Case: 21-1492 Document: 00117908881 Page: 1 Date Filed: 08/12/2022 Entry ID: 6513524
`
`United States Court of Appeals
`For the First Circuit
`
`
`
`
`No. 21-1492
`
`AZURITY PHARMACEUTICALS, INC.,
`
`Plaintiff, Appellant,
`
`v.
`
`EDGE PHARMA, LLC,
`
`Defendant, Appellee.
`
`
`APPEAL FROM THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`[Hon. Rya W. Zobel, U.S. District Judge]
`
`
`
`Before
`
`Barron, Chief Judge,
`Howard and Thompson, Circuit Judges.
`
`
`
`
`
`
`
`
`
`James H. Hulme, with whom Nadia A. Patel, Valerie C. Samuels,
`and Arent Fox LLP were on brief, for appellant.
`Robert J. Fluskey, Jr., with whom Linda L. Morkan, William J.
`Egan, Julianna M. Charpentier, Robinson & Cole LLP, and Hodgson
`Russ LLP were on brief, for appellee.
`
`
`
`
`August 12, 2022
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`United States Court of Appeals
`For the First Circuit
`
`
`
`
`No. 21-1492
`
`AZURITY PHARMACEUTICALS, INC.,
`
`Plaintiff, Appellant,
`
`v.
`
`EDGE PHARMA, LLC,
`
`Defendant, Appellee.
`
`
`APPEAL FROM THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`[Hon. Rya W. Zobel, U.S. District Judge]
`
`
`
`Before
`
`Barron, Chief Judge,
`Howard and Thompson, Circuit Judges.
`
`
`
`
`
`
`
`
`
`James H. Hulme, with whom Nadia A. Patel, Valerie C. Samuels,
`and Arent Fox LLP were on brief, for appellant.
`Robert J. Fluskey, Jr., with whom Linda L. Morkan, William J.
`Egan, Julianna M. Charpentier, Robinson & Cole LLP, and Hodgson
`Russ LLP were on brief, for appellee.
`
`
`
`
`August 12, 2022
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case: 21-1492 Document: 00117908881 Page: 2 Date Filed: 08/12/2022 Entry ID: 6513524
`
`BARRON, Chief Judge. Azurity Pharmaceuticals, Inc.
`
`("Azurity") is a specialty pharmaceutical company. It markets a
`
`hydrochloride vancomycin drug that received pre-market approval
`
`from the United States Food and Drug Administration ("FDA"). Edge
`
`Pharma, LLC ("Edge") is a drug compounding company. It markets a
`
`hydrochloride vancomycin drug that competes with Azurity's but has
`
`not been given pre-market FDA approval.
`
`In 2020, Azurity filed suit in the United States District
`
`Court for the District of Massachusetts against Edge under both
`
`the Lanham Act and a Massachusetts consumer protection law, Mass.
`
`Gen. Laws. ch. 93A ("Chapter 93A"), based on statements that Edge
`
`allegedly made on its website. The suit alleges that a number of
`
`these statements represent or convey the impression that Edge is
`
`not in violation of section 503B of the Food, Drug, and Cosmetic
`
`Act ("FDCA"), which authorizes drug compounders who meet certain
`
`conditions to market their compounded drugs without first
`
`obtaining FDA approval. The suit alleges that these statements
`
`are literally false and/or misleading. The suit further alleges
`
`that another one of Edge's statements on its website is false
`
`and/or misleading because it holds out Edge's vancomycin drug as
`
`being superior to Azurity's.
`
`Edge moved to dismiss Azurity's claims for, among other
`
`things, failure to state a claim on which relief could be granted
`
`under Federal Rule of Civil Procedure ("Rule") 12(b)(6). The
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`- 2 -
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`Case: 21-1492 Document: 00117908881 Page: 3 Date Filed: 08/12/2022 Entry ID: 6513524
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`District Court granted Edge's Rule 12(b)(6) motion as to Azurity's
`
`Lanham Act claim on the ground that the FDCA precluded Azurity's
`
`claim. The District Court based this ruling on the determination
`
`that the claim would require a court to interpret the meaning of
`
`section 503B in a way that would interfere with the FDA's authority
`
`to administer and enforce the FDCA. Azurity Pharms., Inc. v. Edge
`
`Pharma, LLC, 540 F. Supp. 3d 141, 144 (D. Mass. 2021). The District
`
`Court also ruled that, because the FDCA precluded Azurity's Lanham
`
`Act claim, Azurity's Chapter 93A claim "likewise fails as it is
`
`premised on the same allegations" as Azurity's Lanham Act claim.1
`
`Id. (citing Reed v. Zipcar, Inc., 883 F. Supp. 2d 329, 334–35 (D.
