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A Huge Win!

An Appeals Court has reversed a previous decision that dismissed a fraud lawsuit against Hill’s Prescription Pet Food and Petsmart. The lawsuit continues. A huge win for pet owners.

On August 20, 2019, the United States Court of Appeals for the Seventh Circuit issued a potentially future changing decision. Pet food future changing in that the Appeals Court confirmed FDA’s policies are NOT law. The Appeals Court upheld law, not FDA’s policy.

The Appeals Court decision provides background of this lawsuit:

In January 2013 Holly Vanzant’s cat Tarik underwent emergency surgery for bladder stones. At a follow-up appointment, Tarik’s veterinarian prescribed Hill’s Prescription Diet c/d Multicare Feline Bladder Health cat food. That same day Vanzant purchased the food at a PetSmart store. Inside she saw marketing materials indicating that the cat food is “prescription only,” and the label on the bag read “Hill’s Prescription Diet.” PetSmart provided her with a pet prescription card listing Tarik’s name, prescription number, and prescription date. For three years Vanzant purchased Hill’s Prescription Diet cat food from PetSmart, paying a higher price than for nonprescription food. She showed the prescription card to the cashier each time.

Land had a similar experience. In October 2013 a veterinarian diagnosed her cat Chief with diabetes and prescribed Hill’s Prescription Diet m/d Feline Glucose/Weight Management cat food. Within a few weeks, Land purchased Hill’s Prescription Diet cat food at a PetSmart store. She too saw marketing materials inside the store indicating that the food is meant to treat or control diabetes. PetSmart provided Land with a pet prescription card listing Chief’s name, prescription number, and prescription date. For two years Land purchased Hill’s Prescription Diet cat food from PetSmart, paying a higher price than for nonprescription food. She too showed the prescription card each time.

Vanzant and Land eventually learned they were not receiving what they expected. They thought prescription pet food was medically necessary for the health of their pets, had been approved by the FDA, and could not be sold legally without a prescription. But the FDA had not approved it, and nothing required that it be sold with a prescription. They filed a proposed class action in state court against Hill’s and PetSmart alleging claims for violation of the Illinois Consumer Fraud Act and unjust enrichment. The defendants removed the case to federal court and moved to dismiss it under Rule 12(b)(6).

The judge granted the motion. He held that the Consumer Fraud Act claim is foreclosed by the statute’s safe harbor provision, which shields actions authorized by laws administered by a regulatory body. Specifically, the judge relied on an FDA Compliance Policy Guide, which he construed as regulatory authorization for “the gate-keeping role of veterinarians in ensuring that pet owners purchase only appropriate therapeutic foods.” The judge also concluded that Vanzant and Land failed to plead the consumer-fraud claim with the particularity required by Rule 9(b). With no underlying fraud claim remaining, the judge likewise dismissed the unjust-enrichment claim. Vanzant and Land appealed.

In non-legal language – two pet owners filed a lawsuit against Hill’s Pet Food and Petsmart that argued prescription pet food is not a legal product. Hill’s Pet Food and Petsmart argued that FDA’s Compliance Policy Guide allows prescription pet foods to be legal. And the lower federal court agreed with Hill’s Pet Food and Petsmart dismissing the lawsuit.

But these two determined pet owners (and their attorney) appealed. Through appeal, the FDA’s Compliance Policy Guide was closely scrutinized. The FDA policy in question – “Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases” – is a “nonbinding” FDA statement that basically tells the pet food industry the agency won’t enforce law when a pet food makes a drug claim. (To read more about this policy, Click Here.)

The FDA’s statutory authority includes regulation of pet food, so the dispute centers on whether the agency’s guidance qualifies as informal regulatory activity and specifically authorizes the relevant conduct.

In other words, the argument from Hill’s and Petsmart was that because FDA is the regulatory authority over pet food, “the agency’s guidance” (Compliance Policy Guides) is/should be considered law. The appeals court responded with a big NO!, FDA Compliance Policy Guides are not law. It doesn’t matter if Hill’s and Petsmart is abiding by the the FDA Guidance document, requiring a veterinarian prescription for the product. The appeals court ruled FDA policy is not law. Quoting (bold added):

Hill’s and PetSmart characterize the Compliance Policy Guide as informal regulatory activity specifically authorizing the prescription requirement and prescription label for Hill’s Prescription Diet pet food. They are mistaken.

The Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq., regulates pet food. Because Hill’s Prescription Diet cat food is intended to treat or prevent disease and is marketed as such, the products are considered “drugs” under the FDCA. Id. § 321(g)(1)(B). Without FDA approval, a new animal drug cannot be sold in interstate commerce, id. § 331(a), and the product is deemed misbranded and adulterated, id. §§ 352(o), 351(a)(5).

Manufacturers face two additional requirements, regardless of whether the animal drug at issue has been approved. All drug manufacturers must list their drugs and register their facilities or else the drugs are misbranded. Id. § 352(o). And animal drug products must be manufactured in compliance with current good-manufacturing practices applicable to drugs, otherwise the drugs are adulterated. Id. § 351(a)(2)(B).

Most pet-food products claiming to treat or prevent disease lack FDA approval and do not comply with the FDCA’s drug registration and listing requirements. Nor do the manufacturers of these products follow the appropriate manufacturing practices for animal drugs. The FDA issued guidance acknowledging this longstanding noncompliance and identifying circumstances in which the agency may exercise its discretion against initiating an enforcement action.

To be sure, if pet food intended to treat or prevent disease is purchased from or under the direction of a licensed veterinarian, the FDA is less likely to initiate an enforcement action based on the lack of an approved new animal drug application—provided, however, that the other 10 factors are also present. And “less likely” does not mean “will not”; it certainly doesn’t signal authorization. Because the Compliance Policy Guide doesn’t specifically authorize the Hill’s prescription requirement, prescription label, and related marketing representations, the safe harbor does not apply.

The original lawsuit and appeal also argued that Hill’s Pet Food and Petsmart was deceptive, committed fraud and asked for restitution based on “unjust enrichment” (charging higher prices for claimed prescription pet foods). The appeals court allowed everything to move forward.

And the plaintiffs pleaded the fraud claim with the particularity required by Rule 9(b) of the Federal Rules of Civil Procedure. So the statutory claim may proceed. The unjust enrichment claim is more appropriately construed as a request for relief in the form of restitution based on the alleged fraud. The request for restitution based on unjust enrichment therefore rests entirely on the consumer fraud claim, and it too may move forward.

With the safe harbor off the table, our next question is whether the complaint adequately alleges that Hill’s and PetSmart committed a deceptive or unfair practice. Specifically, the complaint must identify the “who, what, when, where, and how” of the alleged fraud.

Here, the complaint alleges that the prescription requirement, prescription label, and associated marketing materials for Hill’s Prescription Diet were deceptive; that Vanzant and Land saw the specific “prescription” language and symbols when they made their purchases; that the prescription pet food was something less than they expected; and that they suffered damages because they paid a higher price. These allegations detail the “who,” “what,” and “how” of the fraud claim with particularity.

The complaint also alleges the “when” and “where” of the fraud. Vanzant saw marketing materials for Prescription Diet pet food before purchasing the cat food at PetSmart in February 2013 and thereafter. Land saw similar marketing materials before purchasing Prescription Diet cat food from PetSmart in November 2013 and thereafter. Nothing more is needed.

To read the full Appeals Court decision, Click Here.

There are many other serious issues that are allowed in pet food based solely on FDA policy or belief. As example, as recent as April 2019 the FDA responded to a formal consumer complaint regarding illegal ingredients in pet food with no warning or disclosure to pet owners: “we do not believe that the use of diseased animals or animals that died otherwise than by slaughter to make animal food poses a safety concern…” As we pointed out in our response to FDA (and as this Appeals Court decision points out), FDA belief is not law.

With this Appeals Court decision – legal confirmation that FDA policy is NOT law – we now have solid ground to move forward on many injustices of pet food. There IS a light at the end of the illegal pet food tunnel!

Congrats and thank you to these pet owners for continuing their fight against the illegal activities of pet food. We would also like to thank the Appeals Court for their ruling – thank you for standing up for enforcement of law in pet food.

