FDA and Elanco Reply in Favor of Approval of Cow Emissions Reducing Drug

Elanco Animal Health and the Food and Drug Administration (FDA), intervenor and defendant respectively in a Northern District of California lawsuit, responded to the plaintiffs’ opposition to their motions to dismiss the lawsuit on Monday. The suit claimed that Experior, a drug designed to be used with cows to reduce emissions, has harmful effects and should not have been approved by the FDA. 

Elanco filed a separate motion to dismiss the suit in late October, each motion claimed that the plaintiffs did not have standing. The FDA also said that the plaintiffs had not attributed the potential harm from the drug to the FDA but rather to third-parties, feedlots, and similar drugs. Elanco purported in its motion to dismiss that the plaintiffs, Animal Legal Defense Fund, Food & Water Watch, and Food Animal Concerns Trust, had not used the required administrative remedies prior to taking the matter to court, specifically a citizen petition. 

The plaintiffs on November 30 opposed the motions to dismiss and argued that they had “associational standing,” they had injury-in-fact from Experior under the National Environmental Policy Act and the Federal Food, Drug, and Cosmetic Act, and they had used all administrative remedies available to them. They said the motions to dismiss “overstate the standard of review” for this stage of litigation as well as mischaracterize the plaintiffs’ allegations of harm and claims for relief. 

Specifically, the plaintiffs purported that distribution of Experior would harm its members and their environment. “Plaintiffs’ members are beef consumers who are harmed because they cannot avoid exposure to Experior in the food supply … they are forced to change their purchasing habits or forgo beef consumption altogether. Other members are rural residents who live and recreate in close proximity to beef feedlots where Experior is approved for use, and beef producers and business owners whose businesses stand to suffer from Experior’s approval.” They claimed the members rely on the FDA to ensure animal drugs are safe and environmentally friendly.

The FDA and Elanco each reiterated their claims in Monday’s reply briefs. The FDA said the plaintiffs had not demonstrated injury-in-fact, and that they did not face “actual or imminent harm,” and that the alleged injuries do not constitute standing.  Further, it said that the plaintiffs continued to show that a decision in its favor would not address the alleged harms of the plaintiffs’ members. The FDA’s brief stated the “Plaintiffs try to escape their inability to establish causation or redressability based on their claim that they ‘challenge the FDA’s faulty approval, not the later application of the approval in specific contexts.’  But those contexts do matter, because Plaintiffs’ members must have a concrete interest at stake—even in a procedural injury case—in order to establish standing.” 

Elanco in its reply also claimed that the injuries alleged by the plaintiffs are not traced to the FDA and that the claims should be dismissed. The company addressed claims from the plaintiffs that it was seeking to bar other challenges to the FDA’s approval of Experior, saying that it only asked for the plaintiffs to be required to meet the standards before bringing the lawsuit, specifically using administrative remedies. The intervenor asked the court to dismiss the lawsuit without prejudice or hold the suit while the plaintiffs first go through the administrative processes. 

Elanco is represented by Covington & Burling, the FDA is represented by the Department of Justice, and the plaintiffs are represented by the Animal Legal Defense Fund and the Law Office of Paige Tomaselli.

A hearing on the motion to dismiss will be held on January 14, 2021.