The opinion
Filed 3/9/23
CERTIFIED FOR PUBLICATION
IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA
FIRST APPELLATE DISTRICT
DIVISION ONE
CENTER FOR ENVIRONMENTAL
HEALTH,
Plaintiff and Appellant, A163682
v. (Alameda County
PERRIGO COMPANY et al., Super. Ct. No. RG20-054985)
Defendants and Respondents.
Appellant Center for Environmental Health (CEH) sued respondents,
various manufacturers and retailers of generic over-the-counter (OTC)
antacids, claiming they failed to warn consumers that the products contained
a known carcinogen under Proposition 65, the Safe Drinking Water and Toxic
Enforcement Act of 1986, Health and Safety Code section 25249.5 et sequitur
(Proposition 65).1 CEH also sued two manufacturers of Zantac, the brand-
name version of respondents’ products.2
Respondents are Dr. Reddy’s Laboratories, Inc., and Dr. Reddy’s
1
Laboratories Louisiana, LLC (collectively, Dr. Reddy’s), Perrigo Company,
Target Corporation, Apotex Corp., Granules USA, Inc., and 7-Eleven, Inc. All
further statutory references are to the Health and Safety Code unless
otherwise noted.
2The brand-name manufacturers sued are Sanofi-Aventis U.S. LLC
and Chattem Inc. Although they are not parties to this appeal, we discuss
issues related to them to provide relevant context.
1
Respondents, whom we will refer to as the generic-drug defendants,
demurred to the complaint on the basis that the federal Food, Drug, and
Cosmetic Act, 21 United States Code section 301 et sequitur (FDCA),
preempted CEH’s claim. The remaining defendants, whom we will refer to as
the brand-name defendants, demurred on the same basis. The trial court
sustained the generic-drug defendants’ demurrers without leave to amend
and entered judgment in their favor. But the court sustained the brand-
name defendants’ demurrers with leave to amend, and CEH’s action against
them is proceeding below.
On appeal, CEH contends the trial court erred by ruling that conflict
preemption bars CEH’s claim against the generic-drug defendants on the
basis that it would be impossible for them to comply with both state and
federal law.3 The court determined that the generic-drug defendants cannot
give a Proposition 65 warning about the products without violating the
federal duty of sameness, which requires the generic version of a drug to have
the same “labeling” as the brand-name version. (See PLIVA, Inc. v. Mensing
(2011) 564 U.S. 604, 612–613 (Mensing).) Given the broad definition of
“labeling” under the FDCA, the court concluded there was no permissible
method of giving a Proposition 65 warning without the manufacturer of the
brand-name equivalent doing so first.
We affirm the dismissal of the action against the generic-drug
defendants. Due to the unusual interplay between an express preemption
provision governing OTC drugs and Proposition 65, the viability of CEH’s
suit against the generic-drug defendants turns on whether federal law
governs warning in a manner that preempts state law governing warning.
3The Attorney General filed an amicus curiae brief in support of CEH,
as authorized under California Rules of Court, rule 8.200(c)(7).
2
We conclude that it does. Although we do not hold that all methods of
publicly communicating a warning about a drug necessarily qualify as
“labeling,” CEH fails to identify any method by which the generic-drug
defendants could provide a warning about their consumer products that
would satisfy both Proposition 65 and the federal duty of sameness. As a
result, until brand-name manufacturers give a Proposition 65 warning on
their products’ labeling, the generic-drug defendants cannot be required to do
so.
I.
FACTUAL AND PROCEDURAL
BACKGROUND
This lawsuit concerns OTC antacids with the active ingredient
ranitidine. The following facts are taken from CEH’s second amended
complaint (SAC), and we accept them as true in reviewing whether the
generic-drug defendants’ demurrers were properly sustained. (See Ace
American Ins. Co. v. Fireman’s Fund Ins. Co. (2016) 2 Cal.App.5th 159, 164.)
The generic-drug defendants either manufacture or sell generic
versions of ranitidine-containing antacids, which are also sold under the
brand name Zantac. The chemical n-nitrosodimethylamine (NDMA), a
known carcinogen that “is used in laboratory research to induce tumors in
experimental animals[,] . . . can . . . form during the manufacturing process of
certain drug products, such as those containing ranitidine.”
In September 2019, after an independent laboratory found “significant
quantities of NDMA” in ranitidine-containing antacids, the United States
Food and Drug Administration (FDA) issued a public alert. Some
3
manufacturers voluntarily recalled their products.4 A subsequent FDA
analysis “determined that NDMA formation can occur in ranitidine through
the use of contaminated materials and ingredients, the application of inferior
drug manufacturing processes, and improper drug storage after
manufacture.” FDA testing also confirmed the presence of NDMA at varying
levels in the generic-drug defendants’ ranitidine products.
In April 2020, the FDA “request[ed that] manufacturers withdraw all
prescription and [OTC] ranitidine drugs from the market immediately.” CEH
alleges that despite “the publicity and recalls,” the generic-drug defendants
“continued to expose individuals to NDMA without prior clear and reasonable
warnings regarding the carcinogenic hazards of NDMA,” and that this failure
to warn is ongoing.5
CEH, as a nonprofit corporation acting in the public interest, originally
sued Perrigo and Target in February 2020.6 (See § 25249.7, subd. (d).) The
remaining respondents, as well as the brand-name defendants, were
subsequently added as defendants. The brand-name defendants manufacture
and sell Zantac; Perrigo, Apotex, Granules, and Dr. Reddy’s manufacture
generic versions of Zantac; and 7-Eleven and Target sell generic versions of
Zantac.
4 CEH filed a request for judicial notice of announcements by four
companies, three of whom are generic-drug defendants, of voluntary recalls of
ranitidine products. We deny the request as unnecessary to our decision.
5 At oral argument, CEH’s counsel stated that respondents stopped
selling contaminated products several years ago.
6 The presence of NDMA in Zantac and generic ranitidine products is
also the subject of a multidistrict litigation in federal court. (See In re Zantac
(Ranitidine) Products Liability Litigation (S.D. Fla. 2021) 548 F.Supp.3d
1225, 1228–1229.)
4
In January 2021, CEH filed the SAC, which alleged a cause of action
for injunctive relief under Proposition 65 to prevent the defendants from
selling the products “without providing prior clear and reasonable warnings”
about “the carcinogenicity of NDMA.” CEH also sought civil penalties and
attorney’s fees and costs.
All the defendants demurred to the SAC on the basis that CEH’s claim
was preempted by federal law. The brand-name defendants contended that it
was impossible for them to add Proposition 65 warnings to their labeling
unilaterally without violating federal law. Similarly, the generic-drug
defendants contended that it was impossible to satisfy Proposition 65 without
violating federal law governing labeling for generic drugs, which must always
be the same as the labeling for the drugs’ brand-name equivalents.7
In May 2021, the trial court issued an order sustaining the brand-name
defendants’ demurrers with leave to amend and the generic-drug defendants’
demurrers without leave to amend. The following month, CEH filed a third
amended complaint against the brand-name defendants only. A judgment
dismissing the complaint against the generic-drug defendants was entered in
August 2021, from which CEH appealed.
II.
DISCUSSION
A. General Legal Standards
1. Federal preemption and standard of review
“The Supremacy Clause provides that the laws and treaties of the
United States ‘shall be the supreme Law of the Land . . . any Thing in the
Constitution or Laws of any state to the Contrary notwithstanding.’ ” (Mut.
7 Apotex also unsuccessfully argued that CEH’s claim was moot and
failed due to field preemption. Apotex does not challenge the trial court’s
rejection of these arguments.
5
Pharm. Co. v. Bartlett (2013) 570 U.S. 472, 479 (Bartlett), quoting U.S.
Const., art. VI, cl. 2.) Thus, “[w]hen a state statute, administrative rule, or
common-law cause of action conflicts with a federal statute, it is axiomatic
that the state law is without effect.” (Geier v. American Honda Motor Co.,
Inc. (2000) 529 U.S. 861, 894.) “Similarly, federal agencies, acting pursuant
to authorization from Congress, can issue regulations that override state
requirements.” (Quesada v. Herb Thyme Farms, Inc. (2015) 62 Cal.4th 298,
308.)
Express preemption occurs when Congress provides by statute that
state law is preempted. (Crosby v. National Foreign Trade Council (2000)
530 U.S. 363, 372.) There are also various forms of implied preemption.
Field preemption occurs “[w]hen Congress intends federal law to ‘occupy the
field.’ ” (Ibid.) And conflict preemption occurs in two main situations:
(1) “where it is impossible for a private party to comply with both state and
federal law” and (2) “where ‘under the circumstances of [a] particular case,
[the challenged state law] stands as an obstacle to the accomplishment and
execution of the full purposes and objectives of Congress.’ ” (Id. at pp. 372–
373.) Here, we are concerned only with the first type of conflict preemption,
which we will refer to as impossibility preemption.
