SoundBody Adhesive Lidocaine Patches Packaging Overstates Effectiveness, Class Action Alleges

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Discount retailer Big Lots faces a proposed class action that claims the efficacy of its SoundBody-brand regular and menthol adhesive lidocaine patches is falsely advertised.

According to the 13-page lawsuit, the claim that SoundBody’s lidocaine patches can provide “long lasting” and “maximum strength” pain relief is deceptive because the patches systematically peel off the skin within three to four hours, or even within minutes, after being applied. Moreover, the promise that the menthol patches deliver “Targeted Immediate Pain Relief” by “Desensitiz[ing] Aggravated Nerves” is misleading to consumers because the statements imply that they provides treatment beyond the capabilities of a non-FDA-approved, over-the-counter product, the suit contends.

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Although the labels of both products direct consumers not to “use more than 2 patches in 24 hours unless, directed by a doctor,” which seemingly insinuates that the patches can adhere for 12 hours, the lidocaine patches regularly fail to stick to the body after being applied, the case alleges.

“Moreover, the implication the Products will adhere for twelve hours is inconsistent with the ‘Uses’ disclosed on the Drug Facts which indicates they can only ‘Temporarily relieve[s] minor pain,’ which consumers will understand as for a short time, not twelve hours,” the filing contends.

The complaint relays that the products’ alleged defect is consistent with a 2018 report from the FDA Adverse Events Reporting System, which found that approximately 70 percent of concerns stemming from lidocaine patches involve their poor adhesion. Similarly, a 2021 study in the Journal of Pain Research discovered that “approximately half of lidocaine patches promising adhesion for eight hours failed to completely adhere to the participant’s skin for the entire time,” the complaint states.

Despite the existence of lidocaine patch technology that can maintain adhesion for at least eight hours under regular conditions like walking, stretching and sleeping, SoundBody’s product uses the same outdated and defective adhesion technology as the lidocaine patches tested in the 2021 study, the case claims.

The suit contends that because the patches fail to adhere to the skin for 12 hours, SoundBody’s product cannot deliver the “maximum strength” amount of lidocaine as advertised. This representation gives consumers the false impression that SoundBody regular and menthol patches are “superior or equivalent in efficacy and results” to other over-the-counter and prescription-strength lidocaine patches that properly adhere to the skin, the complaint contends.

“According to the FDA, when a patch delivering lidocaine becomes ‘partially detached,’ its efficacy of delivery and absorption of the active ingredient is greatly reduced,” the suit reads. “Since ‘[a]dequate adhesion is a critical quality attribute for topical delivery systems,’ if the patches lift or detach during wear such as walking, sleeping or exercising, dosing will be compromised.”

Finally, the case asserts that the menthol patch’s promise to deliver “Targeted Immediate Pain Relief” by “Desensitiz[ing] Aggravated Nerves” is misleading given that consumers will falsely assume the patch is fit to perform medical treatments associated with prescribed, FDA-approved products, even though SoundBody menthol patches possess neither qualifications. The statement also wrongly implies that the patch can “completely block and numbs nerves and pain receptors, eliminate responses to painful stimuli, and … treat neuropathic and musculoskeletal pain, including back and spinal pain,” the filing argues.

The lawsuit looks to represent anyone in New York, Idaho, North Carolina, Nebraska, Kansas, Mississippi, Utah, Oklahoma, Wyoming, Tennessee, South Dakota, Virginia, Louisiana and West Virginia who purchased SoundBody regular and menthol adhesive lidocaine patches during the applicable statute of limitations period.

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