Thursday, May 21, 2026

"toddler drink" plausibly misleads about suitability as next stage after infant formula

Castro v. Abbott Laboratories, Inc., --- F.Supp.3d ----, 2026 WL 184533, No. 25 CV 377 (N.D. Ill. Jan. 23, 2026)

Abbott makes Similac, a milk-based formula powder drink for infants and toddlers. “Go & Grow Toddler Drink by Similac” and “Pure Bliss Toddler Drink by Similac” purport to meet the nutritional needs of children between the ages of twelve and thirty-six months. The labels were allegedly similar to the labels for infant drink formula and indicate that toddler drinks are the next step drink following infant formula. Plaintiffs sought to represent consumers from Illinois, Massachusetts, Florida, Michigan, Minnesota, Missouri, New Jersey, New York, and Washington.

The toddler drink cans’ similarities to the infant drink cans allegedly falsely represent “that the toddler drink is the logical next nutritional step in formula, even when doctors and experts do not necessarily recommend toddler formula drinks.” The labels were also allegedly false and misleading “because they focus on the products’ purported health benefits while omitting information regarding the health harms of their added sugar content.”

The toddler formula label includes the words “Stage 3,” and that label is visually similar to the infant formula label containing the words “Stage 1” and “Stage 2.” Abbott argued that a reasonable consumer would not ascribe the “next stage” meaning to the label because the similarity of the labels and the words “Stage 3” are not nutritional recommendations.  The court disagreed, given the pleading stage. “Stage” can plausibly indicate a progression. “And the similarity of the cans, as well as their placement on the same shelves as the infant formula, could lead a reasonable consumer to conclude that the toddler formula is nutritionally recommended for children aged twelve to thirty-six months in the same way that infant formula is nutritionally recommended for children up to twelve months.”

The court distinguished Martelli v. Rite Aid Corp., No. 21-CV-10079 (PMH), 2023 WL 2058620 (S.D.N.Y. Feb. 16, 2023), which dismissed a similar claim, but there the label also included a disclaimer stating that the product was “intended to supplement the solid-food portion of the older baby’s diet” and was “not intended to replace breast milk or starter formulas.” Whether the disclaimer made a difference was an issue for later.

Additionally, plaintiffs alleged that Abbott’s representations about the health benefits of the drink were misleading because the formula contains four grams of added sugars, which are decidedly unhealthy. The cans did disclose their sugar content on the back labels, but again it was plausible that a reasonable consumer could think they didn’t have to consult the back.

This reasoning also allowed a claim for breach of the implied warranty of merchantability: plaintiffs alleged that “a balanced, nutritious diet excludes sugar-sweetened beverages for children above 12 months, and otherwise limits added sugar to less than 5% of calories, whereas regular consumption of the Toddler Drinks is detrimental, rather than beneficial to health.” They sufficiently alleged that the toddler formula is not “fit for the ordinary purposes for which such goods are used,” namely, to provide a healthy supplement to a toddler’s nutrition.


"complete nutrition" claims for supplements are obviously untrue, but GLP-1 related claims could live again

Cavallaro-Kearins v. Grüns Nutrition Inc., 2026 WL 1398422, No. 25-cv-4998 (LJL) (S.D.N.Y. May 19, 2026)

The court dismissed this California & New York false advertising claim against Grüns based on its Superfood Greens Gummies for Adults and Grüns Cubs for Kids, challenging its claims to offer a “comprehensive” and “complete” solution for daily nutrition, to provide “100% of kids’ daily nutrition,” “all-in-one” support for GLP-1 users, and to act as a replacement for essential nutrients. In this specific context, these claims were unbelievable and demanded reference to the ingredient list, which would clarify matters. Grüns also advertised Grüns Adults as containing “more fiber than 2 cups of broccoli per pack,” the same amount as “9 cups of raw spinach,” and as containing more than 6 grams of fiber, stating that “you’d need a whole salad bar to match the fiber in just one pack of Grüns.” Grüns Kids also claimed it was the “very best way to get all the vitamins, minerals, fruits and veggies growing kids … need” and specifically targeted parents of children with sensory processing difficulties.

But protein, fats, and omega-3 fatty acids are necessary nutrients that aren’t included. Also, the Gummies “contain only minimal amounts of other key minerals like iron and lack others such as calcium altogether.” And the daily recommended amount of fiber for an adult is 28 grams of soluble and insoluble fiber per day, whereas Grüns contain only six grams of “soluble fiber”; the fiber contained in real fruits and vegetables is allegedly fundamentally different from that contained in Grüns, which “may aggravate rather than relieve the very conditions it claims to solve.” Grüns also claimed testosterone benefits that were allegedly misleading, as were claims to multiply, enhance, or substitute for protein. Without calcium or magnesium, the gummies were allegedly not even qualified as a standard multivitamin.

While these challenges (and others) are serious, the court focused on the “comprehensive nutrition” and similar claims. And because it’s obvious that you can’t get complete nutrition from gummies, those claims weren’t plausibly deceptive: combining puffery with ambiguity doctrine, a reasonable consumer would have had to look at the ingredients to figure out the actual nutrient profile:  

Plaintiffs do not contend that the language of the package should be taken literally—that the Gummies provide either complete or comprehensive nutrition such that a person who eats a pack of the Gummies need not eat anything else in order to survive. That is what the plain text read in isolation states. … Such a representation might be reasonably credited if made by a wellness resort or health food spa about the program it offers for visitors. When made by a purveyor of gummies, it is plainly hyperbolic, and no reasonable consumer could understand that a small packet of gummy bear supplements that weighs .7 ounces and that is advertised as a “Dietary Supplement” could replace the need to eat any other foods.

The court thus distinguished Weinstein v. Rexall Sundown, Inc., 2024 WL 4250353 (E.D.N.Y. Aug. 26, 2024), which found plausible misleadingness when the advertiser touted “complete multivitamin gummies” accompanied by the language that the product contained “B Vitamins” and “13 Essential Nutrients” but the product did not in fact contain Victims B1, B2, and B3. Likewise, Cabrera v. Bayer Healthcare, LLC, 2019 WL 1146828 (C.D. Cal. Mar. 6, 2019), held that the claim that a product was a “complete” multivitamin was plausibly misleading when the product was missing 13 vitamins that the body requires. In both cases, the adjective “complete” modified the noun “vitamin.”

Do reasonable consumers understand that, on gummies, “nutrition” literally means all the macro and micronutrients we need? Plaintiffs walked into this problem by talking about fats, protein, etc. They offered the argument that a reasonable consumer would understand that Gummies supply “all essential nutrients,” or “essential nutrients such as calcium and magnesium,” or “all other supplements,” or that the “Gummies provide what fruits and vegetables provide—the same nutrition, in another form.”

But, the court reasoned, if the term “comprehensive nutrition” is not understood by its dictionary definition, then it is ambiguous. [I’m more sympathetic to the “all essential [micro]nutrients” interpretation because that’s what you’d expect from a “comprehensive” supplement: one pill to take! At least I can imagine a substantial number of ordinary consumers thinking that.] And we know that, when there’s ambiguity, a reasonable consumer must consult the ingredient list (and apparently keep track of things like magnesium and iron being missing). I think this is an example of why “ambiguity” is troublesome: the court doesn’t ask whether a reasonable consumer could read the claim as unambiguous and not seek further information, but only whether there’s ambiguity in the abstract.

“No reasonable consumer could understand from the package as a whole that the Gummies contained ‘key macronutrients like protein and fat,’ that it contained adequate “amounts of critical nutrients like fiber and iron,’ or that it contained ‘calcium and omega-3 fatty acids,’ much less that it could ‘replace the nutritional complexity of fruits and vegetables and all other targeted supplementation.’”

As for the off-package claims, they mostly “parrot” the language of “comprehensive nutrition,” or use the adjective “comprehensive” “in an even less specific manner than on the packaging.” They could not save the claim.

What about the specific health issues touted? Some were mere puffery: “Gut health that fits in a lunchbox” and “#1 energy hack.” Grüns also advertises that the Gummies “help reduce colds by 70%,” result in “stronger hair in just 30 days,” and “boost T-levels,” but neither plaintiff alleged that she relied on those ads.

A subset of statements were plausibly misleading: those targeting GLP-1 users in particular. “Even if the advertisements could be understood to be ambiguous, there is no surrounding context that would dispel a reasonable consumer’s understanding that the Gummies contain the nutrients needed to fill gaps created by the medication.” However, plaintiffs failed to sufficiently plead that use of GLP-1 medications creates specific nutritional gaps and that the Gummies do not in fact fill those gaps. It wasn’t enough to allege that the “formulation is not tailored to the specific needs of GLP-1 users and lacks the dosage strength, clinical targeting, or comprehensiveness to meaningfully address the deficiencies it invokes.” This part of the claim was dismissed without prejudice.


it doesn't infringe to use a similar concept in ad photos

Kitsch LLC v. Viori Beauty PBC, 2026 WL 1356424, No. 2:25-cv-10830-SPG-AGP (C.D. Cal. May 8, 2026)

Kitsch is “a leading beauty product and accessories manufacturer and sells its products in major retail stores and online through its website and third-party websites, such as Amazon.” It sells solid shampoo and conditioner products, marketed on Amazon with a photograph depicting the shampoo and conditioner placed on top of the packaging, with images of the ingredients contained in the bars scattered below the packaging.

