A proposed class action alleges the maker of Aspercreme has misrepresented the lidocaine-based pain-reliever through “affirmative statements, half-truths, and omissions.”
The 14-page lawsuit claims defendant Sanofi US Corporation has been able to sell more Aspercreme and at higher prices than it would have absent what the suit describes as misrepresentations about the product’s FDA compliance, maximum strength, “fast-acting” capabilities, ability to “numb” or “completely block pain” and overall uses.
“No independent, credible studies support the claims made in support of the Product,” the lawsuit alleges, echoing a proposed class action filed last month over IcyHot lidocaine patches. “Even if Plaintiff scrutinized the drug facts, it would not cure the misrepresentations.”
According to the complaint, the use of lidocaine, a topical anesthetic, is regulated by the FDA through an “OTC Monograph,” essentially a “rule book” that establishes for each therapeutic category the uses, dosages, labeling and testing under which an over-the-counter drug can be generally recognized as safe and effective. The FDA’s website states that a drug’s OTC Monograph is also necessary for the product to be marketed without a new drug application and FDA pre-market approval.
Per the case, the FDA’s 1983 “Tentative Final Monography for External Analgesic Drug Products for Over-the-Counter Human Use,” what the suit refers to generally as “TFM requirements,” lays out guidelines for the labeling of over-the-counter products that contain between 0.5 and four percent lidocaine. Around 2003, the FDA, according to the suit, initiated rulemaking to classify products that delivered lidocaine in patch form given there existed no data on “[t]he safe and effective concentration” of the pain-relieving agent in that format, and uncertainties concerning the frequency of application considered “safe and effective,” the complaint reads. The FDA, the lawsuit says, proposed categorizing external analgesic patches as Category III products, which require agency review and approval prior to sale.
The issue, the case alleges, is that Aspercreme contains four percent lidocaine and is marketed as compliant with the FDA’s regulations for Category I products, and not Category III products. More specifically, the suit charges Aspercreme “does not comply with the TFM requirements for Category I ingredients and has not undergone review for products with Category III ingredients.”
Moreover, the lawsuit alleges the defendant’s “max strength” claims for Aspercreme are misleading in that they imply that the product contains and delivers the maximum amount of lidocaine in patch form to an affected area. According to the complaint, this is false given the fact that other patch products are able to deliver more lidocaine to an affected area more effectively. The case adds that other, similar products are approved by the FDA for more purposes than Aspercreme and “supported by clinical studies.”
With regard to Sanofi’s “fact-acting” claim, the lawsuit alleges it is also misleading in that it implies that Aspercreme provides immediate pain relief when “it does not.”
“The Product uses a thicker patch than similar products, resulting in a less effective and slower delivery of lidocaine to the affected area,” the suit argues.
The proposed class action goes on to take issue with the defendant’s claim that a consumer can “use 1 patch for up to 12 hours.” According to the complaint, “numerous studies and reports” have revealed that Aspercreme users “seldom experience anything close to 12 hours of relief, because the patch fails to adhere for even six hours.” The suit notes that the FDA has stipulated that the efficacy of delivery and absorption of a lidocaine-delivering patch is greatly reduced once it has become “partially detached” from the body.
Per the lawsuit, Sanofi’s claim that Aspercreme can completely block pain receptors and thereby “numb pain away” is misleading to consumers in that such effects are dependent on how the product is used. Additionally, the case claims that representations that Aspercreme “targets nerves” and “desensitizes aggravated nerves” imply that the product provides pain relief by addressing nerves and/or pain receptors, yet these claims are qualified by an asterisk that appears “in such small print it cannot overcome the message consumers take away from this claim.”
“Consumers understand these representations to mean the Product contains ingredients that target nerves and pain receptors when this is not true,” the suit contends.
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