FDA Seeks to Dismiss Suit Alleging it Should Not Have Approved Drug to Reduce Cattle Waste Emissions

The United States Food and Drug Administration (FDA) and Elanco Animal Health, an animal pharmaceutical company which intervened in favor of the defendants, each filed a motion to dismiss a lawsuit alleging that the FDA, its commissioner Stephen Hahn, and Alex Azar, Secretary of the United States Department of Health and Human Services, should not have approved Experior, a drug which was meant to reduce harmful gasses released by cattle being raised for beef. 

The motions which were filed on Thursday in the California Northern District Court argued that the court should dismiss the case because the plaintiffs do not have standing. Experior is reportedly in a category of drugs called beta-agonists, which are designed to help increase industrial meat production, however, the plaintiffs argued that it inflicts harm on cows and the environment.  

The lawsuit was filed by the Animal Legal Defense Fund, Food & Water Watch, and Food Animal Concerns Trust in June of this year. The parties said in their complaint that the drug, Experior, produced by Elanco US, Inc. “allegedly results in less ammonia gas released from waste produced by cows raised for beef.” The complaint explained that the FDA approved Experior in late 2018, and later denied a petition to stay the approval, violating the Federal Food, Drug, and Cosmetic Act and the National Environmental Policy Act because the defendants reportedly did not meet the standards of the statutes. 

The plaintiffs said that the approval of Experior “will allow producers to administer this controversial new drug to the nearly 100 million cows raised for beef in the United States despite the facts that FDA did not properly announce the approval in the Federal Register, Experior has not been shown to be safe and effective, and FDA did not adequately consider the drug’s environmental impacts.” They further alleged that drugs like Experior could be linked to high mortality rates in cows. 

In their attempt to dismiss the lawsuit, the FDA argued that the plaintiffs, and members of their organizations, had not suffered an injury and do not have standing to file the lawsuit. The motion also claimed that the plaintiffs did not adequately allege that the FDA and its approval of Experior were at fault for the alleged harms, but rather, the harms could be attributed to third-party feedlot practices, other systems similar to Experior, and self-inflicted harms. 

The FDA and lawyers with the Department of Justice, which represents the federal defendants, argued that all of the claims should be dismissed. The motion said that the “Plaintiffs have identified a variety of alleged harms from feedlots, other beta-agonists, and the actions of the industrial farming industry.  Whatever the merits of those allegations, they do not help Plaintiffs to establish standing in this case. Neither Plaintiffs nor their members have been harmed by FDA’s approval of Experior, nor do they sufficiently allege that its approval will harm them in the immediate future.” 

Elanco, represented by Covington & Burling LLP, cited many of the same causes in its motion to dismiss. The plaintiffs were represented by the Animal Legal Defense Fund and the Law Office of Paige Tomaselli.