Amicus Curiae Brief — Johnson & Johnson, et al., Petitioners v. Lynn Fitch, Attorney General of Mississippi, ex rel. Mississippi

No. 21-348

In the

Supreme Court of the United States

________________

JOHNSON & JOHNSON and JOHNSON & JOHNSON

CONSUMER COMPANIES, INC.,

Petitioners,

v.

LYNN FITCH, Attorney General of the State of

Mississippi, ex rel. the STATE OF MISSISSIPPI,

Respondent.

________________

On Petition for Writ of Certiorari to the

Supreme Court of Mississippi

________________

BRIEF OF THE CHAMBER OF COMMERCE

OF THE UNITED STATES OF AMERICA,

COALITION FOR LITIGATION JUSTICE, INC.,

AND AMERICAN PROPERTY CASUALTY

INSURANCE ASSOCIATION AS AMICI

CURIAE SUPPORTING PETITIONERS

________________

Andrew R. Varcoe

Jennifer B. Dickey

U.S. CHAMBER

LITIGATION CENTER

1615 H Street NW

Washington, DC 20062

(202) 463-5337

Counsel for the Chamber

of Commerce of the

United States of America

Ethan P. Davis

Counsel of Record

Matthew V.H. Noller

KING & SPALDING LLP

50 California Street

Suite 3300

San Francisco, CA 94111

(415) 318-1200

edavis@kslaw.com

Counsel for Amici Curiae

(Additional counsel listed on inside cover)

October 4, 2021

Kenneth Stoller

AMERICAN PROPERTY

CASUALTY INSURANCE

ASSOCIATION

555 12th Street NW

Suite 550

Washington, DC 20004

Counsel for American

Property Casualty

Insurance Association

Mark Behrens

SHOOK, HARDY &

BACON L.L.P.

1800 K Street NW

Suite 1000

Washington, DC 20006

Counsel for Coalition for

Litigation Justice, Inc.

TABLE OF CONTENTS

Table of Authorities .................................................... ii

Interest of Amici Curiae ............................................. 1

Summary of Argument ............................................... 2

Argument .................................................................... 4

I.

The decision below misconstrues basic

principles of federal preemption ......................... 4

A. Applying

a

presumption

against

preemption to express preemption

provisions conflicts with the Supremacy

Clause and basic rules of statutory

interpretation ............................................... 4

B. The Mississippi Supreme Court’s holding

that

only

notice-and-comment

regulations can preempt state law cannot

be squared with the text of the FDCA’s

preemption provision.................................... 7

C. The

FDCA

expressly

preempts

Mississippi’s lawsuit, which seeks to

impose labeling requirements the FDCA

does not impose ............................................ 9

II. The Court should grant certiorari to provide

clarity and national uniformity in federal

preemption ......................................................... 13

Conclusion................................................................. 18

ii

TABLE OF AUTHORITIES

Cases

Bates v. Dow Agrosciences, LLC,

544 U.S. 431 (2005)............................................ 8, 13

Bruesewitz v. Wyeth, LLC,

562 U.S. 223 (2011).......................................... 15, 16

Cerveny v. Aventis, Inc.,

855 F.3d 1091 (10th Cir. 2017).............................. 15

Coventry Health Care of Mo., Inc. v. Nevils,

137 S. Ct. 1190 (2017).............................................. 5

Critcher v. L’Oreal USA, Inc.,

959 F.3d 31 (2d Cir. 2020) ............................. passim

Encino Motorcars, LLC v. Navarro,

138 S. Ct. 1134 (2018).............................................. 5

Fort Halifax Packing Co. v. Coyne,

482 U.S. 1 (1987).................................................... 14

Gobeille v. Liberty Mut. Ins. Co.,

577 U.S. 312 (2016)................................................ 13

Grocery Mfrs. of Am., Inc. v. Gerace,

755 F.2d 993 (2d Cir. 1985) ................................... 16

Hillsborough Cnty.

