This story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission

A class action lawsuit was filed May 1 in Northern California against Big Heart Pet Brands Inc. on behalf of consumers and businesses who bought pentobarbital-contaminated dog food manufactured by the company.

Big Heart is owned by the J.M. Smucker Co. 

The lawsuit, referred to as a master consolidated complaint, consolidates four similar actions filed in February and March against the company.

The complaint accuses Big Heart of several counts, including negligent misrepresentation, violation of California’s Consumers Legal Remedies Act, false advertising, negligence, breach of express warranty, breach of implied warranty, fraud and deceptive and unfair trade practices.

Plaintiffs are seeking an order preventing Big Heart from selling the contaminated dog food, a mandatory corrective advertising campaign, full restitution and an unspecified amount of actual, statutory and punitive damages.

The pentobarbital problem came to light in February, when a Washington, D.C.-television station’s investigation into potential pentobarbital contamination in canned, wet dog food revealed the presence of the drug in several Gravy Train products. Veterinarians use large doses of the fast-acting drug to euthanize animals.

Gravy Train is manufactured by Big Heart.

Mark Johnson, one of the plaintiffs named in the class action suit, owned 13 border collie and Australian shepherd mixes, which he used as herding dogs for his cattle. All of Johnson’s dogs developed kidney failure within a few hours after eating a Gravy Train product and had to be put down on Jan. 14 and 15, according to the complaint. 

There is no mention in the complaint of a confirmed cause of the kidney failure, or of any laboratory analyses being carried out either at necropsies on the dogs or on the dog food.

The presence of pentobarbital at any level in animal food renders the product adulterated, according to the US Food and Drug Administration (FDA).

Oral exposure to pentobarbital causes primarily neurological symptoms including drowsiness, dizziness, excitement, loss of balance, jerky eye movements, and, in the most severe cases, coma and death. Kidney failure is not one of the reported manifestations of oral pentobarbital poisoning.  

An investigator from the FDA’s Philadelphia district office visited Big Heart’s Bloomsbury manufacturing facility five times between Feb. 23 and March 12, 2018, according to information obtained by Food Safety News in response to a Freedom of Information Act (FOIA) request.

At the end of the inspection, the investigator cited the presence of pentobarbital in a retained sample of tallow from February 2017 and in a sample from the company’s current inventory of tallow. The tallow is among ingredients used in the manufacture of Gravy Train, Kibbles ‘n Bits, Skippy and Ol’ Roy canned, wet dog food brands.

On Feb. 16, FDA alerted consumers to the potential contamination issue and advised the public that Smucker was withdrawing from the market a wide range of canned, wet dog food products.

The withdrawal was upgraded to a Class III voluntary product recall on March 2.

A Class III recall is one in which the “… product is violative and use of or exposure to the product is not likely to cause any adverse health consequences,” according to FDA’s Regulatory Procedures Manual.

Although the concentration of pentobarbital found in the tallow was included in the investigator’s completed Form 483 (Inspectional Observations), the information was redacted from the copy supplied to Food Safety News.

According to information contained in the class action complaint, the retained sample of tallow contained pentobarbital at a level of 529 parts per billion (ppb). Levels of the drug in the current inventory ranged from 802 ppb to 852 ppb.

The tallow was allegedly supplied by MOPAC, an eastern Pennsylvania rendering facility belonging to JBS USA Holdings Inc.

When asked to confirm the reported levels of pentobarbital in the tallow samples, a spokesperson for FDA declined to comment. An FOIA request for the lab reports and for the Notice of Inspection (Form 482) was turned down on April 20, with the explanation that they were “not available” at the time. 

It is standard procedure for an investigator to issue a Form 482 Notice of Inspection at the outset of any inspection. No explanation was given as to why this document was unavailable.

FDA has issued no updates on the status of its investigation or of the product recalls since the March 2nd recall notice.