“natural” products can be produced in factories

Karabas v. TC Heartland LLC, 2025 WL 777001, No. 24-CV-2722
(AMD) (VMS) (E.D.N.Y. Mar. 11, 2025)

Karabas alleged that Heartland deceptively marketed its
stevia-based sweetener as “100% Natural” when the sweetener’s two ingredients —
stevia leaf extract and erythritol — are synthetic because of the process
through which the defendant produced the ingredients, which were allegedly not
natural. The court granted the motion to dismiss.

There were no allegations that the chemicals used in
production were added to the product:

No reasonable consumer would
conclude that a product contains artificial ingredients merely because it is
produced “in industrial factories” using “synthetic processes.” Indeed, that is
the way most consumer goods are produced. “A reasonable consumer would not
think that a compound found in nature is artificial even if it is produced in a
different way than nature produces it, if the way it is produced is that it is
derived from a natural product and does not contain anything synthetic.”

Moreover, the package included a description of the process
by which the stevia was extracted — that the stevia leaves are steeped in
water, the “sweet parts of the leaf” are extracted, the extract is separated,
filtered, and purified, and the erythritol is fermented. That was sufficient to
clear up any ambiguities, given that the product was a “niche, specialty
product” whose purchasers “are undoubtedly more likely to exhibit a higher
standard of care.”

from Blogger http://tushnet.blogspot.com/2025/03/natural-products-can-be-produced-in.html

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court once again reduces false advertising statutory damages award to 10% of request on constitutional grounds

Montera v. Premier Nutrition Corp., 2025 WL 751542, No.
16-cv-06980-RS (N.D. Cal. Mar. 10, 2025)

I just taught this case!—The court once
again
, after remand,
reduces a statutory damages award based on NY consumer protection law from $83
million to $8.3 million on substantive due process grounds (funny how that
never works in copyright). (At least plaintiffs got their fees for the appeal.)

A jury found Premier liable to a class of New York
purchasers for deceptive advertisement of Joint Juice under GBL Sections 349
and 350, which impose statutory damages of $50 and $500, respectively, or
actual damages, whichever is greater. Wakefield v. ViSalus, Inc., 51 F.4th 1109
(9th Cir. 2022), subsequently held that statutory damages awards could be unconstutionally
excessive as a matter of substantive due process (gone for women! Here for
corporations!). The 9th Circuit told the district court to apply Wakefield
on remand.

Montera asked this time for $83,124,500, or $500 per
violation under GBL § 350, based on sales of 166,249 units of Joint Juice in
New York during the class period; the court determined instead that the award
should be reduced to $50 per unit sold—the amount available under GBL § 349
only.

Possibly a key factor here is that New York law provides
that statutory damages are not an available remedy in class actions under §§349-350,
but that rule doesn’t apply in federal court because the Supreme Court said
that the New York rule was procedural, not substantive. Actual damages for the
class—all that would be available in state court—would be $1.4 million.

Wakefield instructed courts to consider whether
“aggregation [of statutory damages] has resulted in extraordinarily large
awards wholly disproportionate to the goals of the statute” and whether the
award “greatly outmatch[es] any statutory compensation and deterrence goals.” The
case also pointed to the factors articulated in Six (6) Mexican Workers v Ariz.
Citrus Growers, 904 F.2d 1301 (9th Cir. 1990), for “further guidance” in
determining whether statutory damages are disproportionately punitive in the
aggregate: “1) the amount of award to each plaintiff, 2) the total award, 3)
the nature and persistence of the violations, 4) the extent of the defendant’s
culpability, 5) damage awards in similar cases, 6) the substantive or technical
nature of the violations, and 7) the circumstances of each case.”  The “public importance and deterrence goals” to
be considered are: “(i) the public interest; (ii) the opportunities for
committing the offense; and (iii) the need for securing uniform adherence to
the statute.” But, the court noted, “there is a dearth of appellate authority
on how to reduce aggregated statutory damages awards once a constitutional
issue is identified.”

Premier sought to get the court to reject any award of
statutory damages at all.

Wakefield began with the proposition that “[o]nly
very rarely will an aggregated statutory damages award … exceed constitutional
limitations where the per-violation amount does not.”

Although the statute’s language was clear, this was the
uncommon case where the constitution must limit damages “so severe and
oppressive’ as to no longer bear any reasonable or proportioned relationship to
the ‘offense.’ ”

Montera argued that the NY state provision that didn’t allow
statutory damages in class actions was irrelevant because it was merely
procedural and thus inapplicable in federal cases.  But the Ninth Circuit, in remanding, said that
“the relevant statutory goals for the district court to consider on remand
include the Legislature’s compensation and deterrence goals in enacting GBL §§
349 and 350—the statutes that authorized the statutory damages at issue.” “Therefore,
the New York legislature’s explicit concern about the punitive nature of
aggregated statutory damages does some work to differentiate this case” from
others. On the other hand, rejecting statutory damages entirely because of the
NY state rules would be an “end run” around the Supreme Court determination
that the rule was procedural.

So what are the relevant goals? The private right of action was
added when the legislature recognized “the limited ability of the New York
State Attorney General adequately to police false advertising and deceptive
trade practices.” The legislature authorized statutory damages to “encourage
private enforcement” and to “add a strong deterrent against deceptive business
practices,” and increased those amounts in 2007, because “[c]urrent limits
[were] too low to be effective.”

Thus, the statute’s legislative history and text indicated
that the goals were “to compensate injured consumers and deter future
wrongdoing.” The legislature also didn’t reject punitiveness, because there was
no damages range.  “Even a predominantly
punitive award is not necessarily constitutionally unsound.”

Nonetheless, “Premier persuasively argues Montera’s
requested award is disproportionate to the goals of the statute, particularly
in light of the conduct at issue. The $83 million requested by Montera is so
large as to become entirely untethered from the statutory goals.” It was far in
excess of compensation; what about deterrence and punitiveness? Premier argued
that actual damages and attorneys’ fees (nearly $7 million, plus $1 million in
costs) sufficed for deterrence.

And, on deterrence grounds, “while there are important
public interest concerns in protecting New York consumers, the opportunities
for committing this offense are not unlimited. In this matter, Premier has
ceased to sell Joint Juice.” Thus, “an $83 million award would be largely
punitive”—so punitive as to raise constitutional concerns.

