compounding pharmacy must face drugmaker's Lanham Act claims based on false 503B compliance statements

Pacira BioSciences, Inc. v. Nephron Sterile Compounding Center, LLC, No. 3:23-cv-05552-CMC, 2026 WL 2267750 (D.S.C. Aug. 6, 2026)

Pacira sells an FDA-approved pain management drug called EXPAREL. Nephron allegedly made various false and misleading statements about two of Nephron’s competing compounded drug products. Specifically, Nephron allegedly represented those products as compliant with Section 503B of the FDCA, and as safe, effective, and superior to EXPAREL. The court granted partial summary judgment to both sides on the resulting Lanham Act claim.

Section 503B defines an “outsourcing facility” as a facility that “is engaged in the compounding of sterile drugs”; “has elected to register as an outsourcing facility”; and “complies with all of the requirements of [Section 503B].” Outsourcing facilities may distribute compounded drugs without obtaining a patient-specific prescription. They are also exempt from the FDCA’s new-drug approval process and certain labeling and supply-chain requirements. But they have to satisfy 11 statutory “conditions.”

The condition central to this case restricts outsourcing facilities’ use of “bulk drug substances” in compounding. They can’t be used unless the government properly identifies a clinical need or a drug shortage. In 2016, the FDA said it needed time to evaluate nominations and wouldn’t act when a bulk drug substance appeared on a list of “Category 1” substances the FDA maintained on its website, which “may be eligible for inclusion on the [clinical need] list, were nominated with adequate supporting information for FDA to evaluate them, and [had] not been identified by FDA as presenting significant safety risks.”

Nephron compounded BKK, a compounded drug product consisting of bupivacaine, ketorolac, and ketamine; later, it switched to RKK, with ketorolac, ketamine, and ropivacaine. Nephron advertised and sold them as “503B products” and as lower-cost alternatives to Pacira’s EXPAREL. In August 2019, Pacira wrote to the FDA urging it to take action against Nephron over its “illegal marketing and promotion” of BKK. It sued in November 2023, alleging false advertising of both products in terms of 503B compliance, comparability to/substitutability for Exparel, and related safety/efficacy claims.

Laches barred claims based on BKK; Pacira knew about the alleged false advertising since at least August 2019 and failed to offer more than conclusory argument to rebut the presumption of prejudice arising from its more than four-year delay in filing suit (period borrowed from state law). Even without the presumption of prejudice, defendants noted that several key witnesses no longer work for Pacira; some witnesses often could not recall basic facts related to the litigation during their depositions, and two, “both of whom reside beyond the subpoena power of the court, indicated they do not intend to appear at trial.” Of the 28 Nephron employees identified in Pacira’s Rule 26(a) initial disclosures, 17 were now former employees, including 11 who “would have still been current employees had Pacira filed within three years of January 2020.” “The unavailability of witnesses, faded memories, and changes in personnel are all indicators of evidentiary prejudice.”

But RKK came later and was allegedly discovered later. Nephron identified no “facts otherwise indicating a lack of vigilance” on the part of Pacira.

The court first held that the RKK Section 503B claims weren’t statements of opinion. Though lay claims about law are generally opinion, sometimes a law is “so clear on its face that no good faith doubt concerning its interpretation [is] possible, even without an explicit statement from [a court or agency].” In that circumstance, the law’s meaning is “so clear as to be a fact for Lanham Act purposes,” and Section 503B is “clear on its face.” Determining whether an outsourcing facility’s claims of compliance with Section 503B’s “bulk drug substance” provision are true “requires no more than consulting two lists.”

Nephron argued that Section 503B permits an outsourcing facility to market and sell a drug (say, RKK) without FDA approval as long as the individual components of that drug appear on the drug shortage list. But that wasn’t true: the drug shortage exception allows outsourcing facilities to “compound using bulk drug substances” only if “the drug compounded from such bulk drug substance appears on the drug shortage list.” Section 503B also defines “compounding” as “the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug.” That’s what making RKK is.

Nor did the FDCA preclude Pacira’s Lanham Act claim. The “logical building blocks” of Pom Wonderful apply with equal force to “drug marketing, medical device labeling, cosmetics branding, or any other kind of marking or representation which would fall under both the Lanham Act and the FDCA,” Thus, “courts adjudicating Lanham Act disputes outside of the food and beverage realm” have “almost uniformly” interpreted POM Wonderful “to cover products in other FDA-regulated industries,” including pharmaceuticals. The issue here was not an exception because it wouldn’t “require the expertise of the FDA to resolve,” would call on the court “to make an original determination on an issue committed to the FDA’s discretion,” or would “otherwise conflict with an affirmative policy judgment by the FDA.”

The court declined to consider alleged falsehoods not identified in the complaint: statements allegedly conveying that RKK was compounded “in compliance with Section 503B” or “in a 503B-compliant outsourcing facility,” along with the specific statements that RKK is “generic to or substitutable for EXPAREL,” provides “improved value” over EXPAREL, “reduces post-operative pain[,] complications, risk of readmission, length of stay, [and] patient morbidity and mortality,” “eliminates opioid related adverse drug effects,” and has “low reported incidents of nausea and vomiting.”

Were they false? Nephron’s product lists and pricing sheets were distributed to members of group purchasing organizations (GPOs), healthcare systems, and individual hospitals, enough to constitute commercial advertising/promotion. They listed RKK among Nephron’s “503B Products.” This was a false claim as matter of law: “By listing RKK under that heading, Nephron necessarily communicated to purchasers that RKK belonged to the class of products meeting the statute’s requirements; no other conclusion can be drawn from its designation as a ‘503B Product.’”

But statements that Nephron is “a leading manufacturer of 503B outsourcing products” weren’t literally false; appearing at the bottom of a Nephron “Opioid Free” product handout featuring BKK, RCK, and RKK “could be understood as conveying that Nephron manufactures ‘503B outsourcing products’ as part of its broader business, without necessarily implying that BKK, RCK, and RKK fall within that category.” Pacira’s survey didn’t test the “leading manufacturer” statement, so Nephron got summary judgment.

Nephron’s “503B outsourcing facility” logo appeared throughout Nephron’s materials, including the “Opioid Free” handout and the product label for RKK. Again, this was too ambiguous to be literally false. Here Pacira did have a survey, presenting respondents with a sample marketing email about BKK. Pacira’s expert concluded that a net 14.8% of respondents believed BKK was a Section 503B-compliant drug. “That percentage would ordinarily be sufficient to support a finding that an advertisement misled or tended to mislead consumers.”

The court denied Nephron’s motion to exclude. First, though the email shown to participants focused only on BKK, the deception rate calculated by Butler could be “extrapolated” to RKK; the difference went to weight rather than admissibility:

This is not a scenario where Pacira seeks to extend survey results to an entirely separate and untested statement (as with the “leading manufacturer” statement). Rather, the same “503B outsourcing facility” logo appeared on the product labels for both BKK and RKK, and it is not immediately clear consumers would perceive the logo differently depending on the product to which it was affixed. Under these circumstances, the weight to be given [the survey’s] findings, as applied to RKK, is for the jury to decide.

