It’s been more than a year since the United States 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). However, the repercussions of the DCM investigation continue. On February 6, KetoNatural Pet Foods filed a proposed class action lawsuit against it. Hill’s Pet Nutrition. The lawsuit alleged that Hill’s and a group of veterinarians worked together to manipulate the FDA into examining the potential of some grain-free dog foods to increase pets’ risk of 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.
“At its core, the case alleges violations of the Lanham Act (our U.S. trademark laws), and specifically its provisions against false or misleading advertising,” said law firm partner Michael Annis. Husch Blackwell, he told Petfood Industry. “The alleged misrepresentations perpetuate and republish allegedly bad work in Hill’s marketing and promotional materials, including publishing it on his website.”
The lawsuit alleges that Hill’s orchestrated the reporting of DCM cases to the FDA using a network of Hill’s-funded veterinary researchers, including scientists at Tufts University. The alleged motivation was to undermine public trust in other pet food brands, including KetoNaturals, which is marketed as low-carb kibble. This conspiracy was allegedly intended to increase Hill’s sales and reverse the erosion of market share by smaller pet food companies.
“The concept of one competitor bringing a Lanham Act lawsuit against another for allegedly misrepresenting the character or quality of your product or your competitors is based on sound legal theory,” Annis said. “The question here is whether the allegations meet the cause of action requirements.”
By urging the FDA to investigate dog foods made with peas, lentils, other legume seeds or potatoes as key ingredients, Annis said the lawsuit suggests Hill’s is trying to add weight to a purported link between some dog food formulations and DCM. He explained this aspectplaintiff’s theory It’s like uploading a ballot box to the FDA’s Center for Veterinary Medicine’s reporting portal. The rush of reports will influence the FDA’s investigation, which can then be communicated to pet owners. The plaintiff’s theory is that the mere existence of an investigation could establish a connection in the minds of consumers between grain-free or non-traditional diets and DCM, even though Hill’s allegedly knew there was no proven link by scientific research.
Reports submitted to the FDA about DCM involved Hill’s Pet Nutrition products until 2013. Even though the company is reporting fewer cases, Hill’s doesn’t appear to have been left out of the FDA’s focus.
KetoNaturals CEO Daniel Schulof told the Petfood industry, “Hill’s has not encouraged research into its own foods.” “At no time did Hill’s or any of its accomplices encourage the FDA to investigate Hill’s products. As FOIA [Freedom of Information Act] The evidence presented with our complaint shows that defendants merely encouraged the FDA to investigate what defendants described as ‘BEG.’ [boutique, exotic, grain-free] foods. And, because they misled the FDA by using randomly selected cases, they got exactly what they wanted – when the FDA announced its research, it did not issue a general warning about canine DCM, only warning pet owners about “canine dilated cardiomyopathy” (DCM), main articles “In dogs that eat certain pet foods that contain peas, lentils, other legume seeds, or potatoes.”
Hill’s is owned by Colgate-Palmolive. According to the Petfood Industry database of leading companies, Hill’s annual revenue in 2022 was approximately $3.713 billion. This annual revenue has made Hill’s the third-largest pet food company on the planet, behind Mars Pet Care and Nestle Purina Petcare.
“In the four years immediately preceding the initiation of the FDA’s investigation, Hill’s lost 20% of its market share,” according to the lawsuit. “In the five years since the investigation began, it has arguably become the fastest-growing pet food company in the country.”
In 2018, Hill’s annual revenue was approximately US$2.318 billion. Four years ago, in 2013, the company’s annual revenue stood at US$2.211 billion.
History of FDA’s DCM investigation
In July 2018, the FDA publicly announced the agency’s investigation into correlations between dog foods and DCM cases. Federal officials have examined reports of DCM in dogs eating certain diets containing peas, lentils, other legume seeds or potatoes as major ingredients, which are more common in formulations labeled as grain-free. A year later, the agency released data from their study stating that 93% of the 524 reported cases of DCM involved dog foods made with peas and/or lentils, and that 90% of affected dogs ate diets labeled as grain-free.
These reports included Hill’s Pet Nutrition products. One of these reports in 2013 involved an 8-year-old Dalmatian eating Hill’s Prescription Diet canned and dry dog food. Another report included Hill’s Ideal Balance Grain-Free Chicken and Potatoes recipe.