`
`Mass. 2012)).2 We affirm in part (albeit on an alternative ground)
`
`and vacate in part.
`
`
`
`1 Azurity's complaint contains two counts, one for violation
`of the Lanham Act and another for unfair and deceptive trade
`practices under Chapter 93A. The District Court treated Azurity
`as having made one "claim" under each statute. See Azurity, 540
`F. Supp. 3d at 144. On appeal, Azurity frames its complaint has
`having stated four distinct claims under the Lanham Act. Following
`the District Court, we use the singular "claim" to encompass all
`of the theories that Azurity argues for finding Edge to have
`violated the Lanham Act, and we do the same with respect to Chapter
`93A.
`
` 2
`
` In granting Edge's motion to dismiss, the District Court
`also denied Azurity's motion for a preliminary injunction as moot.
`Azurity, 540 F. Supp. 3d. at 145. Azurity referred to this denial
`in its notice of appeal, but it makes no mention of it in its
`briefing to us so any challenge to that ruling is waived. See
`United States v. Zannino, 895 F.2d 1, 17 (1st Cir. 1990).
`
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`Case: 21-1492 Document: 00117908881 Page: 4 Date Filed: 08/12/2022 Entry ID: 6513524
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`I.
`
`Because this appeal is from the grant of a motion to
`
`dismiss Azurity's complaint for failure to state a claim under
`
`Rule 12(b)(6), we accept all well-pleaded facts in Azurity's
`
`operative complaint as true. See Clorox Co. P.R. v. Proctor &
`
`Gamble Com. Co., 228 F.3d 24, 30 (1st Cir. 2000). We also draw
`
`all reasonable inferences in Azurity's favor. Id.
`
`A.
`
`
`
`The FDCA requires the FDA's pre-approval to market any
`
`drug. However, the FDCA exempts "compounded" drugs -- which are
`
`drugs that are produced by "combining, admixing, mixing, diluting,
`
`pooling, reconstituting, or otherwise altering . . . a drug or
`
`bulk drug substance," 21 U.S.C. § 353b(d)(1) -- from the FDCA's
`
`pre-approval requirements in some circumstances.
`
`The circumstances are set forth in section 503B of the
`
`FDCA, 21 U.S.C. § 353b. That section provides that certain pre-
`
`approval requirements "shall not apply to a drug compounded by or
`
`under the direct supervision of a licensed pharmacist in a facility
`
`that elects to register as an outsourcing facility if each of
`
`the . . . conditions [set forth in section 503B] is met." 21
`
`U.S.C. § 353b(a). The FDCA defines an "outsourcing facility" as
`
`a facility that "is engaged in the compounding of sterile drugs;
`
`has elected to register as an outsourcing facility; and complies
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`Case: 21-1492 Document: 00117908881 Page: 5 Date Filed: 08/12/2022 Entry ID: 6513524
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`with all of the requirements of [section 503B of the FDCA]." Id.
`
`§ 353b(d)(4)(A)(i)-(iii).
`
`In specifying the conditions that an outsourcing
`
`facility must meet, section 503B provides that an "outsourcing
`
`facility" may not compound a drug that is "essentially a copy of
`
`one or more approved drugs." Id. § 353b(a)(5). Section 503B
`
`defines "essentially a copy" to mean:
`
`(A) a drug that is identical or nearly
`identical to an approved drug . . . unless, in
`the case of an approved drug, the drug appears
`on the drug shortage list in effect under
`section 356e of this title at the time of
`compounding, distribution, and dispensing; or
`
`(B) a drug, a component of which is a bulk
`drug substance that is a component of an
`approved drug . . . , unless there is a change
`that produces for an individual patient a
`clinical difference, as determined by the
`prescribing
`practitioner,
`between
`the
`compounded drug and the comparable approved
`drug.
`
`Id. § 353b(d)(2).
`
`Another portion of section 503B concerns the use by
`
`"outsourcing facilities" of a "bulk drug substance." Id.
