Case: 23-20533        Document: 74-1      Page: 1     Date Filed: 04/10/2025




         United States Court of Appeals
              for the Fifth Circuit
                              ____________
                                                                    United States Court of Appeals
                                No. 23-20533                                 Fifth Circuit


                              ____________                                 FILED
                                                                       April 10, 2025
Zyla Life Sciences, L.L.C.,                                           Lyle W. Cayce
                                                                           Clerk
                                          Plaintiff—Appellant/Cross-Appellee,

                                    versus

Wells Pharma of Houston, L.L.C.,

                               Defendant—Appellee/Cross-Appellant.
                ______________________________

                Appeal from the United States District Court
                    for the Southern District of Texas
                         USDC No. 4:22-CV-4400
                ______________________________

Before Ho, Duncan, and Oldham, Circuit Judges.
Andrew S. Oldham, Circuit Judge:
       The question presented is whether a State triggers implied obstacles-
and-purposes preemption when it expressly incorporates federal law into
state law. The district court held yes. But as the Supreme Court held almost
a century ago, “there is no conflict in terms, and no possibility of such con-
flict, for the state statute makes federal law its own.” California v. Zook, 

 (1949). Therefore, we reverse.
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                                 No. 23-20533


                                      I
                                      A
                                      1
       All preemption has a constitutional source: the Supremacy Clause. See
Philadelphia v. New Jersey, 

 (1977) (per curiam). In “our
federal system, the States possess sovereignty concurrent with that of the
Federal Government, subject only to limitations imposed by the Supremacy
Clause.” Tafflin v. Levitt, 

 (1990). Under the Supremacy
Clause, any state law that contradicts federal law is preempted. See U.S.
Const. art. VI, cl. 2. But barring any contradiction, the States retain their
sovereign prerogatives to regulate.
       Supreme Court precedent establishes a preemption taxonomy. The
first division is between express and implied preemption. Kansas v. Garcia,

, 202–03 (2020). Implied preemption is further divided into two
types: field preemption and conflict preemption. 

 at 208–211. Conflict
preemption is then divided into two more types. The first is impossibility
preemption. It arises when it is impossible to obey both state and federal re-
quirements. See Fla. Lime & Avocado Growers, Inc. v. Paul, 

, 142–
43 (1963). The second is obstacles-and-purposes preemption (the only type
of preemption at issue here). It arises when state law “stands as an obstacle
to the accomplishment and execution of the full purposes and objectives of
Congress.” Hines v. Davidowitz, 

 (1941). In all these types of
preemption, however, “[e]vidence of pre-emptive purpose [must be] sought
in the text and structure of the [federal provision] at issue.” CSX Transp.,
Inc. v. Easterwood, 

 (1993).




                                      2
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                                 No. 23-20533


                                       2
       The federal provisions at issue here come from the Federal Food,
Drug, and Cosmetic Act (“FDCA”). On June 25, 1938, President Franklin
Delano Roosevelt signed the FDCA into law. See 

 Stat.
1040 (codified as amended at 

 et seq.). The New Dealers who
drafted the FDCA did not start from scratch, though. They responded to
perceived weaknesses in the Pure Food and Drugs Act of 1906, 

 Stat. 768 (repealed 1938), which was signed by Roosevelt’s fifth
cousin by blood and uncle by law, President Theodore Roosevelt.
       The weaknesses with the 1906 Act were brought into the American
consciousness by Arthur Kallet and F.J. Schlink’s 1933 bestseller,
100,000,000 Guinea Pigs: Dangers in Everyday Foods, Drugs, and Cosmetics.
See David F. Cavers, The Food, Drug, and Cosmetic Act of 1938: Its Legislative
History and Its Substantive Provisions, 

, 5–6
(1939). Kallet and Schlink warned that the American people had been
“forced into the role of laboratory guinea pigs” by “the food and drug indus-
tries,” which had “been making profits by experimenting on [Americans]
with poisons, irritants, harmful chemical preservatives, and dangerous
drugs.” Arthur Kallet & F.J. Schlink, 100,000,000 Guinea
Pigs: Dangers in Everyday Foods, Drugs, and Cosmetics
4 (1933). Kallet and Schlink told the stories of men like “William J. A. Bailey,
an ex-auto-swindler,” who made his “money by dissolving radium salts in
water and selling” the resultant concoction “to rich men to cure their ills.”

 at 4–5. To the horror of Kallet and Schlink’s readers, “Bailey’s radium
water” had “sent at least two men to horrible deaths.” Id. at 5. More horri-
fying still was Kallet and Schlink’s premonition that “a similar fate may be
awaiting scores or hundreds of others who drank this deadly fluid.” Ibid.




