Three different cases reading Lexmark differently but mostly kicking out claims:
Eli Lilly & Co. v. Aios, Inc., 2026 WL 836624, No.
25-cv-03535-HSG (N.D. Cal. Mar. 26, 2026)
Eli Lilly sells Mounjaro and Zepbound, GLP-1 inhibitors
containing tirzepatide. These are the only FDA-approved medicines containing
tirzepatide in the United States, and the FDA has not approved any tirzepatide
product in oral or compounded form.
Defendant operates telehealth platforms focusing on drugs
for weight loss, including compounded tirzepatide. Eli Lilly alleged that its
Fella telehealth platform engaged in the unlicensed practice of medicine: For
example, the non-physician founder allegedly “frequently tells customers that
he can help increase their dosage amounts of Fella’s knockoff drugs if they
contact him or his non-physician customer success team directly.” Fella also
allegedly changed patient prescriptions “en masse,” based on Fella’s business
needs, rather than individualized patient needs. Many patients allegedly
learned that their prescription now contained an additive “not through their
doctor but rather when their prescription arrived from Fella Health.” Eli Lilly
alleged that these weren’t “personalized prescriptions”—rather, Fella is
offering “an untested, unapproved, one-size-fits-all drug” to patients without
complying with the California Medical Practice Act’s requirement that
prescriptions be made with “an appropriate prior examination and a medical
indication.”
Eli Lilly also alleged deceptive conduct with claims such as
“[o]ur science-backed methodology delivers results that outperform traditional
weight loss methods”; “[o]ral tirzepatide is the same active ingredient as the
compounded injectable (tirzepatide)”; and “[o]ur advanced oral Tirzepatide
treatment, developed through cutting-edge research, offers a safe and effective
solution tailored to support your weight loss journey and overall health.”
Eli Lilly alleged that Fella knew these statements were
false. In a Reddit post, Fella’s Head of Customer Sales wrote that “oral
[tirzepatide] can be fairly ineffective (though not totally ineffective), and
some may experience more GI discomfort due to daily administration.” One of
Fella’s customer success leads wrote that “[t]he oral version is less effective
than the injectables, but it’s still better than not being on the medication at
all.” Fella’s founder wrote on Reddit that “oral [tirzepatide] is slightly less
effective than subcutaneous.”
But Fella’s website states that oral tirzepatide is
“science-backed” and that Fella uses a “science-backed methodology,” while its
Head of Customer Sales wrote that patients generally lose 15% of their body
weight in one year on oral tirzepatide. Eli Lilly alleged that oral tirzepatide
has never been studied in clinical trials and that Fella has no science at all
supporting its oral product. The statistic cited by Fella on its
female-targeted Delilah website, that patients using oral tirzepatide experience
a weight loss average of “22.5%,” was derived from Eli Lilly’s clinical trial
on injectable tirzepatide, not oral or compounded tirzepatide.
Eli Lilly sued for violations of the UCL, FAL, and Lanham
Act, along with civil conspiracy.
Fella argued that Lilly lacked standing because they weren’t
competitors and Eli Lilly couldn’t allege “something very close to a 1:1
relationship between [Eli Lilly’s] lost sales and the sales diverted to a
defendant.” The court disagreed: Lexmark directed the court to use the zone of
interests test and proximate cause, both of which Lilly properly alleged.
Lilly alleged that “Fella’s unfair, deceptive, misleading,
and false practices, including its false and misleading statements, cause
irreparable harm to Lilly’s brand and customer goodwill by promising results
that consumers cannot obtain from Fella’s product,” and, because Fella relied
on Lilly’s studies on its product, consumers would also think that Lilly’s
product would be that bad. Plus, Lilly alleged injury to its commercial
interest in sales. E.g., on Reddit, one of Fella’s customers said he “was on zepbound”
until mid-November 2024, but “stopped” when the medicine became too expensive
and eventually switched to Fella. Lilly also had standing under the UCL and
FAL, but only as to false advertising, not to the UCL claim based on allegedly
unlawful corporate practice of medicine. “Eli Lilly does not plausibly allege
how Defendants’ claimed lack of authorization to practice in itself causes it
any injury.”
Commercial advertising or promotion: It was plausible that
the Reddit posts were made for the purpose of influencing customers to buy
Fella’s products. Although this was a closer question than statements on
Fella’s own website, the Reddit statements “tout Fella’s success with
statistics, refer to Fella’s oral and injectable tirzepatide products, and
adequately reflect an economic motivation, such that the allegations support a
reasonable inference that ‘the economic benefit was the primary purpose for speaking.’”
