The Supremacy Clause of the United States Constitution declares federal law to be the “supreme Law of the Land.”[i] Thus, when federal law and state law conflict, the state law is “preempted,” or rendered without effect.[ii] Under the Supremacy Clause, Congress has the authority to expressly preempt state law by including preemptive language in federal statutes. The Federal Food, Drug, and Cosmetics Act (“FDCA”) contains several express preemption provisions that prohibit States from imposing certain regulatory requirements on food, non-prescription drugs, medical devices, and cosmetics that do not mirror the requirements imposed by federal law.[iii] These provisions apply not only to state statutes and regulations, but also to legal claims brought by plaintiffs under state law.
The purpose of this article is to explore express preemption in the context of consumer protection actions, which are becoming more and more prevalent for drug and device manufacturers. State consumer protection acts (“CPAs”) historically have been viewed as a way for States to exercise their police powers over consumer health and safety by providing a private right of action for violations of the FDCA.[iv] More recently, though, plaintiffs have begun to rely on CPAs to go beyond the FDCA and impose requirements on manufacturers that do not exist under federal law. Additionally, many CPAs empower State Attorneys General, and in some cases, private plaintiffs, to seek injunctive relief preventing manufacturers from marketing, labeling, or selling their products in a manner that would violate the CPA, even if the manufacturer’s conduct is in compliance with the FDCA. Thus, while a judgment in a typical product liability action may induce a manufacturer to alter its conduct, a consumer protection action presumably requires a change in conduct, and thus could require a manufacturer to violate federal law. This is the type of inconsistency that the FDCA’s express preemption provisions were designed to prevent. Therefore, it is critical that manufacturers are able to identify the competing federal and state requirements implicated by a consumer protection action when evaluating the viability of an express preemption defense.
- The First Step To Preemption: Identifying Applicable Federal Requirements
“The purpose of Congress is the ultimate touchstone in any pre-emption case.”[v] Courts typically presume that Congress did not intend to preempt state law, especially on matters related to the States’ historic police powers.[vi] However, no such presumption exists where Congress has enacted an express preemption statute.[vii] The existence of such a statute is clear evidence of Congress’s preemptive intent with respect to a certain subject matter. “[W]hen Congress has made its intent known through explicit statutory language, the courts’ task is an easy one.”[viii]
The FDCA contains express preemption provisions covering food,[ix] medical devices,[x] non-prescription drugs,[xi] and cosmetics.[xii] One court has explained that “[t]he whole point of [the FDCA’s preemption provisions] is that it is not up to private litigants – or judges – to decide what is ‘false or misleading.’ It is up to the FDA.”[xiii] These statutes all share a common thread of prohibiting any “State or political subdivision of a State” from “establish[ing] or continu[ing] in effect any requirement” that is “different from or in addition to, or that is otherwise not identical with, a requirement” under the FDCA or other applicable law.[xiv] The first step in the preemption analysis, then, is to identify any federal statutes or regulations that impose requirements that would be impacted by the plaintiff’s lawsuit.
In Riegel v. Medtronic, Inc., the United States Supreme Court was asked to decide whether the Pre-Market Approval (“PMA”) process for Class III medical devices enacted under the Medical Device Amendments to the FDCA constituted a federal requirement for express preemption purposes.[xv] The Court first noted that the FDA’s regulations provide that “[s]tate or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act . . . .”[xvi] Thus, the critical inquiry was whether the PMA process imposed device-specific requirements.