                                       3
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                                 No. 23-20533


       The centerpiece of the new FDCA was § 505. See Richard A. Merrill,
The Architecture of Government Regulation of Medical Products, 

, 1761 (1996). Although that provision “was not among the reforms
originally sought by the [FDCA’s] architects,” ibid., it became the focal
point of the new FDCA after nearly a hundred Americans died of poisoning
from the “Elixir Sulfanilamide” drug sold by the S. E. Massengill Company,
see Cavers, supra, at 20. In response to this tragedy, Congress determined
that the Federal Government should act to prevent such incidents from oc-
curring in the first place, rather than merely “respond[] to evidence of harm”
after it had occurred. Merrill, supra, at 1761. So Congress decided to forbid
manufacturers from marketing drugs “without first notifying [the] FDA and
allowing it time to assess their safety.” Id. at 1762. After further amendments
in 1962, Congress converted this “premarket notification system” into to-
day’s “premarket approval system.” Id. at 1764–65 (emphasis added). Under
today’s system, no one may sell “any new drug” without prior approval from
the FDA. See 

(a).
       Ever since the FDCA’s enactment in 1938, Congress has given the
Federal Government power to enforce its substantive provisions. See 52 Stat.
at 1046. Today, those enforcement provisions are codified at 

.
Subsection (a) authorizes the United States to bring “all . . . proceedings for
the enforcement, or to restrain violations,” of the FDCA. And subsection
(b) permits States to bring actions to enforce certain provisions of the
FDCA.
       Originally, the FDCA did not regulate all aspects of drug safety: As
relevant here, it left alone the ancient art of compounding. See Thompson v.
W. States Med. Ctr., 

 (2002); see also Judith E. Thomp-
son, A Practical Guide to Contemporary Pharmacy Prac-
tice 141 (3d ed. 2009) (discussing compounding’s ancient roots).
Compounding fell outside the FDCA’s premarket approval scheme for new



                                      4
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                                   No. 23-20533


drugs. Compounders, after all, do not make new drugs; they merely “com-
bine[], mix[], and alter[]” the “ingredients in” old drugs. Nexus Pharms., Inc.
v. Cent. Admixture Pharmacy Servs., 

, 1042 (9th Cir. 2022). The
goal of compounding is to provide “medication tailored to the needs of an
individual patient.” 

 U.S. at 360–61. For example, some infants
and children might need a certain medication, but the commercially available
forms of the medication provide too high a dosage. 

. Other patients might be allergic to some ingredient in the commercially
available forms. 

 That’s where compounding comes in. Under the origi-
nal FDCA, and for roughly a half-century thereafter, compounding regula-
tion was “generally left . . . to the States.” Thompson, 

.
       Eventually, though, the Federal Government grew “concerned . . .
that some pharmacists were manufacturing and selling drugs under the guise
of compounding, thereby avoiding the FDCA’s new drug requirements.”

 Even as the Federal Government began to regulate compounding, Con-
gress maintained a limited exemption from the FDCA’s premarket-approval
requirement for certain drugs “compounded for an identified individual pa-
tient.” Food and Drug Administration Modernization Act of 1997, 

 Stat. 2296, 2328 (codified as amended at 21 U.S.C. § 353a).
And as relevant in this case, in 2013, Congress also crafted an exemption for
certain registered compounding facilities. See Drug Quality and Security Act,

 Stat. 587, 588 (2013) (codified at 21 U.S.C. § 353b).
But under § 353b, registration alone is not enough for a facility to sell com-
pounded drugs without premarket approval. The compounding facility must
satisfy a host of additional statutory criteria. See ibid.
                                         3
       In the face of this ever-expanding federal regulation of drugs, how-
ever, the States have not forfeited their traditional prerogative to police drug




                                         5
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                                     No. 23-20533


safety. Cf. Medtronic, Inc. v. Lohr, 

 (1996) (highlighting “the
historic primacy of state regulation of matters of health and safety”). As rel-
evant here, six States have decided to mirror federal law by making it illegal
to sell any new drug that has not been approved under 

 (the
original § 505 of the FDCA). See 

(a); 

(1); Conn. Gen. Stat.
§ 21a-110; 