`
`§ 353b(a)(2). That provision requires, as a "condition" for an
`
`"outsourcing facility" to market a compounded drug without prior
`
`FDA approval, that:
`
`The drug is compounded in an outsourcing
`facility that does not compound using bulk
`drug substances . . ., unless--
`
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`Case: 21-1492 Document: 00117908881 Page: 6 Date Filed: 08/12/2022 Entry ID: 6513524
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`(A)(i) the bulk drug substance appears on a
`list established by the Secretary identifying
`bulk drug substances for which there is a
`clinical need, by--
`
`
`(I) publishing a notice in the Federal
`Register proposing bulk drug substances
`to be included on the list, including the
`rationale for such proposal;
`
`(II) providing a period of not less than
`60 calendar days for comment on the
`notice; and
`
`(III) publishing a notice in the Federal
`Register
`designating
`bulk
`drug
`substances for inclusion on the list; or
`
`(ii) the drug compounded from such bulk drug
`substance appears on the drug shortage list in
`effect under section 356e of this title at the
`time of compounding, distribution, and
`dispensing . . . .
`
`
`Id.
`
`B.
`
`
`
`The vancomycin hydrochloride drug that Azurity markets
`
`is called FIRVANQ. FIRVANQ is "indicated for treatment of
`
`Clostridium difficile-associated diarrhea and enterocolitis caused
`
`by Staphylococcus aureus, including methicillin-resistant
`
`strains." Azurity does not purport to be an "outsourcing
`
`facility," but it has received FDA pre-approval to market FIRVANQ.
`
`Edge "produces and markets an oral vancomycin solution
`
`that competes directly with Azurity's FIRVANQ." Edge markets the
`
`drug under the generic name "Vancomycin Oral Solution." Unlike
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`Case: 21-1492 Document: 00117908881 Page: 7 Date Filed: 08/12/2022 Entry ID: 6513524
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`Azurity, Edge has not received FDA pre-approval to market this
`
`drug. Edge is registered, however, as an "outsourcing facility".
`
`Prior to this suit, Edge made the following statements
`
`about its operations, each of which appeared on Edge's website:
`
`a. "Edge Pharma is a pharmaceutical sterile
`and non-sterile 503B Outsourcing Facility
`offering high quality, innovative solutions
`for the health care community."
`
`b. "As your compliance partner, we are
`dedicated
`to
`providing
`turnkey
`503B
`outsourcing with the highest level of quality,
`easy ordering, simple logistics, and excellent
`customer support."
`
`c. "Edge Pharma is an FDA-registered and
`state-licensed, 503B Outsourcing Facility
`providing service to hospital pharmacies,
`outpatient surgery Centers, and clinics."
`
`d. "Our facility is compliant with the
`following
`state,
`local,
`and
`federal
`regulations and guidelines:
`
`USP 795, USP 797, USP 800[,]
`
`Occupational
`Safety
`and
`
`Administration (OSHA)[,]
`
`Food and Drug Administration (FDA)[,]
`
`US Pharmacopeia (USP)[,]
`
`Applicable Good Manufacturing Practice
`
`(GMP) Guidelines."
`
`e. "Edge Pharma is a USP 797 and cGMP compliant
`FDA-Registered 503B Outsourcing Facility that
`specializes in a wide array of sterile and
`non-sterile compounded medications."
`
`f. "As an FDA registered and inspected 503B
`Outsourcing facility, Edge has the ability to
`react quickly to customer requirements and
`deliver cost effective solutions."
`
`
`Health
`
`- 7 -
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`Case: 21-1492 Document: 00117908881 Page: 8 Date Filed: 08/12/2022 Entry ID: 6513524
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`In addition, "Edge . . . claim[ed] to be a 'Registered
`
`and Inspected FDA Outsourcing Facility'" in its marketing
`
`materials. Edge also stated on its website: "commercially
`
`available options are not ideal for use in the hospital setting."
`
`We will refer to the statements that refer to Edge's
`
`"compliance" with the law as the "Compliance Statements." We will
`
`refer to the statements that refer to Edge being a "registered"
`
`and "inspected" "Outsourcing Facility" as the "Registration
`
`Statements." We will refer to the statement that "commercially
`
`available options are not ideal for use in the hospital setting"
`
`as the "Superiority Statement."
`
`C.
`
`
`
`On February 12, 2020, Azurity sued Edge in the District
`
`Court for the District of Massachusetts based on the statements
`
`just described. One count of Azurity's two-count complaint alleges
`
`that the Compliance and Registration Statements, as well as the
`
`Superiority Statement, constitute unfair competition and false
`
`advertising in violation of the Lanham Act, 15 U.S.C. § 1125(a).