v. Automated Med. Labs., Inc.,

471 U.S. 707 (1985).................................................. 4

Int’l Paper Co. v. Ouellette,

479 U.S. 481 (1987)................................................ 13

Kisor v. Wilkie,

139 S. Ct. 2400 (2019)............................................ 14

iii

Medtronic, Inc. v. Lohr,

518 U.S. 470 (1996).................................................. 9

Merck Sharp & Dohme Corp. v. Albrecht,

139 S. Ct. 1668 (2019).......................................... 5, 9

Nat. Res. Def. Council, Inc. v. FDA,

760 F.3d 151 (2d Cir. 2014) ................................... 12

Nw. Airlines, Inc. v. Duncan,

121 S. Ct. 650 (2000).............................................. 14

Puerto Rico v. Franklin Cal. Tax-Free Tr.,

136 S. Ct. 1938 (2016).................................. 3, 4, 5, 6

Riegel v. Medtronic, Inc.,

552 U.S. 312 (2008)........................................ passim

Tarrant Reg’l Water Dist. v. Herrmann,

569 U.S. 614 (2013).................................................. 6

Turek v. Gen. Mills, Inc.,

662 F.3d 423 (7th Cir. 2011).................................. 15

Wyeth v. Levine,

555 U.S. 555 (2009).......................................... 3, 5, 6

Constitutional Provisions

U.S. Const. art. VI, cl. 2 ......................................... 3, 5

Statutes

2 U.S.C. § 300aa-22(b)(1) ......................................... 15

21 U.S.C.

§ 360k(a) ............................................................. 9, 14

§ 362(a) ................................................................... 10

§ 371(a) ..................................................................... 9

§ 379r ...................................................................... 14

§ 379s(a) ......................................................... passim

iv

21 U.S.C.

§ 393(b)(2)(D) ..................................................... 9, 10

§ 678 ....................................................................... 16

42 U.S.C. § 247d-6d .................................................. 17

Food and Drug Administration

Modernization Act of 1997,

Pub. L. No. 105-115, 111 Stat. 2296 ....................... 8

Regulations

21 C.F.R.

§ 10.30 .................................................................... 12

§ 10.45(d) ................................................................ 12

§ 740.1 .................................................................... 10

§ 740.10(b) .............................................................. 11

85 Fed. Reg.

15,198 (Mar. 17, 2020) ........................................... 17

21,012 (Apr. 15, 2020)............................................ 17

35,100 (June 8, 2020) ............................................. 17

52,136 (Aug. 24, 2020) ........................................... 17

79,190 (Dec. 9, 2020) .............................................. 17

86 Fed. Reg.

7872 (Feb. 2, 2021)................................................. 17

9516 (Feb. 16, 2021)............................................... 17

14,462 (Mar. 16, 2021) ........................................... 17

41,997 (Aug. 4, 2021) ............................................. 17

51,160 (Sept. 14, 2021) .......................................... 17

Other Authorities

Am. Heritage College Dictionary

(3d ed. 1997) ............................................................. 8

Black’s Law Dictionary (6th ed. 1990) ....................... 8

Merriam-Webster Dictionary (1997 ed.) .................... 8

v

Random House Webster’s College Dictionary

(2d ed. 1996) ............................................................. 8

Antonin Scalia,

Assorted Canards of Contemporary Legal

Analysis, 40 Case W. Res. L. Rev. 581

(1990) ........................................................................ 5

U.S. Chamber of Commerce Found.,

The Regulatory Impact on Small Business:

Complex. Cumberson. Costly. (2017),

https://perma.cc/G6SX-VTEC ................................ 13

Webster’s Dictionary of Am. English

(1st ed. 1997) ............................................................ 8

INTEREST OF AMICI CURIAE

The Chamber of Commerce of the United States

of America is the world’s largest business federation.

