Case 1:22-cv-05931-PAE Document 1 Filed 07/12/22 Page 1 of 25
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
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`BAYER HEALTHCARE LLC,
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`Plaintiff,
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`PERRIGO COMPANY PLC,
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`v.
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`Defendant.
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`COMPLAINT
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`Plaintiff Bayer Healthcare LLC (“Bayer”), by its attorneys Simpson Thacher &
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`Bartlett LLP for its Complaint against Defendant Perrigo Company plc (“Perrigo”), respectfully
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`alleges as follows:
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`NATURE OF THE ACTION
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`1.
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`This is a case about false advertising in the over-the-counter (“OTC”)
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`allergy relief market. Defendant Perrigo is the maker of Nasonex 24HR Allergy (“Nasonex”),
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`which obtained Food and Drug Administration (“FDA”) approval for sale in the highly
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`competitive OTC market in March 2022. Plaintiff Bayer brings suit to stop Perrigo from
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`misleading consumers about the length of time it takes for Nasonex to relieve allergy symptoms,
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`both independently and relative to competitor products, such as those offered by Bayer. Bayer is
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`the maker of Claritin and Claritin-D, which are antihistamine pills, and has recently launched
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`Astepro, the first-ever antihistamine nasal spray to be in offered over-the-counter in the United
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`States.
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`: No. 22 Civ. 5931
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`: JURY DEMAND
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`Case 1:22-cv-05931-PAE Document 1 Filed 07/12/22 Page 2 of 25
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`2.
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`Perrigo’s false advertising campaign is wrongly claiming that Nasonex
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`works 2x faster than other OTC allergy sprays and that antihistamine pills and antihistamine
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`sprays do not. The truth is that Nasonex is part of a class of steroid nasal sprays that take much
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`longer to work than antihistamine medicines. Steroid nasal sprays take half a day to a full day to
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`start to work, or longer. Antihistamines start to work much faster, some at 30 minutes, some at
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`60 minutes, some at 75 to 180 minutes after the first dose. Given the significant lag time for
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`steroid allergy sprays to start working on the first dose, steroid-based sprays such as Nasonex
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`have significantly longer onset times than antihistamine medicines and are not considered “fast”
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`within the allergy relief market. Perrigo is egregiously misstating these facts to American
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`consumers.
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`3.
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`Perrigo’s advertising campaign makes the untrue and unsupported claims
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`that (1) Nasonex provides relief twice as fast as other OTC allergy sprays; (2) Nasonex “works”
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`at 12 hours or 2x faster than leading nasal allergy sprays; (3) Nasonex provides “fast” relief; and
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`(4) antihistamine pills and antihistamine sprays cannot be compared with respect to onset of
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`action to other OTC steroid nasal sprays (collectively, the “False Onset Claims”).
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`4.
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`The False Onset Claims are false and misleading on their face and cannot
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`be substantiated by clinical results.
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`5.
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`First, Perrigo’s claim that Nasonex provides allergy relief twice as fast as
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`other OTC allergy sprays is false and misleading. Studies conducted to determine the onset
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`speed of Nasonex have concluded that Nasonex begins to take effect, at the earliest, at 11 hours
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`after use. In comparison, clinical studies show that other nasal allergy sprays, such as the
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`leading competitor Flonase begin to relieve symptoms, at the earliest, at 12 hours after treatment.
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`Case 1:22-cv-05931-PAE Document 1 Filed 07/12/22 Page 3 of 25
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`6.
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`Second, Perrigo’s claim that Nasonex “works” in 12 hours or 2x faster
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`than leading nasal allergy sprays is misleading. In contrast to the advertisements, the Nasonex
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`label states that consumers “may start to feel relief within 12 hours.” (emphasis added).
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`Nasonex users can expect to experience “full effect [only] after several days of regular, once-a-
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`day use.” Perrigo has glibly converted the FDA-required message that Nasonex “may” start to
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`provide relief within 12 hours into a slick consumer promise that the products will provide relief
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`at 12 hours or less – that is, two times faster than Flonase based on Perrigo’s misleading
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`interpretation.
