by More than a year has passed since the United States Food and Drug Administration (FDA) announced that the agency did not receive sufficient data to establish causality among pet food products and cases of dilated cardiomyopathy (DCM). However, the consequence of the DCM investigation continues. On February 6, KetoNatural Pet Foods filed a proposed class action lawsuit against him Hill Pet Nutrition. The lawsuit alleges that Hill’s and a group of veterinarians worked together to manipulate the FDA into examining the possibility that certain grain-free dog foods may increase a pet’s risk for the heart disease, DCM. The plaintiff seeks US$2.6 billion in damages from Hill’s. The lawsuit was filed in the United States District Court for the District of Kansas.
“Dear, the case alleges violations of the Lanham Act (our US trademark statutes), and specifically its provisions aimed at false or misleading advertising,” Michael Annis, a partner at a law firm. Husch Blackwell, Petfood Industry said. “The alleged false statements are perpetuating and republishing the allegedly bad studies in Hill’s marketing and promotional materials, including postings on its website.”
The lawsuit alleges that Hill directed the reporting of DCM cases to the FDA using a network of veterinary researchers funded by Hill’s, including scientists at Tufts University. The alleged motivation was to undermine public confidence in other pet food brands, including KetoNaturals, which are marketed as low-carbohydrate kibble. This conspiracy was allegedly intended to improve Hill’s sales and reverse the erosion of its market share by smaller pet food companies.
“The concept of one competitor filing a lawsuit under the Lanham Act against another competitor for allegedly misrepresenting the character or quality of your product or a competitor’s product is based on a sound legal theory,” Annis said. . “The question here is whether the allegations meet the requirements for the reasons for the plea.”
By initiating the FDA’s investigation of dog foods made with peas, lentils, other legume seeds or potatoes as primary ingredients, the lawsuit suggested that Hill’s was trying to add gravitas to the supposed link among some dog food formulations and DCM, said Annis. He described this aspect of tplaintiff’s theory such as loading the ballot box at the FDA Center for Veterinary Medicine reporting portal. The rush of reports would influence the FDA to investigate, which could then be made public to pet owners. An investigation could have directly drawn a link in the minds of consumers between grain-free or non-traditional diets and DCM, even though Hills knew that scientific research had not proven any link, according to the plaintiff’s theory.
Reports to the FDA about DCM included Hill’s Pet Nutrition products as far back as 2013. Hill’s doesn’t appear to have been excluded from the FDA’s focus, even though the company had fewer reported cases.
“Hill’s did not initiate an investigation into its own foods,” Daniel Schulof, CEO of KetoNaturals, told the Petfood industry. “Hill’s or any of its co-conspirators never encouraged the FDA to investigate Hill’s products. As the FOIA [Freedom of Information Act] evidence submitted to our complaint shows, the defendants only encouraged the FDA to investigate what the defendants described as ‘BEG’ [boutique, exotic, grain-free] foods. And, because they misled the FDA using cherry-picked cases, they got exactly what they wanted – when the FDA announced its investigation, it didn’t issue a generalized warning about canine DCM, it just pet owners are aware of “canine dilated cardiomyopathy. DCM) in dogs that eat certain pet foods containing peas, lentils, other legume seeds, or potatoes as primary ingredients.”
Hill’s is owned by Colgate-Palmolive. In 2022, Hill’s annual revenue would be approximately US$3,713 billion, according to the Petfood Industry top companies database. This annual revenue made Hill the third largest pet food company on the planet, trailing Mars Pet Care and Nestle Purina Petcare.
“In the four years immediately preceding the launch of the FDA investigation, Hill lost 20% of its market share,” according to the lawsuit. “In the five years since the investigation began, it has become arguably the fastest growing pet food company in the country.”
In 2018, Hill’s annual revenue was approximately US$2,318 billion. Four years earlier, in 2013, the company’s annual revenue was US$2,211 billion.
History of FDA investigation of DCM
In July 2018, the FDA publicly announced the agency’s investigation into correlations between dog foods and cases of DCM. Federal authorities examined DCM reports of dogs eating certain diets, particularly those containing peas, lentils, other leguminous seeds, or potatoes as primary ingredients, which were more common in formulations labeled as cereal grains. A year later, the agency released data from their investigation that said 93% of the 524 DCM cases reported involved dog foods made with peas and/or lentils, and 90% ate of the dogs fed diets labeled as grain-free.