In terms of the Six Mexican Workers factors, it was
hard to evaluate whether the award to each individual class member (over $1100)
was really out of bounds because there aren’t many comparable cases. Premier’s
culpability was “mixed”: it made the choice to continue marketing its product
as containing joint health benefits. “Despite the arrival of numerous studies
pointing to a lack of benefits from glucosamine and chondroitin in the dosage
at issue, Premier Nutrition continued to market its product not just to people
seeking joint health benefits, but more specifically to people seeking joint
pain and arthritis relief.” And Montera offered evidence that Premier “was
aware of the changing tide in the science yet continued its marketing.” The
violations here were “substantive, not merely technical.”

On the other hand, the harm to consumers was economic and
not physical. On the other other hand: “Class members based reasonable hopes on
Joint Juice’s promises. And while Premier may not have targeted people with
financial vulnerability, it did target people suffering from joint issues
seeking relief. Taken with Premier’s culpability, these economic and intangible
harms again lead to a mixed result on Premier’s overall reprehensibility.”

As noted above, there weren’t really comparable cases. So,
on balance, the Six Mexican Workers factors “support the conclusion
there is a due process issue with Montera’s $83 million requested award.”
(Which factors favored Premier?)

So, how to go about reducing the award? Measuring by actual
damages had no real justification:

Wakefield’s warning against
overstepping the role of the judiciary looms large at this stage. When a
legislature codifies minimum damages in statutory text, courts “are constrained
by a statute’s language and interpret statutes with awareness that [the
legislature] could have enacted limits as to damages, including in large class
action litigation, provided discretion to courts to award damages within a
given range, or limited liability in any number of ways.”

So, the court chose the clear minimum set by § 349 alone, or
$50 per violation. That “more closely hews to the compensatory, deterrence, and
punitive goals of the statutes.” It was compensatory, and enough to deter.  

 

from Blogger http://tushnet.blogspot.com/2025/03/court-once-again-reduces-false.html

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comparative advertising isn’t confusing

Windmar PV Energy, Inc. v. Solar Now Puerto Rico, LLC, 2025
WL 725078, NO. 24-1570 (RAM) (D.P.R. Mar. 6, 2025)

A frivolous lawsuit against comparative advertising; the
court gets the right result at least. Windmar and Solar now compete in the Puerto
Rico market for the sale and installation of solar energy equipment. Windmar
has registrations with various elements including: the silhouette of the sun’s
corona; the words “WINDMAR” or “WINDMAR HOME”; a combination of the colors
orange, blue, black, and grey; and a stylized image of a windmill replacing the
“I” in “WINDMAR.” The typical logo shows the words “WINDMAR HOME” written in
blue and grey, with the “I” replaced by a blue windmill logo; the words are
placed under and within an orange outline of a sunburst or corona. Windmar
alleged that it was the “number one” company in the “solar energy industry in
Puerto Rico.”

Solar Now’s marketing campaign featured ads and billboards that
showed a salesman pointing to a form listing three different options for solar
companies: a colored logo of Solar Now and two greyscale logos that feature the
profile of a sun and its corona, one titled “PAQUITO SOLAR” and the other
“MOLINITO.” Windmar alleged that “MOLINITO” (which translates to “little
windmill”), when used in conjunction with the sun-related imagery, alludes to
Windmar’s logo. Solar Now’s logo is next to a “X” mark of approval while the
two greyscale logos are placed further down the form, allegedly implying that
they are inferior options to Solar Now.

billboard

social media post

This just didn’t plausibly allege likely confusion, although
the court relied way too heavily on the dissimilarity of the Windmar marks from
what Solar Now actually used, as opposed to the obvious comparative advertising
context. At least the court noted that most of the Pignons factors
favoring Windmar (similarity of goods, channels of trade, advertising, and prospective
consumers) “could be true for any two companies competing in the same market
and geographic area, and do not weigh as heavily in the Court’s analysis.” The
court declined to rely on nominative use because the First Circuit hasn’t
adopted a specific test.

Nor did Windmar successfully plead fame for dilution. Even
if the marks were famous, the comparative advertising and parody exclusions
applied. “[W]hen viewed in the light most favorable to Plaintiff, the purpose
of billboards and social media posts at issue is clear to a reasonable
consumer: humorous comparative advertising showing Solar Now should be chosen
over its (fictional or real) competitors.” Separately, the parody exclusion
also applied, because “MOLINITO” “is not a particularly flattering phrase,
mocking Plaintiff’s logo and reputation by referencing it as a tiny windmill.”
It did not plausibly serve as a source-indicator for Solar Now. “It is
abundantly clear that Plaintiff is the subject of Solar Now’s joke.”

Although the court misunderstood descriptive fair use to be
limited to personal names, that didn’t matter.

from Blogger http://tushnet.blogspot.com/2025/03/comparative-advertising-isnt-confusing.html

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“natural” claims proceed because reasonable consumers can know little about pet food

Goetz v. Ainsworth Pet Nutrition, LLC, 2025 WL 692426, No. 24-CV-04799
(JPO) (S.D.N.Y. Mar. 3, 2025)

Plaintiffs alleged violations of Sections 349 and 350 of the
New York General Business Law and breach of warranty based on defendants’
allegedly false claims that their products were “natural” rather than
synthetic. The court denied a motion to dismiss.

Defendants’ products use the label “natural food” in varying
formats and sizes, alongside the phrase “with added vitamins, minerals &
taurine.” Plaintiffs identified forty-seven products so labeled yet containing
ingredients classified as synthetic by the FDA. The labels disclose “added
vitamins, minerals & taurine,” but plaintiffs alleged that “an ordinary
person would understand [this] claim to mean that the added vitamins, minerals
and/or taurine are natural as well.”

The court applied the reasonable consumer standard, noting
that determining reasonableness as a matter of law is appropriate only where a
plaintiff’s claims are “patently implausible or unrealistic.” The requirement
used by the Second Circuit that a “significant portion” of consumers be likely
to be deceived “does not impose a particularly onerous burden on Plaintiffs.”
The court quoted the Second Circuit’s 2008 affirmation that New York’s consumer
protection laws are “meant to take into account the impact of allegedly
deceptive statements on the ‘vast multitude which the statutes were enacted to
safeguard—including the ignorant, the unthinking and the credulous who, in
making purchases, do not stop to analyze but are governed by appearances and
general impressions.’ ” City of New York v. Smokes-Spirits.com, Inc., 541 F.3d
425 (2d Cir. 2008), rev’d on other grounds sub nom. Hemi Grp., LLC v. City of
New York, 559 U.S. 1 (2010) (quoting Guggenheimer v. Ginzburg, 43 N.Y.2d 268,
273 (1977). Reasonable consumers can be “less astute than average.”

