Hundreds of lawsuits were filed vs baby food companies last year over heavy metals… So what happened next?

By Elaine Watson contact

- Last updated on GMT

Judge: 'The court is unable to conclude whether defendant’s labeling was misleading without guidance from the FDA on the heavy metals...’ Images: Gettyimages/Stefan-Tomic
Judge: 'The court is unable to conclude whether defendant’s labeling was misleading without guidance from the FDA on the heavy metals...’ Images: Gettyimages/Stefan-Tomic

Related tags: baby food lawsuits, Baby food, heavy metals, Gerber products company

A tsunami of lawsuits was filed vs food manufacturers last year following a Congressional report alleging ‘dangerous’ levels of heavy metals in leading baby food brands. So how have judges determined if these complaints have legs, and whether the FDA, or the courts, are best placed to decide how much lead, arsenic, cadmium and mercury are acceptable in foods for infants?

Many proposed class actions related to heavy metals are still proceeding through the courts. But as legal experts quizzed by FoodNavigator-USA predicted last year,​ it has been challenging for plaintiffs to argue that individual courts, rather than a federal agency, have the expertise to adjudicate these cases.

As predicted, it has also been tough to prove that consumers have been harmed and that action levels set for other products such as bottled water are relevant to other food categories such as baby food.

Gerber case tossed: ‘There is no actual or imminent injury alleged’

Most recently, in multi-district litigation vs Gerber Products Co* (owned by Nestlé), a court in Virginia tossed the case, arguing that the plaintiffs did not have standing to file claims premised on economic harm theories (ie. that plaintiffs paid over the odds for the products).

To establish standing, plaintiffs must adequately plead three elements: (1) an injury in fact (2) a causal connection between the injury and the conduct complained of, and (3) that it is likely, as opposed to merely speculative, that the injury will be redressed by a favorable decision…

“Plaintiffs fail to allege sufficient facts to support a finding of economic injury for the same reasons they cannot support a personal injury claim: there is no actual or imminent injury alleged.”

Meanwhile, added the judge, the plaintiff’s attempts to point to comparable products on the market that are certified by the Clean Label Project such as Cerebelly or Once Upon a Farm fall short because they cannot show that these other brands feature “the disclosures plaintiffs seek or that the products’ price or value is correlated to their heavy metal content.”

Judge: ‘The court is unable to conclude whether defendant’s labeling was misleading without guidance from the FDA’

Moreover, said the judge, primary jurisdiction should apply here (ie. this is best left to the relevant federal agency) because the FDA is actively working on setting thresholds for heavy metals in baby food via its Closer to Zero ​plan, and the questions at issue are “particularly within the FDA’s discretion and expertise​.

"No tolerance level has been set and no labeling requirement exists for heavy metals in the defendant’s baby food products. The court is thus unable to conclude whether defendant’s labeling was misleading without guidance from the FDA on the heavy metals’ toxicity.

“Further, resolution of the issue involves important policy considerations,” ​he said. "For example, measures to limit toxic elements in foods may have ‘unintended consequences—like limiting access to foods that have significant nutritional benefits by making them unavailable or unaffordable for many families’​ [a point frequently made by the FDA]”

On a more practical level, he added: “Any decision by the court regarding what level of heavy metals is harmful enough to require a warning label… will likely result in a patchwork of decisions that vary by location, court, manufacturer, and product.”

Sprout Foods case tossed: Alleged harm to consumers ‘simply speculative’

A court in New Jersey came to a similar conclusion in April (which was later backed up by the Superior Court of New Jersey in August) in a putative class action vs Sprout Foods Inc** after finding the alleged harm to consumers from Sprout Organics products was “simply speculative​.”

In his dismissal, Judge Chesler quoted the FDA’s March 2021 letter to industry​, which stated that “at the levels we have found through our testing….children are not at an immediate health risk from exposure to toxic elements in foods.”

The judge added: “Atthe very least, this statement weakens the inference that the amount of heavy metals in the baby food products creates a substantial risk of danger to children.”

Judge: Baby food and bottled water are not the same

Meanwhile, an argument made in several of these lawsuits that baby food products must be dangerous because the levels of heavy metals exceed thresholds set for other products such as bottled water, is unscientific, said the judge, given that consumption patterns and food matrices are completely different.

It is not clear that the ’accepted standards’ identified in the first amended complaint are applicable to baby food,” ​he noted, adding that the complaint “does not contain any background information or explanation indicating that these are apt comparisons for use in the context of baby food.”

