Gibson Dunn Scores for Allergan in Eyelash Enhancer Feud
The ruling is a partial win for Allergan and its attorneys at Gibson, Dunn & Crutcher, who will now use it to prevent Athena Cosmetics from marketing in California a prostaglandin-based eyelash enhancer that has not been approved by the FDA.
But Athena, represented by Patterson Belknap Webb & Tyler, persuaded the appellate court to limit the nationwide injunction imposed U.S. District Judge James Selna of the Central District of California to California only.
"The fact that the California Health Code parallels certain FDCA provisions does not mean that it does not implicate an historic state power that may be vindicated under state law tort principles," Judge Kimberly Moore wrote for a unanimous panel. "We do not find a clear purpose by Congress to preempt the state law claim at issue."
The decision follows reasoning set out by the California Supreme Court in 2008 in Farm Raised Salmon Cases, which likewise found that the FDCA does not preempt California law.
That case was about food. Monday's ruling in Allergan v. Athena Cosmetics concerns drugs—specifically, Athena's RevitaLash line of eyelash enhancers. Allergan markets Latisse, which it promotes as "the first and only FDA-approved prescription treatment for inadequate or not enough eyelashes." Allergan charged that Athena is violating California's unfair competition law by marketing a competing drug without FDA approval.
Athena argues that the FDA hasn't required it to get approval, and that enforcement should be left up to the agency.
The Federal Circuit acknowledged that the Food, Drug & Cosmetic Act does not allow a private right of action. But, Moore reasoned, the California Health Code incorporates the FDCA, and does not stand as an obstacle to its enforcement. "To the contrary, it contains provisions that parallel the FDCA, such that the statutes have consistent goals," she wrote.
Athena argued that RevitaLash is a cosmetic—not a drug—because it promotes appearance, rather than health. Moore had expressed skepticism at the argument in October. "You have a chemical that grows eyelashes," she'd said, comparing it to the baldness drug Rogaine, which is FDA-regulated. "That just feels an awful lot like a drug to me."
In Monday's opinion she pointed out that Athena's website referred to "the look of renewed health, strength and beauty," and the company had advertised improved appearance in the context of "a clinical study." RevitaLash is definitely a drug and could also be a cosmetic, Moore concluded.
But the nationwide injunction went too far by letting Allergan wield California's unfair competition law beyond the state's borders, the court ruled. "This injunction is so broad that it would bar Athena from making its product in Idaho, distributing it from a facility in Nevada, and selling it to Connecticut consumers," Moore wrote.
California does not have "the authority to stand in the shoes of the FDA to determine whether Athena's sale of the products at issue amounts to the sale of an unapproved drug under the FDCA."
Chief Judge Randall Rader and Judge Evan Wallach concurred.
Gibson Dunn's Mark Perry argued the case for Allergan. Steven Zalesin of Patterson Belknap argued for Athena.
Scott Graham writes for The Recorder, an American Lawyer sibling publication.