“It is not unreasonable as a matter of law for a consumer to
expect that a product labeled ‘natural’ to contain only natural, and not
synthetic ingredients.” That was true even though product labels said only
“natural” and not “100%,” “solely,” “exclusively,” or “only” “natural.”

Defendants also argued that plaintiffs failed to plead that
the ingredients were actually synthetic.

But the complaint identified at least some “synthetic
ingredients,” including glycerin, xanthan gum, and menadione sodium bisulfate
complex. Although FDA definitions of “synthetic” are not binding, they were “persuasive
evidence” of what a reasonable consumer might consider to be “synthetic” as
opposed to “natural.” Cases involving ingredients with both natural and
synthetic forms were inapposite. “[A]t least some of the ingredients in
Defendants’ products are named in their synthetic forms—for example, ‘menadione
sodium bisulfate complex’ rather than the more generic ‘vitamin K.’” True, some
of the other ingredients can occur naturally, and it was not enough to allege
that “citric acid” must be synthetic simply because “[m]ore than 90 percent of
commercially produced citric acid … is manufactured through a processed
derivative of black mold.” However, given the allegations of unequivocally
synthetic ingredients, “it is not too far a leap to infer that, because
Defendants are willing to use synthetic forms of some vitamins and minerals,
they are more likely to use the synthetic forms of others, particularly in
light of widespread commercial practice.”

Nor did the many possible meanings of “natural” defeat the
claim. “[T]he mere fact that ‘the term’s use is confusing to consumers’ does
not prevent it from being used deceptively.” Also, defendants didn’t offer a
single definition of “natural” that their products did satisfy. “The one
definition they provide— ‘occurring in conformity with the ordinary course of
nature’—is at least plausibly violated by the inclusion of synthetic,
lab-created vitamin and mineral analogues.” The court commented that “it is
unclear what purpose including ‘natural’ on their packaging would serve if not
to indicate a lack of unnatural ingredients or components.”

Nor was it unreasonable for any consumer to believe that pet
food could truly be “natural,” despite defendants’ argument that packaged pet
food has to be processed. “[I]t is not clear why pet food—like some
shelf-stable human food—cannot be made without the addition of synthetic (as
opposed to naturally occurring) vitamins. It is also far from clear that the
ordinary reasonable consumer is intimately familiar with the nature of the pet
food industry and its processing norms.”

Likewise, the court rejected defendants’ argument that any
ambiguity could be cleared up by the ingredient panel. “The Court is
unpersuaded that all reasonable consumers should know what ‘menadione sodium
bisulfate complex’ (synthetic vitamin K) is, for example. This is especially
true given that the naturally occurring forms of the same vitamins and minerals
have similarly difficult-to-pronounce names, like ‘phylloquinone’ (one of two
forms of naturally occurring vitamin K).” Moreover, even if the list of
ingredients were intelligible to an ordinary shopper, “a reasonable consumer
should not be expected to consult the Nutrition Facts panel on the side of the
box to correct misleading information set forth in large bold type on the front
of the box.”

The express warranty claim also survived, for the same
reason. And the court declined to dismiss claims as to unpurchased goods, since
the products that plaintiffs did buy were sufficiently similar to those SKUs. “All
are types of wet and dry pet food that are labeled ‘natural,’ and each contains
a mix of synthetic ingredients. That is enough.” Variations in the prominence of
“natural” and its corresponding potential to mislead created fact issues for
discovery.

 

from Blogger http://tushnet.blogspot.com/2025/03/natural-claims-proceed-because.html

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job postings aren’t “commercial advertising or promotion” for hiring party’s goods/services

Sun Nong Dan Foods, Inc. v. Kangnam1957, Inc., 2024 WL
5440252, No. 2:23-cv-09779-WLH-RAO (C.D. Cal. Nov. 19, 2024)

Not a surprise, but fills a gap in the caselaw: employment
ads aren’t “commercial advertising and promotion” for the business trying to
hire.

SND alleged that defendants stole SND’s recipe for its
“flagship” dish “galbi jjim” and opened a “counterfeit” restaurant offering the
same dish.

SND alleged that “two job posts and the employee training in
2019 which involves the dissemination of false statements, constitute false
commercial adverting.” A customer allegedly posted the following in a review on
Yelp: “We asked a few questions [of employees] since this a new spot, and we
learned the head Chef of [defendant] Daeho was from KTown in LA.” Daeho also
allegedly published job posts to SF Korean and go20.com:

We are looking for servers and
kitchen staff to join our upcoming Korean food restaurant opening in early
February in San Francisco’s Japantown neighborhood.

Former head chef of Sun Nong Dan in
Los Angeles is preparing to open a new restaurant in San Francisco’s Japantown.

The main menu will be tang (hot
pot), and we’ll be serving up some of the best hot pot and other dishes you’ve
never had in San Francisco, like BBQ, galbi jjim, and galbi tang.

Open 7 days a week, starting at
7am, part-time and full-time positions available.

If you’re interested in food, want
to make money, or want to learn the restaurant business, we want to hear from
you….

SF Korean was allegedly the “most well-known media platform
within the Korean community in the San Francisco Bay Area.” Allegedly, “[f]or
the Korean restaurants, recognition within the Korean Community is crucial for
success.” And the representation about having the former head chef was allegedly
false.

Instead, defendant C. Park allegedly sought employment at
SND with the intent of stealing trade secrets which he then misappropriated,
specifically recipes, such that defendants’ “galbi jjim and three side dishes
have identical or nearly identical tastes and flavors to those of Sun Nong Dan,
as noted by numerous Yelp reviewers.” Daeho allegedly “misappropriated Sun Nong
Dan’s confidential galbi preparation method, which has the benefit of the meat
easily falling off the bone.” And it allegedly misappropriated SND’s “confidential
culinary processes and business operations designed to efficiently handle a
large volume of orders for galbi jjim, including order-taking, cooking, the use
of specialized cooking equipment, and serving methods tailored for quick
handling of large-scale orders which preserving the deep flavors of galbi jjim.”

The court granted defendants’ motion to dismiss the state
and federal false advertising claims, though other claims remain.  

SND alleged that the employee training in 2019, where one
defendant allegedly instructed Daeho employees to make false statements about
Daheo Kalbijjim’s relationship with SND, constituted false commercial
advertising. But the Yelp review didn’t reflect that any employee made a false
statement as part of a “commercial advertisement about [defendant’s] own or
another’s product.” “Instead, the allegation indicates that an employee
answered a customer’s questions with an undisputed fact—that the chef had
worked in Koreatown in Los Angeles.”