; Tenn. Code § 53-1-110(a); S.C.
Code § 39-23-70(a). If anyone sells drugs in violation of these state laws,
competitors may bring suit under traditional state unfair-competition law.
                                          B
       This dispute arises between two such competitors: Zyla Life Sciences,
LLC (“Zyla”) and Wells Pharma of Houston, LLC (“Wells Pharma”).
       Zyla sells Indocin Suppositories across the United States.1 Zyla’s sup-
positories contain indomethacin, a drug used to treat various ailments, such
as rheumatoid arthritis. At least until 2023, Zyla’s suppositories were the
only ones containing indomethacin that had obtained FDA approval.
       Wells Pharma sells compounded indomethacin suppositories. Alt-
hough the compounded indomethacin suppositories Wells Pharma sells are
not FDA-approved, Wells Pharma satisfies at least one of § 353b’s many re-
quirements since it is a registered compounding facility under that section.
       Zyla wanted to enjoin Wells Pharma from manufacturing and selling
its suppositories in California, Colorado, Connecticut, Florida, South Caro-
lina, and Tennessee, so it filed suit under those States’ unfair-competition
laws. Wells Pharma filed a motion to dismiss under Rule 12(b)(6), arguing
       _____________________
       1
          Suppositories like Zyla’s deliver medication into the body via small, round or
cone-shaped objects. People place suppositories into their body—ordinarily in less-than-
pleasant places—and once inside, the suppositories dissolve, releasing the medication.




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                                         No. 23-20533


the state laws were preempted. The district court granted the motion. Zyla
appealed.
        The question presented on appeal is whether the state laws somehow
conflict with the FDCA by incorporating it.2
                                              II
        They do not. As we explain, (A) under Zook, Wells Pharma’s conflict-
preemption defense must fail. And (B) Wells Pharma’s arguments to the con-
trary are unpersuasive.



        _____________________
        2
            We address three other theories of preemption briefly in this footnote.
         First, field preemption is foreclosed by Wyeth v. Levine, 

 (2009). See

.
        Second, impossibility preemption is irrelevant. It is obviously possible to comply
with identical requirements.
         The third potential theory, which the district court embraced below, is a bit more
complex. The district court concluded that the state laws were preempted because they
added to federal requirements. Zyla Life Scis., LLC v. Wells Pharma of Hous., LLC, No.
4:22-CV-04400, 

, at *4–5 (S.D. Tex. Sept. 27, 2023). The district court
reasoned that the state laws required Wells Pharma to obtain prior approval from the FDA.

 But under federal law, Wells Pharma did not need to obtain approval if it satisfied
§ 353b. Ibid.
         That’s a big if. Because there is no preemption overbreadth doctrine, to establish
its preemption defense, Wells Pharma needed to prove that the state laws were preempted
“as applied” to it. Kansas v. Garcia, 

, 208, 211 (2020); see also Moody v.
NetChoice, LLC, 

, 2397 (2024). So to establish this theory of preemption,
Wells Pharma needed to prove that the state laws impose additional requirements as to
Wells Pharma. But the state laws do that only if Wells Pharma satisfies the many require-
ments of § 353b. Otherwise, the state and federal requirements are the same: To sell drugs,
Wells Pharma must obtain FDA approval. But at this stage of the litigation, Wells Pharma
cannot have proven that it satisfies § 353b’s many requirements. Wells Pharma has only
moved to dismiss under 12(b)(6). And given this procedural posture, we cannot draw fac-
tual inferences in Wells Pharma’s favor concerning its compliance with § 353b.




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                                  No. 23-20533


                                       A
       Zook controls this case. Zook involved a California law that “pro-
hibit[ed] the sale or arrangement of any transportation over public highways
of the State if the transporting carrier ha[d] no permit from the Interstate
Commerce Commission.” 

. A federal statute had an identical
provision. 

 at 726–27. After Berl B. Zook and Wilmer K. Craig violated the
state law, California prosecuted them. 

. Zook and Craig argued that
the California law was preempted because it mirrored federal law. See 

 at
732–33.
       The Supreme Court held that the California law was not preempted.
The mere “fact of identity,” the Court explained, did “not mean the auto-
matic invalidity of State measures.” 

. On the contrary, there was
“no conflict in terms, and no possibility of such conflict, for the state statute
ma[de] federal law its own.” 

