claim of failure to warn of kratom’s addiction potential not preempted; a “disease claim” involves helping, not causing, disease

Posted on July 3, 2025 by rtushnet

J.J. v. Ashlynn Marketing Gp., 2025 WL 1811854, No. 24-cv-00311-GPC-MSB
(S.D. Cal. Jul. 1, 2025)

Plaintiffs sued on behalf of putative nationwide,
California, and NY classes, alleging that Ashlynn failed to warn consumers of
the potentially addictive nature of its products, which contain dried leaves
from a plant called kratom. As alleged, “the active alkaloids in kratom …
work on the exact same opioid receptors in the human brain as morphine and its
analogs” and it “has the same risks of addiction, dependency, and painful
withdrawal symptoms, among various other negative side effects.” As a result, plaintiffs
allege that kratom “has sunk its hooks into tens of thousands of unsuspecting
customers and caused them serious physical, psychological, and financial harm.”

The symptoms of kratom withdrawal include: “irritability,
anxiety, difficulty concentrating, depression, sleep disturbance including
restless legs, tearing up, runny nose, muscle and bone pain, muscle spasms,
diarrhea, decreased appetite, chills, inability to control temperature, and
extreme dysphoria and malaise.” However, because it “does not produce a
debilitating ‘high’ like cocaine or heroin, it is very easy for users to take
the drug every day without feeling as though they are developing a drug
addiction or harming themselves.”

Plaintiffs alleged that defendant had superior knowledge
compared to reasonable consumers, and that it had received numerous user
reports about the addictive potential of kratom in the United States. They also
alleged that defendant interacted with growers and distributors in Southeast
Asia who have disclosed the addictive nature of kratom to it. Nonetheless, its
product only had “a bog-standard disclaimer stating that the Products are not
regulated or evaluated by the FDA.”

product front (“all natural”)

product back with disclaimer of FDA approval

Defendant argued that the FDCA preempted the claim because a warning about addiction would be a prohibited “disease” claim. A disease claim explicitly or implicitly claims “to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.” As the court easily concluded, a disclosure that a supplement has addictive qualities is not a “claim to diagnose, mitigate, treat, cure, or prevent” disease. “Instead, such a disclosure informs the consumer that, rather than improving one’s health, kratom has exactly the opposite effect.” The defendant “can easily comply with state laws and the FDCA by avoiding false, misleading, or deceptive statements or omissions regarding kratom’s alleged addictiveness.”

The court did, however, dismiss nationwide class allegations because of differences in the consumer protection laws of the various states on reliance, burdens of proof, statutes of limitations, and damages.

Plaintiffs could bring claims for “unpurchased products” (forms in which they didn’t buy kratom) because the products were all substantially similar for purposes of their claims.

NY statutory and common law fraudulent omission claims: A plaintiff bringing a fraudulent omission claim must show either that (1) “the business alone possessed the relevant information,” or (2) “a consumer could not reasonably obtain the information.” This was sufficiently alleged; although defendant didn’t have exclusive knowledge of the risks, “an omission can still be actionable where it is shown that a consumer could not reasonably obtain the omitted information.”

At the pleading stage, it was enough to allege that “selective online materials or niche federally funded studies” are not “reasonably accessible or comprehensible to consumers”; that kratom is marketed as providing benefits without disclosure of its addictive potential, and, “most importantly,” “that consumers are not aware of the risks of kratom consumption before making their purchases because the available information is either difficult to access or, as with the medical literature, incomprehensible to the average person.” Misinformation about kratom is allegedly rampant.

California: A fraudulent omission must either (1) “be contrary to a representation actually made by the defendant,” or (2) “an omission of a fact the defendant was obliged to disclose.” A defendant “has a duty to disclose when either (1) the defect at issue relates to an unreasonable safety hazard or (2) the defect is material, ‘central to the product’s function,’ and the plaintiff alleges … (1) the defendant is in a fiduciary relationship with the plaintiff; (2) the defendant had exclusive knowledge of material facts not known to the plaintiff; (3) the defendant actively conceals a material fact from the plaintiff; or (4) the defendant makes partial representations but also suppresses some material facts.” This too was done.

Although there was a lot of public information about kratom, it was conflicting, and many documents referenced “complex studies” or were “difficult-to-access reports and letters.” It was plausible that the manufacturer had superior knowledge compared to the average consumer. Defendant argued that its labels directed users to consult with a doctor before use, who in turn would have informed a user of kratom’s addictiveness. But “Defendant cannot simply place the onus of warning consumers of the potential adverse effects of its kratom products on consumers’ doctors by adding boilerplate language to its labels.”

Claims for equitable relief also survived because plaintiffs adequately alleged that public injunctive relief would be appropriate. California class members and members of the public are still at risk of harm—public safety harms can’t be redressed through money damages.

from Blogger http://tushnet.blogspot.com/2025/07/claim-of-failure-to-warn-of-kratoms.html

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plaintiffs don’t have to use full FDA methods for testing nutrients to avoid FDA preemption

Posted on July 2, 2025 by rtushnet

Scheibe v. ProSupps USA, LLC, — F.4th —-, 2025 WL
1730272, No. 23-3300 (9th Cir. Jun. 24, 2025)

The FDA specifies testing methods for determining the amount
of carbohydrates and calories in a food, as well as a sampling process for
those tests requiring “a composite of 12 subsamples (consumer packages) or 10
percent of the number of packages in the same inspection lot, whichever is
smaller, randomly selected to be representative of the lot.” A dietary
supplement, is “misbranded” in violation of the FDCA if its label differs by a
specified margin from the results of these tests. Foods containing up to 0.5
grams of carbohydrates can be labeled as zero-carbohydrate, and foods
containing up to 5 calories can be labeled as zero-calorie. State law claims
that aren’t identical to FDCA violations are preempted.

This is the background for the claims here, over a dietary
supplement: Hydro BCAA. The supplement’s FDA-mandated label states that each
13.8-gram serving contains 10 grams of amino acids but zero grams of
carbohydrates and zero calories. Scheibe bought the supplement to help him lose
weight and gain muscle mass; his preliminary testing of one sample, using a FDA-specified
method, found that the supplement contained 5.68 grams of carbohydrates and 51
calories per serving, “far exceeding the FDA’s allowable margins for
zero-carbohydrate and zero-calorie labeling.” He sued under California consumer
protection law.

The district court dismissed the claims because he didn’t
use the 12 random sample process. But a plaintiff need not prove a claim in the
pleadings, and his allegations made misbranding plausible.

Anyway, because compliance with the FDCA can be determined
only by the FDA’s testing methods and sampling processes, “the Act necessarily
preempts mislabeling claims proven only through testing methods and sampling
processes ‘not validated or accepted by the FDA for use in th[at] context.’” But
ProSupps bears the burden of showing preemption, and Scheibe didn’t plead
himself out of court. Instead, he pled facts allowing a reasonable inference
that the supplement was misbranded. His preliminary testing “allows a court to
draw a reasonable inference that testing a composite sample according to FDA
regulations would show that the supplement is misbranded under the Act.” It was
plausible that additional samples would contain similar amounts, and even if
those samples they had far fewer carbohydrates and calories than Scheibe’s
original sample, “they still could lead to a result that exceeds the margins
for zero-carbohydrate or zero-calorie labels and thereby establish misbranding
under the Act.” (It’s not clear whether the result would be the same with lower divergences from the label. If every other sample in a 12-sample group was zero and zero,
the average would be 0.47 grams of carbs and 4.25 calories per serving, just slightly below the relevant thresholds. Whether such a result is likely is of
course well beyond the record and my expertise.) Maybe his test result was
weird. “But the Federal Rules of Civil Procedure do not cast judges as skeptics
of pleadings.”

