Appeals Court Backs Eyedrop Suit Dismissal
The 1st Circuit Court of Appeals has ruled that a federal district court properly dismissed a suit alleging that state laws can require manufacturers of prescription eye drops to redesign their bottles so that they dispense a smaller drop. Both courts ruled that such a packaging change would require FDA approval and thus is exempt from state law claims.
The plaintiffs alleged that the companies deliberately designed their bottles to dispense drops that are larger than the eye can hold, forcing customers to waste drops and thus have to pay for more products. Plaintiffs also alleged that because the larger drops roll down the cheek from the eye, they can cause allergies and pigmentation.
The courts held that although the plaintiffs might have a legitimate cause of action, a change in drug packaging is considered by FDA to be a major change that must have agency approval.