; see also Garcia, 589 U.S. at 212
(“[T]here is no basis for inferring that federal . . . statutes preempt state laws
whenever they overlap.”). Since there was no conflict, the state statute was
not preempted.
       Zook accords well with preemption first principles. As explained,
preemption doctrine comes from the Supremacy Clause. But as the Supreme
Court explained over a century ago, when state law mirrors federal law, it
“recognizes the supremacy of the national law” by “conform[ing] to it.”
Asbell v. Kansas, 

 (1908).
       Because the States’ laws “recognize[] the supremacy of the national
law,” ibid., it would be anomalous to conclude the Supremacy Clause some-
how preempts them. Take the California statute underlying one of Zyla’s
claims, for example. It bars selling a “new drug” that has not been approved
“under Section 505 of the [FDCA].” Cal. Health & Safety Code




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                                       No. 23-20533


§ 111550(a). The other state laws are identical in all relevant respects.3 Those
statutes all “make[] federal law [their] own.” Zook, 

. Thus,
there can be “no conflict in terms” and no preemption. 

                                             B
        Adopting Wells Pharma’s contrary position would raise a host of legal
problems. It would (1) mark the return of an ancien régime of preemption re-
jected both by Congress and the Supreme Court. (2) The logic of Wells
Pharma’s position would undermine state sovereignty. Fortunately, (3) that
logic has been repudiated in multiple throughlines of preemption and feder-
alism precedent.
                                             1
        Adopting Wells Pharma’s position would mark a return to the ancien
régime of Houston v. Moore, 

 (1820). In Houston, Pennsyl-
vania sought to punish a militiaman for refusing to respond when called into
federal service “in pursuance of a requisition from the President of the
United States” during the War of 1812. 

. The Pennsylvania law pro-
vided that any militiaman who “neglected or refused to serve when called

        _____________________
        3
          See FLA. STAT. § 499.023 (“A person may not sell, offer for sale, hold for sale,
manufacture, repackage, distribute, or give away any new drug unless an approved
application has become effective under s. 505 of the [FDCA]. . . .”); TENN. CODE § 53-
1-110(a) (“No person shall sell, deliver, offer for sale, hold for sale or give away any new
drug unless an application with respect to the drug has become effective under § 505 of the
[FDCA].”); S.C. CODE § 39-23-70(a) (“No person shall introduce or deliver for
introduction into intrastate commerce any new drug unless . . . an application with respect
thereto has been approved and such approval has not been withdrawn under Section 505 of
the [FDCA].”); CONN. GEN. STAT. § 21a-110(a) (“No person shall sell . . . any new
drug” that has not “been approved under Section 355 [§ 505 of the FDCA].”); COLO.
REV. STAT. § 12-280-131(1) (“No person shall sell, deliver, offer for sale, hold for sale, or
give away any new drug not authorized to move in interstate commerce under appropriate
federal law.”).




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                                 No. 23-20533


into actual service, in pursuance of any order or requisition of the President
of the United States,” would “be liable to the penalties” set out in various
“act[s] of the Congress of the United States.” Id. at 2. In other words, the
Pennsylvania law punished the failure to report precisely to the extent federal
law did.
       Justice Bushrod Washington concluded that the Pennsylvania law was
preempted. Washington proclaimed that he could not even fathom how two
parallel laws could not contradict: As he put it, “I am altogether incapable of
comprehending how two distinct wills can, at the same time, be exercised in
relation to the same subject, to be effectual, and at the same time compatible
with each other.” Id. at 23. Since the Pennsylvania law sought to act upon
“the same subject” as the federal law, it could not be “compatible with” fed-
eral law. Ibid. Since it was not compatible with federal law, it was preempted.
       But “the Houston rule was doomed” from the start. J.A.C. Grant, The
Scope and Nature of Concurrent Power, 

, 1012 (1934).
       First, Washington’s opinion “cannot be said to have spoken for the
Court.” David P. Currie, The Constitution in the Supreme
Court: The First Hundred Years, 1789–1888, at 110 (1992). Alt-
hough a majority agreed with Washington that the judgment should stand,
Washington himself acknowledged that the other justices who formed the
majority did “not concur in all respects in the reasons which influence[d]
[his] opinion.” Houston, 

. Thus, as Justice Johnson
explained in his concurrence, “there [was] no point whatever decided.” 

 (Johnson, J., concurring). So Washington’s opinion was not
precedential.
       Second, “the premise upon which” Washington “based” his opinion
was “unsound.” Grant, supra, at 1012. Washington’s “assumption that two
distinct wills [could] not, in the nature of things, be exercised in relation to




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                                 No. 23-20533


the same subject at the same time” was “arid logic.” Ibid. Washington him-
self thought that when two laws “correspond in every respect,” as is the case
when state law mirrors federal law, the state provision is only “idle and inop-
erative.” Houston, 

. A conflict occurs, thought Wash-
ington, only when the laws “differ.” 