L: defendant; R: plaintiff. Obvious substantial similarity, right?

Viori also sells solid shampoo and conditioner, including through Amazon’s online marketplace. Its advertising is allegedly highly similar to Kitsch’s, in that “both feature the products shown next to each other with the physical products being placed on top of the packaging and with images of the ingredients contained in the bars scattered below the packaging,” and its packaging contains wording shown in the same order as Kitsch’s packaging, with the same words in larger font.

Viori allegedly didn’t use this ad style until after Kitsch entered the market. Kitsch also alleged that there’s no need for it because other sellers display their products in distinct ways, and that Viori didn’t use this photo on its own website, only on Amazon. 

Plaintiff's examples of noninfringing packaging

Further, purchases from Viori allegedly arrived in different packaging.


All of this allegedly was in the service of confusing consumers, so Kitsch alleged claims for false advertising under the Lanham Act, copyright infringement, and violation of California’s Unfair Competition Law. The court dismissed the complaint because look at those pictures.

Kitsch didn’t plausibly allege any false statement of fact, which defeated both federal false advertising and state UCL claims. Among other things, the product shown in the supposedly different packaging was not the same product as the product shown in the Viori photo. “Viori Hidden Waterfall Shampoo and Conditioner Bar Set Made with Rice Water” is not “Viori Shampoo Bar & Conditioner Bar + Bamboo Holder.” They didn’t show that Viori’s advertised packaging is any different from the actual product. Where, as here, “the allegations of the complaint are refuted by an attached document, the Court need not accept the allegations as being true.”

Even if the actual packaging differed from that in the image, that didn’t plausibly injure Kitsch. Kitsch argued that it was injured because Viori copied its advertising. “Thus, it would make no difference to Plaintiff’s alleged injury whether Defendant’s products arrive in the same packages as advertised.”

Copyright infringement: Not always resolvable at the motion to dismiss stage; very much so here. The photos here received relatively thin protection: a “commercial product shoot” allows for only a “narrow range of artistic expression.” None of the photos contained any particularly unusual elements that defy “the conventions commonly followed” in such photos. Indeed, the competitors’ submitted photographs “bear numerous similarities to the parties’ photographs”:

(1) all five photographs depict a set of two products, including both solid shampoo and conditioner; (2) all five photographs depict both the packaging and the shampoo and conditioner outside the packaging; (3) all five photographs are set against an off-white background with no other foreground or background features; and (4) three of the five photographs include images of the ingredients contained inside the products. Thus, these elements appear to be standard features commonly associated with such advertising images.

Given the thinness of the copyright, only “virtual identical” copies would infringe; those were not present:

Most significantly, while Plaintiff’s photograph places the products directly on top of the packages, Defendant’s photograph places the products behind the package, suspended in mid-air and partially obscured by the package. Defendant’s image also contains reflections underneath the packaging and ingredients, while Plaintiff’s image contains no reflections. Further, Defendant’s photograph contains a larger foreground and places the ingredients closer to the packaging than Plaintiff’s photograph.

For some reason, the court grants leave to amend.

Thursday, April 23, 2026

State barber board wins battle against "Barber Shop" bar

Really wanted a Sweeney Todd reference here but couldn't figure it out.

Osteria Segreto, LLC v. Hilgers, No. 8:26-cv-00065-BCB-MDN (D. Neb. Apr. 20, 2026)

Osteria Segreto, formerly “an Italian speakeasy” in a space that had once been a hair salon, restyled itself as “a barber shop themed bar” named “The Barber Shop Blackstone.” It was surprised to discover the Nebraska Barber Act, which among other things prohibits businesses from using the title of “barber” or “barber shop” or displaying a “barber pole” without a state-issued license to practice barbering. The court refused to enjoin enforcement of the law, finding that this was a regulation of deceptive commercial speech.

The Bar’s logo is a monochromatic barber pole with the name “The Barber Shop” and the tag line, “Where the Buzz is Real.” It’s accessed “through a back-alley door tucked between a wall and a wood fence that is adorned with a small [red, white, and blue] barber pole.”

entrance

logo

Patrons enter a small anteroom, where they “see a lone vintage barber chair, a barber pole, and small television that displays a history of barbering,” and “[a] bouncer greets customers, checks their IDs, and allows them through a hidden door into the bar.” According to the plaintiff, “[t]he walls are filled with historical pictures of barbers and barbering tools. The bar is dimly lit, but at the end of the narrow space is a small seating area next to a floor-to-ceiling light installation designed to mimic the banded lights of a barber pole.” The menu includes drinks called “the ‘Scotch and [Scissors],’ the ‘Classic Cut Old Fashioned,’ and the ‘Barber’s Flight.’”

grand opening ad showing entrance and promising guest barbers

more social media

The bar advertised for a grand opening that mentioned “5 cabinet giveways [sic], secret menu, drink specials, and special guest barbers!”

The Board claimed rights in a “mark” registered with the state in barber poles, defined as “spiral stripes, red, white, and blue or any combination of them.” A state AG pointed out in earlier correspondence:

While the barber pole which you seek to use for the collective mark has been associated with barbers since the Fifth Century, A.D., there still may be some problems with enforcement of the logo exclusively for licensed barbers in this State. When a word or symbol has been in the public domain for a period of time, it is no longer susceptible to exclusive appropriation.

But, the AG continued, maybe it could still serve as a collective mark. The Board doesn’t charge a licensing fee for use of the “mark,” but has issued express consent for approved barber schools to use its barber pole “registered service mark.”

A licensed barber in the State of Nebraska who worked in the Blackstone District (nearby) complained to the Board: “I’m not sure if they are going to be actually cutting hair but they mentioned guest barbers. The whole theme of this place is so disrespectful to the trade I wish people would stop making money off of it because it’s a cool idea.” Then the Board started going back and forth with the bar, claiming both “trademark” rights and exclusivity according to the Barber Act. The bar disavowed any intent to provide barber services, but wanted to use the name and barber pole.

First, the court declined to address any trademark claim by the Board for purposes of the motion. JDI didn’t hold, as the Board argued, that trademark law always “prevails” over the First Amendment, particularly “where, as here, a state actor attempts to regulate commercial speech by asserting a trademark.” Not only were there some pretty serious doubts over the validity of the putative “mark,” but “when the Supreme Court has addressed regulation of commercial speech by governmental entities, it has applied the intermediate scrutiny test from Central Hudson.” (As for those doubts—the Board registered a service mark, not a certification mark, and it never registered “barber shop” as any kind of mark. And there was a reasonable argument that any claim in “barber shop” or “barber pole” was invalid for genericity or descriptiveness.)

Fortunately for the Board, its regulation survived Central Hudson. The state regulated barbers for public health/safety reasons and required them to be licensed as barbers before offering barbering services or holding themselves out as barbers. The law specifically barred the “display [of] a barber pole or use [of] a barber pole or the image of a barber pole in … advertising” without a license.

If commercial speech is inherently misleading, it gets no First Amendment protection. That was likely the case here, the court found. At plaintiff’s bar, “patrons first encounter a fully equipped barber service station with a service mirror, tools, and capes used in barbering.” The name “The Barber Shop Blackstone” was inherently misleading, “carrying no indication that the business is a bar not a barbershop, and using a logo with a barber pole that is exclusively associated with barbering.” The slogan “Where the Buzz is Real” didn’t help; nor did the reference to “special guest barbers” in the grand opening advertisement.

Osteria Segreto relied on the (bad) decision in Express Oil Change, L.L.C. v. Mississippi Bd. of Licensure for Pro. Eng’rs & Surveyors, 916 F.3d 483 (5th Cir. 2019), in which the court ruled that automotive service centers operating under the name “Tire Engineers” couldn’t constitutionally be held liable under state law restricting the use of the term “engineer.” The Fifth Circuit found that, because “engineer” “can mean many things in different contexts,” it was not inherently misleading, despite the state’s survey finding a very high percentage of consumers were deceived.

