West Lafayette company involved in historic animal welfare case

What began with a 2022 raid in rural Virginia has now resulted in millions of dollars in criminal fines for West Lafayette-based pharmaceutical development company Inotiv.

The $35 million fines, the largest penalty ever levied in an animal welfare case, are part of a plea agreement against Envigo and parent company Inotiv in federal court, a U.S. Justice Department release reads. As part of the guilty plea entered June 3, the companies will each pay $11 million for violation of animal welfare and environmental law.

What is Inotiv?

Inotiv is a contract research organization lab that conducts tests and gathers data for its pharmaceutical company clients’ drugs.

Former Purdue chemistry professor Peter Kissinger founded Bioanalytical Systems in 1972, renamed Inotiv in March 2021. It moved to Purdue Research Park in 1974, and Kissinger started his work as a Purdue professor in 1975, according to his LinkedIn page. He retired from Purdue in 2019 and is now the chairman and CEO of development stage medical device company Phlebotics, according to his LinkedIn page.

Inotiv is accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care, which doesn’t have the power to enforce the Animal Welfare Act and whose documents aren’t public, but can take the place of a regulatory body, according to a 2022 report by the Humane Society of the U.S.

Because of the AAALAC accreditation, the facility gets less in-depth, “focused” inspections from the U.S. Department of Agriculture, in which the inspector may not see the animals, according to the report.

The charges stem from a 2022 federal undercover investigation into the operations of Envigo’s breeding facility in Cumberland, Virginia, which closed in September 2022. The investigation found nearly 450 animals in “acute distress.”

The Humane Society of the U.S. published a report detailing the abuse witnessed by the undercover investigator. The dogs at Inotiv, which is located in the Purdue Research Park, owned by Purdue Research Foundation, were used to test multiple kinds of drugs, the report said.

The plea deal also requires Inotiv to spend $7 million over the next three years to improve its facilities and meet standards in excess of the Animal Welfare Act requirements.

On top of animal neglect, Envigo admitted to discharging polluted water into a local creek, opting not to make improvements to its facility necessary to handle the waste, said Todd Kim, assistant attorney general for the Environment and Natural Resources Division of the Justice Department.

“Dogs were subject to euthanasia without proper sedation,” Kim said. “Food was withheld from nursing mothers. Dogs lived in overcrowded kennels cleaned so infrequently that feces accumulated. Dogs were given non-potable drinking water and, at times, food contaminated with maggots and other insects. Envigo knew all this, and more. And yet Envigo failed to take sufficient action to bring this facility into compliance.”

He added that Envigo had received some $16 million through the sale of nearly 15,000 dogs between 2019 and spring 2022.

Both companies are barred from breeding or selling dogs in the future.

Inotiv and Envigo

Inotiv acquired Envigo in November 2021 to improve discovery and preclinical phases of drug development, a release from its website said.

The 2022 Humane Society report said that Inotiv bought beagles from an upstate New York breeder, Marshall Farms, that had 20,000 dogs at a time. It also allegedly used puppies from the facility in Cumberland, Virginia, which bred dogs specifically for toxicity testing.

One technician reportedly told the investigator that the dogs from the Virginia facility “sucked” because they were unsocialized and scared.

Beagles, in particular, are used because of their friendly and submissive natures.

“Beagles wagged their tails as workers picked them up from their cages to (dose) them,” the report read. “Despite knowing what was going to happen to them, the dogs could not resist the human attention.”

Inotiv issued what it called a “statement of contrition” Monday after the plea hearing.

“In committing the crimes identified in the charging document, and by not making the necessary infrastructure upgrades and hiring the requisite staff, we fell short of our standards for animal and environmental welfare and apologize to the public for the harm caused by our conduct,” the company said. “In resolving this matter, we renew our commitment to maintaining the highest standards of animal care.”

Inotiv’s stock price peaked Nov. 15, 2021, at nearly $58 per share and has fallen precipitously since. It is now available at about $1.70 per share.

The West Lafayette company is embroiled in a class action lawsuit for federal security fraud that alleges its top brass concealed animal mistreatment from shareholders, an opinion filed in U.S. District Court on March 29 said.