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`7.
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`Third, Perrigo’s claim that Nasonex offers “fast” relief is incompatible
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`both with clinical results and with industry standards. Industry standards require symptom relief
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`versus placebo at one hour or less in order to qualify as “fast” relief. Nasonex’s onset time of 11
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`hours, at the earliest, does not meet this standard.
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`8.
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`Fourth, Perrigo’s claim that, “unlike allergy pills,” Nasonex works “2X
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`faster” than leading allergy steroid nasal sprays is flatly contradicted by clinical studies. Indeed,
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`Bayer’s Claritin starts working in the range of 75 to 180 minutes, and Bayer’s Claritin-D starts
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`working on allergies with nasal congestion in as little as 30 minutes. Thus, both Claritin and
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`Claritin-D (collectively, the “Claritin Products”), which are “allergy pills,” have significantly
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`earlier onset times than does Nasonex. In addition, Perrigo makes the demonstrably false claim
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`that antihistamine pills and antihistamine nasal sprays cannot be compared with respect to onset
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`of action with “other steroid nasal sprays,” by denoting both antihistamine pills and
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`antihistamine sprays with an “N/A” in a chart showing which medicines work “2x faster” than
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`steroid nasal sprays. Claritin-D, an antihistamine pill, and Astepro, an antihistamine spray, both
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`start to work in as little as 30 minutes, over twenty times faster than both Nasonex and Flonase,
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`Case 1:22-cv-05931-PAE Document 1 Filed 07/12/22 Page 4 of 25
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`steroid nasal sprays. Even under a conservative calculation, Claritin starts to work four times
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`faster than Nasonex and Flonase.
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`9.
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`Bayer therefore brings this action to enjoin Perrigo’s efforts to advertise
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`false and misleading claims about the time within which Nasonex offers allergy symptom relief,
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`and how Nasonex compares to competitor treatments with respect to symptom relief onset. The
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`Court should immediately enjoin Perrigo from further dissemination of the False Onset Claims.
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`JURISDICTION AND VENUE
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`10.
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`This Court has subject matter jurisdiction over Bayer’s claim for violation
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`of Section 43(a) of the Lanham Act pursuant to Section 39 of the Lanham Act, 15 U.S.C. §
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`1121(a), and 28 U.S.C. §§ 1331, 1332 and 1338(a). This Court has supplemental jurisdiction
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`over Bayer’s claims for violation of New York’s General Business statutes and common law
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`pursuant to 28 U.S.C. §§ 1338(b) and 1367(a).
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`11.
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`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391(b) and (c)
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`because Perrigo transacts business in this district, markets and sells its Nasonex product in this
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`district, and, upon information and belief, maintains a manufacturing facility in the Bronx, New
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`York.
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`PARTIES
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`12.
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`Plaintiff Bayer is a limited liability corporation organized under the laws
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`of the state of Delaware and with its principal place of business in Whippany, New Jersey.
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`Bayer is engaged in the business, among other things, of manufacturing and selling
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`nonprescription, or OTC, medicines and other health and personal care products. Bayer’s
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`products include the Claritin Products, which are well-known OTC allergy treatments, as well as
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`the recently launched OTC allergy nasal spray Astepro.
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`13.
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`Upon information and belief, Defendant Perrigo is a corporation organized
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`under the laws of the Republic of Ireland with its international headquarters in Dublin, Ireland.
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`Perrigo’s U.S. headquarters and principal place of business are located in Allegan, Michigan.
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`Perrigo manufactures and sells a variety of OTC medicines in the U.S. market. Perrigo markets
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`and sells its OTC nasal spray Nasonex in the U.S. market.
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`FACTUAL BACKGROUND
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`The Products
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`14.
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`Bayer’s Claritin Products and Astepro compete in the OTC allergy relief
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`market with Perrigo’s Nasonex. Allergy relief medicines treat the symptoms of an allergic
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`reaction to indoor, outdoor, seasonal, and perennial (or year-round) allergens such as pollen and
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`dust. Typical symptoms include nasal and sinus congestion, sneezing, runny nose, and an itchy
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`throat or nose.
