District Court Enters Permanent Injunction Against Pennsylvania-Based Dairy Firms and Individuals to Prevent Distribution of Foods That Contain Excessive Drug Residue
U.S. District Court Judge Kim R. Gibson of the Western District of Pennsylvania has entered a consent decree of permanent injunction against Metzler & Sons LLC and Pleasant View Farms Inc., the Justice Department announced today. The permanent injunction was also entered against Rodney L. Metzler, Gretchen A. Metzler, Rodney T. Metzler and Lee M. Metzler, all of whom have ownership in the firms. The permanent injunction is designed to prevent the distribution of foods that contain excessive drug residue.
The Pennsylvania firms, Metzler & Sons LLC and Pleasant View Farms Inc., own and operate several farms that sell cows for slaughter and for use as food. As set forth in the complaint filed on Dec. 18, 2013, inspections by United States Food and Drug Administration (FDA) and laboratory analyses performed by the United States Department of Agriculture (USDA) indicated that the defendants sold for slaughter for use as food dairy cows and bob veal calves that contained excessive and illegal residues of drugs in their edible tissues. According to the complaint, these inspections revealed that the defendants delivered adulterated food into interstate commerce in violation of the Federal Food, Drug and Cosmetic Act (FDCA). As set forth in the complaint, the defendants received numerous warnings from both FDA and USDA that their conduct violated the law, and despite these warnings, the defendants continued to hold animals that they sold for slaughter as food in a manner that may have rendered the animals’ edible tissues injurious to the public health.
As set forth in the complaint, levels of new animal drugs in the edible tissues of animals in amounts above the tolerances established in federal regulations pose a significant public health
risk. For example, consumers of edible animal tissues who are susceptible to antibiotics may experience severe allergic reactions as a result of ingesting food containing out-of-tolerance
antibiotic levels. Furthermore, food containing above-tolerance antibiotic levels contributes to the development of antibiotic-resistant strains of bacteria in those who eat or handle food containing residues of such drugs.
The complaint filed by the United States asked the court to permanently enjoin the firms and individual defendants from violating the FDCA. The permanent injunction entered by the court requires the firms and individual defendants to take a wide range of actions to correct their violations and ensure that they do not happen again. Among other actions, the firms must establish and implement a written record-keeping system for every animal receiving drugs to prevent the firms from selling or distributing any animals whose edible tissues contain new animal drugs in amounts above the levels permitted by law. The firms must also establish and implement a system that ensures that their use of new animal drugs conforms to the uses approved by the FDA or, for new animal drugs used in an extra-label manner, to the lawful written order of a licensed veterinarian.
“Foods that contain excessive levels of antibiotics and other drugs pose a significant risk to the public health,” said Stuart F. Delery, Assistant Attorney General for the Justice Department’s Civil Division. “Along with our partners at HHS, FDA and USDA, the Department of Justice is committed to making sure that the food on our tables is safe to eat.”
FDA recently said that it is implementing a voluntary plan with industry to phase out the use of certain antibiotics for enhanced food production. For more information on this, you can visit the FDA website at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm378100.htm .
Assistant Attorney General Delery thanked the FDA for referring this matter to the Department of Justice. Roger Gural, Trial Attorney at the Consumer Protection Branch of the Justice Department, in conjunction with Assistant U.S. Attorney David Lew in the Western District of Pennsylvania, and Christopher Fanelli, Assistant Chief Counsel for Enforcement of the Food and Drug Division, Department of Health and Human Services, brought this case on behalf of the United States.