“Consideration of issues arising under the Supremacy Clause ‘starts
with the assumption that the historic police powers of the States [are] not to
be superseded by . . . Federal Act unless that [is] the clear and manifest
purpose of Congress.’ ” (Cipollone v. Liggett Group (1992) 505 U.S. 504, 516.)
Since “ ‘ “[c]ourts are reluctant to infer preemption, . . . it is the burden of the
party claiming that Congress intended to preempt state law to prove it.” ’ ”
(Viva! Internat. Voice for Animals v. Adidas Promotional Retail Operations,
6
Inc. (2007) 41 Cal.4th 929, 936.) Congressional intent “ ‘ “is the ultimate
touchstone” ’ of pre[]emption analysis.” (Cipollone, at p. 516.)
We review de novo an order sustaining a demurrer. (T.H. v. Novartis
Pharmaceuticals Corp. (2017) 4 Cal.5th 145, 162 (T.H.).) Likewise, whether
state law is federally preempted is “a pure question of law” that we
independently review. (Farm Raised Salmon Cases (2008) 42 Cal.4th 1077,
1089, fn. 10.) In deciding whether a demurrer was properly sustained, “[w]e
are not bound by the trial court’s stated reasons, if any, supporting its ruling;
we review the ruling, not its rationale.” (Mendoza v. Town of Ross (2005)
128 Cal.App.4th 625, 631.)
2. Proposition 65
“Proposition 65, which was passed as a ballot initiative in 1986,
requires the state to develop and maintain a list of chemicals ‘known to the
state to cause cancer or reproductive toxicity.’ ” (American Meat Institute v.
Leeman (2009) 180 Cal.App.4th 728, 735 (Leeman), quoting § 25249.8,
subd. (a).) NDMA is listed as a known carcinogen. (Cal. Code Regs., tit. 27,
§ 27001, subd. (b).)8
Proposition 65 provides that “[n]o person in the course of doing
business shall knowingly and intentionally expose any individual to a
chemical known to the state to cause cancer or reproductive toxicity without
first giving clear and reasonable warning to such individual, except as
provided in Section 25249.10.” (§ 25249.6.) In turn, section 25249.10
provides that section 25249.6 does not apply to “[a]n exposure for which the
person responsible can show that the exposure poses no significant risk
assuming lifetime exposure at the level in question for substances known to
8All further references to “Regulations” are to title 27 of the California
Code of Regulations.
7
the state to cause cancer.” (§ 25249.10, subd. (c).) Nor does section 25249.6
apply to “[a]n exposure for which federal law governs warning in a manner
that preempts state authority.” (§ 25249.10, subd. (a).)
The required warning under section 25249.6 “need not be provided
separately to each exposed individual and may be provided by general
methods such as labels on consumer products, . . . posting of notices, placing
notices in public news media, and the like, provided that the warning
accomplished is clear and reasonable.” (§ 25249.11, subd. (f).) Regulations
implementing Proposition 65 “describe optional ‘safe harbor’ warnings that
are deemed to be clear and reasonable.” (Dowhal v. SmithKline Beecham
Consumer Healthcare (2004) 32 Cal.4th 910, 918 (Dowhal); see Regs., § 25600
et seq.) The safe-harbor warning for carcinogens reads, “This product can
expose you to chemicals including [name of one or more chemicals], which is
[are] known to the State of California to cause cancer. For more information
go to www.P65Warnings.ca.gov.” (Regs., § 25603, subd. (a)(2)(A).)
An action under Proposition 65 “fundamentally seeks a form of
declaratory relief—that the product requires a warning.” (DiPirro v. Bondo
Corp. (2007) 153 Cal.App.4th 150, 182 (DiPirro).) Other remedies include
injunctive relief and civil penalties. (§ 25249.7, subds. (a) & (b).)
3. The FDCA
The FDCA “ ‘regulates the manufacture, use, or sale of drugs.’ ” (Merck
KGaA v. Integra Lifesciences I, Ltd. (2005) 545 U.S. 193, 196.) Under the
FDCA, “a manufacturer seeking federal approval to market a new drug must
prove that it is safe and effective and that the proposed label[ing] is accurate
and adequate. [Citations.] Meeting those requirements involves costly and
lengthy clinical testing.” (Mensing, supra, 564 U.S. at p. 612, fn. omitted;
21 U.S.C. § 355(b)(1), (d).) A new drug application (NDA) “will be refused if
8
the FDA determines that the labeling is false or misleading in any particular,
if the application contains an untrue statement of a material fact, or if the
proposed labeling does not comply with . . . [applicable] regulations.”
(Kanter v. Warner-Lambert Co. (2002) 99 Cal.App.4th 780, 785, citing
21 U.S.C. § 355(d)(7) & 21 C.F.R. § 314.125(b)(6)–(8); see 21 U.S.C.
§ 352(a)(1) [drug is considered misbranded “[i]f its labeling is false or
misleading in any particular”].)
The 1984 Drug Price Competition and Patent Term Restoration Act,
98 Stat. 1585 (21 U.S.C. § 355(j)), also known as the Hatch-Waxman Act,
authorizes “a prospective generic drug manufacturer to file an abbreviated
new drug application (ANDA) asserting the generic drug’s bioequivalence to
an existing listed drug that has already been approved by the FDA. . . . The
streamlined application relieves the generic manufacturer of the need to
duplicate the clinical trials previously submitted for the equivalent brand-
name drug.” (T.H., supra, 4 Cal.5th at p. 157; Mensing, supra, 564 U.S. at
p. 612.) Thus, manufacturers can develop generic drugs more cheaply and
pass those savings to consumers. (See Mensing, at p. 612; Andrx
Pharmaceuticals, Inc. v. Biovail Corp. (Fed. Cir. 2002) 276 F.3d 1368, 1370–
1371.)
In addition to asserting bioequivalence, an ANDA “must also ‘show that
the [safety and efficacy] labeling proposed . . . is the same as the labeling
approved for the [brand-name] drug.’ ” (Mensing, supra, 564 U.S. at pp. 612–
613, quoting 21 U.S.C. § 355(j)(2)(A)(v).) The FDCA defines “labeling” as “all
labels and other written, printed, or graphic matters (1) upon any article or
any of its containers or wrappers, or (2) accompanying such article.”
(21 U.S.C. § 321(m).) While the brand-name manufacturer “bears
responsibility for the accuracy and the adequacy of its label ‘as long as the
9
drug is on the market,’ ” a generic manufacturer “is responsible only for ‘an
ongoing federal duty of “sameness.” ’ ” (T.H., supra, 4 Cal.5th at p. 157;
Mensing, at p. 613.) The duty of sameness requires a generic manufacturer
to ensure that its labeling is the same as the brand-name manufacturer’s,
both when its labeling is approved and thereafter. (Mensing, at p. 613; T.H.,
at p. 157.) Otherwise, a labeling difference could “inaccurately imply a
therapeutic difference between the brand and generic drugs and thus could
be impermissibly ‘misleading.’ ” (Mensing, at p. 615.)
In certain circumstances, the manufacturer of a brand-name drug can
change the drug’s labeling without FDA approval. “Generally speaking, a
manufacturer may only change a drug label after the FDA approves a
supplemental application.” (Wyeth v. Levine (2009) 555 U.S. 555, 568;
21 C.F.R. § 314.70.) But under “the FDA’s ‘changes-being-effected’ (CBE)
process,” a manufacturer can make certain changes to a drug’s labeling
without needing to “wait for preapproval by the FDA.” (Mensing, supra,
564 U.S. at p. 614; 21 C.F.R. § 314.7(c)(6).) These include any “[c]hange[] in
the labeling to reflect newly acquired information” that will “add or
strengthen a contraindication, warning, precaution, or adverse reaction.”
(21 C.F.R. § 314.70(c)(6)(iii)(A).) Although the manufacturer of a generic
drug can use the CBE process to “change[] its label to match an updated
brand-name label or to follow the FDA’s instructions,” unlike a brand-name
manufacturer it cannot use the process “to unilaterally strengthen [its]
warning label[].” (Mensing, at p. 614.)
