Case 3:21-cv-01280-LB Document 1 Filed 02/23/21 Page 1 of 26
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`LATHAM & WATKINS LLP
`Steven N. Feldman (CA Bar No. 281405)
` steve.feldman@lw.com
`355 South Grand Avenue, Suite 100
`Los Angeles, CA 90071
`Telephone: +1.213.485.1234
`Facsimile: +1.213.891.8763
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`LATHAM & WATKINS LLP
`David K. Callahan (pro hac vice pending)
` david.callahan@lw.com
`Matthew W. Walch (pro hac vice pending)
` matthew.walch@lw.com
`Sophia L. Méndez (pro hac vice pending)
` sophia.mendez@lw.com
`330 North Wabash Avenue, Suite 2800
`Chicago, IL 60611
`Telephone: +1.312.876.7700
`Facsimile: +1.312.993.9767
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`Attorneys for Plaintiff
`Scilex Pharmaceuticals Inc.
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`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF CALIFORNIA
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`SCILEX PHARMACEUTICALS INC.,
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`SANOFI-AVENTIS U.S. LLC and
`HISAMITSU AMERICA, INC.,
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`Plaintiff,
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`v.
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`Defendants.
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`CASE NO. 21-CV-1280
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`COMPLAINT
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`DEMAND FOR JURY TRIAL
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`Plaintiff Scilex Pharmaceuticals Inc. (“Scilex”), by and through its attorneys, alleges as
`follows for its complaint against defendants Sanofi-Aventis U.S. LLC (“Sanofi”) and Hisamitsu
`America, Inc. (“Hisamitsu”) (collectively, “Defendants”):
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`COMPLAINT & DEMAND
`FOR JURY TRIAL
`CASE NO. 21-CV-1280
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`

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`Case 3:21-cv-01280-LB Document 1 Filed 02/23/21 Page 2 of 26
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`NATURE OF THE ACTION
`Through this action, Scilex seeks an award of damages and the entry of injunctive
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`relief to address Defendants’ ongoing false and deceptive advertising of their respective over-
`the-counter (“OTC”) lidocaine patch products, namely, Sanofi’s IcyHot® Lidocaine Patch,
`Aspercreme® Lidocaine Patch and Aspercreme® XL Lidocaine Patch, and Hisamitsu’s Salonpas®
`Lidocaine Pain Relieving Gel-Patch (collectively, the “OTC Lidocaine Patches”).
`Lidocaine is a topical anesthetic that is used to treat pain by depressing sensory
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`receptors in the nerve endings in the skin, which prevents pain signals from reaching the brain.
`The United States Food and Drug Administration (“FDA”) first approved lidocaine for topical
`use in the early 1950s.
`In 1983, the FDA published the Tentative Final Monography for External
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`Analgesic Drug Products for Over-the-Counter Human Use, 48 Fed. Reg. 5852-01 (Feb. 8, 1983)
`(“TFM”), which provides permissible language for the labeling, ingredients, and doses for OTC
`external analgesic products, including those containing 0.5% to 4% lidocaine.
`In 1999, the FDA approved the first transdermal lidocaine patch, in which 5%
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`topical lidocaine is included in a pressure-sensitive adhesive material that attaches to the skin.
`The patches are indicated by the FDA only for relief of pain associated with post-herpetic
`neuralgia (“PHN”), a complication of shingles. The FDA has since approved other prescription-
`only lidocaine patch products to treat PHN pain. While the FDA has approved these products to
`treat the symptoms of PHN and to provide temporary pain relief, many patients have experienced
`various problems with their adhesion and efficacy.
`These problems led Scilex to develop its ZTlido® (lidocaine topical system) 1.8%
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`product, a patch containing 1.8% lidocaine by weight, which is dissolved in Scilex’s proprietary
`single-layer nonaqueous polymer matrix system, allowing for a thinner patch that both provides
`superior adhesion to the skin over patches containing 5% lidocaine by weight, and efficiently
`delivers lidocaine to the area of pain.
`Extensive scientific studies have demonstrated both the bioequivalence of the
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`1.8% lidocaine in Scilex’s ZTlido® patch to the 5% lidocaine in other companies’ FDA-
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`COMPLAINT & DEMAND
`FOR JURY TRIAL
`CASE NO. 21-CV-1280
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`Case 3:21-cv-01280-LB Document 1 Filed 02/23/21 Page 3 of 26
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`approved, prescription-only lidocaine patches, as well as the superiority in adhesion of Scilex’s
`ZTlido® patch over other companies’ FDA-approved, prescription-only 5% lidocaine patches.
