Petition for Writ of Certiorari — Johnson & Johnson, et al., Petitioners v. Lynn Fitch, Attorney General of Mississippi, ex rel. Mississippi
Supreme Court briefAug 30, 2021
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No. 21-______
IN THE
Supreme Court of the United States
________________
JOHNSON & JOHNSON AND JOHNSON & JOHNSON
CONSUMER COMPANIES, INC.,
v.
Petitioners,
LYNN FITCH, Attorney General of the State of
Mississippi, ex rel. THE STATE OF MISSISSIPPI,
________________
Respondent.
ON PETITION FOR A WRIT OF CERTIORARI TO
THE MISSISSIPPI SUPREME COURT
________________
PETITION FOR A WRIT OF CERTIORARI
________________
Robert M. Loeb
E. Joshua Rosenkranz
Elizabeth R. Moulton
Counsel of Record
Sheila Baynes
ORRICK, HERRINGTON &
Zachary Hennessee
SUTCLIFFE LLP
ORRICK, HERRINGTON & 51 West 52nd Street
SUTCLIFFE LLP
New York, NY 10019
1152 15th Street, NW
(212) 506-5000
Washington, DC 20005 jrosenkranz@orrick.com
Counsel for Petitioners
i
QUESTIONS PRESENTED
1. In Puerto Rico v. Franklin California Tax-Free
Trust, this Court held that courts should “not invoke
any presumption against pre-emption” when a “statute ‘contains an express pre-emption clause.’” 136 S.
Ct. 1938, 1946 (2016). Obeying that command, four
circuits and a state supreme court no longer apply any
such presumption to express pre-emption clauses.
Four state supreme courts (now including the Mississippi Supreme Court) and two circuits, however, continue to apply the presumption to pre-emption
provisions that they find ambiguous, or that touch on
a state’s historic police powers, or both.
Did the Mississippi Supreme Court err in narrowly construing an express preemption clause on the
ground that a presumption against pre-emption applies here because it considered the pre-emption provision ambiguous and because the provision touches
on historic state police powers?
2. The lower courts are divided over what types of
agency actions can pre-empt state law. One circuit
and the Mississippi Supreme Court hold that only notice-and-comment rulemaking qualifies as pre-emptive. In contrast, seven circuits and a state supreme
court reject that line, giving pre-emptive force to final
administrative actions that warrant Chevron deference or to any final agency action with the force of law.
Did the Mississippi Supreme Court err in holding
that only notice-and-comment rulemaking can preempt state law?
ii
PARTIES TO THE PROCEEDINGS
Petitioners Johnson & Johnson and Johnson &
Johnson Consumer Companies, Inc. (now known as
Johnson & Johnson Consumer Inc.) were
defendants-appellants below.
Respondent Lynn Fitch, Attorney General of the
State of Mississippi, ex rel. the State of Mississippi,
was plaintiff-appellee below.
iii
CORPORATE DISCLOSURE STATEMENT
1. Johnson & Johnson is a publicly held company.
It has no parent corporation, and no publicly held
company owns 10% or more of Johnson & Johnson’s
stock.
2. Johnson & Johnson Consumer Companies, Inc.
(now known as Johnson & Johnson Consumer Inc.) is
wholly owned by Janssen Pharmaceuticals, Inc.
Janssen Pharmaceuticals, Inc. is wholly owned by
DePuy Synthes, Inc. DePuy Synthes, Inc. is wholly
owned by Johnson & Johnson International. Johnson
& Johnson International is wholly owned by Johnson
& Johnson.
iv
RELATED PROCEEDINGS
Supreme Court of Mississippi:
Johnson & Johnson et al. v. Fitch ex rel. Mississippi, No. 2019-IA-00033-SCT (Miss. April 1, 2021)
Chancery Court of Hinds County:
State of Mississippi, ex rel. Jim Hood v. Johnson &
Johnson et al., No. G-2014-1207 (Miss. Ch. Ct., Hinds
Cty. Dec. 18, 2018)
v
TABLE OF CONTENTS
Page
QUESTIONS PRESENTED ...................................... i
PARTIES TO THE PROCEEDINGS ....................... ii
CORPORATE DISCLOSURE STATEMENT ......... iii
RELATED PROCEEDINGS .................................... iv
TABLE OF AUTHORITIES .................................. viii
INTRODUCTION ..................................................... 1
OPINIONS AND ORDERS BELOW ........................ 4
JURISDICTION ........................................................ 4
CONSTITUTIONAL AND STATUTORY
PROVISIONS INVOLVED ................................ 5
STATEMENT OF THE CASE .................................. 7
The FDA Regulates Cosmetics Labels............... 7
The FDA Denies Two Citizen Petitions
Seeking To Place Warning Labels On
Cosmetic Talc Products................................. 9
Mississippi Sues J&J For Failing To Give
A Warning The FDA Rejected .................... 10
The Mississippi Supreme Court Concludes
That The State AG’s Labeling Claim Is
Not Pre-Empted .......................................... 12
REASONS FOR GRANTING THE WRIT.............. 13
I.
The Decision Below Deepens Two
Important Splits ............................................... 13
vi
A. The decision below deepens a 6-5 split
on whether, and when, a presumption
against pre-emption applies to express
pre-emption statutes ................................... 14
1. Four state supreme courts and two
circuits continue to apply the
presumption ........................................... 15
2. Four circuits and one state supreme
court faithfully decline to apply the
presumption against pre-emption to
express pre-emption statutes ................ 17
B. The Mississippi Supreme Court
deepened an 8-2 split regarding what
sorts of agency actions can pre-empt
state law ...................................................... 19
II. These Are Recurring Issues Of
Exceptional Importance That Require
This Court’s Review.......................................... 24
A. The presumption against pre-emption
affects the interpretation of dozens of
federal statutes with express preemption provisions ...................................... 24
B. The power of agency action to pre-empt
is dispositive in both the express and
implied pre-emption contexts ..................... 27
III. This Case Provides An Excellent Vehicle
For Resolving Both Issues................................ 30
IV. The Mississippi Supreme Court’s Decision
Is Wrong ............................................................ 32
CONCLUSION ........................................................ 39
vii
APPENDIX A
Opinion of the Supreme Court
of Mississippi (Apr. 1, 2021).......... 1a
APPENDIX B
Opinion of the Chancery Court
of Hinds County Mississippi
(Dec. 18, 2018) ............................. 18a
viii
TABLE OF AUTHORITIES
Page(s)
Cases
Air Evac EMS, Inc. v. Cheatham,
910 F.3d 751. (4th Cir. 2018)...........14, 17, 18, 19
Bates v. Dow Agrosciences LLC,
544 U.S. 431 (2005)..........................12, 15, 16, 38
Bennett v. Spear,
520 U.S. 154 (1997)........................................... 37
Brown v. Mortensen,
253 P.3d 522 (Cal. 2011) ................................... 16
Cal. Trucking Ass’n v. Bonta,
996 F.3d 644 (9th Cir. 2021)............................. 16
Cerveny v. Aventis, Inc.,
855 F.3d 1091 (10th Cir. 2017)................... 23, 27
Chamber of Com. of U.S. v. Whiting,
563 U.S. 582 (2011)............................2, 14, 32, 33
Charter Advanced Servs. (MN), LLC v.
Lange,
903 F.3d 715 (8th Cir. 2018)............................. 22
Chicago & N.W. Transp. Co. v. Kalo Brick
& Tile Co.,
450 U.S. 311 (1981)..................................... 36, 39
ix
Cipollone v. Liggett Grp., Inc.,
505 U.S. 504 (1992)..................................... 12, 33
City of N.Y. v. FCC,
486 U.S. 57 (1988)............................................. 21
City of N.Y. v. Permanent Mission of India
to United Nations,
618 F.3d 172 (2d Cir. 2010) .............................. 21
Colacicco v. Apotex Inc.,
521 F.3d 253 (3d Cir. 2008) .............................. 23
Conklin v. Medtronic, Inc.,
431 P.3d 571 (Ariz. 2018) ................................. 18
Connell v. Lima Corp.,
988 F.3d 1089 (9th Cir. 2021)........................... 17
Coventry Health Care of Mo., Inc. v. Nevils,
137 S. Ct. 1190 (2017)....................................... 14
Cox Broad. Corp. v. Cohn,
420 U.S. 469 (1975)......................................... 4, 5
Critcher v. L’Oreal USA, Inc.,
959 F.3d 31 (2d Cir. 2020) ........................ 7, 8, 25
Dialysis Newco, Inc. v. Cmty. Health Sys.
