Federal Preemption
Preemption in Mass Tort Cases
Federal preemption of contrary state laws is ultimately grounded in the Supremacy Clause of the U.S. Constitution, Article VI, Clause 2, which states the U.S. “Constitution, and the Laws of the United States which shall be made in Pursuance thereof . . . shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.”[1]
The Supremacy Clause works in conjunction with other constitutional provisions, however, particularly the Tenth Amendment, which states “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.”[2] Given historical concerns of federalism and the recognition that “States are independent sovereigns in our federal system,” courts have long assumed that “Congress does not cavalierly preempt state-law causes of action.”[3] As such, a court’s analysis must always proceed with a “presumption against the pre-emption of state police power regulations” and a narrow reading of allegedly preemptive statutes.[4] The U.S. Supreme Court has retracted this presumption as it applies to express preemption, under the reasoning that “the plain wording of the [preemptive] clause . . . necessarily contains the best evidence of Congress’ pre-emptive intent.”[5] Additionally, “an ‘assumption’ or nonpre-emption is not triggered when the State regulates in an area where there has been a history of significant federal presence.”[6]
Express and Implied Preemption
There are two varieties of preemption: express and implied. In some instances, a statute will expressly forbid state laws relating to a particular substantive area. Even where a statute lacks express preemptive language, there are circumstances where preemption is implied, either because the federal regulatory scheme is so pervasive that it is presumed that states may not also regulate in the area, or because of conflicts between state and federal law or regulatory objectives. Each type of preemption is discussed below. Importantly, the existence of express preemption language in a statute does not preclude the possibility of implied preemption relating to the substantive area in question.[7] For example, a statute may expressly preempt certain types of state regulation, but other types of state activities that are not expressly preempted may nevertheless be impliedly preempted.
It is also commonly observed that preemption is a matter of Congressional intent,[8] although that intent is to be discerned primarily from a statute’s text.[9] In the past, the U.S. Supreme Court has interpreted the preemptive language of particular statutes in light of the overall structure of the relevant legislation, as well as the broader regulatory scheme at issue.[10] Given the Court’s increasing emphasis on plain meaning, and concomitant move away from intent-based interpretation, though, one has to wonder about the viability of this approach going forward.
Express Preemption
The Federal Cigarette Labeling and Advertising Act[11] contained the following express preemption provision: “No requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in conformity with the provisions of this [Act].”[12]
In Cipollone, the Court ultimately held that “insofar as claims under either failure-to-warn theory require a showing that respondents’ post-1969 advertising or promotions should have included additional, or more clearly stated, warnings, those claims are pre-empted” because such claims would “rely on a state-law ‘requirement or prohibition . . . with respect to . . . advertising or promotion.’”[13]
Similar (but not identical to) the cigarette labeling preemption statute is the following provision, contained in the Medical Device Amendments of 1976[14]:
Except as provided in subsection (b) [not relevant here], no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
- which is different from, or in addition to, any requirement applicable under this chapter to the device, and
- which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.[15]
There are two vital differences that distinguish this language from the Medical Device Amendments from that in the tobacco labeling statute. First, rather than a wholesale preclusion of any and all state-level requirement or prohibition relating to advertising or promotion of cigarettes, the Medical Device Amendments only prohibit state-level requirements that are “different from” or “in addition to” applicable requirements. This difference has momentous consequences in the area of medical device litigation. Second, the Medical Device Amendments’ preemption statute only applies to requirements that relates to a device’s “safety or effectiveness” or “to any other matter included in a requirement applicable to the device” under the Food, Drug, and Cosmetic Act.[16]
In contrast to devices, the FDCA does not have any express preemption language that applies to drugs.