As for the job postings, which can be commercial speech,
they still weren’t plausibly published with “the purpose of influencing
consumers to buy defendant’s goods or services.” It didn’t even include the
restaurant’s name. (Note that California law doesn’t have the same “commercial advertising or promotion” language–but when competitor-plaintiffs sue, courts usually interpret the relevant state false advertising laws as covering the same conduct.)

However, the complaint sufficiently alleged misappropriation
of SND’s galbi jjim recipe and cooking method. But SND’s order-taking method,
“which involves accepting pre-orders before seating customers,” was not
plausibly a trade secret. By virtue of visiting the restaurant, any patron
could see the method.

 

from Blogger http://tushnet.blogspot.com/2025/03/job-postings-arent-commercial.html

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Rogers v. Grimaldi lives on, at least for work content

Of note because the lawsuit was brought at all, suggesting that trademark owners are willing to try to roll back any First Amendment protections for noncommercial speech.

Pepperdine University v. Netflix, Inc., No. 2:25-cv-01429-CV
(ADSx), 2025 WL 632983 (C.D. Cal. Feb. 26, 2025)Pepperdine sued Netflix for Lanham
Act trademark infringement, contributory infringement, dilution, false
advertising, and coordinate state claims based on Netflix’s Running Point
series, which depicts a team known as the Waves. The court denies a TRO because
Rogers is still good law, at least for things that aren’t titles.

Pepperdine’s athletic teams have been known as the “Waves”
since the University’s founding in 1937, and it has registrations for WAVES marks. 

examples from complaint

Running Point was scheduled for release yesterday. It’s
an “original comedic television series” created by Mindy Kaling and Warner
Bros. about a “very dysfunctional family” who owns and manages a “high-profile,
multi-billion-dollar basketball franchise and arguably the most famous
professional team in all of sports, the Los Angeles Waves.” Pepperdine alleged
that the fictional Los Angeles Waves team uses the word “WAVES” with a
“strikingly similar font” and similar colors. An image in the Running Point
trailer allegedly includes a framed jersey with the number “37,” similar to
that worn by Pepperdine’s mascot and denoting Pepperdine’s founding year. Pepperdine
also alleged that the story depicted in Running Point does not align with
Pepperdine’s values.

comparisons from complaint

Jack Daniels cited Mattel, Inc. v. MCA Records, Inc.,
296 F.3d 894 (2002) (Barbie Girl) and University of Ala. Bd. of Trustees v. New
Life Art, Inc., 683 F.3d 1266 (2012) (sports art), and Louis Vuitton Malletier
S. A. v. Warner Bros. Entertainment Inc., 868 F. Supp. 2d 172 (S.D.N.Y. 2012)
(use of “Louis Vuitton” to describe luggage in movie) with approval as
non-trademark uses.  

Post-Jack Daniels cases have also applied Rogers to
non-title uses. Haas Automation, Inc. v. Steiner, No. 24-CV-03682-AB-JC, 2024
WL 4440914 (C.D. Cal. Sept. 25, 2024) (use of mark on book’s front cover, back
cover, and on several pages, but mark was “not used to tell the consumer who
published the book or the source of the book”; mark told the consumer what the
book was about and who the author worked for); JTH Tax LLC d/b/a Liberty Tax v.
AMC Networks Inc., 694 F. Supp. 3d 315 (S.D.N.Y. 2023) (use of fictional tax
preparation business name in Better Call Saul).

Photos, including on back cover, from Guenther Steiner’s book 

Surviving to Drive: A Year Inside Formula 1, recounting his experiences as Team Principal of the Haas F1 Team 

This is distinct from cases like Punchbowl, which
involved use in a business name, or Mar Vista Entertainment, LLC v. THQ Nordic
AB, No. 2:23-cv-06924-MEMF (SSC), 2024 WL 3468933 (C.D. Cal. July 8, 2024) (rejecting
application of Rogers in a dispute between the owner of the rights to
the Alone in the Dark videogame franchise, and entities who released a horror
film titled Alone in the Dark).

The court found no use of “Waves” or related indicia as source
indicator. The “product” at issue was Running Point, the series, and
defendants didn’t suggest Pepperdine was the source. The title cards confirmed
that Netflix, Warner Bros., and Mindy Kaling are responsible for the series.
They didn’t use Waves in the title (sigh), and, there was an express statement
that the series is a fictional work, and “[a]ny similarity to any actual
persons … events, firms and institutions or other entities, is coincidental
and unintentional.” “Ultimately, on this record, there is no evidence that any
viewer would be misled regarding the source of the series.” (That is not a
precondition for Rogers applying, though the court treats it as such; any
such precondition makes Rogers irrelevant, at least to source
confusion.)

complaint’s social media “evidence”

The use of Waves was artistically relevant: it “was chosen
as a nod to the real-life Lakers, whose team name also alludes to a body of
water.” It also evokes the Los Angeles area and the “Southern California
‘vibe,’ associated with beaches, sun, surfing, and waves.” Nor was there any
explicit misleadingness about source. “Neither Pepperdine nor the Waves Marks
appear in the title cards for the series. There is therefore no implicit, let
alone explicit statement that misleads the consumer as to the source of the
series.”

Of note, not all is lost for Rogers for titles: Down
to Earth Organics, LLC v. Efron, No. 22-CV-06218 (NSR), 2024 WL 1376532
(S.D.N.Y. Mar. 31, 2024), applied Rogers to the use Netflix and Zac
Efron of the phrase “Down to Earth” for the documentary series entitled Down to
Earth with Zac Efron. That court found that the defendants were “undoubtedly
using ‘Down to Earth’ simply to identify the subject matter and tone of the
Series.”

from Blogger http://tushnet.blogspot.com/2025/02/rogers-v-grimaldi-lives-on-at-least-for.html

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5th Circuit discounts confusion caused by overlap in commonly used arbitrary word

Rampart Resources, Inc. v. Rampart/Wurth Holding, Inc., No.
24-30111, 2025 WL 586820 (5th Cir. Feb. 24, 2025)

District court’s denial of preliminary injunction discussed
here
. Rampart Resources) provides real estate and property management
services in Louisiana, Texas, Arkansas, Mississippi, Alabama, West Virginia,
and Ohio. Its services relate to right-of-way acquisition, servitudes, real
estate brokerage, permitting, and property management—across several
industries, including utilities, oil and gas, renewable energy, and public
works. It has a 2018 registration for those services for “the stylized wording
‘RAMPART RESOURCES’ to the right of a graphic image of a road going into the
horizon, with a road curving off to the right and left of the main road.” “To
be clear, Rampart Resources does not have a trademark for the word ‘Rampart’ or
‘Rampart Resources.’”