However, Lilly struggled with its literal falsity arguments,
since “lack of substantiation” is not itself a valid theory under state or
federal law. For example, Lilly alleged that Fella’s statements regarding its
patients typically losing 15-22.5% of their body weight were false because
those statements are in reality based on the results of Eli Lilly’s clinical
trials, which were performed on injectable and non-compounded tirzepatide. And
it’s true that a plaintiff can show falsity by showing that even reliable tests
do not establish the proposition asserted by the defendant. “But here, Eli
Lilly has not alleged that Fella made any representation regarding the specific
basis for its statements about the weight loss results typically achieved for
its patients, and Eli Lilly does not allege any contrary facts (as opposed to
the purported lack of supporting facts).” Lilly didn’t plausibly allege that
Fella’s statements about the existence of rigorous “research” and “testing”
were false just because oral tirzepatide has never been subject to the
particular mechanism of a clinical trial or study. [Seems like a consumer
survey should be relatively easy to do to find deceptiveness even if not
literal falsity.]
The only allegedly false statements sufficiently pled were
those made in connection with Fella’s promotion of “personalized treatment
plans.” Whether defendants actually personalize customers’ treatment was
capable of being proven true or false, not puffery.
Novo Nordisk A/S v. Amble Health, Inc., No. 4:25-CV-01048, 2026
WL 776100 (N.D. Ohio Mar. 19, 2026)
The parties allegedly are competitors in the sale of drug
products containing semaglutide. Novo Nordisk sells the only FDA-approved
medicines containing semaglutide in the United States, Amble is a telehealth
company that sells drugs purportedly containing semaglutide, produced at
compounding facilities. Novo Nordisk alleged that these compounded drug
products are mass produced and create a higher risk to patients than Novo
Nordisk’s medicines, because the FDA does not conduct pre-market reviews of compounded
drugs for safety, quality, or effectiveness.
The complaint also alleged that Amble’s ads falsely claims
that its drugs are personalized: “tailored to you,” and are “tailored to your
personal goals,” with “personalization” of “active ingredients, dosage, and
form of a medication to meet an individual’s personal needs.” The complaint
alleged that, to the contrary, the compounded drugs were “ordered in bulk and
sold to patients off the shelf.”
The court found that Novo Nordisk didn’t plausibly allege
injury in fact. The complaint alleged sales diversion as well as reputational
harm because compounded drugs might “undermine the reputation for quality and
safety established on Novo Nordisk’s FDA-approved medicines.”
But defendants’ use of “personalized” didn’t plausibly threaten
to harm Novo Nordisk’s reputation. “At base, [Plaintiff] appears to argue the
mere fact a medication is compounded makes it an inferior version of an
FDA-approved product with the same active pharmaceutical ingredients. But
compounding is a federally recognized and regulated pharmaceutical practice ….”
Novo Nordisk needed at least facts supporting an inference that Amble’s compounded
medication fails to meet consumer expectations, which it didn’t. Nor did it
plausibly allege that any of Amble’s customers were harmed by the compounded
medication “such that they could draw unwarranted conclusions about the safety
and efficacy” of Novo Nordisk’s drugs. Although Novo Nordisk pled that “the FDA has
received reports of adverse events, some requiring hospitalization related to
overdoses from dosing errors associated with compounded ‘semaglutide’ products,”
dosing errors don’t show that the term “personalized” in and of itself has led
to any patient diversion. [The court is weirdly going back and forth between
reputation and sales diversion.]
Even with Article III standing, Novo Nordisk didn’t properly
allege statutory standing via the proximate cause element: The “personalized”
message didn’t plausibly cause the harm. Compounded medications require prescriptions,
and the physician’s prescribing decision, not the ads, was the proximate cause
of the patient using the compounded medication instead of Novo Nordisk’s
product.
Eli Lilly & Co. v. Willow Health Services, Inc., No.:
2:25–cv–03570–AB–MAR, 2026 WL 639976 (C.D. Cal. Feb. 3, 2026)
Eli Lilly alleged its medicines are backed by rigorous
science and quality controls. It has FDA approval for two injectable tirzepatide-based
medicines. At the time of the complaint, there was no FDA-approved oral
tirzepatide. Willow operates a telehealth platform that markets and sells
weight-loss treatments directly to consumers. Willow offers compounded
tirzepatide products, including an injectable formulation and an oral
formulation.
The FDA allegedly has expressed particular concern about
compounded GLP-1 drugs, many of whose components are manufactured by facilities
that are not subject to the same regulatory oversight as domestic
manufacturers. It has warned about dosing errors, adverse events, and the use
of unapproved salt forms in compounded tirzepatide products.
Willow allegedly marketed its products as clinically
validated and comparable to, or superior to, Lilly’s FDA-approved medicines: that
its tirzepatide treatment has undergone “extensive testing,” is supported by
“science,” and produces significant weight loss outcomes. Imagery of physicians
and references to board-certified doctors allegedly reinforced the impression
of medical endorsement.