`The results of these studies show that Scilex’s ZTlido® patch delivers the same amount of
`lidocaine to the area of pain as other companies’ prescription-only 5% lidocaine patches. In
`addition, the superior adhesion of Scilex’s ZTlido® patch allows it to adhere to the skin for a full
`12 hours and provide pain relief for 24 hours.
`In 2018, the FDA approved Scilex’s ZTlido® product to treat pain associated with
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`PHN. However, doctors routinely prescribe Scilex’s ZTlido® product for off-label indications,
`such as general neuropathic pain, including back and spinal pain. While ZTlido® can be used for
`such off-label indications, Scilex is precluded by FDA regulations from advertising its product
`for such indications.
`In 2003, the FDA issued a proposed rule to amend the TFM to explicitly exclude
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`patches and to classify OTC patches containing analgesic ingredients as Category III products,
`for which “more data [is] needed” to determine if the products are “generally recognized as safe
`and effective.” See External Analgesic Drug Products for Over-the-Counter Human Use;
`Reopening of the Administrative Record and Amendment of Tentative Final Monograph, 68 Fed.
`Reg. 42324-01, 42326 (July 17, 2003). Category III products may only be marketed and sold
`following FDA review and approval of the product and its labeling through a New Drug
`Application (“NDA”) or Abbreviated New Drug Application (“ANDA”).
`In 2016, despite neither complying with the TFM labeling requirements for
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`products containing Category I ingredients nor undergoing the FDA review and approval process
`for products containing Category III ingredients, Defendants began marketing, distributing and
`selling their OTC Lidocaine Patches containing 4% lidocaine by weight under the guise of being
`compliant with FDA regulations. However, Defendants’ labeling and marketing of their OTC
`Lidocaine Patches not only fail to comply with the FDA regulations for OTC lidocaine-
`containing drug products, but are independently false and deceptive.
`Using glossy advertisements featuring Shaquille O’Neil and “Dr. Bob” Arnot,
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`among others, along with other highly deceptive packaging and online marketing, Defendants
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`COMPLAINT & DEMAND
`FOR JURY TRIAL
`CASE NO. 21-CV-1280
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`Case 3:21-cv-01280-LB Document 1 Filed 02/23/21 Page 4 of 26
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`have embarked on an advertising blitz propagating claims that their OTC products: (a) contain
`and/or deliver to the area of pain the maximum amount of lidocaine available in patch form; (b)
`block and/or numb pain; (c) target and/or desensitize aggravated nerves; (d) target more pain
`receptors than other lidocaine patch products; (e) adhere to the skin and provide pain relief for
`periods of 8 or 12 hours, depending on the product; (f) are indicated by the FDA for treatment of
`nerve and neuropathic pain, including back and spinal pain; and/or (g) are FDA-approved,
`prescription products.
`In addition to lacking any FDA review or approval for their products’ marketing
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`and labeling, Defendants’ advertising claims are inaccurate and misleading. Defendants’ false
`and deceptive claims have duped consumers and others into purchasing Defendants’ OTC
`Lidocaine Patches, rather than prescription lidocaine patches produced by Scilex and other FDA-
`approved, prescription-only lidocaine patch producers. Indeed, the FDA has already recognized
`that several of the claims Defendants are making with respect to their OTC Lidocaine Patches
`are misleading to consumers. And cumulatively, Defendants’ claims give the false impression
`that Defendants’ OTC Lidocaine Patches are superior, or equivalent, in efficacy to FDA-
`approved, prescription-only lidocaine patches, such as those offered by Scilex.
`By making such false and misleading advertising claims through various
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`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, which directly compete with Scilex’s ZTlido® patch products.
`Defendants’ unfair and deceptive practices have also caused Scilex to experience significant
`damages, including an adverse impact on the sales of its ZTlido® products and a diminution of
`goodwill in its ZTlido® mark, as Defendants have deceived consumers into buying Defendants’
`patches instead of prescription patches, such as ZTlido®.