Rampart/Wurth offers commercial and residential property
management services throughout Louisiana, Texas, Mississippi, and Alabama. Its
services cover multifamily, single-family, office, retail, and receiver/keeper
properties; it uses different logos to refer to Rampart Multifamily Management
and Rampart Commercial Management.

Rampart Resources found out about Rampart/Wurth’s recent
adoption of that name change in September 2023 when a FedEx driver told its
president that “another Rampart” had just opened in Baton Rouge and that she
had confused the two businesses.

Rampart Resources received at least
seven telephone calls in September and October 2023 from individuals inquiring
about rent collection, leasing units, Section 8 housing vouchers, lease
payments, and refunding deposits. After being told they must have the wrong
number, customers responded, “this is the home office of Rampart, correct?” and
“this is the number I got for Rampart.”

On appeal, the standard was abuse of discretion. “As to each
element of the district court’s preliminary-injunction analysis … the
district court’s findings of fact are subject to a clearly-erroneous standard
of review, while conclusions of law are subject to broad review and will be
reversed if incorrect.” Here, the appeal failed on likely success on the
merits.

The district court found that the type of mark/mark
strength, similarity of products/services, and evidence of actual confusion
weighed in favor of likely confusion; similarity of marks, consumer overlap,
and degree of care of potential purchasers weighed against; and advertising
media/defendant’s intent were neutral.

Rampart Resources argued that mark strength should weigh
heavily in its favor, not just slightly as the district court held. Although
the mark was arbitrary, and although Rampart Resources had used it for 34
years, Rampart/Wurth provided evidence of widespread use of the key portion
(Rampart). This was not clear error.

Mark similarity: “It is visually apparent that all aspects
of the marks (font, color, design, etc.) are different except the use of the
singular word ‘Rampart.’ The common use of the word ‘Rampart’ does not make the
marks similar when considering ‘the total effect of designation.’”

Similarity of services: the district court found only a
minor overlap and didn’t weigh it heavily in Rampart Resources’ favor. “The
district court correctly concluded that while both parties operate broadly in
the real estate industry, there is not substantial overlap between the services
offered.”

But, when there isn’t direct competition, “the confusion at
issue is one of sponsorship, affiliation, or connection.” The critical question,
the court of appeals said, is “whether the consuming public would believe that
the natural tendency of [Rampart Resources]” would be “to expand into the
[property management industry].” “Here, the district court found that it would
be reasonable for a customer of Rampart Resources to believe it was making a
foray into property management, since they have offered property management
services in the past and represent that they are still capable of doing so.” Weighing
this factor in favor of a likelihood of confusion, but only somewhat, not
heavily, was plausible based on the record.

Advertising media: “Both parties stated that word of mouth
advertising is perhaps their strongest form of advertising…. Although both
parties represented they use face-to-face communications and website
advertising, the district court is correct that the evidence presented for this
digit is scant.” Finding the factor neutral was not an abuse of discretion.

Actual confusion: While swayed purchases are not necessary,
“more is required when the confusion did not or cannot sway purchases.”  “[N]ot all confusion counts: evidence of
actual confusion must show ‘more than a fleeting mix-up of names’; rather it
must show that ‘[t]he confusion was caused by the trademarks employed and it
swayed consumer purchases.’ ” Here, seven misdirected phone calls and the FedEx
driver’s confusion was not weighty when evaluated in light of “the high volume
of business conducted by the parties and the fact that there was no evidence
that any of Rampart Resources’ customers had erroneously contacted
Rampart/Wurth.” The court of appeals agreed.

Interestingly, the court found it “[m]ost important[]” that

there is no evidence that any of
the eight incidents of actual confusion were related to Rampart/Wurth’s logo or
conduct. None of Rampart Resources’ anecdotal evidence shows that parties were
confused by the trademarks at issue in this case. Rampart Resources does not
have a trademark on the word “Rampart.” Our court has rejected strictly
anecdotal evidence where “the proponent did not show that ‘a misleading
representation by [the defendant], as opposed to some other source, caused a
likelihood of confusion.’ ”

[This is a covert way of saying that, if the confusion was
caused by the overlap in “Rampart,” too bad for plaintiff—a purely empirical
vision of trademark would say that if the confusion was caused by the overlap,
then plaintiff’s rights would extend past its registration to other uses. But
there is never a purely empirical account of trademark, much as courts often
pretend otherwise. Also: How insulted do you think the Fifth Circuit would be to hear that this is a very European way of looking at it?]

Still, it wasn’t abuse of discretion to weigh actual
confusion slightly in the plaintiff’s favor, even though the only
evidence showed a “fleeting mix-up of names,” and not that any party was
“actual[ly] confus[ed] about the origin of the parties’ products.”

There was no clear error in weighing the factors.  The district court found that the
dissimilarity of the marks, as well as the sophistication of the clients
weighed most heavily against a finding of likelihood of confusion. Given that
each digit “may weigh differently from case to case,” that wasn’t clear error.

 

 

 

from Blogger http://tushnet.blogspot.com/2025/02/5th-circuit-discounts-confusion-caused.html

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pandemic education shutdowns allow unjust enrichment, not contract or false advertising claims

Yodice v. Touro College & Univ. Sys., 2025 WL 579957,
No. 21cv2026 (DLC) (S.D.N.Y. Feb. 21, 2025)

Yodice sued Touro for reimbursement of tuition and fees he
paid during the Spring 2020 semester, when Touro’s campuses were closed due to
the COVID-19 pandemic. On remand, the court dismisses some of the claims. Touro
has nearly 20,000 students across the United States and three other countries.
The Touro system includes an online institution named Touro University
Worldwide (TUW), which offers undergraduate and graduate degree programs.

Yodice alleged that TCDM markets various aspects of the
on-campus student experience to the public. For example, its dental website says
that students begin in the “dental simulation laboratory” and then “treat
patients in our modern clinic.” The website also emphasizes the setting of
TCDM’s Hudson Valley campus, which “attracts talented students who prefer a
suburban lifestyle with easy access to the New York metropolitan area.” The
campus’s location, the website explains, “provides students with numerous
career, residency, clinical, and internship opportunities.” And various
opportunities to work with local institutions “offer a chance for students to
put their learning into practice, conduct research, or interact with patients
and professionals in preparation for their future careers.”

