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October 24, 2018 Articles

First Circuit Joins a Growing Consensus About Claims Seeking “Major Change”

By Abbott Marie Jones

The First Circuit recently issued an opinion touching on two threshold questions common in mass tort cases: standing and preemption. Gustavsen v. Alcon Labs., Inc., No. 17-2066, 2018 WL 4057381 (1st Cir. Aug. 27, 2018). It joined a growing consensus among the federal appellate courts that state law claims involving a “major change” to a drug or medical device are preempted by federal Food and Drug Administration (FDA) regulations. It also weighed in on a possibly emerging circuit split regarding the standard for assessing standing in a pharmaceutical case. This decision highlights the importance of paying close attention to those changes deemed “major” by the FDA regulations when pleading claims and asserting defenses.

Case Background

Alcon Laboratories, Inc., and the other defendants manufacture, market, and distribute prescription eye drop solutions. These solutions are packaged in plastic dispenser bottles, and the size of the nozzle controls the amount of solution dispensed per drop. Id. The bottles themselves do not disclose the size of the drops, nor do they provide an estimate of the number of drops or doses contained in each bottle.

The named plaintiffs represented a putative class of users of the prescription eye drops manufactured by the defendants. They claimed that the bottle nozzles dispense an unnecessarily large drop of 24–52 microliters, though the optimal size for a drop and the most a human eye can absorb is 5–15 microliters. Because the bottles dispense an unnecessarily large drop, much of the solution is wasted per application. The plaintiffs argued this ploy forced them to waste much of the solution in each bottle, resulted in solution streaming down the cheek and causing allergic reactions, and ultimately caused them to buy more product more frequently.

The plaintiffs asserted state law causes of action for unjust enrichment and unfair trade practices. The defendants moved to dismiss for two reasons: lack of standing and preemption. The U.S. District Court for the District of Massachusetts dismissed the case without ruling on the merits, finding that the claims were preempted by FDA regulations; the plaintiffs appealed.


The First Circuit addressed the standing issue first, as the requirement of Article III standing is jurisdictional. Steel Co. v. Citizens for a Better Env’t, 523 U.S. 83, 102 (1998). To demonstrate standing, a plaintiff must satisfy the familiar triad of injury in fact, causation, and redressability. Lujan v. Defs. of Wildlife, 504 U.S. 555, 560–61 (1992). Using the same plausibility standard applicable to the motion to dismiss, the First Circuit concluded that the plaintiffs plausibly demonstrated standing.

On appeal, the plaintiffs focused on their alleged out-of-pocket losses of $500 to $1,000 per year per plaintiff resulting from having to replenish the product more frequently. The defendants argued that these loss calculations were based on an unfounded assumption that the price would remain the same for a bottle that dispensed smaller drops but contained the same volume of solution. The First Circuit acknowledged that this issue “could indeed keep an economist busy for a while,” but the court ultimately declined to assess the merits of the argument, considering it premature at the motion to dismiss stage.

The First Circuit’s standing conclusion is in accord with an opinion in a similar case from the Third Circuit. Cottrell v. Alcon Labs., Inc., 874 F.3d 154, 162–70 (3d Cir. 2017) (reversing the district court’s dismissal for lack of standing). However, the Seventh Circuit has reached the opposite conclusion in another similar case, finding no injury but the plaintiffs’ “disappointment” and therefore no viable cause of action. Eike v. Allergan, Inc., 850 F.3d 315, 318 (7th Cir. 2016) (vacating the class certification and remanding with instructions to dismiss with prejudice). The First Circuit explicitly joined the Third Circuit in rejecting the Seventh Circuit’s approach. Gustavsen, 2018 WL 4057381 at *15 (noting that Eike inappropriately blended standing and the merits together); Cottrell, 874 F.3d at 165–66 (“The Seventh Circuit seemed to begin its standing analysis with a determination that the plaintiffs had ‘no cause of action’ [and therefore] they had no injury. . . . This logic flips the standing inquiry inside out, morphing it into a test of the legal validity of the plaintiffs’ claims . . . . But as we have already emphasized, a valid claim for relief is not a prerequisite for standing.”). Caveat advocatus.


Satisfied that it had jurisdiction, the First Circuit in Gustavsen turned to the question of preemption. The plaintiffs alleged state law claims for unjust enrichment and unfair trade practices based on the defendants’ sale of eye drop bottles that dispense an unnecessarily large amount of the product. The defendants argued that before they could change the dispensing nozzles, they would have to seek prior FDA approval, making their compliance with the asserted state laws impossible.

If a “private party [cannot] independently” comply with state law “without prior FDA approval,” then the application of that state law is preempted. In re Celexa v. Lexapro Mktg. & Sales Practices Litig., 779 F.3d 34, 41 (1st Cir. 2015); compare Wyeth v. Levine, 555 U.S. 555 (2009) (rejecting the manufacturer’s preemption defense to liability under state law where federal regulations allowed the manufacturer to provide a warning on a drug label prior to FDA approval and state law imposed a duty on the manufacturer to do so), with PLIVA, Inc. v. Mensing, 564 U.S. 604, 620 (2011) (declining to extend Wyeth and concluding preemption applied where state law required a generic drug manufacturer to change a label but federal regulation prohibited any change without prior FDA approval).

FDA regulations classify changes to approved drugs as major, moderate, or minor. 21 C.F.R. § 314.70. The classification of the change dictates the manufacturer’s ability to unilaterally implement the change; major changes require prior FDA approval, whereas moderate or minor changes do not. Thus, the First Circuit said, “Our inquiry . . . appears . . . straightforward: Does the change urged by plaintiffs qualify as ‘major’? If so, our work is done.” Gustavsen, 2018 WL 4057381, at *5.

To answer that question, the court turned first to the regulations, which provide examples of major changes requiring approval, including “[c]hanges in a drug product container closure system that controls the drug product delivered to a patient or changes in the type (e.g., glass to high density polyethylene (HDPE), HDPE to polyvinyl chloride, vial to syringe) or composition (e.g., one HDPE resin to another HDPE resin) of a packaging component that may affect the impurity profile of the drug product.” 21 C.F.R. § 314.70(b)(2)(vi).

“Adding belt to suspenders,” the court also considered other FDA resources in which the FDA listed as “major changes” ones that “may affect the controlled (or modified) release, metering or other characteristics (e.g., particle size) of the dose delivered to the patient.” Gustavsen, 2018 WL 4057381, at *7 (quoting FDA, Guidance for Industry: Changes to an Approved NDA or ANDA 12 (2004)).

Based on the language in the FDA regulations, and bolstered by the FDA’s interpretation of those regulations in its other publications, the First Circuit concluded that changing the product bottle to dispense a different amount of eye drop solution would constitute a “major change” under 21 C.F.R. § 314.70. Because such a change would require prior FDA approval, the court held that the “plaintiffs’ attempt to use state law to require such a change was preempted.” Gustavsen, 2018 WL 4057381, at *10 (citing PLIVA, 564 U.S. at 620).


The First Circuit’s decision highlights the importance of paying close attention to threshold questions that might normally be skimmed over. Mass tort and consumer class action litigants should beware that in some cases, the frivolity of the claims may factor into the court’s decision on the jurisdictional question of standing. Pharmaceutical litigants in particular should closely examine the FDA regulations, especially 21 C.F.R. § 314.70, and the related FDA publications concerning “major changes.” If plaintiffs are seeking “major changes” to drugs or medical devices, those claims are likely to be dismissed as preempted.

Abbott Marie Jones is senior counsel at Butler Snow LLP in Birmingham, Alabama.

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