It represents around 300,000 members and indirectly

represents the interests of more than three million

companies and professional organizations of every

size, in every industry sector, and from every region of

the country. 1

The Coalition for Litigation Justice, Inc. is a

nonprofit association formed by insurers to address

and improve the litigation environment for tort

claims. The Coalition includes Century Indemnity

Company; Great American Insurance Company;

Nationwide Indemnity Company; San Francisco

Reinsurance Company; Resolute Management, Inc., a

third-party administrator for numerous insurers; and

TIG Insurance Company.

The American Property Casualty Insurance

Association is the primary national trade association

for home, auto, and business insurers. APCIA

members represent all sizes, structures, and regions—

protecting families, communities, and businesses in

the United States and across the globe.

Amici regularly represent their members’

interests in amicus curiae briefs in cases raising issues

of concern to the nation’s business community. Amici

1 Petitioners and respondent received timely notice of this brief

under Rule 37(a) and have all filed blanket consents to amicus

briefs. No counsel for a party authored this brief in whole or in

part, and no person or entity, other than amici, their members,

or their counsel, made a monetary contribution intended to fund

the preparation or submission of this brief.

2

have a strong interest in ensuring that federal

preemption is enforced correctly, clearly, and

uniformly nationwide, thus alleviating the need for its

members to navigate a patchwork of inconsistent state

regulation Amici ask the Court to grant the petition

for certiorari and reverse the decision below, restoring

clarity and uniformity to federal preemption law.

SUMMARY OF ARGUMENT

This case presents a compelling opportunity for

the Court to anchor preemption jurisprudence to the

original understanding of the Supremacy Clause. In

the decision below, the Mississippi Supreme Court

allowed the State of Mississippi to impose a cosmetic

labeling requirement that the Food and Drug

Administration made an affirmative decision not to

impose. That decision runs right into the express

preemption clause in the Food, Drug, and Cosmetic

Act (FDCA).

That provision preempts “any [state] 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.” 21 U.S.C. § 379s(a). While this clause seems

abundantly clear, the Mississippi Supreme Court

found it to be ambiguous, applied a presumption

against preemption, and held that the only federal

“requirement[s]” with preemptive effect are

regulations enacted through notice and comment.

I. That decision violates basic principles of federal

preemption.

The

Supremacy

Clause

grants

preemptive effect to “the Laws of the United States,”

3

U.S. Const. art. VI, cl. 2, meaning “the statutory text

that was produced through the constitutionally

required bicameral and presentment procedures,”

Wyeth v. Levine, 555 U.S. 555, 585 (2009) (Thomas, J.,

concurring). As this Court has held, this means that

courts must interpret express preemption clauses

according to their text, unmodified by any

presumption against preemption. Puerto Rico v.

Franklin Cal. Tax-Free Tr., 136 S. Ct. 1938, 1946

(2016). Doing otherwise, as the court below did,

extends preemptive effect not to “the Laws of the

United States,” but to individual judges’ extratextual

speculation about congressional intent.

Section 379s(a)’s plain text preempts the claims in

this lawsuit. Mississippi seeks to impose a state-law

requirement that cosmetic talc products include a

cancer warning. But the Food and Drug

Administration, through its denial of two citizen

petitions, affirmatively concluded that the FDCA’s

requirements do not support such a warning. Under

the ordinary meaning of the word “requirement,”

therefore, Mississippi impermissibly seeks to impose a

state-law “requirement” that is “not identical with”

the FDCA’s “requirement[s].” 21 U.S.C. § 379s(a). The

Mississippi Supreme Court could hold otherwise only

by artificially restricting section 379s to notice-andcomment regulations, a limitation with no basis in the

statutory text.

II. The decision below exacerbates a split in the

lower courts about how to interpret express

preemption clauses. Because of that split, different

courts in different regions of the country apply

identical preemption clauses differently, destroying

4

the nationwide uniformity that federal preemption is

intended to foster. Without such uniformity, regulated

businesses will face a crazy-quilt of inconsistent state

legal requirements, multiplying the costs of

compliance and discouraging innovation. Those costs,

in turn, will drive up prices for consumers and hinder

the development of life-saving medications and other

valuable products.

