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had to launch a skillz application before seeing the in app badge so they might have already decided to play before seeing the representations at issue here posted by rebecca tushnet at 1 37 pm no comments email this blogthis share to x share to facebook share to pinterest labels class actions consumer protection false advertising novo struggles once again to allege deception by sellers of compounded drugs novo nordisk v zealthy inc 2026 wl 2212889 no 25 cv 06391 alc s d n y jul 31 2026 novo nordisk makes the fda approved ozempic rybelsus and wegovy while zealthy markets and facilitates access to drug products including compounded medications containing semaglutide novo alleged that zealthy made false representations to consumers that compounded semaglutide medications are equivalent to plaintiffs medications clinically studied evaluated by the fda and deemed safe and effective specifically zealthy stated that glp 1 medications with active ingredient semaglutide are fda approved for type 2 diabetes and have proven effective for weight loss m edications with the active ingredient semaglutide have shown 15 20 average weight loss and semaglutide is the active ingredient in wegovy and ozempic among other similar messages this allegedly violated the lanham act and ny gbl 349 the court found that novo failed to state a claim lanham act false advertising as to fda approval novo argued that zealthy s statements about glp 1 medications being fda approved were false in that such statements represent compounded semaglutide products as fda approved but zealthy also facilitates prescription of novo s fda approved medications and so its statements could reasonably describe novo s own medications making them not literally false novo failed to allege facts indicating likely deception and thus didn t properly allege implicit falsity it also failed to allege deliberate deception which could lead the court to presume deception clinical efficacy novo argued that zealthy misled consumers by describing semaglutide medications as effective without having conducted any clinical studies on the products but novo bore the burden of showing falsity not lack of substantiation equivalence novo pointed to statements that semaglutide is the active ingredient in wegovy and ozempic zealthy also offers semaglutide the active ingredient in ozempic wegovy and i f you were thinking about doing the medication or you were on the medication and insurance doesn t cover it anymore this is a great replacement it s the same medication semaglutide and it works just the same but there was no showing of falsity there although novo alleged that compounded medications were manufactured through different processes and that compounded medications do not have the same effectiveness assurances as fda approved drugs that wasn t enough to allege that the two types of medications do not work the same however novo would have had standing if it had pled falsity misleadingness indeed the court would be inclined to presume injury given that the ads drew direct comparisons between novo s products and compounded drugs in addition claims about fda approval were not fdca preempted because 1 it s preclusion when it comes to the federal lanham act and 2 the court wouldn t have to interpret or apply the fdca to conclude that compounded drugs aren t fda approved on the other hand e valuating whether defendant falsely asserted that compounded medications have shown certain levels of weight loss and whether such statements could only be made with the backing of clinical trials may well be precluded by the fdca so too with equivalence given this result the court declined to address the state law claims posted by rebecca tushnet at 1 17 pm no comments email this blogthis share to x share to facebook share to pinterest labels false advertising fda preclusion not with a bang but with a whimper of whipped dogs vip prevails in ninth circuit vip prods llc v jack daniel s properties inc no 25 2027 9th cir aug 4 2026 vip prevailed on remand on the confusion claim but lost on dilution by tarnishment the court of appeals reversed holding that jdi didn t show that vip s parody dog toy product would tarnish the marks it proved were famous the jack daniel s name and overall trade dress which seems to mean the bottle shape general colors not the print components thereof although this was a fact question the court of appeals can correct errors of law including a finding of fact that is predicated on a misunderstanding of the governing rule of law bose corp v consumers union of u s inc 466 u s 485 501 1984 the key error of law was to fail to disaggregate what jdi owned into famous and non famous matter fame requires a household name but the district court declined to delineate between jack daniel s and old no 7 when finding that jack daniel s trademarks are famous accepting jdi s argument that a ll of vip s bad spaniels marks associate all of jack daniel s famous marks with poop regardless of whether the marks themselves reference poop this erroneously lowered jdi s burden the tdra does not permit borrowing fame from one senior mark to establish the fame of another the district court didn t conduct any separate analysis as to old no 7 and the record didn t show that it was famous so no tarnishment claim could rely on it the bad spaniels mark does not itself refer to defecation and therefore was not facially tarnishing the court then concluded that dilution requires a mark to mark comparison not a general comparison c ourts may not consider senior marks that are not famous or junior marks that are dissimilar when determining the likelihood of reputational harm to the senior mark given that jdi s other senior marks including old no 7 were irrelevant as for 43 poo by vol on the dog toy that phrase does not mimic or reproduce any famous similar mark the equivalent language on jdpi s product 40 alc by vol 80 proof is not a mark the question was whether either famous mark was portrayed in an unwholesome or unsavory context that is likely to tarnish the reputation of the famous marks the district court reasoned that bad spaniels creates a negative association with jack daniel s whiskey by associating whiskey with dog feces and is likely to tarnish jack daniel s trademarks even though bad spaniels as a trademark for a chew toy does not tarnish jack daniel s while using a famous mark or a closely related depiction on a product that is of poor quality or pornographic or illegal may be tarnishing if the other requisites are met the proof here failed jdi s expert dr simonson testified that there would be tarnishment based on the associative network model supported by numerous empirical studies but he didn t conduct any studies on bad spaniels specifically he first asked whether the allegedly dilut ing product will bring or call to mind the allegedly diluted mark then whether it has affected the brand equity and brand association of the allegedly diluted mark since the point of vip s product was to bring jack daniel s whiskey to mind the key was the second step simonson testified that it was satisfied by conclusions that apply to all products and services regarding the impact of adding a negative association onto the association of the existing brand specifically when food or beverage is associated with defecation disgust is generated in the consumer s mind with respect to that food or beverage simonson acknowledged that n o consumer would