On Tuesday in the Northern District of California, Scilex Pharmaceuticals filed a complaint against Sanofi-Aventis U.S. and Hisamitsu America, alleging that the defendants have been falsely advertising their over-the-counter lidocaine products.
Scilex claimed that in 2016, the defendants began selling their products, namely Sanofi’s IcyHot Lidocaine Patch, Aspercreme Lidocaine Patch, and Aspercreme XL Lidocaine Patch, and Hisamitsu’s Salonpas Lidocaine Pain Relieving Gel-Patch, despite allegedly not being compliant with Food and Drug Administration (FDA) regulations nor regulations set by the FDA’s “Tentative Final Monography for External Analgesic Drug Products for Over-the-Counter Human Use” (TFM), which provides regulations for labeling, ingredients, and doses for certain over-the-counter lidocaine products. These products are in direct competition with Scilex’s own lidocaine patch product, ZTlido; thus, the alleged conduct is harmful to the plaintiff, according to the complaint.
The plaintiff alleged that packaging on the defendants’ products depicts the products as more effective than they are in reality and that they imply FDA approval. Wording such as “MAX STRENGTH LIDOCAINE” on IcyHot and Aspercreme’s lidocaine patch packaging and the promise that Salonpas “blocks pain receptors,” “falsely states that Defendants’ products contain and deliver to the area of pain the maximum amount of lidocaine available in patch form” and “(m)isleadingly implies that Defendants’ products completely block pain receptors,” according to the complaint.
The plaintiff argued that these representations are misguided, as the defendants’ products allegedly deliver a lower amount of lidocaine to the pain site than the plaintiff’s because the defendants use “a thicker patch matrix,” which also slows down the time for the topical to kick in.
Further, according to the TFM, the FDA declined to approve topical analgesic products to advertise on their labels that they block pain receptors, because such a representation “may be misleading to consumers because the manner in which external analgesic drug products are used determines whether they cause numbness or not,” according to the FDA.
“By making such false and misleading advertising claims through various channels—including their product packaging, online content, social media, and television advertisements—Defendants have achieved their intended goal of increasing their sales and profits by deceiving consumers regarding the nature, characteristics and efficacy of Defendants’ OTC Lidocaine Patches,” the plaintiff argued.
The plaintiff requests an injunction, an award for damages, and other relief. Scilex Pharmaceuticals is represented by Latham & Watkins.