FDA received at least 1,382 DCM reports from January 1, 2014, through November 1, 2022. But most of these case reports clustered around the dates of the FDA’s announcements regarding its investigation into correlations between grain-free dog foods and DCM.
Following the announcement by the FDA in June 2019 of the 16 dog food brands associated with DCM cases, those brands experienced declines in sales, Nielsen strategic client partner Natasha Davis said during the Petfood R&D Showcase 2019 at Kansas State University in Manhattan, Kansas.
Many of the 16 brands were small, while others belonged to mid-sized or large companies. Blue Buffalo, for example, ranked sixth on the FDA’s list, with 31 cases of DCM reported among dogs consuming the brand’s products. Acquired by General Mills in 2018 Blue Buffalo. According to the Petfood Industry top companies database, the annual revenue of General Mill’s pet food division in 2022 was approximately $2,300,000,000, making it the fifth largest in the world. Similarly, Diamond Pet Food by Taste of the Wild ranked third on the FDA list with 53 associated DCM cases. Diamond Pet Food had the sixth-highest annual revenue in 2022 at $1,500,000,000 in the Petfood Industry database of leading companies. Merrick, the ninth brand on the FDA list with 16 cases of DCM, was owned by Nestle Purina, the second largest pet food maker on the planet. Pet care.
Looking at grain-free dry dog food sales for 16 brands from mid-July through the first week of October 2019, revenues fell about 10% overall, Davis said. At the same time, sales of other dry dog food also increased, rising from a period of decline in mid-2018 to slightly positive growth in early October 2019.
Despite the impact of the FDA investigation on the pet food market, scientists have not found evidence linking certain diets to cases of DCM. More than 150 published studies have not revealed to researchers any definitive link between cases of dilated cardiomyopathy (DCM) in dogs and grain-free dog food. Veterinarians and others at pet industry consulting agency BSM Partners published their review of existing scientific research on canine nutrition and its relationship to DCM in the Journal of Animal Science.
In December 2022, FDA investigators stated that they did not have sufficient data to establish causality between DCM case reports and pet food products eaten by diseased dogs.
Results of the lawsuit filed by KetoNaturals
lawsuit filed against Hill’s Pet Nutrition Annis noted that an application by KetoNaturals was only filed a week ago, so it’s too early to make any predictions. But the result can have serious consequences. Hill’s Pet Nutrition, scientists named in the lawsuit and KetoNaturals Pet Foods.
If the allegations are determined to be false, veterinary researchers at Tufts University and other institutions may respond. Annis said the lawsuit appears to allege that the veterinarians violated the law and committed a crime of moral turpitude, such as serious fraud, deceit or lying.
“Professional reputation is being questioned here,” he said. “This is the kind of allegation that could ruin someone’s career.”
On the other hand, Annis said that if the allegations are true, many consequences may arise. One of these is the actual damages suffered by the plaintiff and the other brands involved in the class action.
“Whether the claims will meet class action requirements, particularly dominance, will undoubtedly be hotly debated,” he said.
“Class actions carry a number of additional pleading and evidentiary burdens beyond the causes of action,” Annis said. “Two of these are that the claims are subject to common evidence and that there are common questions of fact and law that apply to each plaintiff.
Another possibility is that Hill’s was forced to give up profits illegitimately obtained from alleged bad acts, a process known as corruption.
“Courts have not been consistent on whether there must be a causal relationship between the bad act and the profit sought to be squandered,” Annis said.
Another consequence in false advertising cases could be corrective advertising, he said. Hill’s would have to spend as much money putting the genie back in the bottle as it did to bring it out to the public.
The case is still in its early stages, but both the defendants and the plaintiff appear ready for the fight.
“Hill’s Pet Nutrition “We operate with the highest level of integrity in every aspect of our business.” Hill’s Pet Nutrition spokesperson told Petfood Industry. “We believe the allegations are unfounded and will defend our position vigorously.”
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 enlarge, pumping becomes more difficult and the heart valves may leak, causing fluid to accumulate in the chest and abdomen. DCM often causes congestive heart failure. In cases not linked to genetics, heart function may improve if appropriate veterinary treatment and dietary changes are caught early. Breeds generally more commonly affected by DCM include large and giant breed dogs such as Great Danes, Boxers, Newfoundlands, Irish Wolfhounds, Saint 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, Shih Tzu, Bulldogs and Miniature Schnauzers, as well as mixed breeds.