To explore some of the issues in these cases, FoodNavigator-USA first spoke to Adam Fox, partner at Squire Patton Boggs; and David Kwasniewski, an attorney at BraunHagey & Borden (who are not representing any of the defendants in these cases).
We began by looking at the levels of heavy metals referenced in the lawsuits. To support claims that defendants' brands contain dangerous levels of heavy metals, for example, all of the lawsuits cite test results outlined in the recent congressional report, while some also reference a 2019 report called Healthy Babies, Bright Futures.
But will it be hard for plaintiff’s attorneys – who don’t appear to have done any of their own testing yet – to show that the specific products purchased by their clients contained the same levels of heavy metals referenced in the above reports?
"Other putative class action lawsuits have attempted to base their allegations on third party studies," noted Fox. "But it is a risky strategy because the failure of the studies to be precisely on point, to follow a robust scientific method, and to rule out potential limitations can potentially doom the plaintiffs’ case."
Kwasniewski added: "Plaintiffs’ attorneys’ failure to conduct their own testing could easily prove fatal to their claims, particularly because it is entirely unclear what trace amounts of heavy metals consumers would tolerate in food."
'Virtually everything that grows in the ground or breathes the air will accumulate some small amount of heavy metals'
As for the argument that consumers paid over the odds for the baby foods in question (which is relevant when trying to determine potential damages), said Kwasniewski, "Virtually everything that grows in the ground or breathes the air will accumulate some small amount of heavy metals. This will make it challenging for plaintiffs to proceed on a price premium theory, because there will be no comparator product that is completely free of heavy metals."
Fox added: "[The complaints] also suggest that the plaintiffs relied on the absence of any disclosure about the trace amounts [of heavy metals] at issue when making purchases, and that comparable products which actually lack them were both less expensive and alternatives that the plaintiffs would have chosen."
And neither of these things will be easy to prove, he said.
'The heavy metal levels set for other foods or beverages will not have much relevance'
So what about the point - made in several of the lawsuits - that the levels of heavy metals in some of the baby foods at issue greatly exceeded thresholds set for other FDA-regulated products,** such as bottled water?
Kwasniewski argued: "The heavy metal levels set for other foods or beverages will not have much relevance.
"Chemicals dissolved in water or juice are absorbed by the body very differently than heavy metals in food, which are typically bound up with complex carbon ligands that make it less likely for them to be absorbed by the body. On top of that, infants process chemicals differently than adults. Evaluating what levels of heavy metals are safe for infants will require a complex scientific analysis, not simply a crude analogy to standards developed for different products consumed by different categories of people."
Ultimately, said Fox, "if a case like this were to reach the merits phase, plaintiffs would need to prove that a significant amount of actual consumers made their purchasing decisions on some unstated assumption about what was in - or not in - the baby food. These FDA standards most likely play no role in those consumer impressions as most consumers have no idea what standards FDA has set."
Asked about the fact that some baby food companies are alleged to have ignored their own internal standards for some of these metals, Kwasniewski said this is "unlikely to be of much relevance." Even if these guidelines "borrowed standards from other laws such as California’s Proposition 65, they are not authoritative," he added.
'It strikes me as a silly argument'
Finally, we looked at the argument that a reasonable consumer would not expect baby foods advertised as wholesome and nutritious or organic to contain any toxic heavy metals, an argument that has not made much headway in lawsuits over trace levels of glyphosate residue in oatmeal and snack bars.
Is this argument likely to hold up given that the FDA says heavy metals “cannot be completely avoided in the fruits, vegetables, or grains that are the basis for baby foods, juices, and infant cereals made by companies or by consumers who make their own foods” or is it potentially a critical argument if it can be supported by consumer survey data?
It's not a very compelling argument, claimed Kwasniewski: "No consumer could reasonably believe a product is completely free of even trace amounts of heavy metals, since they are present in at least small amounts in virtually all foods."