think that there s poo in the jack daniel s product but that vip nevertheless created a mental association between jack daniel s and poo or old no 2 and therefore for those people exposed to this product vip diluted or more specifically tarnished the jack daniel s whiskey first it was error to rely on old no 2 which wasn t famous second even including that reference the testimony didn t establish a harmful association between any such reference and jdpi s two famous marks jack daniel s and its registered trade dress although simonson opined that it really doesn t matter whether poop themed references are made on this thing that looks very much like a jack daniel s bottle or any other product that creates an association between jack daniel s and defecation but bad spaniels was a parodic dog toy not intended for human consumption there is no evidence in the record from which a court could reasonably infer that scatological references made on a dog toy have the same likelihood of generating disgust as identical references on a consumable product meant for humans might dr simonson s opinion to the contrary is pure conjecture there was no evidence that recognizing a negative message on one parody product would harm the reputation of the referenced product simonson s reliance on the associative network model ignores that bad spaniels is an obvious parody p arody is a relevant factor in evaluating likelihood of dilution even if not dispositive citing haute diggity dog deere and hormel v jim henson prods as well as the timmy holedigger case cited by the supreme court in jdi and jordache v hogg wyld the parody s dual message impacts the dilution analysis because where a parody is successful and not particularly subtle it is a common sense conclusion that consumers are more likely to see it as the joke it was intended to be it was error to disregard the parody in the context of tarnishment dr simonson s analysis ignored the effect of a humorous difference on whether bad spaniels harms the reputation of jdpi s famous marks emphasis added although survey or expert testimony isn t required jdi here rested its case on expert testimony which was insufficient here posted by rebecca tushnet at 12 44 pm no comments email this blogthis share to x share to facebook share to pinterest labels dilution trademark wednesday august 12 2026 fdca mostly preempts claims against ineffective decongestant yousefzadeh v johnson johnson consumer inc f 4th 2026 wl 2192415 nos 24 3296 l 25 119 con 2d cir jul 30 2026 oral phenylephrine oral pe used in popular products as nyquil severe cold flu advil sinus congestion pain and mucinex sinus max was long considered an effective nasal decongestant in 1994 the fda published a final monograph determining that oral pe was generally recognized as safe and effective as a nasal decongestant starting in 2007 however scientific studies began casting doubt on that finding indeed in 2016 some studies concluded that oral pe was no more effective than a placebo as a decongestant yet the fda has continued to require manufacturers to adhere to its existing labeling requirements denoting oral pe as effective in september 2023 the fda convened an expert panel that concluded by a unanimous vote of 16 0 that oral pe products were ineffective as nasal decongestants and in 2024 it proposed an administrative order to remove oral pe from the nasal decongestant monograph until the administrative order becomes final however the fda stated that f or now companies may continue to market otc monograph drug products containing oral pe as a nasal decongestant what does this mean for this consumer protection lawsuit alleging that in the past decade drug manufacturers have sold some 12 billion s worth of ineffective nasal decongestants this consolidated complaint alleged ny gbl and common law claims as well as rico claims which will not be further discussed because they are rico claims the district court found fdca preemption and also rejected a lanham act claim in a related case the court of appeals found that the fdca expressly preempted the majority of the consumer plaintiffs state law claims defendant manufacturers followed the fda s prescribed labeling requirements by designating their decongestants purpose as decongestion defendant manufacturers cannot now be sued for complying with those fda specifications loper bright didn t change things because it didn t subvert agencies authority to promulgate preemptive regulations pursuant to the authority vested in them by statute authority the fdca vests in the fda here indeed the supreme court has given preemptive effect to federal regulations since before chevron the discussion is extensive but a couple of points there was no duty to update the labeling merely because the ingredient didn t work a monograph drug could be considered misbranded if it has a dangerous effect on the user even when the drug s label conforms to the monograph requirements thus allowing a manufacturer to add a safety disclaimer to the product s label but it s not automatically misbranded if it is simply ineffective when used as recommended or suggested in the label thus the fda had declined to impose additional labeling requirements for ineffectiveness as opposed to safety risks because monograph drug manufacturers cannot utilize a specifically provided for process to unilaterally change their labels efficacy information their obligation is to conform to the applicable monograph not to update their labels to reflect new scientific evidence to require additional disclosures would be to impose a requirement other than that imposed by the fdca and any such compulsory language would not be permissible if it was inconsistent with the statements required by the fda what about failure to disclose in marketing and advertising as distinct from labeling the statute s express preemption voids state law marketing and advertising claims not only labeling claims by specifying that its preemptive effect extends to any requirement relating to public information or any other form of public communication relating to a warning of any kind for a drug allowing failure to disclose claims would create an end run around federal labeling rules not preempted allegations that using maximum strength or max strength on certain products constituted a false statement that the products work better than other oral nasal decongestants such as pseudoephedrine no fdca provision or regulation addresses phrases such as maximum strength or claims of comparative strength defendant manufacturers therefore voluntarily and on their own accord placed these maximum strength statements on their products they were not obligated to do so consequently these additional statements are subject to the misbranding provision s requirements and cannot be rescued by the monograph or approved ndas in addition manufacturers who obtained fda approval through the nda new drug application process could have an independent duty to update their drugs labels through the prescribed process to reflect newly acquired information bearing on a drug s efficacy while that process is unavailable for monograph drugs it is available for brand name nda drugs so the court remanded for consideration of this theory as well what about the related lanham act claim not brought by consumer plaintiffs the district court didn t abuse its discretion in dismissing the claim because the competitor plaintiff neglected many 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