Implied preemption
In addition to express preemption, where Congress “define[s] explicitly the extent to which its enactments pre-empt state law,”[17] there are two circumstances where preemption may be implied. First, preemption is implied when Congress has regulated a field so extensively that it can be inferred that the federal government was intended to occupy the regulatory space completely (field preemption). Second, where there is no express preemption, but there is a direct conflict between state and federal law on an issue, preemption is also implied (conflict preemption). Conflict preemption is further subdivided into two types: obstacle preemption, where the state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress,”[18] and impossibility preemption, wherein it is impossible for a party to comply with both state and federal law.[19]
Field Preemption
As a general principle, federal courts begin with the premise that “the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.”[20] This presumption is consistent with broader principles of federalism.
Even though the FDCA lacks an express preemption provision, defendants (and sometimes the FDA as amicus curiae) have argued that given the century-plus provenance of the FDA, the FDA must ipso facto occupy the field.
Additionally, it is clear that, at the time of the FDCA’s passage in 1938, Congress did not intend to preempt any common-law causes of action.[21]
Conflict Preemption
Obstacle Preemption
Obstacle preemption will be found when a state’s “law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.”[22]
Impossibility Preemption
Even if the relevant statute lacks an express preemption provision, a court may find implied preemption of a state law where it is “impossible for a private party to comply with both state and federal requirements.”[23]
The Court held that while it is true “the FDA retains authority to reject labeling changes made pursuant to the CBE regulation in its review of the manufacturer’s supplemental application,” this fact alone does not preempt state claims that a drug should have had a stronger warning label (the basis for failure-to-warn claims) unless there is “clear evidence that the FDA would not have approved a change to [the drug’s] label.”[24]
The U.S. Supreme Court answered the question of what constitutes “clear evidence” in Merck Sharp & Dohme Corp. v. Albrecht.[25] Albrecht involved Fosamax, a drug used to prevent treat osteoporosis in postmenopausal women.[26]
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)
The U.S. Supreme Court held that the notification process under § 510(k) imposed neither safety nor effectiveness requirements for a device. Instead, it merely confirms equivalence to a device that is already on the market.
The plaintiff also raised the important argument that the relevant preemption inquiry is not simply whether a state-law cause of action is a “requirement,” but also must include a determination of whether that requirement is “different from or in addition” to the federal requirements. Only if both conditions are satisfied can a state requirement be preempted, and argument with which the Court agreed. In so doing, the Court observed that state-law requirements in the form of a remedy for common law causes of actions are permissible under the Medical Device Amendments so long as they “parallel federal requirements.”
Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001)
Buckman is a case whose reach is often overstated; the limited scope of Buckman is clear in the Court’s explanation of why it refused to apply the traditional presumption against preemption. The Court resisted the presumption against preemption because “[p]olicing fraud against federal agencies is hardly “a field which the States have traditionally occupied.’”[27] As the Court went on to explain, “the relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.”[28]
Thus, Buckman’s scope is exceptionally narrow. It is clear that a plaintiff may not attempt to flip parens patriae roles with the federal government and attempt to protect it from bad actors. But an act that would be fraud against the FDA but also independently actionable under state law is not preempted. Thus the Court’s comparison with Lohr:
it is clear that the [Lohr] claims arose from the manufacturer’s alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements. In the present case, however, the fraud claims exist solely by virtue of the FDCA disclosure requirements. Thus, although [Lohr] can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim.[29]
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)
Riegel involved a catheter device that had undergone premarket approval. Lohr and Riegel represent the two foundational opinions relating to preemption in cases involving § 510(k) and premarket approval devices, respectively.
In contrast to the notification process under § 510(k), the Court held that the premarket approval process is a safety-focused review that imposes specific requirements for a specific device.
In Riegel, the Court observed that with respect to medical devices (Lohr, interpreting the Medical Device Amendments), herbicides (Bates, interpreting FIFRA), and tobacco (Cippolone, interpreting the Public Health Cigarette Smoking Act of 1969), it had previously held that “requirements” as used in the respective statute included common-law causes of action such as negligence and strict liability.[30]
Importantly, however, the Court allowed that state-law causes of action that “parallel” federal requirements are permissible, even in the case of a premarket approval device.