Judge: The Court recognizes that plaintiffs have reason to be concerned, even alarmed, by the allegations raised in the House Subcommittee’s reports'

In an October 31 ruling on a case against Plum Organics***  the judge dismissed the claims without prejudice on the same grounds but added: "The Court recognizes that Plaintiffs have reason to be concerned, even alarmed, by the allegations raised in the House Subcommittee’s reports, as any parent would be in their desire to protect their children from harmful substances.

"However, the facts as alleged in this matter do not establish an injury-in-fact direct and concrete enough to bring these claims in court whose power is limited by design by Article III of the Constitution."

Attorney: 'There is no evidence or allegation that the products actually harmed anyone or contain any more heavy metals than any other food item you might find at a grocery store'

So what do legal experts make of the rulings thus far?

David-Kwasniewski
David Kwasniewski: 'Courts have been examining standing in cases like these much more closely, and dismissing claims like these with greater frequency...'

David Kwasniewski, a partner at law firm BraunHagey & Borden, told us he was "not surprised that most of these courts have rejected these claims at the pleading stage. This is a matter that the other branches of government, including the FDA and Congress, are actively investigating, so abstaining on primary jurisdiction grounds makes sense."

But he added: "There is also a more fundamental problem with these claims that several courts have now identified — namely, there is no evidence or allegation that the products actually harmed anyone or contain any more heavy metals than any other food item you might find at a grocery store.

"Especially in light of the Supreme Court’s recent decision in TransUnion​ ​[effectively, if there's no concrete harm, there's no standing to sue], courts have been examining standing in cases like these much more closely and dismissing claims like these with greater frequency.

"Even in the cases that survive a motion to dismiss, I expect the question of plaintiff’s standing will be litigated again, perhaps at the summary judgment stage."

Attorney: 'Not every issue or question relating to health or safety is an invitation to litigate'

adam fox squire patton boggs
Adam Fox: 'The Court’s dismissal validates this view and should serve as a cautionary note to plaintiffs that not every issue or question relating to health or safety is an invitation to litigate...'

Adam Fox, partner at Squire Patton Boggs, who predicted​ last year that the plaintiffs in these cases would face an uphill battle, said the dismissals "should serve as a cautionary note to plaintiffs that not every issue or question relating to health or safety is an invitation to litigate."

He added: "There is simply no good evidence—and thus (properly) no allegation—that the trace amounts of heavy metals in the food—and ubiquitous in the environment—are actually harmful. For that same reason, plaintiffs cannot plausibly allege a threat of future injury either, depriving it of standing for either monetary or injunctive relief.

"Given the FDA’s role in regulating food and its public statements about examining the precise issues in this litigation, it is a paradigm case for invoking primary jurisdiction, although the lack of standing ultimately mooted the point."

*RE. Gerber Products Company Heavy Metals Baby Food Litigation 1:21-cv-269 (MSN/JFA) Class Action

** Kimca v. Sprout Foods, Inc Civil Action 21-12977 (SRC) United States District Court, D. New Jersey

*** RE. Plum Baby Food Litigation, Case No. 21-cv-02417 (D.N.J.).

closer-to-zero-FDA

The FDA – which has been under intense pressure to act following the publication of a 2021 Congressional Subcommittee report​​​​​ alleging “dangerous​​” levels of neurotoxic heavy metals in leading baby food brands - has thus far published an action level for inorganic arsenic in infant rice cereal (August 2020​​​), and draft guidance on action levels on lead in juice (April 2022​​​).

Draft guidance on action levels for inorganic arsenic in apple juice, and lead in food intended for babies and young children, will be published by the end of 2022​​,​​ with guidance on mercury and cadmium to follow in 2023 and 2024 under the agency’s ‘Closer to Zero​​’​​ action plan.

Frustrated by this glacial pace, New York Attorney General Letitia James filed a petition​​​ in October 2021 (signed by several other state AGs) calling on the FDA to expedite the process by issuing thresholds based on levels achieved by the ‘best performers’ in the category.

In a letter​​​ denying the petition in May 2022, however, the FDA challenged James’ proposed methodology and said it was inconsistent with federal regulations. A month later, however, James hit back, arguing that FDA regulations governing action levels “do not prescribe any particular methodology” ​​that it is required to follow.

Without your bold and timely leadership to accelerate protective actions by your agencies, American families with young children will be asked to accept this ‘unacceptable’ status quo for several more years," ​she argued.​

US baby food manufacturers continue to largely self-regulate the amount of lead (and other toxic elements) that is contained within their products. Indeed, it remains up to the manufacturers to decide whether even to test their products for these contaminants.”

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