Suit Challenging FDA Approval of Ammonia-Reducing Cattle Drug Survives Motions to Dismiss

Judge Richard Seeborg of the Northern District of California denied motions to dismiss filed by the U.S. Food and Drug Administration (FDA) and Elanco Animal Health yesterday, permitting the animal rights and government accountability groups’ case to proceed. The plaintiffs filed the lawsuit against the FDA after it approved the animal drug Experior, an ammonia gas reductor, for use in cattle feedlots.

The plaintiffs argued that the FDA did not properly announce the drug’s approval in the Federal Register, that Experior has not been proven safe and effective, and that the FDA did not satisfactorily consider the drug’s environmental impacts. Elanco intervened as a defendant, and both it and the FDA moved for dismissal on grounds that the plaintiffs lack Article III standing and, as to Elanco, that they failed to first exhaust their administrative remedies.

The court first held that the plaintiffs met the standing law’s three conjunctive requirements. In the FDA and Elanco’s view, the plaintiffs’ allegations were premature and unspecific. The court explained that this argument, however, would lead to an impermissible result, “effectively insulat[ing] the FDA from decision-making from review until the product had entered the market and its use at specific feedlots could somehow be discovered, or detected in the environment, or in beef products sold to consumers.”

Secondarily, Elanco, but not the FDA, argued that the plaintiffs failed to exhaust their administrative remedies by not filing a citizen’s petition. This argument was rejected on the basis that the plaintiffs filed a petition for a stay under a sister provision, which the court held was alone adequate.

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