Anyone who’s ever used eye drops has experienced solution overflow. You tilt your head back, pry your eye open, hold the dispenser close to your eyeball, and even though you squeeze very gently, some of the liquid flows onto your cheek. What is your logical next move? Is it to grab a tissue and dab up the excess, or reach for the phone and call your lawyer? As readers of Washington Legal Foundation’s Forbes.com posts learned from a March 31, 2017 commentary, some overflow sufferers have actually done the latter.

That March 31 commentary recounted the U.S. Court of Appeals for the Seventh Circuit’s dismissal of a class action against nine eye-drop makers alleging that consumers suffered economic harm from a needlessly oversized drop of medicine. A decision in another eye-drop-overflow suit filed in Massachusetts, Gustavesen v. Alcon Laboratories, et. al, recently came to our attention (HT to our friends at the indispensable FDA Law Blog).

The outcome of this suit was the same as the Eike v. Allergan, Inc. in the Seventh Circuit—class dismissed. Unlike Judge Posner’s typically curt, fanciful opinion in Eike, which tossed out the claims for lack of constitutional standing, District of Massachusetts Judge Mark Wolf found that federal regulation of the prescription eye drops preempted the state-law fraud claims. Judge Wolf’s thorough analysis is worth a careful read.

The same St. Louis, Missouri law firms that represented Illinois and Missouri residents in Eike filed suit in the District of Massachusetts on behalf of Gustavensen and other Massachusetts and New York residents. The suit asserted that Alcon and its co-defendants intentionally designed eye-drop vials to deliver a drop that the average eye could not fully absorb, and that the overflow harmed consumers who payed for unused solution.

Judge Wolf applied “impossibility” preemption, which is a form of implied preemption, by the book. Under impossibility preemption, if the defendant cannot independently, simultaneously comply with both state- and federal-law requirements, the lawsuit is preempted under the U.S. Constitution’s Supremacy Clause. U.S. Supreme Court precedents such as Wyeth v. Levine, PLIVA v. Mensing, and Mutual Pharmaceutical v. Bartlett dictate that state-law claims are preempted if they would require “major changes” to Food and Drug Administration (FDA)-approved products

Under FDA guidance documents, eye drops and their containers are “sterile products,” and any alterations made to them are considered “major changes” that require preapproval by the agency. If the Gustavesen plaintiffs prevailed, the defendants’ products would be out of compliance with state law, requiring a redesign of at least the container’s dropper tip.

Because the defendants could not comply with state law without FDA permission and assistance, Judge Wolf held that federal law impliedly preempted the suit. In doing so, he rejected Gustavesen’s argument that FDA had previously allowed several manufacturers to change their sterile containers without preapproval. When interpreting a federal regulation, the judge explained, an agency’s promulgated standard, not its past actions, are most relevant.