Willow also allegedly claimed that its product is a
“premium” blend that delivers “better results” than tirzepatide generally. Then
it reiterates that its medication undergoes extensive testing. Lilly alleged
that, in fact, Willow has no clinical studies supporting these claims, and no
testing has been conducted on Willow’s compounded products to demonstrate
safety or effectiveness.
Willow allegedly marketed its drops as effective and, at
times, superior to injections, but no clinical data supported the effectiveness
of any oral tirzepatide product.
And Willow allegedly misrepresented that its medications were
custom, “personalized,” and tailored to each patient’s unique needs, rather
than standardized formulations delivered to all patients. Willow’s intake
questionnaire “purports to assess whether Willow’s treatment is appropriate”
but recommends its medication to all users regardless of the information
provided.
After Lilly sued, Willow added a disclaimer to its website
stating that its products are not FDA-approved and have not undergone clinical
trials, but Lilly alleged that this bottom-of-page statement didn’t affect the
overall message. Lilly also alleged that survey conducted by the National
Consumers League found that many consumers incorrectly believe thatcompounded GLP-1 drugs are FDA-approved
and clinically tested. Willow’s advertising allegedly mirrored the types of
statements the FDA has identified as false and misleading in warning letters
sent to compounders and telehealth companies: “clinically proven,” “backed by
extensive clinical research,” and “personalized.”
Lilly alleged that Willow’s marketing falsely equates its
untested compounded products with FDA-approved medicines, diverting sales and
harming Lilly’s reputation. It further alleged that adverse events associated
with compounded tirzepatide products are often mistakenly attributed to Lilly’s
medicines, further damaging its goodwill.
Statutory standing: “[T]he test forecloses suit only when a
plaintiff’s interests are so marginally related to or inconsistent with the
purposes implicit in the statute that it cannot reasonably be assumed that
Congress authorized the plaintiff to sue.”
“If the plaintiff can demonstrate that the defendant is a
direct competitor, there is a presumption of a commercial injury to plaintiff
sufficient to establish standing.” Willow argued that wasn’t a direct
competitor of Lilly evidenced by the fact that Lilly didn’t have direct
evidence of lost sales and it actually had an increase in sales of Mounjaro and
Zepbound. Lilly argued that the presumption of commercial injury conferred by
direct competition couldn’t be rebutted. [Gotta say, that seems correct for the
motion to dismiss stage.]
The court recognized “a split of authority in the Ninth
Circuit on whether a presumption of commercial injury arising from direct
competition is sufficient on its own to establish standing, or whether a
plaintiff must also allege concrete facts demonstrating lost or diverted sales.”
Lilly alleged that Willow’s conduct “results in potential
patients being lured away” and that “Willow[’s] ... materially false statements
... influence consumers’ ... decision to purchase Willow’s [drugs] instead of
Lilly’s FDA-approved medicines.” Lilly also alleged that the products compete
at “similar prices” causing consumers make purchasing decisions “based on
factors other than pricing, including comparative safety and effectiveness.” These
allegations, together with the presumption arising from direct competition, were
sufficient to plead commercial injury.
What about proximate cause? A plaintiff “ordinarily must
show economic or reputational injury flowing directly from the deception
wrought by the defendant’s advertising; and that that occurs when deception of
consumers causes them to withhold trade from the plaintiff.” Proximate
causation may be adequately alleged when “there is likely to be something very
close to a 1:1 relationship between” a plaintiff’s lost sales and the sales
diverted to a defendant.
The court seems to read this Lexmark quote as a requirement
rather than an example. But if I plausibly allege that my competitor & I
would likely have split the sales garnered by a competing false advertiser, it’s
got to be the case that I have standing. It’s not the 1:1 relationship that
creates proximate causation but that, although the parties are at distinct
parts of the value chain (as the parties were in Lexmark), a 1:1 sales
relationship can justify finding proximate causation—a legal rather than
factual conclusion—at a greater competitive distance than a more unbalanced/hard-to-prove
loss ratio would have.
Reading Lexmark that restrictively, Lilly still
failed to plead “a direct causal link between any advertisement by Willow and a
patient choosing a compounded medication over Lilly’s product.” “Critically,
regardless of advertising or patient intent, obtaining a prescription
medication requires a physician to prescribe it. The physician’s prescribing
decision, not Willow’s advertisements, is the proximate cause of the patient
using the compounded medication instead of Lilly’s product.”
Lilly objected in vain that this ruling would categorically
eliminate Lanham Act claims for prescription drugs. You still need “allegations
showing a direct link between advertising and lost sales,” taking into account “the
fact that prescriptions, a foreseeable and legally required step, determine
whether a patient can actually obtain the product.” [Honestly, I’m not sure how
hard this would be for Lilly to plead. The whole point of these services is
that they contract with doctors to prescribe exactly what the services offer. A
patient who contacts a doctor through one of these services is extremely likely
to end up with their products. I don’t think Lilly should have to plead it, but
it seems very plausible.]
No comments:
Post a Comment