On October 17, 2022, the District Court granted Gerber Products Company’s (“Gerber”) motion to dismiss a class action lawsuit in which Plaintiffs had alleged that Gerber deceptively led consumers to believe their baby food products were “healthy” and “safe” despite allegedly containing unsafe levels of toxic metals. See In re: Gerber Products Company Heavy Metals Baby Food Litigation, No. 21-cv-269 (October 17, 2022, Memorandum Opinion and Order) (the “Order”).

Plaintiffs’ allegations had relied, in part, on reports issued by the U.S. House of Representatives Subcommittee on Economic and Consumer Policy, Committee on Oversight and Reform, titled “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury,” which allegedly found measurable levels of these heavy metals in baby food products including those sold by Gerber.

U.S. District Court Judge Michael S. Nachmanoff rejected Plaintiffs’ claims holding that (1) Plaintiffs failed to state a plausible claim that they suffered an economic injury and that they were entitled to injunctive relief, and (2) the FDA should determine what foods are unsafe under the primary jurisdiction doctrine.

Plaintiffs Failed to Plead Economic Injury Sufficient to Establish Standing.

As to standing, the Court concluded that Plaintiffs’ alleged speculative risk of future harm was not enough to confer standing under either a “benefit of the bargain” or “price premium” theory. The Court explained, “Plaintiffs’ only purported basis for economic injury stems from their allegation that the [products] posed a threat of future harm…” Order at 9. Thus, Plaintiffs failed to allege sufficient facts to support a finding of economic injury because there was no “actual or imminent” injury. Id. at 9-10.

The Court rejected Plaintiff’s “benefit of the bargain” theory (i.e., plaintiff was deprived of the benefit of her bargain where, because of the seller’s deceptive act, unfair price or representation, she purchased a product that is worth less than the represented value). The Court explained, here, “Plaintiffs paid for safe and healthy food for their children and apparently received just that—the benefit of their bargain. Accepting the pleadings as alleged, Plaintiffs’ only complaint is that the [products’] levels of Heavy Metals are ‘unsatisfactory to [them]’…[w]ithout more, such an assertion does not amount to a concrete and particularized injury.” Order at 14. Moreover, Plaintiffs’ allegations lacked specificity as to the harm suffered by them, as opposed to some other more generalized risk.

For similar reasons, the Court rejected Plaintiff’s “price premium” theory (i.e., the plaintiff paid more for a product than she otherwise would have as a result of a defendant’s deception).  Here, Plaintiffs failed to allege facts “that would permit the court to determine the economic value of their alleged lost benefit without resorting to mere conjecture.” Order at 18. In other words, Plaintiffs’ complaint lacked, among other things, allegations about how much they paid or how much they would have paid if the allegedly material facts had been disclosed to them. Furthermore, Plaintiffs could not rely on comparisons to other products in the market where Plaintiffs did not allege that those products contained the desired disclosures or that the price correlated to their heavy metal content. Id.

The takeaway here is that allegations of some future generalized harm are simply not sufficient to confer Article III standing.  

The FDA Has Primary Jurisdiction to Determine Safe Amounts of Heavy Metals.

Gerber also argued for dismissal under the primary jurisdiction doctrine (i.e., the FDA, and not the Court, should determine what amounts of heavy metals are safe in these types of products). This doctrine takes “advantage of agency expertise” allowing courts to refer “issues of fact not within the conventional expertise of judges...In this way, primary jurisdiction serves judicial economy because the dispute may be decided by the administrative agency and obviate the need for court intervention.” Id. at 21 (internal citations omitted).

The Fourth Circuit considers four factors in applying this doctrine: (1) whether the issue is within the conventional experience of judges or whether it involves technical or policy considerations within the agency’s particular field of expertise; (2) whether the issue is particularly within the agency’s discretion; (3) whether there exists a substantial danger of inconsistent rulings; and (4) whether a prior application has been made to the agency. Id. at 21-22.

Here, Fourth Circuit precedent weighed in favor of finding that the FDA had primary jurisdiction. Id. 24. The resolution of Plaintiffs’ claims depends on considerations in the FDA’s field of expertise, discretion, and pending litigation related to similar issues may result in a “patchwork of decisions” varying by location, court, manufacturer, and product. Id. at 26-37. The Court also noted that the FDA is presently working on its Closer to Zero Plan, which identifies actions the FDA will take over the next few years to reduce exposure to heavy metals. We have reported elsewhere on FDA’s ambitious action plan for further reducing children’s exposure to toxic elements from foods. Although the Court noted it was not aware that the parties had made any previous application to the FDA on the issues before the Court, this alone was not enough to tip the scales.

Of significance, here, the Court dismissed the case “without prejudice,” which gives the Plaintiffs the opportunity to file an amended complaint to address the deficiencies identified in the Order. It remains to be seen if Plaintiffs will pursue this route or otherwise seek an appeal of the decision. In addition, we will be watching closely to see if jurisdictions with similar pending litigation will follow the District Court’s application of the primary jurisdiction doctrine.