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# Court Says Eye Drop Dispenser Suit Preempted
- URL: https://www.fdaweb.com/court-says-eye-drop-dispenser-suit-preempted/
- Published: 2017-10-05T12:00:00.000Z
- Updated: 2026-09-14T22:54:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139793

A Massachusetts federal court has ruled that a potential class action suit against manufacturers of prescription eye drops could not proceed because of impossibility preemption. Plaintiffs claimed that the manufacturers used eye drop dispensers that were “intentionally designed to dispense more liquid than the human eye is capable of absorbing.” An online [post](http://www.fdalawblog.net/fda%5Flaw%5Fblog%5Fhyman%5Fphelps/2017/10/drug-manufacturers-shed-no-tears-over-ruling-that-state-law-claims-based-on-eye-drop-dispensers-are-.html?ref=fdaweb.com) by attorney **JP Ellison** (Hyman, Phelps & McNamara) in his firm’s *FDA Law Blog* says that the suits said the purpose of this unfair practice was to cause consumers to buy more eye drops and thus increase the manufacturers’ profits.

The court determined that the manufacturers could not have marketed droppers that complied with state consumer protection and unjust enrichment laws in the way the plaintiffs requested without FDA prior approval. Central to the court’s reasoning, Ellison writes, were two FDA guidance documents that classified as major changes, and therefore changes that could not be made under the changes-being-effected regulation, any changes to the size and shape of the container for sterile drug products such as eye drops. Based on the guidance documents, Ellison says, the court reasoned that it was impossible under federal law for the defendants to make the changes that plaintiffs alleged were necessary under state law.