`
`The other count alleges that the Compliance and Registration
`
`Statements, as well as the Superiority Statement, constitute
`
`unfair or deceptive acts or practices under Chapter 93A, Mass.
`
`Gen. Laws. ch. 93A, § 2(a).
`
`To prove a Lanham Act claim for unfair competition and
`
`false advertising, a plaintiff must demonstrate that
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`Case: 21-1492 Document: 00117908881 Page: 9 Date Filed: 08/12/2022 Entry ID: 6513524
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`(1) the defendant made a false or misleading
`description of fact or representation of fact
`in a commercial advertisement about his own or
`another's product; (2) the misrepresentation
`is material, in that it is likely to influence
`the
`purchasing
`decision;
`(3)
`the
`misrepresentation actually deceives or has the
`tendency to deceive a substantial segment of
`its audience; (4) the defendant placed the
`false or misleading statement in interstate
`commerce; and (5) the plaintiff has been or is
`likely to be injured as a result of the
`misrepresentation, either by direct diversion
`of sales or by a lessening of goodwill
`associated with its products.
`
`Cashmere & Camel Hair Mfrs. Inst. v. Saks Fifth Ave., 284 F.3d
`
`302, 310–11 (1st Cir. 2002).
`
`A description or representation of fact in an
`
`advertisement may be either literally false or "true or ambiguous
`
`yet misleading." Id. at 311. Literal falsity and misleadingness
`
`represent two "independent" theories of recovery under the Lanham
`
`Act. Clorox, 228 F.3d at 36.
`
`In assessing a Lanham Act claim for unfair competition
`
`and false advertising, a determination first must be made as to
`
`what the statement by the defendant that grounds the claim
`
`communicates. Id. at 34. A determination then must be made about
`
`whether that statement, given what it communicates, is either false
`
`and/or misleading. See id. at 34, 36. The Lanham Act prohibits
`
`only "false or misleading description[s] of fact." 15 U.S.C.
`
`§ 1125(a)(1) (emphasis added).
`
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`Case: 21-1492 Document: 00117908881 Page: 10 Date Filed: 08/12/2022 Entry ID: 6513524
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`The plaintiff bears the burden of proving that the
`
`statement at issue is false and/or misleading. Clorox, 228 F.3d
`
`at 33. That question is typically for the factfinder to determine.
`
`Id. at 34, 37.
`
`If the statement is alleged to be literally false, "a
`
`violation [of the Lanham Act] may be established without evidence
`
`of consumer deception." Cashmere & Camel Hair Mfrs. Inst., 284
`
`F.3d at 311. If the statement is alleged to be only misleading,
`
`rather than literally false, there is generally "an additional
`
`burden . . . placed upon the plaintiff to show that the
`
`advertisement . . . conveys a misleading message to the viewing
`
`public."3 Id. (second alteration in original) (quoting Clorox,
`
`228 F.3d at 33).
`
`"[F]actfinders
`
`usually
`
`base
`
`literal
`
`falsity
`
`determinations upon the explicit claims made by an advertisement."
`
`Clorox, 228 F.3d at 34-35. However, "they may also consider any
`
`claims the advertisement conveys by 'necessary implication.'" Id.
`
`at 35 (quoting Southland Sod Farms v. Stover Seed Co., 108 F.3d
`
`1134, 1139 (9th Cir. 1997)). We have explained that "[a] claim is
`
`conveyed by necessary implication when, considering the
`
`
`
`3 "[A] plaintiff alleging an implied falsity claim, however,
`is relieved of the burden of demonstrating consumer deception when
`there is evidence that defendants intentionally deceived the
`consuming public." Cashmere & Camel Hair Mfrs. Inst., 284 F.3d at
`311 n.8. No such argument is made here.
`
`- 10 -
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`Case: 21-1492 Document: 00117908881 Page: 11 Date Filed: 08/12/2022 Entry ID: 6513524
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`advertisement in its entirety, the audience would recognize the
`
`claim as readily as if it had been explicitly stated." Id.
