Source: cases/15usc1125/f-supp-3d-378-823-genus-v-lannett.case
Case source: https://www.neochart.com/catalog/cases/f-supp-3d/volume_378/0823_01/index.html
But in order to be actionable, the statements must be accompanied by specific allegations that they were made for the purpose of influencing the customers of cocaine hydrochloride solutions to buy C-Topical, or were disseminated sufficiently to the relevant purchasing public (pharmacists, hospitals, and doctors) to constitute "advertising" or "promotion" within the pharmaceutical industry.
I find that the allegations contained in the SEC filings and investor calls stating that C-Topical is "grandfathered" or under a "preliminary new drug application" cannot, without more, state a claim for Lanham Act false advertising because they do not rest on any statements made in advertising or promotion.
Additionally, allegations about the survey data meet the standard articulated in JHP Pharm., 52 F. Supp. 3d at 1002-03.
Genus has sufficiently alleged that C-Topical's label route of administration is false.
Lannett's statement in its website's meta description states a claim for false advertising under the Lanham Act.
Genus must plausibly allege that the statements actually conveyed the implied message that C-Topical was grandfathered or sold with FDA approval, and deceived a significant portion of recipients. JHP Pharm. , 52 F. Supp. 3d at 1002-03. It has not done so yet.
casedsl 1
case /f-supp-3d/378/0823-01
name Genus Lifesciences Inc. v. Lannett Co.
cite 378 F. Supp. 3d 823 (2019)
court United States District Court for the Northern District of California
date 2019-05-03
url catalog/cases/f-supp-3d/volume_378/0823_01/index.html
source ir/caselaw/f_supp_3d_378.jsonl sha1=a49e70d114195e4099e32015562072528921d5c7 chars=60000
law 15usc1125
role applied
posture Motions to dismiss false advertising and related claims; some Lannett/Cody claims survive, First Databank claims dismissed; canonical IR ends during First Databank discussion.
result mixed
element commercial-promotion : not-satisfied [pleaded]
variant audience/investor-filings-and-calls
party Genus against Lannett
count Grandfathered and preliminary-NDA statements
fact @6179..6371 [cuts-against] | Nevertheless, Lannett claimed that C-Topical was grandfathered in a number of Securities and Exchange Commission ("SEC") filings and investor calls in between December 2017 and September 2018.
fact @27906..28234 [cuts-against absent] | Although the procedural posture in RPost is different, Genus has failed to allege (rather than prove as in RPost ) that the SEC statements and investor calls were made for the purpose of influencing consumers to buy its goods or services, or that they were disseminated sufficiently to pharmacists, doctors, and hospital groups.
rule @30196..30588 | But in order to be actionable, the statements must be accompanied by specific allegations that they were made for the purpose of influencing the customers of cocaine hydrochloride solutions to buy C-Topical, or were disseminated sufficiently to the relevant purchasing public (pharmacists, hospitals, and doctors) to constitute "advertising" or "promotion" within the pharmaceutical industry.
held @30614..30923 | I find that the allegations contained in the SEC filings and investor calls stating that C-Topical is "grandfathered" or under a "preliminary new drug application" cannot, without more, state a claim for Lanham Act false advertising because they do not rest on any statements made in advertising or promotion.
gloss Failure concerns purpose and dissemination, not an absolute SEC-filing exemption. The older cited competition formulation is not adopted as a universal post-Lexmark requirement.
element consumer-deception : satisfied [pleaded]
variant implied-approval/pharmacist-survey
party Genus against Lannett
count Price lists conveyed to customers
fact @24209..24395 [supports] | Genus's complaint contains essentially the same allegations as described in Par. It asserts that Lannett lists C-Topical on price lists and appears to cite to the same studies as in Par.
fact @24650..24776 [supports] | For example, a nationwide survey of 500 pharmacists found that 91% thought all products pharmacists dispense are FDA approved.
held @25027..25146 | Additionally, allegations about the survey data meet the standard articulated in JHP Pharm., 52 F. Supp. 3d at 1002-03.
gloss The complaint connects implied approval to consumer beliefs. The court expressly leaves sufficiency at summary judgment unresolved; this is not a finding that the study proved deception.
element false-fact : satisfied [pleaded]
variant literal-falsity/topical-route-label
party Genus against Lannett
count Route of administration
fact @31994..32171 [supports] | Lannett's label states that C-Topical is "indicated for the introduction of local (topical) anesthesia of accessible mucous membranes of the oral, laryngeal and nasal cavities."
fact @32537..32819 [supports] | Taking Genus's allegations as true for the purposes of this motion, the inside of the nose, mouth, and larynx are not "particular spots on the outer surface of the body" and C-Topical's route of administration cannot accurately be described as "topical" under the FDA's definitions.
held @33762..33849 | Genus has sufficiently alleged that C-Topical's label route of administration is false.
gloss A factual labeling comparison survives pleading review; no safety/effectiveness determination or independent enforcement of FDA approval requirements is recorded.
element false-fact : satisfied [pleaded]
variant misleading-description/generic-search-summary
party Genus against Lannett
count Website meta description
fact @6900..7104 [supports] | Genus points out that Lannett's meta description for its C-Topical webpage is misleading: it states, "Learn more about the facts and characteristics of the generic pharmaceutical C-Topical® Solution CII."
fact @37472..37643 [supports] | It is relevant that consumers would have to click on yet another link to be informed that C-Topical has not completed the ANDA approval process required for generic drugs.
held @37644..37756 | Lannett's statement in its website's meta description states a claim for false advertising under the Lanham Act.
gloss Falsity/misleadingness is the challenged issue for this statement; survival is not used to deem every advertising element satisfied.
element consumer-deception : not-satisfied [pleaded]
variant implied-approval/general-compliance-website
party Genus against Lannett
count General website compliance statements
fact @40130..40327 [supports] | According to the complaint, Lannett's website states that its "leadership is committed to quality, adherence to FDA standards, and compliance with regulatory requirements to ensure patient safety."
held @40886..41145 | Genus must plausibly allege that the statements actually conveyed the implied message that C-Topical was grandfathered or sold with FDA approval, and deceived a significant portion of recipients. JHP Pharm. , 52 F. Supp. 3d at 1002-03. It has not done so yet.
gloss No plausible allegation of misleading audience takeaway for these general statements; distinct from the price-list survey theory that survived.
misfit IR is capped at 60000 characters mid-sentence in the First Databank section. Its opening disposition is observable, but no missing reasoning, later order, contributory test, or unobserved disposition is reconstructed. The statement saying Goprelto is Lannett's product at offset 1593 conflicts with surrounding ownership facts; it is not used as a fact quote.