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible
TruthaboutPetFood.com
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27 Comments

27 Comments

  1. E. Harry Giarratana III

    August 22, 2019 at 1:41 pm

    Yay! Thank God! And thank-you, Susan for your tireless efforts on our behalf.
    God Bless.

  2. Lucky7Mom

    August 22, 2019 at 1:43 pm

    Keep up the good work, Susan! You are the “David” to the pet food “Goliath.” Thank you for all you do for the well being of our beloved pets! I, too, have purchased many of the “prescription” diets over the years through my own vet and through mail order, and I had to learn the hard way that there were much better alternatives to “prescription” food. Never again!

    • Karen Pelletier

      March 4, 2020 at 9:51 pm

      May I ask how you found the prescription alternatives?My cat started on this prescription food in oct.2019.
      Very expensive and stinky, as you know.Was told she would develop stones again if she went back to non prescription food. Help

  3. ~Pet Owner~

    August 22, 2019 at 1:48 pm

    But we never did think “Compliance Policies” were “law.”

    That’s why they were designed to be the “loopholes” enabling adulterated pet food to exist.

  4. Batzion

    August 22, 2019 at 1:57 pm

    It certainly is a HUGE win! And because of that, we need to forward this info to every pet parent we know whether or not their pets are on “prescription” food. We MUST open eyes by getting word of this development out to everyone! Thank you, Susan!

  5. Duncan Ness

    August 22, 2019 at 1:58 pm

    Just the ruling that FDA does not set final law is wonderful!

  6. Cannoliamo

    August 22, 2019 at 1:59 pm

    Great news! …. Hard to believe it’s taken 71 years

    https://www.hillspet.com/about-us/our-company/hills-pet-nutrition-history

    to pull the curtain back and expose “prescription” pet food for what it really is … a cash cow.

  7. Fred St Clair

    August 22, 2019 at 2:02 pm

    This is great news, and it is long overdue. Let us hope that this goes all the way to a conviction. These large corporations have pretty much ruined the world in the name of profit, and it needs to end.

  8. Cheryl Bond

    August 22, 2019 at 2:05 pm

    This is FANTASTIC news! Here’s hoping that future lawsuits will be able to proceed to FINALLY hold the FDA responsible for violating Pet Food laws!

  9. Mary Huber

    August 22, 2019 at 2:18 pm

    Eternally grateful to you, Susan, for your constant, incredibly valuable vigilance!

  10. Toby

    August 22, 2019 at 2:37 pm

    Watch out Royal Canin you’ll be next on the chopping block.. 🙂

  11. Emily Byrum

    August 22, 2019 at 3:18 pm

    OMG! This is TREMENDOUS news, Susan. Bravo! Nice to see justice prevail for a change! And heartfelt gratitude to the folks who relentlessly brought suit. A good day, indeed!

  12. Tina

    August 22, 2019 at 3:28 pm

    This is a great article. Thanks Susan
    Other than from your site, any idea how I can be in the know of future developments of this case?

  13. markokopp

    August 22, 2019 at 4:56 pm

    Yay!!! One brick removed from the Wall of Illegality and Poison Substances created by Big Petfood with assistance from the FDA and Vet schools and the veterinarians they churn out. Its all about money. Its not about our pets.

  14. jnshok

    August 22, 2019 at 5:36 pm

    I think a lot of cases boil down to having the right judge at the right time. Also lawyers have to put forth the right language, meeting all the requirements of what they want charged in the lawsuit. Everything came together properly this time.

    As Susan points out, the precedent that can be set here that “FDA Compliance Policy Guides are not law” might pertain to the other instances where FDA guidelines say it will not enforce laws that say companies cannot allow condemned ingredients into pet feed/food.

    Is FDA possibly more exposed, since the current government administration is pushing for less oversight overall and providing less funds to regulatory agencies? Companies might try to continue their deceptive practices, but since FDA is not enforcing laws and is not as able to help squelch consumer complaints, maybe lawsuits can bring change.

    • Cannoliamo

      August 22, 2019 at 6:35 pm

      When you say “I think a lot of cases boil down to having the right judge at the right time,” you are unfortunately correct and I wish we could petition review by a judicial panel when the interests of the parties involved are so different. Constitutional justice is frequently inconsistent with economic justice or humanitarian justice or environmental justice or social justice and many of the opinions rendered by single-judge courts do not give equal weight to these concerns.