The Court then looked to its prior decision in Medtronic, Inc. v. Lohr, in which it had held that the “substantially equivalent” standard enacted in 21 U.S.C. § 510(k) did not constitute a federal requirement and instead reflected “entirely generic concerns about device regulation generally.”[xvii] The Riegel Court distinguished the PMA process from the substantial equivalency standard, reasoning that premarket approval imposes specific requirements on individual devices and is focused on safety, not just equivalence.[xviii] In other words, while devices that enter the market after substantial equivalency review have not been formally tested for safety or efficacy, the FDA may approve a device under the PMA process only after it determines that the device offers “reasonable assurances of safety and effectiveness.”[xix] Once PMA is granted, a device must be made with almost no deviations from the specification in its approval application.[xx] Accordingly, the Riegel Court concluded that the PMA process for Class III devices constitutes a federal requirement that expressly preempts any conflicting state requirements.[xxi]
The court in Mills v. Warner-Lambert, Inc. relied on Riegel‘s analysis of the PMA process for medical devices in concluding that the New Drug Application (“NDA”) process and monograph systems used to approve non-prescription drugs also constitute federal requirements for preemption purposes.[xxii] The plaintiffs in Mills filed suit under Texas’s CPA alleging that the defendants’ over-the-counter lice treatments amounted to “snake oil” and did not actually kill lice.[xxiii] In reviewing the defendants’ preemption argument under the FDCA, the court first noted that one of the products in question originally was approved through the NDA process.[xxiv] The other two drugs, on the other hand, had been approved through the FDA’s monograph system.[xxv] To determine whether these regulatory processes amounted to “federal requirements” for the purposes of preemption, the court looked to cases interpreting the FDCA’s Medical Device Amendments for guidance.[xxvi]
First, the Mills court acknowledged that the Pre-Market Approval process for Class III medical devices had been deemed a “federal requirement” in Riegel.[xxvii] Due to the striking similarities to the Pre-Market Approval process, the court held that the NDA process constituted a federal requirement.[xxviii] The court further found that the monograph system was comparable to the FDCA’s regulations for Class II medical devices, which have also been deemed to be federal requirements for preemption purposes.[xxix] Because the approved monograph for pediculicides contains specific labeling requirements applicable to the defendants’ products, the court held that the monograph process also constituted a federal requirement.[xxx]
The defendants in Riegel and Mills successfully identified the federal statutes and regulations that would be impacted by the plaintiff’s civil claims. On the other hand, the defendant in Canale v. Colgate-Palmolive Co. was unable to identify any applicable federal requirement that would subject the plaintiffs’ consumer-protection claims to preemption, despite offering several options to the court.[xxxi] The plaintiffs in Canale brought suit under New York’s consumer protection statutes, arguing that the defendant had made false and misleading claims concerning the whitening capabilities of its Optic White toothpastes.[xxxii] The defendant moved to dismiss the plaintiffs’ claims, arguing that they were expressly preempted by the FDCA.[xxxiii] The defendant relied on three purported federal-law requirements as the basis for its preemption argument. First, the defendant pointed to the final FDA monograph regulating “anticaries” OTC drugs, which establishes “conditions under which OTC anticaries drug products . . . are generally recognized as safe and effective and not misbranded.”[xxxiv] The District Court found that the final monograph made no mention of whitening toothpastes or related products.[xxxv] While the monograph permits the sale, without a new drug application, of products with certain active ingredients, “[i]t does not purport to address the issue raised by Plaintiff’s claims here, or otherwise immunize any other representation made by the product’s manufacturer.”[xxxvi]
Next, the defendant in Canale argued that the FDA had specifically addressed the whitening effects of toothpaste in a non-final version of the anticaries monograph.[xxxvii] However, this version of the monograph discussed only whether a warning was appropriate regarding temporary surface teeth staining caused by products containing stannous fluoride.[xxxviii] Accordingly, the court found that the non-final monograph did not impose a federal requirement that applied to the plaintiffs’ claims.[xxxix]
Finally, the defendant in Canale pointed to the FDA’s denial of a citizen petition filed by the American Dental Association, which requested that certain peroxide-containing tooth whiteners be subjected to regulatory classification as over-the-counter drugs.[xl] Reviewing this document, the court determined that the FDA found insufficient evidence to determine whether they should be regulated as drugs.[xli] The court then found that the FDA had not endeavored to regulate representations about peroxide-containing tooth whiteners at all when it rejected the citizen petition.[xlii] Because the defendant was unable to identify any federal requirements applicable to its products beyond the FDCA’s general prohibition against false and misleading labeling, the court found that the plaintiff’s state-law claims were not expressly preempted.[xliii]
Riegel, Mills, and Canale instruct that the existence of express preemption statutes within the FDCA, by itself, does not make for a successful preemption defense. Courts must still “identify the domain expressly pre-empted” by the statute in question.[xliv] It is also insufficient simply to point to the FDCA’s general regulations governing drugs, medical devices and cosmetics. Manufacturers must dig deeper into the plaintiff’s allegations in order to identify the specific federal regulations that touch upon the plaintiff’s specific allegations.[xlv] Otherwise, it will be difficult to prove that a plaintiff’s consumer protection claim imposes a requirement that is different from federal law.
