On June 18, 2015, a California federal judge denied a motion by Gerber Products Co. (“Gerber”) seeking to dismiss a putative class action for false advertising an infant formula based, in part, on the primary jurisdiction doctrine. The court disagreed with Gerber’s argument that the issues raised by plaintiffs in the lawsuit were best left to the U.S. Food and Drug Administration (“FDA”), the agency with expertise on the challenged health claims Gerber used to advertise its infant formula.
Plaintiff’s Complaint alleged that after being introduced to the infant formula Gerber Good Start Gentle by her pediatrician, she researched the product online and reviewed statements on Gerber’s website “highlighting Good Start Gentle’s endorsement by the [Food and Drug Administration (‘FDA’)] and its ability to protect infants from developing allergies.” (Opinion at 1 (citing First Amended Complaint §61)). As a result of representations by Gerber that the formula reduces the risk of infants developing atopic dermatitis and that the FDA endorsed that health claim, plaintiff claimed she discontinued the use of other formula products and exclusively purchased Good Start Gentle.
Plaintiff filed a putative class action against Gerber on January 9, 2015 seeking certification of a class of “[a]ll persons who have purchased Gerber Good Start Gentle infant formula in California during the applicable statute of limitations.” (Opinion at 2 (citing First Amended Complaint §25). Federal jurisdiction was asserted under the Class Action Fairness Act. Defendant moved to dismiss, arguing that, under the doctrine of primary jurisdiction, and in deference to the FDA, the court should abstain from proceeding in the matter.
In denying Gerber’s motion, the court described the history of the FDA’s review of, and communications with, Gerber related to the health claims at issue. This history included the FDA’s rejection of a qualified health claim proposed by Gerber in 2005, a subsequent petition by Gerber followed by an FDA letter of Enforcement Discretion in 2011, and a warning letter to Gerber regarding the marketing and branding of Good Start Gentle in 2014. Just prior to the FDA issuing its warning letter, the Federal Trade Commission sued Gerber in connection with its advertising, marketing, and sale of Good Start Gentle in the District of New Jersey.
In light of these facts, Gerber argued that dismissal or abstention was warranted based on the doctrine of primary jurisdiction because there was a need for FDA expertise in the evaluation of health claims made in product labeling, and because “the FDA is currently considering certain of Gerber’s claims regarding Good Start.” (Opinion at 8 (citing Defendant’s Reply brief). The court disagreed:
“The primary jurisdiction doctrine does not warrant the stay or dismissal of Plaintiff’s claims. Plaintiff raises neither an issue of first impression nor a complex one. Instead, her claims turn on whether Defendant’s representations concerning the health benefits of Good Start Gentle and the FDA’s approval of the formula were false or misleading.” (Opinion at 7).
The court found that the possibility that the factfinder would be required to consider evidence about clinical studies and those evaluated by the FDA was not a sufficient basis to apply the primary jurisdiction doctrine. It also rejected the argument that allowing plaintiff’s claims to proceed would present a “substantial danger of inconsistent rulings,” because the FDA’s October 13, 2014 Warning Letter reiterated the findings of its 2011 determination, which was based on medical evidence available at the time it was made. The claims currently under consideration by the agency “relate to milk allergies and the distinction between whey and whey protein,” which, in the court’s view, were not material to plaintiffs’ class action claims (Opinion at 8).
Although the FDA was involved in reviewing issues related to Gerber’s health claims for many years prior to commencement of this action, the court’s opinion emphasizes that the primary jurisdiction doctrine may be invoked only in limited circumstances. Based on precedent in the consumer class action context, it is not surprising that the court found itself competent to address what it viewed as the core issue: whether a reasonable consumer would be misled by Gerber’s advertising. However, as the opinion even suggests, cases such as this require that the parties be prepared to present substantial and potentially complex evidence regarding the relevant administrative history, including clinical studies, to the jury.