using results from one product to tout another isn’t passing off, but could be false advertising

Ortho-Tain, Inc. v. Colorado Vivos Therapeutics, Inc., 2024
WL 3925408, No. 20 C 4301 (N.D. Ill. Aug. 23, 2024)

Ortho-Tain sued defendants (including a bunch of former
employees); I’ll focus only on the Lanham Act claims alleging that they falsely
took credit for favorable results achieved by Ortho-Tain’s orthodontic
appliance products used to treat various conditions such as sleep disordered
breathing. Basically, dentists working as paid presenters showcased case
studies of several pediatric patients who had achieved favorable results using
Ortho-Tain’s orthodontic appliances. Defendant Vivos sponsored similar
presentations, as well as a “parent webinar,” using the same exact case studies.
The slides displayed the name “Vivos” and the presenters attributed the
favorable results to Vivos’ products, not Ortho-Tain.

This could not be brought as a §43(a)(1)(A) claim because of
Dastar. There was neither forward nor reverse passing off of the devices
themselves, only of the results: “the connection between the favorable results
and appliances is an intangible idea or concept.” It wasn’t about the source of
the tangible good sold in the marketplace.

But (a)(1)(B) also exists! The presentations were plausibly “commercial
advertising or promotion” even if described as “seminars” and “continuing
education courses.” The Seventh Circuit has said that face to face
communication isn’t “commercial advertising or promotion” [though query whether
that makes any sense if there’s a repeated script]. It sufficed at the pleading
stage for Ortho-Tain to allege that the Vivos “course” was presented via online
broadcast and live to in-person attendees on at least 26 occasions; another
event was a multi-date online recorded presentation that thousands of medical
professionals registered for; and the parent webinar was made available online.

And Ortho-Tain plausibly alleged falsity, or at least
misleadingness. “If not explicit, the clear inference to be drawn by attendees
was that the case studies showed results achieved by Vivos’ products.” In
addition, and more controversially, Vivos statements about creating
“revolutionary technology” and the “first-ever hope for a lasting solution to
the problem of sleep apnea” were not “mere puffery.” “In the context of a
scientific field made of up highly educated individuals, it is reasonable to
infer at the pleading stage that ‘revolutionary’ and ‘first-ever’ carry
specific meanings as to the novel nature or method of the appliance being
described.”

from Blogger http://tushnet.blogspot.com/2024/08/using-results-from-one-product-to-tout.html

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Vizzy gets no kick from champagne, and that’s ok

West v. Molson Coors Beverage Co. USA, No. 23-cv-7547 (BMC),
2024 WL 3718613 (E.D.N.Y. Aug. 7. 2024)

Plaintiffs alleged that Molson deceived consumers into
thinking that Vizzy contained champagne (used as a generic term throughout!)
when it didn’t. The court found the allegations implausible, using what may
become a popular framework recently distilled from the cases about how
reasonable consumers think. [This framework isn’t all that bad, but I do note
that it is not based on any qualitative or quantitative evidence about how
consumers actually think except insofar as a poll of chambers might be
qualitative evidence.]

Vizzy costs $17.99 per 12-can box and looks like this:

ingredients list with “alcohol”

First, for standing, plaintiffs didn’t need to allege a
price premium over a comparable product. “[C]onsumers suffer an injury in fact
when, in reliance on alleged misrepresentations, they buy a product that they
otherwise would not have purchased. I fail to see a meaningful distinction
between a price-premium injury and a but-for purchasing injury.”

Nonetheless, it was unreasonable to think Vizzy would have
champagne, based on five considerations: “(1) the presence or absence of
express representations, (2) context of the alleged misrepresentation, (3)
etymological analysis, (4) allegations about competitor products and (5)
consumer survey evidence.”

There were no express representations about champagne,
weighing against plausibility.

Etymology: a mimosa is a champagne drink, or at least a sparkling
wine drink.  Molson argued that the
phrase “hard seltzer” modified the word “mimosa,” which makes clear to
consumers that the beverage is not a mimosa at all.

But what is a hard seltzer? By long tradition, “hard”
connotes “alcoholic,” and “seltzer” means “sparkling water.” “The alcohol in a
generic hard seltzer could theoretically be any type of consumable alcohol,
including champagne. Although defendant’s proffered definitions do not identify
the types of alcohol commonly used in hard seltzer, other definitions specify
fermented cane sugar and malted barley – not champagne or any other type of
wine – as the usual suspects.” Overall, “mimosa” “strongly suggests” the
presence of champagne, and “hard seltzer” doesn’t exclude it. So etymology “slightly”
favored the plaintiffs.

“But the full context of the packaging, viewed through the
eyes of a reasonable consumer, sharply reduces any ambiguity caused by the
etymological association between mimosas and champagne.” The court rejected
plaintiffs’ argument that the tagline “Brunch Just Got Real” reinforced the
champagne connection.

This was basically a familiar issue: “whether a food or
beverage ought to include ingredients associated with its purported flavor, or
whether the presence of the flavor itself, regardless of its source, is
sufficient to make the description accurate.” We also need to know how
consumers think about new/unfamiliar products: product categories “act like
lenses, modifying how consumers see other aspects of those products and form
their reasonable expectations about them.”

True, many cases say that, on a motion to dismiss, “a
federal trial judge, with a background and experience unlike that of most
consumers, is hardly in a position to declare” what consumers know. But it is
proper to consider whether a statement would deceive a reasonable consumer,
which requires considering “what reasonable consumers know about the products
they purchase.” [This is usually resolved by saying that some situations
can be resolved as a matter of law, but not all.]

Reasonable consumers would read “mimosa hard seltzer” together,
and there were no allegations that hard seltzers ordinarily, or even
occasionally, contain champagne. “Because a champagne-based hard seltzer is not
the norm, a reasonable consumer would expect that if a hard seltzer had
champagne in it, the packaging would make that fact abundantly clear.” Any
ambiguity could be resolved by looking at the ingredient list, which makes no
reference to champagne, only to “alcohol.” “[G]iven plaintiffs’ allegation that
consumers actively seek out drinks with champagne, in addition to their failure
to allege hard seltzers are ordinarily (or ever) made with champagne, it would
be odd that Vizzy would have spiked its seltzer with champagne without making
that abundantly clear.” A reasonable consumer would have “serious doubts” after
reading the ingredients. Similarly, there were no pictures of mimosas,
champagne, or grapes anywhere on the packaging. “Vizzy’s direct references to
orange juice, juxtaposed against its lack of reference to champagne, should
make the confused consumer think again: if the product contained champagne, why
not say so?”

Molson argued two additional factors: Vizzy’s allegedly comparatively
low price and the location of purchase (stores prohibited by NY law from
selling beverages containing wine). The latter just didn’t work: “It is
unreasonable to assume that an ordinary consumer has a sufficiently intimate
familiarity with the New York Alcoholic Beverage Control Law to know that
bodegas and grocery stores cannot sell wine.” The former was more persuasive: “Although
it is possible that a seltzer made with a particularly inexpensive champagne
could sell at the same price point as those made with cheaper forms of alcohol
(approximately $1.50 per 12-ounce can), all else equal, a reasonable consumer
would assume that a champagne-based seltzer would sell at a price premium.”