Other challenges also went to weight: Using closed-ended questions after open-ended questions has both critics and supporters and their limits could be the subject of cross-examination. The survey asked, “Which of the following, if any, are message(s) communicated by this email?” and offered the following response options:

1. BKK, an admixture of bulk drug substances from Nephron, is a 503B compliant drug

2. BKK, an admixture of bulk drug substances from Nephron, is opioid free

3. BKK, an admixture of bulk drug substances from Nephron, is packaged in syringe form

4. None of these

5. Don’t know / unsure

Respondents who selected the first option were asked a follow-up open-ended question to assess why they believed this.

Nephron argued that closed-ended questions should be avoided when testing consumer deception because they are “highly susceptible to demand effects and focalism.” But “there is nothing inherently wrong in using closed-ended questions to test consumer impressions.” They can be “suitable for assessing choices between well-identified options” and “may remind respondents of options that they would not otherwise consider or which simply do not come to mind as easily.” And open-ended questions have their own problems, such as decreasing reporting of actually-held views: “respondents answering open-ended questions may be less likely to report some information that they would reveal in response to a closed-ended question when that information seems self-evident or irrelevant” (quoting Shari Diamond). They also require subjective coding: “Because respondents are answering in their own words and may not provide precise answers, many answers are simply not clear enough to definitively evaluate or categorize reliably.” Also, the “Don’t know / unsure” answer choice is a recognized way “to screen out respondents who may not have an opinion on the issue under investigation.”

Nephron also argued that the survey expert made “excessive and biased” changes to the stimulus shown to the control group. The control group saw an email that (1) removed both instances of the “503B outsourcing facility” logo; (2) added a disclaimer stating, “Note: the admixture of bulk drug substances sold as BKK is not compounded in compliance with Section 503B”; (3) removed the statement “Nephron continues to strive to provide drugs that are critically short and meet all needs of the Country!”; and (4) modified the statement “This is something that will be huge in helping hospitals decrease opioid and Exparel use” by deleting the reference to EXPAREL. The disclaimer, Nephron argued, was “overly broad and inaccurate” because it “would likely lead participants to conclude that no part of BKK is 503B-compliant.”

It was logical to address only BKK in the disclaimer because that was the specific product being tested by the survey. “The court struggles to see why respondents needed to be informed of the compliance status of bupivacaine, ketorolac, and ketamine individually when they were being asked about the admixture BKK.” Anyway, this was for cross-examination.

Finally, Nephron argued that the survey was an improper “reading test” because the stimulus was visible while respondents answered questions. Again, experts disagree on this, so it was for cross-examination and competing expert testimony. Thus, there was a genuine issue of material fact on misleadingness for use of “503B outsourcing facility” logo on the “Opioid Free” product handout and RKK’s product label.

Statements that RKK (1) is “generic to or substitutable for EXPAREL” and (2) provides “improved value” over EXPAREL: Pacira didn’t show any use of the exact phrase. The closest it got was one email stating “Nephron produces BKK, RKK, & RCK as generic, clinical need medications as requested by physicians across the country.” That didn’t mention EXPAREL at all.  Summary judgment granted on (1).

The “improved value” statement was in the “Opioid Free” product handout. But it didn’t make an express or implicit comparison to EXPAREL, and it was puffery.

RKK safety and efficacy: these statements claimed that RKK (1) “reduces post-operative pain[,] complications, risk of readmission, length of stay, [and] patient morbidity and mortality”; (2) “eliminates opioid related adverse drug effects”; and (3) has “low reported incidents of nausea and vomiting.” These weren’t establishment claims [side note that courts used to be much more open to the argument that scientific/health claims are establishment claims by necessary implication, which seems right to me], and Pacira showed only that they weren’t substantiated.

Of the remaining statements, there was no genuine dispute that “503B Product” was material, given that GPO customers “required Nephron to warrant that the compounded drugs it sold complied with Section 503B.” “Parties do not typically bargain for guarantees on matters they consider unimportant. That Nephron’s contracts with GPOs included an express warranty of Section 503B compliance is compelling evidence that such compliance mattered to purchasers of RKK.”

But the materiality of the “503B outsourcing facility” logo was still in dispute.

There was also a factual issue of injury based on evidence that certain customers who had previously purchased EXPAREL (1) began buying RKK when it came on the market, (2) simultaneously reduced their purchases of EXPAREL, and (3) were members of GPOs that had received Nephron pricing sheets listing RKK as a “503B Product.” So these issues, and damages and/or disgorgement, remained for trial.

anti-Chinese memory chips blog & report weren't commercial speech despite alleged competitor funding

Yangtze Memory Technologies, Inc. v. Micron Technology, Inc., 2026 WL 2350276, No. 1:25-cv-01795 (CJN) (D.D.C. Aug. 13, 2026)

On the one hand, there’s a risk of suppressing valuable noncommercial speech if we apply the Lanham Act too broadly; on the other, there’s a risk of allowing false advertisers to launder claims through supposedly noncommercial speakers if we interpret it too narrowly. Here, the court finds the political valence of anti-China speech relevant to determining that the alleged falsity was not made in commercial speech.

YMTC alleged that defendants ran an astroturfing campaign that discouraged customers from purchasing memory chips from YMTC due to its connections to the Chinese government. Defendant Micron competes against YMTC in the market for memory chips. It allegedly worked with defendant DCI, a public affairs firm, “to erect a sophisticated ... ‘astroturfing’ campaign ... to damage YMTC’s reputation and business for their own profit.” It allegedly funded a website called China Tech Threat that “purport[ed] to be focused on policy” but was actually a front “to disseminate favorable messages about Micron’s products and disparaging messages about YMTC’s competing products.”

For example, CTT published a blog post, “As YMTC Booms, China Aims to Dominate Flash Memory Industry,” asserting that YMTC was associated with “criminal activity, including a Social Security spoofing scam, identity theft and cyber extortion.” A June 2022 report, “Silicon Sellout: How Apple’s Partnership with Chinese Military Chip Maker YMTC Threatens American National Security,” implored “Apple to voluntarily end its partnership with YMTC” and “source its chips from existing suppliers like Micron.” [Yeah, if the funding facts are as stated, that seems like commercial speech to me.]

Apple allegedly suspended its plans to purchase chips from YMTC in October 2022, resulting in “hundreds of millions of dollars in lost revenue.” The astroturfing campaign also allegedly “inflicted lasting damage on YMTC’s reputation and commercial standing across the technology sector.”

The court found Article III standing because YMTC pled “a plausible chain of events that links DCI’s actions to YMTC’s injuries.” DCI argued that other sources gave the same warnings, “[b]ut the existence of, perhaps, an equally important player in the story does not erase [DCI]’s role.”

However, the blog post and report were not actionable under the Lanham Act, despite including apparently factual claims such as “YMTC chips equipped with spyware and installed on Apple devices could funnel collected data back to Beijing” and “Electronics with embedded chips are enabled with a ‘kill switch’ .... Such features, under Chinese military production, could be enabled ... to shut down remotely by an unauthorized Chinese government actor.”