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`15.
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`Allergy relief medicines rely on one or more of several mechanisms to
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`counteract the symptoms of an allergic reaction. Antihistamines, like Astepro and the Claritin
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`Products, relieve symptoms by blocking the absorption of the chemical histamine, which is
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`released by the immune system during an allergic reaction and causes the symptoms.
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`Decongestants, like the one in Claritin-D, relieve nasal and sinus congestion. Corticosteroids,
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`like Nasonex and Flonase, counteract inflammation caused by one or more substances, including
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`cytokines, that the body produces during an allergic reaction.
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`16.
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`Allergy relief medicines are delivered via various application methods.
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`Some medicines, like the Claritin Products, are taken orally in capsule, tablet, or oral solution
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`form. Others, like Astepro and Nasonex, are taken via a nasal spray.
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`17.
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`Bayer’s Claritin is an oral antihistamine containing the active ingredient
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`loratadine. Claritin offers temporary relief for allergy symptoms including runny nose, sneezing,
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`watery eyes and itchy eyes, nose, and throat. Based on clinical studies, users of Claritin
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`experience onset of nasal symptom relief anywhere in the range of 75 to 180 minutes after the
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`first dose.
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`18.
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`Bayer’s Claritin-D is a combination oral antihistamine and decongestant
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`containing the active ingredients loratadine and pseudoephedrine. Claritin-D offers temporary
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`relief for allergy symptoms including sneezing, runny nose, watery eyes, and itchy eyes, nose,
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`and throat. Claritin-D also offers temporary relief for nasal and sinus congestion and swelling of
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`nasal passages. Based on clinical studies, users of Claritin-D experience onset of nasal symptom
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`relief in as little as 30 minutes after the first dose.
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`19.
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`Bayer’s Astepro is an antihistamine nasal spray containing the active
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`ingredient azelastine hydrochloride (“azelastine”). Astepro offers temporary relief for the
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`following allergy symptoms: nasal congestion, runny nose, sneezing, and itchy nose. Based on
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`clinical studies, Astepro starts working in 30 minutes after the first dose.
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`20.
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`Bayer’s Astepro is targeted at the highly competitive OTC nasal spray
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`market. Unlike competitor allergy relief nasal sprays such as Nasonex and Flonase, Astepro is
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`the first OTC antihistamine nasal spray. Because an antihistamine spray blocks histamine
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`receptors directly and is applied directly to a user’s nasal passages, Astepro’s primary
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`competitive advantage is its short onset time: 30 minutes for nasal symptom relief as compared
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`with 11-12 hours to two days for steroid sprays such as Nasonex and Flonase.
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`21.
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`The FDA approved Astepro for sale as an OTC product on June 17, 2021,
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`marking its entry as a competitor in the OTC allergy relief market. Bayer launched Astepro for
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`OTC sale on July 1, 2022.
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`22.
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`Flonase is a leading corticosteroid nasal spray manufactured by
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`GlaxoSmithKline containing the active ingredient fluticasone propionate. Flonase offers relief
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`for allergy symptoms including nasal congestions, runny nose, sneezing, watery eyes, and itchy
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`eyes and nose. Based on the prescription label, Flonase users have experienced nasal symptom
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`relief as soon as 12 hours after the first dose.
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`23.
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`Perrigo’s Nasonex is a corticosteroid nasal spray containing the active
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`ingredient mometasone furoatemonohydrate (glucocorticoid) (“mometasone”). Nasonex offers
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`temporary relief for allergy symptoms including nasal congestion, sneezing, runny nose, and
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`itchy nose. Based on the prescription label, Nasonex users have experienced improvements in
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`nasal symptoms between 11 hours and within two days after the first dose.
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`24.
