Alexandre v. Alcon Laboratories, Inc.

Background

Clark Alexandre brought a proposed class action against Alcon Laboratories, Inc. concerning Alcon’s over-the-counter “Extra Strength Once Daily Relief” eye drops, sold under the Pataday brand. The product label states “30 Day Supply” and directs consumers to use one drop per day in each eye. Alexandre alleged that, when used as directed, one bottle lasted approximately 20 days rather than 30.

Alexandre alleged that he bought the product several times during the winter and spring of 2022 at CVS and Walgreens stores in Rockland County, New York. He used it as directed and observed over several months that the bottle lasted about 20 days. He initially thought he might have received irregular batches, contacted Alcon, and received three replacement bottles, but the product continued to last approximately 20 days. He alleged that he relied on statements including “Once Daily Relief,” “Full 24 Hour,” and “30 Day Supply,” and that he paid more than he would have paid—or would not have bought the product—if he had known the statements were false or misleading.

The remaining claims were for violations of New York General Business Law sections 349 and 350 and breach of express warranty. On the parties’ stipulation, other state consumer-fraud claims were dismissed without prejudice, while claims involving implied warranties, the Magnuson-Moss Warranty Act, fraud, and unjust enrichment were dismissed with prejudice.

Motion to Dismiss Standard

Alcon moved under Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6). Rule 12(b)(1) concerns the court’s power to hear a case, including whether the plaintiff has standing. Rule 12(b)(6) asks whether the complaint alleges enough facts to support a legally plausible claim. At this stage, the Court generally accepted well-pleaded factual allegations as true and drew reasonable inferences in Alexandre’s favor.

The Court also took judicial notice of an FDA approval letter and the product’s final printed label because they were publicly available and their authenticity and accuracy were not challenged. The Court considered those documents only for the fact that they contained particular statements, not for the truth of facts asserted in them.

Standing

Alcon argued that Alexandre’s continued use of the product after learning that it did not last 30 days eliminated any injury traceable to Alcon’s labeling. Alexandre relied on a price-premium theory: he claimed that the misleading representation caused him to pay more for the product than he otherwise would have paid.

The Court rejected Alcon’s standing argument at the pleading stage. Alexandre alleged that he initially believed he might have received irregular batches and contacted Alcon, which sent replacement bottles. Those allegations did not establish that he had full knowledge of the alleged problem when he continued using the product. The Court therefore denied the motion to dismiss on standing grounds.

New York Consumer-Protection Claims

Sections 349 and 350 of the New York General Business Law prohibit deceptive business practices and false advertising. To state a claim, a plaintiff must allege consumer-oriented conduct, a materially misleading practice, and injury caused by that practice.

Alcon argued that New York’s safe-harbor provision protected the labeling because Alexandre did not allege that Alcon violated FDA requirements. The Court declined to apply the safe harbor because the First Amended Complaint and the judicially noticed documents did not establish that the labeling complied with federal law. The Court held that Alcon had not established that affirmative defense as a matter of fact and law.

Alcon also argued that Alexandre had not alleged a legally recognized injury. The Court held that he adequately pleaded a price-premium theory by alleging that Alcon marketed the product as having a 30-day supply, that the product sold at a premium compared with similar products, and that he would not have bought it or would have paid less if he had known the representation was misleading. The Court therefore found that Alexandre sufficiently pleaded injury under sections 349 and 350.

Federal Preemption

Alcon argued that the Federal Food, Drug, and Cosmetic Act barred Alexandre’s state-law claims. Alcon’s position was that the FDA required the product’s final label to be identical to the approved label, including the “30 Day Supply” language, and that federal law therefore preempted any state-law claim challenging that language.

The Court rejected the express-preemption argument at this stage. The FDA approval letter could be considered only for the statements it contained, not as proof that the FDA required Alcon to use a label identical to the approved label. The Court therefore could not treat “30 Day Supply” as federally mandated language. The Court also noted that a claim challenging whether the statement was truthful could impose a requirement identical to the federal prohibition on false or misleading drug labeling, rather than a different or additional labeling requirement.

The Court likewise rejected Alcon’s implied-preemption argument at this stage. Alcon had not shown from the motion papers that federal law made it impossible to change the “30 Day Supply” statement without prior FDA approval. The regulation cited by Alcon did not specifically address supply information and included exceptions that might apply. The Court denied the motion to dismiss based on preemption but stated that the issue could be revisited at summary judgment after discovery.

Express-Warranty Claim

An express warranty may arise from a seller’s factual statement or promise about goods when that statement becomes part of the basis of the bargain. Alcon argued that the “30 Day Supply” statement was not a misleading warranty.

The Court disagreed at the pleading stage. It held that a reasonable consumer could plausibly understand “30 Day Supply” as a promise that the product would last 30 days when used as directed. The Court therefore denied Alcon’s motion to dismiss Alexandre’s express-warranty claim.

Disposition

Judge Halpern denied Alcon’s motion to dismiss the First Amended Complaint. The Court directed Alcon to file an answer within 14 days of the opinion and order’s issuance and directed the Clerk to terminate the pending motion sequence.