Somewhat in contradiction to the idea of arbitrary trademarks, the court here ruled that “nothing suggests that ‘barber’ or ‘barber shop’ can mean many things in different contexts,” so the terms could only mean licensed professionals. (And Apple can only mean fruit?) State law defines “barber shop” “expressly—and narrowly”—as “an establishment or place of business properly licensed as required by the act where one or more persons properly licensed are engaged in the practice of barbering.” And the contextual factors here reinforced that, including the logo, so the name and logo “inevitably will be misleading” as to the services available to customers:

The Court would not hesitate to hold that calling a bar “The Hospital Blackstone,” “The Doctor’s Office Blackstone,” “The Law Office Blackstone,” or “The Department of Motor Vehicles Blackstone” would be inherently misleading.

The remaining context didn’t help, as noted above. “There is an inevitably misleading inference that ‘The Barber Shop Blackstone’ provides barbering services although it may also provide alcoholic beverages—even if there is no evidence that anyone was actually deceived about the services or goods provided. The parties do not dispute that there are barber shops that also have liquor licenses.”

Although technically Central Hudson analysis can simply end if the regulated commercial speech is inherently misleading, the court considered the other prongs. The only serious challenge was to the regulation’s tailoring. Central Hudson requires a restriction to “directly advance” a “substantial” governmental interest. “Restricting unlicensed entities from using ‘barber shop’ and a ‘barber pole’ in their advertising plainly provides effective support for and directly advances the government’s purposes of protecting both ‘the interest of public health, public safety, and the general welfare’ and ‘the skilled trade of barbering and the operation of barber shops [that are] affected with a public interest.’” Although the existence of less restrictive alternatives is relevant, intermediate scrutiny doesn’t require a perfect fit, and the fit here was reasonable.

Wednesday, April 22, 2026

compounding pharmacies lose a round with Lilly on personalized medicine and GLP-1 comparison claims

Eli Lilly & Co. v. Mochi Health Corp., 2026 WL 1076831, No. 25-cv-03534-JSC (N.D. Cal. Apr. 20, 2026)

Eli Lilly’s claims were previously dismissed, and Lilly tried again with claims under California’s UCL, Lanham Act false advertising, and civil conspiracy. Civil conspiracy failed but Lilly was allowed to proceed with the advertising claims.

Lilly makes two FDA-approved weight-loss medications containing tirzepatide. “Mochi Health is a telehealth company that connects consumers with physicians who can prescribe weight-loss medications, including compounded versions of tirzepatide.”

Lilly’s first UCL claim arose from Mochi Health’s alleged corporate practice of medicine. It allegedly changed patient doses en masse without consulting patients or receiving a clinical indication from a physician—several times over the course of a year. The changes were allegedly based Mochi’s developing business relationships with various pharmacies: whether compounded medications included niacinamide, glycine, and pyridoxine depended on the pharmacy. Lilly alleged that these additives were not meant to achieve a therapeutic effect, but rather reflected Mochi’s financial considerations. Thus, Mochi allegedly made medical decisions for patients based on profit motives rather than clinical need. It also allegedly “steer[s] its patients to compounded products over Lilly’s FDA-approved tirzepatide medicines” through its hiring of Mochi physicians, its development of obesity treatment protocols, and training of Mochi medical staff.

Lanham Act: Lilly alleged that Mochi misrepresented its compounded tirzepatide medications as safe and effective based on studies conducted of Lilly’s products; misrepresented its products as FDA-approved; and misrepresented its tirzepatide drugs as “personalized.”

Along with lost sales, Lilly alleged reputational harm because Mochi compared an inferior, compounded product to Lilly’s FDA-approved medicine, causing consumers to conflate the higher incidence of adverse events found in compounded medications with Lilly’s drugs. Lilly cited studies indicating a higher risk of adverse events from utilizing compounded versions of tirzepatide, such as “abdominal pain, diarrhea, nausea, suicidality, and cholecystitis.”

Mochi once again challenged Article III standing. But this time Lilly successfully alleged both sales diversion and reputational harm. “Coupled with Mochi Health’s alleged unilateral ability to modify existing compounded medication doses for customers, Lilly asserts Mochi Health exercises control over the Mochi Medical practice to reduce patients’ ability to choose MOUNJARO® or ZEPBOUND® over a compounded option.” Its ads about the safety and personalization of compounded tirzepatide also plausibly steered consumers in the market for weight-loss medication away from Lilly’s products.

As for reputational injury, Lilly connected its allegation about higher side effects for compounded medications to research findings from the National Consumers League that show consumer confusion about the difference between compounded medications and FDA-approved medications, and conflation of the two. “Combined, these allegations permit a reasonable inference of harm to Lilly’s reputation through public perception that FDA-approved tirzepatide medications have similar rates of adverse side effects compared to compounded medications.”

Defendants argued that consumers of compounded tirzepatide were different from consumers of MOUNJARO or ZEPBOUND, relying on statements Lilly made in a separate case involving the FDA’s determination that there was no longer a nation-wide “shortage” of tirzepatide-based drugs, where Lilly said that “there were good reasons to think much of the market for compounded tirzepatide would not translate to future demand for Lilly’s FDA-approved products. Compounded products are often promoted for uses different from the indications FDA has approved, including by affiliated telehealth providers, so patients may be less likely to get a prescription from a physician for FDA-approved medicine. There also might not be insurance coverage for those off-label uses, and some compounded products use a different formulation than Lilly’s products.”

This didn’t estop Lilly from alleging harm here. Lilly did not make any claims about Mochi Health’s marketing and customer base. And its prior statement that “much of the market for compounded tirzepatide” may not overlap was consistent with its allegations in this case of some consumers being diverted.

Even though they operated in different market strata and Mochi doesn’t prescribe, manufacture, or sell the compounded tirzepatide medications, Lilly still plausibly alleged that misleading advertisements about the safety and personalization of Mochi’s medicines attracted customers in the market for weight-loss medication that may have otherwise purchased a Lilly medication and that Mochi patients were steered away from Lilly’s products. “It is not necessary that Mochi Health personally profited from the diverted sales; the relevant inquiry is whether Lilly has plausibly alleged it suffered an economic injury caused by Mochi Health’s conduct. Accordingly, Lilly’s and Mochi Health’s relative positions in the market are not dispositive of the economic injury question here.”

Mochi further argued that the causal chain was interrupted by the requirement that any consumer receive a valid prescription from a treating physician before purchasing compounded tirzepatide. But a single third-party’s actions do not necessarily upend traceability given the requirement is “less demanding than proximate causation.” And Lilly alleged that Mochi influenced the prescription process, including by changing the formulation of compounded tirzepatide medications for all patients en masse without advanced notice or a clinical indication. That was plausible traceability.

As for redressability, Mochi argued that an injunction could not force physicians—who are not parties to this case—to prescribe Lilly’s products instead of a compounded drug. But damages are available, and any equitable relief would redress Mochi’s alleged false advertising practices and corporate intervention in the practice of medicine.

UCL claim: Lilly plausibly alleged that it was injured as a result of the allegedly unlawful corporate practice of medicine. The California Medical Practice Act is violated if a “non-physician exercises ‘control or discretion’ over a medical practice.” And that was sufficiently alleged.

Lanham Act: Statutory standing was present both through sales diversion and reputational damage.

Indeed, Mochi Health allegedly deployed search-engine optimization to show Mochi Health’s compounded tirzepatide medication advertisements to consumers searching for Lilly products. Moreover, Mochi Health directly compares its own compounded medications to Lilly’s products in social media advertising. These allegations permit a reasonable inference that any alleged misrepresentations by Mochi Health put Lilly at a competitive disadvantage in the market—either by losing customers or suffering damage to its reputation. So, Lilly’s allegations permit a reasonable inference that any misrepresentation by Mochi Health proximately caused its injuries.

Reputational injury doesn’t require direct competition, and diverted sales also counted even without a supposed 1:1 relationship of lost sales. Lexmark found the 1:1 relationship important because “Lexmark’s anticompetitive actions primarily targeted remanufacturers, not [plaintiff] Static Control.” Here, Mochi allegedly operates in the weight-loss market by advertising directly to those consumers. “The relevant allegations here permit a plausible inference that any false or misleading statements issued by Mochi Health injured Lilly because they targeted the same segment of the market from which Lilly stood to profit.”

What about the intervening cause of a doctor’s prescription? Not intervening enough to defeat proximate cause. Eli Lilly & Co. v. Willow Health Servs., Inc., No. 2:25-CV-03570-AB-MAR, 2025 WL 2631620, at *6 (C.D. Cal. Aug. 29, 2025), found the prescriber’s conduct to defeat proximate cause. The court here disagreed. First, Lilly here alleged direct interference with patient prescriptions. “Second, drawing inferences in Lilly’s favor, that a medication requires a prescription does not prevent a consumer from relying on advertising to request one product over another from their physician. Since both products at issue contain tirzepatide, it is a reasonable inference that a consumer would have some basis for asking her physician to prescribe a specific medication.”