Grp. Health Plan,
938 F.3d 246 (5th Cir. 2019)................. 17, 18, 19
Dirty Boyz Sanitation Serv., Inc. v. City of
Rawlins,
889 F.3d 1189 (10th Cir. 2018)................... 18, 19
x
Dolin v. GlaxoSmithKline LLC,
951 F.3d 882 (7th Cir. 2020)............................. 22
Dowhal v. SmithKline Beecham Consumer
Healthcare,
88 P.3d 1 (Cal. 2004) ............................. 22, 23, 37
Entergy La., Inc. v. La. Pub. Serv. Comm’n,
539 U.S. 39 (2002)....................................... 28, 36
Feikema v. Texaco, Inc.,
16 F.3d 1408 (4th Cir. 1994)............................. 22
Fellner v. Tri-Union Seafoods, L.L.C.,
539 F.3d 237 (3d Cir. 2008) .......20, 21, 22, 23, 37
Ferrell v. Air EVAC EMS, Inc.,
900 F.3d 602 (8th Cir. 2018)............................. 18
Geier v. Am. Honda Motor Co.,
529 U.S. 861 (2000)......................3, 20, 35, 36, 38
General Motors Corp. v. Abrams,
897 F.2d 34 (2d Cir. 1990) .......................... 28, 29
Gobeille v. Liberty Mut. Ins. Co.,
577 U.S. 312 (2016)........................................... 33
Good v. Altria Grp., Inc.,
501 F.3d 29 (1st Cir. 2007) ......................... 20, 21
Hardeman v. Monsanto Co.,
997 F.3d 941 (9th Cir. 2021)................. 16, 22, 38
xi
In re Incretin-Based Therapies Prods.
Liab. Litig.,
--- F. Supp. 3d ---, 2021 WL 880316 (S.D.
Cal. Mar. 9, 2021) ............................................. 23
Int’l Bhd. of Teamsters, Loc. 2785 v.
Fed. Motor Carrier Safety Admin.,
986 F.3d 841 (9th Cir. 2021)............................. 17
La. Pub. Serv. Comm’n v. FCC,
476 U.S. 355 (1986)........................................... 35
Lipschultz v. Charter Advanced Servs.
(MN), LLC,
140 S. Ct. 6 (2019)..............................3, 20, 22, 23
Lupian v. Joseph Cory Holdings LLC,
905 F.3d 127 (3d Cir. 2018) .............................. 15
Medtronic, Inc. v. Lohr,
518 U.S. 470 (1996)..........................14, 15, 33, 35
Merck Sharp & Dohme Corp. v. Albrecht,
139 S. Ct. 1668 (2019)......................19, 35, 37, 38
Minn. Pub. Utils. Comm’n v. FCC,
483 F.3d 570 (8th Cir. 2007)............................. 22
New York v. FERC,
535 U.S. 1 (2002)............................................... 35
PLIVA, Inc. v. Mensing,
564 U.S. 604 (2011)........................................... 38
xii
Puerto Rico v. Franklin Cal. Tax-Free Tr.,
136 S. Ct. 1938 (2016)...i, 2, 14, 16, 17, 24, 32, 33
Reid v. Johnson & Johnson,
780 F.3d 952 (9th Cir. 2015)............................. 22
Riegel v. Medtronic, Inc.,
552 U.S. 312 (2008)....................14, 20, 28, 36, 37
Robinson v. McNeil Consumer Healthcare,
615 F.3d 861 (7th Cir. 2010)............................. 23
SEC v. Chenery Corp.,
332 U.S. 194 (1947)........................................... 28
Shuker v. Smith & Nephew, PLC,
885 F.3d 760 (3d Cir. 2018) .............................. 15
Sprietsma v. Mercury Marine,
537 U.S. 51 (2002)............................................. 38
State v. Norfolk S. Ry. Co.,
107 N.E.3d 468 (Ind. 2018)............................... 16
Ter Beek v. City of Wyoming,
846 N.W.2d 531 (Mich. 2014) ........................... 16
Turek v. Gen. Mills, Inc.,
662 F.3d 423 (7th Cir. 2011)............................. 26
United States v. Mead Corp.,
533 U.S. 218 (2001)........................................... 22
xiii
Utah Native Plant Soc’y v. U.S. Forest
Serv.,
923 F.3d 860 (10th Cir. 2019)........................... 22
Wyeth v. Levine,
555 U.S. 555 (2009)........................................... 33
In re: Zofran (Ondansetron) Prods.
Liab. Litig.,
--- F. Supp. 3d ---, 2021 WL 2209871
(D. Mass. June 1, 2021) .................................... 23
U.S. Constitutional Provisions
U.S. Const. art. VI, cl. 2 ................................ 5, 36
Statutes & Regulations
Federal Insecticide, Fungicide, and
Rodenticide Act, 7 U.S.C. § 136 et seq. ............ 16
7 U.S.C. § 136d.................................................. 29
7 U.S.C. § 4817(b)................................................... 25
Fair Packaging and Labeling Act,
15 U.S.C. § 1451 et seq. ...................................... 6
Poison Prevention Packaging Act of 1970,
15 U.S.C. § 1471 et seq. ...................................... 5
16 U.S.C. § 824d................................................ 28
16 U.S.C. § 824e ................................................ 28
xiv
Food, Drug, and Cosmetic Act,
21 U.S.C. § 301 et seq. ........................................ 1
21 U.S.C. § 331.................................................. 36
21 U.S.C. § 331(a) ............................................... 7
21 U.S.C. § 331(b) ............................................... 7
21 U.S.C. § 331(c)................................................ 7
21 U.S.C. § 331 (g) .............................................. 7
21 U.S.C. § 360k(a) ........................................... 25
21 U.S.C. § 362.............................................. 7, 36
21 U.S.C. § 371.................................................... 7
21 U.S.C. § 371(a) ............................................. 36
21 U.S.C. § 374(a)(1) ........................................... 7
21 U.S.C. § 379s ........... 5, 8, 13, 17, 25, 26, 34, 35
21 U.S.C. § 379s(a)......... 2, 5, 8, 13, 20, 34, 37, 38
21 U.S.C. § 379s(b).................................... 8, 9, 34
21 U.S.C. § 379s(d)........................................ 9, 35
21 U.S.C. § 379s(e) ................................ 5, 7, 9, 35
21 U.S.C. § 393(b) ............................................. 36
21 U.S.C. § 393(b)(2)(D) ................................ 7, 26
xv
21 U.S.C. § 467e ................................................ 25
21 U.S.C. § 678.................................................. 25
21 U.S.C. § 1052(b) ........................................... 25
28 U.S.C. § 1257(a) ............................................. 4
29 U.S.C. § 1144(a) ........................................... 25
42 U.S.C. § 247d-6d(b)(8).................................. 25
49 U.S.C. § 14501(c)(1) ..................................... 25
49 U.S.C. § 41713(b)(1) ..................................... 25
21 C.F.R. § 10.20(a) ...................................... 8, 39
21 C.F.R. § 10.20(j) ........................................... 39
21 C.F.R. § 10.20(j)(1)(i)...................................... 8
21 C.F.R. § 10.45(d) ...........................8, 37, 38, 39
21 C.F.R. §§ 701.1-701.13 ................................... 7
21 C.F.R. § 740.1 ................................................. 7
21 C.F.R. § 740.1(a) ............................................ 7
21 C.F.R. § 740.1(b) ............................................ 8
21 C.F.R. § 740.2 ................................................. 7
xvi
Mississippi Regulation of Business for
Consumer Protection Act,
Miss. Code § 75-24-5.................................... 11
Other Authorities
Amy Coney Barrett, Substantive
Canons and Faithful Agency,
90 B.U. L. Rev. 109 (2010) .......................... 33
FDA-1994-P-0067,
https://tinyurl.com/44vx7dpe ...................... 10
FDA-2008-P-0309,
https://tinyurl.com/djs996bx ....................... 10
Jay B. Sykes, et al. Cong. Rsch. Serv.,
R45825, Federal Preemption: A Legal
Primer (July 23, 2019),
https://tinyurl.com/wp3mfu92 ..................... 24
H.R. Rep. No. 105-399 (1997) (Conf.
Rep.) ............................................................. 26
Petition, Monsanto Co. v. Hardeman,
No. 21-241 (Aug. 16, 2021) .......................... 17
Press Release, Johnson & Johnson
Consumer Health Announces
Discontinuation of Talc-based
Johnson’s Baby Powder in U.S. and
Canada, Johnson & Johnson (May
19, 2020),
https://tinyurl.com/dvymsfka ...................... 11
INTRODUCTION
The lower courts are making a hash out of preemption law in ways that dangerously flout both congressional commands and important federal policies.
This case is the latest—and most extreme—illustration of the trend in judicial defiance and confusion regarding express pre-emption statutes.
The Food, Drug, and Cosmetic Act (FDCA) grants
the Food and Drug Administration (FDA) broad authority to regulate cosmetic products and to decide
when warning labels are necessary. In 2014, the FDA
made a reasoned regulatory decision not to require
talc products—like Johnson’s Baby Powder—to bear
warning labels stating that using talcum powder increases the risk of ovarian cancer. The decision came
in the form of a final agency action that denied two
citizen petitions. The FDA issued those rulings after
considering a large body of scientific literature and
public comments. The agency concluded that the evidence did not justify a warning. The FDA’s decision
was public, final, and appealable.
The Attorney General of Mississippi disagrees
with the FDA’s expert determination. Just months after the FDA announced its regulatory decision, the
State AG filed this action contradicting the FDA.