The court primarily reasoned that the 2021 blog post and 2022 report do not constitute “expression related solely to the economic interests of the speaker and its audience,” which strikes me as a way to insulate all factual claims from scrutiny given that we’re at a point in which anything can be politicized. But:

The blog post warned about the risk of China overtaking the United States in the flash memory industry and accordingly encouraged the Trump administration “to implement controls to stop the flow of [semiconductor manufacturing equipment] to China.” Given this clear focus on national security concerns, the post was not primarily—much less solely—about economic interests. As for the report, although it at least arguably contained some references to economic competitors in the chip industry, the vast majority of it either outlined the foreign policy risks of the deal between YMTC and Apple or proposed potential solutions to mitigate those risks. The report mentioned that the deal may have economic implications, but it was far from solely focused on that aspect.

The court also thought that the post and report weren’t “speech proposing a commercial transaction,” and that “this non-advertising medium strongly counsels against YMTC’s position.” (Just because astroturfing isn’t identified as a conventional ad shouldn’t make it ok!) “[E]ven if Micron, through DCI and China Tech Threat, would potentially benefit financially from seeing its competitor’s reputation suffer, that general economic motivation cannot alone transform the specific means at issue here—a blog post [and report] flagging national security concerns—into commercial speech.”

What about references to specific products, also part of the commercial speech inquiry? Well, discussing the potential risks of “YMTC chips” “generally” aren’t enough to constitute a reference to a specific product. That conclusion seems quite bizarre. An entity that sold flavored condoms, different sizes of condoms, lubricated and unlubricated condoms, and then touted condoms generally is making a specific product reference (Young of Bolger v. Young made Trojans, and also wanted to send flyers promoting condoms generally as well as Trojans specifically). And targeting a specific producer seems certainly within the Lanham Act’s concerns (see also “commercial activities” in 43(a)(1)(B)).

Ultimately, the court concluded, the publications are “political speech expressing a point of view, not commercial speech attempting to promote a good or service.” They called for government—not consumer—action. “YMTC’s attempt to focus on only four statements out of a 20-page report and one sentence out of a two-page blog post cannot overcome the overwhelmingly political nature of the publications.” This also distinguished Ariix, LLC v. NutriSearch Corp., 985 F.3d 1107 (9th Cir. 2021), which concerned a review guide “that compares and reviews nutritional supplements sold in the direct marketing industry”— “a much more commercial publication.” [Again, this distinction seems wrong to me. The issue in Ariix wasn’t that publications about nutritional supplements are inherently more likely to be commercial speech—plenty of such speech is noncommercial. It was the secret control by a funder who was spoken of well in the guides. And there was no showing in Ariix that the disparaging matter was a significant part of the guides, which covered lots of different supplements.]

heavy weather for heavy metals in infant food

Choudhry v. Mead Johnson & Co., 2026 WL 2349932, No. 25-cv-09480 (ER) (S.D.N.Y. Aug. 13, 2026)

Plaintiffs alleged that various Enfamil infant formulas contained arsenic, cadmium, and lead, heavy metals that present significant health risks, particularly to young children, and “can cause serious and often irreversible damage to brain development,” including from “low levels of exposure.” They sued for false advertising under NY law.

They allegedly relied on the following claims on the packaging: “ ‘Brain Building,’ ‘#1 Recommended Brand by Pediatricians,’ ‘The Only Hypoallergic [sic] Formula With LGG® Probiotic,’ ‘No Artificial Growth Hormones,’ ‘LGG® probiotic to help support digestive health’ and ‘does not use table sugar,’ ” along with “expert recommended,” and some others. They alleged that reasonable consumers would not think these products contained heavy metals.

A consumer survey conducted by their counsel found that 77.8% of survey participants answered “No” when asked, “After seeing the label would you expect arsenic, cadmium, lead, and/or mercury in the infant formula?” The survey followed up:, “how important, if at all, would it be to your purchasing decision if the infant formula you purchased contained, or risked containing, even a small amount of arsenic, cadmium, lead, and/or mercury,” and 71.0% of participants answered “Very important,” 25.4% “Important,” and 3.6% “Not at all important.” Mead Johnson received judicial notice for the fact that, “[i]n April 2026, the FDA released a report finding low levels of Heavy Metals in many infant formulas, cautioned that this was not automatically reason for alarm, and that additional guidance is forthcoming, but did not provide a timeline for that guidance.”

The court declined to apply the primary jurisdiction doctrine. White v. Beech-Nut Nutrition Co., 2024 WL 194699 (2d Cir. Jan. 18, 2024) vacated the district court’s dismissal of a similar case based on the primary jurisdiction doctrine; detailed consideration wasn’t required because “the FDA had no expected timeline to provide actionable guidance on the safe levels of Heavy Metals in infant formulas, which outweighed ‘any advantages of deferring to the FDA under the primary jurisdiction doctrine.’” That was still true.

Also, courts are well-suited to determine if a product’s packaging was misleading or deceptive. This case didn’t require the court to determine what levels of heavy metals should be permissible, so there is not “a substantial danger of inconsistent rulings.”

Standing for unpurchased products: although the ingredients weren’t identical, the same alleged misrepresentation was on all of them, which was enough at this stage.  

GBL §§ 349 and 350: Not subject to 9(b) pleading requirements. Mead Johnson questioned plaintiffs’ reliance, but they alleged that they “read and relied upon the packaging of the Infant Formulas when making their purchasing decisions,” which sufficed.

Material misleadingness to “a significant portion of the general consuming public or of targeted customers, acting reasonably in the circumstances”: Courts will not permit such claims “where the plaintiffs’ alleged inference appeared fundamentally incompatible with basic common sense.” Plaintiffs didn’t allege that the formulas advertised that they didn’t have heavy metals, “but that the packaging misleadingly represented the products as healthy, safe, and nutritious when they contained or risked containing Heavy Metals,” with claims like “Brain Building,” “expert recommended,” and “#1 Recommended Brand by Pediatricians.” The court agreed that the survey bolstered this inference.

Interesting comment:  

Plaintiffs’ pleading satisfies this low burden because it demonstrates that the majority of consumers would assume the product did not contain Heavy Metals based on its label. This does not definitively establish that a reasonable consumer would be misled by the packaging. However, at this stage, despite certainly requiring an inferential leap, Plaintiffs sufficiently allege that this supposed deception is not “patently implausible” such that the Court can determine as a matter of law that reasonable consumers could not be misled by the packaging. (emphasis added)

Is the court saying that a majority of consumers could still be unreasonable? Empirical v. normative claims about reasonable consumers are scattered throughout cases, with courts rarely articulating the relationship between “reasonable” and “common.”

Anyway, implicit misrepresentation was plausible. What about an omission theory?  Mead Johnson argued that plaintiffs failed to allege that knowledge about heavy metals was solely in its possession and that consumers could not obtain the information, and also that heavy metals in food is widely known.

At the motion to dismiss stage, “a plaintiff bringing an omission-based claim for § 349 liability must show that ‘the business alone possesses material information that is relevant to the consumer and fail[ed] to provide this information,’ or that plaintiffs could not ‘reasonably have obtained the relevant information they now claim the [defendant] failed to provide.’ ” This was sufficiently alleged. Plaintiffs alleged Mead Johnson’s superior knowledge; that consumers reasonably expected Mead Johnson to test for heavy metals and disclose that information to the public; that Mead Johnson deceptively hid that it failed to monitor for the presence of heavy metals in its products; and that consumers could not detect their presence without conducting scientific tests.

Materiality to a reasonable consumer: not a separate element, but it would be reasonable to assume that heavy metals’ presence would be material because of their health risks.