The court also weighed the interest in innovation: “Lest we
stifle development and distribution of innovative forms of consumer products in
the name of avoiding consumer ‘deception,’ we have to give manufacturers
reasonable leeway in marketing their products without handcuffing them with
lawsuits.” This is a consideration that only fits into a normative conception
of the reasonable consumer, not an empirical one: manufacturers should be able
to push the definition of terms because that gets us cheaper goods. It has
nothing to do with whether people would be materially deceived. That doesn’t
mean it’s wrong, but courts that go back and forth between normative and
empirical concepts of what’s deceptive to a reasonable consumer become hard to
predict.

The court cautioned that it wasn’t endorsing trickery, but rather
“tastes like” marketing. “If the manufacturer’s advertising is wrong, and it
does not taste like what the label says it tastes like, then the consumer is
not going to buy it again and the product will fail. The market is a much more
efficient check on that kind of representation than lawsuits.” [GI proponents should
strongly object to this argument.]

 

from Blogger http://tushnet.blogspot.com/2024/08/vizzy-gets-no-kick-from-champagne-and.html

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9th Circuit orders district court to reconsider statutory damages award to NY class under NY law

Montera v. Premier Nutrition Corporation, — F.4th —-, 2024
WL 3659589, No. 22-16375, 22-16622 (9th Cir. Aug. 6, 2024)

The key legal issue here arises from the quirk that NY bans
GBL §§ 349 and 350 class actions in state court, but they can be brought in
federal court. Premier sold Joint Juice for treating/preventing joint pain; a
jury found it liable to a consumer class for false advertising under NY law;
and the district court awarded statutory damages to the class, but cut them by
over 90%. The court of appeals affirms liability/class certification and remands
for recalculation based on an intervening appellate decision, as well as reversing
the grant of prejudgment interest—overall, seems like a win for Montera.

The evidence showed that Premier targeted Joint Juice ads to
people who suffer joint pain as a result of osteoarthritis. The packaging used
the Arthritis Foundation logo and name, and made claims such as “Use Daily for
Healthy, Flexible Joints” and “A full day’s supply of glucosamine combined with
chondroitin helps keep cartilage lubricated and flexible.” On liability,
“Montera introduced peer-reviewed, non-industry-funded studies finding that
Joint Juice’s key ingredients, glucosamine and chondroitin, have no effect on
joint function or pain; Premier maintained the product’s efficacy based on
industry-funded studies.” Premier was aware of the no-effect studies; in 2011,
the brand director for Joint Juice wrote, “there is no scientific evidence for
chondroitin at 200 mg.” When Premier considered running its own study, its
president wrote: “if poor—don’t publish.”

Montera’s expert testified that
92.5 percent of respondents to his study “believed that the product packaging
was communicating one or more of [the packaging’s claimed] joint health
benefits,” and 56% of respondents said that Joint Juice’s claimed joint health
benefits “were material to their purchase decisions.” Montera also introduced
Premier’s internal customer survey in which 96% of those surveyed said they
were managing chronic pain, 75% said they bought Joint Juice because they have
joint pain and thought the drink would help them, and 56% said they had been
diagnosed with arthritis. In Premier’s expert’s survey, 21.5% of respondents
said that information on Joint Juice’s packaging influenced their purchase
decisions, and 32.3% said they had generally heard about the benefits of
glucosamine.

GBL §§ 349 and 350 require courts to award the greater of
actual damages or statutory damages of $50 or $500, respectively. Montera
sought $550 per unit sold in statutory damages, totaling over $91 million. The
district court, though, thought that would violate due process and awarded
statutory damages of $50 per unit sold—the amount available under §
349—totaling roughly $8.3 million, along with roughly $4.5 million in
prejudgment interest.

The court of appeals rejected Premier’s argument that there
could be no misleadingness as a matter of law because it possessed substantiation
for its claims. But deceptiveness is a question of fact, and the jury
appropriately considered the studies introduced by both sides. This wasn’t a
case where the plaintiff’s interpretations were implausible or unrealistic.

The court of appeals also rejected Premier’s argument that it
was entitled to an instruction on safe harbors: Section 349 provides that “it
shall be a complete defense” to liability if a challenged practice is “subject
to and complies with the rules and regulations of” a federal regulatory agency.
Premier argued that it complied with the FDA’s supplement regulations, which
permit structure/function claims as long as those aren’t disease claims. But,
to comply with this regulation, “a manufacturer must notify the FDA within 30
days of first marketing a supplement that the product’s label includes a
qualifying claim, and certify that the claim is substantiated, among other
requirements.” Premier didn’t dispute that it failed to comply with the 30-day
notice—it began making the claims at issue in 2009 but didn’t notify the FDA
until 2012. There was no evidence that the FDA excused its failure to comply or
that the 2012 notification cured the earlier noncompliance. Thus, the district
court did not err by declining to instruct the jury on the safe harbor
provision.

Injury: The district court instructed the jury that the
class was “injured by purchasing Joint Juice if it was valueless for its
advertised purpose.” The jury found, by special verdict, that the class was
injured by purchasing Joint Juice, and it awarded damages equal to the total
amount spent on Joint Juice during the class period based on average purchase
price. It thus the jury declined to reduce the damages amount on account of
Joint Juice having any residual value for hydration/containing vitamin C apart
from its advertised purpose.

NY law does not require a price premium or a physical
injury. It requires only, as here, that class members didn’t get what they paid
for: they bought a product that was advertised to improve joint health but in
reality did not.  Indeed, “this case
arguably takes the price premium theory to its logical endpoint: the jury found
that Joint Juice was entirely ‘valueless for its advertised purpose,’ so the
entirety of the purchase price could be viewed as a price premium.” Adopting
Premier’s view would “immunize from liability the age-old deceptive tactics of
the ‘grifting snake oil salesman,’ which spurred the adoption of some of the
earliest consumer protection laws in this country.”

The court next rejected Premier’s argument that Montera did
not show that each one of the class members’ injuries were caused by the
statements on Joint Juice’s packaging. But that’s not the rule in NY. It is
emphatically the law that reliance isn’t required to show causation under GBL
§§ 349 and 350. New York uses “an objective definition of deceptive acts and
practices.” Liability “turns on what a reasonable consumer, not a particular
consumer, would do.” “Because the test is objective and turns upon the
reasonable consumer, reliance is not at issue, and the individual reason for
purchasing a product becomes irrelevant and subsumed under the reasonable
consumer standard, i.e., whether the deception could likely have misled
someone, and not, whether it in fact did.” As a result, “Rule 23(b)(3)’s
predominance requirement poses no barrier to class treatment of [§ 349] claims
because it’s unnecessary to make any individualized inquiry into what each
plaintiff knew and relied on in purchasing his or her [product].”