`
`When the Lanham Act claim is predicated on finding the
`
`advertisement to be misleading, the question is whether "the
`
`advertisement, though explicitly true, nonetheless conveys a
`
`misleading message to the viewing public." Id. at 33. In other
`
`words, in that circumstance, the question is whether the
`
`advertisement, though "literally true or ambiguous," nonetheless
`
`is "likely to mislead and confuse consumers" into believing a
`
`"false . . . representation of fact." Id. 33 & n.6. Moreover,
`
`when the plaintiff is pursuing a claim based on a statement's
`
`misleadingness, "the plaintiff must show how consumers have
`
`actually reacted to the challenged advertisement, rather than
`
`merely demonstrating how they could have reacted." Id. at 33.
`
`Chapter 93A provides that "[u]nfair methods of
`
`competition and unfair or deceptive acts or practices in the
`
`conduct of any trade or commerce are hereby declared unlawful."
`
`Mass. Gen. Laws ch. 93A, § 2(a). The elements of a Chapter 93A
`
`claim "overlap[]" with those of a Lanham Act false advertising
`
`claim. See Cashmere & Camel Hair Mfrs. Inst., 284 F.3d at 320.
`
`D.
`
`
`
`Edge moved to dismiss Azurity's complaint on March 20,
`
`2020, pursuant to Rule 12(b)(6) and Rule 12(b)(1). Edge gave the
`
`following grounds for dismissal.
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`Case: 21-1492 Document: 00117908881 Page: 12 Date Filed: 08/12/2022 Entry ID: 6513524
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`First, Edge contended that Azurity had not plausibly
`
`alleged a claim under the Lanham Act based on any of the statements
`
`described above because the complaint plausibly alleges no more
`
`than that each of the statements contains "non-actionable puffery,
`
`opinion, and generalized comments about compliance with
`
`administrative law." Edge asserted in support of that contention
`
`that Azurity's complaint lacked the factual allegations necessary
`
`to plausibly allege a Lanham Act claim for either literal falsity
`
`or misleadingness, insofar as the claim relies on the Compliance
`
`or Registration Statements.
`
`Edge contended in the alternative that, under the
`
`analysis set forth in POM Wonderful, the FDCA precludes Azurity's
`
`Lanham Act claim in any of its variants. Thus, Edge contended,
`
`Azurity's Lanham Act claim must be dismissed even if the complaint
`
`plausibly alleges that any or all of the statements at issue are
`
`literally false or misleading.
`
`Relatedly, Edge contended that Azurity's Lanham Act
`
`claim -- again, even if based on plausible allegations of literal
`
`falsity or misleadingness, and no matter on which of the statements
`
`that claim is based -- must be dismissed under the doctrine of
`
`primary jurisdiction. That doctrine requires a federal court
`
`presented with an issue that falls within the primary jurisdiction
`
`of a regulatory agency to "defer any decision in the action before
`
`it until the agency has addressed the issue that is within its
`
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`primary jurisdiction." Ass'n of Int'l Auto. Mfrs., Inc. v. Comm'r,
`
`Mass. Dep't of Env't Prot., 196 F.3d 302, 304 (1st Cir. 1999)
`
`(quoting 2 Kenneth Culp Davis & Richard J. Pierce, Jr.,
`
`Administrative Law Treatise 271 (3d ed. 1994)).
`
`Finally, Edge asserted that Azurity's Chapter 93A claims
`
`must be dismissed. That was so, according to Edge, "because the
`
`allegedly false statements cited by Azurity are not actionable"
`
`under the Lanham Act, Cashmere & Camel Hair Mfrs. Inst., 284 F.3d
`
`at 320 (explaining there that if "plaintiffs were unable to satisfy
`
`the requirements of a Lanham Act claim, they would not be able to
`
`prove their state law claims, as the two have overlapping
`
`requirements"), and because "to the extent that Azurity's state
`
`law claims mirror its Lanham Act claims, they are preempted by the
`
`FDCA."
`
`Azurity filed an opposition to the motion to dismiss.
`
`The opposition addressed each of Edge's asserted grounds for
`
`dismissal.
`
`E.
`
`
`
`The District Court granted Edge's motion and dismissed
`
`the complaint per Rule 12(b)(6) on May 18, 2021. Azurity, 540 F.
`
`Supp. 3d at 145. The District Court began by explaining its ruling
`
`as to the Lanham Act claim. The District Court relied solely on
`
`FDCA preclusion to dismiss the Lanham Act claim.