Scheibe wasn’t arguing that every serving must have the same
amount of nutrients; he was arguing for a reasonable inference about the results
of the FDA-mandated twelve-sample process. Indeed, it may be “impracticable”
for a plaintiff to test 12 different samples “randomly selected to be
representative of the lot” before discovery opens. “[T]he fact that defendants
may have exclusive control and possession of critical facts—like their own
product inventory—cannot categorically prevent plaintiffs from stating a
plausible claim.”

from Blogger http://tushnet.blogspot.com/2025/07/plaintiffs-dont-have-to-use-full-fda.html

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Scotts loses trade dress claim over green & gold for Miracle-Gro

Posted on July 1, 2025 by rtushnet

Scotts Co. v. Procter & Gamble Co., 2025 WL 1779167, No.
2:24-cv-4199 (S.D. Ohio Jun. 27, 2025)

A different Scotts trade dress claim than the
one I blogged last year. While it’s hard to get rid of trademark claims on
a motion to dismiss, a preliminary injunction may be a different matter—as it
is here, where the court does a thorough job with an expansive trade dress
claim (which frankly should have John Deere’s lawyers taking notice, given its
own reliance on green and yellow). This might be a good case to give students,
given its accessibility.

Scotts makes the Miracle-Gro line of plant food and lawn and
garden products, some of which are depicted below: 

P&G recently introduced a new non-selective herbicide—a weed
killer—called “Spruce”:

Scotts is the market leader in the lawn and garden business.
What is its Miracle-Go trade dress? It has an incontestable registration that “consists
of a rectangular shaped box in the colors green and yellow” for “plant food.” When
the appropriate colors are transposed onto the lined image in the registration, the
mark looks something like this:

But Scotts claimed more, alleging a trade dress comprising:

(1) A green and yellow color combination;

(2) With each color presented as a separate horizontal band
and the top color taking up a smaller ratio than the bottom color;

(3) With the two bands sharing a common border that runs
horizontally along the package;

(4) With a straight line dividing the two colored bands; and

(5) A circular horizontally centered graphic element.

The court referred to the “rectangular shaped box”
combination as the Registration, to avoid confusion with this broader trade
dress claim—broader because it lacked a shape restriction and applied to more
than plant food. Nonetheless, Scotts has never used the Miracle-Gro Trade Dress
with any herbicide, nor did it plan to. Also, the broader trade dress did have
some greater specificity—specifically, the “circular horizontally centered
graphic element.” As implemented, this element was the Miracle-Gro logo or
wordmark, which consists of “white text overlaid on (and extending beyond the
horizontal border of) a black circle with some additional graphic sheen.”

Products using this broader trade dress have been on the
market from 15 to 70 years, depending on the product. Plant food was the
original, sold for over 70 years, and was most closely associated with the
registration.

Since 2014, Scotts has sold around 104 million units of this
product for approximately $650 million. During the same period, Scotts sold
roughly one billion units of Miracle-Gro, generating approximately $5.6 billion
in revenue, although just under one-third came from so-called “specialty
products” or “flavors,” “which come in quite different packaging (although
sometimes with at least some of the design elements from the Trade Dress).” 

Ninety percent of sales occur at brick-and-mortar stores,
including “do-it-yourself … home centers” like “Lowe’s, Home Depot, Menards”;
large chain retailers like Target, Walmart, and Meijer; and hardware, garden,
and club stores. The cost ranges from $6 to $20 depending on the product and
configuration.

Spruce became available to consumers mid-November 2024. It
costs between $12.99 to $39.99 depending on the configuration. Spruce is
carried in brick-and-mortar retailers such as Home Depot, Lowe’s, Walmart,
Target, Ace, and True Value, as well as online. P&G has invested
significantly in television, online/social media, print, and in-store
advertising as part of the product rollout:

The bottom of each container consists of a clear or
transparent section. The transparent portion is designed to allow consumers to
see the liquid product. A spruce green portion predominates most of the product
packaging. “The Miracle-Gro green is a brighter green with a glossy finish that
resembles a freshly cut lawn on a sunny day, while the green on the Spruce
packaging has a matte finish and is darker, more like a pine (or spruce) tree
in a shadowy forest.” On most packages, a round, yellow dandelion image (with
an even darker green background) traverses the clear and dark green portions, intended
to depict a half-living, half-dehydrated-and-dying, dandelion. The Spruce
trademark appears in bold white text, with a yellow “violator” containing the
text “Visible Results in 1 HOUR.” I learned: “A graphic violator is a visual
element used in product design that sellers use to draw the consumer’s
attention to certain messaging the seller wants to emphasize.”

Many third-party lawncare products similarly use green and
yellow color combinations: 

Although market presence for all of these wasn’t shown, Scotts
admitted that Preen Weed Preventer Plus Plant Food product (leftmost) is
“widely sold in the lawn-and-garden marketplace” (perhaps outselling the
Miracle-Gro weed preventer product) and at times “shelved right next to” that
Miracle-Gro product. That is true also of Spectracide (center), which Scotts
admitted is “a leading weed killer product.”

Plaintiff’s witness Sass had worked for Scotts for over 20
years. He testified about the 12 distributor declarations and 110 consumer
declarations submitted to the PTO for the Registration. The declarants each
said something like: “when I see packaging which is green on top and yellow on
the bottom in connection with plant food products, I interpret the packaging
design as an indication that the goods come from a single source, i.e., the
makers of Miracle-Gro.”

Testifying about differences from other products on the
market, Sass emphasized the importance of the proportions (“typically one-third
green on top, two-thirds yellow on the bottom”) and a dark circle element for
the Scott products. The court concluded that the proportions were “perhaps more
important” than Scott argued.

Meanwhile, P&G’s witness Croswell testified that P&G
settled on Spruce’s dark green because P&G believed it would make Spruce
distinctive in the weed-killer market and because it invoked the namesake of
the brand (i.e., Spruce trees). “[D]uring development, P&G and one of the
third-party marketing companies it used identified concerns about whether a
certain version of the Spruce design may have been too similar to a particular
competitive product. But at no point during that process did anyone raise a
concern that any version of the proposed Spruce design was too similar to the
Miracle-Gro line of products.” And P&G has no plans to expand the Spruce
brand into other product categories in the lawn and garden space.

Nobody was aware of instances of actual confusion.

Winning my heart, the court began its confusion analysis by cautioning
that it would not allow Scotts to extend the benefits of incontestability to
the common-law trade dress, and that incontestability and likely confusion are
two different questions.

Strength of the mark: Miracle-Gro’s trade dress likely
acquired distinctiveness through secondary meaning, even though its PTO declarations
were only directed to a rectangular box and it had no survey evidence. Length
of time on the market, advertising, sales volume, and market leadership favored
secondary meaning nonetheless.

The trade dress was also probably nonfunctional.

Without evidence of actual confusion, “it basically comes
down to the Court’s assessment of the objective likelihood of confusion based
on the products and packaging, along with the evidentiary value of the
competing consumer surveys the parties tendered.”

Given that strength of the plaintiff’s mark and similarity of
the marks are the most important, Scotts lost primarily because of
dissimilarity.