The court also rejected challenges to certain evidentiary
rulings at trial. Montera offered, among other things, “a list of Google
AdWords that Premier purchased to market Joint Juice, many of which related to
arthritis, and a television commercial featuring a celebrity recommending Joint
Juice to help joint stiffness.” Although not every NY purchaser would have seen
these, the evidence was not irrelevant; it was relevant to show the message
conveyed by the packaging, including that the packaging was meant to convey a
disease claim, not a structure/function claim. The trial court also properly
instructed the jury to limit its analysis to the packaging.

Likewise, it wasn’t improper to admit a letter Premier’s tax
advisor sent to the California Department of Resources Recovery and Recycling
in 2010. The letter argued that Joint Juice should not be subject to a
five-cent bottle deposit tax because it did not qualify as a “beverage” under
California law, but rather was a “medical supplement” and “over-the-counter
medication.” The letter also stated that “the only reason to purchase Joint
Juice® supplement is for the medicinal value of the glucosamine and chondroitin
it contains.” [On the one hand, ouch; on the other, this is glaringly obvious.]
Again, this was relevant to the structure/function versus disease claims
argument, and references to California law were not unduly confusing.

Likewise, Montera’s counsel’s arguments were not unduly
inflammatory. Suggesting that Premier was “prey[ing] on the vulnerable” was
allowed because counsel “is allowed to argue reasonable inferences based on the
evidence,” and counsel’s argument that “Joint Juice set out to target people
who suffer from arthritis” was consistent with the evidence of Premier’s
marketing strategy. Counsel’s argument that Premier used “paid hacks and
certified [q]uacks in the articles that they publish” was not “untethered from
the record; it was consistent with evidence about Premier relying on
industry-backed studies, evidence that some of the sponsoring companies refused
to release the underlying data for external review, and the note written by
Premier’s president not to publish the study Premier contemplated if it yielded
unfavorable results.” References to the company’s size/consumers banding
together were limited and not inappropriate as a response to defense counsel’s
suggestion that Premier was a small company.

Statutory damages: The relevant statutes aren’t explicit
about whether statutory damages are calculated on a per-person or per-violation
basis. The district court, looking at federal cases (remember, there can’t be
state cases on this), concluded that the statutory damages should be assessed on
a per-unit basis. The court reasoned that GBL §§ 349 and 350 create private
causes of action for persons “injured by reason of any violation” of either
statute. “In our view, the plainest reading of that phrase is that a cause of
action arises for each violation. Here, a class member suffered a violation
each time they purchased a unit of Joint Juice bearing a deceptive label,
whether packaged in a six-or thirty-pack, and New York law entitled them to
receive either actual or statutory damages for each violation.” The history and
consumer protection purpose of the statutes supported this reading, including
an increase from $50 to $500 for § 350 because “[c]urrent limits are too low to
be effective.”

The court noted that, given that class actions are not
allowed in state court, “the Legislature was surely aware that the statutes’
deterrent function would not be accomplished by aggregating statutory damages
across a large number of plaintiffs.” Individual filing fees were at least $400
when NY amended the law; using a per-person calculation would mean that “a
consumer deceived into making several purchases of the same low-cost item might
have to pay $400 in up-front filing fees to potentially recover $550 in
combined statutory damages under §§ 349 and 350. We are not persuaded that the
Legislature would have considered that such a meager incentive would accomplish
the Legislature’s express goal of deterring statutory violations.”

So, does a $91 million statutory damages award violate due
process? Wakefield v. ViSalus, Inc., 51 F.4th 1109 (9th Cir. 2022), concerned a
company that placed over 1.8 million robocalls in violation of the Telephone
Consumer Protection Act (TCPA). The TCPA’s statutory penalty is $500 “for each
[ ] violation.” The district court ordered the defendant to pay $925.2 million.
Instead of using the factors the Supreme Court has applied to common-law torts,
the 9th Circuit mandated the use of seven factors to decide “when an
award is extremely disproportionate to the offense and ‘obviously’ unreasonable”:
“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 violation, and 7) the circumstance of each case.” This was
intervening precedent because of how long 9th Circuit cases take. [The
underlying precedent is Lochner-era caselaw letting courts strike down
statutory damages as excessive as a matter of substantive due process. Judicial
supremacy over legislators strikes again, I guess. Compare how courts treat
this argument in copyright cases.]

The court thus remanded without expressing an opinion about
what would be unreasonable. The district court previously considered the NY
legislature’s goals in barring aggregate damages in class actions, and
concluded that such an intent supported reducing the total damages award. On
remand, it should also consider the legislature’s goals for deterrence and
compensation in enacting GBL §§ 349 and 350.

Prejudgment interest was unwarranted because the statutory
damages award wasn’t compensatory; it exceeded the jury’s actual damages award
of roughly $1.5 million, and thus awarding both statutory damages and
prejudgment interest would constitute a windfall.

from Blogger http://tushnet.blogspot.com/2024/08/9th-circuit-orders-district-court-to.html

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FDCA doesn’t preclude lawsuit based on allegedly false claims about compounding drugs

Pacira Biosciences, Inc. v. Nephron Sterile Compounding
Center, LLC, No. 3:23-5552-CMC, 2024 WL 3656489 (D.S.C. Jul. 15, 2024)

Pacira, which sells non-opioid pain management products, including
Exparel, sued Nephron for false advertising. Exparel is “bupivacaine suspended
in multivesicular liposomes,” and is injected at a surgical site during or
shortly after surgery to manage and reduce post-surgical pain.

Nephron allegedly operates a compounding pharmacy that
compounds BKK, comprised of ketorolac, ketamine, and bupivacaine in a syringe
for combined use, and RKK, a compounded drug consisting of syringes of
ketorolac, ketamine, and ropivacaine for combined use.

Compounded drugs are not FDA-approved, but may be made and
sold under certain circumstances, including rules about outsourcing facilities,
which may not compound using bulk drug substances unless the bulk drug
substances are on a relevant FDA list of clinical need/shortage drugs.

Pacira alleged that the production of BKK and RKK was not covered
by the FDCA’s protection for compounded drugs because (1) BKK and RKK do not
appear on the FDA’s drug shortage list, and (2) the bulk drug substances from
which BKK and RKK are made do not appear on the FDA’s list of bulk drug
substances for which there is a clinical need. But, of course, the FDCA may not
be enforced by private parties, so Pacira turned to the Lanham Act.

Thus, Pacira alleged that defendants “have engaged in a
sustained campaign to promote their drug cocktail products as safe and
effective opioid alternatives through demonstrably false and misleading
advertisements – including blatantly false statements that their drugs are
safer and more effective than EXPAREL.” They also allegedly claimed or implied
that BKK and RKK compounds have been approved by the FDA and/or subjected to
clinical studies and trials.

Caption: Nephron is fully inspected and approved by the FDA!

Footer with FDA approved logo

Nephron argued that its website was not false: The allegedly
deceptive statements, a “Nephron is fully inspected and approved by the FDA!”
banner and “FDA APPROVED” logo at the foot of Nephron’s website appeared in the
same place on every page of Nephron’s website, including its landing page. It
argued that, in context, the banner and footer, which included other logos,
such as “MADE IN U.S.A.,” obviously referenced only Nephron, and Nephron is, in
fact, a registered 503B outsourcing facility both certified and regularly
inspected by the FDA. Anyway, it argued, implicit misrepresentations of FDA
approval weren’t actionable.