The distinction between the holdings in Mills and Canale is also instructive. While the defendants in both cases relied on the FDA’s monographs for their respective categories of products, only the monograph in Mills contained regulations that specifically applied to the subject matter of the plaintiffs’ claims. Thus, the existence of a regulatory regime like a monograph may not be sufficient to preempt a state-law claim.
- Consumer Protection Actions Are State-Law “Requirements” Under the FDCA
In Bates v. Dow Agrosciences, Inc., the United States Supreme Court reasoned that a state-law cause of action did not necessarily constitute a “requirement” for purposes of the express preemption provision found in the Federal Insecticide, Fungicide, and Rodenticide Act because “[a]n occurrence that merely motivates an optional decision does not qualify as a requirement.”[xlvi] However, in reviewing the FDCA’s preemption provisions, the Court more recently clarified in Riegel that “Congress is entitled to know what meaning this Court will assign to terms regularly used in its enactments. Absent other indication, reference to a State’s ‘requirements’ includes its common-law duties.”[xlvii] Indeed, “[state] regulation can be as effectively exerted through an award of damages as through some form of preventive relief. The obligation to pay compensation can be, indeed is designed to be, a potent method of governing conduct and controlling policy.”[xlviii] Because the FDA is best equipped to balance the competing concerns of safety and effectiveness, state-law liability that is premised on those same concerns can upset the balance. Thus, federal preemption can prevent a plaintiff from bringing any state-law cause of action that would impose a requirement on the defendant that differs from the requirements imposed on it by federal law.[xlix]
Other courts have relied on Riegel to hold that the FDCA’s preemption provisions apply to both statutory and common-law causes of action, including consumer protection claims. In Mills, for example, the court found that there is no substantive difference between state-law claims founded on common-law duties and those founded on statutory duties and that the FDCA’s preemption provisions were drafted broadly enough to encompass any cause of action that does not meet the definition of a “product liability claim.”[l] The court in Carter v. Novartis Consumer Health, Inc. took a similar approach, finding that Riegel had adopted a particularly broad definition of “requirements.”[li] The Carter court found that “Riegel held that any state law liability imposed upon a Class III device manufacturer who is otherwise in full compliance with FDA regulations may establish a ‘requirement’ that is “different from, or in addition to’ federal law.”[lii] The court also looked to Section 379r(c)(2), which provides that any requirements involving public “warning[s] of any type of drug” are subject to preemption.”[liii] The courtreasoned that this provision “expands the universe of potentially preempted state law claims to include those that require additional warnings in the advertising for nonprescription drugs, and not only on the labeling.”[liv] The court concluded that, “[t]aken together, Riegel and § 379r(c)(2) suggest that virtually any state requirement that relates to the regulation of nonprescription drugs can be preempted, regardless of the common law theory under which it is brought.”[lv]
In light of Riegel’s broad definition of “requirements,” it is clear that state consumer protection claims qualify as state-law requirements and fall within the scope of the FDCA’s preemption provisions. Therefore, the next step in the analysis is to compare the requirements imposed by the plaintiff’s state-law claims to determine whether they conflict with federal law.