Miracle-Gro’s trade dress had substantial commercial
strength, but its conceptual strength was unclear, especially given the definitional
questions (are proportions key to the trade dress, or not?). The court noted
that, on all the products it saw, the one-third/two-thirds division was the
same, and the green was above the yellow. With that, plus the “circular
horizontally centered” black circle at the dividing line between the colors,
there was likely some conceptual strength.

“But when you start subtracting individual elements from
that combination, the distinctiveness quickly vanishes.” There was nothing
particularly distinct about using green and yellow for packaging in the lawn
care industry: they “are the colors of sunshine and plants.” Although the
burden is on the defendant to show what actually happens in the market, P&G
did so, showing that several other strong market performers use green and
yellow. It’s not that those others are confusing—it’s that reasonable consumers
wouldn’t just rely on seeing green and yellow to attribute source given the
market.

The dissimilar Miracle-Gro variants also sapped some of the
conceptual strength of the trade dress. “[T]he more consumers come into contact
with Miracle-Gro products with a different style of packaging, and in
particular different color combinations, the less likely they are to look for
the green and yellow combination as identifying their favorite lawn and garden
product.” (But the black circle abides.)

Nonetheless, this factor overall tilted towards Scotts.

Relatedness of the goods: One of the products bearing the Scotts
trade dress is a “Weed Preventer.”

That didn’t move the needle much (herbicide is not “weed
preventer” but killer, and you’d use the weed preventer on a flowerbed but not
the weed killer, and vice versa for weeds sprouting between bricks), but the
products were somewhat related insofar as they are all in the lawn and garden
category.

Similarity of the marks: a “defendant’s resounding success
on this factor makes the plaintiff’s burden of prevailing on the seven other Frisch’s
factors effectively insurmountable.” Similarity doesn’t depend on a
side-by-side, element-by-element comparison; it is based on the overall
impression arising from the combination of elements. Even going element by
claimed element, there was substantial dissimilarity.

Color: Very distinct shades of green, and Spruce was matte
(and transparent in part) while Miracle-Gro was glossy and entirely opaque.

Separate horizontal bands of color with top smaller: Scotts
has the one-third/two-third ratio, and Spruce uses a clear, bottom portion (about
one-fifth), then dark green predominates over most of the rest. The yellow
portion, it is relatively small and is used to highlight a message—“Visible
Results in 1 HOUR.”

True, on both packages, the colors “shar[e] a common border
that runs horizontally along the package” in the form of “a straight line
dividing the two colored bands.” “But these visual elements are wholly
unremarkable and add little to the overall visual impression of each product.”

Likewise, both products contain a “horizontally centered
graphic element.” But on one, it’s the Miracle-Gro logo, which is white text on
a black circle with some additional features. Spruce, has a circular yellow
dandelion (with different graphics on each half) overlaid on a dark green
background. Moreover, the circular graphics are “in different places on the
package ([top] v. bottom).” “The dissimilarity on this element could not be
more stark.”

There were other dissimilarities as well, including in the
actual containers—with five Spruce configurations versus the entire Miracle-Gro
product line, “none of them even remotely resemble each other in shape.” Scotts
didn’t have text in the top portion; P&G did. The graphics were “meaningfully”
different: photorealistic images of vegetation versus graphic design-like
elements (e.g., an outlined paw print). And the Spruce trademark creates its
own distinct visual impression, serving as a house mark.

The trade dresses at issue are “clearly distinguishable and
would appear so to all but the most obtuse consumer.”

Scotts tried to change this result with survey evidence. Its
expert, Dr. Wind, conducted a Squirt survey—one that presents survey
respondents with both of the conflicting marks and “do[ ] not assume that the
respondent is familiar with the senior mark.” Potential purchasers of
Miracle-Gro and Spruce were broken into three groups, Home Depot, Lowe’s, or
Meijer, each with a test and control cell. After telling respondents to imagine
they were considering purchasing a lawn and garden product, the survey showed
respondents in each group in-store displays from the stores to which they were
assigned (except the Lowe’s, which was mistakenly shown Home Depot; the court
found this rendered the survey “suspect and deserving of little weight” as to
this subgroup). E.g., Home Depot respondents saw these: 

Then test respondents were shown some of the same photos
containing Spruce, with red lines surrounding the Spruce products, and asked
how they would describe those products to a friend.

Finally, test respondents were shown the in-store display
that included Miracle-Gro products along with various other third-party
products (the right-most photo in the initial photo array above) and were
asked: “Do you believe that any of these products or product lines on this
plant food display were made by the same company that manufacturers the
products you saw that were circled in red?” Respondents were asked some
follow-up questions (e.g., the reason they selected the products).

The survey repeated the process for (1) asking whether
respondents thought any of the products or product lines in the display with
the Miracle-Gro “ha[d] a business affiliation or connection with the company
that manufactures the products you saw that were circled in red” [I note that
there was no training on what a “business affiliation” is, and there probably
should be]; and (2) asking whether respondents thought any of the products or
product lines in the display with the Miracle-Gro “gave permission or approval
to the company that manufactures the products you saw that were circled in
red.”

Control groups saw the same images and stimuli, except the
colors on the Spruce products were black, white, and silver.

If a respondent who answered positively mentioned green and
yellow in connection with Spruce, the coders tagged that respondent as
“confused.” Dr. Wind calculated net confusion rates, “[d]ue to explicit
reference to the green and yellow packaging” of 16.2% for the Lowe’s subgroup,
9.1% for Home Depot, and 17.7% for Meijer.

P&G objected to (1) the Squirt survey format; (2)
the design; and (3) what Wind counted as “confusion.”

Squirt: P&G argued that Miracle-Gro and Spruce do
not appear side-by-side in the marketplace and that an Eveready survey
is the appropriate tool to use where one of the marks at issue (here Miracle-Gro)
is a strong mark. The court agreed with this criticism. “The products at issue
are typically not displayed side-by-side in a retail setting, nor was there a
sufficient showing that the typical consumer sees them sequentially,” and
Miracle-Gro is commercially strong. The court quoted McCarthy to the effect
that “Squirt methodology is inappropriate unless there are ‘a significant
number of real world situations in which both marks are likely to be seen in
the marketplace sequentially or side-by-side.’”

Design: P&G argued that Squirt surveys have an
inherently leading nature (seems true), which was amplified by stimuli unreflective
of true market conditions. This was even more problematic than choosing Squirt
in the first place. First, there was the Lowe’s error. Second, in the Home
Depot image, nearly half of the “plant food” display shown to respondents was
dominated by a pallet of Miracle-Gro potting mix. “[T]he Court finds it
unlikely that large pallets of Miracle-Gro potting mix typically sit directly
in front of Home Depot’s plant food shelves (or at least, that customers
typically would stand behind such a pallet while selecting something on the
plant food shelf). Simply put, the Home Depot photo was highly suggestive.”

Identification of confused respondents: Dr. Wind “classified
any respondent ‘confused’ for simply describing the products as ‘green and
yellow’—even if they mentioned nothing about Scotts or Miracle-Gro.” That is,
if a respondent accurately noted that the packaging for Spruce products
contained the colors green and yellow, that would be coded as reflecting
“confusion.” This the court found most troublesome of all. “P&G identified
a significant number of responses that clearly should not have been coded in
that manner—namely, respondents who referenced “Spruce” in their answers, and
who did not mention “Miracle-Gro” or “Scotts” at all, but who happened to
mention that the Spruce bottle was green and yellow (which it is).”