Falsity: Mochi allegedly misled consumers by (1) citing to Lilly’s clinical trials to support its claims and (2) advertising that “tirzepatide is a safe medication that has been approved by FDA.” The court agreed that these were plausibly misleading, accepting Lilly’s allegation that “the FDA does not approve an active pharmaceutical ingredient for treatment of patients, but rather approves specific formulations of that ingredient that have been subjected to rigorous study.” Mochi cited the Lilly studies to tout “tirzepatide,” then connected that to “compounded tirzepatide,” and didn’t mention the difference between compounded and FDA-approved formulations, but instead suggested the medicines were interchangeable.

Mochi argued that was a mere lack of substantiation theory. While some district courts have agreed, the court reasoned that it was plausible that Mochi’s statements misled consumers into believing that the Lilly studies actually considered compounded medication. “The issue is not whether Mochi Health had a basis for its statements, but rather, whether Mochi Health misrepresented the contents of the studies.” That’s a workable theory.

Likewise, Mochi’s statements could be reasonably understood to indicate that compounded tirzepatide medications are FDA-approved: “Tirzepatide is a safe medication that has been approved by the FDA” followed by a representation that Mochi’s compounded medication is “safe,” citing only the Lilly studies and the FDA approval of Lilly’s drugs.

“Personalized” medicine claims: Mochi offered “much more accessible alternatives to brand-name medications that are customized to the medical needs of the patient” and claimed that “[c]ompounded medications are custom-prepared to meet an individual patient’s specific needs.” But Lilly alleged that’s not what happened. If Mochi changes the formulation and dosage of its compounded medication en masse based on its business relationships with pharmacies, not medical indication, that would directly contradict the ad claims. Mochi’s interpretation that all it advertised was “customized” or “personalized” care plans was meritless.

Nor did the court apply FDCA preclusion. The “personalized” theory didn’t conflict with the FDCA’s regulatory scheme. Mochi argued that the FDCA allows compounding; that compounded medications are “personalized” by definition; and that Lilly’s theory contradicts a permissible practice of creating “batches of compounded medications for subsequent dispensing.” But Lilly’s falsity theory was about advertising that Mochi “personalized” medications but then did not tailor changes in dosage or formulation of the compounded drug to individual patients’ medical needs. “Whether Mochi Health or Aequita Pharmacy prepared the medication in “batches” is ultimately beside the point: the falsity derives from Lilly’s allegations that Mochi Health changed the formulation of patients’ medications based on business interests and evolving relationships with certain pharmacies rather than patient needs. Defendants have not identified any FDCA provision or FDA policy directly in conflict with this misrepresentation theory.”

What about safety claims: better left to the FDA? The court won’t have to determine the scientific validity of citing the Lilly studies to support safety claims about compounded medications. It would only have to determine whether Mochi misled consumers into believing that the Lilly studies tested the effects of compounded tirzepatide medications. “This misrepresentation theory presents a binary question of whether the studies considered any compounded tirzepatide formulation.” Nor would resolving the claim about misrepresentation of FDA approval impinge on the FDA’s policy choices. Defendants could renew their preclusion argument if discovery warranted it.

Bayer can't enjoin J&J's cancer superiority claims by showing methodological disputes

Bayer Healthcare LLC v. Johnson & Johnson, Inc., 2026 WL 1045917, No. 26 Civ. 1479 (DEH) (S.D.N.Y. Apr. 17, 2026)

The court denied Bayer’s request for a preliminary injunction against its competitor J&J’s advertising of a drug used in the treatment of metastatic castration-sensitive prostate cancer. In a presentation and a press release, J&J described a retrospective observational study that purportedly showed a roughly 50% reduction in the risk of death for patients prescribed its drug, apalutamide (ERLEADA), compared to Bayer’s drug, darolutamide (NUBEQUA). Bayer alleged severe methodological flaws rendering J&J’s claims literally false or false by necessary implication in violation of the Lanham Act and NY state law.

The court found that Bayer failed to show methodological errors substantial enough to render J&J’s claims literally false or even misleading. Instead, J&J accurately described the results, the methodology, and the study’s limitations.

Super interesting methodological questions (but possibly much more appropriate for doctors to debate than courts): Bayer argued that studied patients receiving its drug were mostly prescribed it off-label (given the study period); that such patients would generally only get an off-label prescription when patient-specific issues warranted avoidance of the on-label options (J&J’s) already on the market; and that J&J’s product’s side effects made it risk for patients with seizure history, fall and fracture risk, independent treatment with anticoagulants, general frailty, or other comorbidities, whereas Bayer’s product wasn’t associated with those side effects and thus the uncertainty of off-label use was justified for them. Thus, patients prescribed Bayer’s drug would disproportionately have these other conditions, which were already associated with higher mortality, confounding any association based on the drugs themselves.

Likewise, Bayer offered testimony that its drug was prescribed to patients who were seen as possibly needing chemotherapy at some point because at least some doctors thought it was the better treatment option for patients receiving chemotherapy. But, Bayer argued, such patients were likely to be suffering from a more advanced disease or otherwise more frail, thus introducing further bias in the respective study populations.

J&J had responses, including that the off-label prescription of Bayer’s drug was “ubiquitous[],” in Bayer’s own words, at the relevant time; and that patients must have a baseline level of health to receive chemotherapy, so possible chemotherapy was not a sign of significant frailty. J&J also presented testimony that its statistical controls adequately accounted for any potential bias from differences in the treatment cohorts by controlling for age and other comorbidities. “Bayer’s experts admitted that their criticisms regarding the treatment cohorts were essentially hypothetical, because they had no empirical data showing that off-label darolutamide doublet patients were sicker, more frail, or more likely to have non-cancer comorbidities than on-label apalutamide patients.” At this stage, Bayer failed to show that study patients who received its drug were sicker than patients who received J&J’s.

Bayer’s attacks on the control methodology also failed. J&J’s expert testified that the necessary magnitude of an unmeasured confounder “to explain away the [51%] observed difference found in the study” would be “enormous”: to “explain away” the observed difference across cohorts, unmeasured confounders would have to simultaneously make a patient 350% more likely to receive darolutamide and 350% more likely to die. That would be a stronger relationship than that between heart disease and smoking. Bayer didn’t rebut this.

Bayer also criticized the underlying data sources of the study. “For example, in one Bayer study, as many as 40% of patients that initially appeared to be eligible to be included in the study based on [the data source used] were, in reality, ineligible once researchers examined the patients’ underlying charts.” But Bayer has used the same datasets in the same way in their own retrospective studies on multiple occasions. In addition, both the conclusions slide of the PowerPoint and the overview slide of J&J’s presentation acknowledged the possibility of data errors, acknowledging possible “misclassification bias” and “that not all death or treatment data [were] captured” and that, because “the study used clinical records, some information may be missing or incorrect.”

Nor did Bayer’s attack on the “overall hazard ratio” reported by J&J succeed. “A hazard ratio is generally accepted as the standard method of reporting comparative survival results for oncology studies. The measured ratio here is 0.49, meaning a patient being treated with apalutamide was 0.49x as likely to die during the observed period as a patient receiving darolutamide. Thus, the Study’s top line result stated a 51% reduction in the risk of death between the cohorts, ‘another way of saying the same thing.’” Bayer argued that it was inappropriate to calculate a hazard ratio calculated over the 24-month study period. “Because a hazard ratio presents a single measurement for the entire period, where outcomes may differ over time, a hazard ratio may over- or understate the likelihood of an event at a given moment.” But this was “a generally-accepted method for reporting retrospective comparative study,” Bayer had used the same reporting methodology in its own research. Bayer presented no statistical analysis to estimate varying hazard ratios using different time periods.

So much for the challenges to the study itself. Did J&J’s statements misrepresent the methodology and results? There were no consumer-facing advertisements at issue, but Bayer argued that the press release was picked up by search engines and AI-generated results to answer general public questions, and offered evidence that patients can often influence prescribing decisions.

But J&J’s evidence suggested that only doctors, not patients, were the target audience for the challenged communications. Two treating physicians testified that they were not aware of a single instance of a patient identifying either drug during an appointment, and in this particular context, it was highly unlikely that a patient would be driving a treatment decision.

51% risk of death reduction: Study patients receiving Bayer’s product had a roughly 86% survival rate, while those receiving J&J’s apalutamide had a roughly 92% survival rate—statistics that are disclosed in the overview slide. Bayer argued that the public seeing “92.1 percent for J&J’s product and a ‘51 percent reduction in risk of death’ would plausibly infer that Bayer’s product has a survival rate of approximately 60 percent.” (Why not 46%?) But failure to include the 86% absolute survival measure didn’t misrepresent the results, and J&J used sufficient disclaimers. “It would be obvious to any medical practitioner that a hazard ratio reflects a relative, rather than absolute, difference.”