- State Requirements That Do Not Mirror Federal Requirements Are Preempted
Critically, the FDCA’s preemption provisions “[do] not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements.”[lvi] State requirements also need not use the exact same language as their federal counterparts.[lvii] Rather, the focus is on the equivalence, or lack thereof, between the requirements imposed by federal and state law. If the manufacturer cannot comply with both the FDCA and the state requirement the state law requirement must yield. Once a court has determined that federal law imposes requirements on the subject matter of the plaintiff’s claims, this inquiry should be relatively straightforward.
The courts in Mills and Carter both made short work of determining that the plaintiffs’ consumer protection claims imposed requirements that conflicted with the FDCA and therefore were preempted. The court in Mills reasoned that “Defendants can market their products in compliance with the FDA requirements or they can refrain from marketing their products in order to comply with the requirements (and avoid liability) imposed by Plaintiffs’ lawsuit. They cannot do both.”[lviii] Similarly, the court in Carter found that the defendants’ liability for the plaintiffs’ consumer protection claims was founded on the allegation that the defendants’ products were not safe and effective for children under the age of six.[lix] Because these claims deviated from the FDA’s specific regulations establishing labeling and dosage requirements for the defendants’ products, the court concluded that the plaintiffs’ claims were preempted.[lx]
The plaintiffs in Carter attempted to argue that their claims for monetary damages were not preempted because they did not force the defendants to deviate from the FDCA’s labeling requirements.[lxi] While recognizing that a monetary judgment may induce, but not require, a manufacturer to alter its conduct, the court concluded that the United States Supreme Court’s holding in Riegel did not suggest any distinctions between various theories of liability or categories of remedies sought: “if the defendant is in full compliance with FDA regulations, any non-parallel state law liability, including a jury verdict for damages, imposes a ‘requirement’ and is expressly preempted.”[lxii] Because the plaintiffs did not allege that the defendants had violated any provision of the FDCA, their claims were not parallel.[lxiii]
The plaintiffs’ claims in Mills and Carter were preempted because they would have required the defendants to violate the FDCA in order to avoid state law liability. In Vermont Pure Holdings, Ltd. v. Nestle Waters North America, Inc., however, the court found that the plaintiff’s consumer protection claims were not preempted because they imposed a requirement that was identical to federal law.[lxiv] In Vermont Pure Holdings, the plaintiff sued Nestle Waters North America (“Nestle”) under the Lanham Act and various state consumer protection acts for allegedly making false and misleading statements regarding the source, nature, and purity of Poland Spring bottled water.[lxv] The defendant argued that the plaintiff’s claims were preempted by the FDCA, which contains regulations explicitly defining “spring water.”[lxvi] The court rejected this argument, finding that the plaintiff’s claims could proceed to the extent that they were based on the FDCA’s definition of “spring water.”[lxvii] In other words, while the FDA’s spring water regulations defined the scope of the federal requirement at issue, the mere existence of those regulations did not preempt the plaintiff’s claims if those claims did not differ from the federal requirements.[lxviii] In this regard, the plaintiff’s cause of action merely sought to enforce the provisions of the FDCA.
- Savings Clauses: What is a “Product Liability Claim?”
Not all state-law causes of action are preempted by the FDCA. In enacting the FDCA’s preemption provisions, Congress carved out exemptions for claims brought under state product liability law, at least with respect to non-prescription drugs and cosmetics. The question of whether a consumer-protection claim qualifies as a product liability claim is one that has not been heavily litigated, but courts generally have agreed that this determination must be made by reviewing applicable state law. Courts have distinguished these two categories of claims by recognizing that injury to the plaintiff is an essential element of a product liability claim. Thus, consumer protection claims based solely on allegations of deceptive advertising or labeling, without evidence of a resulting injury to the plaintiff, do not fall within the scope of a product liability claim and are not exempted from preemption.