P&G offered its own survey by Dr. Simonson: an “aided Eveready
survey.” An Eveready format assumes that survey respondents “are aware
of the [senior] mark from their prior experience.” This “format is especially
useful when the senior mark is readily recognized by buyers in the relevant
universe.” Respondents are shown the allegedly infringing products,, then asked:

• Who do you think makes or puts out this product?

• Does the company that makes this product put out any other
products?

• Does the company that makes this product have a business
affiliation or connection with any other company? [Again, no definition/training.]

• Did the company that makes this product receive permission
or approval from another company?

However, Simonson used the typical Eveready questions, but displayed
multiple products from the marketplace (as would occur in a Squirt
survey), instead of the single, allegedly infringing product. Each respondent
viewed a picture array of products, like so:

They were asked to review all the products “as they would if
they were considering purchasing a weed preventer at an online store.” The
respondents then saw one of the four images below, with the Spruce product (or
a control version of the Spruce product, bottom) blown up on the left-hand
side: 

They were then asked variations of the four standard
Eveready questions along with follow-up probing questions as necessary. The
“control” “had a different trade dress, but still incorporated green and yellow
elements as well as the language and small icons used on Spruce.” Simonson found that “only 2.9% of the Test group respondents … mentioned either Miracle-Gro or Scotts.” Although the
court didn’t rely on the Simonson survey, it didn’t like the control.

Here, the characteristic being
assessed was the color combination. But instead of altering solely Spruce’s
color, as Dr. Wind did for his control, Dr. Simonson created an entirely new
shape, maintained the colors green and yellow (but making white the most
prominent color), and added a circular graphic element to the top portion of
the packaging. In many ways, Dr. Simsonson crafted a control that was more
similar to the Miracle-Gro’s Trade Dress than Spruce’s current packaging, which
may explain why the control group displayed greater confusion than the test
group.

(The court  did reject Scotts’ criticism that
the answers “Ortho,” “RoundUp,” “fertilizer,” or the like should have been
coded as confused. “This case is about Miracle-Gro; not every brand Scotts
uses. And Scotts certainly does not have a monopoly on the word ‘fertilizer.’”)

Remaining factors: Marketing channels favored Scotts; degree
of purchaser care was not very significant/it was dependent on mark similarity.
Intent: (1) P&G considered other packaging designs with other color
schemes; (2) some third-party reports prepared for P&G, as part of Spruce’s
packaging development process, featured images of Miracle-Gro products; (3)
Scotts sent P&G a letter expressing concerns about confusing similarity
between the products’ designs in May 2024. This was “attenuated at best” intent
evidence. “It seems natural to the Court that a product development team might
consider different colors and designs, then test those options before going to
market.” Nor was a study’s inclusion of “a few images of Miracle-Gro products
(along with many, many other lawn and garden care products)” evidence of
intentional copying. “Scotts is the category leader; you would expect some of
its products to appear in any report about the market.” Finally, the Scotts
letter had no bearing on intent—the packaging design was nearly finalized by
then. No weight.

Likely product line expansion: Not likely; no weight.

Dilution: In the Sixth Circuit, “[t]he ‘similarity’ test for
dilution claims is more stringent than in the infringement milieu.” Given the
high level of dissimilarity here, that was fatal.

from Blogger http://tushnet.blogspot.com/2025/07/scotts-loses-trade-dress-claim-over.html

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“local” can be literally false when a company is foreign

Posted on July 1, 2025 by rtushnet

El Paso Disposal, LV. v. Ecube Labs Co., 2025 WL 1766310,
No. EP-24-CV-97-KC (W.D. Tex. Jun. 26, 2025)

Plaintiffs operate waste collection companies that collect
trash from customers in Texas, New Mexico, and Oklahoma. Defendant Haulla, a
“waste broker” that acts as an intermediary between waste haulers and their
customers, allegedly fraudulently obtained their confidential customer
information by posing as customers, accessing plaintiffs’ customer portal in
violation of its terms of use. Using that information, Haulla allegedly
contacted customers to entice them to break their contracts and switch to
another, Haulla-affiliated waste pickup company. The false advertising part is
that Haulla’s agents allegedly falsely claim to be calling from a “local
pickup” or “local [waste] collection company” when they contact plaintiffs’
customers. (Common law fraud and tortious interference claims were preempted by
Texas’s trade secret law to the extent that the relevant information was a
trade secret, but not if they weren’t; plaintiffs could  plead in the alternative.)

This motion addressed state and federal false advertising
claims as well as negligent misrepresentation.

Was “local” plausibly false here, where Haulla operates in Texas
but is a South Korean company that operates out of the Philippines? Bimbo
Bakeries USA, Inc. v. Sycamore, 29 F.4th 630 (10th Cir. 2022), found that “local”
was puffery in the tagline, “Fresh. Local. Quality,” for bread baked in
multiple out-of-state locations. “Local” could take on multiple different
meanings, including that the company merely hired local workers.  But there have to be limits, for example “if
somebody says they support the ‘local’ NFL team” but instead support a team
“more than two thousand miles from here,” “then they have undoubtedly deceived
you.” Thus, the phrases “local pickup company” or “local collection company” provided
more specificity than the slogan in Bimbo and could be falsified—they could
imply “that the company maintains an office in close enough physical proximity
to collect the customer’s trash.” And Haulla’s offices were allegedly located “halfway
around the world, much too far away to drive to businesses in Texas and pick up
their trash,” so that was plausibly false.

Commercial advertising or promotion: Like almost all courts
(and correctly), the court decides that Lexmark means that “by a competitor”
is not part of the current test, only the other three elements of Gordon
& Breach. So, what constitutes sufficient public dissemination to be commercial
advertising or promotion in the context of this industry? Plaintiffs offered
only one specific allegation where a customer was contacted by Haulla and it
referred to itself as a local trash pickup company. It was unclear exactly how
large the customer group was, though Haulla allegedly created more than “2,500
fake customer profiles.” But, given that plaintiffs alleged a “sophisticated
and wide-ranging fraudulent scheme that turns on Haulla’s attemptsto secure
confidential information, which it then uses to systematically target
Plaintiffs’ customers and entice them to switch waste collection providers,”
there was “a reasonable inference that these statements were made a substantial
number of times to Plaintiffs’ customers, and as part of broader efforts to
encourage customers to switch to a Haulla-represented company.” [This is a
classic example of the manipulability of Twiqbal. A hostile court could
easily have said exactly the opposite.] The court noted that evidence on this point
would be required to avoid summary judgment. The rest of the elements of the commercial
advertising test weren’t disputed.

Materiality: Taking what is the increasingly minority view,
the court found that literal falsity (which it characterized as being allegedly
present here) allowed a presumption of deception without need for materiality.
Even though plaintiffs conceded that Haulla was “registered to do business in
Texas” and that it acts as a middleman for Texas-based waste collection
companies, “this does not take away from the literal falsity of Haulla’s
alleged statements that it is a local trash collection company even though it
does not actually collect trash and is not local under any reasonable reading
of that term in this context.”

Plaintiffs also plausibly pled injury, so the Lanham Act
claim survived.

Texas common-law false advertising: claim dismissed because
it doesn’t exist in Texas, per two Texas appellate decisions.

Negligent misrepresentation (based on the alleged statements
to plaintiffs): not barred by the economic loss doctrine. Plaintiffs allegedly relied
on Haulla’s representation of “being a customer or acting with a customer’s
authorization” to supply “Haulla with information that enabled Haulla to access
[Plaintiffs’] confidential and proprietary information and steal [Plaintiffs’]
customers through use of the information.”

