Class action lawsuits may not results from cases of canine dilated cardiomyopathy (DCM) correlated to certain grain-free dog foods, although the potential exists. Pet food industry lawyer, Michael Annis, partner with Husch Blackwell, pointed out four reasons why prosecutors may have a hard time presenting a successful case against pet food companies related to DCM, even the 16 dog food brands named by the U.S. Food and Drug Administration in an update to the agency’s investigation of DCM’s connection to grain-free dog foods.
“There is the potential this could turn into a class action or series of class actions – but we think there will need to be good science that links the term to a purchasing decision and to the disease process,” Annis told Petfood Industry in an email.
“It is not uncommon for those folks who file class action cases to watch the regulatory bodies to help them identify when regulatory guidance, procedure or rules have arguably been violated and then determine whether they can turn those into a claim for false advertising, breach of warranty or the like,” he said. “And consumers, special interest groups and plaintiffs’ counsel do pay attention to FDA actions when deciding to file lawsuits. But we think this area will likely be difficult for them to formulate a viable claim on the product safety side of things (not that they won’t try). We think the key issues that relate to that area:
- FDA has not identified a violation of the FDCA by any of the brands included in the report.
- No recalls have been initiated, and FDA has stated very clearly that FDA does not have definitive information that the pet foods need to be removed from the market, nor has FDA mandated any marketing or product formulation changes. A recall would change the calculus in a hurry.
- The report doesn’t provide any specific scientific findings that link nutrition, the brands identified, and DCM.
- Additionally, the report indicates that the causes of DCM are unknown and there are a variety of factors in addition to diet that may cause the disease (genetic predisposition, taurine deficiency, etc.).
“At this point, on the safety side, things aren’t as cut and dry as an illness caused by contamination of the product from a pathogen or chemical and then a pet falling ill,” Annis said. “Time will tell if there could be any claims related to the safety of the foods. And that will need to be shown/proven/linked by sound science.
“The brands identified are no doubt more vulnerable to suit – particularly on the labeling and marketing end of things, each dependent upon what types of claims are included on each product. That said, we don’t see a way to base those claims on a violation of an FDA regulation at this time, and do not believe AAFCO has a definition or guidelines for ‘healthy’ claims (unlike their guidelines for ‘natural’ and ‘human-grade’ claims).
No causation found between dog food ingredients and DCM
While the FDA has found correlations between certain grain-free dog foods and DCM, they have found no causality. Thousands of dogs have eaten the same diets as the dogs stricken with DCM without becoming ill. FDA lab analysis of grain-free versus conventional dog foods revealed little difference in levels of minerals, amino acids, taurine, protein or other nutrients.
“Another puzzling aspect of the recent spike in DCM cases is that they have occurred just in the last few years,” wrote FDA officials in the update. “The FDA is working with the pet food industry to better understand whether changes in ingredients, ingredient sourcing, processing or formulation may have contributed to the development of DCM."
History of FDA investigation into DCM and grain-free dog food
In July 2018, the U. S. Food and Drug Administration alerted pet owners and veterinary professionals about reports of canine dilated cardiomyopathy (DCM) in dogs eating certain pet foods containing peas, lentils, other legume seeds, or potatoes as main ingredients. High levels of legumes or potatoes appear to be more common in diets labeled as “grain-free,” but it is not yet known how these ingredients are linked to cases of DCM.
These reports are unusual because DCM is occurring in breeds not typically genetically prone to the disease. The FDA’s Center for Veterinary Medicine and the Veterinary Laboratory Investigation and Response Network, a collaboration of government and veterinary diagnostic laboratories, are investigating this potential association.
Diets in cases reported to the FDA frequently list potatoes or multiple legumes such as peas, lentils, other “pulses” (seeds of legumes), and their protein, starch and fiber derivatives early in the ingredient list, indicating that they are main ingredients. Early reports from the veterinary cardiology community indicate that the dogs consistently ate these foods as their primary source of nutrition for months to years.
In the reports the FDA has received, some of the dogs showed signs of heart disease, including decreased energy, cough, difficulty breathing and episodes of collapse. Medical records for four atypical DCM cases, three Golden Retrievers and one Labrador Retriever, show that these dogs had low whole blood levels of the amino acid taurine. Taurine deficiency is documented as potentially leading to DCM.