Pacira responded that (1) the FDA doesn’t approve facilities,
(2) the statements would be attributed to BKK and RKK’s FDA approval, (3)
customers looking for information on those specific products wouldn’t
necessarily peruse every page to see what repeats, and (4) “Made in the USA” is
the kind of statement that consumers would attribute to the products, not
the facilities, so the footer logos encouraged confusion rather than diminished
it.

Despite the plausibility of these arguments, the court
adopted the rule that “the law does not impute representations of government
approval … in the absence of explicit claims.”

example of product benefit claims for pain, complications, etc.

slide specifically claiming superiority to Exparel and identifying it as “competition”

Allegedly false claims to hospitals and providers in
presentation and other marketing materials about the efficacy, safety, and
superiority of BKK and RKK: First, it was plausible to attribute those to Nephron
because it hired the person who created the slide show and conducted the
presentations. He allegedly “not only developed advertisements and marketing
materials for BKK, but he also actively participated in sales pitches and other
promotional events nationwide to sell.” This was enough at the pleading stage
to impute his actions to Nephron. However, the same “implicit misrepresentation
of government approval” rule applied to FDA-approval-related claims. But Pacira
also alleged that claims of improved patient safety, satisfaction, recovery
time, outcomes, and patient experience were false and misleading. It also
alleged that Nephron’s superiority claims, including that BKK and RKK are more
“efficacious for long term analgesia” and “post operative pain” than Exparel
were literally false. At this stage, the allegations were sufficient as to the
safety, efficacy, etc. statements.

footer claiming that Nephron is a 503B outsourcing facility

503B outsourcing facility claim as part of Nephron logo

Somewhat puzzlingly to me, the court also allowed claims
based on the idea that the logo indicating Nephron is a 503B outsourcing
facility conveys the false impression that BKK and RKK products are produced by
a 503B-compliant facility. A facility isn’t compliant if it compounds drugs it
shouldn’t, and Pacira alleged that this was the case. “Nephron’s claim it is a
503B outsourcing facility, even if true, could falsely imply BKK and RKK
satisfy the requirements of § 353b, if, indeed, they do not.” Pacira also
alleged reasonable consumer reliance on the misrepresentation by alleging that,
“[o]n information and belief, healthcare providers and consumers have
reasonably relied on Defendants’ false and misleading statements when deciding
to purchase BKK or RKK instead of EXPAREL” and that if they’d known the truth,
they wouldn’t have bought the drugs.

What about “commercial advertising or promotion”? Nephron
objected that Pacira didn’t define the relevant market or allege to whom the
presentations were disseminated. First, the statements were commercial speech
promoting Pacira’s products that were provided to a relevant market –
healthcare providers. But were such “product overview” statements in presentations
just medical education? No; “it would strain credulity to find Nephron did not
intend to turn a profit convincing its target audience to purchase BKK and RKK.”

Pacira sufficiently alleged injury.

Were the Lanham Act claims precluded by the FDCA? Nephron
argued that it could only be found to be falsely advertising if the court
interpreted the FDCA and determined that it was violating the compounding
regulations, but that interpretation/determination is for the FDCA. [Side note:
does this argument work in an age of lack of deference to agencies? Especially
if the question is what conduct satisfies the legal standard set out in the law?
Without Chevron, is a decision really committed to the FDA, or to a
court? I think I just found an interesting student note topic.]

Pom Wonderful LLC v. Coca-Cola Co., 573 U.S. 102 (2014), provides
the governing law. [This isn’t really correct—Pom involved a deception
theory that didn’t rely on the FDA’s rules and Coca-Cola argued that its
compliance with FDA’s rules precluded the deception theory. Here, the deception
theory does rely on the FDA’s rules.] The court here relied on Pom’s
policy-based reasoning: The FDA is for health and safety, not primarily
consumer protection; the Lanham Act is primarily about consumer protection. The
FDA lacks expertise in assessing whether people are deceived. [Again, while I’m
substantively in sympathy with Pacira on the policy, that may be true—but the
FDA is the expert on whether compounding facilities are complying with
its rules, which is factual key to this specific theory of deception.] Thus,
while characterizing defendant’s conduct as “illegal,” “unlawful,” and posing
“significant risks to patient safety and health” in the complaint was “overzealous”
because it could “implicate the need for enforcement by the FDCA,” the gravamen
of Pacira’s allegations were falsity and misleadingness and resulting harm to
Pacira.

from Blogger http://tushnet.blogspot.com/2024/08/fdca-doesnt-preclude-lawsuit-based-on.html

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Lanham Act unclean hands defenses are hard to win

World Nutrition Inc. v. Advanced Enzymes USA, No.
CV-19-00265-PHX-GMS, 2024 WL 3665360 (D. Ariz. Aug. 6, 2024)

The parties—here WNI and AST—sell enzyme supplements and sued
each other under the Lanham Act, and both prevailed on their affirmative claims
and got disgorgement. The claims generally related to enteric coating (that is,
its absence despite the parties’ representations), though WNI also falsely
advertised certain certifications. WNI got a permanent injunction. WNI’s award
of disgorged profits was larger than AST’s, so AST was ordered to pay WNI
$1,827,651.68.

What about unclean hands? This requires a defendant to show
by clear and convincing evidence (1) “that the plaintiff’s conduct is
inequitable,” and (2) “that the conduct relates to the subject matter of its
claims.” Of relevance to dueling false advertising claims: “Factual similarity
between the misconduct that forms the basis for an unclean hands defense and
the plaintiff’s allegations in the lawsuit is not sufficient.” The defense only
protects those who “have acted fairly and without fraud or deceit as to the
controversy in issue.” And, in the Lanham Act context, “fraudulent intent” is
required. Plus, unclean hands isn’t automatic even then; it depends on what
justice requires.

Given this high mountain, AST didn’t show that it was
protected by WNI’s unclean hands. AST falsely advertised with literally false
claims about enteric coating. WNI’s claims of a buffer-enteric coating
and manufacturing compliance were also literally false, but AST failed to show
that WNI’s products were not enterically coated. If AST had proved that WNI’s
claim its products had an enteric coating that was 100% effective was false,
the court would have reached a different result on this part of the inquiry,
and would rule that justice was best served by offsetting damages. “The fact
that AST ultimately owes WNI damages is a reflection of two things: (1) each
party’s ability to prove damages and (2) the fact that AST earned more profits
while misleading consumers.”

from Blogger http://tushnet.blogspot.com/2024/08/lanham-act-unclean-hands-defenses-are.html

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Court accepts survey with disclaimer control that causes 38% confusion

 Another ruling in the PNC v. Plaid case:

PNC Financial Services Gp. v. Plaid Inc., 2024 WL 3691607,
No. 2:20-cv-1977 (W.D. Pa. Aug. 7, 2024)

Daubert motions for this case. I’ll only discuss the
stuff I find interesting.  