Obviously, that didn’t happen through 2020. “Yodice left
campus sometime in March. He did not have access to any of Touro’s facilities
for the rest of the semester, and he was unable to experience the in-person
academic, social, and professional interactions he would have had if not for
the pandemic. Touro did not refund the tuition or fees paid by Yodice and other
students who were unable to participate in in-person instruction or campus life
for much of the Spring 2020 semester.”

Yodice alleged breach of contract, unjust enrichment, and
consumer protection false advertising claims. The Second Circuit affirmed
dismissal of his contract/unjust enrichment claims based on fees he paid, but
reversed on tuition, concluding that the plaintiff “plausibly stated a claim
for breach of an implied contract to recover tuition.” It likewise remanded for
further consideration of the GBL false advertising claims.

The court here dismissed the contract and GBL claims, but
allowed unjust enrichment to proceed as to those who paid tuition for the
Spring 2020 semester at Yodice’s dental college.

Limiting the claim to that group: Yodice didn’t sufficiently
allege that the other Touro schools were similar: “The FAC itself emphasizes
the representations by specific Touro schools as to the quality of the
on-campus experiences they offered. The only characteristic that the dozens of
Touro schools around the world share is affiliation with the same corporate entity.
And Yodice provides no reason to think he has anything in common with most of
the class he seeks to represent except that they were, like him, students
during the pandemic.”

Yodice argued that Touro’s class standing arguments would be
properly handled in assessing the adequacy and commonality of the class
representative and class pursuant to Rule 23(a), but “the independent
requirement of class standing requires a connection between his claims and
those of the class he seeks to represent even at the motion to dismiss stage.”

Breach of contract: dismissed because performance was
impossible. “There is no dispute that holding in-person classes and other
functions, as Yodice alleges was promised, would have been illegal.”

But that did mean that Yodice could proceed with his unjust
enrichment claim seeking a prorated refund of the tuition he paid at the
beginning of the semester. “To recover under a theory of unjust enrichment
under New York law, a litigant must show that (1) the other party was enriched,
(2) at that party’s expense, and (3) that it is against equity and good
conscience to permit the other party to retain what is sought to be recovered.”
He stated a claim by alleging Touro

retained his tuition even after
providing a less valuable and less costly service than was expected when the
parties entered their relationship. The FAC alleges essentially that the
tuition was conferred under a mistake of fact — that is, that in-person
instruction would be possible. It plausibly alleges that Touro spent less money
operating TCDM remotely than it would have on a normal, open physical campus.
Whether equity and good conscience require a partial refund cannot be decided
at this stage, but Yodice has sufficiently alleged that they do.

Unjust enrichment may be available where one party’s duty to
perform is unenforceable due to impossibility. In Goldberg v. Pace Univ., 88
F.4th 204 (2d Cir. 2023), a similar unjust enrichment claim failed because an
enforceable force majeure provision in the contract limited the defendant’s
duties to provide in-person instruction. There, the plaintiff was attempting to
circumvent the terms of the parties’ contract by alleging unjust enrichment. But
here, the plaintiff has pled that Touro had a contractual duty to provide
in-person instruction, but its performance was excused by the doctrine of
impossibility. Fault is not necessary for “circumstances [to] create an
equitable obligation running from the defendant to the plaintiff.”

GBL: Usually, the GBL is broader than contract law. But
there was no false advertising here because no reasonable person would think
that Touro had promised to provide in-person instruction regardless of what
happened. “Yodice has not plausibly alleged that Touro’s representation of an
on-campus experience was deceptive, or that a reasonable consumer would have
understood it to mean that in-person instruction would continue even in a
pandemic.” In summary, “Sections 34 9 and 350 are far-reaching, but they do not
require businesses to append ‘unless impossible’ to the end of every
advertisement.” Nor could this be characterized as a materially deceptive
omission; there was no allegation that “Touro possessed some piece of material
information at the beginning of the Spring 2020 semester unknown to its
students that would have affected prospective students’ decision to attend the
university.”

from Blogger http://tushnet.blogspot.com/2025/02/pandemic-education-shutdowns-allow.html

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disgorging a CEO’s salary, then trebling the amount?

Multiple Energy Technologies, LLC v. Casden, 2025 WL 579641,
№ 2:21-cv-01149-ODW (RAOx) (C.D. Cal. Feb. 21, 2025)

I just
posted
about courts’ increasing openness to disgorgement. Here, the court
trebles an award in a way that seems definitionally disconnected to the amount
of defendant’s profits from false advertising—three times his total salary—in ways
that seem to me inconsistent with Dewberry. I wonder if a motion for
reconsideration is justified.

Plaintiff MET sued an individual, Casden, for false
advertising and tortious interference with contractual relations. MET developed
a patented bioceramic infrared material; Casden is the co-founder and CEO of
Hologenix, which made a competing product. MET sued Hologenix for false
advertising, and they settled in 2020. Casden negotiated and signed the
Settlement Agreement on behalf of Hologenix. The settlement involved agreed payments
and a permanent injunction against Hologenix barring it from “stat[ing] or
suggest[ing]” that the Food and Drug Administration (“FDA”) “approved” Celliant
or “made a ‘determination’ ” that Celliant promoted any benefits.

Afterwards, Casden made or approved statements about
Celliant that violated the stipulated permanent injunction. And, the day before
Hologenix was scheduled to pay $1,400,000 to MET pursuant to the Settlement
Agreement, Hologenix filed for Chapter 11 bankruptcy. As a result of the
bankruptcy proceedings, MET returned $100,000 it had received from Hologenix.
MET then sued Casden for Lanham Act and state law false advertising violations,
as well as tortious interference contractual relations. The court found that
Casden acted to advance his personal interests when he tortiously interfered
with the settlement agreement, thus foreclosing any agency immunity defense. The
jury returned an advisory verdict in MET’s favor on its tortious interference
cause of action with an award of $1 in nominal damages and a verdict in MET’s
favor on its Lanham Act false advertising cause of action, similarly awarding
$1 in nominal damages.

The court then awarded MET $2.5 million in damages on the
tortious interference claim, and found that, on the Lanham Act claim, MET was
entitled to disgorgement of Casden’s profits, treble damages, and attorneys’
fees. “[T]he jury viewed exhibits that reflect the statements Casden authorized
or made himself, and they heard testimony from Casden acknowledging his
discovery admissions that those statements were not true. This evidence is
sufficient such that a reasonable jury could find the statements literally
false.”