The FDCA contains a provision expressly preempting state law
regarding OTC drugs. 21 United States Code section 379r (section 379r),
titled “National uniformity for nonprescription drugs,” provides that “no
State or political subdivision of a State may establish or continue in effect
10
any requirement . . . [¶] (1) that relates to the regulation of a
[nonprescription] drug . . . and [¶] (2) that is different from or in addition to,
or that is otherwise not identical with, a requirement under this Act.”
(§ 379r(a).) For purposes of section 379r(a), “a requirement that relates to
the regulation of a drug shall be deemed to include any requirement relating
to public information or any other form of public communication relating to a
warning of any kind for a drug.” (§ 379r(c)(2).)
Proposition 65 is exempted from express preemption under section 379r
by “a savings clause designed specifically to preserve [it].” (Dowhal, supra,
32 Cal.4th at p. 919.) Under the savings clause, section 379r does “not apply
to a State requirement adopted by a State public initiative or referendum
enacted prior to September 1, 1997.” (§ 379r(d)(2).)9 “Proposition 65 is the
only state enactment that falls within the savings clause.” (Dowhal, at
p. 919.)
B. The Limited Nature of Our Holding
Before we analyze CEH’s claims of error, we mention two aspects of
this case that distinguish it from cases involving similar issues and that limit
our holding and its practical effect. First, NDMA is a contaminant, not an
intended ingredient of the drugs at issue. The SAC alleges that the products
have been subject to recalls, but it also alleges that the generic-drug
defendants continue to sell products containing NDMA. Although for
9 Section 379r also contains a second savings clause, under which
nothing in the statute “shall be construed to modify or otherwise affect any
action or the liability of any person under the product liability law of any
State.” (21 U.S.C. § 379r(e).) It is undisputed that this savings clause does
not apply because CEH’s claim does not involve California product-liability
law, under which “injury to the plaintiff from a defective product is an
essential element of a cause of action.” (Kanter v. Warner-Lambert Co.,
supra, 99 Cal.App.4th at p. 790.)
11
purposes of our review we must accept the allegation that contaminated
drugs continue to be sold, our record does not reveal how the generic-drug
defendants could continue to sell them without running afoul of the FDA. A
lawsuit seeking to require warnings that the products contain NDMA—
which, again, is not supposed to be in them at all—seems a poor way to
address the potential danger to consumer health. Consumers would likely be
better protected by removing the contaminated drugs from the market than
by allowing the drugs’ sale, even with a warning, in a contaminated state.
Proposition 65 is intended “to regulate toxic substances [that] are
deliberately added or put into the environment by human activity.” (Nicolle-
Wagner v. Deukmejian (1991) 230 Cal.App.3d 652, 659, italics added.) Thus,
regardless of preemption issues, a Proposition 65 warning about NDMA
would only be required if it became acceptable for the drugs to contain the
contaminant and the generic-drug defendants continued selling contaminated
products. As a result, resolving whether CEH’s claim is preempted because it
seeks to impose a state-law “labeling” requirement is something of a
theoretical exercise; as a practical matter, no such labeling is likely to result
from this litigation.
Second, this appeal concerns only the generic-drug defendants. As we
have said, CEH’s claim against the brand-name defendants is proceeding
below, based on the possibility that they could unilaterally add a
Proposition 65 warning to their products through the CBE process. Putting
aside the contamination issue, if CEH were to prevail and the brand-name
defendants were required to provide a Proposition 65 warning on their
products’ labeling, then the generic-drug defendants would have to do so as
well to comply with the federal duty of sameness. Thus, our holding that
CEH’s claim against the generic-drug defendants is preempted does not
12
foreclose the possibility that a Proposition 65 warning could be required for
their products, so long as such a warning was first required of manufacturers
of brand-name equivalents.
C. The Effect of the Statutory Preemption Provisions
We now turn to the preemption-related provisions of the FDCA and
Proposition 65. It is undisputed that if not for the savings clause of
section 379r, that statute would preempt CEH’s claim because the claim
seeks to establish a “requirement relating to public information or any other
form of public communication relating to a warning of any kind for [an OTC]
drug” that “is different from or in addition to, or . . . otherwise not identical
with, a requirement under [the FDCA].” (21 U.S.C. § 379r(a)(2), (c)(2).) But
because the savings clause of section 379r provides that the statute does not
apply to Proposition 65 (21 U.S.C. § 379r(d)(2)), federal law does not
expressly preempt suits under Proposition 65 involving OTC drugs.
Dowhal held that although section 379r’s savings clause excludes
Proposition 65 from express preemption, the clause “does not entirely exclude
conflict preemption,” that is, impossibility or obstacle preemption. (Dowhal,
supra, 32 Cal.4th at pp. 923–924, 926.) Dowhal determined that Geier v.
American Honda Motor Co., Inc., supra, 529 U.S. 861 “established a general
rule upholding conflict preemption even if the applicable federal law contains
a savings clause” exempting a state requirement from express preemption.
(Dowhal, at pp. 925–926.) Thus, if a Proposition 65 requirement is “in direct
conflict with . . . or frustrate[s] the purpose of” an FDA requirement, the state
requirement is preempted. (Id. at pp. 924, 926.)
Dowhal quoted, but did not discuss the effect of, Proposition 65’s
provision that section 25249.6 does not apply to “[a]n exposure for which
federal law governs warning in a manner that preempts state authority.”
13
(§ 25249.10, subd. (a); Dowhal, supra, 32 Cal.4th at p. 918.) Referring to this
provision as Proposition 65’s “self-exception,” the trial court here concluded
that it “does more than state the obvious, which is that federal law preempts
state law.” The court interpreted it to mean “that if federal law on warning
preempts state law on warning, then there is no liability for an exposure
under [section] 25249.6,” regardless of the basis for that liability, “and thus
the court cannot order any non-warning injunctive relief or award any
penalties.” Later in the order, the court also indicated that even if “the
FDCA might not prevent the [manufacturers] from voluntarily putting
Proposition 65 warnings in advertisements for the [p]roducts, the FDCA’s
regulation of warnings on labels and in label[]ing means that ‘federal law
governs warning in a manner that preempts state authority,’ which means
that [Proposition 65’s] self-exception applies.”
CEH claims the trial court erred by interpreting Proposition 65’s self-
exception to “compel[] preemption even in circumstances where the federal
Constitution does not, e.g., where the violations could be rectified by means
other than providing a warning (such as reformulation), or where certain
types of warnings may be precluded but others are not (e.g., a label warning
versus an advertisement warning).” In other words, CEH contends the court
interpreted Proposition 65’s self-exception “to mean that where federal law
preempts any aspect of state authority under Proposition 65, Proposition 65
is wholly preempted.”
We review issues of statutory interpretation de novo. (Lopez v.
Ledesma (2022) 12 Cal.5th 848, 857.) Under “ ‘the ordinary rules and canons
of statutory construction,’ ” which also apply to initiative measures, “ ‘[w]e
look first to the language of the statute, giving the words their ordinary
meaning, and construing the statutory language in the context of the statute
14
as a whole and the overall statutory scheme.’ . . . ‘ “We give the language its
usual and ordinary meaning, and ‘[i]f there is no ambiguity, then we presume
the lawmakers meant what they said, and the plain meaning of the language
governs.’ . . . Ultimately we choose the construction that comports most
closely with the apparent intent of the lawmakers, with a view to promoting
rather than defeating the general purpose of the statute.” ’ ” (DiPirro, supra,
153 Cal.App.4th at pp. 190–191.) As “ ‘a remedial law, designed to protect
the public,’ ” Proposition 65 must be “ ‘construe[d] . . . broadly to accomplish
that protective purpose.’ ” (Lee v. Amazon.com, Inc. (2022) 76 Cal.App.5th
200, 226.)
It is not clear that the trial court interpreted Proposition 65’s self-
exception as broadly as CEH claims it did. In any event, the generic-drug
defendants disclaim any interpretation under which Proposition 65 is wholly
preempted if even one method of satisfying it is preempted. We agree with
the parties that the self-exception does not mean that section 25249.6 would
be inapplicable if federal law were to preempt a single type of warning that
would otherwise be required under Proposition 65 but not other types of
Proposition 65 warnings. For example, there is no dispute that federal law
bars the manufacturer of a generic OTC drug from unilaterally putting a
Proposition 65 warning on its product’s container. Even though federal law
thus governs warning in a manner that preempts some state authority, we
decline to conclude that Proposition 65’s self-exception therefore establishes a
manufacturer cannot be liable for failing to warn in a manner that federal
law would allow. Such a reading is inconsistent not only with the principle
that Proposition 65 be interpreted in a manner that effectuates its remedial
purpose but also with section 379r’s savings clause, which expresses a
congressional intent to permit Proposition 65 warnings involving OTC drugs.
