Lawyer analyzed US$2.6 billion DCM lawsuit against Hill’s Pet Nutrition

The lawsuit alleged that Hill’s and a group of veterinarians worked together to manipulate the FDA into examining the possibility that certain grain-free dog foods increased pets’ risk for the potentially deadly heart disease, dilated cardiomyopathy.

More than a year has passed since the United States Food and Drug Administration (FDA) announced that the agency found insufficient data to establish causality between pet food products and cases of dilated cardiomyopathy (DCM). Nevertheless, the results of the DCM investigation are pending. On February 6, KetoNatural Pet Foods filed a proposed class action lawsuit against Hills Pet Nutrition.

The lawsuit alleges that Hills and a group of veterinarians worked together to manipulate the FDA into investigating the possibility that certain grain-free dog foods increased the risk of heart disease, DCM, in pets. . The plaintiffs are seeking US$2.6 billion in damages from Hills. The lawsuit was filed in the United States District Court for the District of Kansas.

Michael Ennis, partner at law firm Husch Blackwell, told PetFood Industry, “Basically, this case alleges violation of the Lanham Act (our U.S. trademark law) and specifically its provisions that are directed at false or misleading advertising. ” “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 orchestrated the reporting of DCM cases to the FDA using a network of veterinary researchers funded by Hill, including scientists at Tufts University. The alleged motivation was to reduce public confidence in other pet food brands, including KetoNaturals, which is marketed as a low-carbohydrate kibble. The purpose of this conspiracy was allegedly to improve Hill’s sales and reverse the decline of its market share by smaller pet food companies.

Ennis said, “The concept of a lawsuit being filed under the Lanham Act by one competitor against another for allegedly misrepresenting the character or quality of your product or that of your competitors is based on sound legal principle.” “The question here is whether the allegations meet the requirements of a cause of action.”

By prompting the FDA to investigate dog food made with peas, lentils, other legume seeds or potatoes as main ingredients, Ennis said, the lawsuit suggested that Hill’s could be responsible for the alleged link between some dog food formulations and DCM. Was trying to add gravitas to the relationship. He equated this aspect of the plaintiffs’ theory to loading a ballot box onto

the FDA’s Center for Veterinary Medicine reporting portal. The rush of reports will influence the FDA to investigate, which can then be publicized among pet owners. According to the plaintiffs’ theory, the mere existence of an investigation could create an association in consumers’ minds between grain-free or non-traditional diets and DCM, although Hill allegedly knew that no link could be proven by scientific research. Has happened.

Hill’s pet nutrition products were included in reports to the FDA about DCM until 2013. Hill does not appear to have been excluded from the FDA’s focus, although fewer cases were reported with the company.

“Hills did not encourage testing of their own foods,” Daniel Schuloff, CEO of KetoNaturals, told the pet food industry. “At no point did Hill or any of his co-conspirators encourage the FDA to investigate Hill’s products. As the FOIA [Freedom of Information Act] evidence submitted with our complaint shows, the defendants encouraged the FDA to investigate only what the defendants came to

describe as ‘BEG’ [boutique, exotic, grain-free] foods. And, because they encouraged the FDA to use cherry-picked cases Misled, They Got Just What They Wanted – When the FDA announced its investigation, it did not issue any generalized warnings about canine DCM, it only warned pet owners that “peas, lentils as main ingredients “Canine Dilated Cardiomyopathy (DCM) in Dogs Eating Certain Pet Foods Containing , Other Legumes, or Potatoes”.

Hills is owned by Colgate-Palmolive. According to the Database of Top Companies in the Pet Food Industry, Hill’s annual revenue in 2022 was approximately US$3,713 billion. This annual revenue made Hill’s the third largest pet food company on the planet, surpassing Mars Pet Care and Nestle Purina Petcare.

According to the lawsuit, “In the four years immediately before the FDA investigation began, Hill’s lost 20% of its market share.” “In the five years since the investigation began, it has arguably been 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 was US$2,211 billion.

History of FDA investigation of DCM
In July 2018, the FDA publicly announced the agency’s investigation into the relationship between dog food and DCM cases. Federal officials investigated reports of DCM in dogs eating certain diets, particularly those containing peas, lentils, other legumes, or potatoes as main ingredients, which are more common in formulations labeled as grain-free.

ted cases of DCM, involved dog foods made with peas and/or lentils, while 90% of the afflicted dogs had eaten diets labeled as grain-free.

