There is a special kind of optimism—some might call it magical thinking—that animates the modern failure-to-warn claim against prescription drug manufacturers. It goes something like this: Yes, the FDA-approved label warned about the exact risk that happened to me, but the manufacturer still failed to warn.

Which is a pretty accurate summary of plaintiff’s argument in True v. AbbVie, Inc., 2025 WL 3560299 (N.D. Ga. Sep. 9, 2025). Let’s start with the inconvenient truth (sorry, True)–prescription drug labels are not written by vibes. They are the product of exhaustive clinical data, regulatory scrutiny, and FDA approval. When a label says, in plain English, that a drug carries a risk of X, and X is exactly what happened, it is difficult to argue—without blushing—that the manufacturer failed to warn. But that is exactly what plaintiff True did.

Plaintiff was prescribed an eyedrop to treat her presbyopia—not a disease so much as a rite of passage for anyone over forty or the time when your arms become mysteriously too short.  The active ingredient in the drug is pilocarpine hydrochloride, a member of a class of drugs called miotics. The label on the eyedrops plainly states that retinal detachment has been reported with the use of miotics.  Plaintiff used the drops as directed and within several weeks suffered retinal detachment. Her suit alleges claims for strict liability design defect, strict liability failure to warn, and negligence. Defendants moved to dismiss all claims.  

As the court explains in True, the approval of a New Drug Application (“NDA”), is an “onerous and lengthy” process, that includes the approval of the exact text of the approved label.  Id. at *4. Once approved, a drug manufacturer cannot unilaterally change a product’s label and warnings—with one narrow exception. The “changes being effected” (“CBE”) regulation allows a manufacturer to add or strengthen a warning without prior FDA approval where there is “newly acquired information about the evidence of a causal association between the drug and a risk of harm.” Id.  So, to avoid conflict preemption, a plaintiff must plausibly allege that there is a warning deficiency that the manufacturer could have corrected using the CBE process.

None of the information plaintiff cited to qualified as “newly acquired” information of a new or greater risk. She cited medical literature, case reports, and clinical studies. But none indicated that the risk of retinal detachment is any more severe or frequent than the risks already reviewed by the FDA and warned of in the labeling. Plaintiff also tried to rely on adverse event reports reported in the FDA reporting database (FAERS). But numerous courts, including True, hold that FAERS data is not newly acquired information that would support a CBE label change absent evidence of a causal association between the drug and the risk. Id. at *5. Even the FDA cautions that adverse event reports are not conclusions or admissions “that the drug caused or contributed to an adverse effect.” Id. (citing 21 CFR § 314.80(1).  

Without evidence of a causal link, the best plaintiff could do was put together a graph showing an uptick in adverse event reports. But the plaintiff provided no context, no time parameters, no explanation as to how the graphs demonstrated newly acquired information. Finally, plaintiff argued that defendant could have warned about the risk via its sales representatives and promotional materials, but the allegations of the complaint rest “solely on the inadequacy of the FDA-approved Label.” Id. at *6. Since the argument was “disconnected” from the allegations of the complaint, it could not save plaintiff’s failure to warn claim.

Failure-to-warn claims like this implicitly assume the manufacturer had a legal obligation to do the impossible: change an FDA-approved warning without legal authority to do so. Federal preemption exists precisely to prevent juries from deciding that drug manufacturers should have ignored federal law and rewritten labels on their own initiative.

The court also summarily dismissed plaintiff’s design defect and negligence claims. Plaintiff did not defend either cause of action. Plaintiff’s only design defect claim went to the drug’s formulation which the manufacturer cannot change without FDA approval. Therefore, like failure to warn, it was preempted. Id. To the extent plaintiff’s negligence claims were premised on the same design and warning allegations, they also failed. Id. at *7-8. Which left only negligent failure to research and test which Georgia law does not recognize as an independent cause of action. Id. at *8.   

Because plaintiff’s claims were either preempted or failed as a matter of law, the case was dismissed with prejudice.

And while we always celebrate a preemption win, we can’t overlook that in this case, the label warned of the risk; the risk occurred. End of story. Or at least it should be. The subtext of a claim like this is not that the warning was absent, but that the plaintiff wishes it had been more reassuring. The truth is that a warning can be adequate even if the risk materializes. Warnings are not guarantees. They are disclosures. And when a label discloses the very risk at issue, the failure-to-warn claim should collapse under the weight of its own contradiction.