 But since an “idle” law is not a
conflicting law, there is no reason to think it should be preempted even under
Washington’s own theory of preemption.
       Regardless, a parallel state law would not be “idle.” States may have
a legitimate interest in punishing or providing redress for wrongs even if fed-
eral law already does so. The Federal Government is not the only one with
an interest in criminalizing murder or rape. See Zook, 

 (“[T]he
State may punish . . . for the safety and welfare of its inhabitants; the nation
may punish for the safety and welfare of interstate commerce. There is no
conflict.”). Nor is it the only government with an interest in providing rem-
edies for civil wrongs. Cf. Silkwood v. Kerr-McGee Corp., 

(1984). Indeed, the Federal Government often has an interest in allowing par-
allel state regulation. For that reason, “the Federal Government fully sup-
ports [Zyla’s] position,” Garcia, 589 U.S. at 212, as it has shown by filing an
amicus brief in a related case not long ago. See Brief for the United States as
Amicus Curiae, Athena Cosmetics, Inc. v. Allergan, Inc., 

 (2015)
(No. 13-1379), 

. That should surprise no one. The Federal
Government has limited resources. Thus, it often welcomes state aid in en-
forcing shared legal norms.
       And Washington’s opinion has been thoroughly repudiated. Just a few
years after Houston, Congress rejected its understanding of congressional in-
tent. Congress passed a statute explaining that federal criminal legislation
should not “be construed to deprive the courts of the individual state of ju-
risdiction,” under their own parallel laws, “over offenses” that federal law
also criminalized. See Crimes Act of 1825, ch. 65, § 26, 

, 122–23;



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                                        No. 23-20533


see also United States v. Coombs, 

 (1838).4 And of course, Zook
also rejected Washington’s opinion. See supra, Part II.A (describing Zook);
see also Garcia, 589 U.S. at 212.
                                              2
        The logic of Wells Pharma’s position would undermine state sover-
eignty and principles of federalism. Start with Wells Pharma’s theory. It con-
tends the conflict comes from the FDCA’s allocation of enforcement
discretion to the Federal Government. In short, allowing States to enforce
their own parallel laws would upset the discretion given to federal officials in
enforcing the FDCA.
        Now consider some of the state criminal laws Wells Pharma’s theory
would require us to find preempted. Federal law allocates exclusive enforce-
ment discretion to the Federal Government over “offenses against the
United States.” See 

 (imposing enforcement duties upon the
U.S. attorneys); 

 (granting the Attorney General authority to
“supervise all” such “litigation”). And “[t]he district courts of the United

        _____________________
        4
           True, Houston and the congressional response to it dealt only with parallel
criminal laws. But if parallel criminal laws are not preempted, it follows a fortiori that
parallel civil laws are not. Parallel criminal laws raise the concern that “enforcement
officers are able to circumvent the constitutional guarantees against a second jeopardy for
the same offense.” Grant, supra, at 996–97; see also U.S. Const. amend. V (forbidding
anyone from being “twice put in jeopardy of life or limb” “for the same offence”); Gamble
v. United States, 

, 681 (2019) (recognizing the dual-sovereignty doctrine which
permits “a State [to] prosecute a defendant under state law even if the Federal Government
has prosecuted him for the same conduct under a federal statute”). Because of these
background constitutional norms, the arguments for interpreting federal law to preempt
parallel criminal laws are much more forceful than they are for parallel civil laws, as Justice
Bushrod Washington’s opinion in Houston recognized. See 

(explaining that parallel laws were “particularly” concerning “in a case inflicting pains and
penalties”). Constitutional concerns sounding in double jeopardy, of course, do not arise
in the context of parallel civil laws.




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                                        No. 23-20533


States” have “exclusive” jurisdiction over such “offenses.” 