Bayer also challenged the use of the claim that J&J’s product “reduces” mortality risk rather than merely being “associated with” decreased mortality. This was closer: “associated with a reduction in X” would be a more apt description of the results of a retrospective, observational study like the one here, whereas the causation implied by “reduces” generally can be shown only through a randomized trial. But the word wasn’t literally false for the target audience. “Bayer failed to present any evidence that doctors would not understand the press release’s headline claim in light of the release’s repeated references to the real-world and observational nature of the Study.” And J&J’s witnesses “repeatedly emphasized that doctors would look closely at the underlying study rather than relying just on one word in a headline.”

Bayer also challenged the use of the phrase “through 24 months.” Many patients were “in” the study for only a portion of that time and therefore were tracked for a shorter duration. But “through 24 months” accurately (and literally) describes the period in which patients were included in the study, and there was testimony that a reasonable doctor would recognize that it was impossible that every patient in the study was followed for a full 24-month period. For example, patients died during the period. “Readers familiar with health outcomes studies understand that the stated follow-up period is not universal.”

Bayer also challenged a press release’s statement that the study “replicat[ed] the conditions of a randomized clinical trial.” True, retrospective observational studies are generally inferior to randomized trials. In isolation, this statement could be misleading, but not in the full context. Disclosure of the underlying methodological approach, including noting that the study was a “real-world” study rather than a randomized clinical trial at least 14 times throughout the press release sufficed. While “no observational study can actually duplicate the effect of a randomized trial,” “the audience of medical professionals to whom the communications were targeted would know that.”

The court also referred to the Second Circuit’s decision in ONY, which held on relevantly similar facts that, “to the extent a speaker or author draws conclusions from non-fraudulent data, based on accurate descriptions of the data and methodology underlying those conclusions, on subjects about which there is legitimate ongoing scientific disagreement, those statements are not grounds for a claim of false advertising under the Lanham Act.”

J&J argued that, under ONY, Bayer had to prove that the study was based on fraudulent or false data, or that J&J had falsely described the underlying methodology, but the court wasn’t quite willing to go that far. ONY dealt with statements made “in a scientific article reporting research results,” and also in “a press release touting [the article’s] conclusions.” Other courts have declined to grant broad immunity to “statements made outside of an academic context.” The court also pointed to a series of opinions standing for the proposition that “statements about a study’s results may still be challenged as false under the Lanham Act if the underlying study can be shown to suffer from severe methodological defects such that the study cannot be said to support the statements in question.”

The court didn’t need to resolve the issue, because Bayer couldn’t win under either standard: fraud or showing that the study compared apples to oranges. (It did comment that ONY involved not just a paper but a press release, and that it wasn’t clear that “the extent of First Amendment protections for statements of scientific research deemed applicable by the Second Circuit in ONY could properly be limited to academic fora.”)


Monday, April 20, 2026

"higher standard of safety" is puffery even as to child car seats

ElSayed v. Columbus Trading Partners USA Inc., No. 25-cv-01347 (FB) (TAM), 2026 WL 1042209 (E.D.N.Y. Apr. 17, 2026)

ElSayed alleged that CTP’s infant car seat were faulty and defective in violation of NY consumer protection law. The court dismissed the complaint because “safety” claims were too vague to be actionable.

CTP advertised that its car seat conforms to a “higher standard of safety” because it was “engineered in Germany—where safety standards are among the highest in the world,” among other claims. But it was voluntarily recalled because one of the harness system anchor pins tended to break. It also offered a free remedy kit, though that wasn’t available when the complaint was filed, at which time CTP advised consumers that they should check the anchor pins for damage before every use until the remedy kits became available.

CTP argued that “New York law requires a manifested defect for a plaintiff to recover on any claim.” But unlike the products described in the cited cases, the car seat didn’t perform satisfactorily:

The recall explicitly instructs caregivers to check the Aton G’s harness pins before every use, because they were prone to bend or break. This is not a situation of theoretical harm caused by a potential defect; at issue here is an actual defect manifested in every Aton G subject to the recall. Accordingly, Plaintiff did not get the benefit of her bargain, instead finding herself saddled with a faulty and dangerous CRS which she could not use as expected and which she had to manually examine before every use. This is not how a car seat is supposed to be used, and it is therefore defective by definition.

However, the false advertising claims failed because they were too vague. Along with the phrases above, CTP also said that the car seat had “advanced safety features;” “combines advanced technologies with luxurious details to deliver an exceptional first car seat for your child”; “marries the highest standard of safety with a focus on child comfort”; and “[o]ffer[s] maximum convenience and safety without comprising on design.”

But general statements about a product’s safety “do not create an enforceable promise.” The court pointed to judicial divisions over whether Uber’s claims to have “the strictest safety standards possible” and “the safest rides on the road” were puffery—some said they were actionable because superiority over other methods was verifiable and others said they were “too boastful, self-congratulatory, aspirational, or vague to amount to misrepresentation.” Under this “vague and inexact” standard, the plaintiff failed to state a claim. CTP’s “highest standards of safety” claim was not paired with any superlative statements and stayed general and vague statements. The court also found a “meaningful difference between a company claiming that they offer the safest product and claiming that they set the highest safety standards. Standards in the abstract are necessarily aspirational, as they describe a policy or plan and not the actual outcome or product.” [Requiring consumers to read like lawyers always goes well!]

phthalates could be "ingredient" for purposes of falsifying "only natural ingredients"

Wysocki v. Chobani, LLC, --- F.Supp.3d ----, 25-cv-00907-JES-VET, 2026 WL 926713 (S.D. Cal. Apr. 6, 2026)

Wysocki alleged that Chobani’s Greek Yogurt had dangerous phthalates in it. Phthalates are “a group of chemicals [the U.S. Food and Drug Administration (“FDA”) has deemed to be used safely] in hundreds of products, such as ... food packaging, pharmaceuticals, blood bags and tubing, and personal care products.”  But plaintiffs alleged that they were bad for people.

The court rejected various challenges to the pleadings, including that the cited testing didn’t show that the actual product Wysocki purchased actually contained phthalates because the tested products differed in size (32 oz vs. 5.3 oz), which could reasonably affect phthalate levels, as each size container calls for a different amount of #5 plastic. That is, under Wysocki’s leaching theory, phthalate levels in the 5.3 oz product would likely be lower than those detected in the 32 oz product. Moreover, half of the cited tests detected no phthalates and the testing entity’s own caveat was that results “may not be representative of actual product contents.” These were all factual disputes, and plaintiff pled enough to get past Rule 9(b), with the exception of one phthalate that was not specifically mentioned in the allegations about testing. Allegations that phthalates readily leach into surrounding surfaces and food and are commonly used as a catalyst to make the # 5 plastic container that Chobani predominately uses for its products also helped.

The court rejected the argument that Chobani’s “only natural ingredients” claims weren’t misleading because there was no allegation that phthalates are used, or act, as ingredients in the products. But Wysocki plausibly alleged that allegations of “only natural ingredients,” while affirmatively disclaiming the presence of any “artificial flavors,” “artificial sweeteners,” or “preservatives”, represented to her and other reasonable consumers that the product is free of unsafe, unnatural, toxic substances, such as phthalates. At the motion to dismiss stage, a reasonable consumer could understand representations that use terms such as “100% natural” or “natural,” modified by other terms connoting that it is “all natural,” to mean “that a product does not contain any non-natural ingredients.” And “only” was just such a modifier.

A reasonable consumer was also likely to interpret the meaning of the term, “ingredient,” by its ordinary definition: “something that enters into a compound or is a component part of any combination or mixture.” If phthalates’ presence in the yogurt was shown, that would plausibly lead a reasonable consumer to find that the yogurt’s ingredients include phthalates, rendering “only natural ingredients” false.

It didn’t matter that phthalates aren’t on the ingredient list; reasonable consumers don’t have to cross-check the ingredients list when a claim is clear on the face of the product. (And here, the ingredient list wouldn’t help!) Given the “only” representation, “even trace amounts of a non-natural substance, like phthalates, would exponentially alter the previously stated percentages, which in turn results in a misleading ‘natural’ claim.”

Chobani also argued that Wysocki failed to allege that the levels of phthalates in the products render them unhealthy or unsafe to consume. While some courts have required plaintiffs to allege the presence of the alleged harmful substance, at a particular level, to support a misrepresentation claim, that was a question of fact. Wysocki alleged that “natural ingredients are one of the most important aspects of healthy food,” and that, when food packaging does not contain the word “natural,” over half of reasonable consumers assume the product must contain chemicals.” And she alleged a risk of “unsafe levels” of phthalates, and that disruptions of the endocrine, respiratory, and nervous systems can result from both high and low dose exposure.

However, Wysocki’s partial omission theory failed: she alleged literal falsity, not that a representation was misleading absent further disclosure.