15
The true dispute on appeal is whether Proposition 65’s self-exception
means, as CEH claims, that “compliance with Proposition 65 by any means
must be completely impossible for Proposition 65 to be entirely preempted,”
or, as the generic-drug defendants claim, that a defendant is not liable under
section 25249.6 if all possible warnings are preempted by federal law. We
conclude that the generic-drug defendants have the better argument.
To begin with, the parties disagree about the potential methods of
complying with section 25249.6. CEH claims that “a defendant may avoid
Proposition 65 liability” for exposing consumers to consumer products that
contain carcinogens “either by (a) providing a clear and reasonable warning,
or (b) taking any number of steps to eliminate or reduce the levels of the
listed chemical to below the level requiring a warning.”10 Similarly, the trial
court indicated that a defendant can “avoid liability by either providing a
warning or ensuring that its products have chemical exposure below the ‘no
significant risk’ level.”11 The generic-drug defendants, however, reject this
“novel ‘dual compliance’ construction of Proposition 65,” arguing that “a duty
to warn is the only duty imposed by [section 25249.6].” Likewise, in his
10CEH identifies numerous examples of how manufacturers could
reduce the amount of NDMA in the products at issue, including by “adopting
better drug manufacturing practices,” “storing the [p]roducts at lower
temperatures,” or “spot-testing [p]roducts . . . and not selling those that are
found to contain high NDMA levels.” For the sake of simplicity, we will refer
to any action that would result in the products no longer containing an
amount of NDMA requiring a warning as “reformulation.”
11Elsewhere in the order, the trial court stated that “liability for an
exposure under [section] 25249.6” may be “based on either lack of warning or
knowing exposure to chemicals.” This statement is puzzling, since “knowing
exposure to chemicals” is not enough to establish liability. To the contrary,
an entity is free to “knowingly and intentionally expose” consumers to
carcinogens so long as it “first giv[es] clear and reasonable warning” it is
doing so. (§ 25249.6.)
16
amicus curiae brief the Attorney General argues that “reformulation is not a
statutory duty or requirement” under Proposition 65.12
In our view, the parties’ positions on this issue do not substantively
conflict. Section 25249.6 does “not apply” to an exposure to a low-enough
level of a carcinogen (§ 25249.10), meaning CEH is correct that reformulation
is one way to avoid liability under Proposition 65. But the generic-drug
defendants and the Attorney General are correct that section 25249.6 itself
does not impose a duty to reformulate, because exposures below a certain
level are exempted from that statute’s reach.
This is significant because even if reformulation is a potential remedy
for a violation of section 25249.6, a suit under that provision fundamentally
seeks to impose a state-law warning requirement, not a reformulation
requirement. (See DiPirro, supra, 153 Cal.App.4th at p. 182.) In turn,
Proposition 65’s self-exception provides that section 25249.6 is inapplicable to
an exposure if “federal law governs warning in a manner that preempts state
authority.” (§ 25249.10, subd. (a), italics added.) Thus, the most reasonable
interpretation of Proposition 65’s self-exception is that if federal law governs
warning in a manner that preempts state law authority governing warning,
there is no liability for exposing consumers to a regulated substance—
meaning that no remedy, including reformulation, is available. CEH’s
interpretation, in contrast, would mean that even if it were impossible to
comply with both federal and state warning requirements, a suit under
12 CEH also filed a request for judicial notice of the Attorney General’s
amicus curiae brief filed in another Proposition 65 appeal. CEH claims the
brief shows that the Attorney General agrees that Proposition 65 “plainly
contemplates two methods of compliance: providing a clear and reasonable
warning or not exposing persons to listed chemicals.” We deny the request,
because whatever the Attorney General’s position on this issue may be in a
different case is not relevant to our decision.
17
section 25249.6 would never be preempted by the self-exception because
federal law would never “govern[] warning” in a manner that preempted
reformulation.
In sum, we conclude that Proposition 65’s self-exception applies, and
CEH’s action against the generic-drug defendants cannot go forward, if
federal law governs warning in a manner that preempts state law governing
warning. Thus, the determinative issue is whether it is possible for the
generic-drug defendants to provide warnings about their products that satisfy
both Proposition 65 and federal law. If it is possible, then federal law
governing warning does not preempt state authority governing warning,
Proposition 65’s self-exception does not apply, and CEH’s suit may proceed.
If it is not possible, then federal law governing warning preempts state
authority governing warning despite section 379r’s savings clause,
Proposition 65’s self-exception does apply, and CEH’s suit against the
generic-drug defendants may not proceed. Therefore, we turn to whether the
generic-drug defendants could give warnings about their products that
comply with both Proposition 65 and federal law.
D. CEH Identifies No Method by Which the Generic-drug Defendants
Could Both Comply With the Federal Duty of Sameness and Give
Warnings that Satisfy Proposition 65.
1. The generic-drug defendants’ duties under state and
federal law
Impossibility preemption exists “where ‘compliance with both federal
and state regulations is a physical impossibility.’ ” (Arizona v. United States
(2012) 567 U.S. 387, 399.) The first step in determining whether this form of
preemption applies is to identify a defendant’s duty under state law.
(Bartlett, supra, 570 U.S. at p. 480; Trejo v. Johnson & Johnson (2017)
13 Cal.App.5th 110, 153.) As noted above, Proposition 65 requires a company
18
to “giv[e] clear and reasonable warning” before “knowingly and intentionally
expos[ing] any individual” to a carcinogen. (§ 25249.6.) The required
warning “need not be provided separately to each exposed individual and may
be provided by general methods such as labels on consumer products, . . .
posting of notices, placing notices in public news media, and the like,
provided that the warning accomplished is clear and reasonable.”13
(§ 25249.11, subd. (f).)
Regulations implementing Proposition 65 identify acceptable methods
of providing warnings, although a party may “provid[e] a warning using . . .
methods other than those specified . . . that nevertheless complies with
[s]ection 25249.6.” (Regs., § 25600, subd. (f).) For consumer products,
“exposure warnings must be prominently displayed on a label, labeling, or
sign, and must be displayed with such conspicuousness as compared with
other words, statements, designs[,] or devices on the label, labeling, or sign,
as to render the warning likely to be seen, read, and understood by an
ordinary individual under customary conditions of purchase or use.” (Id.,
§ 25601, subd. (c).) In addition to being placed “on the label,” a warning may
be conveyed “on a posted sign, shelf tag, or shelf sign, for the consumer
13 The potential liability for failure to give a Proposition 65 warning is
more limited for retailers of consumer products than it is for manufacturers
of those products. (See § 25249.11, subd. (f); Regs., § 25600.2; Lee v.
Amazon.com, Inc., supra, 76 Cal.App.5th at p. 231.) The parties do not
address this distinction, and we therefore do not differentiate between the
manufacturer respondents and the retailer respondents in our discussion of
state-law duties. Likewise, although retailers of generic OTC drugs are not
subject to FDA oversight, we follow the parties’ lead and focus on the federal-
law duties of manufacturers of those drugs. Ultimately, because we conclude
that CEH’s claim is preempted as to the manufacturer respondents, we need
not determine whether there are additional reasons the claim fails as to the
retailer respondents.
19
product at each point of display of the product”; or by “any electronic device or
process that automatically provides the warning to the purchaser prior to or
during the purchase of the consumer product, without requiring the
purchaser to seek out the warning.” (Id., § 25602, subd. (a)(1)–(4).) If a
product is sold by internet or catalog, a warning must also be provided
through the website or in the catalog. (Id., § 25602, subds. (b)–(c).)
Next, we address a generic manufacturer’s duty to warn under federal
law. (See Bartlett, supra, 570 U.S. at p. 486.) As Mensing discussed at
length, a generic manufacturer has an ongoing duty to “ensur[e] that its
warning label is the same as the brand name’s.” (Mensing, supra, 564 U.S. at
p. 613.) We note that Mensing concerned generic prescription drugs, not OTC
drugs. (Id. at p. 610.) But as another court observed in applying Mensing to
OTC drugs, “[t]he key distinction in the relevant regulatory structure and
case law is not between prescription and non-prescription drugs but between
NDA holders and ANDA holders. The distinction makes a difference because
of the [CBE] regulation, which permits NDA holders—but not ANDA
holders—to ‘add or strengthen’ a warning on the product’s label [citation],
without waiting for preapproval from the FDA.” (Greager v. McNeil-PPC,
Inc. (N.D.Ill. 2019) 414 F.Supp.3d 1137, 1142.) Thus, we agree with the
generic-drug defendants that the duty of sameness also applies to
manufacturers of generic OTC drugs.