`Based on the foregoing conduct, as alleged in more detail below, Scilex seeks an
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`award of damages against Defendants and the entry of injunctive relief enjoining further
`dissemination of Defendants’ false and deceptive advertising. Such relief is appropriate because
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`COMPLAINT & DEMAND
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`CASE NO. 21-CV-1280
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`Case 3:21-cv-01280-LB Document 1 Filed 02/23/21 Page 5 of 26
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`Defendants have violated Sections 43(a)(1)(A) and 43(a)(1)(B) of the Lanham Act (15 U.S.C. §§
`1125(a)(1)(A) & 1125(a)(1)(B)), California’s False Advertising Law (Cal. Bus. & Prof. Code
`§17500) (“FAL”), and California’s Unfair Competition Law (Cal. Bus. & Prof. Code § 17200)
`(“UCL”).
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`JURISDICTION AND VENUE
`The Court has jurisdiction over the subject matter presented by this Complaint
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`pursuant to 28 U.S.C. § 1331 because it includes a claim of false and deceptive advertising under
`the Lanham Act (15 U.S.C. §§ 1051, et seq.), including 15 U.S.C. § 1121, which expressly
`provides that claims arising thereunder are subject to federal subject matter jurisdiction.
`Pursuant to 28 U.S.C. § 1338(b), this Court has supplemental jurisdiction over
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`Scilex’s state law claims, in that those claims are joined with substantial and related claims under
`the Lanham Act. This Court also has supplemental jurisdiction over Scilex’s state law claims
`pursuant to 28 U.S.C. § 1367(a), in that all of Scilex’s claims arise out of a common nucleus of
`operative facts.
`Venue is proper in this district pursuant to 28 U.S.C. § 1391(a) because a
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`substantial part of the events or omissions giving rise to Scilex’s claim occurred in this district,
`as Defendants conduct substantial business within California, including the marketing,
`distribution, and sale of their respective products in California, and because Scilex’s claims arise
`from the marketing, distribution and sale of Defendants’ respective products in California.
`PARTIES
` Plaintiff Scilex is a Delaware corporation, with its principal place of business at
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`960 San Antonio Road, Palo Alto, CA 94303. Plaintiff Scilex markets, distributes, and sells the
`FDA-approved, prescription-strength topical analgesic self-adhesive patch under the brand name
`ZTlido®. ZTlido® is manufactured by Oishi Koseido Co., Ltd.
`Defendant Sanofi is a Delaware corporation, with its principal place of business at
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`55 Corporate Drive Bridgewater, New Jersey 08807. Defendant Sanofi markets, distributes, and
`sells the IcyHot® Lidocaine Patch, the Aspercreme® Lidocaine Patch, and the Aspercreme®
`Lidocaine Patch XL, which are manufactured by Chattem, Inc. Defendant Sanofi markets,
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`COMPLAINT & DEMAND
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`CASE NO. 21-CV-1280
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`Case 3:21-cv-01280-LB Document 1 Filed 02/23/21 Page 6 of 26
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`distributes and sells the aforementioned products to California citizens through drug stores, mass
`retailers, and online retailers.
`Defendant Hisamitsu is a California corporation, with its principal place of
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`business at 100 Campus Drive, Suite 117, Florham Park, New Jersey 07932. Defendant
`Hisamitsu markets, distributes, and sells the Salonpas® Lidocaine Pain Relieving Gel-Patch,
`which is manufactured by its parent company, Hisamitsu Pharmaceutical Co., Inc. Defendant
`Hisamitsu markets, distributes and sells the Salonpas® Lidocaine Pain Relieving Gel-Patch to
`California citizens through drug stores, mass retailers, and online retailers.
`FACTUAL BACKGROUND
`Scilex’s Prescription ZTlido® Patch
`A.
`ZTlido® is a prescription topical analgesic, self-adhesive patch. The patch
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`contains lidocaine—a local anesthetic and topical analgesic—in the amount of 1.8% by weight,
`or 36 mg per patch. The ZTlido® patch is administered by applying the patch to intact skin
`covering the painful area. The patch design is intended to provide improved adhesion compared
`to other prescription lidocaine patches, which contain 5% lidocaine by weight. Scilex has an
`exclusive license to market, distribute, and sell ZTlido® within the United States.
`The FDA approved a New Drug Application for ZTlido® on February 28, 2018
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`under § 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(b)), for the relief
`of pain associated with PHN.
`PHN is a syndrome of persistent neuropathic pain, which frequently follows an
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`outbreak of shingles (also known as herpes zoster rash). Shingles is a painful vesicular skin rash
`caused by the reactivation of latent varicella zoster virus—the same virus that causes
`chickenpox.