Chobani’s argument that it was insulated by Proposition 65’s warning thresholds was premature. Prop. 65 provides that “no person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual where the amount exceeds the [agency-established] no significant risk level.” But, pursuant to a statutory safe harbor, this duty to warn does not apply to business operators when Prop. 65-regulated chemicals exposure levels are equal to or less than the “no significant risk level.” And private plaintiffs who sue to enforce its private right of action have to give pre-suit notice, an unwaivable requirement.

But Wysocki argued that she wasn’t bringing claims under Prop. 65, even though two of the alleged phthalates in the products are on the Prop. 65 chemical list. Though Prop. 65 is concerned with cancer or “reproductive toxicity,” she alleged endocrine disruption, developmental harm, immunological and renal harm, and hormone disruption, “outside the scope of Proposition 65.” Resolving this would require more factfinding than appropriate at this stage.

However, equitable relief and express warranty claims were dismissed.


Brita's clearly qualified filtration claims couldn't mislead reasonable consumers as to lack of qualification

Brown v. Brita Products Company, --- F.4th ----, 2026 WL 1028347 No. 24-6678 (9th Cir. Apr. 16, 2026)

Unlike 800-thread count sheets (see previous post), a reasonable consumer would not expect a fifteen-dollar water filter to “remove or reduce to below lab detectable limits common contaminants hazardous to health” in tap water, notwithstanding clear disclosures to the contrary. Brown brought the usual California claims against Brita.

The Standard Filter, Brita’s lowest cost filter, is certified to reduce five contaminants—copper, mercury, cadmium, chlorine, and zinc—to below the levels recommended by the NSF and EPA. [At least, for now; I assume those recommendations will soon be lifted.] The Elite Filter, a more expensive model, reduces more than a dozen other contaminants to less than or equal to NSF/EPA recommended levels.

The package advertises that the filter “reduces” certain harmful contaminants. The Brita Everyday Water Pitcher, which includes the Standard Filter, claims: “Reduces Chlorine (taste & odor), Mercury, Copper and more” and directs consumers to “see back panel for details.” The back label likewise claims to “reduce” “Copper,” “Mercury,” “Cadmium,” “Chlorine (taste and odor),” and “Zinc (metallic taste).” The product labels offer links to additional sources of information known as “Performance Data Sheets,” which provide more information. Performance Data Sheets contain more detailed information on exactly which contaminants are filtered by Brita’s Products, and to what extent. For example, the Standard Filter’s Performance Data Sheet discloses the following information:

Brown bought the Brita Everyday Water Pitcher with the Standard Filter and alleged that he received the misleading message that the product “removes or reduce[s] common contaminants hazardous to health ... to below lab detectable limits.” He pointed to the claims: “BRITA WATER FILTRATION SYSTEM”; “Cleaner, Great-Tasting Water”; “Healthier, Great-Tasting Water”; “The #1 FILTER”; “REDUCES Chlorine (taste and odor) and more!”; “REDUCES Chlorine (taste and odor), Mercury, Copper and more”; and “Reduces 3X Contaminants.” He alleged that the filter didn’t reduce to below lab detectable levels various hazardous contaminants, including arsenic, chromium-6, nitrate and nitrites, perfluorooctanoic acid (PFOA), perfluorooctane sulfonate (PFOS), radium, total trihalomethanes (TTHMs), and uranium.

Material omission claims: Absent a contrary misrepresentation, a duty to disclose arises under California law if either (1) a product contains a defect that poses an unreasonable safety risk; or (2) a product contains a defect that defeats its central function. The omission must also be material. The reasonable consumer standard is not satisfied where plaintiffs allege only “a mere possibility that [the] label might conceivably be misunderstood by some few consumers viewing it in an unreasonable manner.” Even if there was an unreasonable safety hazard or defect in central function, Brita lacked a duty to disclose that its filters didn’t completely remove or reduce to below lab detectable levels all of the alleged contaminants. “Such a disclosure would not be important to a reasonable consumer in light of Brita’s other disclosures on its Products’ packaging and the objective unreasonableness of such an expectation.”

“As a matter of law, no reasonable consumer would expect Brita’s low-cost filters to completely remove or reduce to below lab detectable levels all contaminants present in tap water, particularly in light of Brita’s extensive disclosures to the contrary.” Brita discloses that its filters “reduce” contaminants from tap water, not that they remove contaminants entirely, and specifically discloses the contaminants that are reduced. It also provided “easily accessible information” (the Performance Data Sheets) about the extent of the reductions. Thus, “[b]ecause a reasonable consumer has been made aware of the Products’ limitations, we cannot say that a reasonable consumer would have been misled by Brita’s omission of these limitations on its Products’ packaging.

an impossible claim is literally false and actionable if believing it is reasonable

Panelli v. Target Corp., --- F.4th ----, 2026 WL 1042441, No. 24-6640 (9th Cir. Apr. 17, 2026)

Something that I don’t yet have a full handle on is happening in 9th Circuit consumer protection cases around literal falsity v. ambiguity. It could be good, but I’m nervous about the potential for weird Lanham Act interactions since “literal falsity” and “ambiguity” sound like the Lanham Act concepts but currently have important differences. FWIW, the emerging consumer protection approach has some things going for it—and if Lanham Act cases started to recognize that consumer surveys shouldn’t rigidly be required in cases of “ambiguity,” that would be a very good thing indeed.

Anyway, Panelli alleged that Target sells some of its “100% cotton” bedsheets with claimed thread counts of 600 or greater, but that it is impossible to achieve that high of level of thread counts with 100% cotton textile. The court of appeals held that the district court erroneously concluded that Panelli could not be deceived as a matter of law by an impossible claim under the usual California consumer protection laws.

Panelli alleged that independent testing showed the sheets he purchased had a thread count of only 288—not 800, as claimed on the sheet’s label. Indeed, he alleged, “it is physically impossible for cotton threads to be fine enough to allow for 600 or more threads in a single square inch of 100% cotton fabric.” The district court relied on Moore v. Trader Joe’s Co., 4 F.4th 874 (9th Cir. 2021), a badly reasoned case holding, in this opinion’s words, that “a reasonable consumer would be dissuaded by contextual information from reaching an implausible interpretation of the claims on the front label of the challenged product.” If it was physically impossible to achieve 800 thread count, the district court reasoned, then no reasonable consumer would interpret the ad as promising an impossibility.

The court of appeals distinguished Moore because there, “100% New Zealand Manuka Honey” was ambiguous: it didn’t necessarily mean that the bees making the honey fed only on the manuka flower. (This is not the poorly reasoned part, which is the stuff the court says a reasonable consumer should know about honey grading and pricing.) As a result, “reasonable consumers would necessarily require more information before they could reasonably conclude Trader Joe’s label promised a honey that was 100% derived from a single, floral source.” And “(1) the impossibility of making a honey that is 100% derived from one floral source, (2) the low price of Trader Joe’s Manuka Honey, and (3) the presence of the ‘10+’ on the label [which apparently signifies a relatively low manuka content] … would quickly dissuade a reasonable consumer from the belief that Trader Joe’s Manuka Honey was derived from 100% Manuka flower nectar.”

Here, the district court “skipped a step by not analyzing whether the label was ambiguous and therefore required the reasonable consumer to account for outside information to interpret the label’s claim.” The challenged claim here was not ambiguous. It “purports to communicate an objective measurement of a physical aspect of the product.”

Target argued that there are multiple possible measures of thread count—but it doesn’t produce consumer protection law ambiguity, which asks only whether a substantial number of reasonable consumers could think their questions about the feature had been answered without further information, not whether all reasonable consumers would necessarily think that. Note that the multiple possible measures of thread count would produce Lanham Act ambiguity, if the non-false possibilities are reasonable. Here, “it is unlikely that a reasonable consumer would know there are multiple thread-counting methodologies.” Indeed, consumers are not “expected to look beyond misleading representations on the front of the box” to discover the truth of the representations being asserted, and are “likely to exhibit a low degree of care when purchasing low-priced, everyday items,” “like bed sheets sold by a mass-market retailer.”

A reasonable consumer is “unlikely to be familiar with the intricacies of textile manufacturing.” [Moore said that reasonable consumers know how honey is made; its error was to assume that knowledge “bees collect pollen” would somehow translate to “and therefore they’d likely collect lots of different kinds of pollen” when people generally don’t give that much thought to that kind of background information.] “Realistically, a reasonable consumer’s knowledge of textile manufacturing is likely limited to the fact that a higher thread count listed on packaging indicates a higher quality sheet.”

The court added: “Allegations of literal falsity are the most actionable variety of consumer protection claims on California’s spectrum of actionability.” True, some claims can be so clearly false as to avoid deception. But Panelli’s claims weren’t unreasonable or fanciful:

While a vast majority of consumers are, for instance, familiar with the biological nature of bees so that it would be unreasonable for a consumer to think honey was sourced from a single type of flower, they likely would not have that same kind of baseline knowledge about textile manufacturing. Neither common knowledge nor common sense would cause a Target shopper to question the veracity of the claim on the bed sheet’s label that the product was of 800 thread count.