Mills and Carter are two examples of the rare cases in which the courts have been asked to analyze a plaintiff’s consumer protection claims under the FDCA’s preemption savings clause for non-prescription drugs. The plaintiffs in Mills argued that their claims were exempted from preemption by the savings clause for products liability claims relating to non-prescription drugs.[lxix] They claimed that Congress intended Section 379r(e) to apply broadly to any action based on a defective product, regardless of its categorization under state law.[lxx] But the court rejected this argument, finding that “the statute’s language reflects an intent to defer to each State’s interpretation of ‘product liability,’ and thereby avoid interfering with the State’s product liability regime.”[lxxi] Because the plaintiffs’ claims did not meet the Texas statutory definition of a “products liability claim” – i.e., plaintiffs did not allege personal injury, wrongful death, or property damage – the court found that Section 379r(e) did not save their claims from preemption.[lxxii]
The court in Carter applied a similar analysis to find that the plaintiffs’ claims were preempted by the FDCA. The plaintiffs in Carter contended that their consumer protection claims qualified as “product liability actions” and therefore were saved from preemption by Section 379r(e).[lxxiii] The court rebuffed this argument, finding that injury to the plaintiff is an essential element of a product liability action under California law.[lxxiv] The plaintiffs had not alleged that they or their children were injured by the defendants’ products; on the contrary, they alleged in their complaints that “damages for personal injuries . . . are not within the scope of this case.”[lxxv] Thus, their claims could not be considered actions for “product liability.”
Two important lessons can be extracted from the courts’ holdings in Mills and Carter. First, it is clear that the determination of whether the plaintiff’s consumer protection claim qualifies as a “products liability action” turns on the applicable state-law definition of a “product liability action.” Accordingly, defendants must review the applicable CPA and any case law interpreting that statutory scheme in order to determine whether any or all claims brought under the CPA are considered “product liability actions.” Courts in some states have explicitly held that claims brought under their CPAs do not qualify as product liability actions, but the answer will not be this straightforward in every state.[lxxvi] Defendants must still compare the elements of a product liability claim and a consumer protection claim and be prepared to highlight any substantive differences.
Second, the courts in Mills and Carter both distinguished claims seeking solely economic damages from those in which the plaintiff alleges a personal injury arising from the defendant’s allegedly deceptive conduct. Because injury to the plaintiff is typically an essential element of a product liability claim, consumer protection actions that do not allege an injury cannot take advantage of the product liability savings clause. Nevertheless, it is possible that a court would reach a different result if the plaintiff did allege an injury, even in the absence of an express tort claim. It is therefore important to identify whether the plaintiff, whether a private individual or a State Attorney General, has alleged a specific injury as a result of the defendant’s deceptive practices.
The express preemption provisions of the FDCA provide a powerful defense against state law causes of action based on deceptive marketing and labeling of products, but manufacturers must be prepared to identify the specific federal requirements that would be affected by the plaintiff’s claim before they can present a successful preemption defense. Manufacturers must also carefully define the specific requirements imposed by the plaintiff’s cause of action and explain how those requirements conflict with federal law. Finally, the manufacturer must be able to determine whether a plaintiff’s claim can qualify as a product liability action under applicable state law, which may save it from preemption.
Given that consumer protection actions have become more ubiquitous in recent years, the defense of preemption should be raised whenever possible in order to prevent these actions from creating a patchwork of inconsistent drug and device requirements in every State.
[i] U.S. Const. Art. VI, cl. 2.
[ii] See Maryland v. Louisiana, 451 U.S. 725, 746 (1981) (“[W]e have long recognized that state laws that conflict with federal law are ‘without effect.’”).
[iii] See, e.g., 21 U.S.C. §§ 343-1, 360k, 379r, 379s.
[iv] See Medtronic, Inc. v. Lohr, 518 U.S. 470, 475 (1996).
[v] Id. at 494.
[vi] Altria Group, Inc. v. Good, 555 U.S. 70, 77 (2008).
[vii] See Puerto Rico v. Franklin Cal. Tax-Free Trust, 136 S. Ct. 1938 (2016).
[viii] English v. Gen. Electric Co., 496 U.S. 72, 79 (1990).
[ix] 21 U.S.C. § 343-1.