. Still, many state statutes incorporate federal criminal requirements.
Such statutes touch on areas ranging from the most mundane,5 to the consti-
tutionally controversial,6 to the classic criminal.7 All those laws, under Wells
Pharma’s theory, would be preempted because they purportedly undermine
U.S. Attorneys’ enforcement discretion.
        Adopting Wells Pharma’s theory would also undermine traditional
state tort laws. For instance, violation of a federal statute often constitutes a
breach of the duty of care under the negligence per se doctrine. See Restate-
ment (Third) of Torts § 14 (2010); see also Wiersgalla v. Garrett, 

, 292–93 (Iowa 1992) (acknowledging that violation of a federal statute or
regulation may constitute negligence per se); Barbara Kritchevsky, Tort Law
Is State Law: Why Courts Should Distinguish State and Federal Law in Negli-
gence-Per-Se Litigation, 

, 91 (2010) (explaining that
“[m]ost courts . . . find no distinction between state and federal law in apply-
ing the doctrine of negligence per se”). Under Wells Pharma’s theory, that
would be preempted in any case in which the federal statute at issue vests


        _____________________
        5
           See, e.g., 

 (“A provider of Internet service who
violates the provisions of 

 is guilty of a misdemeanor”); Ky. Rev. Stat.
§ 222.429 (barring “solicit[ing] or receiv[ing] any remuneration . . . for referring a resident
to a treatment program” unless such conduct is permitted under 

 and
conversely barring any conduct which violates 

(b)).
        6
          See, e.g., N.M. Stat. § 30-7-7.1 (providing that a person generally cannot sell
firearms “without conducting a federal instant background check” unless they “hold[] a
current and valid federal firearms license” under 

(a)); Tenn. Code § 39-
17-1316(a)(1)(A)(iii) (barring selling firearms to anyone “ineligible to receive firearms
under 18 U.S.C. § 922”).
        7
           See, e.g., Conn. Gen. Stat. §§ 21a-243(g)–(h), 279 (generally incorporating
the Federal Controlled Substances Act); 

, 7403
(similar).




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                                 No. 23-20533


enforcement discretion in the federal government with limited state or pri-
vate involvement.
       Moreover, if the concern is that state law will interfere with federal
enforcement discretion, it is not only parallel laws that should be preempted;
any state laws that regulate the same primary conduct as federal law should
also be preempted. If anything, parallel standards, which ensure that the
same primary conduct is regulated in the same way, pose reduced risk to fed-
eral enforcement priorities as compared to non-parallel standards, which reg-
ulate the same primary conduct in different ways. So under Wells Pharma’s
theory, any time a State regulates the same conduct that the Federal Govern-
ment does, the state regulation should be preempted because it might upset
federal enforcement prerogatives.
       The implications are staggering. Given the extraordinary reach of
federal law in our post-Wickard world, the Federal Government has its hands
in nearly every facet of human existence. See Wickard v. Filburn, 

(1942); see also Escobedo v. Ace Gathering, Inc., No. 23-20494, 

, at *2 (5th Cir. Sept. 30, 2024) (Oldham, J., dissenting from denial
of rehearing en banc). Under our circuit’s precedent, for instance, the
Federal Government may regulate “subterranean, eyeless arachnids, ranging
in size from 1.4mm to 4mm, that are born, reproduce, and die without ever
leaving a cave in Texas and have zero connection to economic activity of any
kind.” Escobedo, 

, at *2. So if Wells Pharma’s theory is
correct, the States would be deprived of just about any power to regulate any
conduct at all, simply because of a judicial hunch concerning mysterious
congressional purposes allegedly lurking in the bowels of the U.S. Code.
Practically any conduct the State wants to regulate is already regulated by the
Federal Government. So state regulation would be preempted. But as the
Founders understood, one of the fundamental features of sovereignty is the
power to regulate “every thing that passes” within one’s own territory.



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                                 No. 23-20533


Emer de Vattel, The Law of Nations, § 204 (1797). So by
preventing the States from regulating just about anything federal law touches,
we judges would bring to fruition the Anti-Federalists’ worst fear: the “entire
subversion . . . of the individual states” to an all-powerful federal overlord.
Brutus XI, ¶ 2.9.139, in 2 The Complete Anti-Federalist 420
(Herbert Storing ed., 1981) (“Storing”); see also Centinel II ¶ 2.7.17, in 2
Storing 141.
                                       3
       Fortunately for our federal system, Wells Pharma’s logic has been re-
jected in at least four ways.
       First, States may generally regulate the same conduct the Federal
Government does. See Richard H. Fallon et al., Hart and
Wechsler’s Federal Courts and the Federal System 680
(7th ed. 2015); see also Gamble v. United States, 

, 690 (2019). That
is especially so when state standards mimic federal ones, as in this case. See
Zook, 

.
       Second, the “possibility that federal enforcement priorities might be
upset is not enough to provide a basis for preemption.” Garcia, 589 U.S. at
212.
       Third, it is irrelevant that the States have provided remedies under
state law that supplement the FDCA’s remedial scheme. Providing redress
for a civil wrong under state law does not create a conflict with a distinct
“federal remedial scheme.” Silkwood, 

. State law often pro-
vides remedies federal law does not. See California v. ARC Am. Corp., 

 (1989) (permitting States to offer remedies to certain individuals un-
der state antitrust laws despite federal antitrust law not providing any remedy
to those same individuals).




