Background of the Case
On October 17, 2022, the Eastern District of Virginia District Court granted Gerber Products Company (“Gerber”) a motion to dismiss a class action lawsuit in re: Gerber Products Company Heavy Metals Baby Food. The facts of the case were as follows: The United States House of Representative Subcommittee on Economic and Consumer Policy, Committee on Oversight and Reform released a report on February 4, 2021 finding dangerous levels of the heavy metals (hereinafter “Heavy Metals”)–specifically arsenic, lead, cadmium, and mercury— in baby food products sold by Gerber.Footnote 1 This report was followed by a Supplemental Report outlining testing done by the State of Alaska’s Department of Environmental Health Laboratory that supported the report’s findings.Footnote 2
Plaintiffs filed a Complaint alleging that the Baby Food Products sold by Gerber contained Heavy Metals at “levels above what is considered safe for babies” and was considered harmful to their children.Footnote 3 Plaintiffs’ allegations are supported by standards set forth by the Food and Drug Administration (“FDA”), the Congressional Reports mentioned above, and other organizations.Footnote 4 For example, Arsenic was found to be at concentrations 116 parts per billion (“ppb”) as compared to the 100 ppb allowed by the FDA standard.Footnote 5 Gerber failed to disclose on its packaging that (a) “Gerber Baby Food Products contain or were at material risk of containing harmful Heavy Metals; (b) Gerber inadequately tested, or never tested for all Heavy Metals in all the ingredients it uses and/or its finished products; and (c) when Gerber does set internal standards, they allow for the sale of Baby Food Products with Heavy Metals in amounts that could cause harm to babies and children and at times, the Baby Food Products have failed to meet even those internal standards.”Footnote 6
Given that a person is said to have been “deprived of the benefit of their bargain, when, due to a seller’s deceptive act, unfair practice, or misrepresentation, they purchase a product that is in fact worth less than the represented value,” the Plaintiffs similarly claim that when the Plaintiffs purchased Geber’s defective products containing toxic levels of Heavy Metals, they were themselves denied the benefit of the bargain, as they would have looked for other options and not bought the product had Gerber disclosed the toxic levels of Heavy Metals in its products.Footnote 7 Plaintiffs sought injunctive relief and monetary damages.Footnote 8
The motion to dismiss by Gerber was granted on the grounds that: (1) the Plaintiffs failed to state a plausible claim that they suffered an economic injury and thus are entitled to an injunctive relieve, and (2) the Court is not in a position to determine this matter, but rather under the doctrine of primary jurisdiction, the FDA should be the appropriate entity to determine what foods are unsafe.Footnote 9
Legal Analysis
Gerber argued that the case should be dismissed as the FDA, not the Court, should be the one to determine what amounts of Heavy Metals in their baby food is considered unsafe, under the primary jurisdiction doctrine.Footnote 10 This doctrine “coordinate[s] administrative and judicial decision-making” by deferring to agency expertise when: (1) the facts of the case are not within the “conventional expertise” of judges or (2) the case requires administrative discretion.Footnote 11 The primary jurisdiction doctrine applies to claims “that contain some issue within the special competence of an administrative agency” in which “the court must enable a ‘referral’ to the agency by either staying the case to give the parties a ‘reasonable opportunity to seek an administrative ruling,’ or, if it would not prejudice the parties, dismissing the case without prejudice”- the latter being the route taken in this case.Footnote 12
The four-factor test to determine whether the primary jurisdiction doctrine should be utilized for this case was: “(i) whether the question at issue is within the conventional experience of judges or whether it involves technical or policy considerations within the agency’s particular field of expertise; (ii) whether the question at issue is particularly within the agency’s discretion; (iii) whether there exists a substantial danger of inconsistent rulings; and (iv) whether a prior application has been made to the agency.”Footnote 13
Given that the FDA is the agency with the research capability and expertise to evaluate harmful levels of Heavy Metals, this agency has the administrative authority to require food labeling requirements for these Heavy Metals, and has been working on a plan to reduce exposure to Heavy Metals.Footnote 14 Although the last factor was not satisfied, the Court found that the first three factors were undoubtedly met and therefore the primary jurisdiction doctrine favorably applied to Gerber.Footnote 15
Commentary
In the current public health legal landscape where lawsuits are perpetually increasing in number given unsafe standards in Baby Products, it is important to consider how much the Court’s want to weigh in on these issues.Footnote 16 Although administrative agencies like the FDA have specialized knowledge that may allow them to make more informed decisions on specific subject matter, we should not close the door on other litigation seeking justice for damages from unsafe standards in infantile products. Parents should be able to seek recourse for their children’s health. However, we should understand that prevention of a disease or condition is not the Court’s job, and therefore agencies such as the FDA are set in place. This again though calls into consideration the difficult balance the Court has undertaken when looking at similar litigation with baby formula. Cases on unsafe baby formula and laboratories have been brought to the Courts starting in 2011 but are often dismissed on similar grounds to this Gerber case. Footnote 17 Now that a spotlight has been put on both the FDA’s inspection standards and the Baby Formula shortage which left many infants without anything to eat after Abbott laboratories had to close for unsafe standards in baby products, it will be important to follow the class action lawsuits that are on the docket.Footnote 18
If application of the primary jurisdiction doctrine will be the course of action taken by many of the federal courts, a focus should be given to appropriately fund the FDA- an underfunded agency who has been unable to meet many of its statutory responsibilities, such as ensuring the safety of products, in a timely manner. A recent of example of this occurred in September of 2021, when the FDA received a complaint about a Minnesota infant hospitalized with a bacteria that had been traced back to baby formula production plants reportedly after consuming formula from the plant.Footnote 19 The agency inspectors inspected the appropriate plant at the time, but “it was not until February that the authorities swabbed the plant and discovered the bacteria near production areas.”Footnote 20 Given the FDA is short of resources, allowing these sorts of cases to be brought forth to the Courts, could reduce administrative burdens and more efficiently address harms, rather than facing the alternative- where the burden will lie on the already resource-strained FDA to hear these cases and act in a timely manner. When agencies fail to protect American consumers and the welfare of children, consumers should be given other forms of redress through the judicial system to promote public health and well-being.