`Pain associated with PHN may include itching, burning, aching, or throbbing as a
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`result of damaged nerve fibers and can last for as little as three months or as long as several
`years. Approximately one million people develop shingles annually, and 5-20% of those
`individuals will develop PHN.
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`COMPLAINT & DEMAND
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`CASE NO. 21-CV-1280
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`Case 3:21-cv-01280-LB Document 1 Filed 02/23/21 Page 7 of 26
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`The FDA-approved product labeling for ZTlido® provides that up to three patches
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`may be applied for up to 12 hours within a 24-hour period. Patches may be cut into smaller sizes
`with scissors before the adhesive backing is peeled away. A user may wear clothing over the
`area of application.
`In addition to its indicated use, ZTlido® is often prescribed for off-label uses,
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`including general neuropathic pain, such as back and spinal pain. There is evidence that
`prescription-strength lidocaine patches, such as ZTlido®, can be effective as first-line therapy in
`the management of neuropathic pain. A 2012 study found that over 82% of usage of prescription
`lidocaine patches was off-label.
`Experts in the field have concluded that the therapeutic effectiveness of the
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`ZTlido® patch stems from its proprietary single-layer nonaqueous polymer matrix technology
`that delivers a controlled dose of lidocaine through the skin to provide an analgesic effect. This
`proprietary formulation allows ZTlido® to provide the same efficacy as prescription 5% lidocaine
`patches with less lidocaine by weight, allowing for a thinner patch with superior adhesion to the
`skin. Formulations that deliver less lidocaine through the skin have not been shown to be as
`effective (or more effective) than ZTlido®.
`The superior adhesion of ZTlido® over other lidocaine patches allows it adhere to
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`the body for a full 12 hours and provide pain relief for 24 hours, and allows ZTlido® patches to
`continue to work and have the same efficacy during physical exercise. ZTlido®’s superior
`adhesion also reduces the incidence of possible negative consequences of patch detachment,
`including the dangers posed by consumption of patches by children or pets and the cost of
`replacement patches.
`ZTlido® is a Tier 2 or Tier 3 product on the formularies of many managed health
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`care organizations in the U.S., meaning that many patients prescribed ZTlido® can obtain it with
`only a reasonable co-pay.
`FDA Regulations Applicable to Defendants’ OTC Lidocaine Patches
`B.
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`The FDA regulates the sale and advertising of all drugs, whether available only by
`prescription or OTC. Under the FDA’s current statutory and regulatory framework, an OTC
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`COMPLAINT & DEMAND
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`CASE NO. 21-CV-1280
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`Case 3:21-cv-01280-LB Document 1 Filed 02/23/21 Page 8 of 26
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`drug product can enter the market in one of three ways: (i) by complying with the applicable
`monograph; (ii) as the subject of an FDA-approved NDA or, in the case of generic approval, an
`ANDA; or (iii) through an FDA-approved prescription-to-OTC switch. Obtaining FDA approval
`through the second and third options requires extensive clinical studies or, at a minimum, a
`finding by the FDA that a generic drug is bioequivalent to an already approved drug.
`Currently, drug products containing 0.5% to 4% lidocaine, such as Defendants’
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`OTC Lidocaine Patches, are governed by the FDA’s TFM for external analgesic products. 48
`Fed. Reg. 5852-01 (Feb. 8, 1983). The TFM provides that such products containing lidocaine as
`the active ingredient are indicated only for the temporary relief of pain and itching associated
`with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations. Id. at 5863.
`The TFM states that “the labeling of the product . . . is limited” to this indication. Id.
`In its 2003 proposed rule, the FDA proposed adding the following language to the
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`TFM for external analgesic products until the FDA could determine whether patches containing
`analgesic ingredients, such as lidocaine, were “generally recognized as safe and effective”: “The
`active ingredients of the product consist of any of the following, within the established
`concentration for each ingredient, but not for use in a patch, plaster, or poultice dosage form.”
`68 Fed. Reg. 42324-01, 42325-26 (July 17, 2003) (emphasis added).
