Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—S.D.N.Y.: Pro se plaintiff's claims against FDA over psychiatric drug regulation dismissed, (Jan 21, 2026)

By Wendy Biddle, J.D.

There is no private right of action under FDCA.

The district court in New York City dismissed a pro se plaintiff's lawsuit against the Food and Drug Administration alleging the agency failed to properly regulate psychiatric medications, but granted the plaintiff 30 days to file an amended complaint. The court dismissed the amended complaint on multiple grounds, including failure to state a claim and lack of subject matter jurisdiction (Ballentine v. FDA, No. 25-CV-3905 (PAC) (S.D.N.Y. Jan. 15, 2026)).

Background. According to the amended complaint, the plaintiff was diagnosed with multiple psychiatric disorders between 2005 and 2025 and subjected to long-term administration of powerful psychotropic medications, including antipsychotics, antidepressants, and mood stabilizers. The plaintiff alleged these medications were administered without disclosure of serious and well-documented adverse effects, including neurological damage, cardiovascular complications, and cognitive impairment. He further claimed healthcare providers failed to offer or document the availability of non-pharmacologic alternatives and did not obtain meaningful informed consent.

The plaintiff asserted he has developed irreversible injuries, including memory loss, seizure activity, and emotional blunting. He attributed these harms to the FDA's failure to enforce statutory protections requiring full labeling disclosures, adverse event reporting, and transparent safety reviews.

Additionally, the plaintiff raised claims regarding racial disparities in psychiatric treatment. He alleged the FDA has long been aware that minority populations are disproportionately diagnosed with severe psychiatric conditions and prescribed antipsychotics at significantly higher rates than their white counterparts. Specifically, he asserted that scholarly research supports the conclusion that African Americans are three to four times more likely to be diagnosed with schizophrenia and subjected to pharmacological interventions over therapeutic alternatives.

The plaintiff sought declaratory and injunctive relief, as well as monetary damages, asserting claims under the FDCA, the Fourteenth Amendment's Due Process Clause construed as Fifth Amendment claims, and general negligence theories.

FDCA claims. The court first addressed the plaintiff's claims under the Food, Drug, and Cosmetic Act. The court explained that the FDCA creates a closed regulatory system in which the FDA regulates the manufacture, marketing, and labeling of drugs sold in the United States. However, the Act does not include a private right of action permitting individuals to sue alleged violators.

The court noted that enforcement proceedings under the FDCA must be brought by and in the name of the United States under 21 U.S.C. § 337(a). Because individuals cannot bring private actions under the statute, the court dismissed the FDCA claims for failure to state a claim under 28 U.S.C. § 1915(e)(2)(B)(ii).

Constitutional claims. Regarding the plaintiff's constitutional claims raised under the Fifth Amendment and seeking monetary relief, the court determined these must be dismissed based on the doctrine of sovereign immunity. The court explained that sovereign immunity bars federal courts from hearing all suits for monetary damages against the federal government, including its agencies and employees acting in their official capacities, except where sovereign immunity has been waived.

The court cited precedent establishing that absent a waiver, sovereign immunity shields the federal government and its agencies from suit. As a governmental agency, the FDA is entitled to sovereign immunity protection. Accordingly, the court dismissed the constitutional claims seeking monetary relief as barred under the doctrine of sovereign immunity pursuant to 28 U.S.C. § 1915(e)(2)(B)(iii).

Negligence claims. The court then turned to the plaintiff's negligence claims. The court acknowledged that the Federal Tort Claims Act generally provides for a waiver of sovereign immunity for injuries arising from the tortious conduct of federal officers or agents acting within the scope of their office or employment. The FTCA authorizes civil actions for monetary damages when personal injury or death is caused by the negligent or wrongful act or omission of any government employee while acting within the scope of their office or employment, under circumstances where the United States would be liable if it were a private party.

However, the court noted a critical limitation: the FTCA only waives immunity for actions of the type that a private party could undertake. The court found that the FDA's actions in regulating pharmaceuticals are not of this type. The court explained that quasi-legislative or quasi-adjudicative action by a federal agency is action of the type that private persons could not engage in and hence could not be liable for under local law.

Because the FDA's regulatory activities fall into this category of governmental action that private parties cannot perform, the FTCA does not waive the agency's sovereign immunity. The court therefore dismissed the negligence claims on the basis of sovereign immunity for lack of subject matter jurisdiction.

Leave to amend. Despite dismissing all claims, the court granted the plaintiff leave to file a second amended complaint. The court emphasized that district courts generally should grant self-represented plaintiffs an opportunity to amend a complaint to cure its defects unless amendment would be futile. The court noted that because the plaintiff may be able to allege additional facts to state a valid claim, leave to amend was appropriate.

The case is No. 25-CV-3905 (PAC).

Judge: Crotty, P.

Attorneys: Quintin J. Ballentine, pro se.

Companies: Food and Drug Administration

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