The court declined to create a situation where “manufacturers would face no liability for false advertising so long as the claims were wholly false—regardless of whether this falsity is generally knowable to consumers.”

Friday, April 17, 2026

Panel 6: Unanticipated Consequences of New Technologies and Practices

29th Annual BTLJ-BCLT Spring Symposium: Origins, Evolution, and Possible Futures of the 1976 Copyright Act

Jennifer Urban, UC Berkeley Law (Speaker and Moderator)

Daniel Gervais, Vanderbilt Law: Copyright act as undergirding licensing architectures for AI. © rights are inert without exchange. A reproduction right is sterile if the transaction costs of licensing exceed the value of any license. Ghost architecture of the statute: the licensing machinery built around it by antitrust enforcement/courts, and extended by subsequent legislative initiative. Why a mix of compulsory licenses, court-supervised blanket licenses, CMOs, and congressionally sponsored organizations? Reflects judgments about when markets will work to create licensing regimes on their own and when they won’t.

Congress understood that certain uses would produce market failures if left entirely to the private system—difficulty of advance licensing millions of daily transactions, supervising individual uses. Compulsory licenses are not concessions to users at the expense of rightsholders; they are a mechanism to have market activities occur when otherwise they’d be unlikely to occur at all—tech would be frozen out of the market or rightsowners would be uncompensated. ASCAP, BMI, SESAC allowed for licensing without compulsory licensing.

The initial compulsory license was created to prevent monopolization, not to subsidize record companies. The streaming eras revealed some weaknesses, including “address unknown” filings to the Copyright Office, demonstrating a systemic breakdown. The MMA in 2018 tried to address that failure with a mandatory administrator of a blanket license, reducing the loophole and creating a matching database to find authors & deal with unclaimed royalties.

SoundExchange is neither voluntary nor a traditional intermediary—does not require opt-in. The compulsory license is one half of the architecture. The other is voluntary licensing in text & images, showing judicial calibration of licensing market. This played out with the CCC and fair use litigation—the early fortunes of CCC were modest without a judicial determination that licensing was important. Texaco (2d Cir. 1994) changed that landscape by holding that systematic copying of journal articles was not fair use.

AI is a stress test b/c of the scale of reproduction beyond any existing licensing system. International system: no national licensing scheme can avoid the possibility of arbitrage. The licensing system is starting to respond for high-value sources like NYT. CCC has expanded to cover AI uses. Other countries are introducing AI specific licenses. Voluntary arrangements can try to fill that space even before legislation.

History in US: incremental expansion of compulsory license as scale increases. American experience counsels against using a levy to respond: AHRA’s statutory royalty on digital audio recording devices and blank media seemed designed well but the tech passed through the market like a comet.

How can a system built on territoriality deal with cross-border content? Reciprocal agreements, through voluntary licensing. Each adaptation is slower and imperfect but it does happen. AI: most demanding test b/c of scale, speed, and international complexity.

Matthew Sag, Emory Law: Nonconsumptive uses. © is built on the metaphor of the printing press. Copyright provides incentives to authors whose works would otherwise be reely copied on first publication. Thus, reproduction is the locus of exchange b/t reader and author, where the toll can be imposed. But what if there are no readers?

We have seen a series of copy-reliant technologies—search engines, plagiarism detection, machine learning, generative AI. They necessarily copy works but usually don’t deliver prior original expression to any human reader. This issue wasn’t anticipated in 1976, even if AI authorship clearly was.

Should hidden intermediate copies be permissible if no one ever reads them? Tension b/t 2 intuitions—copying (the technical act) is infringement versus copyright’s purpose is to protect expression communicated to audiences—consider how we judge substantial similarity, or give rights over public performance.

His solution: nonexpressive use is fair use. When he started, he mostly had software reverse engineering in mind, then plagiarism detection and Google Books. Gen AI produces outputs that might compete with human-made expressive works, which changes the politics entirely, if not the law.

Courts have generally held that technical copying is fair use when the copying isn’t communicating to the public. Bartz & Kadrey both found model training to be highly transformative fair use; Ross Intelligence disagreed and currently under review by 3d Circuit. If that case goes the other way, it may be on narrow grounds related to the 4th factor.

Where is this heading? Courts have done a pretty reasonable job with the nonexpressive use cases. But we don’t have to rely on courts. Netcom: an analogous issue; court did a great job recognizing insanity of holding infrastructure providers liable for passive passthrough, and articulated volitional conduct requirement. Congress also stepped in and gave us 512, modeled on Netcom but more predictable than the volitional/nonvolitional conduct line. A functional Congress could provide additional clarity.

To that end: proposes revising 107 to recognize that copying works to extract unprotected information or enable nonexpressive computational functions is highly transformative—not fair use b/c there should be room for courts to evaluate the whole picture.

Lots of people perceive licensing as a solution for LLM training. ASCAP is amazing, efficient, but they don’t pay anyone a check for less than $100 or direct deposit for less than $1. It works b/c the authors w/ works of negligible value don’t get paid. But we have no way of tracing which individual works are important to the system. We’d have to divide revenues among a lot of people, not just songwriters, book authors, but everyone who ever posted on social media or commented on Stack Overflow. That’s billions—a very large sum of money divided by billions turns into a lot of transaction costs. You could still send checks to large content owners, but those are precisely the folks who can do deals w/large companies. This would just be a tax system. If you want to tax LLMs and redistribute $ for worthy causes, that’s a great idea, but tax!

Rebecca Tushnet, Harvard Law School: And now for something completely different!

When I started my career writing about fan fiction, which involves fans writing, for example, the further adventures of Kirk and Spock from Star Trek or Mulder and Scully from the X-Files, people in the legal community were often surprised that I cared—wasn’t this a bunch of infringing derivative works? Now, when I talk about fan fiction, people in the legal community are often surprised that I care because noncommercial fanworks seem obviously transformative and fair, or at least obviously not going to come under legal threat. Chloe Zhao directs movies for Marvel and talks about her fan fiction; the actress who plays Dr. Javadi on The Pitt says that her character is a regular girl and gives as a key example that she’s on AO3, which she expects you to know means the Archive of Our Own. My students have never known a world in which fan fiction was hard to find. I’m more pleased to be in the latter situation, but it does make me feel a bit old! And given that noncommercial fanworks were not on the radar of the drafters of the Copyright Act—even if some of them almost certainly knew about science fiction fan culture—my placement on this panel makes sense.

A bit about my relationship with fanworks: a founder and presently co-chair legal committee of the Organization for Transformative Works, or OTW. Mission, to support and defend noncommercial fanworks, explicitly framed as transformative both in the legal copyright sense and in the broader sense of being different in exciting ways. One of the ideas was that we’d try to show up in the rooms where it happens to give fans a voice in policy and legal discussions as creators, the way the EFF does for general internet freedom.

Today, the OTW’s Archive of Our Own hosts over seventeen million fanworks—works based on existing media. We’re a Library of Congress American heritage site. The OTW also supports a wiki, Fanlore, dedicated to fan-related topics; a peer-reviewed open-access journal named Transformative Works and Cultures; and a legal advocacy project to help protect and defend fan works from legal challenge and commercial exploitation. The OTW routinely submits amicus briefs and policy comments to courts, legislatures, and regulators regarding copyright, trademark, and right-of-publicity issues.

One of our most longstanding projects has been seeking and obtaining exemptions from 1201 for noncommercial remix videomakers—vidders or fan editors. Our exemption currently allows noncommercial remixers to rip clips of video from DVDs, Blu-Ray and streaming video in order to make their own transformative works.  In the 1201 exemption process the Copyright Office perceives its job to be narrowing your requested exemption as much as possible. Still, we showed that noncommercial fan videos were regularly fair use and that 1201 hampered fans’ ability to make those fair uses. We’ve obtained renewal of those exemptions several times.

Some lessons:

First, there is no substitute in the modern state for organizations that can speak the language of regulation. Citizens must organize or they will be ignored. But a small group of people can effectively do that! Very few of the more radical anti-copyright, anti-capitalist people who think the OTW is a liberal (derogatory) organization are in this room, but I think we’ve had a productive effect on the overall conversation that includes them.

Second: It is not good for everyday practices to get fundamentally out of sync with formal law. If the everyday practices are acceptable and even good, the formal law ought to recognize that, and we can use fair use to do so.

There are those who say that fanworks are tolerated infringement. Some of those people are probably in this room. This is at best an argument that the formal law sweeps way too broadly under any justification you want to give for copyright rights—yes, the main “tolerators” are big conglomerates, simply because as we heard yesterday they’re the source of most of the widely disseminated for-profit copyrighted works we have today, but there’s a reason that even the individual authors who say they oppose fanworks haven’t actually sued over noncommercial fanworks.