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`In POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102
`
`(2014), the Supreme Court of the United States rejected the
`
`defendant's contention that the FDCA precluded a Lanham Act claim
`
`that involved a challenge to a statement that had been made in a
`
`label on a food item that was regulated by FDA pursuant to its
`
`authority to administer the FDCA's food labeling provisions. POM
`
`Wonderful, 573 U.S. at 121.
`
`In so deciding, the Court reversed the Ninth Circuit's
`
`holding that the claim was precluded by the FDCA. See POM
`
`Wonderful LLC v. Coca-Cola Co. ("POM I"), 679 F.3d 1170 (9th Cir.
`
`2012), rev'd, 573 U.S. 102 (2014). The Ninth Circuit had found
`
`the claim precluded based on its own precedent establishing that
`
`"a Lanham Act claim may not be pursued if the claim would require
`
`litigating whether [the underlying] conduct [to which the alleged
`
`misstatement refers] violates the FDCA" when the FDA itself has
`
`not determined a violation occurred. See id. at 1176-78 (citing
`
`PhotoMedex, Inc. v. Irwin, 601 F.3d 919, 924 (9th Cir. 2010)).
`
`This was so, the Ninth explained in that prior case, because "the
`
`FDCA may be enforced only by the [federal government]," id. at
`
`1175 (citing 21 U.S.C. § 337(a)), and "allowing such a suit would
`
`undermine" that exclusive enforcement authority, id. at 1176.
`
`The Supreme Court thought differently. In POM
`
`Wonderful, the Court reasoned that "the centralization of FDCA
`
`enforcement authority in the Federal Government does not indicate
`
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`that Congress intended to foreclose private enforcement of other
`
`federal statutes." POM Wonderful, 573 U.S. at 117. Thus, because
`
`the plaintiff there sought to "enforce the Lanham Act, not the
`
`FDCA or its regulations," the FDA's exclusive enforcement
`
`authority did not itself warrant preclusion of the plaintiff's
`
`Lanham Act claim. Id.
`
`In so concluding, the Court did not rule out the
`
`possibility that the FDCA might preclude a Lanham Act claim in
`
`some circumstances, id. at 118, and it specifically noted that the
`
`case before it did not involve a claim of preclusion regarding a
`
`statement about a drug, id. at 109, 116 ("Unlike other types of
`
`labels regulated by the FDA, such as drug labels, it would appear
`
`the FDA does not preapprove food and beverage labels under its
`
`regulations and instead relies on enforcement actions, warning
`
`letters, and other measures." (internal citation omitted)). But,
`
`the Court did not purport to identify any circumstance in which
`
`the FDCA would preclude a Lanham Act claim, and it noted that "the
`
`FDCA and the Lanham Act complement each other in the federal
`
`regulation of misleading food and beverage labels." Id. at 106.
`
`None of the statements at issue in this case appear on
`
`any label that must be approved by the FDA. The statements are
`
`all ones that Edge allegedly made on its website. Nonetheless,
`
`the District Court concluded that the FDCA precluded Azurity's
`
`Lanham Act claim -- seemingly in all its variants -- on the ground
`
`- 15 -
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`
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`Case: 21-1492 Document: 00117908881 Page: 16 Date Filed: 08/12/2022 Entry ID: 6513524
`
`that the evaluation of the merits of the claim necessarily "would
`
`require the court to determine whether defendant is violating the
`
`FDCA and the FDA's interim policies." Azurity, 540 F. Supp. 3d at
`
`143-44. The District Court explained that the FDA had not itself
`
`made those determinations and that "[e]nforcement of the FDCA and
`
`the detailed prescriptions of its implementing regulations is
`
`largely committed to the FDA," id. at 144 (quoting POM Wonderful,
`
`573 U.S. at 115), such that "[i]t would be inappropriate . . . to
`
`resolve plaintiff's Lanham Act claim, which necessitates
`
`resolution of 'thorny questions that may require the FDA's
`
`expertise,'" id. (quoting Allergan USA Inc. v. Imprimis Pharms.,
`
`Inc., No. 17-1551, 2017 WL 10526121, at *7 (C.D. Cal. Nov. 14,
`
`2017)); see also id. ("Because the FDCA forbids private rights of
`
`action . . . [a] Lanham Act [claim] may not be pursued when, as
`
`here, the claim would require litigation of the alleged underlying
`
`FDCA violation where the FDA has not itself concluded that there
`
`was such a violation." (quoting PhotoMedex, Inc., 601 F.3d at
`
`924)). The District Court went on to explain that, because the
`
`FDCA precluded the Lanham Act claim, Azurity's Chapter 93A claim
`
`had to be dismissed as well. Id.