To be approved, an ANDA must include, with exceptions that are not
relevant here, “information to show that the labeling proposed for the new
drug is the same as the labeling approved for the [brand-name] drug.”
(21 U.S.C. § 355(j)(2)(A)(v); 21 C.F.R. § 314.94(a)(8)(iv).) An OTC drug’s label
must have a “Warning” or “Warnings” section that includes all applicable
warnings from a specified list. (21 C.F.R. § 201.66(c)(5).) That list includes
20
warnings about particular side effects, contraindications for the product’s
use, and the need to consult a medical professional before taking the product.
(Ibid.) Unlike a brand-name manufacturer, a generic manufacturer cannot
“use[] the CBE process to unilaterally strengthen [its] warning labels.”
(Mensing, supra, 564 U.S. at p. 614.) Thus, a generic manufacturer can list
on its labeling only warnings that are identical to the warnings listed on the
brand-name manufacturer’s labeling.14
Mensing concerned state-law tort claims that manufacturers of generic
prescription drugs “fail[ed] to provide adequate warning labels” about the
risk of a particular side effect. (Mensing, supra, 564 U.S. at pp. 608–610.)
After explaining a generic manufacturer’s ongoing duty of sameness, the
Supreme Court concluded the manufacturers could not “use a different,
stronger label than the label they actually used” without violating federal
law, which “prevented [them] from independently changing their generic
drugs’ safety labels.” (Id. at pp. 617–618.) Therefore, impossibility
preemption barred the consumers’ claims. (Id. at p. 618.)
In reaching this holding, Mensing rejected the consumers’ arguments
that the manufacturers could have complied with both state and federal law
by (1) using the CBE process to change their labels, (2) using “ ‘Dear Doctor’
letters to send additional warnings to prescribing physicians and other
14 As a result, a lawsuit may be preempted merely because it concerns a
generic version instead of a brand-name version of the same drug. (See
Mensing, supra, 564 U.S. at p. 625.) Here, the trial court relied on this
distinction when it dismissed the suit against the brand-name manufacturers
without prejudice and gave CEH leave to amend for it to allege, if possible,
that the NDMA exposure was serious enough that the brand-name
manufacturers could unilaterally add a Proposition 65-compliant warning to
their labeling through the CBE process. (See 21 C.F.R. §§ 201.57(c)(6)(i),
314.70(c)(6)(iii)(A).)
21
healthcare professionals,” or (3) “ask[ing] the FDA for help in strengthening
the corresponding brand-name label.”15 (Mensing, supra, 564 U.S. at
pp. 614–616, 619–620.) The Supreme Court determined that the first two
methods were not available to the manufacturers. (Id. at pp. 614–615.)
Specifically, deferring to the FDA’s interpretation of its regulations, the
Court concluded that generic manufacturers cannot use the CBE process to
change warning labels unilaterally, and “Dear Doctor” letters qualify as
“labeling” under the FDCA and its regulations. (Ibid.)
As for the third method, asking the FDA to change the labeling,
Mensing concluded that it was insufficient to avoid impossibility preemption.
(Mensing, supra, 564 U.S. at p. 621.) Even assuming the FDA was correct
that generic manufacturers had a duty to propose “stronger warning labels to
the agency if they believed such warnings were needed,” preemption was not
avoided based on the mere “possib[ility] that, had the [m]anufacturers asked
the FDA for help, they might have eventually been able to strengthen their
warning label.” (Id. at pp. 616, 620.) The Supreme Court concluded that
“[t]he question for ‘impossibility’ is whether the private party could
independently do under federal law what state law requires of it,” not
whether “a third party or the Federal Government might do something that
makes it lawful for a private party to accomplish under federal law what
state law requires of it.” (Id. at p. 620, some italics added.) The consumers’
claims were preempted because state law required the generic manufacturers
to strengthen their labels and federal law prevented them from doing so
unilaterally. (Id. at pp. 623–624.)
15“Dear Doctor” letters are mailings that drug manufacturers may be
required to send to medical professionals conveying “important information
about their products.” (Teva Pharmaceuticals USA, Inc. v. Superior Court
(2013) 217 Cal.App.4th 96, 104; see 21 C.F.R. § 200.5.)
22
Two years later, Bartlett applied Mensing to hold that “state-law
design-defect claims that turn on the adequacy of a drug’s warnings are pre-
empted by federal law.” (Bartlett, supra, 570 U.S. at p. 476.) The plaintiff
sued the manufacturer of a generic prescription drug after she became
“severely disfigured” by using it. (Id. at p. 478.) The First Circuit Court of
Appeals held that her claim was not preempted, because “generic
manufacturers facing design-defect claims could simply ‘choose not to make
the drug at all’ and thus comply with both federal and state law.” (Id. at
p. 479.)
The Supreme Court reversed, concluding the manufacturer could not
comply with both its state-law duty to ensure its product was not
“ ‘unreasonably dangerous’ ” and its federal-law duty not to change its
product’s label unilaterally. (Bartlett, supra, 570 U.S. at pp. 480, 482.) The
state-law duty could be satisfied only by redesigning the drug or changing its
labeling. (Id. at p. 482.) Redesigning the drug was impossible because of the
federal duty of sameness and because any altered composition “would be a
new drug that would require its own NDA to be marketed in interstate
commerce.” (Id. at p. 484.) As a result, “the only way for [the manufacturer]
to ameliorate the drug’s ‘risk-utility’ profile,” and thereby avoid liability
under state law, “was to strengthen ‘the presence and efficacy of [the drug’s]
warning’ in such a way that the warning ‘avoid[ed] an unreasonable risk of
harm from hidden dangers or from foreseeable uses.’ ” (Ibid.) But that was
impossible under Mensing, because the manufacturer could not unilaterally
change its labeling to differ from the brand-name version’s labeling.
(Bartlett, at p. 486.) Finally, the Supreme Court rejected the “ ‘stop-selling’
rationale” for finding no impossibility preemption as “incompatible with [the
Court’s] pre-emption jurisprudence.” (Id. at p. 488.)
23
2. The effect of Dowhal
Before considering whether it is possible for the generic-drug
defendants to give warnings that comply with both Proposition 65 and the
federal duty of sameness, we address the Attorney General’s argument that
Dowhal, supra, 32 Cal.4th 910 provides the proper “framework for analyzing
the preemption question in this case.” According to the Attorney General,
under Dowhal, section 379r’s savings clause “preserves Proposition 65 from
preemption in this case because [the] addition of a Proposition 65 warning for
NDMA does not present any conflict with FDA requirements relevant to
consumer health.” Dowhal cannot sustain the weight the Attorney General
places on it.
Dowhal addressed whether the FDCA preempted a claim that
manufacturers of OTC “products containing nicotine sold . . . as aids to stop
smoking” were required to place Proposition 65 warnings on the products.
(Dowhal, supra, 32 Cal.4th at pp. 917–918.) Since “California listed nicotine
as a chemical known to cause reproductive toxicity,” Proposition 65 required
the manufacturers to warn of the danger of reproductive harm. (Id. at
p. 918.) The FDA, however, refused to permit the manufacturers to put such
a warning on their products, because it did not want to discourage pregnant
women from using the products to quit smoking. (Id. at pp. 918–919.) The
FDA informed the manufacturers that they could warn only that nicotine
might increase a baby’s heart rate and advise pregnant women to seek
professional advice before using the products. (Id. at p. 920.)
Dowhal held that the FDA’s labeling policy preempted Proposition 65’s
warning requirement. (Dowhal, supra, 32 Cal.4th at p. 918.) The Supreme
Court recognized that section 379r’s savings clause still permits impossibility
or obstacle preemption of Proposition 65. (Dowhal, at p. 924.) If a
24
Proposition 65 requirement is “in direct conflict with . . . or frustrate[s] the
purpose of” an FDA requirement, the state law is preempted. (Id. at pp. 924,
926.) Since the FDA had “established a federal policy prohibiting [the]
defendants from giving consumers any warning [about use during pregnancy]
other than the one approved by the FDA . . . , the use of a Proposition 65
warning would conflict with that policy,” and the suit was therefore
preempted. (Id. at p. 929.)