Wielding a state consumer protection statute, the
State AG sued J&J 1 insisting that J&J was legally required to use an ovarian cancer warning label even
though the FDA already rejected one. The State AG
sought an injunction forcing J&J to affix that warning
1 Petitioners are collectively referred to as “J&J.”
2
label, plus a retroactive penalty of up to $10,000 for
every bottle of baby powder sold in Mississippi for the
last 50 years.
The State AG’s effort to impose a cancer warning
the FDA rejected runs headlong into an express preemption provision that prohibits a state from imposing “any requirement for labeling … that is different
from or in addition to … a requirement specifically applicable to a particular cosmetic.” 21 U.S.C. § 379s(a).
In holding that the State AG’s claim is not preempted, the Mississippi Supreme Court deepened two
entrenched splits among the circuits and state supreme courts over two of this Court’s commands—
commands that seemed clear but have engendered
profound confusion.
The first command is that when a “statute ‘contains an express pre-emption clause,’ [courts] do not
invoke any presumption against pre-emption but instead ‘focus on the plain wording of the clause, which
necessarily contains the best evidence of Congress’
pre-emptive intent.’” Puerto Rico v. Franklin Cal.
Tax-Free Tr., 136 S. Ct. 1938, 1946 (2016) (quoting
Chamber of Com. of U.S. v. Whiting, 563 U.S. 582, 594
(2011)). Yet, the Mississippi Supreme Court applied
the presumption against pre-emption as justification
for torturing the plain language of the FDCA’s preemption provision. This holding took sides on a broad
and acknowledged 6-5 split. Some courts apply this
Court’s command faithfully, but others carve out exceptions, as the court below did, for pre-emption provisions that the court considers unclear or that touch
on subjects of traditional state police power.
3
The second command also seems clear, but likewise is not being followed. This Court has held that
courts may not “insist on a specific expression of
agency intent to pre-empt, made after notice-andcomment rulemaking,” because to do so “would be …
to tolerate conflicts that an agency, and therefore
Congress, is most unlikely to have intended.” Geier v.
Am. Honda Motor Co., 529 U.S. 861, 885 (2000).
Again, without acknowledging this rule, the Mississippi Supreme Court held that “[i]n order to” pre-empt
state law, “the Food and Drug Administration must
follow the notice and comment rule making process.”
Pet. App. 15a.
That holding deepened another entrenched 7-2
split on what types of agency actions are capable of
pre-empting state law. As Justice Thomas recently
observed, the time has come for this Court to address
that very question “in an appropriate case.” Lipschultz v. Charter Advanced Servs. (MN), LLC, 140 S.
Ct. 6, 7 (2019) (concurring in the denial of cert.). This
is that case.
If the Mississippi Supreme Court’s ruling stands,
other state officials will join the fray, seeking their
own paydays. Consumers will soon find drugstore
shelves filled with products covered in conflicting
warnings. Manufacturers will face the threat of huge
retroactive penalties for failing to include labels the
FDA rejected as scientifically unsound, and will be
forced to defend their labels before juries who will second-guess the FDA’s expert judgment. More broadly,
rulings like this will undermine dozens of express preemption provisions and nullify the pre-emptive effect
of innumerable federal agency actions, subjecting a
4
wide range of federally regulated industries to confusing and contradictory state and local requirements.
This Court should grant certiorari to resolve both
enduring and important splits.
OPINIONS AND ORDERS BELOW
The opinion of the Mississippi Supreme Court is
reported at 315 So. 3d 1017, and reprinted at Pet.
App. 1a-17a. The decision of the Chancery Court of
Hinds County is not reported, and is reprinted at Pet.
App. 18a-22a.
JURISDICTION
The Mississippi Supreme Court issued its decision on April 1, 2021. Pet. App. 2a. This petition is
timely under this Court’s March 19, 2020 order extending the deadline to petition for a writ of certiorari
to 150 days.
This Court has jurisdiction under 28 U.S.C.
§ 1257(a). The Mississippi Supreme Court finally decided the federal pre-emption issues raised in this petition when it affirmed the denial of J&J’s motion for
summary judgment. See Cox Broad. Corp. v. Cohn,
420 U.S. 469, 482-83 (1975). If this case proceeds to
trial, J&J may “prevail on the merits on nonfederal
grounds, thus rendering unnecessary review of the
federal issue by this Court.” Id. at 482. The matter is
final under § 1257(a) because “reversal of the state
court on the federal issue would be preclusive of any
further litigation on the relevant cause of action.” Id.
at 482-83. Moreover, “a refusal immediately to review
5
the state court decision might seriously erode” the
federal policy of uniform nationwide labeling requirements for cosmetics. Id. at 483.
CONSTITUTIONAL AND STATUTORY
PROVISIONS INVOLVED
The Supremacy Clause, U.S. Const. art. VI, cl. 2,
provides:
This Constitution, and the Laws of the United
States which shall be made in Pursuance
thereof; and all Treaties made, or which shall
be made, under the Authority of the United
States, 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.
21 U.S.C. § 379s provides:
(a) In general
Except as provided in subsection (b), (d), or
(e), no State or political subdivision of a State
may establish or continue in effect any requirement for labeling or packaging of a cosmetic that is different from or in addition to,
or that is otherwise not identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics under this
chapter, the Poison Prevention Packaging Act
of 1970 (15 U.S.C. 1471 et seq.), or the Fair
6
Packaging and Labeling Act (15 U.S.C. 1451
et seq.).
(b) Exemption
Upon application of a State or political subdivision thereof, the Secretary may by regulation, after notice and opportunity for written
and oral presentation of views, exempt from
subsection (a), under such conditions as may
be prescribed in such regulation, a State or
political subdivision requirement for labeling
or packaging that—
(1) protects an important public interest
that would otherwise be unprotected;
(2) would not cause a cosmetic to be in violation of any applicable requirement or
prohibition under Federal law; and
(3) would not unduly burden interstate
commerce.
(c) Scope
For purposes of subsection (a), a reference to
a State requirement that relates to the packaging or labeling of a cosmetic means any specific requirement relating to the same aspect
of such cosmetic as a requirement specifically
applicable to that particular cosmetic or class
of cosmetics under this chapter for packaging
or labeling, including any State requirement
relating to public information or any other
form of public communication.
7
(d) No effect on product liability law
Nothing in this section shall be construed to
modify or otherwise affect any action or the
liability of any person under the product liability law of any State.
(e) State initiative
This section shall not apply to a State requirement adopted by a State public initiative or
referendum enacted prior to September 1,
1997.
STATEMENT OF THE CASE
The FDA Regulates Cosmetics Labels
Congress charged the FDA with ensuring that
“cosmetics are safe and properly labeled.” 21 U.S.C.
§ 393(b)(2)(D). The FDCA “establishe[s] a comprehensive regulatory scheme” governing cosmetics, including cosmetic talcum powder. Critcher v. L’Oreal USA,
Inc., 959 F.3d 31, 35 (2d Cir. 2020). The FDCA prohibits “misbranded” cosmetics, and it empowers the
FDA to inspect, sample, seize, and otherwise broadly
regulate any cosmetic product. See 21 U.S.C.
§§ 331(a)-(c), (g), 362, 371, 374(a)(1).
The FDA has developed detailed requirements
governing the placement, size, and content of cosmetics labels. 21 C.F.R. §§ 701.1-701.13, 740.1-2. It requires all cosmetics “bear a warning statement
whenever necessary or appropriate to prevent a
health hazard that may be associated with the product.” Id. § 740.1(a). The FDA can require cosmetic
8
warning labels either on its own initiative or in response to a citizen petition from “any interested person.” Id. § 740.1(b). When filed, citizen petitions are
publicly docketed, id. § 10.20(j)(1)(i), and subject to
public comment after the petition is published on regulations.gov, id. § 10.20(a). The FDA’s decision on a
citizen petition is a “final agency action” judicially reviewable under the Administrative Procedure Act. Id.
§ 10.45(d).
The FDCA includes an “expansive preemption
provision” specific to cosmetics, which is designed to
“ensure that these various federal requirements are
not obstructed by state law.” Critcher, 959 F.3d at 35
(citing 21 U.S.C. § 379s). Section 379s prohibits any
state from “establish[ing] or continu[ing] in effect any
requirement for labeling or packaging of a cosmetic
that is different from or in addition to, or that is otherwise not identical with, a requirement specifically
applicable to a particular cosmetic or class of cosmetics under” the FDCA. 21 U.S.C. § 379s(a).
Three savings clauses (none of which applies
here) cabin the scope of § 379s(a). First, § 379s(b) allows “a State or political subdivision thereof” to apply
for an exemption. The Secretary of HHS “may by regulation, after notice and opportunity for written and
oral presentation of views,” grant the exemption to a
“State or political subdivision requirement for labeling or packaging that—
(1) protects an important public interest that
would otherwise be unprotected;
9
(2) would not cause a cosmetic to be in violation of any applicable requirement or prohibition under Federal law; and
(3) would not unduly burden interstate commerce.”
Id. § 379s(b). Second, § 379s(d) clarifies that product
liability causes of action are not expressly preempted. Third, § 379s(e) exempts state requirements
adopted by public initiative or referendum prior to
September 1, 1997.
