Relying on the United States Supreme Court’s recent decision in POM Wonderful v. Coca-Cola, a federal court judge in California found that FDA regulations do not preclude Lanham Act claims, and allowed a false advertising suit brought by Par Sterile Products, LLC, against competitors to move forward.
Par Sterile Products, the manufacturer of injectable epinephrine under the brand name Adrenalin, brought the Lanham Act suit against Hospira Inc. and other defendants in connection with the advertising and marketing of defendants’ epinephrine products.
According to the complaint, the defendants engaged in false and misleading advertising because they represented that their products were FDA approved and that the products were therefore “safe” and “effective.” The complaint further alleges that the defendants purposely omitted the adverse reaction label warning required by the Food, Drug and Cosmetic Act and, by so doing, misled consumers into thinking plaintiff’s product was more dangerous because its label contained the requisite warnings.
The defendants moved to dismiss the suit, arguing that it was preempted by the FDCA and the FDA’s primary jurisdiction.
Taking a close look at the U.S. Supreme Court’s June decision in POM Wonderful v. Coca-Cola, U.S. District Court Judge Dean D. Pregerson declined to dismiss the suit.
His broad reading of the POM decision emphasized that the Lanham Act and the FDCA are two discrete statutory schemes that can regulate the advertising, marketing, and labeling of food and drugs in harmony without precluding the other.
“It is true that the Court makes frequent mention of ‘food and drink’ or ‘food and beverage’ in the course of its opinion,” Judge Pregerson wrote. “But the arguments, logic and holding of POM Wonderful are couched in much broader language and strongly suggest a more wide-ranging application.”
He noted that: “The logical building blocks of the Court’s specific holding with regard to food and beverage labeling would seem to be equally applicable to food and beverage advertising, drug marketing, medical device labeling, cosmetics branding, or any other kind of marking or representation which would fall under both the Lanham Act and the FDCA, unless preclusion is required for some specific reason. The general presumption following POM Wonderful, then, is that Lanham Act claims with regard to FDCA-regulated products are permissible and, indeed, desirable.”
The ruling applied the broad language of Pom and concluded that the FDCA does not preclude claims alleging false or misleading drug labels under the Lanham Act, and that the Supreme Court viewed the two acts as “complementary.” The judge, however, dismissed the remaining claims. The claims that the defendants marketed their products as “safe” and “effective” and the misleading-label claims were dismissed for a lack of factual specificity. With respect to the false advertising claim, the judge found that Par must first obtain a clear FDA statement that defendants are selling their epinephrine illegally in order to pursue a Lanham Act claim.
To read the order in JHP Pharmaceuticals, LLC v. Hospira, Inc., click here.
Why it matters: One of the first decisions interpreting the Supreme Court’s holding in POM, Judge Pregerson’s expansive reading of the high court opinion found it applicable to a host of claims under the Lanham Act, from food and beverage labeling to cosmetics branding to drug and medical device marketing. The court also held that POM established a general presumption that Lanham Act claims with regard to FDCA-regulated products are permissible and will move forward absent a specific reason for preclusion.