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Aspercreme Lidocaine Patches Misleading Claims Illinois Class Action

The Food and Drug Administration (FDA) regulates the claims that drug companies are permitted to make for over-the-counter products. The complaint for this class action alleges that Sanofi US Corporation makes excessive claims on the packaging and labeling of its Aspercreme external analgesic patches, which use the active ingredient lidocaine at a concentration of 4%.

The class for this action is all those who live in Illinois who bought the product during the applicable statutes of limitations.

Lidocaine is applied to the skin to reduce pain. It operates, the complaint claims, “by depressing sensory receptors in the nerve endings in the skin, which prevents pain signals from reaching the brain.”

In 1983, the FDA put out a Tentative Final Monography (TFM) for External Analgesic Drug Products for Over-the-Counter Human Use, which include guidelines for labeling products that contain 0.5%-4% lidocaine. Around 2003, the FDA undertook to make rules for products that delivered lidocaine via a skin patch.

According to the complaint, the FDA proposed classifying patches as Category III products, which require much more extensive application and testing procedures than Category I products. The Aspercreme patches are currently marketed as Category I products, the complaint alleges, but does not meet the TFM requirements for Categroy I products.

The complaint finds a number of things wrong with the Aspercreme patches’ marketing and labeling.

First, the “Max Strength” claims are misleading, it says, “because other patch products deliver more lidocaine to affected areas are more effective, are approved by the FDA for more purposes than [the Aspercreme product] and are supported by clinical studies.

Second, it says that the “Fast Acting” claim is false because it implies immediate relief, while the Aspercreme product “uses a thicker patch than similar products, resulting in a less effective and slower deliver of lidocaine to the affected area.”

Third, consumers are told to “use 1 patch for up to 12 hours.” The complaint alleges this is false “because the patch fails to adhere for even six hours.”

The complaint also takes issue with the claims that the product “numbs away pain,” “targets nerves,” and “desensitizes aggravated nerves,” saying that these are also inaccurate and more than the product is permitted to claim.

Lidocaine is only approved by the FDA, the complaint alleges, “for use as an active ingredient for only the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.” But the complaint claims that other representations on the packaging “give consumers the impression the Product can treat neuropathic and musculoskeletal pain, including back and spinal pain.”

The complaint claims that the company “misrepresented the product through affirmative statements, half-truths, and omissions” and claims that consumers were willing to pay higher prices for it because it promised more than it could deliver.

Article Type: Lawsuit
Topic: Consumer

Most Recent Case Event

Aspercreme Lidocaine Patches Misleading Claims Illinois Complaint

May 1, 2021

The Food and Drug Administration (FDA) regulates the claims that drug companies are permitted to make for over-the-counter products. The complaint for this class action alleges that Sanofi US Corporation makes excessive claims on the packaging and labeling of its Aspercreme external analgesic patches, which use the active ingredient lidocaine at a concentration of 4%.

Aspercreme Lidocaine Patches Misleading Claims Illinois Complaint

Case Event History

Aspercreme Lidocaine Patches Misleading Claims Illinois Complaint

May 1, 2021

The Food and Drug Administration (FDA) regulates the claims that drug companies are permitted to make for over-the-counter products. The complaint for this class action alleges that Sanofi US Corporation makes excessive claims on the packaging and labeling of its Aspercreme external analgesic patches, which use the active ingredient lidocaine at a concentration of 4%.

Aspercreme Lidocaine Patches Misleading Claims Illinois Complaint
Tags: Deceptive Advertising, Deceptive Labels, Item Does Not Do What It Is Advertised to Do, Untrue Product Claims