`
`Azurity timely filed this appeal. We review de novo the
`
`District Court's grant of Edge's Rule 12(b)(6) motion to dismiss
`
`Azurity's Lanham Act and Chapter 93A claims. See Clorox, 228 F.3d
`
`at 30.
`
`- 16 -
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`
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`Case: 21-1492 Document: 00117908881 Page: 17 Date Filed: 08/12/2022 Entry ID: 6513524
`
`II.
`
`We start with Azurity's challenge to the District
`
`Court's dismissal of the variant of Azurity's Lanham Act claim
`
`that alleges that Edge's Compliance and Registration Statements
`
`communicate the message that Edge is not "in violation of"
`
`section 503B of the FDCA. Azurity contends that its complaint
`
`plausibly alleges in this variant of its Lanham Act claim that
`
`Edge has engaged in conduct that is barred by the portion of
`
`section 503B that restricts the marketing of compounded drugs that
`
`are "essentially a copy" of approved drugs, 21 U.S.C. § 353b(a)(5).
`
`Accordingly, Azurity contends, it has plausibly alleged that the
`
`Compliance Statements are literally false and the Registration
`
`Statements are misleading due to the messages that those statements
`
`communicate concerning Edge's purported compliance with the
`
`"essentially a copy" portion of section 503B and what conditions
`
`that portion of that section of the FDCA sets forth. Azurity
`
`further contends that, given that this variant of its Lanham Act
`
`claim is otherwise actionable, the District Court erred in
`
`dismissing it, because the FDCA does not preclude it.
`
`We reject Azurity's challenge to the District Court
`
`order of dismissal as to this variant of Azurity's Lanham Act
`
`claim. We do not do so, however, based on FDCA preclusion, even
`
`though Edge urges us to affirm the ruling below on that basis. We
`
`do so because, as we will explain, we are persuaded by the
`
`- 17 -
`
`
`
`Case: 21-1492 Document: 00117908881 Page: 18 Date Filed: 08/12/2022 Entry ID: 6513524
`
`alternative ground that Edge advances to us on appeal for affirming
`
`the District Court's order of dismissal for this variant of
`
`Azurity's Lanham Act claim. See Lin v. TipRanks, Ltd., 19 F.4th
`
`28, 36 (1st Cir. 2021) ("We, of course, may affirm the District
`
`Court's ruling on any ground manifest in the record.").
`
`A.
`
`We begin with Edge's assertion that, FDCA preclusion
`
`aside, Azurity fails to state a claim on which relief can be
`
`granted in the variant of its Lanham Act claim that alleges that
`
`the Compliance Statements, insofar as they communicate that Edge
`
`is not in violation of the "essentially a copy" provision of
`
`section 503B, make a literally false representation of fact.4 In
`
`advancing this non-preclusion-based ground for dismissal, Edge
`
`relies chiefly on two out-of-circuit precedents that set forth a
`
`framework for assessing when a statement that concerns whether an
`
`entity is in violation of a law is actionable under the Lanham
`
`Act. The two precedents are Coastal Abstract Service, Inc. v.
`
`
`
`4 Azurity mentions in passing that the Compliance Statements
`"mislead health care providers and other customers into believing
`that Edge's vancomycin product complies with state and federal
`law, and that it is safe, effective, and legal." But, Azurity
`develops no argument as to whether, or why, the Compliance
`Statements are misleading as to the "safe[ty], effective[ness],
`and legal[ity]" of Edge's vancomycin product if the assertion that
`Edge is not in violation of section 503B is not literally false.
`Thus, any such argument is waived for lack of development. See
`Zannino, 895 F.2d at 17.
`
`
`- 18 -
`
`
`
`Case: 21-1492 Document: 00117908881 Page: 19 Date Filed: 08/12/2022 Entry ID: 6513524
`
`First American Title Insurance Co., 173 F.3d 725 (9th Cir. 1999),
`
`and Dial A Car, Inc. v. Transportation, Inc., 82 F.3d 484 (D.C.