ARGUMENT

I.

The decision below misconstrues basic

principles of federal preemption.

The Mississippi Supreme Court improperly

disregarded this Court’s clear holding that courts

should “not invoke any presumption against

preemption” when interpreting express preemption

provisions. Puerto Rico, 136 S. Ct. at 1946. That

erroneous decision conflicts with the Supremacy

Clause and misinterprets the FDCA’s express

preemption provision.

A. Applying

a

presumption

against

preemption to express preemption

provisions conflicts with the Supremacy

Clause and basic rules of statutory

interpretation.

1. Federal preemption enforces the “familiar and

well-established principle that the Supremacy Clause

invalidates state laws that interfere with, or are

contrary to, federal law.” Hillsborough Cnty. v.

Automated Med. Labs., Inc., 471 U.S. 707, 712 (1985)

(cleaned up). Courts must, therefore, analyze

preemption “in accordance with [the Supremacy

5

Clause’s] terms.” Wyeth, 555 U.S. at 585 (Thomas, J.,

concurring).

As relevant here, those terms grant supreme

status “to ‘the Laws of the United States.’” Merck

Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668,

1679 (2019) (quoting U.S. Const. art. VI, cl. 2). And

more than that, to federal “Laws” that are “made in

Pursuance” of “[t]his Constitution.” U.S. Const. art.

VI, cl. 2. Under the Supremacy Clause, it is “the

statute” that ultimately “strips state law of its force.”

Coventry Health Care of Mo., Inc. v. Nevils, 137 S. Ct.

1190, 1198 (2017).

It follows that when Congress enacts an express

preemption clause, an analysis of whether that clause

preempts state law begins and ends with the statutory

text. Puerto Rico, 136 S. Ct. at 1946. In interpreting

any statute, the goal is “neither liberally to expand nor

strictly to constrict [the statute’s] meaning, but rather

to get the meaning precisely right.” Antonin Scalia,

Assorted Canards of Contemporary Legal Analysis, 40

Case W. Res. L. Rev. 581, 582 (1990); see Encino

Motorcars, LLC v. Navarro, 138 S. Ct. 1134, 1142

(2018) (refusing to interpret statute “narrowly”

without “‘textual indication’” requiring such a

construction). That is no less true for express

preemption clauses.

2. The Mississippi Supreme Court below departed

from these first principles by applying a presumption

against preemption to the FDCA’s express preemption

clause for cosmetics. Pet. App. 11a. That decision

conflicts with the Supremacy Clause by refusing to

extend preemptive effect to “the Laws of the United

States.” U.S. Const. art. VI, cl. 2.

6

The “presumption against pre-emption is rooted

in” an “assum[ption] that Congress does not cavalierly

pre-empt state laws.” Tarrant Reg’l Water Dist. v.

Herrmann, 569 U.S. 614, 631 n.10 (2013) (internal

quotation marks omitted). But an express preemption

clause makes clear that Congress deliberately

intended to preempt state law. Riegel v. Medtronic,

Inc., 552 U.S. 312, 326 (2008). In that case, there is no

justification for assuming that Congress did not mean

exactly what it said. A court may not depart from

“what a pre-emption clause . . . does by its terms” by

“speculat[ing] upon congressional motives.” Id.

Otherwise, state law would be preempted not—as

the Supremacy Clause requires—by the “Laws” duly

enacted by Congress and signed by the President, but

by “extratextual considerations” conjured up by

judges. Wyeth, 555 U.S. at 603 (Thomas, J.,

concurring). Such judicial guesses about unexpressed

congressional

intent

“do

not

satisfy

the

[constitutional] requirements for enactment of federal

law and, therefore, do not pre-empt state law under

the Supremacy Clause.” Id. at 587-88. Instead, the

Supremacy Clause “accords pre-emptive effect to only

those policies that are actually authorized by and

effectuated through the statutory text.” Id. at 602.