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`On March 17, 2022, Perrigo announced that the FDA had approved
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`Nasonex for sale as an OTC product. Perrigo has been advertising Nasonex with OTC retailers
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`since June 23, 2022 at the latest, and has started offering Nasonex for sale on the Walmart and
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`Target websites and in retail stores, as shown in Exhibits C and D attached to this Complaint.
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`While these websites state on some web pages that Nasonex is “not available”, they state on
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`other web pages that Nasonex is available for pick-up and shipping the week of July 11.
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`Nasonex is also available for direct purchase in retail stores.
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`Perrigo’s Advertisements Making False Onset Claims
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`25.
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`Perrigo’s False Onset Claims mislead consumers as to the relative onset of
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`action of Nasonex as compared to other OTC allergy medicines, including the Claritin Products,
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`Astepro, and Flonase. Specifically, Perrigo significantly overstates the absolute and the relative
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`onset time of Nasonex.
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`Case 1:22-cv-05931-PAE Document 1 Filed 07/12/22 Page 8 of 25
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`26.
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`Onset time is important to allergy patients and consumers because it
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`provides an estimate of how long a patient can expect to wait between taking a medicine and
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`beginning to experience relief from allergy symptoms on the first day of taking the medicine.
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`27.
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`The False Onset Claims include the claims that: (1) Nasonex provides
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`relief twice as fast as other OTC allergy sprays; (2) Nasonex “works” at 12 hours or 2x faster
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`than leading nasal allergy sprays; (3) Nasonex provides “fast” relief; and (4) antihistamine pills
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`and antihistamine sprays cannot be compared with respect to onset of action to other OTC
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`steroid nasal sprays. Perrigo thus claims to offer a superior product to allergy patients and
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`consumers who value quick relief from their symptoms.
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`28.
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`In one advertisement, attached as Exhibit A to this Complaint, Perrigo
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`claims that Nasonex offers “allergy relief that works 2x faster* than leading nasal allergy sprays”
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`with a smaller font qualifier below: “*As compared to other OTC steroid nasal sprays, based on
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`FDA approved labeling.” Perrigo does not identify the “leading nasal allergy sprays” or the
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`“OTC steroid nasal sprays” to which it is comparing Nasonex; nor does it state onset times,
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`whether for Nasonex or for the unidentified competitor medicines.
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`29.
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`The advertisement attached as Exhibit A appears as an image on retailer
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`Walmart’s ecommerce product page for Nasonex, found at:
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`https://www.walmart.com/ip/Nasonex-24HR-Allergy-Nasal-Spray-24-Hour-Allergy-Medicine-
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`120-SPR-17-0ML/173526382?wmlspartner=wlpa&selectedSellerId=0.
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`30.
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`The Walmart advertisement for Nasonex includes another graphic, titled
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`“Distinctly Different Allergy Relief,” attached as Exhibit B to this Complaint. In this graphic,
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`Perrigo offers a comparison chart in checklist format, using six criteria, comparing Nasonex to
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`three allergy medicine categories: (1) leading allergy nasal sprays, (2) antihistamine pills, and
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`Case 1:22-cv-05931-PAE Document 1 Filed 07/12/22 Page 9 of 25
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`(3) antihistamine sprays. Perrigo again claims that Nasonex “works 2x faster” by marking
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`Nasonex with a positive white √ while marking “leading allergy nasal sprays” with a negative
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`red “X.” For antihistamine pills and antihistamine sprays, the chart shows a light gray “N/A.”
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`There is an asterisk on the “works 2x faster” claim, which ties to miniscule print at the bottom of
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`the page, stating: “*As compared to other OTC steroid nasal sprays, based on FDA approved
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`labeling.” The “N/A” for antihistamine pills and antihistamine sprays communicates two false
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`messages. First, the literal words – N/A or “Not Applicable” for antihistamine pills and
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`antihistamine sprays – indicate that Nasonex (claimed to be “distinctly different”) cannot be
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`compared to these two categories of medicines when it comes to onset time. By stating that
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`speed of onset is not “applicable” to the antihistamine pills and antihistamine sprays, the chart
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`literally conveys that speed of onset is not “relevant or appropriate” for these medicines, whereas
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`the truth is that both antihistamine pills and antihistamine sprays are significantly faster than
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`Nasonex. Second, the “N/A” communicates that antihistamine pills and antihistamine sprays
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`cannot be compared to other OTC steroid nasal sprays (referred to in the footnote), despite the
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`fact that, again, both antihistamine pills and antihistamine sprays are significantly faster than all
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`OTC steroid nasal sprays.