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                                   No. 23-20533


       Fourth, under Wyeth v. Levine, 

 (2009), the FDCA itself
permits States to regulate conduct related to drug safety and effectiveness
concurrently with the Federal Government. In Wyeth, a Vermont court held
a drug manufacturer liable under state tort law for failure to provide an ade-
quate warning on its label for the drug Phenergan. 

. But “[t]he warn-
ings on Phenergan’s label had been deemed sufficient by the [FDA].” 

So not only did the State and Federal Governments regulate the same con-
duct; they did so in different ways.
       Still, the Supreme Court held there was no conflict. See 

 at 573–81.
The Court reasoned as follows:
       If Congress thought state-law suits posed an obstacle to its
       objectives, it surely would have enacted an express pre-
       emption provision at some point during the FDCA’s 70-year
       history. But despite its 1976 enactment of an express pre-
       emption provision for medical devices, . . . Congress has not
       enacted such a provision for prescription drugs. . . . Its silence
       on the issue, coupled with its certain awareness of the
       prevalence of state tort litigation, is powerful evidence that
       Congress did not intend FDA oversight to be the exclusive
       means of ensuring drug safety and effectiveness.

 at 574–75 (citations omitted). Simply put, “Congress did not regard state
tort litigation as an obstacle to achieving its purposes.” 

.
       Thus, Wyeth foreclosed Wells Pharma’s expansive theory of
preemption in the specific context of the FDCA. The Court held that States
could regulate concurrently with the Federal Government the same primary
conduct related to drug safety and effectiveness in different ways without
interfering with FDA oversight. If regulating the same primary conduct in
different ways does not upset federal enforcement prerogatives, it follows a
fortiori that regulating it in parallel ways does not either.




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                                 No. 23-20533


                                     III
       Wells Pharma’s principal response is a single case: Buckman Co. v.
Plaintiffs’ Legal Committee, 

 (2001). But Buckman is not to the
contrary.
                                      A
       In that case, plaintiffs brought state fraud claims against Buckman af-
ter sustaining injuries from FDA-approved bone screws. 

. They ar-
gued Buckman had made fraudulent representations to the FDA and those
representations had induced the FDA to approve the bone screws. 

       The Supreme Court held that the FDCA preempted these “state-law
fraud-on-the-FDA claims.” 

. The States had no role, the Supreme
Court reasoned, in “[p]olicing fraud against federal agencies.” 

.
“To the contrary, the relationship between a federal agency and the entity it
regulates is inherently federal in character.” 

 And the FDCA gave am-
ple methods to “the FDA to punish and deter fraud against the Administra-
tion.” 

.
       On this front, Buckman picked up where prior cases had left off. For
instance, in In re Loney, 

 (1890), the Supreme Court held that
States had no power to punish perjury committed before a federal tribunal.
As the Court explained, “the power of punishing a witness for testifying
falsely in a judicial proceeding belongs peculiarly to the government in whose
tribunals that proceeding is had.” 

. Otherwise, it might deter “wit-
nesses” from feeling “able to testify freely before them” because of “fear of
punishment” or other form of liability under “legislation of the state.” 

Buckman recognized similar concerns. “[F]raud-on-the-FDA claims” under
state law, the Court reasoned, would “cause applicants to fear that their dis-
closures to the FDA” would “later be judged insufficient in state court.”
Buckman, 

. As a result, applicants would “‘submit a deluge of




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                                  No. 23-20533


information that the [agency] neither wants nor needs, resulting in additional
burdens on the [agency’s] evaluation of an application,’ and harmful delays
in the agency process.” Chamber of Com. of U.S. v. Whiting, 

 (2011) (quoting Buckman, 

). That would “directly inter-
fere[] with the operation of the federal program.” 