These reports included Hill Pet Nutrition products. One of these reports from 2013 involved an 8-year-old Dalmatian who ate canned Hill’s Prescription Diet u/d and dry dog food. Another report was about Hill’s Ideal Balance Free Chicken and Potatoes recipe.
The FDA received at least 1,382 reports of DCM from January 1, 2014 to November 1, 2022. However, most of those case reports were clustered around the dates of FDA announcements about its investigation into correlations between cheap dog foods from grain and DCM.
After the FDA’s June 2019 announcement that 16 dog food brands were correlated with DCM cases, sales of those brands declined, said Natasha Davis, strategic client partner at Nielsen, during the 2019 Petfood R&D Show at Kansas State University in Manhattan, Kansas .
While some of the 16 brands were small, others were medium-sized or owned by large corporations. For example, Blue Buffalo was sixth on the FDA list with 31 reported cases of DCM among dogs consuming the brand’s products. In 2018, General Mills received Blue buffalo. In 2022, General Mill’s annual revenue for its pet food division will be approximately US$2,300,000,000 making it the fifth largest in the world, according to the Petfood Industry top companies database. Similarly, Taste of the Wild produced by Diamond Pet Food was third on the FDA list with 53 DCM related cases. Diamond Pet Food had the sixth highest annual revenue on the Petfood Industry top companies database at US$1,500,000,000 in 2022. The ninth brand on the FDA list with 16 DCM cases, Merrick, is owned by the second largest pet food producer in the world , Nestle Purina. PetCare.
Looking at sales of grain-free dry dog food for the 16 brands from mid-July 2019 through the first week of October, aggregate revenue declined about 10%, Davis said. At the same time, there was an increase in sales of other dry dog food, rising from a down period in mid-2018 to slightly positive growth by the end of October 2019.
Despite the effect of the FDA’s investigation into the pet food market, scientists have not found evidence linking certain diets to cases of DCM. More than 150 published studies have revealed to researchers no solid link between cases of canine dilated cardiomyopathy (DCM) and grain-free dog food. Vets and others with BSM Partners, a pet industry consulting agency, published their review of current scientific research on dog nutrition and its relationship to DCM in the Journal of Animal Science.
In December 2022, FDA investigators stated that they did not have enough data to establish causality among case reports of DCM cheese and pet food products consumed by dogs with the complication.
Legal opinions at KetoNaturals
The law against Hill Pet Nutrition at KetoNaturals filed only a week ago, so it is still early to make any predictions, Annis noted. However, the result could have serious consequences Hill Pet Nutrition, the scientists named in the lawsuit and KetoNaturals Pet Foods.
If the allegations are ruled false, the veterinary researchers at Tufts University and other institutions could go on strike. The lawsuit appears to allege the vets broke the law and committed a crime of moral turpitude such as aggravated fraud, fraud or perjury, Annis said.
“Professional reputations are being questioned here,” he said. “This is the kind of claim that could destroy someone’s career.”
On the other hand, if the allegations are found to be true, there could be several consequences, Annis said. One is actual damages suffered by the plaintiff and other brands included in the class action.
“Whether the claims could satisfy the requirements of a class action, particularly sovereignty,” he said, will certainly be contested.
“Class actions carry some additional burden of pleading and proof than pleading causes,” Annis said. “Two of them are that the claims are subject to common proof and that common questions of fact and law are applicable to all plaintiffs.
Another possibility is that Hill’s would have to give up ill-gotten gains from the alleged wrongdoing, a process known as disgorgement.
“The courts are not consistent as to whether there must be a causal relationship between the bad act and the profit sought to be disgraceful,” Annis said.
Corrective advertising can be a different outcome in cases of false advertising, he said. The Hill’s would have to spend as much to put the genie back in the bottle as they spent to get it out in public.
The case is still in its early stages, but both the defendants and the plaintiff seem ready to fight.
“Hill Pet Nutrition works with complete integrity in all aspects of our business,” a Hill Pet Nutrition said a spokesman for Petfood Industry. “We believe the allegations are without merit, 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 become narrowed, pumping becomes more difficult and heart valves may leak, causing fluid to build up in the chest and abdomen. DCM often leads to congestive heart failure. Heart function in cases not linked to genetics may improve with appropriate veterinary treatment and dietary modification if caught early. Breeds 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, with the exception of American and English Cocker Spaniels. Cases reported to the FDA included Golden and Labrador Retrievers, Whippets, Shih Tzu, Bulldog and Miniature Schnauzers, as well as mixed breeds.
