Fourth Circuit Affirms FDA’s Authority to Issue Contamination Warnings
The Fourth Circuit Court of Appeals has upheld a lower court’s determination that the U.S. Food and Drug Administration (FDA) had the discretion to issue an incorrect contamination warning about Salmonella-tainted tomatoes, which devalued a tomato farmer’s crop by $15 million. Seaside Farm v. United States, No. 15-2562 (4th Cir., order entered December 2, 2016). Details about the lower court’s decision appear in Issue 588 of this Update.
The lawsuit stemmed from FDA’s warning against eating raw tomatoes in 2008 following an outbreak of Salmonella that was later traced to jalapeno and Serrano peppers. Seaside Farm filed suit alleging FDA negligently issued the warning, impairing the value of its crop. The trial court found that FDA was acting within its discretion to issue the warning.
Seaside argued that FDA’s warning was overly broad and based on insufficient evidence, noting that the agency failed to test any tomatoes before issuing its warning. The court disagreed, finding that Seaside misunderstood FDA’s discretion. “The decision to issue a contamination warning, especially in the middle of an escalating salmonella outbreak, clearly implicates the policy considerations which FDA was established to weigh,” the court held. “Whether the agency pursued its investigation, interpreted relevant evidence, or balanced policy considerations in what Seaside believes to be an optimal manner does not affect the discretionary function analysis. Seaside essentially invites us to engage in the very judicial second guessing that the discretionary function exception forbids.” Accordingly, the court affirmed the lower court’s ruling in favor of FDA.
Issue 625
