More than a year has passed since the U.S. Food and Drug Administration (FDA) announced that the agency had found insufficient data to establish causality between pet food products and cases of dilated cardiomyopathy (DCM). Yet the consequences of the DCM investigation continue. On February 6, KetoNatural Pet Foods filed a proposed class action lawsuit against Hill’s Pet Food. The lawsuit alleged that Hill’s and a group of veterinarians worked together to manipulate the FDA into investigating the possibility that certain grain-free dog foods increased pets’ risk of the heart disease DCM. The plaintiff is seeking $2.6 billion in damages from Hill’s. The lawsuit was filed in the United States District Court for the District of Kansas.
“Fundamentally, the case involves violations of the Lanham Act (our U.S. trademark statute), and in particular its provisions targeting false or misleading advertising,” said Michael Annis, partner at law firm. Husch Blackwell, said Petfood Industry. “The alleged false statements perpetuate and republish the allegedly bad research in Hill’s marketing and promotional materials, including posting on its website.”
The lawsuit alleges that Hill’s orchestrated the reporting of DCM cases to the FDA using a network of veterinary researchers funded by Hill’s, including scientists from Tufts University. The alleged motivation was to undermine public confidence in other pet food brands, including KetoNaturals, which is marketed as low-carb kibble. This conspiracy was allegedly intended to improve Hill’s sales and counter the erosion of its market share by smaller pet food companies.
“The concept of bringing a lawsuit under the Lanham Act by one competitor against another for allegedly misrepresenting the character or quality of your or your competitors’ product is based on sound legal theory ,” said Annis. “The question here is whether the allegations meet the requirements for trial.”
By pushing the FDA to investigate dog foods made with peas, lentils, other legume seeds or potatoes as main ingredients, the lawsuit suggested that Hill’s was trying to add gravitas to the supposed link between some dog food formulations and DCM, Annis said. He described this aspect of tthe plaintiff’s theory similar to loading the ballot box on the FDA’s Center for Veterinary Medicine reporting portal. The flurry of reports would prompt the FDA to launch an investigation, which could then be disclosed to pet owners. The mere existence of a study could create a link in the minds of consumers between grain-free or non-traditional diets and DCM, although Hill’s reportedly knew that no link had been proven by scientific research, according to the plaintiff’s theory .
Reports to the FDA about DCM included Hill’s Pet Nutrition products as early as 2013. Hill’s does not appear to have been excluded from the FDA’s focus, although the company had reported fewer cases.
“Hill’s did not encourage an investigation into its own foods,” Daniel Schulof, CEO of KetoNaturals, told the Pet Food Industry. “At no time did Hill’s or any of its co-conspirators ever encourage the FDA to investigate Hill’s products. Like FOIA [Freedom of Information Act] The evidence submitted in our complaint shows that Defendants merely encouraged the FDA to investigate what Defendants came to describe as “BEG.” [boutique, exotic, grain-free] foods. And because they tricked the FDA using hand-picked cases, they got exactly what they wanted: When the FDA announced its investigation, it did not issue a blanket warning about DCM in dogs, but merely warned pet owners about “canine dilated cardiomyopathy.” . DCM) in dogs eating certain pet foods containing peas, lentils, other legume seeds or potatoes as main ingredients.”
Hill’s is owned by Colgate-Palmolive. According to the database of Petfood Industry’s top companies, Hill’s annual revenue was approximately $3,713 billion in 2022. These annual sales made Hill’s the third largest pet food company in the world, behind Mars Pet Care and Nestle Purina Petcare.
“In the four years immediately preceding the launch of the FDA investigation, Hill’s lost 20% of its market share,” the lawsuit said. “In the five years since the survey began, it may be the fastest growing pet food company in the country.”
In 2018, Hill’s annual revenue was approximately $2,318 billion. Four years earlier, in 2013, the company’s annual revenue was $2,211 billion.
History of the FDA Investigation of DCM
In July 2018, the FDA publicly announced the agency’s research into the correlations between dog food and DCM cases. Federal authorities investigated reports of DCM in dogs eating certain diets, especially those with peas, lentils, other legume seeds or potatoes as the main ingredient, which were more common in formulations labeled as grain-free. A year later, the agency published data from their study showing that 93% of the 524 reported cases of DCM involved dog food made with peas and/or lentils, while 90% of affected dogs had eaten diets labeled as grain-free.
Those reports included Hill’s Pet Food Products. One of these reports from 2013 involved an 8-year-old Dalmatian eating Hill’s Prescription Diet u/d canned and dry dog food. Another report involved Hill’s Ideal Balance Grain Free Chicken and Potato recipe.