Under Texas law, courts analyze the economic loss doctrine by
first determining the extent to which a legal duty exists between the parties
independent of the contract, then examining the extent to which a party
suffered an independent injury, or is merely seeking to recover
benefit-of-the-bargain damages under the terms of the contract.

But the allegations supported the theory that there was no
valid contract, thus no economic loss doctrine involved, because plaintiffs’
website terms of use prohibited uses by third parties, only allowing “customers
and their respective employees” who are limited to using the site “solely for
purposes relating to their own respective account(s).” Under Texas law, “if a
contract is fraudulently induced, ‘there is in reality no contract’ because
there was no assent to the agreement.”

Even if there were a valid contract, Haulla allegedly breached
an independent duty, causing Plaintiffs an independent injury. First, “a party
has a legal duty to use reasonable care when supplying information in the
course of its business for the guidance of others in their business,” which
“exists independent of any contractual obligation.” Haulla’s agents had a “duty
imposed by law” to use reasonable care in communicating information to plaintiffs,
which they allegedly breached when misrepresenting themselves as customers or
customers’ agents.

Second, an independent injury is one that goes beyond the
“economic loss” that is the “subject matter of a contract.” Plaintiffs alleged
reputational damage due to Haulla’s actions: a non-economic loss.

Fraud claims also survived.

from Blogger http://tushnet.blogspot.com/2025/07/local-can-be-literally-false-when.html

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Visa logo doesn’t represent that cards will be protected against fraud

Posted on June 25, 2025 by rtushnet

Schuman v. Visa U.S.A., Inc., — F.Supp.3d —-, 2025 WL
1731795, No. 1:24-cv-666-GHW (S.D.N.Y. Jun. 23, 2025)

This one is interesting both as a fraud warning and as a
pronouncement on what reasonable consumers think about the possibility of
fraud.

Schuman bought eight Visa-branded gift cards at a CVS,
loaded each of them with $500, and gave them to his employees as holiday
presents.

Three of the cards, however, had
been emptied of funds by scammers before Plaintiff’s employees could use them.
The scammers allegedly stole the cards’ funds using a well-known technique
called “card draining”: they removed the cards from their packaging on the
shelf, recorded the cards’ account numbers, returned the cards to their
packaging, and when Plaintiff later loaded money onto the cards, they used the
account numbers to quickly make purchases before his employees could.
Defendants’ cards, Plaintiff says, are especially susceptible to “card
draining” because their flimsy cardboard packaging allows scammers to access
the cards inside without enough evidence of tampering to alert a reasonable
consumer.

Schuman alleged “that the cards’ prominent display of Visa’s
logo gave him the false impression that their funds would be secure from fraud,
and that without this peace of mind, he would not have purchased the cards.” The
cards’ express warnings regarding tampering and other potential security
threats allegedly did not do enough to put him on notice of the potential for
“card draining.” There were also allegations of other barcode vulnerabilities
(a scammer can attach a barcode to an unsold gift card, leading the consumer to
load money onto the scammer’s card), though he didn’t allege that happened to
him. He sued under NY’s GBL.

The back of the packaging includes two warnings related to
potential tampering by third parties. First, in the top right corner, the
packaging states, in capital letters: “IF TAMPER EVIDENT, DO NOT PURCHASE. NO
VALUE UNTIL ACTIVATED AT REGISTER.” Second, above the account number associated
with the card, the packaging states, in red lettering: “For security purposes,
please check that the underlined portion of this number matches the number
below.” Visa allegedly knew that its Visa Vanilla cards were susceptible to
fraud because scams affecting those cards were “known and widespread.”

But “no reasonable consumer would fail to recognize the
possibility that a gift card they bought may be subject to a third-party scam.
Nor would one reasonably expect that the Visa logo, standing alone, was a
promise that no scam could ever occur.”

“The Visa logo consists simply of the word ‘VISA’—it makes
no assertions about the security from the possibility of fraud of the cards or
of their packaging.” It didn’t claim that fraud would be prevented, or that if
it did occur that Visa would help out in good faith (something plaintiff also said
he trusted Visa to do). “No reasonable consumer would expect the allegedly ‘widespread’
practice of third-party scams affecting prepaid cards to somehow not affect one
of the industry’s major suppliers.” Other statements from Visa about the
importance to Visa of keeping its consumers’ cards secure were, among other
things, nonactionable puffery. (These statements included that Visa is “one of
the most trusted brands in the world,” that it “protects consumers,” that
“security is embedded in everything we do,” and that it “aim[s] to increase
transaction approvals so that business can thrive while customers are protected
and satisfied.”)  Finally, Visa’s use of
specific statements about its commitment to anti-fraud measures “only confirms
that the word ‘Visa’ alone does not, in and of itself, include a promise about
the cards’ fraud security or the measures Visa takes to combat the possibility
of fraud.”

Plaintiff also objected to the failure to warn about
specific scams/card draining in particular. The anti-tampering warning didn’t
warn consumers of the possibility that a card-drainer may access a card’s
account information by tampering with the packaging in a way “that can go
unnoticed by the reasonable consumer.” And the red-letter instruction consumers
to compare the portion of the card’s barcode number that is visible through a
window in the packaging with a number inside the packaging and confirm that
they are the same was equally nonmisleading. For omissions, Second Circuit
cases read NY law to require that a plaintiff must plausibly plead either 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.’ ” The latter is the more important standard. Given the
allegations of widespread complaints and reporting on card fraud, as well as
the warnings on the card itself, plaintiff could reasonably have obtained the
relevant omitted information.

from Blogger http://tushnet.blogspot.com/2025/06/visa-logo-doesnt-represent-that-cards.html

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“natural” plausibly meant “all natural”

Posted on June 25, 2025 by rtushnet

Cobovic v. Mars Petcare US, Inc., No. 24-CV-7730 (ARR)
(JAM), 2025 WL 1726261 (E.D.N.Y. Jun. 20, 2025)

Cobovic alleged that Mars’s use of the word “natural” on the
label of its pet food products violates New York consumer protection law and
constitutes a breach of express warranty. The claims survived a motion to
dismiss. I’m blogging this mostly because consumer protection caselaw is
beginning to develop a distinction between “ambiguous” and “unambiguous” label
claims that uses the same words as Lanham Act caselaw, but possibly to
different effect. It’s only a matter of time before the streams cross, and we
should probably think about whether there is in fact a difference, and if there
is, if there is justification for the different ways to slice the salami of
meaning.

Anyway, Mars sells a product labeled “NATURAL CAT FOOD +
VITAMINS, MINERALS & OTHER NUTRIENTS.” But the products allegedly contain
“multiple synthetic ingredients.” Although the label includes the phrase “Plus
Vitamins, Minerals and other nutrients,” Cobovic alleged that a reasonable
consumer would assume that the vitamins, minerals, and other nutrients are
themselves “natural” rather than “synthetic.” Anyway, Cobovic alleged that
“some of the synthetic ingredients in the Products,” such as xanthan gum,
cannot be categorized as vitamins or minerals, such that the label was false
either way.