`The FDA proposed this amendment because it had become aware that it needed
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`further data on “[t]he safe and effective concentration of the drug ingredient(s),” “how often the
`plaster or poultice needs to be changed for effective use,” and “[t]he frequency of application
`that is considered safe and effective,” among other areas of concern with external analgesic
`patches. Id. at 42325. The FDA further noted that it “is not aware of sufficient data to classify
`any OTC external analgesic active ingredient in a patch, plaster, or poultice dosage form as
`Category I.” Id. Category I products are those which have been determined by the FDA to be
`generally accepted as safe and effective and can be marketed without FDA review and approval
`by complying with the applicable monograph.
`Due to the concerns regarding safety and efficacy, the FDA proposed classifying
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`external analgesic patches as Category III products, which may only be marketed and sold
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`COMPLAINT & DEMAND
`FOR JURY TRIAL
`CASE NO. 21-CV-1280
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`Case 3:21-cv-01280-LB Document 1 Filed 02/23/21 Page 9 of 26
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`following FDA testing, review, and approval of the product through the NDA or ANDA process.
`Id. at 42325-26.
`As detailed below, Defendants’ marketing and sale of their OTC Lidocaine
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`Patches does not comply with either the TFM or the FDA requirements for review and approval
`of OTC drug products offered outside an applicable TFM. Given that Defendants’ marketing
`and labeling of their OTC Lidocaine Patches fails to comply with either the FDA’s TFM or its
`proposed rule, Scilex submitted a Citizen Petition under 21 U.S.C §§ 321, 352, and 355 and 21
`C.F.R. § 10.30 in December 2018 to request that the Commissioner of the FDA finalize the 2003
`proposed amendment to the TFM and remove any OTC lidocaine-containing patches that lack
`FDA approval from the market, among other requests. Scilex noted in its petition that OTC
`lidocaine patch producers, such as Defendants, have been marketing and selling OTC lidocaine
`patch products for several years without complying with the TFM or undergoing FDA review
`and approval, which presents both safety and efficacy concerns. Scilex’s petition is currently
`pending, and Defendants’ noncompliant and misleading marketing of their OTC Lidocaine
`Patches is ongoing. With this Complaint, Scilex addresses the false and deceptive nature of the
`Defendants’ advertising claims under federal and state law, claims that are independent of those
`addressed in Scilex’s Citizen Petition.
`Defendants’ Misleading Marketing Campaign
`C.
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`Defendants’ packaging for and other marketing of their respective products
`contain a variety of false and deceptive claims aimed at enticing consumers to purchase
`Defendants’ OTC Lidocaine Patches instead of prescription lidocaine patches, such as Scilex’s
`ZTlido® product.
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`COMPLAINT & DEMAND
`FOR JURY TRIAL
`CASE NO. 21-CV-1280
`
`
`

`

`Case 3:21-cv-01280-LB Document 1 Filed 02/23/21 Page 10 of 26
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`1.
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`Sanofi’s False and Deceptive Advertisements Regarding Its IcyHot®
`Lidocaine Patch
`
`Defendant Sanofi’s packaging for its IcyHot® Lidocaine Patch makes the
`36.
`following claims with respect to the product in bold, all caps lettering: “MAX STRENGTH
`LIDOCAINE” and “DESENSITIZES AGGRAVATED NERVES.” The packaging portrays
`additional claims that the product: “targets more pain receptors,” “blocks pain signals,” and
`“numbs away pain,” providing “targeted relief” for the “back” and “neck.” The packaging
`further claims that the product is “fast acting” and that consumers may “use 1 patch for up to 12
`hours.”
`
`
`
`Defendant Sanofi, on its product webpage for the IcyHot® Lidocaine Patch,
`37.
`claims that the product “relieve[s] pain fast,” “targets more pain receptors,” “numbs away pain,”
`and “temporarily relieves pain caused by [the] back” and “neck,” in addition to the claims
`depicted on an image of the product’s packaging.
`Defendant Sanofi, in the “Frequently Asked Questions” page accessible via a link
`38.
`on its product webpage for the IcyHot® Lidocaine Patch, claims that “Icy Hot pain relief patches
`are designed to work on muscle aches, strains, sprains, simple backache, and bruises.”
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`COMPLAINT & DEMAND
`FOR JURY TRIAL
`CASE NO. 21-CV-1280
`
`
`

`

`Case 3:21-cv-01280-LB Document 1 Filed 02/23/21 Page 11 of 26
`
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`Defendant Sanofi reiterates these false and deceptive claims in its television
`39.