For common law fraudulent misrepresentation, Mead Johnson argued that its efforts as part of a trade organization to lobby against a California bill that would require disclosure of heavy metals content was insufficient to plead scienter because it is “legitimate First Amendment activity,” not “conscious misbehavior.” That alone wasn’t sufficient to establish the required “strong circumstantial evidence” of scienter, but it could bolster the claims.

However, unjust enrichment was dismissed as duplicative.

a lot of balls: golf ball manufacturer states claim for allegedly false UV light comparison

TaylorMade Golf Co. v. TopGolf Callaway Brands Corp., 2026 WL 2244259, No. 3:26-cv-250-GPC-BJW (S.D. Cal. Aug. 4, 2026)

TaylorMade sued Callaway, a competitor in the golf ball market, for federal and state false advertising/unfair competition. TaylorMade alleged substantial investment in innovating and advertising its golf balls, including a golf ball for tour-level performance known as “TP5 Brand.” Callaway has a TP5 brand golf ball equivalent called “Chrome Tour” golf balls.

TaylorMade alleged a misinformation campaign, including through sales reps and influencers and promotion to third-party golf publications.

TaylorMade’s TP5 Brand golf balls allegedly have two layers of coating: the first inner layer is white paint, and the second outermost layer is “clearcoat” that has a low concentration of “optical brightener” for cosmetic and stain-resistance purposes. TaylorMade alleged that the optical brightener had no impact on ball flight, distance, spin trajectory, or any other performance attribute. However, the “clearcoat has the highest potential impact on ball performance in flight” and therefore, its intentional thin coating approach is allegedly a deliberate design decision to improve ball performance. “As such, the splotchiness on its balls under UV light is Plaintiff’s design choice to have a single, thin, clearcoat layer to prioritize performance and not inferior quality or performance.”

TaylorMade alleged that Callaway similarly applies two layers of coating to their Chrome Tour golf balls, but both layers contain clearcoat with optical brightener, resulting in a brighter appearance that allegedly does not increase quality or performance.

TaylorMade was not alleging that uneven paint application cannot impact golf ball performance or quality; rather, it claimed that Callaway’s UV light demonstration was an unreliable way to evaluate paint coverage, paint uniformity or golf ball quality and performance. “In fact, the UV light demonstration only reveals the distribution of optical brightener additives, a cosmetic ingredient that has no bearing on ball flight.” Thus, using a UV light demonstration to make comparative quality claims was false/misleading—but that is what Callaway allegedly did.

For example, one sales agent stated that the demonstration would show whether there is “too much paint” on the ball, and if so, would result in a “mudball.” “Mudball is a derogatory term used to describe a golf ball that has a bad flight, trajectory, shape and distance due to the presence of mud on the ball and is the ‘bane of any pro golfer’s existence.’” The sales rep claimed that dark spots on the ball could “potentially act like a piece of mud is on the ball and who knows where the ball is going to go... all about quality control.”

Thus, TaylorMade challenged the following claims: (1) the use of UV light can measure golf ball quality or performance; (2) the difference in appearance of golf balls under UV light are indicative of overall golf ball quality and performance, (3) the uniform appearance of Calloway’s golf ball dimples and brightness under UV light is indicative of superior quality or performance; (4) TaylorMade’s golf balls are “mudballs”; and (5) TaylorMade’s quality control is inferior to Callaway’s.  

TaylorMade further alleged that the UV light test is unreliable, misleading, and lacks standardization “because it is highly sensitive to other variables including wavelength and intensity of UV light, distance and angle of which the light is held, the duration of the UV light exposure, prior UV exposure, and ambient lighting conditions, none of which can be standardized.”

This campaign was allegedly extensive. For example, MyGolfSpy, “a popular digital platform with over 22 million consumers,” published “Callaway Doubles Down on Speed and Precision With New Chrome Tour, Chrome Tour X, and Chrome Soft Golf Ball” which contained several statements from the alleged misinformation campaign and had a “DIY side note” encouraging consumers to conduct their own UV light demonstration as a way to measure a golf ball’s quality and performance based on its “paint coverage.”

Callaway argued that its claims were puffery.  A claim that golf balls act “like a piece of mud” due to the uneven paint coating on the ball which negatively impacts the ball’s ability to fly straight was a specific and measurable claim and not puffery, as were the other claims about UV light as a method of proof.  The complaint explained why the UV light demonstration wasn’t reliable.

Did TaylorMade have standing under California’s UCL and FAL? Yes, it sufficiently pled lost sales: “because Defendant is a direct competitor, any alleged false misrepresentations about the quality and performance of TaylorMade’s golf ball will increase sales of Callaway’s golf balls and cause sales of TaylorMade golf balls to decrease.” Also, it was independently sufficient that TaylorMade allegedly lost money when it incurred financial expenses to combat the misinformation campaign by responding to inquiries from customers who saw or heard about the UV light demonstration.

What about reliance? In federal district courts, the majority view is that a plaintiff must allege its own reliance and not the reliance of third parties. But the court here adopted the minority view that a “competitor may allege false advertising claims under the UCL and FAL without alleging its own reliance and need only allege it suffered an injury, loss of money or property, as a result of the alleged misrepresentations.” [seems correct]

Given the alleged Lanham Act violation, “unlawfulness” UCL claims survived, as did unfairness claims, which would allegedly “encourage a race to the bottom” where competitors will resort to misleading demonstrations and pseudo-scientific claims rather than competing on the actual merits of their products.

"battery tender" isn't generic for guess what, but keyword advertising is fine

Deltona Transformer Corporation v. NOCO Company, --- F.4th ----, 2026 WL 2236806, No. 24-13590 (11th Cir. Aug. 4, 2026)

Competitors aren’t generally allowed the same freedom as consumers to “genericize” a term. Here, the 11th Circuit finds no error in a district court’s holding that “battery tender” wasn’t generic, despite calling the product category at issue by that name throughout the opinion (“specialized vehicle-battery chargers called ‘battery tenders’”—they recognize when a battery is fully charged so they don’t overcharge and degrade it, an innovation when introduced). [What is the name of this specialized subcategory, if not “battery tender”? This is an exercise for the reader because the court sure won’t tell you, but moments in the opinion offer “battery-maintaining chargers” or “trickle chargers.”]

Deltona federal registrations for “Battery Tender” and “Deltran Battery Tender.” NOCO made similar charges and advertised its own products as “battery tenders.” A jury found for Deltona on its federal and state infringement claims, and further concluded that NOCO had engaged in false advertising in violation of federal law. The court of appeals kicked out some of the theories—specifically, based on keyword purchases and Lanham Act false advertising—and remanded to recalculate damages.

The allegedly infringing conduct: (1) bidding on Deltona’s marks as “keywords” and using them to trigger NOCO’s ads in Amazon search results; (2) using the term “battery tender” in the text of its own Amazon ads; (3) incorporating the term “battery tender” in its product descriptions on Amazon; and (4) holding out its chargers as “battery tenders” in communications with marketing firms and customers.

Category (1) couldn’t infringe, but the rest could. NOCO’s position was summarized by a sales manager: An email drafted by Nook and sent by a NOCO sales manager to a potential customer said, “We understand Battery Tender is a well known brand, but most customers usually refer to the function (battery tender meaning a trickle charger), than the actual brand.” Internal documents showed that NOCO was willing to use “tender” and “battery” in ways that were “passive aggressive.”