The FDA Denies Two Citizen Petitions Seeking
To Place Warning Labels On Cosmetic Talc
Products
Before the State AG commenced this action, the
FDA actively studied whether a warning label was appropriate. The Cancer Prevention Coalition filed two
citizen petitions requesting that all cosmetic talc
products include an ovarian cancer warning on the label. The first petition, filed in 1994, asked the agency
to mandate that all cosmetic talc products bear a
warning stating that “[t]alcum powder causes cancer
in laboratory animals. Frequent talc application in
the female genital area increases the risk of ovarian
cancer.” App’x 96. 2 The second petition, filed in 2008,
similarly urged the FDA to “[i]mmediately require
cosmetic talcum powder products to bear labels with
a prominent warning such as: ‘Frequent talc application in the female genital area is responsible for major
2 The appendix before the Mississippi Supreme Court is
cited as “App’x.”
10
risks of ovarian cancer.’” App’x 102. Both petitions
were publicly docketed and open to public comment. 3
The State did not submit any comment on either petition.
The FDA denied both petitions. App’x 88-93. The
FDA explained that one of the principal studies on
which the citizen petitions relied “lack[ed] convincing
scientific support because of serious flaws in its design and conduct” and had “no relevance to human
risk.” App’x 90-91. Other studies had “biases in the
study design,” failed to “consider[] all the factors that
potentially contribute to ovarian cancer,” and “revealed no overall association” between talc use and
ovarian cancer. App’x 91-92. The FDA’s review included an “expanded literature search dating from the
filing of the petition in 2008 through January 2014,”
and an “exploratory survey of … cosmetic products
containing talc.” App’x 90, 93. That investigation
“failed to identify any new compelling literature data
or new scientific evidence” supporting the petitions.
App’x 93. Accordingly, the FDA concluded that the
“evidence is insufficient” to warrant the warning requested. App’x 92. No one sought judicial review of
that final FDA decision.
Mississippi Sues J&J For Failing To Give A
Warning The FDA Rejected
Shortly after the FDA’s decision denying a talc
warning, the Mississippi Attorney General sued J&J
in state court, asserting a single cause of action under
3 See FDA-2008-P-0309, https://tinyurl.com/djs996bx; FDA1994-P-0067, https://tinyurl.com/44vx7dpe.
11
Mississippi’s consumer protection act, Miss. Code
§ 75-24-5. The complaint alleges that J&J “should
have warned the public … not to use its Talc Products
perineally [sic] or in the alternative, at a minimum,
should have informed the public that perineal use of
talc-containing products causes an increased risk of
ovarian cancer.” App’x 61.
The State AG’s consumer protection act complaint
cites many of the same studies the FDA found insufficient to justify a warning label. 4 The complaint
sought a wide array of relief: actual and punitive damages; disgorgement of “ill-gotten revenue”; an injunction requiring a warning and removal of
nonconforming products; and a civil penalty of up to
$10,000 for each sale of J&J’s talc products since
1974. App’x 35-36. 5
4 For instance, it relies heavily on a 1993 study published
by the National Toxicology Program, App’x 24-25, which the
FDA deemed to “lack[] convincing scientific support because of
serious flaws in its design and conduct,” App’x 90. Similarly, it
features the Nurse’s Health Study, which the FDA found to “reveal[] no overall association with … talc use and … ovarian cancer.” App’x 92.
5 In May 2020, J&J announced that it would cease selling
its talc-based baby powder in the United States. Johnson &
Johnson Consumer Health Announces Discontinuation of Talcbased Johnson’s Baby Powder in U.S. and Canada, Johnson &
Johnson (May 19, 2020), https://tinyurl.com/dvymsfka (explaining that “[d]emand for talc-based Johnson’s Baby Powder in
North America has been declining due in large part to changes
in consumer habits and fueled by misinformation around the
safety of the product and a constant barrage of litigation advertising”). The State AG’s claims for relief, other than injunctive
relief, are still live.
12
The Mississippi Supreme Court Concludes That
The State AG’s Labeling Claim Is Not PreEmpted
J&J moved for summary judgment, including on
the ground that the FDCA pre-empts the State AG’s
claim. The trial court denied summary judgment, asserting that there were “genuine issues of material
fact,” but did not identify any disputed facts relevant
to J&J’s case-dispositive pre-emption argument. Pet.
App. 20a.
The Mississippi Supreme Court affirmed. Pet.
App. 17a. The court recognized that the State AG
seeks to impose an ovarian cancer warning label that
the FDA had rejected. Pet. App. 3a-4a, 13a-15a. But
it held the action is not pre-empted.
The court gave two separate reasons—one relating to the limits on express pre-emption clauses and
the other about what sorts of federal agency actions
have pre-emptive force. As to the first, the court
“start[ed] 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.” Pet. App. 11a (second and third
alterations in original) (quoting Cipollone v. Liggett
Grp., Inc., 505 U.S. 504, 516 (1992)). It held, “courts
‘have a duty to accept the reading that disfavors preemption.’” Pet. App. 15a (quoting Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449 (2005)).
As to the second, the court opined that the only
federal agency actions capable of pre-empting state
law are regulations: “In order to be binding on the
13
public, the [FDA] must follow the notice and comment
rule making process.” Pet. App. 15a. The court accordingly narrowly construed § 379s’s use of the term “requirement” to encompass only “positive expression[s]
of regulation.” Pet. App. 15-16a. Because the FDA had
not “adopt[ed] any such regulation,” the court held
that the State AG’s claim was not expressly preempted. Id.
The court rejected J&J’s implied pre-emption argument for similar reasons. Because, in the court’s
view, the FDA had not “exercise[d] its regulatory authority” to set requirements for talc products through
notice-and-comment rulemaking, the State AG had
the “freedom to regulate cosmetics instead.” Pet. App.
16a-17a.
REASONS FOR GRANTING THE WRIT
I.
The Decision Below Deepens Two Important
Splits.
The Mississippi Supreme Court deepened two entrenched splits on federal pre-emption. First, the
court applied a presumption against pre-emption in
interpreting the FDCA’s express pre-emption provision for cosmetics. This compounds the lower courts’
confusion over whether—and when—the presumption continues to apply to express pre-emption provisions. Second, the court held that no agency action can
expressly or impliedly pre-empt state law except notice-and-comment rules, situating itself on the most
anti-pre-emption end of a wide-ranging split among
the lower courts as to what agency actions have preemptive force.
14
A. The decision below deepens a 6-5 split on
whether, and when, a presumption
against pre-emption applies to express
pre-emption statutes.
Before Puerto Rico v. Franklin California TaxFree Trust, 136 S. Ct. 1938 (2016), there was some
confusion as to whether the presumption against preemption applied to express pre-emption provisions.
Compare, e.g., Medtronic, Inc. v. Lohr, 518 U.S. 470,
485 (1996) (applying the presumption to the express
pre-emption provision of the Medical Device Amendments to the FDCA), with Riegel v. Medtronic, Inc.,
552 U.S. 312, 324-26 (2008) (finding that plaintiff’s
state-law claims were expressly pre-empted under the
Medical Device Amendments without mentioning the
presumption).
This Court attempted to lay any such doubt to
rest in Franklin, holding that where a “statute ‘contains an express pre-emption clause,’ [courts] do not
invoke any presumption against pre-emption but instead ‘focus on the plain wording of the clause, which
necessarily contains the best evidence of Congress’
pre-emptive intent.’” 136 S. Ct. at 1946 (quoting Whiting, 563 U.S. at 594). Since Franklin, this Court has
not applied the presumption to any express pre-emption provisions. E.g., Coventry Health Care of Mo., Inc.
v. Nevils, 137 S. Ct. 1190, 1198-99 (2017).
Nonetheless, the circuits and state supreme
courts continue to engage in “the great preemption
presumption wars,” Air Evac EMS, Inc. v. Cheatham,
910 F.3d 751, 762 n.1. (4th Cir. 2018), and are split 6-
15
5 on whether, and when, the presumption applies to
express pre-emption clauses.
1. Four state supreme courts and two
circuits continue to apply the
presumption to express pre-emption
statutes.
On one side of the divide are the Supreme Courts
of Mississippi, Indiana, California, and Michigan, and
the Third and Ninth Circuits. These courts continue
to believe that the presumption against pre-emption
persists for express pre-emption provisions in either
of two circumstances—both of which the Mississippi
Supreme Court embraced here.
The first is where the federal law touches on an
area of traditional state police powers. The Third Circuit has reasoned, for example, that “‘the historic primacy of state regulation of matters of health and
safety’ requires us to apply the ‘presumption against
the pre-emption of state police power regulations.’”
Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 771
(3d Cir. 2018) (quoting Lohr, 518 U.S. at 485). The
court justified marginalizing Franklin on the ground
that Franklin involved “a Bankruptcy Code provision”
and “did not address claims involving areas historically regulated by states.” Lupian v. Joseph Cory
Holdings LLC, 905 F.3d 127, 131 n.5 (3d Cir. 2018);
see also id. at 131 (quoting Bates, 544 U.S. at 449);
Shuker, 885 F.3d at 771 n.9.