`commercials featuring ex-NBA player Shaquille O’Neal, wherein Defendant Sanofi shows
`various individuals suffering from back pain and Mr. O’Neal asks viewers: “Ready to take
`control of your back pain?” Defendant Sanofi then claims in bold, all caps lettering on the
`screen that the product “DESENSITIZES NERVES,” over an image of the patch on an
`individual’s lower back. Defendant Sanofi makes additional claims that the IcyHot® Lidocaine
`Patch “desensitizes aggravated nerves with the max strength lidocaine available.”
`
`2.
`
`Sanofi’s False and Deceptive Advertisements Regarding Its
`Aspercreme® Lidocaine Patch and Aspercreme® Lidocaine XL Patch
`
`Defendant Sanofi’s packaging for its Aspercreme® Lidocaine Patch and
`40.
`Aspercreme® Lidocaine XL Patch include the following claims with respect to its products, in
`bold, all caps lettering: “FAST ACTING,” “MAX STRENGTH,” “NUMBS AWAY PAIN,”
`“TARGETS NERVES,” and “TARGETED NO MESS RELIEF” for the “BACK” and “NECK.”
`
`Defendant Sanofi, on its product webpages for the Aspercreme® Lidocaine Patch
`41.
`and Aspercreme® Lidocaine Patch XL, claims that both products offer “targeted, maximum
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`COMPLAINT & DEMAND
`FOR JURY TRIAL
`CASE NO. 21-CV-1280
`
`
`

`

`Case 3:21-cv-01280-LB Document 1 Filed 02/23/21 Page 12 of 26
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`strength pain relief to numb pain away” and “temporarily relieve[] minor pain associated with
`[the] back” and “neck,” in addition to the claims on images of the products’ packaging.
`Defendant Sanofi further claims that consumers may “[u]se 1 patch for up to 12 hours.”
`Defendant Sanofi reiterates these false and deceptive claims in its print
`42.
`advertisements, wherein Defendant Sanofi claims that the Aspercreme® Lidocaine Patch
`provides the “MAX STRENGTH LIDOCAINE” and is “fast acting.”
`Defendant Sanofi repeats these false and deceptive claims in its television
`43.
`commercials, wherein Defendant Sanofi claims in bold lettering on the screen that the product
`“Desensitizes Aggravated Nerves,” over an image of the product on an individual’s lower back.
`Defendant Sanofi makes additional claims that its Aspercreme Lidocaine Patch “quickly
`desensitizes aggravated nerves to block pain for maximum strength relief” and can “Relieve the
`nerves. Stop the pain.”
`Hisamitsu’s False and Deceptive Advertisements Regarding Its
`3.
`Salonpas® Pain Relieving Gel-Patch
`Defendant Hisamitsu’s packaging for its Salonpas® Lidocaine Pain Relieving Gel-
`44.
`Patch makes the following claims with respect to the product, in bold, all caps lettering:
`“MAXIMUM STRENGTH” with “IMPROVED ADHESION.” The packaging further claims
`that the product “desensitize[s] aggravated nerves for temporary relief of pain [in] back, neck,
`shoulders, knees & elbows,” and provides “numbing relief.” The packaging also claims that
`consumers may “apply [the product] for 8 hours.”
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`COMPLAINT & DEMAND
`FOR JURY TRIAL
`CASE NO. 21-CV-1280
`
`
`

`

`Case 3:21-cv-01280-LB Document 1 Filed 02/23/21 Page 13 of 26
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`Defendant Hisamitsu, on its product webpage for the Salonpas® Lidocaine Pain
`45.
`Relieving Gel-Patch, makes the following claims with respect to the product: “desensitizes
`aggravated nerves” and “provides numbing relief,” in addition to those displayed on an image of
`the product’s packaging.
`Defendant Hisamitsu makes further misleading statements in its television
`46.
`commercials, claiming that its Salonpas® Lidocaine Pain Relieving Gel-Patch product “blocks
`pain receptors for effective, non-addictive relief.” Defendant Hisamitsu’s commercials feature
`“Dr. Bob” Arnot, misleadingly indicating to consumers that its product is an FDA-approved or
`prescription product. In at least one commercial, which is accessible via a link on the Salonpas®
`Lidocaine Pain Relieving Gel-Patch product webpage, Defendant Hisamitsu depicts Dr. Bob
`wearing a white lab coat in a doctor’s office, telling an apparent patient that the Salonpas®
`Lidocaine Pain Relieving Gel-Patch “blocks pain receptors for effective, non-addictive relief”
`and recommending the product for the patient’s back pain. A screen shot of that advertisement is
`shown below.
