey v. Rockhard Laboratories LLC et al., slip op. (C.D. Cal., Sep. 19, 2014).  At the same time, the court dismissed claims against the defendants based on their failure to attain FDA approval for their product, holding that the plaintiff had not plausibly alleged the product is a “drug” required to have FDA approval.

The background

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Plaintiff Kenny Dorsey brought the action on behalf of himself and all other consumers who purchased a product known as “Rockhard Weekend” (“RHW”), marketed and sold by defendants, Rockhard Laboratories, LLC and Rockhard Laboratories Holdings, LLC.  Id. at 1-2. Plaintiff complained that in purchasing RHW, he relied on explicit label claims that RHW would enhance his sexual performance, but that the product was “not as advertised.”  Id. at 3.  Plaintiff also alleged the RHW labeling was “unlawful” because the product is a “new drug” unapproved by the FDA to make aphrodisiac claims. Id.

The advertising, labeling and package claims

In refusing to dismiss Plaintiff’s false advertising claims, the court stated it was unpersuaded that the statements, “Sexual Performance Enhancer for Men,” “Fast & Effective,” and “Rockhard Results,” were non-actionable puffery. Id. at 11-12. Instead, the court concluded the statements make specific claims of enhanced sexual performance as a benefit of taking RHW. Id. at 12.

The court also refused to dismiss Plaintiff’s claim based on labeling describing RHW as  “Doctor Tested, Doctor Approved.” Plaintiff alleged, the defendants had not and could not cite any studies or unsolicited doctor endorsements of RHW, and that product was not used in clinical settings for the treatment of male impotence or any other condition. Id. at 14.  Although the defendants argued this claim comprised an improper “lack of substantiation” claim, the court disagreed, noting, “Plaintiff does not merely allege that Defendants have not substantiated their claim, but also that the claim is false.” Id. at 15.  However, the court noted Plaintiff would bear the burden of proving that the “Doctor Tested, Doctor Approved” claim is false or misleading. Id. at 15, n. 4.

Finally, the court dismissed Plaintiff’s claim based on labels purporting to advertise RHW as an aphrodisiac.  Id. at 17. Plaintiff had alleged that Defendants’ intended use of RHW as an aphrodisiac meant the product must be approved by the FDA as a “new drug.” Id. at 16.  Plaintiff contended that because the FDA had not approved RHW as an aphrodisiac, it was “misbranded.” Id. In dismissing this claim, the court noted that the defendants explicitly labeled RHW as a “dietary supplement,” and not a “drug.”  Id. at 17. The court further observed that while the packaging may represent that RHW will improve male sexual performance, the word “aphrodisiac” does not appear on the label, nor does any other statement that RHW is designed to cure or mitigate  impotence or any other disease.  Id.  Therefore, the court found Plaintiff had not plausibly alleged that RHW is a “drug” requiring prior approval by the FDA. Id.

Source:  Kenny Dorsey v. Rockhard Laboratories LLC et al, Case No. 2:13-cv-07557-DDP-RZ (C.D. Cal.)

This article was prepared by Katharyn A. Grant (katharyn.grant@nortonrosefulbright.com and +1 210 270 7182) of Norton Rose Fulbright’s San Antonio office.