Supreme Court Turns Down Athena v. Allergan; 'Torrent' Of Suits To Come?

Following the recommendation of Solicitor General Donald Verrilli, the Supreme Court has declined to review Allergan v. Athena Cosmetics, a case examining if the Federal Food, Drug and Cosmetic Act preempts an unfair competition claim in California characterizing Athena's RevitaLash products as unapproved drugs. Athena predicts a "torrent of novel and disruptive litigation" could ensue.

Courts may have a larger role in determining if a product should be regulated as a cosmetic or a drug following the Supreme Court's refusal to hear Athena Cosmetics, Inc. v. Allergan, Inc.

Athena's was one of numerous petitions for writs of certiorari denied by the Supreme Court June 29.

The court's decision not to hear the case means a lower court ruling stands, effectively enjoining Athena from selling its RevitaLash products in California because, according to the courts, they are unapproved drugs.

The case potentially has broader implications for the overall cosmetics industry at a time when firms increasingly are invoking federal preemption arguments to combat litigation alleging violations of state laws.

"Besides clogging the courts," the deluge of suits predicted by Athena on the coattails of its case "would create a crazy-quilt, where products are salable in some jurisdictions but banned in others, depending on where plaintiffs choose to sue and how each court applies the nebulous 'intended use' test."

Athena's lengthy legal battle began in California district court, with pharmaceutical firm Allergan asserting that Athena's prostaglandin-containing RevitaLash offerings compete unfairly against its prescription Latisse eyelash-growth treatment, which contains bimatoprost, also a prostaglandin.

According to Allergan, Athena's products are unapproved drugs due to their intended use as eyelash growth stimulants, and the California district and Federal Circuit courts agreed with that interpretation of the company's marketing and claims, rejecting Athena's contention that FDA, rather than federal courts, should make that determination.

U.S. Solicitor General Donald Verrilli weighed in on the case upon Athena's appeal to the Supreme Court, recommending that the court pass on the requested review, which in the view of many Supreme Court watchers made a denial all but a foregone conclusion (Also see "Supreme Court Review Of Athena Cosmetics Case, Federal Preemption Argument Unlikely" - HBW Insight, 10 Jun, 2015.).

In his amicus curiae brief, Verrilli echoed the lower courts' position that federal food and drug law does not impliedly preempt an unfair competition claim concerning an FDA-regulated product, and lack of FDA enforcement action against a cosmetic with drug-like properties cannot be taken as an agency endorsement.

Cosmetics stakeholders and defense attorneys are concerned that by following the Solicitor General's recommendation and denying the case, the Supreme Court has provided an answer to Athena's question – "Who should decide … whether products in interstate commerce are drugs or cosmetics – FDA, or judges and juries acting under state law?” – and it isn't the one they were looking for.

Athena has suggested that the ramifications could be dire.

In a supplemental brief filed June 8 with the Supreme Court, the firm quoted from Verrilli's brief, arguing that a system in which "judges and juries in private lawsuits may 'determine what must be submitted' to FDA, and ban products if those submissions have not been made … would lead to absurd consequences. It cannot be correct."

Athena goes on: "It invites a torrent of novel and disruptive litigation. … Besides clogging the courts, these suits would create a crazy-quilt, where products are salable in some jurisdictions but banned in others, depending on where plaintiffs choose to sue and how each court applies the nebulous 'intended use' test."

Attorney Michael Walsh, a partner in the Dallas office of Strasburger & Price, LLP, is similarly apprehensive. In a June 9 post on the law firm's Food and Drug Law blog, he asserted that leaving the drug/cosmetic decision to state court juries "is an invitation for litigation chaos" (Also see "New Litigation Risks Possible From Pending Allergan V. Athena Case" - HBW Insight, 17 Jun, 2015.).

Remarking on the Solicitor General's brief, he said: "The government’s position breaks new ground by allowing state courts to decide a product’s drug status and may significantly blur the lines between state law claims and claims seeking to enforce the FDCA."

Under the Federal Food, Drug and Cosmetic Act, which California's Sherman law parallels, it must be construed from product labeling and marketing claims whether an item is simply meant to beautify, cleanse or alter a user's appearance, identifying it as a cosmetic, or to affect body structure or function, rendering it a drug.

However, the dividing line can be hazy. FDA increasingly has been working to clarify the matter with warning letters issued to cosmetics firms for claims that overstep the line from the agency's point of view (Also see "Gemdo Warning Letter Speaks Volumes About FDA Concerns, Industry Challenges" - HBW Insight, 5 May, 2015.).

Athena maintains that such policing should remain FDA's exclusive jurisdiction.

The firm says the Solicitor General presumed in his brief that RevitaLash would be considered a new drug, "a proposition that has never been established (and the government does not even advance). The true question is different: whether the need for 'drug' approval can be determined in a private state-law suit, to which FDA is not a party."

Allergan issued its own supplemental brief on June 15. According to the drug firm, the Solicitor General rightly concluded that state law claim is not preempted by the FDCA and that state law applied in this instance does not conflict with federal law.

"The government’s brief leaves no doubt that FDA does not disagree with the judgment of the courts below that RevitaLash is a drug," Allergan says.

The firm also suggested that "courts regularly decide the intended use of products in this context" and dismissed Athena's prognostication that the courts will be inundated with lawsuits if the lower court decision were allowed to stand.

In his blog post, Walsh suggested that "no matter how the Court rules, this could well be a landmark Supreme Court ruling for those defending purported 'new drug' claims."