In 2014, the Supreme Court decided POM Wonderful LLC v. The Coca-Cola Company, 134 S.Ct. 2228, which we have discussed in detail here, and here, and here. In POM Wonderful the Supreme Court held that “Congress did not intend the [Food, Drug and Cosmetic Act] FDCA to preclude Lanham Act suits like POM’s.” Since that decision, enterprising plaintiffs have tried to interpret the decision broadly to argue that post-POM Wonderful district courts could not dismiss Lanham Act claims that allege a violation of the FDCA.
The Ninth Circuit’s recent opinion in Astiana v. Hain Celestial Group, Inc., __ F.3d __ (9th Cir. 2015) confirms that district courts can and should defer to the expertise of the Food and Drug Administration (FDA) under the primary jurisdiction doctrine.
Before POM Wonderful, it was clear that “a private action brought under the Lanham Act may not be pursued when . . . the claim would require litigation of the alleged underlying FDCA violation in a circumstance where the FDA has not itself concluded that there was such a violation.” PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010).
At the motion to dismiss phase, courts were willing to dismiss a case under the doctrine of primary jurisdiction. Thus, one strategy regularly employed in defending these advertising cases has been to move to dismiss under the doctrine of primary jurisdiction. “Primary jurisdiction is a prudential doctrine that permits courts to determine ‘that an otherwise cognizable claim implicates technical and policy questions that should be addressed in the first instance by the agency with regulatory authority over the relevant industry rather than by the judicial branch.” Astiana, __ F.3d __ quoting Clark v. Time Warner Cable, 523 F.3d 1110 (9th Cir. 2008).
Although the plaintiffs in the recent Ninth Circuit Astiana case were (apparently) wise enough not to pursue an overreaching interpretation of POM Wonderful, the Court’s opinion confirms that the doctrine remains alive and well in our post POM Wonderful world. In Astiana the plaintiffs filed a putative class action claiming that they were deceived into purchasing defendant’s products, which contain allegedly synthetic and artificial ingredients because the products were labeled as “All Natural,” “Pure Natural,” or “Pure, Natural & Organic.” Defendant filed a motion to dismiss, arguing that the state law claims were preempted by the FDCA or, in the alternative, that the suit should be stayed or dismissed under the primary jurisdiction doctrine.
The district court dismissed the plaintiff’s case under the doctrine of primary jurisdiction, and the Ninth Circuit in Astiana considered on appeal whether this was error. The Ninth Circuit concluded that it was, but not because primary jurisdiction could not apply, but because the district court should have stayed, not dismissed the case.
The Ninth Circuit in Astiana explained that primary jurisdiction doctrine is “reserved for a ‘limited set of circumstances’ that ‘requires resolution of an issue of first impression, or of a particularly complicated issue that Congress has committed to a regulatory agency.’” It further held the district court did not err in invoking the primary jurisdiction doctrine in Astiana because “[d]etermining what chemical compounds may be advertised as natural on cosmetic product labels is ‘a particularly complicated issue that Congress has committed to’ the FDA.” Thus, “[o]btaining expert advice from that agency would help ensure uniformity in administration of the comprehensive regulatory regime established by the FDCA.”
Once a district court determines that primary jurisdiction is appropriate, it may either dismiss or stay the case. Notwithstanding the Supreme Court’s holding in POM Wonderful, district courts may still apply the primary jurisdiction doctrine to determine whether to stay or dismiss a case. This is welcome news for industries whose products are regulated by the FDCA because the Ninth Circuit’s opinion does not disrupt the guidance and regulation that Congress bestowed first in the FDA over those products.