The Mississippi Supreme Court here echoed that
same line when it held that Congress must demonstrate a “clear and manifest purpose” to displace
16
“historic police powers of the States.” Pet. App. 11a
(quotation marks omitted).
The second is where the court finds a pre-emption
provision ambiguous. The Indiana Supreme Court,
for example, holds that Franklin’s instruction not to
apply the presumption to express pre-emption clauses
governs only when the words of the clause “are clear.”
State v. Norfolk S. Ry. Co., 107 N.E.3d 468, 474 (Ind.
2018). The presumption continues to apply, the court
holds, when the “words are ambiguous.” Id. The Mississippi Supreme Court echoed that logic, reasoning
that courts “have a duty to accept the reading that
disfavors pre-emption.” Pet. App. 15a (quoting Bates,
544 U.S. at 449). The California and Michigan Supreme Courts have drawn the same line (albeit preFranklin). See Ter Beek v. City of Wyoming, 846
N.W.2d 531, 536-37 (Mich. 2014); Brown v. Mortensen, 253 P.3d 522, 529 (Cal. 2011). None of these
courts explains why this Court would have bothered
rejecting “any presumption” when that prohibition
applies only to clear statutory provisions for which a
presumption would not matter. Franklin, 136 S. Ct.
at 1946.
The Ninth Circuit sits on both sides of this fence.
Sometimes, it continues to “presum[e] that Congress
did not intend to preempt a law that is within a state’s
historical police powers.” Cal. Trucking Ass’n v.
Bonta, 996 F.3d 644, 654, 664 n.14 (9th Cir. 2021), pet.
for cert. filed, No. 21-194 (Aug. 9, 2021); see also Hardeman v. Monsanto Co., 997 F.3d 941, 958 (9th Cir.
17
2021). 6 Other times, the court has rejected arguments
that “a presumption against preemption should …
still apply,” reasoning that “a state’s traditional regulation in an area is not, standing alone, sufficient to
defeat preemption in the face of an express preemption clause.” Int’l Bhd. of Teamsters, Loc. 2785 v. Fed.
Motor Carrier Safety Admin., 986 F.3d 841, 853 (9th
Cir. 2021), pet. for cert. filed, No. 20-1662 (May 28,
2021)); see also Connell v. Lima Corp., 988 F.3d 1089,
1097 (9th Cir. 2021) (quoting Franklin, 136 S. Ct. at
1946. The Ninth Circuit has never explained what
distinguishes the cases that warrant the presumption
from those that do not.
2. Four circuits and one state supreme
court faithfully decline to apply the
presumption against pre-emption to
express pre-emption statutes.
In contrast, the Fourth, Fifth, Eighth, and Tenth
Circuits and the Arizona Supreme Court correctly recognize that Franklin’s directive applies to all express
pre-emption clauses, regardless of the context of the
state-law claim or the clarity of the provision. Air
Evac, 910 F.3d at 761-62; Dialysis Newco, Inc. v.
6 In Hardeman, the Ninth Circuit held that the express preemption provision of the Federal Insecticide, Fungicide, and Rodenticide Act, which is similar to § 379s, does not pre-empt failure-to-warn claims regarding glyphosate pesticides, even though
the EPA had repeatedly rejected such a warning. A petition for
certiorari in Hardeman is pending. Pet., Monsanto Co. v. Hardeman, No. 21-241 (Aug. 16, 2021). If the Court grants certiorari
in Hardeman, it may want to hear that case together with this
one. At a minimum, it should hold this petition pending its disposition of Hardeman, or vice versa.
18
Cmty. Health Sys. Grp. Health Plan, 938 F.3d 246,
257-59 (5th Cir. 2019); Ferrell v. Air EVAC EMS, Inc.,
900 F.3d 602, 606 (8th Cir. 2018); Dirty Boyz Sanitation Serv., Inc. v. City of Rawlins, 889 F.3d 1189, 1198
(10th Cir. 2018); Conklin v. Medtronic, Inc., 431 P.3d
571, 574 (Ariz. 2018).
As to the substantive areas to which Franklin applies, these courts have declined to apply any presumption to express pre-emption statutes even in
cases involving traditional areas of state regulations.
That includes health insurance contracts, Dialysis
Newco, 938 F.3d 246, garbage collection, Dirty Boyz
Sanitation, 889 F.3d 1189, deceptive trade practices,
Ferrell, 900 F.3d 602, and common-law failure-towarn claims against medical device manufacturers,
Conklin, 431 P.3d 571.
Several of these courts have expressly acknowledged the split, and still have rejected the view that
Franklin’s holding “appl[ies] only to bankruptcy
cases” and does not apply to “claims historically regulated by the states.” Dialysis Newco, 938 F.3d at 258,
259. The Fifth Circuit, for example, has opined: “[W]e
do not read the clear language of Franklin’s holding
on this point as being so limited.” Id. at 258. And the
Fourth Circuit has noted that the circuits “may not be
in full accord” on this issue and concluded that the
“best course is simply to follow … the wording of the
express preemption provision, without applying a presumption,” regardless of the substantive area being
pre-empted. Air Evac EMS, 910 F.3d at 762 n.1.
These courts likewise decline to apply a presumption favoring a narrow reading of an express pre-
19
emption statute, even where the text is “not clear,” id.
at 766, is “ambiguous as to Congressional intent,”
Dirty Boyz Sanitation, 889 F.3d at 1199 (quotation
marks omitted), or “does not mention the particular”
issue “in question,” Dialysis Newco, 938 F.3d at 259.
They reason that, “[i]n [express pre-emption clause]
case[s], our task is simply to interpret the words as
they are written.” Air Evac EMS, 910 F.3d at 762.
***
In sum, express pre-emption provisions are now
being interpreted differently based on the court considering the dispute, the type of state-law claim at issue, and the purported susceptibility of the text to
multiple interpretations. The outcome of a case filed
in Arizona or Mississippi will depend on whether it
was filed in state or federal court. The split is
acknowledged and entrenched. Only this Court can
clear up the confusion.
B. The
Mississippi
Supreme
Court
deepened an 8-2 split regarding what
sorts of agency actions can pre-empt
state law.
The Mississippi Supreme Court’s decision also
deepens a split regarding what sorts of agency actions
have pre-emptive force. This Court has repeatedly
recognized that the FDA has multiple means to “communicate its disapproval of a warning” label, and any
means that “carr[ies] the force of law” can be pre-emptive so long as the FDA is operating pursuant to its
“congressionally delegated authority.” Merck Sharp &
Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1679 (2019);
20
see also Riegel, 552 U.S. at 322-23 (FDA premarket
approval order pre-empted state law). This Court has
further held that “[t]o insist on a specific expression
of agency intent to pre-empt, made after notice-andcomment rulemaking, would be … to tolerate conflicts
that an agency, and therefore Congress, is most unlikely to have intended.” Geier, 529 U.S. at 885.
Despite this guidance, the circuits and state supreme courts are hopelessly split, 8-2, on this question. Courts on both sides of the split have
acknowledged, and rejected, the contrary view. Compare Fellner v. Tri-Union Seafoods, L.L.C., 539 F.3d
237, 244 (3d Cir. 2008), with Good v. Altria Grp., Inc.,
501 F.3d 29, 51-53 (1st Cir. 2007), aff’d on other
grounds and remanded, 555 U.S. 70 (2008). Noting
this disarray, Justice Thomas has urged this Court to
find “an appropriate case” to decide the type of federal
agency action that is capable of pre-empting state
law. Lipschultz, 140 S. Ct. at 7 (concurring in denial
of cert.).
1. On one side of the split stand the Mississippi
Supreme Court and the First Circuit. In this case, the
Mississippi Supreme Court held that the FDA’s denial of the citizen petitions requesting a warning on
cosmetic talc did not bar the State AG from seeking to
impose a warning that the FDA rejected. The court
reached that result because it concluded that the FDA
“must follow the notice and comment rule making process” to pre-empt state law. Pet. App. 15a. On this basis, the court held that the State AG’s claim was not
expressly pre-empted, because the term “requirement” in § 379s(a) is limited to a “positive expression
of regulation.” Pet. App. 16a. And it also held that the
21
action was not impliedly pre-empted, because “the
Food and Drug Administration chose not to exercise
its regulatory authority.” Pet. App. 17a.
The First Circuit adopted the same line: “Limiting
the preemptive power of federal agencies to exercises
of formal rulemaking authority … ensures that the
states will have enjoyed these protections before suffering the displacement of their laws.” Altria, 501
F.3d at 51. The First Circuit acknowledges that its
holding breaks with other circuits, which “have held
that an agency can preempt state law through action
short of [notice-and-comment] rulemaking.” Id.
2. On the other side of the split are seven circuits
and a state supreme court. They all recognize that
agency actions “short of formal, notice and comment
rulemaking may … have preemptive effect over state
law.” Fellner, 539 F.3d at 244. They reject the view
that “the only regulatory process which can produce
‘federal law’ for purposes of the Supremacy Clause is
formal, notice and comment rulemaking.” Id. All of
them would give pre-emptive force to the denial of a
citizen petition—although they have adopted three
different tests as to which agency actions have preemptive force.