Dowhal was careful to note that “a Proposition 65 warning cannot be
preempted solely because it is not identical with [a] federal requirement,”
since section 379r’s legislative history revealed that the provision’s savings
clause was intended to allow Proposition 65 warnings even if they resulted in
different labeling in California. (Dowhal, supra, 32 Cal.4th at p. 926.) Thus,
an FDA requirement can preempt a Proposition 65 warning only “on a basis
relevant to consumer health, and not because the [warning] would frustrate
the FDA’s policy favoring national uniformity.” (Ibid.)
The Attorney General claims that under Dowhal, Proposition 65 cannot
be preempted in this case unless there is “a conflict, relevant to consumer
health, between providing a Proposition 65 cancer warning for NDMA
exposure . . . and the FDA’s regulation of the[] products under the FDCA.”
He argues that the federal duty of sameness “serves the FDCA’s national
uniformity policy,” not consumer health, and therefore “cannot be used to
evade the savings clause” of section 379r.
We do not agree with the Attorney General’s characterization of the
federal duty of sameness. The duty of sameness “ensures that generic drugs
are of the same safety and effectiveness as their branded counterparts.”
(Fulgenzi v. PLIVA, Inc. (6th Cir. 2013) 711 F.3d 578, 585, italics added.) By
making it easier to obtain FDA approval for generic drugs, the Hatch-
25
Waxman Act “recognized that conducting new human clinical trials for
generic drugs was ‘unnecessary and wasteful’ where demonstrating sameness
was enough to show the drug to be ‘safe and effective.’ [Citation.] The
Hatch-Waxman Act’s cost savings, therefore, were accomplished without
[compromising] the FDCA’s core safety policies.” (Fulgenzi, at p. 586.) Thus,
the duty of sameness is meant to ensure consumer safety, not merely
uniformity in labeling.
Moreover, Dowhal’s conclusion that “a Proposition 65 warning cannot
be preempted solely because it is not identical with [a] federal requirement”
was based on the need to give effect to section 379r’s savings clause.
(Dowhal, supra, 32 Cal.4th at p. 926.) Our state Supreme Court rejected the
argument that “any nonidentical state warning would constitute
misbranding,” as that “would nullify the savings clause . . . , which plainly
permits Proposition 65 warnings that differ from the FDA warnings.” (Id. at
p. 934.) But here, a determination that the federal duty of sameness
prevents the generic-drug defendants from unilaterally adding Proposition 65
warnings to their labeling would not nullify section 379r’s savings clause.
Rather, the clause preserves the ability of brand-name manufacturers to use
the CBE process to add a Proposition 65 warning that is not identical to
federal requirements.16 In turn, if brand-name manufacturers added
16 CEH claims it would be “a surprising result” if section 379r’s savings
clause preserved Proposition 65 claims against brand-name manufacturers
only, since nothing in the legislative history of section 379r suggests Congress
thought the savings clause “would be wholly inoperative for generic OTC
drugs unless the brand[-]name manufacturers provided such warnings.” But
section 379r was enacted several years before Mensing made clear that even
if it may seem arbitrary, due to the federal duty of sameness a claim against
a generic manufacturer may be preempted where the identical claim against
a brand-name manufacturer is not preempted. (See Mensing, supra, 564 U.S.
at p. 625.)
26
Proposition 65 warnings to their ranitidine products, the generic
manufacturers would have to do so as well.
It is also significant that Dowhal was decided several years before
Mensing and Bartlett clarified that impossibility preemption bars a claim if a
defendant cannot independently comply with state law without violating
federal law. In Dowhal, the manufacturers sought approval from the FDA to
add a Proposition 65 warning, but the FDA denied the requests, offering the
policy justification on which our state Supreme Court relied to find conflict
preemption. (Dowhal, supra, 32 Cal.4th at pp. 920–921, 922, 929.) Thus,
Dowhal had no reason to address whether the suit was preempted for the
separate reason that the manufacturers could not add a Proposition 65
warning without first obtaining FDA approval. But here, even if the mere
lack of identity between a Proposition 65 warning about NDMA and federally
required labeling does not suffice to establish preemption under Dowhal,
CEH’s claim is still preempted if it would require the generic-drug defendants
to obtain FDA approval before giving such a warning.
In short, we do not agree that Dowhal is determinative. Therefore, we
proceed to address whether it is impossible for the generic-drug defendants to
comply with their federal-law duties and Proposition 65’s warning
requirement.
3. CEH’s claim is preempted.
The generic-drug defendants argue that CEH’s claim is preempted
under Mensing and Bartlett because those cases, and subsequent decisions
applying them, stand for the proposition that “any state-law claim that
imposes a legal duty to issue some other type of warning that is not on the
brand-name label conflicts with federal law and is preempted.” We need not
decide whether Mensing and its progeny establish such a sweeping principle
27
or whether, as CEH claims, the trial court incorrectly determined that “any
and all communications involving a warning are properly characterized as
‘labeling’ that require FDA approval.” Rather, because CEH fails to identify
a method by which the generic-drug defendants could give a Proposition 65
warning that would not constitute “labeling” under the FDCA, we conclude
that the federal duty of sameness renders it impossible for the generic-drug
defendants to comply with both state and federal law under Mensing.17
Our determination rests on the broad definition of “labeling” under the
FDCA. We begin by discussing two decisions that are crucial to our analysis,
Kordel v. United States (1948) 335 U.S. 345 (Kordel) and Leeman, supra,
180 Cal.App.4th 728. We then explain why the two primary methods CEH
proposes in which the generic-drug defendants could give Proposition 65
warnings without violating the duty of sameness—point-of-sale displays and
“public advertising”—do not avoid preemption.
a. Kordel and Leeman
As noted above, the FDCA defines “labeling” as “all labels and other
written, printed, or graphic matters (1) upon any article or any of its
containers or wrappers, or (2) accompanying such article.” (21 U.S.C.
17 In reaching this conclusion, we reject CEH’s argument that the duty
of sameness does not apply because this case involves the generic-drug
defendants’ “undisclosed contamination of the [p]roducts with NDMA.” The
fact that the generic-drug defendants may have violated the duty of sameness
by selling products that contained different amounts of NDMA than did the
brand-name versions does not mean that the duty is inapplicable to
Proposition 65 warnings about NDMA. Rather, because CEH’s suit seeks to
impose a warning requirement, we must consider whether the generic-drug
defendants could give a Proposition 65 warning while complying with the
duty of sameness, even though reformulation is the more realistic response to
contamination. For the same reason, the possibility of reformulation cannot
save CEH’s claim from preemption if all possible methods of giving
Proposition 65 warnings would conflict with federal law.
28
§ 321(m).) In Kordel, the United States Supreme Court addressed this
definition in the context of a criminal case. (Kordel, supra, 335 U.S. at
pp. 346–348.) The defendant was found guilty of introducing misbranded
drugs into interstate commerce, which required a finding that the drugs’
“ ‘labeling [was] false or misleading in any particular’ ” or did not “bear[]
‘adequate directions for use.’ ” (Id. at pp. 346–347.) “The alleged
misbranding consist[ed] of statements in circulars or pamphlets” about the
products’ efficacy. (Id. at p. 346.) The defendant provided the materials to
vendors, who in turn “distributed [them] to consumers” through means
including displaying them in stores, giving them away with the sale of the
products, or mailing them. (Id. at pp. 346–347.) The issue was whether the
fact that some of this “literature . . . was shipped separately from the drugs
and at different times . . . saved the drugs from being misbranded” because
the literature did not “accompany[] such article” and was therefore not
“labeling” under the statutory definition. (Id. at pp. 347–349.)
Kordel held “that the phrase ‘accompanying such article’ is not
restricted to labels that are on or in the article or package that is
transported.” (Kordel, supra, 335 U.S. at p. 349.) The Supreme Court
reasoned that the phrase did not by its terms require labeling to be on or in
the same package or container as the drugs: “One article or thing is
accompanied by another when it supplements or explains it, in the manner
that a committee report of the Congress accompanies a bill. No physical
attachment [of] one to the other is necessary.” (Ibid.) Since “[t]he false and
misleading literature . . . was designed for use in the distribution and sale of
the drug[s]” as part of “an integrated distribution program,” it qualified as
“labeling.” (Ibid.)
29
In Leeman, the Fourth District Court of Appeal relied on Kordel in
holding that the Federal Meat Inspection Act (FMIA) “expressly preempts
point of sale warning requirements imposed by Proposition 65 with respect to
meat.” (Leeman, supra, 180 Cal.App.4th at pp. 735, 752–753.) The FMIA’s
preemption statute provides in relevant part that “ ‘labeling . . . requirements
in addition to, or different than, those made under this chapter may not be
imposed by any State.’ ” (Leeman, at pp. 748–749, quoting 21 U.S.C. § 678.)