`
`Defendant Hisamitsu repeats these false and deceptive claims in its social media.
`47.
`In an October 16, 2017 blog post titled “Frequently Asked Questions with Dr. Bob Arnot,”
`which is found on Hisamitsu’s website for Salonpas®, “Dr. Bob” states that “many doctors
`prescribe off-label uses for [prescription] lidocaine patches including aggravated nerve pain in
`the back, neck, shoulders, knees and elbows,” and claims that the Salonpas® Lidocaine Pain
`Relieving Gel-Patch has “4% of lidocaine which I’d argue is close to the 5% lidocaine patch
`COMPLAINT & DEMAND
`FOR JURY TRIAL
`CASE NO. 21-CV-1280
`
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`Case 3:21-cv-01280-LB Document 1 Filed 02/23/21 Page 14 of 26
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`you would get with a prescription” and that “Salonpas® followed the same principles used
`for the Rx (5% Lidocaine) version, making it the same size and using the same hydrogel
`technology as its Rx cousin. The only change they made was to improve the price so as to
`make the product more accessible to the general public.” (emphasis added). The same claims are
`found in a January 9, 2017 blog post on Defendant Hisamitsu’s website for Salonpas®, titled “Dr.
`Bob Arnot on Keeping Healthy and Active with Salonpas.”
`Defendant Hisamitsu further compares its product to prescription-strength
`48.
`lidocaine patches in an October 2, 2017 blog post on its website for Salonpas®, titled “Lidocaine
`for Pain Relief.” Defendant Hisamitsu claims that “Medicare and many insurance companies are
`no longer providing coverage for off-label use of lidocaine patches. A monthly supply of
`lidocaine patches can cost hundreds of dollars[,]” and again represents that its Salonpas
`Lidocaine Pain Relieving Gel-Patch “us[es] the same size and hydrogel technology as the
`prescription lidocaine patch.”
`The False and Deceptive Nature of Defendants’ Claims
`4.
`
`Defendants’ marketing of their OTC Lidocaine Patches misleads managed health
`49.
`care companies, pharmacies, doctors and consumers regarding the characteristics and efficacy of
`Defendants’ products.
`Cumulatively, Defendants’ claims misleadingly imply that their OTC Lidocaine
`50.
`Patches have FDA approval for certain indications, and are superior, or at least equivalent, in
`efficacy and results to prescription lidocaine patches, such as Scilex’s ZTlido® patch, and that the
`products are otherwise substantially similar or identical in all material respects.
`Defendants have targeted consumers of prescription lidocaine patches, such as
`51.
`ZTlido® patches, through their false and misleading advertisements, and in doing so have
`secured substantial sales to the detriment of Scilex as a result of their misconduct. On
`information and belief, Defendant Sanofi’s 2019 U.S. sales for its IcyHot® and Aspercreme®
`products exceeded $155 million and $106 million, respectively. On information and belief,
`Defendant Hisamitsu’s 2019 U.S. sales for its Salonpas patch products exceeded $125 million.
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`COMPLAINT & DEMAND
`FOR JURY TRIAL
`CASE NO. 21-CV-1280
`
`
`

`

`Case 3:21-cv-01280-LB Document 1 Filed 02/23/21 Page 15 of 26
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`Defendants have implemented their marketing plan through the following
`52.
`statements, conveying false and deceptive messages to consumers:
`Defendants’ Statements and Sources
`False/Misleading Messages
`• “MAX STRENGTH LIDOCAINE”
`• Falsely states that Defendants’
`(IcyHot® patch packaging)
`products contain and deliver to the
`area of pain the maximum amount
`• “max strength lidocaine available”
`of lidocaine available in patch form
`(IcyHot® patch commercial)
`• Misleadingly implies that
`• “MAX STRENGTH” (Aspercreme®
`Defendants’ products are superior,
`patches packaging)
`or at least equivalent, in efficacy
`• “maximum strength pain relief”
`and results to prescription-strength
`(Aspercreme® patches webpages)
`lidocaine patch products
`• “MAX STRENGTH LIDOCAINE”
`(Aspercreme® patches print
`advertisements)
`• “maximum st