Kivetz was PNC’s survey expert. The survey showed
respondents a 22-second video clip simulating the user flow within fintech app
Venmo from 2019: the Venmo home screen that an already-registered Venmo user
would see when they opened the app, then a cursor moving between the Venmo
screens. The survey then showed a series of static screens that a consumer
would see when connecting a bank account to their Venmo account, including the
Plaid Link consent, institution select, and credentials panes. There were
limited interactive elements on the screens.

The test group for this survey was shown the Plaid user
interface that allegedly appropriated PNC’s marks. The control group was shown
a “workup” of what a “Plaid branding only” user interface would look like.

Test stimulus, L; control stimulus, R

Richard Craswell’s work on controls in surveys remains a must-read in this area: choosing a noninfringing control is often very important because it can determine the amount of net confusion. One particularly interesting point here: the “control” shows very high levels of confusion (38%), which would ordinarily seem like a lot. PNC would ordinarily have a strong incentive to argue that disclaimers don’t work. But that would run up against a strong preference for truthful speech, especially if the alternative seems to be that PNC can control what apps its customers can use. There’d be some obvious competition law problems with that as well as nominative fair use (what Plaid argued before PNC dropped the argument that the current screen, which is not entirely unlike the control, infringed). Craswell makes the argument that there is an implicit cost-benefit analysis in control selection: we’re asking what’s the least confusing option that’s worth it. If some confusion is irreducible but we still want the activity to continue, that’s the level of confusion we should accept. That could indeed justify a control with 38% confusion, but that may not be something many TM owners want to admit. And it calls into question the broad definition of “affiliation” confusion that courts have adopted–often by assuming that “affiliation” in the Lanham Act means whatever consumers think it means in response to survey questions, although it could reasonably be read more strongly or consumers could be educated/asked for their definitions thereof.

Anyway, after the survey showed the stimuli, it then asked: “which company provides this credentials screen,” “does the company that provides this credential screen have a business affiliation or connection with another company or companies,” “with which other company or companies does the company that provides this credentials screen have a business affiliation or business connection,” and “did…the company that provides this credentials screen receive approval or sponsorship from another company or companies?”

PNC’s expert Kivetz concluded that 79% of the participants in the test group were confused into believing that the company that provides that credentials screen either (1) was PNC (75%); (2) has a business affiliation or connection with PNC (5.9%); and (3) received approval or sponsorship from PNC (5.4%). (Id. at 59–60). In contrast, participants in the control group experienced a confusion rate of 38.1%. The net confusion rate (the difference between the two confusion rates) was 41.3%.

Plaid challenged the survey based on the control, the lack of an interactive process in the survey, and the failure to limit the survey to PNC customers. The sample issue didn’t merit exclusion; the survey included potential PNC customers by asking potential respondents whether they engage in online banking and geographically limiting the population to states in which PNC had a physical branch location. Anyway, any effect of the allegedly skewed sample was “speculative,” since the broader question was about “whether the average consumer who connects a bank account to cash payment and investment account fintech applications would be confused by the use of a given set of marks (PNC’s) on Plaid’s user interface(s) during the connection process.” So too with the static visuals—that increased survey completion, and if respondents had actual options they might have tried to reach a different bank’s credentials login screen. The survey explained to respondents what was happening; they could click on and read the Plaid privacy policy before going forward.

The control group argument gave the court more pause. The control screen “displayed a disclaimer that was not present in the Plaid Link user interface, at least at the later stages of a consumer’s interactions with Plaid Link.” This could have been “so visually different (and perhaps, so obviously affiliated with Plaid) from the PNC institutional and credentials login screens that it diluted the confusion results on that side of the survey.” But the control was also similar, though not identical, to the credentials screen Plaid actually uses today. This was a question of weight, not admissibility. The disclaimer left nearly 2/5 of respondents confused, which undermined the assertion that the control wrongly pushed people away from PNC.

However, the expert’s opinion on “tarnishment” was excluded since it relied on non-record evidence of “bad acts” by Plaid and he only speculatively linked that to PNC, rather than showing a basis relying on a reliable process or analysis.

Plaid’s consumer confusion expert, Dhar, used a “consumer journey approach,” designed to mimic what users would be seeing when deciding whether to buy or use a given product or service. He opined that users were unlikely to be confused by Plaid’s use of PNC’s marks, especially given consumers’ ultimate goal of connecting their bank accounts to a given fintech app. He also opined that any confusion wasn’t material, based on internal Plaid testing, “which purportedly shows that the effect of the usage of bank marks on the institutional login and credentials login screens had minimal impact on consumer conversion (that is, minimal effect on whether consumers entered their banking information into the fintech app via Plaid Link).”

The court declined to exclude Dhar’s testimony. He provided context that might assist a jury, opining that “by the time a given user encountered a Plaid Link screen within a fintech app, the decisions to (1) download the app, (2) use it, and (3) link a bank account were likely already made,” meaning that confusion was unlikely. “While an expert’s application of their own experience and of principles in the field may not be as empirically rigorous as an experiment or a survey, FRE 702 does not bar the admission of more ‘qualitative’ expert testimony.” His methodology was not novel or pseudoscience; the consumer journey approach is “well recognized” in the field of consumer behavior.  

He wouldn’t be permitted to testify on the ultimate likelihood of consumer confusion, but he could testify as an expert about how the considerations outlined in his report impact the applicable factors: “the care consumers take in using fintech apps and Plaid Link and/or the relationship of Plaid Link and PNC in the minds of consumers.”

The court also allowed Dhar’s materiality opinion.  “Plaid ran a series of internal tests and studies that addressed the impact of Plaid’s use of bank logos in its user interface, and the notion that the data were unreliable solely because the data came from Plaid is inaccurate.” He explained the internal testing in his expert report, with detailed descriptions, and he applied scientific principles to the data, including in his visualizations. “Plaid was experimenting with different institutional selection and credentials panes for years, seeking to measure conversion rate, i.e., whether users would be more inclined to enter their banking information depending on the presentation of the given user interface. These tests are squarely applicable to one of the ultimate merits issues in this case: whether consumers were more or less likely to enter their banking credentials when Plaid used PNC’s marks.”

The court allowed PNC’s damages expert’s disgorgement analysis, though not his “contributed capital” damages theory, which was based on the idea that Plaid’s use of PNC’s marks constituted a forced investment in Plaid by PNC. That latter had issues of fit and reliability.

“PNC never made an investment in Plaid, and the notion that the fact finder in this case should view a portion of Plaid’s enhanced valuation over time as directly and proportionally attributable to the connections that Plaid made between PNC consumers and fintech apps during a one-year span in Plaid’s early days in a straight-line fashion is the kind of speculative opinion, unmoored from scientific rigor, that courts are to exclude under FRE 702.”

The disgorgement opinion, though, was fine because, given the statutory burden-shifting, it was ok to assume that 100% of PNC conversions were attributable to Plaid’s use of PNC’s marks.

Plaid’s damages expert, like its consumer expert, relied on Plaid’s internal testing suggesting that PNC customers using Plaid Link to connect their bank account to a fintech app “would still have connected their PNC account…95 percent to 99 percent of the time,” regardless of whether PNC’s marks were displayed. It was ok for the expert to rely on studies she didn’t conduct, especially a study that perfectly fit a key question here.