Fox added: "It strikes me as a silly argument. It is unreasonable for consumers to expect that a food product made from whole foods (fruits, vegetables, grains, etc.) will somehow be 'purified' so that the trace contaminants ubiquitous in the modern world will somehow disappear."
Plaintiff's attorney: 'Often the FDA’s silence or inaction on an issue is where consumer class actions can come in...'
So what do plaintiff's attorneys say?
Annick Persinger, partner at law firm Tycko & Zavareei LLP, who is representing plaintiff Mattia Doyle in a proposed class action lawsuit* against Beech-Nut Nutrition Co, said it was reasonable to reference thresholds set for other products, as the authors of the Congressional committee report had done.
While bottled water is not the same as baby food, she acknowledged, “I think those thresholds are still relevant."
“These levels [found in baby foods cited in the congressional committee report] exceed other barometers ... and the fact that the FDA is silent on an issue [ie. it hasn't yet set upper limits for lead, mercury, cadmium in baby food] does not mean that there isn’t a serious risk.
“The FDA is limited in what it has time and ability to do; often the FDA’s silence or inaction on an issue is where consumer class actions can come in and pick up some of that burden.”
'I don’t think anyone would expect dangerous neurotoxins in baby food marketed for the first year of life'
While courts have not been particularly receptive to lawsuits over trace levels of pesticide residues in foods, the issue of heavy metals in baby food is different, even though the FDA says said that heavy metals “cannot be completely avoided,” argued Persinger.
“I think that this is a different situation especially based on the findings in the Healthy Babies, Bright Futures report and the recent Congressional report that really document the dangers to neurological development for this very vulnerable group of infants in their first year. I think that having words like ‘naturals’ in the name also just adds insult to injury.
“These products are being marketed to young Millennials with young children and I don’t think anyone would expect dangerous neurotoxins in baby food marketed for the first year of life.”
But what are the ‘safe levels’ to which Beech-Nut and other baby food brands should adhere? “This will require expert consultation and testimony,” she said. “But I think the other foods that are regulated [water, juice, candy,etc] are a good barometer to start with.”
Beech-Nut’s “internal guidelines of 3,000 ppb for cadmium and 5,000 ppb for lead for certain ingredients… far surpass any existing regulatory standard in existence and toxic heavy metal levels for any other baby food manufacturer that responded to the Subcommittee’s inquiry,” according to the Congressional report, added Persinger.
According to the report, she said, Beech-Nut also tested and used 57 ingredients that contained over 20 ppb lead, the EU’s standard for lead in infant formula, and accepted 89 ingredients that tested at or over 15 ppb lead, EPA’s action level for drinking water, and 483 ingredients that tested at or over 5 ppb lead, FDA’s standard for lead in bottled water.
'At this point in the process, we don’t have to wed ourselves to a damages theory'
Asked about the damages model, Persinger said: “If a jury finds that these products are dangerous, then these products are not just sold at a premium, and worth less than what was paid; they are potentially worthless to the parents that brought them.”
But she added: “At this point in the process, we don’t have to wed ourselves to a damages theory.”
Beech-Nut: 'Heavy metals are in the soil and water and become part of crops as they grow'
Beech-Nut Nutrition told FoodNavigator-USA that it does “not comment on pending litigation,” but a spokesperson added: “We want to reassure parents that Beech-Nut products are safe and nutritious. We are currently reviewing the subcommittee report. We look forward to continuing to work with the FDA, in partnership with the Baby Food Council, on science-based standards that food suppliers can implement across our industry.”
In a December 2019 letter to the Congressional subcommittee, Beech-Nut Nutrition president Mark Rodriguez said Beech-Nut supported “all science-based and risk-based standards for heavy metals in all foods,” but noted that “addressing the issue at the soil level will take time.”
He also noted that “funding of studies through the USDA would be one way to close the knowledge gaps and lower the levels and risks to infants.”
He added: “Heavy metals are in the soil and water and become part of crops as they grow; these substances cannot be avoided by making foods at home or switching to organic products.”