      From a personal perspective, there is no way a veterinarian or pet food manufacturing company should be able to use regulatory neglect as a causal basis for unsafe or ineffectual animal (or human) health care and to defy this dogmatic rule should be judged as both unconscionable and unconstitutional. Unfortunately, in our capitalistic and corporate-driven society, it often can be determined as acceptable behavior. Maybe it’s time to widen our perspective in settling class-action lawsuits, especially when they involve Federal agencies.

  15. JT

    August 22, 2019 at 10:07 pm

    Magnificent! Susan, you’re a gem. Thank you for the hard, long work you put in.

  16. Dianne & Pets

    August 23, 2019 at 12:04 am

    Interesting side note that I saw elsewhere on facebook. Hill’s has a patent on the term prescription diet. Royal Canin uses the term, the other brands have to use something else. It could be interesting to look at the patent and see how it is defined for the purposes of its use as a copyrighted expression.

    • Dianne & Pets

      August 23, 2019 at 12:09 am

      ignore royal canin uses the term

      • ~Pet Owner~

        August 23, 2019 at 9:53 am

        RC uses “Veterinary Diet”

        • DIanne & Pets

          August 23, 2019 at 2:10 pm

          Thanks, I had looked it up, forgot, couldn’t find the page again and then didn’t edit it out of my original post.

  17. Maria McGuinness

    August 23, 2019 at 9:40 am

    Thank you Susan and your team for your tireless work on behalf of pets and animal lovers everywhere! This IS a HUGE win!

  18. Cannoliamo

    August 23, 2019 at 12:54 pm

    In addition to market labels of prescription diet and veterinary diet, the term “therapeutic” pet food is being used by AVMA. The AVMA policy pertaining to “therapeutic” pet food can be found here …

    https://www.avma.org/KB/Policies/Pages/Pet-Food-Health-Claims.aspx

    I appears that the AVMA wants the FDA to make therapeutic pet food only available through a licensed veterinarian or veterinary prescription. (Pay particular attention to the last three bullets)

    ??????????? ??? ???? ?????? ??????

    The AVMA recognizes that the Food and Drug Administration (FDA) uses enforcement discretion in the oversight of certain pet food claims. Even though many of these foods could legally be considered drugs, certain claims are not FDA approved; consequently, efficacy for these products cannot be assured. Therefore:

    ▪️ The AVMA encourages the pet food industry to act responsibly by only making health or therapeutic claims that are supported by defensible scientific evidence.

    ▪️ Veterinarians should assess relevant product information through principles of evidence-based medicine prior to using or recommending wellness or therapeutic pet foods.

    ▪️ In the interest of pet safety, AVMA recommends the FDA require all pet food products with implied or explicit health or drug claims include a prominent statement on the label indicating that these claims have not been evaluated by the FDA as well as appropriate warning and cautionary statements when appropriate.

    ▪️ In the interest of pet safety, AVMA recommends the FDA require the product to be made available to the public only by order of a licensed veterinarian within the confines of a veterinarian-client-patient relationship.

    ▪️ The AVMA encourages the public to consult with their veterinarian before purchasing pet foods that are marketed to have specific health and therapeutic benefits.

  19. VCHS

    August 23, 2019 at 1:53 pm

    Since Hill’s is being accused of fraud, among other things, I wonder if the Plaintiff’s attorneys will also decide to go after the “pushers” and “peddlers” of these so-called “Prescription Diets” who have been profiting off this fraud for decades?

  20. Steve

    June 6, 2021 at 3:45 pm

    Why do veterinarians risk committing fraud for these pet food companies? I bid a huge BS if they claim it’s the science behind the therapies. How are they bribed, threatened or coerced into committing fraud? I just want my vet to be honest with me. They could easily change their methods into a sponsorship for vet clinics and make even more money than this dishonest racket makes. Just a tiny spin and it’s all good, without prescriptions required. Look at Sobe branding and the like. Just list what needs are actually being assured by slight increases in specific nutritional needs and make it safe and based in hypotheses that have shown promise in the given research. Just stop lying. Stop lying. SSSSTTTOOOPP LLLLYYYIIINNNGGG! It’s that simple.

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