The director of advertising at a company that handles Deltona’s marketing testified that one of its customer-service agents spoke to a consumer who had initially reached out to NOCO and was “very confused” when one of its employees “referr[ed] to [NOCO’s] products as a battery tender charger.” And an email exchange in the record shows that a retailer considering whether to stock a new line of battery tenders reached out to NOCO with an inquiry about Deltona’s product.

The jury held that Deltona was entitled to actual damages of $1.3 million and that NOCO had committed intentional misconduct or gross negligence, entitling Deltona to punitive damages of $5.75 million. The district court ordered NOCO to disgorge profits of over $12 million and issued a permanent injunction. The injunction prohibited NOCO from “selling, marketing, advertising, [or] promoting” its products using the terms “Battery Tender,” “Deltran Battery Tender,” “Deltran,” or “Tender,” the latter of which was included because “[t]here was abundant evidence that [the company’s] use of ‘tender’ on its own was done in a way that caused customer confusion and infringed [Deltona’s] Marks.” The injunction exempted keyword purchases and comparative advertising.

Deltona had a genericity survey, but the jury could have rejected it. The marks weren’t inherently generic because they were registered; they were descriptive with acquired secondary meaning. “The fact of registration puts a heavy thumb on the scale against genericness.” [Does that mean that the burden is clear and convincing evidence? Or something else?]

“Battery tender”

entails some level of abstraction—“tend[ ]” is more a metaphorical than literal description of what a battery tender does, which is to preserve the battery by maintaining its charge. That makes “battery tender” more like “vision center”—which might sell glasses and contact lenses but doesn’t literally sell “vision”—than, say, “liquor store”—which is nothing more than a store that sells liquor. Indeed, the term “battery tender” might even be suggestive; it “suggest[s] characteristics of the good[ ]” and seems to require at least some “effort of the imagination” to understand how the product works.

Sigh. Nothing has “inherent” meaning with the partial exception of onomatopoeia.

Deltona’s co-founder made up the term based on an analogy to a ship’s tender. [But if he made it up to identify this new category and distinguish it from prior types of chargers, that shouldn’t matter—“dry ice” didn’t have to be the term for solid carbon dioxide.] The court says that, “as a matter of historical fact, it’s not accurate to say that ‘battery tender’ referred from the very beginning simply to ‘a kind of battery-charging device,’” but doesn’t explain what the generic word was at the very beginning.

NOCO’s consumer survey found that 78% of 558 respondents reported that they believed that “Battery Tender [was] a type of product” rather than a reference to a particular brand. The jury was free to reject that, though; Deltona had challenged the survey’s methodology on the ground that it included people who might simply have been “exposed” to battery tenders [generic use again!] “from shopping near [them]” when walking through an automotive store or department.

The court then held that keyword bidding alone can’t be trademark infringement because the use of the plaintiff’s mark for keyword-bidding purposes occurs “behind the scenes.” [Twenty years later, they figure this out. Sincerely: thanks, Abitron!] Likelihood of confusion “turn[s] on what the consumer s[ees] on the screen and reasonably believe[s], given the context.” (Citing Eric Goldman and the Second, Ninth, and Fifth Circuit cases to similar effect.)

Use in product titles and product descriptions on Amazon, however, was potentially infringing, as was use in communications with marketing firms and consumers, so that part of the award was upheld. Unlike keyword advertising, “[t]he inclusion of ‘battery tender’ in the description automatically not only affected Amazon search results but also drove shoppers searching for Deltona’s battery tenders to NOCO chargers without alerting them in any way—through a ‘sponsored’ tag or otherwise—that they weren’t really looking at battery tenders.”

“A reasonable jury certainly could have concluded that these explicit statements to customers—that ‘battery tender’ was a generic term—were likely to confuse them.” (Confuse them about what? Not about source or sponsorship, given the statement that it was generic.)

The Florida Deceptive and Unfair Trade Practices Act damages award was also problematic, even though the Lanham Act violation could also violate FDUTPA. Monetary relief in the form of actual damages is available only to a “person who has suffered a loss as a result of a violation of this part,” and Florida law generally defines actual damages as “the difference in the market value of the product or service in the condition in which it was delivered and its market value in the condition in which it should have been delivered.” Thus, Deltona couldn’t base its damages on “harm to its reputation or goodwill,” because consequential damages like that aren’t compensable under FDUTPA.

Finally, the district court erred by instructing the jury on false advertising under the Lanham Act based on the same conduct. Deltona’s complaint alleged unfair competition and false designation of origin under the Lanham Act; it never separately articulated a false advertising theory. It was not enough to use the phrase “misleading description and representation of fact,” when read in conjunction with the complaint’s “numerous allegations involving advertisements” and its generic citation to § 43(a), to warrant a separate jury instruction on false advertising under § 43(a)(1)(B).  In context, the complaint clearly referred to § 43(a)(1)(A). NOCO neither expressly nor impliedly consented to trying a false-advertising claim.

The court of appeals had “substantial and ineradicable doubt” whether the jury was properly guided, so that part of the judgment was reversed.

Disgorgement was appropriate, given the willful conduct. [Recalculation doesn’t seem to be required because of how disgorgement is assessed—even kicking out the keyword advertising doesn’t seem to matter (though you’d think that sales made through keyword ads alone wouldn’t have the right causal relationship).]

Also ok: an injunction extending a ban on standalone use of “tender.” “[E]ven though NOCO seems to have ceased its misconduct, the record shows that it has, after brief interludes, repeatedly returned to infringing Deltona’s marks.” “In fashioning relief against a party who has transgressed the governing legal standards, a court of equity is free to proscribe activities that, standing alone, would have been unassailable.”

But the damage award needed to be reassessed, so remand for a new trial it was.

is an avocado a vegetable or a fruit? Court says it's ambiguous

Parashos v. Once Upon A Farm, No. 26-cv-00314-EMC,  2026 WL 2283647 (N.D. Cal. Aug. 7, 2026)

Once Upon A Farm allegedly violated California consumer protection laws by misleadingly labeling its baby product as the “Wild Rumpus Avocado ‘Fruit & Veggie Blend’ ” when in fact it contains no vegetables (but does contain avocados). The court found the claim implausible.

The front of the pouch displays multiple images of avocados, along with images of apples, banana, and pineapples. The back lists its ingredients as pineapple, banana, apple, avocado and mint.

The FDA classifies avocados as fruit and mint as an herb. So does the pouch contain “veggies”? The target audience is allegedly “health-conscious parents” who are “willing to pay a premium to ensure that the food that they provide to their children is nutritious and includes vegetables.” Plaintiff brought the usual California claims.