And so it is that text that controls, unmodified by any

presumption against preemption. Puerto Rico, 136 S.

Ct. at 1946.

3. The text of the FDCA’s express preemption

clause for cosmetics is straightforward. It provides

that “no 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

7

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).

This “broad preemption provision” displaces “not only

those state laws that are in conflict with it (i.e., any

law that is ‘different from’ the FDCA) but also any

state law that provides for labeling requirements that

are not exactly the same as those set forth in the FDCA

and its regulations (i.e., any law that is ‘in addition to’

the FDCA).” Critcher v. L’Oreal USA, Inc., 959 F.3d

31, 34-36 (2d Cir. 2020).

Whether the FDCA preempts a state law

regulating cosmetics thus depends on whether the

state law imposes “any requirement” that is “not

identical” to a federal “requirement specifically

applicable to a cosmetic or class of cosmetics.” 21

U.S.C. § 379s(a). That is the only analysis supported

by the text.

B. The

Mississippi

Supreme

Court’s

holding that only notice-and-comment

regulations can preempt state law

cannot be squared with the text of the

FDCA’s preemption provision.

Section 379s’s text provides no basis for the

Mississippi Supreme Court’s holding that only noticeand-comment regulations can preempt state law.

Pet. App. 15a-17a.

As explained, section 379s extends preemptive

force to the FDCA’s “requirement[s].” 21 U.S.C.

§ 379s(a). This Court has held that “requirement”

means “a rule of law that must be obeyed.” Bates v.

Dow Agrosciences, LLC, 544 U.S. 431, 445 (2005).

8

Confirming that holding, dictionaries in effect when

the preemption clause was enacted 2 defined

“requirement” as “something that is required.” Am.

Heritage College Dictionary 1160 (3d ed. 1997). 3 And

the ordinary meaning of “require” is “[t]o direct, order,

demand, instruct, command, claim, compel, request,

need, [or] exact” or “to ask for authoritatively or

imperatively.” Black’s Law Dictionary 1304 (6th ed.

1990). 4 So anything the FDCA “direct[s], order[s],

demand[s],

instruct[s],

command[s],

claim[s],

compel[s], request[s], need[s], exact[s],” or “ask[s] for,”

id., is a preemptive “requirement” under section 379s.

Nothing in the statute supports limiting those

“requirements” to notice-and-comment regulations.

Agencies can impose requirements—“rule[s] of law

that must be obeyed,” Bates, 544 U.S. at 445—without

going through notice and comment. To take just one

example, the term “requirement” in the FDCA’s

express preemption clause for medical devices, 21

2 Food and Drug Administration Modernization Act of 1997,

Pub. L. No. 105-115, § 412, 111 Stat. 2296, 2376.

See also Merriam-Webster Dictionary 627 (1997 ed.)

(“something (as a condition or quality) required”); Random House

Webster’s College Dictionary 1104 (2d ed. 1996) (“something

required”).

3

4 See also Am. Heritage College Dictionary 1160 (3d ed. 1997)

(“to call for as obligatory or appropriate; demand”); Random

House Webster’s College Dictionary 1104 (2d ed. 1996) (“to order

or enjoin to do something,” “to ask for authoritatively or

imperatively,” “to make necessary or indispensable,” or “to place

under an obligation”); Webster’s Dictionary of Am. English 628

(1st ed. 1997) (“to order (someone) to do something; demand, esp.

with authority,” “to make necessary,” or “to place (someone)

under an obligation to do something”).

9

U.S.C. § 360k(a), encompasses “premarket approval”

of a medical device, even though the FDA does not

approve

devices

through

notice-and-comment

rulemaking. Riegel, 552 U.S. at 322-23.

The same is true for the term “requirement” in

section 379s. Congress tasked FDA with “ensuring

that . . . cosmetics are safe and properly labeled.” 21

U.S.C. § 393(b)(2)(D). As long as the FDA “act[s]

within the scope of [that] congressionally delegated

authority,” it may enact binding requirements with

preemptive effect whether or not it acts through

“notice-and-comment rulemaking.” Albrecht, 139 S.