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`31.
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`The Walmart advertisement contains another statement, included as
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`Exhibit C to this Complaint, in which Perrigo claims that Nasonex provides “Fast, 24-Hour
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`Relief: Unlike allergy pills, once daily Nasonex scent-free mist works 2X faster than leading
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`allergy steroid nasal sprays, as compared to other OTC steroid nasal sprays, based on FDA
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`approved labeling.” Perrigo again does not identify the OTC steroid nasal sprays to which it is
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`comparing Nasonex; nor does it state the onset speeds for those medicines as reported on the
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`relevant FDA approved labeling.
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`Case 1:22-cv-05931-PAE Document 1 Filed 07/12/22 Page 10 of 25
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`32.
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`The statement in Exhibit C communicates that Nasonex has a superior
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`onset speed when compared to allergy pills like the Claritin Products because it, “[u]nlike
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`allergy pills . . . works 2X faster than leading allergy steroid nasal sprays.”
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`33.
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`The statement shown in Exhibit C also falsely claims that Nasonex offers
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`consumers “fast” allergy relief.
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`34.
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`The statement shown in Exhibit C appears on Walmart’s ecommerce
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`product page for Nasonex found at: https://www.walmart.com/ip/Nasonex-24HR-Allergy-
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`Nasal-Spray-24-Hour-Allergy-Medicine-120-SPR-17-
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`0ML/173526382?wmlspartner=wlpa&selectedSellerId=0.
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`35.
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`A similar statement also appears on Target’s ecommerce product page for
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`Nasonex, a copy of which is attached as Exhibit D. This advertisement can be found at:
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`https://www.target.com/p/nasonex-allergy-mometasone-furoate-nasal-spray-0-38-fl-oz/-/A-
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`86065697.
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`36.
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`The False Onset Claims as presented in Perrigo’s advertisements
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`collectively make unsupported and unsubstantiated claims about the absolute and relative onset
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`speed of Nasonex.
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`37.
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`Perrigo began to publish the advertisements for Nasonex reflected in
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`Exhibits A, B, C, and D no later than June 23, 2022.
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`38.
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`On June 29, 2022, Bayer sent a cease-and-desist letter to Perrigo stating
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`that Perrigo’s Nasonex advertisements are false and misleading and demanding that Perrigo
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`cease disseminating the False Onset Claims, including by removing the False Onset Claims from
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`Walmart’s and Target’s ecommerce websites and any other media. Representatives from Bayer
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`and Perrigo thereafter communicated by phone and in writing in an attempt to achieve a
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`Case 1:22-cv-05931-PAE Document 1 Filed 07/12/22 Page 11 of 25
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`consensual resolution of Bayer’s concerns and to ensure that false and misleading information
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`not be presented to allergy relief consumers.
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`39.
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`On July 8, 2022, Perrigo informed Bayer that Perrigo would not withdraw
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`its False Onset Claims. While Perrigo offered to make minor revisions to the advertisements,
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`Perrigo’s proposed amendments do not change the fundamental falsity of the False Onset
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`Claims. To the contrary, Perrigo insists that it should be able to advertise the False Onset Claims
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`on an ongoing basis.
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`Perrigo’s Claims About Nasonex’s Onset Speed Are Contradicted By Clinical Studies
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`40.
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`Clinical allergy relief studies can measure the time within which allergy
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`medicines will provide study participants with symptom relief. These studies are generally
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`conducted by exposing participants to an allergen, either in a controlled or natural setting (also
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`known as a “park” setting), to induce an allergic response. Participants are randomly divided
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`into the testing groups and, according to the study protocol, receive either a placebo or a dose of
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`the active ingredient being tested. The actual identity of the drug given to each participant is
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`hidden from everyone involved in the study until the study is completed. Researchers and
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`participants record allergy symptoms over time pursuant to the study protocol, and the results of
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`participants who received different active ingredients and/or the placebo are compared.