The court found that Casden’s salary could be disgorged as
profits, and that this award could be trebled, because it had the discretion to
award up to three times the “financial benefit [Casden] received because of the
[false] advertising.” I don’t think that’s true if there’s no uncertainty about
the amount of financial benefit received, because trebling the damages just
because the deception was willful is a penalty, which disgorgement under the
Lanham Act is not supposed to be.

The court determined that Casden’s annual salary of $300,000
since 2019 should be disgorged, because it was undisputed that the only product
Hologenix sold was Celliant. And “the deliberate and willful nature of Casden’s
conduct warranted trebling the award of Casden’s financial benefit.” The court
found that it was not awarding a “penalty” or “windfall.” “Rather, the trebled
amount is the amount the Court found to be ‘just, according to the
circumstances of the case.’” But if it’s only just because Casden is bad, how
is that not a penalty?

MET was also awarded nearly $600,000 in attorneys’ fees.

from Blogger http://tushnet.blogspot.com/2025/02/disgorging-ceos-salary-then-trebling.html

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FDA preclusion doesn’t work as often after Pom Wonderful (or Loper Bright?)

Pacira BioSciences, Inc. v. Ventis Pharma, Inc., 2025 WL
576549, No. 2:24-cv-07554-MRA-RAO, (C.D. Cal. Jan. 17, 2025)

Pacira alleged that its competitor (here Ventis) violated
the Lanham Act by making claims about its drugs relating to (1) exemption from
FDA approval, (2) FDA approval, and (3) comparative superiority, safety, and
efficacy.

The FDA doesn’t require preapproval of drugs compounded by
registered “outsourcing facilities, aka the “503B exemption.” The exemption
requires that the “bulk drug substances” in the compounded drug must be on the
FDA’s Drug Shortage List or Clinical Need List.

Pacira makes EXPAREL, an FDA-approved injectable drug
product used to manage and reduce post-surgical pain whose active ingredient is
bupivacaine. Pacira allegedly uses a a proprietary multivesicular liposome (pMVL)
technology and created a new category of drugs known as the “Post-Surgical
Non-Opioid Regional Analgesia,” in which EXPAREL is the leading product.

Ventis makes, inter alia, Enduracaine and Endura-KT, which
consist of three bulk drug substances: (1) epinephrine, (2) tetracaine, and (3)
lidocaine. Enduracaine and Endura-KT have not been approved by the FDA. Below
the header “FDA Disclaimer,” Ventis’ website states that under the FDCA, human
drug products compounded by an outsourcing facility “are exempt from the
following three sections of the [FDCA] section 505 (21 U.S.C. 355).” In an
advertisement in Anesthesiology News, Ventis claimed that Endura-KT is
“produced following cGMP manufacturing guidelines under 503B outsourcing
standards overseen by the FDA.” However, none of the three component bulk drug
substances are on the CNL. Lidocaine and epinephrine are on the DSL, but not tetracaine,
and it is not approved for use as an injection.

Ventis also allegedly implied FDA approval, as in a white
paper on its website describing Endura-KT as an “off-label use version of
Enduracaine.” “Off-label use” is allegedly generally recognized as the use of
an FDA-approved product for an unapproved use. Ventis advertised in
Anesthesiology News that Endura-KT is “made from a combination of currently FDA
approved USP products.” But the FDA allegedly does not oversee production of
Endura-KT, and it has not approved the use of bulk drug substances as combined
in Endura-KT.

Ventis also advertised Enduracaine and Endura-KT as
comparable to, and replacements for, EXPAREL. It marketed Endura-KT as “safe
and acceptable for use,” advertised that Endura-KT provides an “EXTENDED
DURATION” of pain relief and that it is “Quick Onset – Long Lasting,” “Safe,”
for “Pediatric Use,” and “Cost Effective.” It advertised that Endura-KT is
“clinically significant over other commercially available products.” But Endura-KT
has allegedly not been reviewed, been approved, or undergone any clinical
trials to confirm its capabilities, efficacy, or safety.

Exemption-based statements: The court rejected defendant’s
preclusion argument under Pom Wonderful. Although the Ninth Circuit
previously did not allow Lanham Act claims that required significant
interpretation of the FDCA, the court here relied more heavily on the general
statements in Pom Wonderful (and it’s hard not to imagine that the
recent rejection of agency interpretive authority in Loper Bright is
having an effect here too). Pom Wonderful characterized the FDCA as
“designed primarily to protect the health and safety of the public at large” rather
than to prevent false advertising.  The
mere fact that “an agency enacted regulations that touch on similar subject
matter but do not purport to displace [a] remedy [under the Lanham Act] or even
implement the statute that is its source” cannot displace such a
“well-established federal remedy.” That is because “[a]n agency may not reorder
federal statutory rights without congressional authorization.” (Note that the
issue here is not just regulations “touching on” similar subject matter, but
actually defining that which is legal to produce and market.)

Anyway, as a result, “courts have adopted a general
presumption that Lanham Act claims pertaining to FDCA-regulated products are
permissible and, often, desirable.” The Ninth Circuit’s decision in PhotoMedex,
Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010), the court reasoned, did not
clearly survive, so it wasn’t necessarily enough for preclusion that “the claim
would require litigation of the alleged underlying FDCA violation in a
circumstance where the FDA has not itself concluded that there was such a
violation.” Regardless, even PhotoMedex said that it didn’t mean that
“the Lanham Act can never support private party claims involving FDA approval
or clearance of drugs or medical devices.” The Ninth Circuit said that, where
an affirmative statement of FDA approval was required to market a product, “a
Lanham Act claim could be pursued for injuries suffered by a competitor as a
result of a false assertion that approval had been granted.”

Defendant argued that FDA policy allows for the compounding
of tetracaine, and thus that allowing this claim to proceed would “clearly
interfere” with the FDA’s policy judgment in that regard. It pointed to the
FDA’s 2017 “Interim Policy on Compounding Using Bulk Drug Substances Under
Section 503(b) of the [FDCA].” As to categories of drugs nominated for
inclusion on the CNL, the FDA stated that “at this time [the] FDA does not
intend to take action against an outsourcing facility for compounding a drug
using a bulk drug substance that does not appear on the [CNL] and that is not
used to compound a drug that appears on the [DSL] at the time of compounding,
distribution, and dispensing,” provided certain conditions are met.

