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

It has been more than a year since the US Food and Drug Administration (FDA) announced the agency found insufficient data to establish causality between animal food products and cases of dilated cardiomyopathy (DCM). Still, the repercussions of the DCM investigation continue. On February 6, KetoNatural Pet Food deposited a class action proposal 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 potential that certain grain-free dog foods increase the pet’s risk of heart disease, DCM. The plaintiff is seeking 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 heart, the case alleges violations of the Lanham Act (our US trademark statute), and specifically its provisions that are directed at false or misleading advertising,” Michael Annis, partner at the lawyer Husch Blackwell, said Petfood Industry. “The alleged false statements perpetuate and republish the allegedly bad studies 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 trust 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 reverse the erosion of its market share by smaller pet food companies.

“The concept of filing a lawsuit under the Lanham Act by one competitor against another for misrepresenting the character or quality of your product or that of your competitors is grounded in sound legal theory,” Annis said. . “The question here is whether the allegations meet the requirements for causes of action.”

By urging the FDA to investigate dog foods made with peas, lentils, other vegetable seeds or potatoes as main ingredients, the lawsuit suggested that Hill’s was attempting to add gravitas to the supposed connection between some dog food formulations and DCM , said Annis. It was a kind of charge of the urn The FDA’s Center for Veterinary Medicine reporting portal to get involved in an investigation and then publicize the investigation to pet owners. This investigation would make a link in the minds of consumers between grain-free or non-traditional diets and DCM, although Hill’s knew that there was no link proven by scientific research.

Reports to the FDA on DCM included Hill’s Pet Nutrition products until 2013.

“Hill’s did not encourage an investigation of its own foods,” Daniel Schulof, CEO of KetoNaturals, told the Petfood industry. “At no point did Hill’s or any of his co-conspirators ever encourage the FDA to investigate Hill’s products. Like the FOIA [Freedom of Information Act] The evidence submitted with our complaint shows, the defendants only encouraged the FDA to investigate what the defendants would describe as “BEG”. [boutique, exotic, grain-free] food And, because they tricked the FDA with cherry-picked cases, they got exactly what they wanted—when the FDA announced its investigation, it didn’t issue a blanket alert about canine DCM, it only notified dog owners. animals on “canine dilated cardiomyopathy”. DCM) in dogs that eat certain pet foods that contain peas, lentils, other vegetable seeds, or potatoes as main ingredients.”

Hill’s is owned by Colgate-Palmolive. In 2022, Hill’s annual revenue was about 3.713 billion US dollars, according to the Petfood Industry. database of leading companies. This annual revenue made Hill’s the third largest pet food company on the planet, after Mars Pet Care and Nestle Purina Petcare.

“In the four years immediately prior to the launch of the FDA investigation, Hill lost 20% of its market share,” according to the lawsuit. “In the five years since the survey began, it has arguably been 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 investigation into correlations between dog foods and cases of DCM. Federal authorities investigated reports of DCM in dogs eating certain diets, particularly those containing peas, lentils, other vegetable seeds, or potatoes as main ingredients, which were more common in formulations labeled as without wheat. A year later, the agency released data from its investigation which stated that 93% of the 524 reported 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 include Hill’s Pet Nutrition products One such report from 2013 involved an 8-year-old Dalmatian who was 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 since January. 1, 2014 to November 1, 2022. However, most of those case reports clustered around the dates of FDA announcements about their investigation of correlations between grain-free dog foods and DCM.

Following the June 2019 FDA announcement of the 16 brands of dog food related to more DCM cases, those brands experienced sales declinessaid Natasha Davis, strategic client partner Nielsenduring the 2019 Petfood R&D Showcase at Kansas State University in Manhattan, Kansas.

While many of the 16 brands were small, others were medium-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 about US$2,300,000,000, making it the fifth largest in the world, according to the Petfood Industry. database of leading companies. In the same way, Diamond Pet Food produced Taste of the Wild was third on the FDA list with 53 associated cases of DCM. Diamond Pet Food had the sixth highest annual revenue on the database of Petfood Industry companies at US$ 1,500,000,000 in 2022. The ninth brand on the FDA list with 16 DCM cases, Merrick , was the second largest pet food producer on the planet. Nestle Purina PetCare.

Looking at sales of 16 brands of grain-free dry dog ​​food from mid-July 2019 through the first week of October, aggregate revenue declined about 10%, Davis said. At the same time, other dry dog ​​food sales increased, from a period of decline in mid-2018 to slightly positive growth in early October 2019.

Despite the effect of the FDA’s investigation on the pet food market, scientists have not found evidence that connects certain diets to cases of DCM. More than 150 published studies have not revealed to researchers any firm connection between cases of canine dilated cardiomyopathy (DCM) and grain-free dog food. Veterinarians and others with BSM partnersa pet industry consulting agency, published its 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 the pet food products eaten by the affected dogs.

Ramifications of the process from KetoNaturals

The process against Hill’s Pet Nutrition from KetoNaturals was only introduced a week ago, so it’s still too early to make predictions, Annis said. However, the result could have serious ramifications Hill’s Pet Nutrition, the scientists named in the lawsuit and KetoNaturals Pet Foods.

If the allegations are found to be false, veterinary researchers at Tufts University and other institutions may retaliate. The trial appears that the vets violated the law and committed a crime of moral turpitude such as serious fraud, deception or lying, Annis said.

“Professional reputations have been called into question here,” he said. “This is the kind of statement that could derail someone’s career.”

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

“Whether the claims could ever meet the requirements of a class action, particularly predominance, will no doubt be hotly contested,” he said.

“Class actions carry a number of additional burdens of pleading and proof beyond those of a class action lawsuit,” Annis said. “Two of which are that the claims are subject to common evidence 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 ill-gotten gains from the alleged wrongdoing, a process known as disgorgement.

“Courts are not consistent as to whether there must be a causal relationship between the bad act and the profit sought to be derived,” Annis said.

Another outcome in false advertising cases may 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 into the public domain.

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

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

Canine dilated cardiomyopathy

DCM affects the heart muscles of dogs. The disease results in an enlarged heart. When the heart and its chambers are dilated, pumping becomes more difficult and the heart valves can leak, leading to an accumulation of fluid in the chest and abdomen. DCM often results in congestive heart failure. Heart function can improve in cases that are not related to genetics with appropriate veterinary treatment and dietary modification if taken early. The breeds that are typically most 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 include Golden and Labrador Retrievers, Whippets, a Shih Tzu, a Bulldog and Miniature Schnauzers, as well as mixed breeds.