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`41.
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`For Claritin, several reliable clinical studies show that loratadine, the
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`active ingredient in Claritin, has onset of action in 75 to 180 minutes after dosing. Studies
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`conducted in 2004 by Dr. Petra Stübner et al. found that loratadine has onset of action in 75
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`minutes for seasonal allergic rhinitis and in 90 minutes for perennial allergic rhinitis. A 1997
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`study conducted by Dr. Friedrich Horak concluded that loratadine has onset of action in 90
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`minutes. And a 1997 study conducted by Dr. James Day also concluded that loratadine has onset
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`Case 1:22-cv-05931-PAE Document 1 Filed 07/12/22 Page 12 of 25
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`of action in 90 minutes. Other studies show loratadine achieving separation from placebo with
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`respect to symptom relief at 180 minutes after the first dose. Consequently, Bayer maintains that
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`Claritin has an onset of action of anywhere from 75 to 180 minutes.
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`42.
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`For Claritin-D, a reliable clinical study from 1997 shows that the medicine
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`has onset of action of 30 minutes after dosing. This randomized, double-dummy, double-blind,
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`placebo-controlled, multicenter clinical study by Dr. John Georgitis concluded that the active
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`ingredients of Claritin-D (loratadine-pseudoephedrine) had an onset of action of 30 minutes. A
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`2009 study by Horak et al. also showed that pseudoephedrine had an onset of action of 30
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`minutes.
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`43.
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`For Astepro, two reliable clinical studies show onset of action at 30
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`minutes. A 2009 randomized, double-blind, placebo-controlled study by Shah et al. determined
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`that azelastine, the active ingredient in Astepro, began to relieve symptoms at 30 minutes. A
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`2021 randomized, double-blind, placebo-controlled crossover study sponsored by Bayer
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`similarly determined that azelastine began to relieve symptoms at 30 minutes.
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`44.
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`For Flonase, the FDA-approved label for prescription Flonase states that
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`“[i]n 4 randomized, double-blind, vehicle placebo-controlled, parallel-group allergic rhinitis
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`studies and 2 studies of patients in an outdoor ‘park’ setting (park studies), a decrease in nasal
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`symptoms in treated subjects compared to placebo was shown to occur as soon as 12 hours after
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`treatment with a 200-mcg dose of Fluticasone Propionate Nasal Spray, USP. Maximum effect
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`may take several days.”
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`45.
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`The FDA-approved label for OTC Flonase (which has the same active
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`ingredient and dosage as prescription Flonase) informs consumers that “you may start to feel
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`relief the first day and full effect after several days of regular, once-a-day use.”
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`Case 1:22-cv-05931-PAE Document 1 Filed 07/12/22 Page 13 of 25
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`46.
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`For Nasonex, the FDA-approved label for prescription Nasonex states that
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`“[i]n patients with seasonal allergic rhinitis, NASONEX Nasal Spray 50 mcg, demonstrated
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`improvement in nasal symptoms (vs. placebo) within 11 hours after the first dose based on one
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`single-dose, parallel-group study of patients in an outdoor ‘park’ setting (park study) and one
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`environmental exposure unit (EEU) study, and within 2 days in two randomized, double-blind,
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`placebo-controlled, parallel-group seasonal allergic rhinitis studies. Maximum benefit is usually
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`achieved within 1 to 2 weeks after initiation of dosing.”
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`47.
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`The FDA-approved label for OTC Nasonex (which has the same active
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`ingredient and dosage as prescription Nasonex) informs consumers that “you may start to feel
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`relief within 12 hours and full effect after several days of regular, once-a-day use.”
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`Perrigo’s False Onset Claims Are Literally False and Misleading
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`False “2x Faster” Claims
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`48.