But that wasn’t enough. An FDA policy of non-enforcement was
not equivalent to a finding that the compounding was “exempt.” “Under the plain
terms of section 503B, the compounded bulk drug substance must appear on the
CNL or DSL to qualify for exemption.” Indeed, the interim guidance “would seem
to tacitly acknowledge that the compounding of a Category 1 substance does not
yet satisfy the requirements for 503B exemption, only that the agency does not
presently consider such conduct an enforcement priority.” And nonenforcement of
the FDCA wasn’t relevant, given that the plaintiff “seeks to enforce the Lanham
Act, not the FDCA or its regulations.” “If anything, the FDA’s non-enforcement
cautions against preclusion of Plaintiff’s Lanham Act claim,” given the FDA’s
limited resources. The court pointed to Pom Wonderful’s similar
discussion of FDA nonenforcement:

Because the FDA acknowledges that
it does not necessarily pursue enforcement measures regarding all objectionable
labels, if Lanham Act claims were to be precluded then commercial interests—and
indirectly the public at large—could be left with less effective protection in
the food and beverage labeling realm than in many other, less regulated
industries. It is unlikely that Congress intended the FDCA’s protection of
health and safety to result in less policing of misleading food and beverage
labels than in competitive markets for other products.

“This reasoning applies with added importance in the context
of drug marketing.”

Plus, an FDA interim policy may “touch on similar subject
matter” as a Lanham Act claim, but it “do[es] not purport to displace that
remedy[.]” Nor is it even an “agency regulation[ ] with the force of law that
purport[s] to bar other legal remedies.” The Interim Policy clearly states,
“FDA’s guidance documents do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency’s current thinking on
a topic and should be viewed only as recommendations.” Thus, this is not “a
case where a lawsuit is undermining an agency judgment.”

As the First Circuit said in Azurity Pharmaceuticals, Inc.
v. Edge Pharma, LLC, 45 F.4th 479 (1st Cir. 2022), involving similar
statements, “the parties have identified no FDA regulation that governs the
statements that outsourcing facilities may make in advertising—let alone a
regulation that would risk subjecting [the defendant] to inconsistent
obligations ….” Here, “[i]n claiming 503B exemption specifically, Ventis is
representing that it complies with the statutory requirements. Even under PhotoMedex,
determining the falsity of such statements does not ‘require litigation of the
alleged underlying FDCA violation.’”

Was the statement non-actionable opinion?  The general rule is that, “[a]bsent a clear
and unambiguous ruling from a court or agency of competent jurisdiction,
statements by laypersons that purport to interpret the meaning of a statute or
regulation are opinion statements, and not statements of fact. Statements of
opinion are not generally actionable under the Lanham Act.” But that didn’t
make “exempt” a statement of opinion:

In advertising that its product is
exempt from FDA approval under section 503B, Defendant is not interpreting the
FDCA and related regulations. Given the unambiguous text of section 503B,
“there is no interpretation necessary to determine” the conditions for
establishing exemption under section 503B. Section 503B “plainly” provides that
the bulk drug substances in the compounded drug must appear on either the CNL
or DSL. By purportedly invoking 503B exemption, Defendant represents that it
has satisfied these criteria. Yet, as Azurity observed, “one of these
lists does not yet even exist, while there is no dispute that [Plaintiff] has
plausibly alleged that the other list does not include the bulk drug substance
in question.”

The FDA’s interim policy doesn’t purport to mean that section
503B “does not impose the condition that it plainly imposes with respect to the
use of ‘bulk drug substances.’ ” Anyway, the opinion versus fact distinction was
for a factfinder. (Both of these things can’t be true.)

Turning to allegedly approval-based statements, like “produced
following cGMP manufacturing guidelines under 503B outsourcing standards
overseen by the FDA,” “made from a combination of currently FDA approved USP
products,” and “off-label use version of Enduracaine,” defendant argued that
there was no false statement or implication of FDA approval.

Mylan Laboratories, Inc. v. Matkari, 7 F3d 1130 (4th Cir.
1993), rejected a theory that “the very act of placing a drug on the market,
with standard package inserts often used for FDA-approved drugs, somehow
implies (falsely) that the drug had been ‘properly approved by the FDA.’ ” Several
district courts have relied on Mylan to hold more broadly that “[f]alse
advertising claims based on allegations of implied governmental approval have
not been allowed, for ‘the law does not impute representations of government
approval … in the absence of explicit claims.’ ” Here, though, the court
found that plaintiff plausibly alleged that defendant’s description of
Endura-KT as an “off-label” use of Enduracaine falsely implied that Enduracaine
is FDA approved. It didn’t evaluate the other statements one way or another.

Comparison-based statements: Ventis allegedly falsely
advertised its products as “superior to liposomal bupivacaine products like
EXPAREL” and that its products are “equivalent or are otherwise substitutable.”
An infographic on the site purported to summarize the findings of two studies,
and stated in a footer that “[t]he preponderance of evidence fails to support
the routine use of liposomal over plain bupivacaine.”

Defendant argued that this was nonactionable scientific
opinion, under Pacira BioSciences, Inc. v. Am. Soc’y of Anesthesiologists,
Inc., 63 F.4th 240 (3d Cir. 2023), which held that the studies summarized in
the infographic were nonactionable opinion. But that conclusion didn’t insulate
the infographic. First, unconvincingly, the court said that the Third Circuit
was only dealing with trade libel, not Lanham Act claims. Second, the Third
Circuit relied the context in which the statements were made: “a peer-reviewed
journal for anesthesiology specialists.” But the infographic wasn’t an academic
article, and the footer statement wasn’t attributed to either study. In
publishing the infographic on its website, the defendant “los[t] the benefits
that scholarly articles and scientific debate typically enjoy.”

What about “EXTENDED DURATION,” “Quick Onset,” “Long
Lasting,” “Safe,” and “Cost Effective,” and “safe and acceptable for use”? Are
they fact or puffery? Finally, the defendant won an argument: these were
“generic adjectives without any specific, objectively verifiable measure.”

As to alleged comparative superiority/ “generic or
substitutable” statements, plaintiff didn’t specifically identify where and
when Ventis made those statements in advertising or promotion. A general
statement that “Medications can only be ordered by healthcare providers when it
is determined the product is clinically significant over other commercially
available product” wasn’t specific to either EXPAREL or Endura-KT, and thus
couldn’t form the basis of a claim.

from Blogger http://tushnet.blogspot.com/2025/02/fda-preclusion-doesnt-work-as-often.html

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