[x] 21 U.S.C. § 360k.
[xi] 21 U.S.C. § 379r. No preemption provision exists for prescription drugs.
[xii] 21 U.S.C. § 379s.
[xiii] Bowling v. Johnson & Johnson, 65 F. Supp. 3d 371, 377 (S.D.N.Y. Nov. 4, 2014).
[xiv] See, e.g., 21 U.S.C. § 379r.
[xv] 552 U.S. 312 (2008).
[xvi] Id.at 322 (quoting 21 C.F.R. § 808.1(d)).
[xvii] Lohr, 418 U.S. at 501.
[xviii] Riegel, 552 U.S. at 323.
[xix] Id. See 21 U.S.C. 360e(d).
[xxii] 581 F. Supp. 2d 772, 776 (E.D. Tex. 2008).
[xxiv] Id. at 783.
[xxv] Id. at 783.
[xxvi] Id. at 785-86.
[xxvii] Id. at 785 (citing Riegel, Inc., 552 U.S. 312; Gomez v. St. Jude Medical Daig Division Inc., 442 F.3d 919 (5th Cir. 2006), Martin v. Medtronic, Inc., 254 F.3d 573 (5th Cir. 2001), and Stamps v. Collagen Corp., 984 F.2d 1416, 1420-22 (5th Cir. 1993)).
[xxix] Id. at 787.
[xxx] Id. at 788.
[xxxi] 258 F. Supp. 3d 312, 316 (S.D.N.Y. 2017).
[xxxiii] Id. at 318.
[xxxiv] Id. at 321.
[xl] Id. at 322
[xliii] Id. at 323.
[xliv] Cippollone v. Liggett Group, Inc., 518 U.S. 470, 484 (1996).
[xlv] Lohr, 518 U.S. at 500 (holding that federal requirements must be “‘applicable to the device’ in question, and, according to the regulations, pre-empt state law only if they are ‘specific counterpart regulations’ or ‘specific’ to a ‘particular device.’”
[xlvi] Bates, 544 U.S. at 443.
[xlvii] Riegel, 552 U.S. at 324.
[xlviii] San Diego Bldg. Trades Council v. Garmon, 359 U.S. 236, 247 (1959).
[xlix] See Riegel, 552 U.S. at 312 (finding plaintiffs’ claims under New York tort law to be preempted by the FDCA to the extent they imposed requirements “different from, or in addition to” the requirements imposed by the FDCA).
[l] 581 F. Supp. 2d 772, 776 (E.D. Tex. 2008).
[li] 582 F. Supp. 2d 1271, 1281 (C.D. Cal. 2008)
[lii] Id. (emphasis in original).
[liii] Id. at 1282. See 21 U.S.C. § 379r(c)(2).
[lvi] Riegel, 552 U.S. at 330.
[lvii] In re PepsiCo Bottled Water Marketing and Sales Practices Litig., 588 F. Supp. 2d 527, 533 (S.D.N.Y. 2008) (holding that courts “‘should bear in mind the concept of equivalence’ rather than requiring that the state law requirements ‘be phrased in the identical language as its corresponding [federal] requirement’ in order to survive preemption.”).
[lviii] Mills, 581 F. Supp. 2d at 790.
[lix] Carter, 582 F. Supp. 2d at 1282.
[lxiv] 2006 WL 839486, at *1 (D. Mass. Mar. 28, 2006).
[lxvii] Id. at *6.
[lxix] Mills, 581 F. Supp. 2d at 790-91. See 21 U.S.C. § 379r(e).
[lxx] Id. at 791
[lxxii] Id. at 793. See Tex. Civ. Prac. & Rem. Code § 82.001(2).
[lxxiii] Carter, 582 F. Supp. 2d at 1287 (quoting 21 U.S.C. § 379r(e)).
[lxxvi] See Sinclair v. Merck & Co., Inc., 195 N.J. 51, 948 A.2d 587, 595 (2008) (holding that claims under the New Jersey Consumer Fraud Act are not “products liability actions”).