The United States has filed suit in the U.S. District Court for the Eastern District of Wisconsin against Dan Nolan Livestock LLC. and its owner Daniel W. Nolan to block them from violating the Food, Drug and Cosmetic Act (FDCA) in connection with their alleged unlawful use of new animal drugs in cows slaughtered for food. The Justice Department filed the suit on behalf of the Food and Drug Administration (FDA).
The defendants have agreed to settle the litigation and be bound by a Consent Decree of Permanent Injunction that enjoins them from committing violations of the FDCA. The proposed consent decree has been filed with the court and is awaiting judicial approval.
The government’s action results from a series of inspections of the Bonduel, Wis.-based livestock company, which revealed, according to the FDA, that the defendants failed to maintain treatment and sales records for their animals and that, in the previous year, they sold an animal for slaughter containing excessive and illegal antibiotic drug residues in its edible tissues. The complaint also alleges that the defendants have dispensed prescription new animal drugs on more than one occasion without a lawful order from a veterinarian.
The complaint states that excess drug residues in animal tissues can harm consumers by causing allergic reactions and by contributing to the spread of antibiotic-resistant bacteria. Both FDA and the U.S. Department of Agriculture (USDA) have warned the defendants that their conduct violates the FDCA. Nonetheless, according to the complaint, the most recent FDA inspection, concluded in November 2011, documented the continuing nature of the defendants’ violations, and established their responsibility for the illegal drug residues found in edible tissue sampled by the USDA in January 2011.
The government’s complaint asserts that the defendants have introduced adulterated food into interstate commerce, caused new animal drugs to become misbranded and adulterated while held for sale after shipment in interstate commerce, and failed to comply with statutory and regulatory requirements concerning the extra-label use of new animal drugs. The consent decree, to which the defendants agreed, requires that Dan Nolan Livestock cease operations and be allowed to resume its business only after it has documented to the FDA’s satisfaction that it has corrected all of the problems observed by the agency’s inspections and has instituted procedures to ensure that there will be no recurrence of those or any other violations that could present a threat to the consuming public.
“When farms fail to maintain appropriate controls concerning the medication of food-producing animals, they jeopardize the public health,” said Stuart F. Delery, Acting Assistant Attorney General for the Justice Department’s Civil Division. “Today’s filing is intended to make certain that Dan Nolan Livestock will put in place the procedures and documentation necessary to help ensure that consumers receive safe foods for their family table.”
Mr. Delery thanked the FDA for referring the case to the Department of Justice. Andrew Clark, of the Consumer Protection Branch, prosecuted the case together with Sonia Nath of FDA’s Office of the General Counsel. The U.S. Attorney’s Office for the Eastern District of Wisconsin joined in the prosecution of the matter.
A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.