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U.S. Government, FDA Urge the Supreme Court to Decline Review in Drug-Cosmetic Unfair Competition Case

In October 2014, the Supreme Court asked the Solicitor General to provide the federal government’s view on whether the Court should review a case that raises questions about the interplay between state unfair competition law and the Federal Food, Drug, and Cosmetic Act (“FDCA”).  

Athena Cosmetics, Inc. v. Allergan, Inc. involves a claim for unfair competition under California’s Unfair Competition Law (“UCL”).  In the suit, Allergan asserts that Athena markets RevitaLash as a cosmetic when it is really an illegally marketed drug that has never been approved by the Food and Drug Administration (“FDA”) or the State of California.  According to Allergan, those acts violate the UCL.  Allergan won on its claim at the district court and the Federal Circuit.  Athena appealed to the Supreme Court, arguing Allergan’s suit is an impermissible attempt to enforce the FDCA which has no private cause of action, see 21 U.S.C. § 337.  (The procedural history of the case is discussed in further detail here.)  Last Tuesday the Solicitor General recommended the Court deny Athena’s petition for discretionary review.

The government rejected Athena’s position that Allergan’s claim is pre-empted by the FDCA.  The government found “[n]o conflict” between Allergan’s claim and “federal law or with any of decision of FDA.”  According to the government, Allergan’s state law action falls within the scope of the role “the FDCA preserves . . . for the States where, as here, there is no conflict with federal law.”

As part of its petition, Athena argued that suits like Allergan’s would undermine national uniformity and the FDA’s role in policing the market.  The government—FDA included—rejected this argument.  Citing the Supreme Court’s decision in Wyeth v. Levine, 555 U.S. 555 (2009), the government noted its limited “capacity to police the vast marketplace of consumers products [(like Athena’s)] that have never been submitted to FDA for pre-market review.”  The implication is that suits like Allergan’s are a useful supplement to FDA's regulatory scrutiny.  The Supreme Court raised a similar point in its decision in POM Wonderful LLC v. Coca-Cola Co., 134 S. Ct. 2228 (2014), noting how private litigation creates “synergies among multiple methods of regulation.”  Id. at 2239.  The government did not cite this passage in its brief.

The Court will likely decide the fate of Athena’s petition later this month.

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