Drawing on the “large body of case law” about product
packaging that is alleged to be false or misleading “with respect to the
product’s actual ingredients,” the court concluded that “the relevance of the
product’s ingredient list depends on whether or not the allegedly deceptive
statement is considered ‘ambiguous.’” Where the plaintiff’s claim “turns on”
the “unavoidable interpretation” of the statement in question, the reasonable
consumer is not expected to consult the ingredient list to ascertain the label’s
meaning. “But where the statement in question is ambiguous, a reasonable
consumer is expected to consult the ingredient list ‘in order to clarify his or
her understanding of the label.’” “Consumers who interpret ambiguous statements
in an unnatural or debatable manner do so unreasonably if an ingredient label
would set them straight.”

First, labelling a product that contains synthetic and/or
artificial ingredients as “natural” may be false or misleading; the label need
not state that the product is “all natural” or “100% natural” for a reasonable
consumer to infer that the product is free from synthetic ingredients. And Mars
didn’t meaningfully contest the allegations that the products contained
multiple synthetic ingredients. Even if “+ vitamins, minerals, and other
nutrients” indicated that not all ingredients are natural, at least one ingredient—xanthan
gum—appeared to be neither “natural” nor a “vitamin, mineral, or other
nutrient[ ].”

Plus, Mars was arguing that the ingredient list would reveal
to consumers the presence of synthetic ingredients. The court was unwilling to
assume that “a reasonable consumer can identify which listed ingredients are
natural and which are not,” especially because many “naturally occurring forms
of the same vitamins and minerals have similarly difficult-to-pronounce names.”
A jury would have to decide. (Note that the jury would be resolving any
ambiguity, and the court isn’t requiring extrinsic evidence.)

from Blogger http://tushnet.blogspot.com/2025/06/natural-plausibly-meant-all-natural.html

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parties’ marketing to Spanish speakers in SoCal is not meaningful marketing overlap

Posted on June 25, 2025 by rtushnet

Olé Mexican Foods Inc. v. SK Market Inc., 2025 WL 1717646, No.
2:25-cv-01877-WLH-BFM (C.D. Cal. May 13, 2025)

Courts have already converged on “everybody uses the
internet to market, so that’s not a significant overlap.” This is the first
decision I’ve seen to extend the same reasoning to Spanish-language marketing,
but since that conclusion was already implicit for English-language marketing
(nobody ever claims that overlap in targeting English speakers deserves weight)
it’s not that surprising.

Olé sued SK for its use of the Olé City Market; the court
denied a preliminary injunction.  

Olé has registrations for OLÉ for what the court describes
as “authentic Mexican-inspired foods,” which it sells in various grocery
stores, including in Southern California. SK Market adopted the Olé City Market
mark for its grocery stores in Southern California. They sell items such as
fruits, vegetables, meats, seafood, deli and frozen goods, beverages,
detergents, toothpastes, cleaning supplies, and alcohol.

SK filed ITU applications for OLÉ CITY MARKET to use with
“retail grocery store services and in retail grocery stores. Olé objected in
February 2023 and filed a notice of opposition after June 2023. It also sued
for state and federal trademark infringement/false advertising.

The court found the word marks similar, though distinguished
by the additional words “city” and “market.” The design marks were not similar:

Instead, they were “easily distinguishable from the Olé City
Market design mark in use of images (bull v. sun), color, font, arrangement and
overall appearance.” Weighed slightly in favor of confusion for the word marks
and “decidedly against” for the design marks.

Relatedness of goods: related, but not closely so. Olé’s
marks were directly related to specific Mexican foods, while SK’s were for a
grocery store selling a wide variety of goods and products. “[T]he Court finds
persuasive the distinction between Plaintiff’s sale to customers of certain
types of packaged Mexican food on the one hand and Defendant’s operation of a
chain of grocery stores on the other.” But this factor might be “markedly”
different if SK sold house-branded Mexican food; it just doesn’t do so or plan
to do so. Weighed against confusion.

Marketing channels: neutral. “While the trade channels used
by the parties include websites and print ads, those are the obvious channels
that anyone in business today would use.” Marketing “target[ing] the Hispanic
community” by having Spanish language advertising was not significant “because
anyone marketing anything in Southern California would find Spanish language
advertising appropriate.”

Strength of plaintiff’s mark: Neutral. Though the mark was
arbitrary and used since 1988, “Olé is a common word in Spanish meaning
“hooray,” and Plaintiff’s Olé word mark exists within a crowded field,
including among others registrations for use with 1) nachos, tacos, tortillas,
enchiladas, chalupas, tamales, coffee, and tea; 2) restaurant services; and 3)
frozen Mexican entrees and prepared foods.” So the mark wasn’t especially
strong in relation to grocery stores.

Degree of purchaser care: Disputed—inexpensive, but maybe
the cultural significance of Mexican food increases care; plaintiff didn’t meet
its burden at this stage.

Intent: Uncontroverted evidence showed that SK didn’t learn
of the Olé marks until after they filed the ITUs. Although Olé’s registrations
provided constructive knowledge, that didn’t persuade the court of any bad
intent.

Actual confusion: no evidence.

Likely expansion: SK didn’t intend to expand into
house-branded Mexican foods. (The court didn’t explicitly address whether Olé
intended to open grocery stores, but that seems inherently less likely.)

Unsurprisingly, then, the requested PI was denied.

from Blogger http://tushnet.blogspot.com/2025/06/parties-marketing-to-spanish-speakers.html

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Federal Circuit reads “literal falsity” way too narrowly

Posted on June 20, 2025 by rtushnet

BPI Sports, LLC v. Thermolife Int’l LLC, Nos. 2023-1068,
2023-1625, 2023-1112, 2025 WL 1683234 (Fed. Cir. Jun. 16, 2025)

This is a false advertising case involving allegedly false
patent marking. Creatine nitrate is an amino-acid nitrate used in dietary
supplements. At the time of the trial, ThermoLife owned several patents
covering creatine nitrate, which it licensed to manufacturers. BPI sells supplements
that compete with licensees of ThermoLife; it sued for false advertising under
the Lanham Act and unfair competition under state law in connection with ThermoLife’s
CRTN-3, as well as false patent marking under the Patent Act. A jury found that
BPI showed false advertising and unfair competition but awarded zero damage,
and found in favor of the defendants as to the false patent marking claim. In
the cross-appeals, the court found that ThermoLife should have gotten judgment
as a matter of law.

“JMOL should be granted only when the [moving party]
presents no legally sufficient evidentiary basis for a reasonable jury to find
for him on a material element of his cause of action.” Adopting a perjury-like
standard, the court of appeals found that no reasonable jury could have found
in favor of BPI under the falsity element of a false advertising claim: that
CRTN-3 label’s statement of “increase vasodilation” was literally false. (BPI
didn’t preserve misleadingness as an alternative ground, and there was no
survey or other evidence of consumer reaction in the record.)

The claim was literally true because BPI’s own evidence
shows that the dosage disclosed in CRTN-3’s label would “cause vasodilation”
for people weighing 113 pounds or less. However, the dosage amount of creatine
nitrate needed for “an average adult in the U.S. weighing 177 pounds” is more
than the amount disclosed in CRTN-3. But the label didn’t claim to increase
vasodilation for average people.