The first test is the one the Second, Fourth, and
Seventh Circuits and the California Supreme Court
have adopted. These courts give pre-emptive force to
any agency action that carries the “force of law”—that
is, any final agency action taken pursuant to “‘congressionally delegated authority.’” City of N.Y. v. Permanent Mission of India to United Nations, 618 F.3d
172, 187 (2d Cir. 2010) (quoting City of N.Y. v. FCC,
22
486 U.S. 57, 63-64 (1988)); see also Feikema v. Texaco,
Inc., 16 F.3d 1408, 1416 (4th Cir. 1994); Dolin v. GlaxoSmithKline LLC, 951 F.3d 882, 891 (7th Cir. 2020);
Dowhal
v.
SmithKline
Beecham
Consumer
Healthcare, 88 P.3d 1, 9-11 (Cal. 2004). These courts
ask simply whether the agency action is “sufficiently
definite and authoritative” to pre-empt state law.
Dowhal, 88 P.3d at 9.
The second test is the one the Third, Ninth, and
Tenth Circuits have embraced: that an agency action
has pre-emptive force so long as it “provides for a relatively formal administrative procedure tending to
foster … fairness and deliberation.” Fellner, 539 F.3d
at 245 (quoting United States v. Mead Corp., 533 U.S.
218, 230 (2001)); see also Hardeman, 997 F.3d at 957;
Reid v. Johnson & Johnson, 780 F.3d 952, 964 (9th
Cir. 2015); Utah Native Plant Soc’y v. U.S. Forest
Serv., 923 F.3d 860, 868 n.5 (10th Cir. 2019). These
courts give “preemptive effect” to any agency action so
long as the action “should be afforded Chevron deference.” Fellner, 539 F.3d at 245. As the Ninth Circuit
puts it, “[c]reation of federal law should demand at
least the same formality for purposes of preemption
as it does for purposes of Chevron deference.” Reid,
780 F.3d at 964.
A half-step further is the third test: The Eighth
Circuit has held that a “federal policy of nonregulation” may have pre-emptive force. See Charter Advanced Servs. (MN), LLC v. Lange, 903 F.3d 715, 718
(8th Cir. 2018) (quoting Minn. Pub. Utils. Comm’n v.
FCC, 483 F.3d 570, 580 (8th Cir. 2007)), cert. denied
sub nom., Lipschultz, 140 S. Ct. 6. This is the case in
23
which Justice Thomas noted the need for this Court
to intervene. 140 S. Ct. at 7.
Regardless of the precise test, every one of the
courts on this side of the split would give pre-emptive
force to the denial of a citizen petition—and several
have done exactly that. Applying the “force of law”
test, the California Supreme Court and the Seventh
and Tenth Circuits have concluded that the FDA’s denial of a citizen petition was “sufficiently definite and
authoritative” to pre-empt state law. Dowhal, 88 P.3d
at 9; see also Robinson v. McNeil Consumer
Healthcare, 615 F.3d 861, 873 (7th Cir. 2010); Cerveny
v. Aventis, Inc., 855 F.3d 1091, 1105 (10th Cir. 2017).
The Third Circuit has done the same, applying the
Chevron test. It reasoned that it was sufficient that
the agency had “previously considered the scientific
evidence relied upon by plaintiffs and had exercised
its prerogative under the regulations to reject [the requested] warnings.” Fellner, 539 F.3d at 245 (discussing Colacicco v. Apotex Inc., 521 F.3d 253, 271 (3d Cir.
2008)). Federal district courts, too, are aligned that
the FDA’s denial of a citizen petition is pre-emptive.
See In re: Zofran (Ondansetron) Prods. Liab. Litig.,
--- F. Supp. 3d ---, 2021 WL 2209871, at *33 (D. Mass.
June 1, 2021); In re Incretin-Based Therapies Prods.
Liab. Litig., --- F. Supp. 3d ---, 2021 WL 880316, at
*16 (S.D. Cal. Mar. 9, 2021).
The divide between the courts requiring noticeand-comment-rules and those requiring something
less is so stark, and so entrenched, that only this
Court can resolve the split and restore clarity.
24
II. These Are Recurring Issues Of Exceptional
Importance That Require This Court’s
Review.
A. The presumption against pre-emption
affects the interpretation of dozens of
federal statutes with express preemption provisions.
The split over whether courts should read express
pre-emption statutes narrowly injects uncertainty
into “most major industries, including drugs and medical devices, banking, air transportation, securities,
automobile safety, and tobacco.” Jay B. Sykes, et al.
Cong. Rsch. Serv., R45825, Federal Preemption: A Legal Primer 1 (July 23, 2019), https://tinyurl.com/wp3mfu92. Unless this Court resolves the
split, Congress will have no assurance that the words
it enacts will be faithfully applied to pre-empt state
law. States, in turn, will continue to encroach upon
areas that Congress committed to uniform federal
regulation. And the regulated community will be subject to the risk of contradictory rulings in different jurisdictions—with the potential to throw entire
industries into disarray overnight.
As this Court recognized in Franklin, applying a
presumption narrowing the language that Congress
enacted in an express pre-emption statute necessarily
fails to afford the plain text its natural meaning. 136
S. Ct. at 1946. That, in turn, dramatically limits the
intended reach of dozens of federal statutes.
In the food and drug context alone, statutes with
express
pre-emption
provisions
govern
the
25
nationwide regulation of meat, pesticides, poultry,
pork advertising, medical devices, public health emergencies, and egg products, among other examples.
See, e.g., 21 U.S.C. § 678 (Federal Meat Inspection
Act); 42 U.S.C. § 247d-6d(b)(8) (Public Readiness and
Emergency Preparedness Act); 21 U.S.C. § 467e
(Poultry Products Inspection Act); 7 U.S.C. § 4817(b)
(Pork Promotion, Research, and Consumer Information Act); 21 U.S.C. § 360k(a) (Medical Device Regulation Act); 21 U.S.C. § 1052(b) (Egg Products
Inspection Act). And the application of the presumption—and its limiting scope—reaches far beyond
these industries, to employee pension plans, domestic
air travel, and trucking. See 29 U.S.C. § 1144(a)
(ERISA); 49 U.S.C. § 41713(b)(1) (Airline Deregulation Act); 49 U.S.C. § 14501(c)(1) (Federal Aviation
Administration Authorization Act).
Applying a presumption against pre-emption to
any of these express pre-emption statutes even in a
single jurisdiction will have far-reaching consequences. Any time an express pre-emption clause permits an alternative, non-pre-emptive interpretation—
even if that reading is not the ordinary plain language
construction—Congress’s intent to pre-empt state law
and to create uniform rules on which that industry
and the public rely will be thwarted. Congress’s statutes should not be subjected to different interpretive
criteria in different parts of the country.
The different approaches are typically outcomedeterminative, as they are here. Compare Pet. App.
15a-16a (holding that § 379s is not pre-emptive after
applying the presumption against pre-emption), with
Critcher, 959 F.3d at 38 (pre-empting the state action
26
without applying any presumption disfavoring preemption, because of the “sweeping preemptive force”
of § 379s, a “broad preemption clause”). And the split
in authority over whether a presumption against preemption may apply to express pre-emption statutes is
so wide and entrenched that these disruptive consequences will continue to arise with alarming frequency.
This case presents an especially dire threat,
which requires this Court’s intervention here and
now. Congress charged the FDA with ensuring that
“cosmetics are safe and properly labeled.” 21 U.S.C.
§ 393(b)(2)(D). In doing so, Congress advanced the
goal of “national uniformity” with respect to “requirements that relate to labeling … [and] warnings.” H.R.
Rep. No. 105-399, at 103 (1997) (Conf. Rep.). But the
opinion below authorizes a state official to impose a
labeling requirement even though the FDA has already carefully weighed and rejected one. This type of
collateral attack on the FDA’s decision not to require
a warning undermines the FDA’s authority and the
ability of the cosmetics industry to rely upon decisions
the expert agency rendered. The result will be exactly
the opposite of the uniformity Congress sought when
it enacted the pre-emption provision. Congress did
not want to allow states to force manufacturers to
print “50 different labels, driving consumers …
crazy.” Turek v. Gen. Mills, Inc., 662 F.3d 423, 426
(7th Cir. 2011).
If this Court does not step in to prevent the Mississippi Attorney General from seeking her own warnings—and recovering penalties of $10,000 for every
single bottle of cosmetic talc sold in the state since
27
1974—her counterparts in other states, or plaintiffs’
lawyers, will quickly jump in and seek similar jackpots under their own consumer protection statutes.
In addition to inviting a whole new wave of litigation, permitting this decision to stand will produce a
cacophony of warning labels that will undermine the
efficacy of those warning labels that are actually
needed to protect the public. Consumers can become
desensitized to legitimate warning labels and may
end up ignoring them altogether. See Cerveny, 855
F.3d at 1102 (explaining that “the FDA views” unnecessary state warning requirements “as problematic
because they can render the warnings useless”).
There is no need to wait for further percolation
before resolving this important conflict and avoiding
the harms from allowing it to persist. When pre-emption is at issue, just one deviation can wreak havoc on
a uniform national regulatory regime. But here the
Court already has guidance from the 11 courts that
have grappled with the issue and split right down the
middle.