Duelling marketing experts also mostly got in. PNC’s marketing expert opined that Plaid benefited from the usage of PNC’s marks and that Plaid’s usage of PNC’s marks harmed PNC’s brand. His report purported “to demonstrate how PNC built its brand, how it continues to invest in its brand, how valuable its brand is, how Plaid utilized PNC’s brand (and the brands of other banks), and how that usage impacted PNC’s brand.” The court excluded his opinion regarding the general risk of harm to PNC’s brand from Plaid’s use, but not the rest of it. (Given that 2019 is now several years in the past, presumably there’s also real-world data about whether the brand was harmed.)

It was ok to use a qualitative analysis of “bad press” that allegedly came about from Plaid’s screens’/CSRs’ criticism of PNC. This went to the claim that required evidence of damage to goodwill (that is, false advertising). But his opinion that the mere use of PNC’s marks, in and of itself, put PNC’s brand at risk wasn’t reliable; it was speculation rather than expert analysis.

Beyond that, it also appears to the Court to be nothing more than an argumentative truism, akin to saying that a person lending her car to another necessarily places all of the assets of the lender at risk in the event the loaned car becomes involved in an accident. Adding the patina of an expert opinion to such a truism does not aid the finder of fact and is therefore unnecessary, as that is an argument that PNC can make without relying on expert testimony. Under FRE 702, PNC has not met its burden in demonstrating the reliability of this particular opinion. This specific aspect of Dr. Carpenter’s testimony—that Plaid’s use of PNC’s marks inherently placed PNC’s brand at considerable risk—is therefore excluded.

Plaid’s marketing expert rebutted PNC’s experts. It was also ok for him to use qualitative analysis.

PNC also offered proposed expert testimony on Plaid’s cybersecurity in “seeking as part of its damages out-of-pocket costs incurred [by PNC] from fraud on PNC customers that used Plaid Link.”  But the expert was unable to link the use of the trademarks to that harm, as opposed to Plaid’s retention of customer authentication information. Here, it mattered that the record showed that “at least some meaningful portion of PNC customers would have used Plaid Link even without visibility of PNC marks.” And Plaid’s central causal contribution was allegedly storing PNC customer data and then, critically, “auto populating” the “challenge question” authentication credentials that a PNC customer previously entered into the Plaid Link screens. That just wasn’t sufficiently tied to the trademark claims. The experts were unable to quantify or differentiate the harms to PNC that were caused by the marginal customers who might have been driven by the use of the marks.

However, if Plaid relied on its own cybersecurity processes or questioned those of PNC, expressly or by implication, the court might allow an expert to opine on “the mechanics of how authentication credentials operate generally and any vulnerabilities such would foster.”

Also, PNC would be allowed to use lay witness testimony that it contended demonstrates that “Plaid’s true purpose in using PNC’s marks was not to ease consumer use in connecting to fintech apps but was instead to increase Plaid’s data repository of consumer banking information for its own purposes.” And PNC would be permitted via lay witnesses to state generally what motivated it to alter how it dealt with Plaid, and how/why its limitations on PNC customer access to fintech apps via Plaid Link came to be, since that’s relevant to intent. “Lay or expert testimony as to who caused/did not cause the 2019 Cybersecurity Event, and the details ‘under the hood’ and/or explanations of that Event, will not be permitted, as such would readily lead to substantial jury confusion in light of the actual claims/defenses in this case and would likely generate substantial undue prejudice that eclipses any probative value under FRE 403.”

from Blogger http://tushnet.blogspot.com/2024/08/court-accepts-survey-with-disclaimer.html

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Plaid must face jury on PNC’s TM/advertising claims, but has good laches/acquiescence argument

PNC Financial Services Gp. v. Plaid Inc., 2024 WL 3687956,
No. 2:20-cv-1977 (W.D. Pa. Aug. 7, 2024)

PNC is “a large, diversified financial institution offering
retail and wholesale banking services,” while Plaid connects cash payment and
investment account applications like Venmo, Robinhood, and Coinbase with a
user’s banks. This allows a user to input the username and password affiliated
with their bank account to create the connection between the user’s bank and
the fintech app so money can be transferred between them.

PNC interface, L; Plaid connection interface with PNC logo, R
sample Plaid bank selection workflow

PNC alleged that Plaid infringed its trademarks by
replicating the authentic PNC log-on screen to get them to provide private
financial information, allowing Plaid to collect their data. Plaid responded
that PNC knew about this as early as 2017 and worked with Plaid to make it
easier for PNC customers to connect to fintech apps. The relationship became
hostile in 2019, when a third party allegedy got PNC customer information that
had been obtained by Plaid and leaked it on the “Dark Web.” At that point, PNC
blocked Plaid from accessing/linking PNC account information using Plaid Link
software in fintech apps.

Plaid allegedly then presented PNC consumers who were trying
to connect to fintech apps via Plaid Link with messaging screens, using
allegedly confusing branding, that said, “we’re currently experiencing
connectivity issues with this bank” and “PNC has made a change that prevents
you from being able to link your accounts.” One such screen also provided a
link to the CFPB website and advised such users that they could file a
complaint against PNC about their lack of fintech app access with that federal
enforcement agency, “which PNC says led to users (who were presumably PNC
retail customers) filing complaints against PNC with the CFPB. Plaid’s
messaging also encouraged PNC customers to change banks.” In late 2020, a new
Plaid user interface finally propitiated PNC.

PNC sued for counterfeiting, infringement, and false
advertising/unfair competition under federal and Pennsylvania law. This opinion
denies summary judgment to everybody on everything they sought, including
claims and defenses.

Counterfeiting is probably the most eye-opening charge. A
jury could find that the marks used by Plaid were spurious, that is,
substantially indistinguishable from PNC’s actual marks and suggesting a false
origin. There were “subtle color differences,” but indistinguishability was a
“hallmark” question of fact.  And,
interestingly, counterfeiting has to cover the “same” goods and services as the
registrant’s, and the court considered it a jury question whether this was so.
A jury could rationally conclude that Plaid and PNC do not offer the same
financial services, given that “Plaid is not a bank.” Its customers are
primarily fintech apps, not bank account holders. However, a reasonable jury
could also find that Plaid offers the same “financial services” as PNC, or at
least that both offer “financial services” covered by PNC’s registrations,
especially given statements Plaid made to the PTO that it offered financial
services. (The court did find that there was no judicial estoppel preventing
Plaid from offering a defense that the services weren’t the “same,” given the
gray areas involved.) A jury could also conclude that even if bank customers
aren’t Plaid customers, they’re Plaid’s target audience—although how that
matches up with the counterfeiting requirement I don’t know.

Trademark claims: The court declined to do a shortcut around
the likely confusion factors despite the similarity of the uses and related
services. (As is so common these days, the real issue is affiliation confusion,
which also matters.)