It is important to note the Court’s confirmation that “§ 360k does 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.”[31] Invariably, defendants’ preemption briefing will cite Buckman for the proposition that any reliance on FDA regulations is preempted. Not only is that reading contrary to Buckman’s holding, but it is squarely rejected by the Court in Riegel.
FIFRA
In contrast to the cigarette labeling statute at issue in Cipollone and the preemption statute found in the Medical Device Amendments of 1976, FIFRA contains language expressly permitting states to regulate the sale or use of any federally registered pesticide or device in the State, but only if and to the extent the regulation does not permit any sale or use prohibited by [FIFRA].”[32] But similar to those statutes, FIFRA expressly prohibits states from “impos[ing] or continu[ing] in effect any requirements for labeling or packaging in addition to or different from those required under [FIFRA].”[33]
Under FIFRA, a pesticide is misbranded if “its labeling bears any statement, design, or graphic representation relative thereto or to its ingredients which is false or misleading in any particular.”[34] Accordingly, misleading is misbranding.
[1] Art. VI, Cl. 2.
[2] U.S. Const. amend. X.
[3] Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996), discussed infra.
[4] See Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 518 (1992), discussed infra.
[5] Puerto Rico v. Franklin California Tax-Free Truest, 579 U.S. 115, 125 (2016) (citing Chamber of Commerce of United States of America v. Whiting, 563 U.S. 582, 594 (2011)).
[6] United States v. Locke, 529 U.S. 89, 108 (2000) (citing Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977); Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996)).
[7] See Geier v. American Honda Motor Co., 529 U.S. 861, 881–82 (2000).
[8] Wyeth v. Levine, 555 U.S. 555, 565 (2009) (quoting Retail Clerks v. Schermerhorn, 375 U.S. 96, 103 (1963)).
[9] Medtronic, Inc. v. Lohr, 518 U.S. 470, 486 (1996).
[10] See id.
[11] Pub. L. No. 89-92, 79 Stat. 282 (codified at 15 U.S.C. § 1331 et seq.).
[12] 15 U.S.C. § 1334(b).
[13] Cipollone v. Liggett Group, Inc., 505 U.S. 504, 524 (1992) (emphasis added).
[14] Pub. L. 94-295, 90 Stat. 539.
[15] 21 U.S.C. § 360k(a).
[16] U.S. Code, Title 21, Chapter 9.
[17] English v. Gen. Elec. Co., 496 U.S. 72, 78 (1990) (citing Shaw v. Delta Air Lines, Inc., 463 U.S. 85, 95–98 (1983)).
[18] Hines v. Davidowitz, 312 U.S. 52, 67 (1941).
[19] Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142–43 (1963).
[20] Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947).
[21] Hearings Before Subcomm. of Comm. on Commerce on S. 1944, 73d Cong., 2d Sess. 400, 403 (1933); Robert S. Adler & Richard A. Mann, Preemption and Medical Devices: The Courts Run Amok, 59 Mo. L. Rev. 895, 924 & n. 130 (1995) (noting that “Congress rejected a provision in a draft of the original FD&C providing a federal cause of action for damages because ‘a common law right of action [already] exist[ed].’”).
[22] Hines v. Davidowitz, 312 U.S. 52, 67 (1941).
[23] English v. General Elec. Co., 496 U.S. 72, 79 (1990).
[24] Wyeth v. Levine, 555 U.S. 555, 571 (2009).
[25] 139 S. Ct. 1668 (2019).
[26] Albrecht, 139 S. Ct. at 1673.
[27] Buckman Co., 531 U.S. at 347 (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947)).
[28] Id. (citation omitted).
[29] Id. at 352–53 (emphasis added) (internal citation omitted).
[30] Riegel v. Medtronic, Inc., 552 U.S. 312, 323–24 (2008).
[31] Id. at 330 (2008).
[32] 7 U.S.C. § 136v(a).
[33] 7 U.S.C. § 136v(b).
[34] 7 U.S.C. § 136(q)(1)(A).