In addition, the “tolerated infringement” argument is a profound indictment of statutory damages specifically. If damage to the exclusivity in a copyrighted work is both infringed by a noncommercial, nonreproductive work and subject to up to $150,000 in damages, that damage ought to be bad, not just an annoyance. Pam Samuelson has always had the right of it and we heard yesterday various forms of agreement with her position that statutory damages have been harmful to the rest of the copyright scheme.

Third and More broadly, noncommercial fanworks are good because they offer a distinct field for creative endeavors, separate from the copyright-enabled commercial system. They are both artisanal and widely distributed, making them an important alternative form of expression. Noncommercial works are fundamentally different in the aggregate from commercial works. They can be Poetry; 100-word drabbles; short stories; 20,000 word stories; million-word stories; other things there’s not much commercial market for. This is part of what makes fanworks worth preserving and protecting: they are part of the background of a thriving modern creative ecosystem.

Noncommerciality complicates questions around blanket licensing: don’t want money, don’t want to participate in the commercial system.

In addition and relatedly, fan cultures have a long connection to queer writing: fan fiction is inherently about difference/the fact that the story could be different/possibility—encourages both repetition with difference and experimentation, which allows some people to open themselves to various possibilities in the rest of their lives. If you want to cry about the power of creativity, read the stories we collected for our submission to the NTIA’s inquiry into the legal framework for remixes: the power of making stories and other creative works within a community that is excited to hear everyone speak has literally saved lives.

Beyond its transformative effects on people, noncommercial fandom is a huge boon to creativity generally. Professors Andrew Torrance and Eric von Hippel have identified “innovation wetlands”: largely noncommercial spaces in which individuals innovate that can easily be destroyed by laws aimed at large, commercial entities, unless those individuals are specifically considered in the process of legal reform.   Their description fits remix cultures well:

The practice of innovation by individuals prominently involves factors important to “human flourishing,” such as exercise of competence, meaningful engagement, and self-expression. In addition, the innovations individuals create often diffuse to peers who gain value from them …. 

Innovation requires that individuals have rights to make, use, and share their new creations, collaborating with others to improve them, as remix authors do.  Given the small scale and limited resources of most individuals, “[a]nything that raises their innovation costs can therefore have a major deterrent effect.” 

Things I have personally been around for: the adoption of curated folksonomy/AO3-style tags in publishing. New story types and tropes: five things that never happened for exploring different scenarios for characters that together illustrate something about the fan author’s view of the characters; the fan-invented “omegaverse” tropes about humans with certain animalistic characteristics.

If you forget about noncommercial works in your creativity policy, you enable the destruction of vital diversity and seed corn for the next generation.

Finally, a coda with another view of internationalism: The US was at the time of the OTW’s founding, nearly twenty years ago, the only place we could count on a strong and flexible fair use defense. This has somewhat changed, including by adoption of fair use in several other jurisdictions, Canada’s noncommercial user-generated content exception, and most recently by greater European flexibility on pastiche, but fair use’s impact is still really notable. American hegemony meant that we didn’t even need a term like “the Brussels effect” for the effect of American fair use and safe harbor laws, but it really did seem like the internet was another American territory. That’s changing, more every day, but we are probably going to miss it when it’s gone.

Jennifer Urban: In-formalization, term extension, and orphan works. Although there was a near-consensus and energy to address it, c2004-2015, efforts were ultimately not a rousing success.

Orphan works: policy questions are related to your sense of who is an author & what authors generally want. Orphan=owner can’t be identified and someone wants to make use of a work in a manner that requires the owner’s permission. 76 Act increased the number of orphan works by removing the formalities.  Widespread agreement thus on the definition and scope of the problem

Solution space: limitations on remedies of injunctive relief, especially when a significant amount of original expression was added; limitations on damage remedies (US proposals); statutory exceptions (EU directive w/r/t making available and reproduction rights); compensation to later-appearing © owners (reasonable compensation, extended collective licensing).

Conditions on relief: proposed: reasonably diligent search; identify use as orphan work on the use itself (notice requirement); register use, potentially with waiting period before use; takedown/stop use upon appearance of © owners; pay compensation to later-appearing owner; provide attribution to later-appearing owner; categorical limitation on type of users (e.g., EU © Directive: educational, library, & public heritage institutions & public broadcasters).

Why so complicated? Different uses are different: archive/library digitization are sensitive to search costs; takedown on notice is more feasible; licensing fees may be prohibitive at scale. Derivative works/smaller scale: more extensive search may be more feasible but takedown/removal not feasible and injunctive relief is prohibitive. Where you were willing to compromise depends on where you sit.

Similarly for copyright owners, © owners like photographers/illustrators were worried they’d be hard to find & usually don’t need to use orphan works themselves. Filmmakers are easier to find and more likely to want to use orphan works.

Limited effectiveness: administrative/centralized licensing adopted in Canada, Japan, Korea, Hungary, UK—fewer than 1000 licenses total by 2015 since 1999. Expensive, not productive. [CASE Act looks better than that!]

2021 EU directive followup found very limited use of EUIPO database and very limited use overall by most eligible organization. 70% of entries in database registered by British Library, and number dropped hugely after Brexit. Lots of complaints about strict search requirements.

Fair use case law also developed to allow a lot of the big data uses; a risk management question. People worried about orphan works protection cabining fair use, even with a savings clause, and that slowed momentum.

Where are we now? Substantial strides in digitization of Office records, which is helpful. But records remaining are in the “sour” spot of 1945-1978. Later-appearing © owner can still register and then sue. Risk aversion is still an issue. Gatekeepers for small creators, libraries—people making decisions about risk aren’t necessarily fully economically rational but have practical effects. Same things with fair use. Occasionally, courts have considered market unavailability in the fair use analysis, but that brings in gatekeepers/risk aversion, leading to “clearance required” policies. And the definition of an orphan work is that it can’t be cleared.

AI raises similar but maybe harder problems.

Urban to RT: how does AI training compensation come into this?

A: it’s incommensurable. It’s like offering me payment after I had you over for dinner at my house. There’s nothing immoral about restaurants but that’s not the kind of relationship I was seeking.

Q about 103(b) and fanworks: if they're fair use, then 103(b) doesn't come into it. Fan authors sometimes worry about commercial misappropriation: they have a copyright in their fair use fanworks, so they can try to shut down unauthorized commercial uses, and they also aren't responsible for such unauthorized uses. Goldsmith even makes this a bit clearer by establishing that the analysis goes use by use; a fanwork created for noncommercial purposes is fair regardless of whether deliberate monetization by the creator would be unfair.

Urban to Sag: how does international nature of training affect this?

Sag: the international scene is quite complicated. Peter Yu & Sag survey the global scene—different jurisdictions take very different approaches, but each trying to (1) make a pathway for legal text data mining, (2) have some protections for © owners. What you see is difference in regulatory style. EU is far more prescriptive in DSM directive. There’s clarity there; some others go further than fair use, but may require, e.g., not just noncommerciality but affiliation w/a library or university. People who think we can put the genie back in the bottle are likely wrong, but even if that’s what you wanted to do, a lot of this activity is portable—you can go to other jurisdictions to train. And that fact of int’l competition should be recognized. Hard to see how a licensing system or tax & redistribution system could work on an int’l basis. We don’t have the political competence to do it here on a national basis, but they might be able to do it in the EU. Only a handful of jurisdictions have TDM protections, but it’s 52% of the world’s GDP. The fact that we allow it in the US isn’t an outlier among our peers.

Gervais: voluntary licensing can deal with crossborder issues. Collective or individual licenses can say something like “parties don’t agree on current scope of fair use” but contracts can manage that risk up to a point, waiting until there’s more coherence in the courts.

RT: maybe we should bring Kalshi in and just use prediction markets. [joke!]

Urban: if there’s nobody to pay, then the orphan works schemes involving collection don’t support the © system.

Q: about licenses b/t major copyright owners and AI companies: will they narrow the scope of fair use?

Sag: I don’t think those licenses should narrow the scope of fair use, though the editor of the Atlantic did say that he entered into one such license to prove the existence/validity of the licensing market. A few notes: most of the licenses, as far as he can tell, are not just for AI training but for retrieval-augmented generation—the economics and copyright implications of sending an AI agent onto the web and assemble them into a report are quite different from the AI training cases and it makes sense to license that activity. Mostly they’re licensing access, which you can see most easily with Reddit, which doesn’t own © in content but charges $60 million/year for firehose access. That’s fine, though it shows need to update robot.txt protocol, but they don’t prove that licensing is a general training solution. We’ll see more of those licensing deals and they’re good, but hopes courts don’t jump to “market for training.”

Litman to Sag: instead of amending fair use to presume training highly transformative, consider moving away from fair use and avoid “transformative,” which attracts additional political, emotional, religious opposition that you don’t need.