Federal Preemption Ruling Flushes Another Eye-Drop Class Action

eyedropAnyone 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 the WLF Legal Pulse learned from a March 31, 2017 post, 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.

During arguments on the motion to dismiss, Judge Wolf sua sponte asked the parties whether the defendants could have avoided the impossibility of simultaneous state and federal law compliance by submitting differently designed containers to FDA when they sought initial approval. He sought supplemental briefing to determine whether such an opportunity would defeat preemption. After weighing the conflicting precedents, the judge sided with the defendants.

Because, as the Supreme Court made clear in Bartlett, implied preemption turns on whether a defendant could independently “do under federal law what state law requires of it,” it is irrelevant whether the defendants could have initially presented an alternative design that delivered a smaller drop: the defendants would still need FDA approval to market its eye drops which, Judge Wolf noted, “may never have been granted.”

Consumer class-action defendants routinely argue federal preemption in motions to dismiss, but of late, have found little success with the argument. Closely-regulated product manufacturers, such as drug makers, should thus find Judge Wolf’s decision encouraging.

Gustavesen is the latest defeat for the St. Louis law firms that have filed copycat eye-drop class actions around the country. Eike, as noted previously, failed for lack of standing, as did another suit in the District of New Jersey, Cottrell v. Alcon Laboratories. We trust that the Third Circuit, which is currently considering Cottrell’s appeal, will affirm and bring all of this ludicrous litigation to a merciful end. We will (no pun intended) keep an eye out for that decision.

Also published by Forbes.com on WLF’s contributor page.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s