The “consumer care” factor weighed against Plaid because of
evidence that “Plaid Link’s entire system was designed to make consumers feel
more comfortable in providing Plaid their banking information,” e.g. “[W]e use
the bank logo and color scheme because it has a significant impact on
conversion. It gives users more familiarity and trust in completing the linking
flow.” Although banking may be “high engagement,” the evidence of confusion in
the survey was “rather high (perhaps surprisingly high) in the control
condition” at 38%; Plaid’s own statements indicated that using the logos made
consumers more “comfortable” “and thereby perhaps less likely to be careful
with their banking information”; and Plaid’s own experts “emphasize[d] that
Plaid Link’s design structure promotes near-autonomous consumer decision
making.”

But other consumer-based factors were up for grabs. A jury
could readily conclude that “Plaid and PNC provide far different services and
market to very different customers.” [Part of the issue here is: who’s confused
about what? Plaid’s customers aren’t likely to be confused.]

Length of time/actual confusion: Record evidence “unconnected
to Plaid’s messaging on the heels of the 2019 Cybersecurity Event” was “relatively
sparse.” A consumer complaint cited by PNC might be relevant to false
advertising, but didn’t obviously show trademark confusion:  

Venmo says they have lost
connection with my bank – sounds like Venmo’s problem. I attempt to reconnect.
Then the ‘Plaid’ screen appears. (As noted, I’m sure it’s safer to have this
extra level of security – when it functions). Then the PNC (?) ‘Enter your
credentials’ screen appears; when I enter my username and password the PNC
screen says ‘the username you provided was incorrect.’ I have called PNC to
confirm my username, and it’s the same one that works on the pnc.com site. So
what next?

Maybe the complaining consumer believed that Plaid is a
security feature of PNC, but “this consumer complaint could also be read as
saying that Plaid is an independent software service that provides another
level of security. More importantly, there is minimal other record evidence of
actual confusion based exclusively off of Plaid’s use of PNC’s marks.” There
was the survey, but a jury could find in Plaid’s favor.

Plaid’s purposes— “consumer ease of use and bank
identification”—were not bad faith as a matter of law. However, bad faith isn’t
required, only “intentional conduct” [what can this possibly mean? It seems to
turn knowledge into bad intent]. And “statements from Plaid’s CEO regarding
Plaid’s efforts to conceal its use of bank marks from the banks supports the
conclusion that Plaid’s intent was willing and voluntary.” That is, the CEO
told employees to make sure that they did not send an email announcing the addition
of over 6,000 new bank logos to Plaid Link to the banks themselves. “A jury
could readily conclude that Plaid wanted to guise itself in the marks of other
banks, including PNC.”

PNC has a stake in another company, Akoya, designed to
compete with Plaid. “[W]hile a jury could reasonably conclude that PNC is
likely to indirectly compete with Plaid and that Plaid’s use of PNC’s marks
harms PNC’s hypothetical future efforts in the account linking and data
aggregation field, a jury could also conclude that PNC is prosecuting this case
less to foster its own expansion plans and more to undermine Plaid before
advancing its competing product.”

False advertising: This claim was based on Plaid’s messaging
screens blaming PNC after PNC implemented changes that prevented users from
using Plaid to link their PNC accounts with their chosen fintech apps. Plaid
encouraged consumers to report PNC to the CFPB, and Plaid customer service
representatives told those customers to switch banks.

Surprisingly, the court found that these statements could be
“intentionally misleading,” because the statements “implicitly place the
culpable fault on PNC for the measures it took to protect its customers’ data
after the 2019 Cybersecurity Event. … [A] jury could conclude that Plaid did
not tell PNC customers the full story, namely that there had been a security
breach involving Plaid by which PNC customers’ private data was leaked on the ‘Dark
Web.’” And the reference to the CFPB “could also be found to imply that PNC’s
conduct was at least wrongful, if not illegal.” [But the precedents usually
agree that statements by laypeople about violations of laws that are
arguable/not yet decided are not factual and therefore can’t violate the Lanham
Act. Unless Plaid was under a duty to disclose the security incident, it’s usually
ok to give only information that favors yourself.] And PNC identified “multiple
communications from consumers to the CFPB regarding their dissatisfaction with
PNC after Plaid’s messaging screens went live,” such as “PNC has blocked access
to Plaid, which allows me to transfer funds in and out of my account. It’s
extremely inconvenient and I will have to switch banks because of it.” But that
doesn’t demonstrate deception! That was true! Still, the court found this to be
evidence of materiality.

Nor could Plaid win summary judgment on harm. A jury could
find harm to goodwill.

PNC didn’t manage to kick out laches/acquiescence as a
defense. PNC delayed four years before objecting, and another before suing, “despite
evidence that shows that PNC worked with Plaid during much of that four-year
period and had access to demos that showed PNC what the Plaid Link user
interface looked like.” Prejudice was a closer question; it may have run up the
potential damages, and Plaid could argue that to the jury. Acquiescence was
similar: there was “plenty of record evidence that suggests that PNC made a
thoughtful decision to continue working with Plaid despite having access to
Plaid’s allegedly infringing user interface, at least in demo version, such
that PNC conveyed implied consent to Plaid to use PNC marks as it did.” A jury
could find this was more than mere inaction, especially given the participation
of PNC senior executives.

from Blogger http://tushnet.blogspot.com/2024/08/plaid-must-face-jury-on-pncs.html

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Punchbowl, punchback: district court finds confusion unlikely between invitation and political news sites

Punchbowl, Inc. v. AJ Press LLC, 2:21-cv-03010-SVW-MAR (C.D.
Cal. Aug. 22, 2024)

Punchbowl home page

Punchbowl News home page

On remand from the 9th Circuit, the court conducts
a multifactor likely confusion analysis and finds that Punchbowl’s digital invitation
services are too distinct for likely confusion with Punchbowl News’s political reporting.
Two points stand out: first, the court considers it significant that mostly
women use Punchbowl and mostly men use Punchbowl News.

Second, there’s a useful discussion of misdirected
communications in light of the unrelatedness of the services. There were about 100, which in the context of thousands of queries a year for each party was not significant. Moreover, misdirected
communications may be probative of the fact that the names are similar, but not
of likely confusion, because relevant confusion has to relate to some kind of
purchase opportunity. Otherwise, trademark would turn into a right in gross:

Ultimately, the dissimilarity and
lack of proximity between the services provided by Plaintiff and Defendant carry
the day. This conclusion is the obvious one. At worst, some consumers might
mistakenly contact one party when they mean to contact the other party. A
misaddressed email, Facebook comment, or X post is a negligible friction that
stems from the fact that both parties have named their services a common word.
No reasonable consumer would purchase a subscription to a party planning software
platform when they intended to subscribe to a news website (or vice versa)
because they thought they came from the same source. No reasonable jury could
find otherwise.

from Blogger http://tushnet.blogspot.com/2024/08/punchbowl-punchback-district-court.html

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Trademark question of the day

 Spotted around town:

back of bus ad: "slow down. this isn't a video game" over video game image; "you speed, you lose--DMV" on right, all in Grand Theft Auto font

For reference, here’s the Grand Theft Auto font:

from Blogger http://tushnet.blogspot.com/2024/08/trademark-question-of-day.html

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State Little FTC Acts still have teeth, as Georgia’s proves

Federal Trade Commission v. Peyroux, — F.Supp.3d —-, 2024
WL 1283344, No. 1:21-cv-3329-AT (N.D. Ga. Mar. 11, 2024)

The FTC and the state of Georgia sued three corporate
defendants and two individual defendants, Peyroux and Detelich. The underlying
acts carried out by various defendants involved promoting stem cell therapy,
which “involves the injection of shots with products containing cells or growth
factors derived from birth tissue, including amniotic tissue or fluid,
placenta, Wharton’s jelly, umbilical cord blood, adipose tissue, and bone
marrow.” To get a sense of the costs at issue, over 2017-2019, at least 485
consumers purchased stem cell therapy injections from one defendant, Superior,
at a total cost of $3,350,416. Many patients were seniors.