Dismissal is appropriate if the claim that a label is misleading “runs counter to ordinary common sense or the obvious nature of the product.” And “a survey of dictionary definitions, of which the Court takes judicial notice, suggests that the question of whether an avocado is a vegetable is not so clear-cut in common parlance, notwithstanding the technical botanical definition of avocados as a fruit.” Avocados, which contain a pit like peaches or cherries, fit the scientific definition of the “product of fertilization in a plant with its modified envelopes or appendages, specifically : the ripened ovary of a seed plant and its contents.” But another meaning of “fruit” is “the usually edible reproductive body of a seed plant especially: one having a sweet pulp associated with the seed.” “Avocados, like peppers, zucchini, and other botanical fruits, lack the ‘sweet pulp’ that would place them firmly within the ‘fruit’ category of popular usage.” Avocados also fit within broad definitions of “vegetable” such as “a usually herbaceous plant (such as the cabbage, bean, or potato) grown for an edible part that is usually eaten as part of a meal.” Different dictionaries variously call an avocado a fruit or a vegetable.

Famously, in construing a tariff statute, the Supreme Court held that while “botanically speaking,” tomatoes are fruits, in “the common language of the people,” they are vegetables. Nix v. Hedden, 149 U.S. 304, 307 (1893), as are the technical seeds beans and lentils. Avocados are like tomatoes: “commonly served at meals as ingredients in e.g. burritos and sandwiches, and not, like fruits, as a sweet snack or a part of a dessert. And people eating chips and guacamole are not likely to think they are eating a fruit dip.” At the very least, the claim wasn’t unambiguously false. See, e.g, Henderson v. Gruma Corp., 2011 WL 1362188 (C.D. Cal. Apr. 11, 2011) (granting a motion to dismiss on the grounds that a label promising “Garden Vegetables” was confirmed by the inclusion of avocado powder, dehydrated onion, garlic powder, and bell pepper); Gates v. Upfield US Inc., 2024 WL 3362857 (C.D. Cal. July 9, 2024) (“Avocado oil is a type of vegetable oil known for its healthy qualities”; granting a motion to dismiss because a product labeled “made with avocado oil” and “79% vegetable oil spread” would not imply to a reasonable consumer that the product was made without other forms of vegetable oil).

Nor was this plausibly misleading. The front label was ambiguous enough that a reasonable consumer would have consulted the back label. “Ambiguous” in this context does not simply mean “susceptible to more than one reasonable meaning,” but rather that a reasonable consumer “would necessarily have required more information before concluding that the products’ front labels were making a specific promise.” Such “inherent ambiguity” was present here. The context reinforced that, with explicit reference to “Avocado” in the name of the product and a label showing multiple images of avocados, as well as bananas, apples, and pineapples. There was no other conceded vegetable shown. “There is thus an ambiguity as to whether the product contains vegetables other than avocados. Faced with this ambiguity, the reasonable consumer is expected to check the back label for complete information.”

The likelihood that a reasonable consumer would look to the back label was underscored by the fact that the product’s “target audience” was allegedly “health-conscious parents” who “would have particular reason to check the back label.”

trademark claim proceeds with essentially no detail, despite trade dress failure

Honest Company, Inc., v. Butterblu, LLC, 2026 WL 2211834, No. 2:26-cv-00019-WLH-MBK (C.D. Cal. Jul. 28, 2026)

Honest sued former partner Butterblu for trademark infringement and related claims. Honest sells products in the diaper and wipes, skin and personal care, and household and wellness categories. It registered two trademarks for HONEST registered for swaddling and crib blankets and various children and infant related products, and also owned HONEST BABY CLOTHING (and logo) for baby and toddler-related products.

The parties previously entered into an agreement (where Honest took over ownership of all products in inventory, and Butterblu sourced, marketed and sold these products in exchange for a service fee. Honest alleged breach for, among other things “secretly developing and selling a baby apparel product line in direct competition with Honest Baby Clothing brand products.” Honest claimed rights in two print designs with stylized holiday trees and a striped, pastel rainbow used on various products that Butterblu allegedly copied.

claimed Honest design

Claimed Honest design

Consumers allegedly commented on online forums, such as Reddit, that Butterblu’s products “look like” Honest products but “rebranded” or similar language, that Butterblu is the “creator” of Honest’s products, and otherwise expressed confusion as to the source of and/or affiliation between the parties’ respective products. Honest alleged that “at least one” consumer has contacted Honest with questions about a recent purchase in which the consumer intended to buy Honest products from Amazon but instead received products bearing a Butterblu label.

Honest pine PJs

Butterblu pine PJs

Honest rainbow PJs

Butterblu rainbow PJs

Butterblu’s website allegedly includes a misleading statement that “Honest’s new leadership team ultimately decided to exit the apparel space.”

Showing a common tolerance for trademark claims, despite Butterblu’s argument that Honest didn’t plead use of its marks, it was enough to allege that Butterblu “has used Honest’s intellectual property without authorization” and “mislead consumers and prospective consumers into believing the Infringing Products are affiliated or associated with, or sponsored by, Honest” and to submits screenshots showing that Butterblu “sold products that bear striking resemblance to its own products.” Products, not marks. Ugh.

And pleading that Reddit users have commented on forums about Honest and Butterblu products looking similar and have expressed confusion “as to the source of and/or the affiliation between the Parties’ respective products” also sufficed.

Plus, “many courts have held that an ex-licensee’s continued use of a trademark is enough to establish likelihood of confusion,” and the court agreed. Ugh again! Which trademark? Especially because the court also says that the trade dress infringement claim failed for want of pleading secondary meaning.

Explain to me how this screenshot shows use of the Honest marks?

Honest alleged that intentional copying showed secondary meaning. But “proof of deliberate copying is not determinative ... competitors may intentionally copy product features for a variety of reasons.” Thus, pleading intentional copying alone is insufficient. The online comments about “looking like” or “rebranding” weren’t enough because they didn’t specifically discuss the two claimed prints, and “looking like” does not equal confusion. Why doesn't this also doom the claim about trademark infringement, since the commenters doesn't seem to depend on the word marks or logo?

False advertising: Butterblu argued that Honest’s own public statements confirm the truth of the alleged false statement that Honest was exiting apparel, and, that the continued availability of remaining products during a sell-through or transition period does not render the “apparel-exit” statement false. But “[w]hether the alleged misrepresentations are false or misleading is a factual question generally inappropriate for resolution on a motion to dismiss.” The complaint alleged that “HONEST-branded apparel continues to be advertised, offered for sale, and sold to consumers, contrary to the representations made on Butterblu’s website” and that “Honest has a one-year sell off period for existing inventory.” Honest also argues that Butterblu knew that the statement was misleading because Honest explicitly stated in its earnings release that it was “ ‘exiting our relationship with our current apparel provider’ —i.e., Butterblu” and did not state that it was exiting the apparel space as a whole. This was enough on a motion to dismiss.

consumers face more skepticism than competitor in online gaming case

Mitchell v. Skillz Platform Inc., 2026 WL 2212876, No. 26-cv-00674-AMO (N.D. Cal. Jul. 31, 2026)

Although competitors can aggregate harm to sue under the Lanham Act, consumers—the direct victims of false advertising—tend to have more trouble. Skillz just lost a big claim to its main competitor over falsely advertising that it didn’t use bots in mobile cash games. Here, with similar allegations under various state laws, the consumers struck out. Plaintiffs didn’t sufficiently allege reliance, causation, or lack of an adequate remedy at law (for the restitution claim).

Representations that users match with “real players” and have “no bots guaranteed” were plausibly false and deceptive, as were representations that users match with “players of equal skill.” But the representation that users can make “easy withdrawals” was non-actionable puffery with no set meaning.

