Court Rules Del Monte Claim of Pattern of FDA Exam Delays Not Allowed
The U.S. District Court for the District of Columbia has dismissed Del Monte’s1 complaint that the Food and Drug Administration engaged in an unlawful pattern and practice of delay in sampling and inspecting Del Monte’s produce for import to the U.S.
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Del Monte Said FDA’s Pattern of 6-11 Day Delays Affects Value of Produce
Del Monte, which imports fresh produce into the U.S. and is therefore subject to the FDA’s occasional inspection of samples, alleged that the FDA often allows too much time to pass before completing those inspections, causing Del Monte’s produce to become less fresh and therefore to lose value.
Del Monte described six instances between early 2008 and early 2009 in which the FDA requested a sample of a shipment of produce and did not issue the resulting Notice of Action to Del Monte for six to eleven days, harming Del Monte.
However, Del Monte’s specific complaint was that since at least 2006, FDA has engaged in a pattern of unreasonable and/or unlawful delay of sampling, inspection, examination and release of Del Monte’s imported perishable fresh produce. Therefore, it sought a court injunction compelling FDA to stop the delays in inspecting Del Monte produce and a judgment that FDA has engaged in a “pattern or practice that constitutes agency action unlawfully withheld and/or unreasonably delayed.”
U.S. Argued “Pattern of Delay” Claim Disallowed by APA
The U.S. argued that by bringing a “pattern and practice” claim, rather than seeking relief from particular agency actions, Del Monte was asking the Court to order “wholesale improvements,” an action which is disallowed by the Administrative Procedure Act.
Court Dismisses Claim, Says Complaint Must be Incident-Specific
The Court agreed with the U.S., and granted its motion to dismiss the case. According to the District Judge, the Supreme Court has made explicit that a court may only review an agency’s failure to act, or unreasonable delay in acting, if the action not taken, or taken too late, is discrete. He added that such broad review of agency operations as suggested in Del Monte’s complaint, is just the sort of “entanglement” in daily management of the agency’s business that the Supreme Court has instructed is inappropriate.
1Del Monte Fresh Produce N.A., Inc.
(Civil Action 08-02161, dated 04/19/10)