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`Clinical studies and FDA-approved labeling show that Nasonex offers
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`comparable onset of allergy relief to other corticosteroid nasal sprays, such as Flonase. The
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`False Onset Claims mislead consumers by falsely stating that Nasonex offers faster, and indeed
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`twice as fast, symptom relief.
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`49.
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`Perrigo’s claim that Nasonex provides “Allergy Relief That Works 2x
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`Faster than Leading Nasal Allergy Sprays” is literally false and misleading.
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`50.
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`The FDA-approved label for OTC Nasonex states that users “may start to
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`feel relief within 12 hours.” The FDA-approved label for OTC Flonase, the leading OTC steroid
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`nasal allergy spray, states that consumers “may start to feel relief the first day.” Read literally,
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`this means that Flonase users could experience relief at any time from hour 1 to hour 24.
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`Accordingly, it is false for Perrigo to claim that Nasonex offers relief that is two times as fast as
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`Case 1:22-cv-05931-PAE Document 1 Filed 07/12/22 Page 14 of 25
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`the relief offered by Flonase (or other steroid nasal sprays) because Nasonex’s 12-hour onset is
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`not as fast, let alone twice as fast, for every point between 1 and 24 hours. Further, Perrigo fails
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`to include industry-standard “first dose” language, required by NAD precedent, clarifying that
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`the time for onset of symptom relief applies only to the first dose.
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`51.
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`Perrigo’s advertisement refers to “FDA approved labeling.” As just
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`explained, the OTC labels for Nasonex and Flonase demonstrate the falsity of Perrigo’s 2x faster
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`claim. The prescription labels for Nasonex and Flonase are also “FDA approved” labels and
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`provide even more detailed content showing the clear falsity of Perrigo’s onset clams. The
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`prescription label for Nasonex states that two studies showed symptom relief within 11 hours and
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`two studies showed symptom relief within two days. The prescription label for Flonase states
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`that users experienced a decrease in symptoms “as soon as 12 hours” after initial treatment and
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`describes six studies where symptom relief was shown to occur as soon as 12 hours after the first
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`dose was administered.
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`52.
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`Perrigo’s misleading onset claim for Nasonex is also false, and indeed
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`more so, when Nasonex is compared to Astepro. Astepro’s key competitive advantage as the
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`first antihistamine nasal spray is that it offers faster relief than steroid nasal sprays like Nasonex
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`and Flonase, and another important competitive advantage is that Astepro does not contain
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`steroids. By falsely claiming that Nasonex offers “2X faster” relief than leading nasal sprays like
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`Flonase and giving antihistamine sprays like Astepro a “not applicable” for this comparison,
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`Perrigo falsely conveys that Nasonex is the superior nasal spray from an onset standpoint. This
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`claim is false, as Astepro, a nasal allergy spray, begins to relieve symptoms at 30 minutes.
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`Nasonex is thus neither faster nor “2x faster” than Astepro. Rather, Nasonex is 20 times slower
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`than Astepro.
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`Case 1:22-cv-05931-PAE Document 1 Filed 07/12/22 Page 15 of 25
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`53. Murray S. Kessler, CEO of Perrigo, purposefully and publicly stated the
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`false claim that Nasonex “works 2x faster” during a presentation to investors at the Oppenheimer
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`22nd Annual Consumer Conference held on June 15, 2022 without explaining either the basis for
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`this claim or the medicines to which he was comparing Nasonex, stating: “I’m very excited
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`about NASONEX. It was once a $1 billion brand at Rx that still has high brand, unaided recall
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`of the brand awareness. That product, we’re launching into the lower seasonality. Spring allergy
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`season is much bigger than that, but it will help us adjust our marketing plans. And – but it’s a
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`great product, works 2x faster. It treats multi-symptoms and has great brand awareness.”
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`False Promise That Nasonex “Works” In 12 Hours
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`54.