The claims failed because plaintiffs didn’t allege that they relied on or even read any particular representation. “Most of the representations are allegedly located across Skillz’s website and social media accounts, so it is not reasonable to infer that Plaintiffs must have seen them.” Even an in-app badge displayed “in front of every single player, every time they launch a Skillz-powered application” since at least the beginning of 2024 wasn’t enough to plead that they actually read the alleged misrepresentations. Seems pretty fixable, but language quoted rejecting the RICO claim was bad news (and maybe another reason to avoid RICO claims): “[A]s the Ninth Circuit noted in a similar case, ‘there may be no single, logical explanation for gambling—it may be an addiction, a form of escape, a casual endeavor, a hobby, a risk-taking money venture, or scores of other things.’ As a result, it may well be that the representations ‘did nothing to influence [users’] perceptions’ or that users ‘played fully aware of how the [platform] operate[s].’” While the evidence in the competitor case tends to negate that idea, “users 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.”

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.

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.

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 opportunities to preserve or raise the claim. Given the fact that there’s no preemption of federal claims, this seems like a serious error on its part.

interactive website offering illegal-in-CT ghost guns wasn't covered by CUTPA, but any sales were

Connecticut v. Indie Guns LLC, NO. (X06) UWY-CV23-6072307S, 2026 WL 2322641 (Ct. Super. Ct. Aug. 6, 2026)

The state sued Indie Guns for selling illegal ghost guns into Connecticut. Indie Guns defaulted, but the court only granted partial default judgment—merely having an interactive website doesn’t make the company subject to the Connecticut Unfair Trade Practices Act (CUTPA), although selling illegal products into the state is deceptive and unfair in violation of the law.

“[A]n out-of-state or foreign company that operates an interactive internet website is not, on that basis alone, engaged in trade or commerce in Connecticut.” And CUTPA requires such in-state trade or commerce, so this isn’t about personal jurisdiction but the scope of the law.

The state argued that the website was deceptive and unfair because it advertised its products to all consumers without warning of their illegality, and offered to sell to Connecticut consumers.

A violation of a Connecticut criminal statute such as the ban on ghost guns does constitute a CUTPA violation via unfairness. Unfairness requires considering: “(1) [W]hether the practice, without necessarily having been previously considered unlawful, offends public policy as it has been established by statutes, the common law, or otherwise—in other words, it is within at least the penumbra of some common law, statutory, or other established concept of unfairness; (2) whether it is immoral, unethical, oppressive, or unscrupulous; (3) whether it causes substantial injury to consumers, [competitors or other businesspersons].” “Inarguably, selling and delivering illegal gun parts in Connecticut readily satisfies all three criteria.”

So too with deception, which requires (1) a representation, omission, or other practice likely to mislead consumers; (2) interpreted reasonably under the circumstances; that is (3) material. “When a defendant sells a product to a buyer, the defendant represents, expressly or implicitly, that the product is legal in the state in which the buyer purchases or receives delivery of the product.” (Given that this was a test buy, there was no actual deception, but the state as enforcer isn’t required to show that.)

But there liability ended. CUTPA  defines “trade” and “commerce” as “the advertising, the sale or rent or lease, the offering for sale or rent or lease, or the distribution of any services and any property, tangible or intangible, real, personal or mixed, and any other article, commodity, or thing of value in this state.” (Emphasis added.). Actual sales/shipment to Connecticut definitely constitute engaging in trade or commerce, but not “the mere existence of an interactive website.” Although this does require the AG to wait until illegal products are shipped to Connecticut, so it creates some risk, that’s a policy decision for the General Assembly to make. (The court also commented that reaching Connecticut via distributors or other independent contractors would support application of CUTPA to a manufacturer.)

In part because of the default, we don’t actually know how many times Indie Guns sold into Connecticut. “Those practical challenges are likely why the state focuses on the Indie Guns’ website, rather than on gun sales, as the basis for imposing civil penalties. Those practical challenges, however, do not permit the court to speculate about the extent of Indie Guns’ sale of illegal gun parts to Connecticut consumers. Nor do those challenges permit the court to ignore the geographic scope limits of CUTPA.”

The state was entitled to judgment that Indie Guns acted willfully when it sold a ghost gun part to the investigator. But the state didn’t seek the $5000 maximum penalty for that sale. It was entitled to a permanent injunction against sales into Connecticut.

Foiled: Reynolds must face "Made in USA" class

Washington v. Reynolds Consumer Products LLC, No. 1:24-cv-02327-ALC-RFT, 2026 WL 2210008 (S.D.N.Y. Jul. 30, 2026)

The court certified a class of NY consumers under the NYGBL’s false advertising provisions, based on alleged falsity of aluminum foil that’s sold with a label claiming, “FOIL MADE IN U.S.A.”

Plaintiffs argued that reasonable consumers expect that the raw materials used in the products are sourced from within the United States and that a substantial amount of the transformation of raw materials into the foil takes place within the United States. But the only commercial source of aluminum is bauxite. “Since 1981, none of the bauxite mined in the U.S. was used for aluminum, and in 2013, U.S.-mined bauxite comprised less than 0.1 percent of world production.” Thus, plaintiffs alleged, Reynolds must be sourcing from outside the US.

To make aluminum foil, bauxite is processed and refined into alumina, which is then turned into aluminum through smelting. The resulting ingots undergo further processing to make aluminum foil. Plaintiffs alleged that a substantial portion of this processing occurs outside of the United States.

Reynolds’ (bad) argument was that the “Made in the U.S.A.” label referred only to the final foil itself, not to the ingots (as if people knew about the processing stages of aluminum foil).

Only discussing parts of the certification standard: Reynolds argued that plaintiffs lacked proof of a classwide definition of “made in USA,” common evidence of consumer exposure to the label, and common evidence of a price premium. But they had enough for certification on commonality and predominance.

The Third Circuit still stands alone in its extreme ascertainability rulings. The proposed class was comprised of all persons who purchased Reynolds Wrap aluminum foil labeled with the words “FOIL MADE IN U.S.A.” in New York from March 27, 2021, to the present, which was ascertainable “because the putative class has been concretely identified by subject matter, timing, and location.”

Plaintiffs had a common theory of deception. “Defendants focus much of their analysis on whether or not Plaintiffs can prove materiality and injury, rather than show whether these questions are common because they may be determined on a classwide basis.” All class members would have been exposed to the “FOIL MADE IN U.S.A.” label on the front of all aluminum foil products. Common evidence was required to determine materiality to a reasonable consumer.

And price premium injury was common injury; they proposed a damages model consistent with their theory of liability. Plus, given that statutory damages would be less than $50 or $500 here, most class members would opt for statutory damages over actual damages. “Statutory damages can be assessed on the basis of common proof,” creating a perfectly viable common damages model even without the proposed conjoint analysis.

Beats plausibly deceived consumers with Android feature claims

Saucedo v. Beats Electronics, LLC, 2026 WL 2210908, No. 26-cv-01363-RFL (N.D. Cal. Jul. 31, 2026)

Saucedo’s California claims against Beats partially survived for alleged misrepresentations about the Android compatibility of its headphones. The Amazon product page allegedly said, “Whether you’re on iOS or Android, you can enjoy the same seamless compatibility.” The accompanying footnote did not distinguish between features, saying only: “Requires an iCloud account and a compatible Apple device running the latest operating system software or a compatible Android device running the latest operating system software with Google Play Services enabled.” The Amazon page also claimed “Personalized Spatial Audio with dynamic head tracking” as a feature of the headphones, without any qualifier about its availability on Android within the graphic or nearby it.