B. The power of agency action to pre-empt
is dispositive in both the express and
implied pre-emption contexts.
The issue of what types of agency action have preemptive force is also a recurring issue of exceptional
importance—with ramifications far beyond express
pre-emption. Agencies—and the regulated community—need to know in advance whether or not specific
agency actions will have pre-emptive effect.
28
The decision below artificially curtails agencies’
policy-making flexibility, effectively limiting agencies
to notice-and-comment rulemaking if they want their
decisions enforced nationwide. The decision below
would strip pre-emptive force, for example, from the
FDA’s “rigorous” process of premarket approval for
medical devices held to be pre-emptive in Riegel, 552
U.S. at 317-18 (“The FDA spends an average of 1,200
hours reviewing each application….”). The same
would be true for Federal Energy Regulatory Commission orders governing cost allocation among energy companies—legally binding, published orders
that are decided after proceedings in which all interested parties are able to participate. See Entergy La.,
Inc. v. La. Pub. Serv. Comm’n, 539 U.S. 39, 49-50
(2002) (holding that FERC order pre-empts state requirement); 16 U.S.C. §§ 824d, 824e. Such federal
agency decisions carry the force of law, but would be
deprived of any pre-emptive weight in some jurisdictions.
The issue, then, will have a profound effect on
agencies’ effectiveness. “It is well established that
when developing law on a subject, an agency usually
has a choice between the method of rulemaking and
that of adjudication.” General Motors Corp. v.
Abrams, 897 F.2d 34, 39 (2d Cir. 1990). Agencies can
properly determine that a problem is best resolved
case by case, allowing the agency to closely consider
individual circumstances and develop law incrementally. See SEC v. Chenery Corp., 332 U.S. 194, 202-03
(1947). And an agency may follow a specialized decisionmaking procedure set out by Congress in its enabling statute that contains many of the hallmarks of
rulemaking—such as public notice and opportunity to
29
submit comments—but was designed for the needs of
that policy area. E.g., 7 U.S.C. § 136d (procedure for
suspension or cancellation of pesticide regulations).
An agency may also preserve its limited resources for
other policy priorities by tackling an issue through focused adjudications that apply narrowly to discrete
entities.
None of those scenarios would result in a decision
entitled to pre-emptive force in jurisdictions following
Mississippi’s approach. Even “where a comprehensive
federal regulatory scheme authorized a process for
the agency to apply a federal standard to concrete circumstances,” and the agency “had utilized that process in a manner establishing a federal duty or
policy,” courts on this far side of the split would find
the action incapable of pre-empting state law. Fellner,
539 F.3d at 244. This is so even when a decision legally binds one or more entities, as when an agency
issues a decision following a “quasi-judicial” adjudication. Id. (“[B]oth agencies’ quasi-legislative as well as
their quasi-judicial powers ‘have the binding force of
federal law.”’ (quoting Abrams, 897 F.2d at 39)). If
this split endures, agencies that want to preserve uniformity at Congress’s behest will have to think twice
about taking any of these actions, which, in turn, will
distort institutional decisionmaking and undermine
federal policy.
The breadth and depth of the split in the circuits
and state courts demonstrates that the issue will continue to crop up frequently. And it will have effects far
beyond the express pre-emption context, to all preemption cases involving federal executive action.
30
Federal and state government actors—and the
public—need to know what federal agency actions will
be deemed pre-emptive. And they need a uniform answer that applies across the country. Such fundamental principles of our constitutional structure should
not vary based on where (and in which court) the issue
is raised.
III. This Case Provides An Excellent Vehicle For
Resolving Both Issues.
Granting review in this case would provide a
uniquely suitable vehicle for resolving both splits.
Both questions presented were squarely raised and
resolved below. The case presents the legal issues
cleanly, without factual issues that could interfere
with the Court’s assessment of the questions presented. Notably, Mississippi does not contest that the
FDA issued a final decision denying two citizen petitions that sought to require a warning label on talc
products. Mississippi also acknowledges that its suit
defies the FDA’s decision that such a warning label is
unwarranted.
Moreover, the Mississippi Supreme Court’s decision was limited to the threshold federal pre-emption
issue. That court recognized the fundamental, dispositive nature of the issue, and the importance of resolving it before permitting the case to move forward. The
issue is no less pressing and fundamental now. And
this Court’s resolution of the questions presented
would be outcome-determinative if this Court agrees
that federal pre-emption bars the Mississippi Attorney General from collaterally challenging the FDA’s
decision.
31
The Mississippi Supreme Court presents these issues well for this Court’s review. On the issue of
whether a presumption against pre-emption requires
express pre-emption provisions to be narrowly construed, the court invoked both contested lines of rationale for continuing to apply a narrow construction,
even after this Court’s ruling in Franklin: that the
presumption applies where the pre-emption provision
is unclear and that an express pre-emption provision
must be read narrowly to the extent it addresses traditional state powers. Pet. App. 11a, 15a. Thus, granting review here would allow this Court to address
both threads of the court cases seeking to limit Franklin.
Likewise, the decision of the Mississippi Supreme
Court presents a clean vehicle for addressing when
federal agency action has pre-emptive force. The court
squarely held that only formal notice-and-comment
rules are capable of pre-empting state law. Pet. App.
15a-17a. Moreover, the case arises in a context where
the agency conducted a “careful review” of the available information, including public comments, and issued a reasoned decision that is acknowledged to be
final and subject to judicial review. Pet. App. 4a, 14a15a. This case, thus, presents the opportunity to clarify whether such final agency actions can have preemptive effect, or whether, as the Mississippi Supreme Court held, the only agency actions that are
deemed pre-emptive must result from formal noticeand-comment rulemaking.
32
IV. The Mississippi Supreme Court’s Decision Is
Wrong.
The Mississippi Supreme Court’s two central
holdings were wrong—both its decision to apply a presumption against pre-emption and its view that only
notice-and-comment regulations have pre-emptive
force. Had the court correctly applied the law, it would
have dismissed this action.
A. This Court spoke expansively when it held that
courts “do not invoke any presumption against preemption” when a “statute ‘contains an express preemption clause.’” Franklin, 136 S. Ct. at 1946 (quoting Whiting, 563 U.S. at 594). That holding and the
rationale behind it are incompatible with both of the
Mississippi Supreme Court’s rationales for cabining
this holding.
To start, Franklin leaves no doubt that its holding
applies to pre-emption statutes whose meaning is unclear, because that was the situation in Franklin.
This Court declined to apply the presumption even
though there were multiple potential readings of the
pre-emption clause at issue there. See id. at 1947-49
(rejecting the dissent’s non-pre-emptive interpretation of the provision). The very notion of an exception
for unclear statutes is absurd. It would swallow the
rule. A presumption has effect only where a provision
is unclear—i.e., where there is more than one way to
read the provision. It would have made no sense for
Franklin to declare that courts should “not invoke any
presumption against pre-emption” when a “statute
‘contains an express pre-emption clause,’” id. at 1946
(emphasis added), if it really meant that courts should
33
always invoke the presumption, but only when it matters.
Nor does anything in Franklin suggest that the
holding depended on whether the pre-emption clause
was in a bankruptcy statute as opposed to a statute
governing health and safety. This Court cited cases
involving traditional state powers in support of its
holding that no presumption applies to express preemption statutes. Id. at 1946 (citing Whiting, 563 U.S.
at 594 (addressing state business licenses), and Gobeille v. Liberty Mut. Ins. Co., 577 U.S. 312, 323-26
(2016) (addressing the “State’s traditional power to
regulate in the area of public health”)). And the substantive context of the provision played no role in the
Court’s analysis.
Moreover, the rationale for rejecting the presumption applies with full force to all pre-emption clauses.
This Court has held that congressional intent is the
“ultimate touchstone in every pre-emption case.” Wyeth v. Levine, 555 U.S. 555, 565 (2009) (quoting Lohr,
518 U.S. at 485). And in rejecting the presumption,
this Court recognized that the “plain wording of” an
express pre-emption clause “‘necessarily contains the
best evidence of Congress’ pre-emptive intent.’”
Franklin, 136 S. Ct. at 1946; see also Cipollone, 505
U.S. at 545 (Scalia, J., concurring in part) (the presumption “dissolves once there is conclusive evidence
of intent to pre-empt in the express words of the statute itself”). So the best way to discern Congress’s intent is to find the best reading of the words it wrote,
without a thumb on the scale in either direction. Anything else empowers judges to advance their own
policy preferences. See generally Amy Coney Barrett,
34
Substantive Canons and Faithful Agency, 90 B.U. L.
Rev. 109 (2010). None of that depends on the regulatory context of the statute.
Reading the statute faithfully is particularly important here. In drafting § 379s, Congress commanded that states not impose labeling requirements
of the sort Mississippi seeks to enforce here: It did not
want any “State or political subdivision” to “establish
… any requirement for labeling” that is in any way
“different from or in addition to, or that is otherwise
not identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics under
this chapter.” 21 U.S.C. § 379s(a). The statute leaves
no room for a state to impose a “requirement for labeling” the FDA has flatly rejected.