The FDA has received at least 1,382 reports of DCM between January 1, 2014 and November 1, 2022. However, most of these case reports were clustered around the dates of FDA announcements about its research into the correlations between grain-free dog food and DCM.
Following the FDA’s June 2019 announcement of 16 dog food brands linked to DCM cases, those brands experienced a decline in sales, Nielsen strategic client partner Natasha Davis said at the 2019 Petfood R&D Showcase at Kansas State University in Manhattan, Kansas .
While several of the sixteen brands were small, others were mid-sized brands or owned by large companies. For example, Blue Buffalo ranked sixth on the FDA list with 31 cases of DCM reported in dogs consuming the brand’s products. General Mills took over in 2018 Blue Buffalo. In 2022, General Mill’s annual sales for its pet food division were approximately US$2,300,000,000, making it the fifth largest in the world, according to the Petfood Industry database. Similarly, Taste of the Wild produced by Diamond Pet Food was third on the FDA list with 53 associated cases of DCM. Diamond Pet Food had the sixth highest annual sales in the Petfood Industry database at $1,500,000,000 in 2022. The ninth brand on the FDA list with 16 cases of DCM, Merrick, was owned by the second largest pet food manufacturer in the world , Nestle Purina. Animal care.
Looking at sales of grain-free dry dog food from the 16 brands from mid-July 2019 through the first week of October, sales fell by about 10% overall, Davis said. At the same time, sales of other dry dog food increased, from a period of decline in mid-2018 to slightly positive growth in early October 2019.
Despite the effect of the FDA investigation on the pet food market, scientists have found no evidence linking certain diets to cases of DCM. In more than 150 published studies, researchers have found no clear link between cases of canine dilated cardiomyopathy (DCM) and grain-free dog food. Veterinarians and others from BSM Partners, a pet industry consulting firm, published their review of existing scientific research on dog nutrition and its relationship to DCM in the Journal of Animal Science.
In December 2022, FDA investigators stated that they had insufficient data to establish causality between DCM case reports and pet food products eaten by affected dogs.
Consequences of the lawsuit by KetoNaturals
The lawsuit against Hill’s Pet Food by KetoNaturals was only filed a week ago, so it’s still early to make predictions, Annis noted. Nevertheless, the outcome could have serious consequences Hill’s Pet Food, the scientists named in the lawsuit and KetoNaturals Pet Foods.
If the allegations are proven false, veterinary researchers at Tufts University and other institutions could strike back. The lawsuit appears to allege that the vets broke the law and committed a crime of moral turpitude, such as aggravated fraud, deceit or lying, Annis said.
“The professional reputation here is being called into question,” he said. “This is the kind of claim that could destroy someone’s career.”
On the other hand, if the allegations are determined to be true, there could be different outcomes, Annis said. One of these concerns the actual damages suffered by the plaintiff and other brands involved in the class action.
“Whether the claims could ever meet the requirements of a class action, particularly on dominance, will undoubtedly be hotly contested,” he said.
“Class actions carry a number of additional pleading and evidentiary burdens beyond those of the pleadings,” Annis said. “Two are that the claims are subject to common evidence and that there are common questions of fact and law that apply to each claimant.
Another possibility is that Hill’s would be required to give up profits ill-gotten from the alleged bad acts, a process known as “disgorgement.”
“The courts are inconsistent when it comes to whether there must be a causal link between the bad act and the intended gain,” Annis said.
Another outcome in false advertising cases can be corrective advertising, he said. Hill’s would have to spend as much to put the genie back in the bottle as it did to get it into the public domain.
The case is still in its early stages, but both the defendants and the plaintiff appear ready to fight.
“Hill’s Pet Food operates with the utmost integrity in all aspects of our business,” said one Hill’s Pet Food spokesperson told Petfood Industry. “We believe the allegations are unfounded and we will vigorously defend our position.”
Canine dilated cardiomyopathy heart disease
DCM affects the heart muscles of dogs. The disease results in an enlarged heart. As the heart and its chambers widen, pumping becomes more difficult and the heart valves may leak, leading to a build-up of fluid in the chest and abdomen. DCM often results in congestive heart failure. Heart function can improve in cases not related to genetics, with proper veterinary treatment and dietary adjustments if caught early. Breeds that tend to be more commonly affected by DCM include large and giant breed dogs such as Great Danes, Boxers, Newfoundlands, Irish Wolfhounds, St. Bernards, and Doberman Pinschers. It is less common in small and medium breed dogs, except American and English Cocker Spaniels. Cases reported to the FDA included Golden and Labrador Retrievers, Whippets, a Shih Tzu, a Bulldog and Miniature Schnauzers, as well as mixed breeds.