Those reports included Hill’s Pet Nutrition 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 received at least 1,382 reports of DCM from Jan. 1, 2014 to Nov. 1, 2022. However, most of those case reports clustered around the dates of FDA announcements about its investigation of correlations among grain-free dog foods and DCM.

Following the June 2019 FDA announcement of 16 dog food brands correlated to DCM cases, those brands experienced sales declines, said Natasha Davis, strategic client partner with Nielsen, during the Petfood R&D Showcase 2019 at Kansas State University in Manhattan, Kansas.

While several of the 16 brands were small, others were mid-sized or owned by large corporations. For example, Blue Buffalo ranked sixth on the FDA list with 31 cases of DCM reported among dogs consuming the brand’s products. In 2018, General Mills acquired Blue Buffalo. In 2022, General Mill’s annual revenue for its pet food division was approximately US$2,300,000,000

making it the fifth largest in the world, according to Petfood Industry’s top companies database. Similarly, Diamond Pet Food produced Taste of the Wild was third on the FDA list with 53 associated cases of DCM. Diamond Pet Food had the sixth-highest annual revenue on Petfood Industry’s top companies database at US$1,500,000,000 in 2022. The ninth brand on the FDA list with 16 DCM cases, Merrick, was owned by the second largest pet food producer on the planet, Nestle Purina PetCare.

Looking at the 16 brands’ grain-free dry dog food sales from mid-July 2019 through the first week of October, revenues in aggregate decreased about 10%, Davis said. At the same time, other dry dog food sales were increasing, rising from a down period in mid-2018 to slightly positive growth by early October 2019.

Despite the FDA investigation’s effect on the pet food market, scientists didn’t find evidence connecting certain diets to cases of DCM. More than 150 published studies didn’t reveal to researchers any firm connection among cases of canine dilated cardiomyopathy (DCM) and

grain-free dog food. Veterinarians and others with BSM Partners, a pet industry consulting agency, 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 among DCM case reports and pet food products eaten by afflicted dogs.

Ramifications of the lawsuit by KetoNaturals
The lawsuit against Hill’s Pet Nutrition by KetoNaturals was only filed a week ago, so it’s still early to make any predictions, Annis noted. Nevertheless, the outcome could have serious ramifications for Hill’s 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 strike back. The lawsuit seems to allege that the veterinarians violated the law and committed a crime of moral turpitude like serious fraud, deceit or lying, Annis said.

“Professional reputations are being called into question here,” he said. “This is the type of claim that could wreck someone’s career.”

On the other hand, if the allegations are determined to be true, there could be several outcomes, Annis said. One is actual damages suffered by the plaintiff and other brands included in the class action.

“Whether the claims could ever satisfy class action requirements, particularly predominance, will undoubtedly be hotly contested,” he said.

“Class actions carry a number of additional pleading and proof burdens beyond those of the causes of action plead,” Annis said. “Two of which are that the claims are subject to common proofs and there are common questions of fact and law applicable to each plaintiff.

Another possibility is that Hill’s would be required to give up profits illegitimately gained from the alleged bad acts, a process known as disgorgement.

“The courts are not consistent in whether there has to be a causal relation between the bad act and the profit sought to be disgorged,” 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 they spent to get it out in the public domain.

The case is still in its early stages, but both the defendants and the plaintiff seem ready to fight.

“Hill’s Pet Nutrition operates with the utmost integrity in all aspects of our business,” a Hill’s Pet Nutrition spokesperson told Petfood Industry. “We believe the allegations are without merit, and we will defend our position vigorously.”

Canine dilated cardiomyopathy heart disease

DCM affects dogs’ heart muscles. The disease results in an enlarged heart. As the heart and its chambers become dilated, pumping becomes more difficult and heart valves may leak, leading to a buildup of fluids in the chest and abdomen. DCM often results in congestive heart failure. Heart function may improve in cases that are not linked to genetics with appropriate veterinary treatment and dietary modification if caught early. Breeds that are typically more frequently 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, a Shih Tzu, a Bulldog and Miniature Schnauzers, as well as mixed breeds.

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