Another challenge to "up to 8 hours of relief" proceeds

Sheiner v. Supervalu Inc., 2024 WL 2803030, No. 22 Civ. 10262 (NSR) (S.D.N.Y. May 28, 2024)

Supervalu sold a “Maximum Strength Lidocaine Patch” product which contained “topical anesthetic 4% Lidocaine” which “desensitize[s] aggravated nerves” to provide “temporary relief of pain” to the “back, neck, shoulders, knees, elbows” for “up to 8 Hours of relief.” Sheiner’s GBL claims challenged the “up to 8 hours numbing relief” claim, alleging that the patch “is unable to adhere to skin for more than four hours, often peeling off within minutes of light activity” and “did not reliably adhere to Plaintiff’s body for anywhere close to eight hours, which prevented it from providing even temporary pain relief,” also citing a study by the Journal of Pain Research.

Sheiner also challenged “Maximum Strength” because “prescription lidocaine patches exist on the market that deliver greater amounts of lidocaine to the user.” In addition, the package’s “compare to Salonpas® Lidocaine Patch active ingredient” instruction allegedly contributed to confusion because Supervalu’s product “contains roughly forty percent less lidocaine” than found in the Salonpas® OTC Lidocaine Patch product.

In addition, Steiner alleged that the phrase “numbing relief” implies the OTC Product provides relief associated with “medical treatments requiring a prescription and FDA approval,” implying that the product would “completely block and numb nerves and pain receptors, eliminate responses to painful stimuli, and can treat neuropathic and musculoskeletal pain, including back pain.”

Supervalu argued that courts have “recognized that ‘up to’ statements ‘are generally not construed as concrete promises about a product’s maximum yield.’ ” But it was “plausible to contend that the ‘Up to 8 Hours’ language on the label indicates the patch can provide pain relief for as long as eight hours, and the label says nothing about other factors relating to the patch that may result in a much shorter period of pain relief.” Compared to other situations, where self-evident or disclosed contextual factors (like the strength at which coffee is brewed affecting the number of cups that could be brewed from a given amount) informed consumers about whether they could expect to get the “up to” results, “the lidocaine patch labels at issue ‘include no identification of any factors that might limit the amount of time that the patch would remain adhered to the body and deliver relief.’ ”

The other alleged deceptions failed less well: “The argument that a consumer would expect an OTC product to be equivalent to the most powerful prescription medicine is a nonstarter.” A reasonable consumer “would plainly ‘understand that OTC products differ from products that are available with a prescription,’ ” and contain only the “maximum strength” dose available at the drug store. But 4% is the maximum lidocaine concentration allowed by law in OTC products, which this product had, and Steiner failed to identify an OTC lidocaine patch available on the market that is stronger. (The court distinguished cases reaching the opposite conclusion; they only made sense when an OTC drugmaker made a direct comparison to a prescription product.) Also, even if the FDA cautioned manufacturers not to use “Maximum Strength” claims, “the FDA’s regulations or views are irrelevant or at least not dispositive when it comes to determining whether a reasonable consumer would be deceived or misled under GBL §§ 349-50.”

Claims based on “numbing relief” also failed. The interpretation that it would completely block pain was unreasonable. The label explicitly limits its use to “temporary relief of pain,” and Steiner didn’t even allege that he believed that the product would completely block or eliminate pain. Breach of express warranty claims failed for want of timely, prelitigation notice.  

On fraud, the plaintiff failed to allege facts that give rise to a strong inference of fraudulent intent.