CASE DISMISSED! Lawsuit against FDA over SSRI warning label is thrown out
The case - dismissed on a technicality of standing - enables the FDA to disregard its own legal obligations and evade accountability for its inaction on citizen petitions.
A lawsuit against the U.S. Food and Drug Administration (FDA) has been dismissed, highlighting the difficulty of holding federal agencies accountable.
The case focused on the FDA’s failure to update antidepressant warning labels to alert patients and doctors about Post-SSRI Sexual Dysfunction (PSSD), a serious condition that can persist long after stopping the medication.
Despite legal action, the court ruled that the plaintiff lacked “standing,” hence, they were not entitled to bring a case against the FDA in federal court.
The lawsuit
In 2018, Dr. Antonei Csoka, a researcher and advisor to the PSSD Network, joined medical experts in filing a citizen petition urging the FDA to update SSRI drug labels.
The agency is required by law to respond within 180 days, but six years later, it still hasn’t acted.
Subsequently, Public Citizen, a consumer advocacy group representing Dr. Csoka, sued the FDA in May 2024, arguing that the agency’s inaction was unlawful and posed a risk to public health.
Attorney Michael Kirkpatrick, who led the case, stated, “The FDA needs to act in a timely way to inform the public about the risks associated with these drugs. The potential for life-long harm is too serious to ignore.”
The lawsuit mirrored previous cases where Public Citizen successfully sued the FDA over delayed drug warnings, such as the 2021 case involving finasteride, a hair-loss drug linked to suicidal behaviour.
Dr. Csoka had hoped for a similar result in this case, but the court saw things differently.
Court ruled "lack of standing"
On 31 March, 2025, the court dismissed the case, stating that the plaintiff lacked "standing," meaning they couldn’t show a direct, personal injury resulting from the FDA’s delay.
The judge noted:
“The mere failure of an agency to act within a prescribed time frame does not automatically confer standing upon a petitioner… Because plaintiff has not suffered an injury in fact, he lacks standing to bring this action.”
Instead, the judge viewed the case as a "procedural" issue, where frustration over government inaction wasn’t enough to justify legal action.
Dr. Csoka expressed disappointment at the ruling.
“The FDA has taken far too long to act, but the judge ruled that I didn’t show the delay caused me a concrete, specific injury, and therefore I 'lacked standing.' It’s just a legal technicality,” he said.
He added, “In the eyes of the law, unless you can show a concrete personal harm, and that a court decision would clearly fix that harm, you don't have 'standing,' even if you're absolutely correct on the scientific facts or principles.”
“I personally find this ridiculous, but it is the reality,” remarked Dr. Csoka.
The ruling followed a precedent from the 2021 case Campaign Legal Center v. Federal Election Commission, which also rejected a lawsuit over agency inaction.
The court determined that while the FDA had failed to meet its legal deadlines, the delay didn’t cause the specific harm required to justify a lawsuit.
Kirkpatrick said the decision frustrating.
“Even though the court recognises the FDA is failing to follow its own rules, it considers this a minor procedural violation. Apparently, the FDA can ignore its own deadlines with no consequences,” he explained.
Rosie Tilli, a PSSD sufferer who has been raising awareness about the condition, also expressed her dismay.
“What’s most concerning is that the system is set up in such a way that it’s nearly impossible to hold the FDA accountable,” said Tilli.
“The FDA has yet to issue any warnings on PSSD, despite evidence from clinical trials and letters from pharmaceutical companies, like Eli Lilly, warning them about the issue as early as 2011,” she explained. “That the FDA has failed to act is a glaring example of negligence.”
The bigger picture
The ruling raises concerns about accountability. The FDA is legally bound to respond to petitions, but as this case shows, there may be no way to enforce that rule.
Dr. Csoka criticised the system: “It’s like the court saying, ‘Yes, the system is broken, but you’re not the one allowed to fix it.’”
For patients, the delay is troubling. Studies suggest that PSSD could affect a significant number of antidepressant users, and without updated warnings, doctors and patients remain uninformed.
A 19-year retrospective cohort analysis recently published in the Annals of General Psychiatry, found that 1 in 216 males taking a serotonergic antidepressant (80% took an SSRI) experienced erectile dysfunction long after discontinuing their medication.
What’s next?
Despite the legal setback, advocates aren’t giving up.
“We will look into possible appeals or other ways to push for a decision,” Dr. Csoka said.
Kirkpatrick added that the lawsuit may still have an impact: “The FDA often acts once it feels pressure from litigation, even if the case gets dismissed.”
For now, the FDA remains silent on when—if ever—it will respond.
Additional info:
June 2023: Antidepressants can cause 'chemical castration'
May 2024: FDA sued for not acting on petition about antidepressant harms
There is no "JUSTICE" system, only a "LEGAL" system ! 😏
Just disgraceful. There is a long way to go in fixing our regulatory agencies.