`
`Cir. 1996).5
`
`In Coastal Abstract, the Ninth Circuit considered
`
`whether a plaintiff could state a Lanham Act claim based on a
`
`defendant's statement that the plaintiff "was not licensed in
`
`California as an escrow company," 173 F.3d at 729, and the fact
`
`that the defendant "stated or clearly implied" that such a license
`
`was "required [by California law] . . . for [the plaintiff's]
`
`activities in connection with refinancing California property,"
`
`id. at 731. The Ninth Circuit concluded that, "[a]bsent a clear
`
`and unambiguous ruling from a court or agency of competent
`
`jurisdiction, statements by laypersons that purport to interpret
`
`the meaning of a statute or regulation are opinion statements, and
`
`not statements of fact," and, as such, are "not generally
`
`actionable under the Lanham Act." Id. The Ninth Circuit ruled on
`
`
`
`5 In its briefing to us, Edge also cites to a district court
`case that presented a similar situation to Dial A Car, in which
`that court adopted the reasoning of the D.C. Circuit in that case,
`Greenwich Taxi, Inc. v. Uber Techs., Inc., 123 F. Supp. 3d 327,
`335-36 (D. Conn. 2015), as well as several other cases in which
`the district courts there concluded that a legal opinion could not
`form the basis of a Lanham Act claim, see Metro. Reg'l Info. Sys.,
`Inc. v. Am. Home Realty Network, Inc., 948 F. Supp. 2d 538, 554
`(D. Md. 2013); Language Line Servs., Inc. v. Language Servs.
`Assocs., LLC, No. 10-02605, 2011 WL 5024281, *11 (N.D. Cal. Oct.
`13, 2011). These cases accord with our understanding that Edge is
`asking us to apply the analytic framework that Dial A Car and
`Coastal Abstract adopt.
`
`- 19 -
`
`
`
`Case: 21-1492 Document: 00117908881 Page: 20 Date Filed: 08/12/2022 Entry ID: 6513524
`
`that basis that the plaintiff had not sufficiently plead that the
`
`statement at issue was false or misleading in violation of the
`
`Lanham Act, because "the correct application of [the statutory
`
`licensing requirement] was not knowable to the parties at the time
`
`that [the defendant] made the licensure statement." Id. at 732.
`
`In Dial A_Car, the D.C. Circuit considered a plaintiff's
`
`contention that the defendants "violat[ed] the Lanham Act by
`
`misrepresenting to [the plaintiff]'s actual and potential . . .
`
`customers that [the defendants'] taxicabs can legally provide
`
`within [Washington, D.C.]" point-to-point transportation to
`
`corporate clients using taxicabs licensed in Virginia or Maryland,
`
`but not D.C. 82 F.3d at 486. The plaintiff argued there that an
`
`order by the D.C. Taxicab Commission Office prohibited the
`
`defendants' taxicabs from providing the service in question to or
`
`from D.C. unless their passengers' origin or destination was in
`
`the county of the taxicabs' licensure. Id. The D.C. Circuit held
`
`that the defendants' representations at issue were not actionable
`
`under the Lanham Act, because "there must be a clear and
`
`unambiguous statement from the Taxicab Commission regarding [the
`
`defendants'] status before a Lanham Act claim can be entertained"
`
`based on the defendants' statements "that they lawfully may
`
`perform" a particular service and there was none in that case.
`
`Id. at 485, 489 (emphasis in original).
`
`- 20 -
`
`
`
`Case: 21-1492 Document: 00117908881 Page: 21 Date Filed: 08/12/2022 Entry ID: 6513524
`
`The D.C. Circuit did acknowledge that it was possible
`
`that "a regulation might conceivably be drafted that would be so
`
`clear on its face that no good faith doubt concerning its
`
`interpretation would be possible, even without an explicit
`
`statement from the [relevant regulatory entity]." Id. at 489 n.3.
`
`In such a circumstance, the court posited, the meaning of the
`
`regulation in question could be "so clear as to be a fact for
`
`Lanham Act purposes," id., such that a representation concerning
`
`the meaning of that law in advertising -- as a representation as
`
`to whether the defendant was violating a law would necessarily
`
`make -- might be actionable as a "false or misleading
`
`representation of fact," 15 U.S.C. § 1125(a)(1). But, the D.C.
`
`Circuit explained, the regulation at issue in that case was not of
`
`that sort. Dial A Car, 82 F.3d at 489 n.3. It thus held the
`
`Lanham Act claim there could not go forward on that basis. Id.
`
`Azurity does not take issue with the framework for
`
`analysis that Coastal Abstract and Dial A Car s
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