A recent decision from the Southern District of New York on a defendant’s motion to dismiss provides a bird’s eye view of at least one court’s judgment of what a reasonable consumer could reasonably take away from a variety of on-pack claims for an OTC product. 

This putative class action involves adhesive lidocaine pain relief patches sold under Stop & Shop Supermarket’s private label brand, CareOne.  The front label of the product states that it is a “Maximum Strength Lidocaine Pain Relief Patch,” describes the product as “4% Lidocaine/Topical Anesthetic,” and states that it “Desensitizes Aggravated Nerves” and provides “Up to 8 Hours” of “Numbing Relief.”   Plaintiff alleged that the label is misleading in a number of ways. 

First, plaintiff alleged that because of the “up to 8 hours” language on the front of the label, reinforced by the directions on the back panel that instruct consumer to apply 1 patch not more than 3 to 4 times daily, and to remove the patch after no more than 8 hours, consumers could expect that the product would adhere to their bodies for no less than eight hours.  Plaintiff claimed that this language is misleading because the product does not adhere for anywhere near 8 hours.

Plaintiff also alleged that the term “Maximum Strength” on the product's front label is misleading because prescription lidocaine patches exist on the market that deliver greater amounts of lidocaine to the user. Further, the plaintiff alleged, the claim is misleading because the FDA has “cautioned manufacturers of [over-the-counter (“OTC”)] analgesic products against making ‘maximum strength’ claims because higher strength and greater potency versions of such items were available with a prescription.”

Further, plaintiff alleged that the statements “Desensitizes Aggravated Nerves” and “Numbing Relief” on the product's front label are misleading because they imply that using the product will completely block and numb nerves and pain receptors and that the seal on the Product's front label is misleading because its “Rx” symbol and “Our Pharmacists Recommend” statement would lead reasonable consumers to expect that the product is prescription strength.

Defendant filed a motion to dismiss the complaint, which the Court granted in part and denied in part.  Of most interest to me in the Decision is the section addressing the claims asserted under New York’s false advertising statute (Sections 349 and 350 of the General Business Law). First, the Court determined that although it would be unreasonable for a consumer to read “up to 8 hours” as meaning “no less than 8 hours,” a reasonable consumer buying the product with a label that states both that it provides “Up to 8 Hours [of] Numbing Relief,”  and directs users to “remove [it] from the skin after at most 8 hours of application,” could “plausibly expect to be able to use the Product for approximately 8 hours based on that full context.”  And, because the product allegedly fails to last 8 hours, the Court determined that plaintiff stated a viable GBL claim.

By contrast, the Court determined that a reasonable consumer would not expect this OTC product to work like a prescription product.  The Court noted that the plaintiff purchased the product without a prescription at a supermarket. In such circumstances it is “simply not plausible” that plaintiff would understand the phrase “maximum strength” to mean “the highest dose that money can buy.”  Indeed, the Court found, “common sense dictates that no reasonable consumer could plausibly think [what plaintiff thought] when faced with overwhelming evidence to the contrary.”  Similarly, no reasonable consumer could understand the performance claims on the label as a promise that the product would completely block and numb the nerves, contrary to plaintiff’s allegation, particularly in light of the additional claim on the label that the product provides “temporary relief.”  Accordingly, the Court determined that because neither the “Maximum Strength” nor the “Desensitizes Aggravated Nerves” and “Numbing Relief” statements on the product's label would mislead a reasonable consumer acting reasonably, and it dismissed the GBL claims predicated on those statements.

The takeaway here is that, in a false advertising case hinging on consumer takeaway, context matters: the wording of the claims themselves, the product instructions and other statements on the label, and even where the product is purchased could all be relevant in determining what reasonable consumers might think is communicated by a label. (And, possibly, the price may be communicative too, as I’ve blogged about earlier.)

EDWARD FULLER v. THE STOP & SHOP SUPERMARKET COMPANY LLC (No. 22-CV-9824 (CS))(filed 11/17/2023), 2023 WL 8005319