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# Court Says Eye Drop Case is Preempted
- URL: https://www.fdaweb.com/court-says-eye-drop-case-is-preempted/
- Published: 2017-10-19T12:00:00.000Z
- Updated: 2026-09-14T22:57:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139917

A Massachusetts federal court has ruled that a putative class action suit against a group of drug companies alleging that their prescription eye drops were intentionally designed to dispense more liquid than the human eye can absorb is preempted by federal law. Attorney **Michelle Yeary** (Dechert) writes in an online blog [post](https://www.lexology.com/library/detail.aspx?g=467e9c64-61be-4ac4-b5d0-2e82b6129a5d&ref=fdaweb.com) that the plaintiffs pushed two theories of liability that they said were not preempted.

While the plaintiffs said the companies could have changed the eye dropper tip, the court held that such a change would be considered a major change by FDA and thus could not happen without agency approval before the drug is distributed.

When the plaintiffs raised several instances in the past in which FDA allowed a container change without prior approval, the court held that FDA’s failure to follow its own procedures on occasion does not cast doubt on the plain language of a 2004 guidance deeming all changes to the size or shape of a sterile product’s container to be major changes requiring pre-approval.

“The regulations and official guidances control over individualized instances where FDA chose not to apply them,” Yeary writes. “The court can’t be guided by internal decision-making processes in one-off situations.”