Csoka v. FDA

We represent Dr. Antonei B. Csoka in a case against the U.S. Food and Drug Administration (FDA) seeking to compel the FDA to act on a citizen petition submitted in May 2018. The petition asks the FDA to require the revision of product labels for selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) products to warn of the risk that sexual side effects may persist after stopping SSRI or SNRI treatment.

SSRIs and SNRIs are prescription drugs approved by FDA to treat clinical depression and certain other conditions. SSRIs include citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), paroxetine (Paxil), sertraline (Zoloft), and vortioxetine (Trintellix). SNRIs include desvenlafaxine (Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor). SSRIs and SNRIs are known to cause adverse sexual effects, and current product labeling in the United States warns of disturbances to sexual functioning from continued treatment with SSRIs and SNRIs. The labeling does not currently convey the risk of persistent, worsening, or new symptoms of sexual dysfunction after stopping use of an SSRI or SNRI.

Six years have passed since Dr. Csoka and others filed the petition, and FDA has neither granted nor denied it. The lawsuit seeks a declaration that FDA has violated the Administrative Procedure Act by unlawfully withholding action on the petition and an order requiring FDA to issue a decision on the petition.

The FDA, contending that its 6-year delay caused Dr. Csoka no injury, moved to dismiss for lack of standing. Opposing the motion, we explained that the FDA’s delay injured Dr. Csoka by depriving him of a substantive response to which he is legally entitled and of the information provided in a response.