The Leeman plaintiff did not “dispute that a Proposition 65 warning is in
addition to, or different than, any requirement set forth in the FMIA,” nor
“that a Proposition 65 warning affixed directly to a package containing meat
would constitute ‘labeling’ within the meaning of the FMIA’s preemption
provision.” (Leeman, at p. 749, italics omitted.) Rather, she argued that
“point of sale warnings do not constitute ‘labeling,’ and thus, Proposition 65
does not create ‘labeling . . . requirements in addition to, or different than,
those made under [the FMIA].’ ” (Ibid., italics omitted.)
Leeman rejected the plaintiff’s position, holding that point-of-sale
warnings qualify as “labeling requirements” under the FMIA’s preemption
provision. The definition of “labeling” under the FMIA was taken from the
FDCA, and likewise provides that the term means “ ‘all labels and other
written, printed, or graphic matter (1) upon any article or any of its
containers or wrappers, or (2) accompanying such article.’ ” (Leeman, supra,
180 Cal.App.4th at p. 752 & fn. 27, quoting § 21 U.S.C. § 601(p).) The Fourth
District determined that in importing the FDCA’s definition to the FMIA,
Congress intended that Kordel’s interpretation of “labeling”—to refer to
“material that accompanies a product in the sense that it ‘supplements or
explains it,’ but is not necessarily physically attached”—applies to the FMIA
as well. (Leeman, at p. 757.) Leeman then concluded that under
30
Proposition 65 “a properly designed point of sale warning will ‘supplement[]
or explain[]’ the meat offered for sale in that it will give consumers additional
information about the product” and “will necessarily be ‘designed for use in
the distribution and sale’ of the product,” meaning a point-of-sale warning
qualifies as “labeling” under Kordel. (Leeman, at p. 761, quoting Kordel,
supra, 335 U.S. at p. 350.)
b. Point-of-sale warnings
We agree with Leeman that “labeling,” as interpreted by Kordel,
includes point-of-sale warnings under Proposition 65. A point-of-sale
warning is “designed for use in the distribution and sale of the drug” and
“supplements or explains” the drug. (Kordel, supra, 335 U.S. at p. 350.)
Indeed, some of the material that Kordel found to be “labeling” under the
FDCA was “literature . . . displayed in stores in which the [defendant’s]
products were on sale.” (Id. at p. 346.) In turn, since the manufacturer of a
generic drug cannot deviate from the labeling of the brand-name version of
the drug, it would be impossible for the generic-drug defendants to give a
Proposition 65 point-of-sale warning without violating the federal duty of
sameness.
CEH attempts to distinguish Leeman from this case but does not
explain why the identified distinctions suggest Leeman’s interpretation of
“labeling” to include point-of-sale warnings is inapplicable. For example, it is
not apparent why it matters that “the FDA has never stated that it believes
Proposition 65 warnings for NDMA on [the generic-drug defendants’
products] would be inappropriate.” As Mensing makes clear, the duty of
sameness makes it “impossible” for a generic manufacturer to change its
labeling unilaterally even if the FDA has no specific objection to the change.
Nor is it apparent why the fact that the FMIA has no express savings clause
31
matters. As Dowhal makes clear, a Proposition 65 claim involving OTC
drugs may be preempted despite section 379r’s savings clause.
CEH also states that “Leeman failed to note the . . . observation in
Dowhal that ‘point-of-sale signs’ are not ‘product labeling.’ ” In the cited
portion of Dowhal, however, our state Supreme Court was not addressing the
FDCA’s definition of “labeling” but merely summarizing the content of a
former Proposition 65 regulation as providing that a “warning may be
communicated through product labeling, point-of-sale signs, or public
advertising.” (Dowhal, supra, 32 Cal.4th at p. 918.) The fact that the Court
differentiated between these three categories sheds no light on the definition
of “labeling” under the FDCA. In any case, to the extent Dowhal could be
read to suggest that point-of-sale signs are not “labeling,” that would conflict
with Kordel’s conclusion that materials displayed in stores are “labeling.”
(See Kordel, supra, 335 U.S. at pp. 346, 350.)
CEH also points out that the Ninth Circuit Court of Appeals rejected a
“broad reading of Kordel” and suggests we do the same. In Chemical
Specialties Mfrs. Ass’n, Inc. v. Allenby (9th Cir. 1992) 958 F.2d 941 (Allenby),
the Ninth Circuit addressed an action in which the plaintiff trade association
sought a declaratory judgment that the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) preempted Proposition 65 warning requirements.
(Allenby, at pp. 942, 945.) FIFRA defines “labeling” in relevant part as “all
labels and all other written, printed, or graphic matter—[¶]
(A) accompanying the pesticide or device at any time; or [¶] (B) to which
reference is made on the label or in literature accompanying the pesticide or
device.” (7 U.S.C. § 136(p)(2).) Thus, like the FDCA, FIFRA includes
material “accompanying” the product in its definition of “labeling.” (7 U.S.C.
§ 136(p)(2); 21 U.S.C. § 321(m).)
32
The trade association argued that Proposition 65 was preempted
because “FIFRA expressly prohibits states from imposing labeling
requirements that differ from those registered with the [Environmental
Protection Agency (EPA)],” and “the warnings required under Proposition 65
fall squarely within FIFRA’s definition of ‘labeling.’ ” (Allenby, supra,
958 F.2d at p. 945.) The Ninth Circuit disagreed, concluding that point-of-
sale warnings are not “labeling” under FIFRA. (Id. at pp. 946–947.) Allenby
determined that “FIFRA’s definition of labeling cannot encompass every type
of written material accompanying the pesticide at any time. If this were true,
then price stickers affixed to shelves, sheets indicating that a product is on
sale, and even the logo on the exterminator’s hat would all constitute
impermissible labeling.” (Id. at p. 946.) Rather, relying on a Second Circuit
Court of Appeals decision that interpreted “labeling” under FIFRA, Allenby
held that point-of-sale signs did not qualify because they were “not attached
to the immediate container of a product and [would] not accompany the
product during the period of use.” (Allenby, at p. 946; New York State
Pesticide Coalition, Inc. v. Jorling (2d Cir. 1989) 874 F.2d 115, 119 [signs
posted on site where pesticides used not “labeling” because “FIFRA ‘labeling’
is designed to be read and followed by the end user”].)
In reaching its holding, Allenby declined to adopt Kordel’s definition of
“labeling,” finding that decision distinguishable. (Allenby, supra, 958 F.2d at
p. 946.) The Ninth Circuit explained: “First, the written materials in Kordel
were aimed at the ultimate user of the drug, not the purchaser that is
targeted by Proposition 65. [Citation.] Second, the materials at issue in
Kordel contained directions for use, which the EPA had clearly stated must
be on the label. [Citation.] Finally, the context of the manufacturer’s
33
mailings in that case suggested that the manufacturer was attempting to
circumvent the [FDCA] rather than supplement it.” (Id. at pp. 946–947.)
We agree with Leeman that “Allenby’s attempt to distinguish Kordel [is
not] . . . persuasive” (Leeman, supra, 180 Cal.App.4th at p. 758, fn. 36), and
we decline to follow a Ninth Circuit decision interpreting a different statute
instead of binding United States Supreme Court precedent interpreting the
FDCA. Although Allenby’s focus on materials accompanying a pesticide
during use may have been appropriate under FIFRA, “we see no basis for
importing that focus into the [FDCA].” (Leeman, at p. 758.) Rather, similar
to the FMIA, the FDCA’s primary purpose is to protect consumers from
harmful products. (See Wyeth v. Levine, supra, 555 U.S. at p. 574; Leeman,
at p. 758.) Consistent with this purpose, Kordel focused on whether the
materials at issue there—which, again, included in-store displays—were
“designed for use in the distribution and sale of the drug[s].” (Kordel, supra,
335 U.S. at pp. 346, 350; Leeman, at p. 758, fn. 36.)
Our conclusion is not altered by CEH’s argument that “an all-
encompassing definition of ‘labeling’ ” cannot be reconciled with section 379r’s
savings clause. In CEH’s view, since section 379r preempts state-law
requirements “relating to public information or any other form of public
communication relating to a warning of any kind for a drug” (§ 379r(c)(2)),
the term “labeling” must have a narrower meaning than that phrase or else
Congress would have simply stated that all “labeling” requirements are
preempted. As we have said, we need not decide whether “labeling” includes
all forms of public communication related to drug warnings but only whether
the term includes all valid methods of conveying a Proposition 65 warning
involving generic OTC drugs. And we perceive nothing in section 379r
suggesting an intent to reject Kordel’s interpretation of “labeling” which,
34
while broad, is not equivalent to any public communication about any drug
warning. Because point-of-sale warnings qualify as “labeling” under Kordel,
we conclude that the generic-drug defendants cannot unilaterally provide
them without violating the federal duty of sameness.
c. Public advertising
Finally, we turn to whether the generic-drug defendants could comply
with federal and state law by conveying Proposition 65 warnings in
advertising or similar communications to the public.18 We conclude they
cannot, and CEH’s claim is therefore preempted.