Congress punctuated the point by refining the
precise scope of pre-emption with three separate savings clauses. The first is particularly salient: It allows
a state, such as Mississippi, to impose a warning even
though the FDA has rejected one—but only with the
FDA’s permission. Congress prescribed a procedure
for seeking and granting such exemptions from the
pre-emptive force of the statute. 21 U.S.C. § 379s(b).
Mississippi’s decision to take matters into its own
hands, without seeking any exception, negates this
provision. And it is all the more inconsistent with
Congress’s objective, since Mississippi seeks to impose a cancer warning requirement that the FDA had
just rejected as unwarranted—an exemption the FDA
would surely have denied.
The other two savings provisions are inapplicable
here: an exemption for product liability causes of
35
action (this is a consumer protection case), id.
§ 379s(d), and a grandfather clause for state requirements adopted by public initiative or referendum before September 1, 1997 (this consumer protection
statute was enacted by a legislature), id. § 379s(e).
They are relevant, though, because they further illustrate how carefully Congress considered the reach of
the express pre-emption provision and made nuanced
policy judgments to balance competing state interests
against the federal regulatory interests. Courts cannot “presume[] that Congress” “cavalierly preempt[ed] state-law causes of action” given the careful
carveouts in § 379s. Lohr, 518 U.S. at 485. To engraft
onto the statute additional, atextual limitations
would upset the careful balance Congress struck—
which is exactly the opposite of what Franklin directed.
B. This Court was also expansive when it held
that any “agency action carrying the force of law” and
taken pursuant to “congressionally delegated authority” may pre-empt state law, Albrecht, 139 S. Ct. at
1679, and that it is wrong “[t]o insist on a specific expression of agency intent to pre-empt, made after notice-and-comment rulemaking,” Geier, 529 U.S. at
885; see also New York v. FERC, 535 U.S. 1, 18 (2002)
(“[A] federal agency may pre-empt state law … if it is
acting within the scope of its congressionally delegated authority ….” (quoting La. Pub. Serv. Comm’n
v. FCC, 476 U.S. 355, 374 (1986))); Lohr, 518 U.S. at
505 (Breyer, J., concurring in part) (observing that
agencies possess “leeway to determine which rules,
regulations, or other administrative actions will have
pre-emptive effect” (emphasis added)). Indeed, this
Court has routinely granted pre-emptive force to
36
agency actions that fall short of notice-and-comment
rulemaking. E.g., Riegel, 552 U.S. at 323 (FDA premarket approval order pre-empted state law); Entergy
La., 539 U.S. at 49-50 (FERC order pre-empted state
requirement); Chicago & N.W. Transp. Co. v. Kalo
Brick & Tile Co., 450 U.S. 311, 327 (1981) (agency’s
approval of carrier’s application to abandon rail line
was pre-emptive).
For good reason. Congress gives agencies a variety of tools by which to advance their missions because it recognizes that different tools fit different
needs. The Supremacy Clause says that “the laws of
the United States”—not just notice-and-comment regulations—“shall be the supreme Law of the Land.”
U.S. Const. art. VI, cl. 2. If an agency action has the
force of law, it pre-empts without regard to how that
law was created. To privilege “notice-and-comment
rulemaking” above all the other forms of agency lawmaking “would be … to tolerate conflicts that an
agency, and therefore Congress, is most unlikely to
have intended.” Geier, 529 U.S. at 885.
That conclusion is especially apt here. The FDA
issued its decision pursuant to its congressionally delegated authority over cosmetic labels. See 21 U.S.C.
§ 371(a); see also id. §§ 331, 362, 393(b). In response
to citizen petitions seeking a warning on cosmetic
talc, the FDA examined the evidence offered by both
the citizen petitioners and other commenters, conducted its own “expanded literature search,” and ultimately concluded that the evidence did not support
the requested warning label. App’x 93. And, as the
court below acknowledged, the FDA’s denial of the citizen petitions “constitutes a final agency action that
37
is subject to judicial review.” Pet. App. 14a. The FDA’s
regulations expressly say so, 21 C.F.R. § 10.45(d), and
the decision denying the citizen petitions plainly
“mark[s] the ‘consummation’ of the agency’s decisionmaking process,” determines “rights [and] obligations,” and has “legal consequences,” Bennett v. Spear,
520 U.S. 154, 178 (1997) (citations omitted). Thus, the
FDA’s decision denying the citizen petitions “carr[ies]
the force of law,” and has pre-emptive effect. Albrecht,
139 S. Ct. at 1679; see id. at 1683 (Thomas, J., concurring) (“final agency action with the force of law” is preemptive); see also Dowhal, 88 P.3d 1 at 9 (rejecting
argument that the FDA’s response to a citizen petition was “not sufficiently … authoritative” to preempt state law); Fellner, 539 F.3d at 244 (acknowledging that “quasi-judicial agency proceedings” with procedural protections like those involved in the FDA’s
citizen petition process “constitute ‘federal law’ under
the Supremacy Clause”).
C. Had the Mississippi Supreme Court not
adopted these erroneous pre-emption carve-outs, it
would have had to conclude that the State AG’s labeling claim is both expressly and impliedly pre-empted.
The State AG’s claim satisfies each of the elements of § 379s(a). She seeks to enforce a state “requirement,” i.e., a “state-law obligation,” or “legal
duty,” see Riegel, 552 U.S. at 324, that is “for labeling,” 21 U.S.C. § 379s(a). And, because she seeks to
hold J&J liable for failing to include a warning label
on its talc products that the FDA expressly rejected,
the state requirement is “different from,” “in addition
to,” and “not identical” to a federal “requirement
38
specifically applicable to a particular cosmetic or class
of cosmetics.” Id.
The FDA’s denial of the citizen petitions is a federal “requirement” under § 379s(a)—i.e., a “rule of
law that must be obeyed.” Bates, 544 U.S. at 445. Far
from being mere “inaction,” Pet. App. 15a, the FDA’s
decision was an affirmative, final, and appealable administrative order, see 21 U.S.C § 10.45(d). The State
AG’s claim is therefore expressly pre-empted under
21 U.S.C. § 379s(a); see Hardeman, 997 F.3d at 957
(agency actions that follow “relatively formal administrative procedure[s] tending to foster … fairness and
deliberation” “establish requirements that can
preempt state law”).
Even apart from the explicit pre-emption provision, the State AG’s claim is also impliedly preempted because it poses an “actual conflict with a federal objective.” Geier, 529 U.S. at 871. The conflict is
stark: The Mississippi Attorney General seeks to impose a warning that the FDA rejected as unsupported
by the available evidence. The FDA has “convey[ed]
an ‘authoritative’ message of a federal policy” against
the Attorney General’s desired warning label. Sprietsma v. Mercury Marine, 537 U.S. 51, 67 (2002); see
also Albrecht, 139 S. Ct. at 1684-85 (Alito, J., concurring in the judgment) (FDA’s decision not to “require
a label change despite having received and considered
information regarding” the purported risk is “highly
relevant to the pre-emption analysis”); PLIVA, Inc. v.
Mensing, 564 U.S. 604, 637 (2011) (Sotomayor, J., dissenting) (state claim would be pre-empted where
“FDA had itself considered whether to request enhanced warnings in light of the evidence on which a
39
plaintiff’s claim rests but had decided to leave the
warnings as is”). Federal agencies simply cannot operate effectively if states can freely reverse the decisions they reach after due deliberation.
It bears emphasizing that Congress granted the
State multiple options to attempt to impose the warning label it now seeks. See Kalo Brick, 450 U.S. at 33031 (action collaterally attacking agency’s decision was
“plainly contrary to” congressional intent, where
plaintiff had multiple “avenues for relief” under federal law, but “chose[] not to” pursue any of these “express remedies”). Apart from seeking the exception
mentioned above (at 34), the State AG could have participated in the citizen petitions or filed a new petition. See 21 C.F.R. § 10.20(a), (j). If, as the State AG
now contends, the FDA’s decision making process was
infected by some far-reaching conspiracy between
J&J and the FDA, judicial review was available. See
id. § 10.45(d). The State AG did none of that.
What Congress did not allow—and the pre-emption provision explicitly rejects—is the route the State
AG chose here: to collaterally attack the FDA’s decision in her State’s courts. The FDCA bars the State
AG’s efforts to retroactively impose a warning that
the FDA rejected and to extract billions of dollars in
penalties for failing to include such a warning.
CONCLUSION
The Court should grant the petition and reverse
the Mississippi Supreme Court. Alternatively, the
Court should hold this petition if it grants certiorari
in Hardeman, No. 21-241.
40
Respectfully submitted,
Robert M. Loeb
Elizabeth R. Moulton
Sheila Baynes
Zachary Hennessee
ORRICK, HERRINGTON &
SUTCLIFFE LLP
1152 15th Street, NW
Washington, DC 20005
Date: August 30, 2021
E. Joshua Rosenkranz
Counsel of Record
ORRICK, HERRINGTON &
SUTCLIFFE LLP
51 West 52nd Street
New York, NY 10019
(212) 506-5000
jrosenkranz@orrick.com
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.