What happens next?
Since the Congressional Subcommittee report was published on Feb. 4, Gerber, Beech Nut Nutrition, Campbell Soup (Plum Organics), Nurture Inc (Happy Family Organics) and Hain Celestial (Earth’s Best) have all been hit with lawsuits alleging violations of state consumer protection laws, while New York attorney general Letitia James has written to the FDA urging it to set limits for toxic metals across all baby foods.
As the lawsuits pile up, said Kwasniewski, "It’s very common for serial class actions to be consolidated. But given the number of cases filed across the country, they may be a candidate for multi-district litigation ('MDL'), in which all the cases against certain defendants are consolidated before just one court. That one court will then oversee all phases of the litigation, including by selecting a few 'bellwether' cases to push towards trial."
*The case is Doyle v. Beech-Nut Nutrition Corp., Inc. 1:21-cv-00186 filed in the US District Court for the Northern District of New York. It alleges violations of California’s False Advertising Law, Unfair Competition Law, and Legal Remedies Act; New Jersey’s Consumer Fraud Act; and breach of warranty, fraudulent misrepresentation, fraud by omission, negligent misrepresentation, and unjust enrichment.
According to the complaint, Beech-Nut Nutrition’s “claims that the baby foods are natural, nutritious, quality, pure, healthy, and safe for consumption by babies are literally false and likely to deceive the public.”
** The FDA has set maximum allowable levels in bottled water at 10 ppb inorganic arsenic, 5 ppb lead, and 5 ppb cadmium, while the EPA has capped the allowable level of mercury in drinking water at 2 ppb. The FDA has also set limits on lead in juice [50ppb], and candy [0.1ppm], and has proposed a 100ppb limit on inorganic arsenic in infant rice cereals. However, it has not set upper limits for lead, mercury or cadmium in baby food.
- Baby food brands defend protocols as congressional report alleges ‘highly dangerous’ levels of heavy metals in infant foods; expect lawsuits, says attorney
- Heavy metals in baby food: How should the food industry respond?
- ‘The agency has failed to adequately regulate baby food…’ NY attorney general urges FDA to set standards for heavy metals
- And now the lawsuits… Plum, Gerber, Beech-Nut, Hain, hit with class actions in wake of report on heavy metals in baby food
- FDA weighs in on heavy metals in baby food as lawsuits pile up
In a statement released Feb. 16, 2021, the FDA explained that heavy metals such as lead and arsenic “are present in the environment and may enter the food supply through soil, water or air” and therefore “cannot be completely avoided in the fruits, vegetables, or grains that are the basis for baby foods, juices, and infant cereals made by companies or by consumers who make their own foods [the latter is an important point as some consumers have responded to the recent headlines by assuming making their own baby food will resolve the issue].”
They also “cannot be completely avoided by using organic farming practices,” added the agency. “Our goal is to reduce exposure to toxic elements in foods to the greatest extent feasible and to further advance progress in this area through more research and enhanced collaboration among stakeholders.”
FDA scientists “routinely monitor levels of toxic elements in baby foods, along with other foods consumed in the country’s diet, through the Total Diet Study, the compliance program for Toxic Elements in Food and Foodware, and Radionuclides in Food and through targeted sampling assignments," said the agency.
For example, FDA sampling of infant rice cereal since 2011 has shown that manufacturers have made significant progress in reducing arsenic in infant rice cereal products through selective sourcing and testing of rice and rice-derived ingredients such as rice flour.
However, it has not said whether it agrees with the characterization of the levels of heavy metals allegedly in some of the baby foods cited in the congressional report as “highly dangerous,” and has not said what levels of mercury, lead, or cadmium it considers to be too high in baby food, presenting challenges for firms facing lawsuits as there is no federal 'safe harbor' level to point to that is specific to baby food (with the exception of 2020 guidance on inorganic arsenic in infant rice cereal, set at 100ppb).