Initially, it is not obvious to us that public advertising can ever be a
sufficient method of providing a Proposition 65 warning about a consumer
product. True, as CEH observes, Proposition 65 provides that a warning
“need not be provided separately to each exposed individual and may be
provided by general methods such as labels on consumer products, . . .
posting of notices, placing notices in public news media, and the like,
provided that the warning accomplished is clear and reasonable.”
(§ 25249.11, subd. (f).) Although this provision is broad enough to include
public advertising, a Proposition 65 regulation pertaining to consumer
products in particular requires that the warning be delivered so “as to render
[it] likely to be seen, read, and understood by an ordinary individual under
customary conditions of purchase or use.” (Regs., § 25601, subd. (c), italics
added.) Unlike the safe-harbor methods of providing consumer-product
warnings, which require that the warning be on the product’s label, displayed
at the point of sale, or “automatically provide[d] . . . to the purchaser prior to
18 CEH also identifies “postings on websites or over social media” as
possible methods of conveying Proposition 65 warnings. Our discussion of
“public advertising” includes such means of communicating with the general
public.
35
or during the purchase” (Regs., § 25602, subd. (a)), advertising is not
necessarily likely to be seen during purchase or use of the product.19 But the
parties do not address this issue, so we will assume for the sake of argument
that public advertising could be a valid method of conveying a Proposition 65
warning about the generic-drug defendants’ products.
The question, therefore, is whether a Proposition 65 warning
transmitted through public advertising constitutes “labeling” under the
FDCA. Kordel addressed the relationship between advertising and labeling,
stating that advertising qualifies as labeling “where the advertising performs
the function of labeling.” (Kordel, supra, 335 U.S. at p. 350.) The Supreme
Court recognized that the Federal Trade Commission (FTC) had
responsibility for false advertising of drugs under legislation that created the
commission.20 (Kordel, at p. 351; 52 Stat. 111 (1938).) But the Court found
nothing in the legislative history suggesting that Congress thereby “had the
19 We recognize that Dowhal referred to advertising as a permissible
method of giving a Proposition 65 warning. (See Dowhal, supra, 32 Cal.4th
at p. 918.) But when Dowhal was decided, former California Code of
Regulations, title 22, section 12601, subdivision (b)(1)(C), provided that a
Proposition 65 warning could be given through “[a] system of signs, public
advertising identifying the system and toll-free information services, or any
other system that provides clear and reasonable warnings.” Now, the
regulations no longer identify advertising as part of a suitable method of
conveying a warning and focus on whether a consumer will see the warning
before or during purchase or use. Thus, CEH is simply incorrect that “almost
any form of public communication can serve as [a] proper warning method
under Proposition 65.”
20 Under the Federal Trade Commission Act, it is “unlawful for any
person, partnership, or corporation to disseminate, or cause to be
disseminated, any false advertisement” meant to “induc[e] . . . the purchase
. . . of foods, drugs, devices, services, or cosmetics.” (15 U.S.C. § 52(a).) “The
term ‘false advertisement’ means an advertisement, other than labeling,
which is misleading in a material respect.” (Id., § 55(a)(1).)
36
purpose to eliminate from the [FDCA] advertising [that] performs the
function of labeling. Every labeling is in a sense an advertisement. The
advertising which we have here performs the same function as it would if it
were on the article or on the containers or wrappers.” (Kordel, at p. 351.)
In 1971, “[t]o resolve issues of enforcement resulting from [the]
concurrent jurisdiction” of the FDA and the FTC over the marketing of OTC
drugs, the agencies “agreed to a division of regulatory authority: the FDA
regulates the labeling of OTC drugs while the FTC monitors the advertising
for these drugs.” (Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc.
(3d Cir. 1990) 902 F.2d 222, 226–227.) Under the agencies’ memorandum of
understanding, the FTC “has primary responsibility with respect to the
regulation of the truth or falsity of all advertising (other than labeling)” of
OTC drugs, whereas the FDA “has primary responsibility for preventing
misbranding” of OTC drugs and “will exercise primary jurisdiction over all
matters regulating [their] labeling.” (36 Fed. Reg. 18539 (1971).) In contrast,
the FDA retains primary responsibility for regulating the advertising of
prescription drugs. (Ibid.; see 21 U.S.C. § 352(n); 21 C.F.R. § 202.1.)
As both Kordel and the 1971 memorandum of understanding
demonstrate, there is no firm dividing line between “labeling” and
“advertising,” and materials normally thought of as advertising can
constitute “labeling” under the FDCA. Under Kordel, the touchstone is
whether the material is “designed for use in the distribution and sale of the
drug” and “part[] of an integrated distribution program.”21 (Kordel, supra,
21 We reject CEH’s claim that Kordel held that the “function of labeling”
is providing “directions for drug use.” The material at issue in Kordel related
to the drugs’ usage (Kordel, supra, 335 U.S. at p. 348), but the Supreme
Court never suggested that the only function of drug labeling is to provide
directions for use. Clearly, it is not.
37
335 U.S. at p. 350.) In our view, any public advertising containing a
Proposition 65 warning that is “likely to be seen, read, and understood by an
ordinary individual under customary conditions of purchase or use” (Regs.,
§ 25601, subd. (c)) would qualify as “advertising [that] performs the function
of labeling” under Kordel. (Kordel, at p. 351.)
CEH focuses on disproving the notion that “any and all warning
statements are ‘labeling.’ ” Again, even if some advertising that contains
warnings does not constitute “labeling” under federal law, CEH’s claim is still
preempted if all advertising that would comply with Proposition 65 qualifies
as “labeling.” Thus, CEH’s arguments based on (1) the differentiation
between “advertising” and “labeling” in the FDCA and its regulations and
(2) cases involving the FDCA’s preemptive effect on other state laws miss the
mark. Likewise, CEH’s observation that some of the generic-drug defendants
issued press releases warning about NDMA in their products without first
obtaining FDA approval is irrelevant. Even assuming such press releases
complied with federal law, CEH does not argue that the generic-drug
defendants could lawfully issue Proposition 65 warnings by the same method.
In short, CEH fails to demonstrate that the generic-drug defendants
could give Proposition 65 warnings by any method that would not constitute
“labeling” under the FDCA. Accordingly, it would be impossible for the
generic-drug defendants to give such warnings without violating the federal
duty of sameness, and CEH’s claim is preempted.
III.
DISPOSITION
The judgment is affirmed. Respondents are awarded their costs on
appeal.
38
_________________________
Humes, P.J.
WE CONCUR:
_________________________
Banke, J.
_________________________
Swope, J.*
*Judge of the Superior Court of the County of San Mateo, assigned by
the Chief Justice pursuant to article VI, section 6 of the California
Constitution.
Center For Environmental Health v. Perrigo Company et al., A163682
39
Trial Court:
Superior Court of the County of Alameda
Trial Judge:
Hon. Winifred Y. Smith
Counsel:
Lexington Law Group, Mark N. Todzo, Joseph Mann, for Plaintiff and
Appellant
Steptoe & Johnson LLP, Dennis Raglin; Goodell, DeVries, Leech &
Dann LLP, Richard M. Barnes, Derek M. Stikeleather, Sean L. Gugerty;
Norton, Rose, Fulbright US LLP, Jeffrey B. Margulies, Lauren A. Shoor;
Lewis Brisbois Bisgaard & Smith LLP, Paul A. Desrochers; Arnold & Porter
Kaye Scholer LLP, Trenton H. Norris, Willis M. Wagner; Blank Rome LLP,
Cheryl S. Chang, Jessica A. McElroy, Terry M. Henry; Gordon Rees Scully
Mansukhani LLP, Brian M. Ledger, for Defendants and Respondents
Rob Bonta, Attorney General, Edward H. Ochoa, Senior Assistant
Attorney General, Laura J. Zuckerman, Supervising Deputy Attorney
General, Raissa S. Lerner, Deputy Attorney General, for Amicus Curiae in
support of Plaintiff and Appellant
Center For Environmental Health v. Perrigo Company et al., A163682
40