Once again, a court ignores ordinary rules of implicature.
Other cases have (in my view correctly) held that a product that self-evidently won’t work for
most people can’t claim to “work” in general. Under the Federal Circuit’s view,
apparently, an advertiser could claim that its product “treats hair loss” if it
could help the small percentage of people whose hair loss stems from a specific
vitamin deficiency. That’s a mistake, and it’s one that thinking about “what would the true message look like?” could help.

from Blogger http://tushnet.blogspot.com/2025/06/federal-circuit-reads-literal-falsity.html

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“abortion reversal” promoter engaged in inherently and potentially misleading commercial speech, court rules

Posted on June 20, 2025 by rtushnet

Culture of Life Family Services, Inc. v. Bonta, 2025 WL
1677783, No. 3:24-cv-01338-GPC-KSC (S.D. Cal. Jun. 13, 2025)

In two opinions on the same day, the court didn’t give much
comfort to an “abortion reversal” provider.

COLFS sought to enjoin AG Bonta’s pending state court false
advertising proceeding against its “abortion reversal” claims. APR is touted
for pregnant women who have started the chemical abortion process by ingesting
mifepristone, the first pill out of two; it involves taking the hormone
progesterone in order to counteract mifepristone’s blocking of the body’s
natural supply of progesterone. The main proponent, COLFS’s medical director,
has done small human case studies, claiming an overall fetal survival rate was
48%, higher for the subgroup that received progesterone intramuscularly (64%)
and the subgroup that received a high dose of oral progesterone followed by
daily oral progesterone until the end of the first trimester (68%).  

The state enforcement action under California’s UCL and FAL
challenged as unsupported by credible scientific evidence: the use of the terms
“reverse” and “reversal”; claims that APR “has been shown to increase the
chances of allowing the pregnancy to continue”; claims that APR has a success
rate of 64-68%; claims that the rate of birth defects following APR is “less or
equal to the rate in the general population”; claims that “thousands of lives
have been saved” through APR; claims that APR may be effective at longer time
ranges and following administration of misoprostol and methotrexate; and
claims that APR can cause only non-life-threatening side effects, even though
it can cause severe bleeding.

The court found the UCL and FAL to be content-neutral,
because they were laws of general applicability that prohibit false and misleading
statements. (This is probably not consistent with Reed, but Reed
doesn’t make a ton of sense, especially applied to commercial speech—the underlying
conclusion that strict scrutiny doesn’t apply is correct.)

Bonta argued that COLFS’s APR statements were commercial
speech, used to advertise the treatment, and that fundraising provided an
economic motivation for the APR claims. The court noted that many of the
disputed statements appeared on COLFS’s website, and appeared more informational
and educational than client-soliciting. Statements about APR in fundraising
weren’t as clear as in a previous case, where a “majority” of fundraising
communications involved the advertising language at issue, nor did COLFS
anywhere claim to compete with abortion providers. However, in exchange for its
APR services, COLFS accepts insurance and/or payment from women who have
insurance or the means to pay; it also provides free treatment. On a motion to
dismiss, COLFS sufficiently pled that its statements weren’t commercial speech.

However, the Free Exercise claim failed. A Free Exercise
claim requires that a government entity has “burdened [a plaintiff’s] sincere
religious practice pursuant to a policy that is not ‘neutral’ or ‘generally
applicable.’ ” But the UCL and FAL “protect consumers by prohibiting false and
misleading advertisements – because of the stated interest in consumer
protection, not because of any sort of motivations underlying those
advertisements – and as such these laws are neutral.” There were no exceptions
to the UCL and FAL that could discriminate against religious conduct, nor did
they treat “any comparable secular activity more favorably than religious
exercise.” The AG “regularly enforces” these laws against secular entities. Although
the UCL and FAL don’t apply to public entities or political speech, that wasn’t
required to make them “generally applicable” laws. Instead, laws of general
application treat religious and secular speech comparably. “Whether secular and
religious activity are ‘comparable’ is evaluated ‘against the asserted
government interest that justifies the regulation at issue’ and requires
looking at the risks posed, not the reasons for the conduct.” The risks posed
by public entity and political speech were different. Public entities are
exempted because the state is a “sovereign entity representing the people,” and
can have sovereign immunity. Political speech is exempted because “false and
misleading political speech is protected while inherently false and misleading
commercial speech is not.”

Although COLFS claimed that allowing progesterone to be
prescribed for everything except APR treatment was not neutral and generally
applicable, “laws do not need to cure every problem or aspect of a problem.” Seems
like the correct result for the wrong reason—it might not be false or
misleading to proscribe progesterone for something else! Plus, the claim here
isn’t against the prescription, it’s against the advertising. The court gets
there: “AG Bonta is not banning APR treatment, but is enforcing consumer
protection laws against specific advertisements of APR treatment.”

COLFS argued selective enforcement against COLFS, but not
Planned Parenthood. But “COLFS’s statements refer to a medical treatment that
has only undergone studies for efficacy and safety since 2012, while Planned
Parenthood’s statements speak to an FDA-approved medical procedure…. COLFS’s
statements about APR treatment and Planned Parenthood’s statements about the
abortion pill are not comparable.” There was no indication that Planned
Parenthood had violated the UCL or FAL.

COLFS also didn’t have a valid “right to receive information”
claim, which is cognizable “only where the listener has a concrete, specific
connection to the speaker.” That wasn’t pled here, for statements outside a
doctor-patient relationship.

The substantive due process claims for “COLFS’s patients’
rights to procreation, reproductive privacy, and to reject unwanted medical
treatment” also failed.

 

Culture of Life Family Services, Inc. v. Bonta, 2025 WL
1687929, No. 3:24-cv-01338-GPC-KSC (S.D. Cal. Jun. 13, 2025)

The court denied a preliminary injunction against AG Bonta.

Continuing the First Amendment analysis: Content-neutral
regulations like the FAL and UCL “are generally subject to heightened scrutiny:
the government may impose reasonable restrictions on the time, place, or manner
of protected speech, provided the restrictions ‘are justified without reference
to the content of the regulated speech, that they are narrowly tailored to
serve a significant governmental interest, and that they leave open ample
alternative channels for communication of the information.’” This is weird
framing because false advertising does assess content; the court thus turns to
the commercial speech inquiry, which is the dispositive issue.

The court credited the AG’s evidence that COLFS uses the APR
statements in advertisements that are directed towards, and solicit, women to
become potential clients. The statements were “placed in a commercial context
and are directed at the providing of services rather than toward an exchange of
ideas.” COLFS’s use of the APR statements in its yearly fundraising gala and use
of patient stories about APR to solicit donations also provided a “powerful
economic motivation.” Plus, even though COLFS argued that it provided “numerous
free services,” including “free APR treatment,” it still accepts insurance and
payment for APR treatments from women who do have the ability to pay. That was
an obvious economic motivation, which COLFS didn’t address.

What about falsity/misleadingness? “Three district courts
have struck down state laws that required abortion providers, under threat of
criminal sanction, to inform patients about supplemental progesterone therapy
in language providers objected to for being untruthful or misleading.” Plus,
district courts have split on this situation: “a pro-life organization asking
for a preliminary injunction that would disallow an attorney general from
pursuing a hypothetical enforcement action against them based on APR-related
speech.”

Use of the terms “reverse” and “reversal”: These statements
are based on a theory that supplemental progesterone can “outcompete”
mifepristone to counteract or “reverse” the effects of mifepristone. Typically,
mifepristone acts as a “competitive binder of the progesterone receptor – it
binds to progesterone receptors at twice the avidity of progesterone itself,
thus blocking endogenous progesterone from acting to support a pregnancy.” But,
given high amounts of progesterone in pregnancy, mifepristone is still able to
work; adding more progesterone would be like “rain on a swimmer in a pool – the
swimmer cannot get more wet.” Rat studies were unhelpful because “there are
significant differences between rat and human pregnancies and progesterone’s
actions in each” and “[p]rogesterone receptors also vary widely between species
in their responsiveness to different molecules…”

A recent placebo-controlled study on nine people was
designed to examine the effects of progesterone supplementation, after
mifepristone administration, on the endometrium (the inner lining of the uterus
where implantation occurs) on nonpregnant persons, but the endometrial lining,
uterus, and hormonal milieu of a pregnant person are all “vastly different”
from those of a nonpregnant person.

