CENTER FOR ENVIRONMENTAL HEALTH, Plаintiff and Appellant, v. PERRIGO COMPANY et al., Defendants and Respondents.
A163682
IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA FIRST APPELLATE DISTRICT DIVISION ONE
March 9, 2023
CERTIFIED FOR PUBLICATION
(Alameda County Super. Ct. No. RG20-054985)
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.
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
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 dеfendants “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
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. Pharm. Co. v. Bartlett (2013) 570 U.S. 472, 479 (Bartlett), quoting
“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, Inc. (2007) 41 Cal.4th 929, 936.) Congressional intent ” ’ “is the ultimate touchstone“’ of pre[]emption analysis.” (Cipollone, at p. 516.)
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
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.” (
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.” (
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. (
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;
The 1984 Drug Price Competition and Patent Term Restoration Act, 98 Stat. 1585 (
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
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;
The FDCA contains a provision expressly preempting state law regarding OTC drugs.
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.” (
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
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
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].” (
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.”
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
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, therе 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.
To begin with, the parties disagree about the potential methods of complying with section 25249.6. CEH claims that “a dеfendant 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
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 (
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.” (
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 а 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
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
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.” (
warnings about рarticular 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
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 addеd.) 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.)
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.)
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
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-
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
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
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.” (
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 оf “an integrated distribution program,” it qualified as “labeling.” (Ibid.)
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
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 nоt 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
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 assoсiation 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.” (
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
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” (
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.” (
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
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 respeсt 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. (
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,
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 mаrk. 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.
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
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