 

“A reasonable consumer could plausibly read these representations and be deceived into thinking Android users would be able to use the Personalized Spatial Audio feature.”  Even if she should have looked beyond these, deception was still plausible. Though a separate graphic about “Apple and Android Compatibility” listed specific features that users could “[e]njoy,” it was plausible that users would not understand that as an exclusive list of cross-platform features. And one of the Frequently Asked Questions addresses the Personalized Spatial Audio feature, but does not disclose that the feature is unavailable on Android devices. It states:

Do my headphones have Spatial Audio?

Beats Solo 4 has personalized Spatial Audio with dynamic head tracking and uses built-in gyroscopes and accelerometers to surround you with sound as you move, creating a truly immersive listening experience on Apple platforms. You can customize your Spatial Audio in your iOS settings by going to Settings > Personalized Spatial Audio and following the on-screen instructions.

An “almost entirely illegible” disclaimer (which isn’t super clear) didn’t help: “Compatible hardware and software required .... iPhone with TrueDepth camera required to create a personal profile for Spatial Audio, which will sync across Apple devices ....”

"disclaimer"

Plaintiff was granted leave to amend to add allegations that she might repurchase the headphones because she might “reasonably, but incorrectly, assume the product was improved.” “It seems possible that Saucedo could plausibly allege that given the rapid pace at which technology develops,” so the request for injunctive relief was dismissed with leave to amend.

 

insurer can't use "promotional event" exclusion to avoid coverage for recurring club nights

Acosta v. Clear Blue Specialty Ins. Co., 2026 WL 2093910, No. CV-24-03681-PHX-DJH (D. Ariz. Jul. 21, 2026)

Plaintiffs are models trying to recover for claims resolved by consent judgment in their underlying lawsuit, one of the many against adult clubs around the country.

In various social media posts, the insured used plaintiffs’ images to advertise club events, such as “Champagne Saturdays,” “Latin Ladies Night,” “Working Man Specials,” and “2 por 1 Martes.” Plaintiffs claim that their injury constituted a “personal and advertising injury” under the policy.

But the Policy excludes coverage of “personal and advertising injury” that arises out of “exhibitions and related marketing,” defined as:

(a) The creation, production, publication, performance, exhibition, distribution or exploitation of motion pictures, television programs, commercials, web or internet productions, theatrical shows, sporting events, music, promotional events, celebrity image or likeness, literary works, and similar productions or work, in any medium including videos, phonographic recordings, tapes, compact discs, DVDs, memory cards, electronic software or media, books, magazines, social media, webcasts and web sites.

(b) The conduct of individuals in shows, theatrical productions, concerts, sporting events, or any other form of exhibition.

(c) Merchandising, advertising or publicity programs or material for the operations and material described in (a) or (b) above.

Plaintiffs argued that a “promotional event” is not “a party at a nightclub but rather an ‘event’ thrown in furtherance of promoting something…”

The insurance company responded contested images were advertisements for “promotional events” as the events advertised “were not ordinary nightclub evenings.” They touted “drink specials, free admission for women, reduced dance pricing, and other deals.”

The policy didn’t further define “promotional event,” so the court analyzed the terms of the policy as written and from the “viewpoint of one untrained in law or in the insurance business.” Sampedro v. Clear Blue Specialty Insurance Company, 2026 WL 1291919 (M.D. Fla. May 12, 2026), held that the same exclusion unambiguously excused the insurer from defending the nightclub in a similar case involving ads for “the ‘Pretty Chicks & Kicks’ and ‘Tastee Tuesday’ events.” The court reasoned that, even under such a definition, “[the nightclub’s] promotional events promoted the nightclub itself through alcohol sales and DJ appearances.”

Nobriga v. Clear Blue Specialty Insurance Company, 2026 WL 1998727 (D. Conn. July 10, 2026), used dictionary definitions to define a “promotional event” as “a noteworthy happening or social occasion or activity serving the means of furthering the growth or development of something, particularly the acceptance and sale of merchandise through advertising, publicity, or discounting.” Based on this definition, ads for the café’s “Cinco de Mayo Party,” “Halloween and St. Patrick’s Day parties,” and “Baseball Night” constituted advertisements for “promotional events.” “[E]ach advertisement offered discounts on food and entertainment with the goal of bringing additional customers through [the café’s] doors, and tied such discounts to specific holidays or themed nights such as baseball night” making them “advertising” for “promotional events.”

The court agreed that a “promotional event” need not be in furtherance of something other than a business itself. But it thought that the common understanding of “promotional event” wasn’t broad enough to encompass “every promotion put in place by a business.” While holiday parties qualify as “promotional events,” the same couldn’t be said for ads “tied to…a recurring weekly promotion[,]” such as “Baseball Night.”

Here, some of the events advertised seemingly occurred on the same day each week or at a defined time every day. Those were “a routine part of” the insured’s business, not a “noteworthy happening” or “social occasion,” and were untethered to anything but the promotions themselves. There was no special food; “merely offering drink and dance specials does not definitively transform a promotion into a promotional event,” nor did giving the promotion a title. “The lack of ties to a special occasion or specific occurrence” made the exclusion inapplicable. “To rule otherwise would require reading the word ‘event’ out of the phrase ‘promotional event.’”

The court also rejected the insurer’s argument for judgment on the pleadings that the exclusion applied because the underlying litigation arose out of the publication of a celebrity image or likeness. But not all recognized models are “celebrities.” More facts were required.

Clear Blue Specialty Ins. Co. v. 05 Petete, Inc., 2026 WL 2196263, No. 26-1891 (E.D. Pa. Jul. 29, 2026)

Similar result here on the same language. One underlying plaintiff pled herself out of coverage by pleading that she was a “social media celebrity,” but the others didn’t. “Being well-known in one’s profession or endeavors does not by itself raise one’s status to the level of a celebrity.”

As for the promotional events exclusion, “Contrabando’s High-Voltage Wednesdays,” “Exclusive Fridays,” “Matinee Sundays,” and “Euphoric Saturdays” were “certainly promoting Euphoria’s nightclub itself and are using the images of plaintiffs to do so.” But the ads were

merely encouraging the presence of patrons on Wednesdays, Fridays, Saturdays and Sundays generally and are not pointing to any Wednesday, Friday, Saturday or Sunday in particular. It is the standard business of a nightclub to sell liquor to its clientele and to provide musical entertainment. The offer of reduced prices from time to time is a standard business practice to entice customers. The reduced prices are not tied to a specific event or events but are in place for all Wednesdays, Fridays, Saturdays, and Sundays.

“While the World Series is an event, the baseball season is not an event. Likewise, while the grand opening of Euphoria’s nightclub or the opening of any business would be an event, its continual and regular day-to-day operation is not in ordinary parlance deemed to be an event or series of events. Such operation may continue for years.” Thus, the ambiguous policy language was construed against the drafter/insurer and it had a duty to defend against three of the underlying plaintiffs’ claims, and thus a duty to defend in the underlying lawsuit.