 (discussing Buckman).
       The problem in Buckman had nothing to do with state law mirroring
federal requirements; the state law at issue was ordinary, generally applicable
fraud. Instead, the problem in Buckman was that the claim “involve[d]” a
“uniquely federal area[] of regulation,” since it alleged only “fraud on a fed-
eral agency.” Whiting, 

 (discussing Buckman). In other words,
the plaintiffs in Buckman, just like the States in Loney, sought to wield state
law to vindicate a wrong committed against the Federal Government. The
plaintiffs were hurt by that wrongdoing only incidentally.
       This case is different. No one here argues that Wells Pharma’s wrong-
doing was really committed against the Federal Government, like the fraud
in Buckman or the perjury in Loney. Wells Pharma has not unfairly competed
against the FDA, leading to some incidental harm to Zyla.
       Moreover, Zyla is not policing the uniquely federal relationship be-
tween Wells Pharma and the FDA. So there is no reason to think that allow-
ing Zyla’s claims to proceed will “directly interfere[] with the operation of the
federal program.” Whiting, 

 (emphasis added). There is no
sense in which any action “deemed appropriate by the Administration, will
later be judged insufficient in state court.” Buckman, 

. And
Wells Pharma gives no reason to think allowing Zyla’s claims to proceed
would somehow “deluge” the FDA in unwanted “information”; result in
harmful delays in the FDA’s processing of applications; or deter applicants
from seeking FDA approval. 

 In short, there is no reason to think




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                                 No. 23-20533


allowing these claims to proceed will in any sense upset any purposes and
objectives of Congress whatsoever.
                                      B
       Wells Pharma points to certain language in Buckman about the
preemptive effect of the FDCA’s allocation of enforcement discretion to the
Federal Government. But the Supreme Court’s language, like all language,
must be understood in context. And four aspects of that context make us
doubt Wells Pharma’s interpretation.
       First, even Buckman’s most sweeping language fully accords with the
analysis above when read in context: In context, Buckman holds that the
FDCA’s allocation of enforcement to the Federal Government forecloses
non-federal actors from policing wrongdoing against the Federal Government.
See, e.g., 

 (“The balance sought by the Administration can be
skewed by allowing fraud-on-the-FDA claims under state tort law.” (empha-
sis added)); 

 (“The FDA thus has at its disposal a variety of en-
forcement options that allow it to make a measured response to suspected
fraud upon the Administration.” (emphasis added; footnote omitted)); 

 (“State-law fraud-on-the-FDA claims inevitably conflict with the FDA’s
responsibility to police fraud consistently with the Administration’s judg-
ment and objectives.” (emphasis added)).
       Second, any broader reading of Buckman would conflict with the
Court’s more recent pronouncements in Wyeth v. Levine. Wyeth permitted
distinct state regulation under the FDCA. If that does not conflict with fed-
eral enforcement prerogatives, neither does parallel state regulation. See su-
pra, at 14, 16.




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                                         No. 23-20533


        Third, many federal statutes grant the Executive Branch extensive en-
forcement discretion.8 But as we have explained, those statutes do not pre-
clude parallel or non-parallel state regulation of the same conduct. If they
were read to do so, the States’ power over criminal and tort law would dissi-
pate. See supra, Part II.B.2.
        Fourth and finally, there is no way to maintain Wells Pharma’s broad
reading of Buckman while escaping these problems. Buckman cannot be arti-
ficially limited to cases where state law incorporates federal standards. Buck-
man itself was not such a case—rather the plaintiffs there sued under
generally applicable tort law.
                                     *        *         *
        For the foregoing reasons, the district court’s order granting Wells
Pharma’s motion to dismiss is REVERSED. Wells Pharma’s cross-appeal
of the denial of its motion for an award of attorney’s fees is DISMISSED
AS MOOT. The district court’s order denying Zyla’s motion for leave to
amend is VACATED. And the case is REMANDED for further proceed-
ings consistent with this opinion.




        _____________________
        8
           For this reason, 

(a) is beside the point. Section 337(a) only confers
a cause of action upon the Federal Government to enforce the FDCA. That is necessary
because otherwise the Federal Government’s power to bring non-statutory actions to
enforce federal law is unclear. Cf., e.g., 3 Joseph Story, Commentaries on the
Constitution of the United States § 1274, at 154 (Boston, Hilliard, Gray &
Co. 1833) (noting that the Federal Government has a right to sue only if Congress
statutorily authorizes it). Section 337(a) says nothing about the States’ authority to provide
remedies for violations of state law. See ARC Am. Corp., 490 U.S. at 103 (explaining that
offering a state remedy for conduct that violates both state and federal law does not “affect
remedies available under federal law” but merely offers a separate remedy under state law
for violations of state law).




                                              20