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`Perrigo’s claim that Nasonex “works” in 12 hours is false and misleading
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`because there is a clinical difference between “starts to work” and “works” that Perrigo is not
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`respecting and is purposefully trying to blur. Perrigo claims that Nasonex “works” twice as fast
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`as a leading steroid nasal spray like Flonase. Because the FDA-approved label for OTC Flonase
`
`states that users “may start to feel relief the first day,” Perrigo necessarily claims that Nasonex
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`“works” in, at most, 12 hours.
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`55.
`
`Perrigo’s advertisements repeatedly state that Nasonex “works” 2x faster.
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`The fact of the matter is that Nasonex’s OTC label states only that “you may start to feel relief
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`within 12 hours and full effect after several days of regular, once-a-day use.” (emphasis added).
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`56.
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`The FDA required Perrigo to use conditional language on its OTC label:
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`“may start to feel relief.” Perrigo’s advertisements wrongly convert this language into a promise
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`of full-on “working” and further promise that the effect happens in half the time of other steroid
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`sprays. Because other sprays like Flonase indicate that “you may start to feel relief the first
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`day,” Perrigo is promising that Nasonex “works” in 12 hours or less. This is plainly wrong when
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`Case 1:22-cv-05931-PAE Document 1 Filed 07/12/22 Page 16 of 25
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`the medicine in Nasonex is only “starting to work” and its full effect may not happen until after
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`several days. Indeed, one clinical study on the active ingredient in Nasonex found that only 28%
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`of Nasonex subjects experienced clinically significant relief within 12 hours after the initial dose.
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`Far from Perrigo’s guarantee that Nasonex “works” in 12 hours or less, the vast majority of
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`Nasonex users did not experience relief that is clinically significantly different than taking a
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`placebo.
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`57.
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`By way of contrast, other advertisers in the allergy field are more careful
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`and accurate in stating that their medicines “start to work” at their onset times. For example,
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`Bayer regularly advertises that Claritin-D “starts working on allergies with nasal congestion in as
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`little as 30 minutes.” Bayer similarly advertises that Astepro “starts to work in 30 minutes.” It is
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`wrong and factually erroneous for Perrigo to claim that “starts to work” and “working” mean the
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`same thing.
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` False Promise Of “Fast” Relief
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`58.
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`Perrigo falsely claims that Nasonex offers “Fast, 24-Hour Relief” and
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`“FAST 24HR RELIEF,” as reflected in the text of Exhibits C and D. Based on established
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`industry standards, however, Nasonex does not provide “fast” relief.
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`59.
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`Advertising disputes in the allergy category have led to the development
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`of an industry standard that “fast” for purposes of allergy relief means significant symptom relief
`
`at one hour or less.1 To qualify as providing “fast” allergy relief, a medicine must provide
`
`
`1 The one-hour mark for “fast” allergy relief has been discussed in a plethora of decisions at the
`National Advertising Division of the Better Business Bureau going back many years. See, e.g.,
`CHATTEM, INC. (Allegra®), NAD Case Reports, Case #5360, at 19 (Aug. 2011); McNeil
`Consumer Healthcare (Zyrtec), NAD Case Reports, Case #5108, at 10 (Nov. 2009) (finding that
`a claim that Zyrtec provides “fast” relief was supported by studies showing an onset of action of
`60 minutes, but recommending that the claim be “qualified to expressly state that onset of action
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`Case 1:22-cv-05931-PAE Document 1 Filed 07/12/22 Page 17 of 25
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`consumers with symptom relief within one hour after initial use. Thus, for example, Bayer’s
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`Claritin-D is “fast” because it starts to work on allergy nasal congestion in as little as 30 minutes.
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`Similarly, Bayer’s Astepro is “fast” because it starts to work at 30 minutes. Bayer does not
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`claim, however, that Claritin, which starts to work in 75-180 minutes, is “fast” because Claritin
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`is not starting to work at one hour or less. Given Nasonex’s longer onset time, Nasonex users
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`“may start to feel relief within 12 hours and full effect after several days of regular, once-a-day
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`use.” Nasonex therefore fails to qualify as “fast” by at least 11 hours, and Perrigo’s claims to the
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`contrary are literally false and