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.

from Blogger http://tushnet.blogspot.com/2024/06/another-challenge-to-up-to-8-hours-of.html