Given that the science was “unclear on how exactly
supplemental progesterone reacts with mifepristone,” the court turned to the common
understanding of the word “reverse” to determine whether it accurately captures
what we do know about the effects of supplemental progesterone. According to
dictionary definitions, “reverse” means “to change the direction, order,
position, result, etc. of something to its opposite.” Or, “to turn completely
about in position or direction” or “to undo or negate the effect of (something,
such as a condition or surgical operation).” “Reversal” was the wrong way to
describe the evidence here. It was also plausible that “failing to continue
taking the second drug in the medication abortion regimen, misoprostol, may
result in continued pregnancy in some percentage of women who take
mifepristone[.]” (The court notes that there is no agreement on the baseline
here. In studies, continuing pregnancy rates ranged from 8% to 46%, depending
on the mifepristone regimen used, making it hard to conclude that supplemental
progesterone did any better than simply not taking the second medication.) Without
better evidence, “it would be at the very least potentially misleading to state
that supplemental progesterone can ‘reverse’ an abortion.”

Effectiveness statements: COLFS’s principal’s study purportedly
showed that progesterone increases the chances of a pregnancy continuing after
taking mifepristone. But some patients were screened by ultrasound for viable
pregnancies before joining the study, which biased the data towards pregnancies
already likely to continue. It also did not record how far along in her
pregnancy each patient was or how much progesterone each patient took – even
though mifepristone is less effective at terminating pregnancies as they
progress. And there were no controls in the study, despite treatment by 325
different medical providers. Thus, the study didn’t support the statement that APR
is “effective” in continuing pregnancies. [Reminder: the AG can go after
advertising for lack of substantiation.] “The Court finds that given the lack
of robust scientific study on this issue, statements on the effectiveness of
APR are potentially misleading.”

Likewise, there wasn’t enough evidence to conclude that the
side effects were limited/that APR was safe. “No study offered or used by COLFS
appears to track health or safety outcomes for the pregnant individual.” The
first and only randomized clinical study to attempt to test the safety and
efficacy of APR had to stop because of the serious “safety concerns” after 3 of
the 12 participants experienced “severe bleeding” after taking mifepristone
without misoprostol. Two of those three received a placebo; the third person
had been given progesterone. The “dearth” of evidence made it potentially
misleading to say that APR can only cause non-life-threatening side effects.

Birth defects: Again, the evidence was limited and tiny. “Given
the lack of scientific evidence on this specific question, the Court finds the
statements on birth defects following APR to be potentially false and
misleading.”

That APR has a 64-68% success rate was also inherently false
and misleading, given the defects in the supporting studies and the lack of
clarity about what percentage of COLFS patients would use which methods of
administration.

“Thousands of lives saved” statement: This claim was based
on the number of pregnant people who used APR and were confirmed by Heartbeat
International to remain pregnant at 13 weeks, plus the number of those who
started APR (but Heartbeat cannot confirm remained pregnant) multiplied by a
64% success rate. But there was no reason to generalize this statistic to all
women who started APR. These were potentially false and misleading.

Statements on non-standard situations (after 72 hours have
passed from the ingestion of mifepristone and t after taking the second pill of
medication abortion): “From the Court’s review, nothing from the expert
declarations submitted by COLFS even purports to support either of these
statements.” These statements were inherently misleading.  

Where the statements were inherently misleading, the court’s
analysis was done. Where they were only potentially misleading, the court
proceeded to apply Central Hudson. (In my view, this is the wrong
approach. The potentially misleading standard goes to the scope of a prohibition—if
a statement is potentially misleading, the question is whether it can be
communicated in a nonmisleading way, in which case the properly presented claim
can’t be prohibited entirely. But the particular way in which a defendant is
communicating a claim may be actionable/enjoinable even if the state would be
required to allow a properly qualified claim. Given the posture of the case, I
would expect this to be an issue for the state court.)

Under Central Hudson, the regulation of misleading advertising
by medical professionals directly advances a substantial government interest
(protecting medical consumers). And it directly advances the asserted
government interest and was not more extensive than necessary to serve that
interest. “AG Bonta is not aiming to limit the actual practice of APR. And
reproductive choices are not apart from consumer choices: women, in exercising
their reproductive rights, are also consumers who must be given the correct
information to make knowledgeable decisions for themselves.”

 

from Blogger http://tushnet.blogspot.com/2025/06/abortion-reversal-promoter-engaged-in.html

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it’s plausibly deceptive to sell “Kids” gummies identical to adult gummies

Posted on June 6, 2025 by rtushnet

Barrales v. New Chapter, Inc., 2025 WL 1584424, No.
2:25-cv-01171-HDV-KES (C.D. Cal. Jun. 4, 2025)

Plaintiff alleged that defendant’s Fiber Gummies were deceptively
labeled (1) because the claim “with 4g of probiotic fiber” was false because it
implies that each gummy contains that amount of fiber, when the serving size is
2 gummies; and (2) because the KIDS Organic Fiber Gummies falsely implies that
the product is specifically formulated or uniquely suitable for kids. She
brought the usual
California claims (including common-law claims).

regular gummies

Kids gummies

Compared to the regular gummies, the front label of the Kids
Gummies has the word “kids” with each letter a different color, but they have
the exact same chemical composition and consumption method as the Fiber
Gummies.

Defendant argued that the FDCA preempted the claim because
it expressly allows claims made by serving size. FDCA regulations allow “direct
statements about the level (or range) of a nutrient in the food” so long as
they “do not in any way implicitly characterize the level of the nutrient in
the food and are not false or misleading in any respect.” Here, the allegations
were that the nutrient content claims were false or misleading; thus, plaintiff
was seeking only to enforce a requirement identical to federal law and her
claims weren’t preempted.

Defendant argued that “with 4g[rams] prebiotic fiber” was
specifically allowed because it was based on the “reference amount customarily
consumed,” i.e., serving size, FDA-defined as the “maximum amount recommended,
as appropriate, on the label for consumption per eating occasion.” “But the
Ninth Circuit differentiates between claims that challenge and seek to alter
accurate statements about serving size and the nutrient content thereof, and
claims that a defendant’s ‘omission of supplemental or clarifying language’
misleads consumers.” The plaintiff wasn’t seeking to alter how the serving size
is calculated, nor how the fiber content of each serving is calculated.

Misleadingness was also plausible; a reasonable consumer
might not consult the back label. Believing that each gummy contains four grams
of fiber was “plausibly an unambiguous interpretation of the label based solely
on the language used.”

Likewise, it was plausible for a reasonable consumer to be
deceived by the “KIDS” label into thinking it was especially suitable for kids.
Contrary cases involved factual differences, e.g. a medicine whose “infant”
version came with a dropper for administration and its otherwise identical “children’s”
version had a cup. “Here, there is nothing, pharmacologically or otherwise,
that differentiates the Fiber Gummies from the Kids Gummies.”

 

from Blogger http://tushnet.blogspot.com/2025/06/its-plausibly-deceptive-to-sell-kids.html

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