The other corporate defendants were consulting services that
advised chiropractors and healthcare clinics on how to increase revenue by
offering additional services to patients. They provided “resources — marketing
manuals, flyers, lectures, sample emails ads, and PowerPoints — and a procedure
to launch advertising campaigns.” They provided coaching on how to deliver
PowerPoint presentations to potential patients, including on “handling
objections” and arranging financing; offered medical training for clinics; ordered
supplies for the stem cell injections, and provided other sales training, for
example, on how to track patients and potential patient responses to marketing
campaigns. Defendant Stem Cell Institute of America (SCIA) also “advertised
stem cell therapy directly to consumers through lectures, postcards, emails,
its website, YouTube, a documentary, and more.”

Peyroux was the 100% owner of all three corporate defendants;
Detelich was, among other things, a co-founder, officer, and director of SCIA,
and directly involved in developing, marketing, and delivering consulting
services about stem cell therapy for the other two corporate defendants.
Superior and SCIA filed for bankruptcy in 2019 (this proceeding continues as an
exercise of the police power, despite the automatic bankruptcy stay).

The ads at issue misrepresented the efficacy of stem cell
therapy, e.g., “stem cells can be used to treat nearly any type of condition
caused by injury or degeneration” and specifically claimed the ability to treat,
inter alia, COPD, Parkinson’s disease, multiple sclerosis, and congestive heart
failure. The ads offered to “reduce and even eliminate your pain without
surgery or additive medications.” Some of the ads claimed FDA approval. One of
the training videos included a role-play about how to respond to customer resistance:
“Over the past few years that we’ve done this, we have treated hundreds of
patients with knee conditions with amazing results. So the level of
degeneration you have in your knee makes you a really good candidate for this
procedure. And I feel very confident in telling you that this is going to be a
positive outcome for you as far as improving your range of motion, quality of
life, and decreasing pain.”

The court granted summary judgment to the FTC and the State
on many issues, including that the corporate defendants engaged in a common
enterprise and that the individual defendants were liable for the corporate
defendants’ acts. In addition, they made false or unsubstantiated efficacy
claims; false claims of FDA and FTC approval; and supplied their client clinics
with false/unsubstantiated ads and so provided clients with the means and
instrumentalities to commit further deceptive acts and practices.

Both the false efficacy claims and the false FDA/FTC
approval claims related to health and thus were presumptively material. And the
defendants supplied the means and instrumentalities of deception to clinics
through their extensive provision of ads and related services.

As to individual liability, this requires (1) control of the
corporation’s relevant acts and (2) some level of knowledge. Where a defendant
is a corporate officer of a small, closely-held corporation, “the individual’s
status gives rise to a presumption of ability to control the corporation.” Knowledge
means that the individual had “ ‘actual knowledge of the [unlawful] conduct,
was recklessly indifferent to its [unlawfulness], or had an awareness of a high
probability of [unlawfulness] and intentionally avoided learning of the truth.’
” Furthermore, “[a]n individual’s degree of participation in the business is
probative of knowledge.” Both of the individual defendants here directly
participated in the unlawful acts and advertising—they even delivered seminars
for the scheme—and also had authority to control the acts.

Georgia’s little FTC law, the GFBPA, outlaws “[u]nfair or
deceptive acts or practices in the conduct of consumer transactions and
consumer acts or practices in trade or commerce.” Examples of such unfair or
deceptive acts and practices include “[r]epresenting that goods or services
have sponsorship, approval, characteristics, ingredients, uses, benefits, or
quantities that they do not have.” It also bars using “a computer or computer
network” to “[e]ngage in any act, practice, or course or business that operates
… as a fraud or deceit upon a person.” “[T]he legislative intent and
interpretation provision of the GFBPA makes clear that the Act should be
interpreted broadly to end deceptive practices, and that the Act should be
interpreted as coterminous with the FTC Act.” The court therefore rejected defendants’
arguments that joint GFBPA liability could only be imposed if the corporate
veil could be pierced under Georgia law, noting that courts applying the laws
of several other states have found similarly.

On remedies, Detelich argued that there should be no injunctive
relief against him because there was no risk that he will engage in similar
conduct again. In determining whether there is “some cognizable danger of a
recurrent violation,” courts consider “the egregiousness of the defendant’s
actions; the isolated or recurrent nature of the actions; the degree of
scienter involved; the sincerity of the defendant’s assurances against future
violations; the defendant’s recognition of the wrongful nature of his conduct;
and the likelihood that the defendant’s occupation will present opportunities
for future violations….”

Using this standard, injunctive relief was appropriate as to
all existing defendants, who engaged in  “a
comprehensive campaign to develop and disseminate misleading advertisements
about the efficacy and approval of stem cell therapy on a massive scale.” The
ads were the focus of their business, and they profited massively therefrom.
The degree of scienter was high, and the individual defendants currently held
interests in many other healthcare companies.

The State also sought monetary relief in the form of civil
penalties and restitution under the GFBPA, which allows civil penalties up to
$5000 per violation (without specifying a method for identifying how many
violations occurred). There are additional penalties for targeting elderly and
disabled people online, up to $10,000 per violation.

Georgia sought $5000/day for misrepresentations on Superior’s
website ($6,650,000), $10,000/violation for 59 online advertising campaigns,
161 brochures downloaded online, 148 seminars delivered, and 335 elderly
consumer purchases of stem cell shots ($7,030,000); $5000 for each individual
consumer who purchased a stem cell shot who was not elderly ($750,000); and (4)
restitution for the 485 customers who purchased stem cell injections from Superior
($3,350,416).

The court declined to decide on an amount at this time and
noted the additional information it sought, but rejected some defense
challenges to the availability of monetary relief. First, civil penalties under
state law can be obtained in federal court, given an amendment specifying that “the
Attorney General is authorized to initiate … or otherwise appear in any
federal court or administrative agency to implement the provisions of this
article.”

Nor was the civil penalty provision unconstitutionally vague,
even though defendants argued that it had no specific method for calculating
the number of violations or setting an amount within the range. The
per-violation language should be interpreted in concert with the rest of the
statute, suggesting that “each unfair or deceptive act or practice, or consumer
transaction, serves as a separate violation of the statute.” Courts
interpreting similar statutes have assessed per violation penalties “based on
the number of ads published, transactions completed, consumer purchases, or a
mix of these measures.”

from Blogger http://tushnet.blogspot.com/2024/08/state-little-ftc-acts-still-have-teeth.html

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