Ct. at 1679 (internal quotation marks omitted). The

statutory text, therefore, provides “no sound basis” for

interpreting the term “requirement” narrowly, as the

Mississippi Supreme Court did. See Medtronic, Inc. v.

Lohr, 518 U.S. 470, 512 (1996) (O’Connor, J.,

concurring in part).

C. The

FDCA

expressly

preempts

Mississippi’s lawsuit, which seeks to

impose labeling requirements the FDCA

does not impose.

Read according to its text, section 379s preempts

Mississippi’s lawsuit. Mississippi seeks to impose on

Johnson & Johnson a labeling “requirement” that the

FDA specifically considered and rejected as not

supported by the FDCA in its denial of two citizen

petitions requesting the same requirement. Pet. 3839. Because the FDCA tasks the FDA with

interpreting its labeling provisions and the FDA has

done so, see 21 U.S.C. §§ 371(a), 393(b)(2)(D),

Mississippi seeks a warning label that is “not identical

with” the label required under the FDCA’s prohibition

10

on false or misleading labels. Id. § 379s(a). Its lawsuit

is preempted. Id.; Critcher, 959 F.3d at 35-38.

1. The two citizen petitions relevant to this case

asked the FDA to require an ovarian cancer warning

on the label for cosmetic talc products. Pet. 10-11. The

FDA has authority to enforce the FDCA’s prohibition

on “false or misleading” labels. 21 U.S.C. §§ 362(a),

393(b)(2)(D). It has exercised this authority by

requiring “[t]he label of a cosmetic product [to] bear a

warning

statement

whenever

necessary

or

appropriate to prevent a health hazard that may be

associated with the product.” 21 C.F.R. § 740.1(a).

FDA may thus “prescrib[e] a warning for a cosmetic,”

either on its own or in response to a citizen petition.

Id. § 740.1(b). In exercising its authority to do so, or to

decline to do so, the FDA is of course imposing an

additional “requirement specifically applicable to a

particular cosmetic or class of cosmetics under this

chapter.” 21 U.S.C. § 379s(a).

The FDA exercised its authority to interpret the

FDCA when it reviewed the citizen petitions here. By

denying those petitions, the FDA necessarily

concluded that a cancer warning was not “necessary or

appropriate” for talc products, 21 C.F.R. § 740.1(a),

and thus that a label omitting such a warning would

not be “false or misleading” under the FDCA, 21

U.S.C. § 362(a); see App’x 92 (“[T]he evidence is

insufficient for FDA to require as definitive a warning

as you are seeking.”). The warning that Mississippi

seeks is therefore “in addition to” and “not identical

with” the FDCA’s labeling requirements. 21 U.S.C.

§ 379s(a); Critcher, 959 F.3d at 38.

11

2. Indeed, Mississippi’s lawsuit also contradicts

the FDA’s regulation addressing when a cosmetic

manufacturer must provide a warning about “[a]n

ingredient or product having a history of use in or as

a cosmetic [that] ha[s] its safety brought into question

by new information.” 21 C.F.R. § 740.10(b). That

regulation requires no warning “for such an ingredient

or product” when “(1) [t]he safety of the ingredient or

product had been adequately substantiated prior to

development of the new information; (2) [t]he new

information does not demonstrate a hazard to human

health; and (3) [a]dequate studies are being conducted

to determine expeditiously the safety of the ingredient

or product.” Id.

The FDA’s denial of the citizen petitions shows

that talc qualifies for this exemption. First, talc had

been used as a cosmetic ingredient for decades before

the first citizen petition, and the FDA found it

sufficiently safe not to require a warning. App’x 89-92;

see 21 C.F.R. § 740.10(b)(1). Second, the FDA found

that “the new information” submitted in the citizen

petitions did “not demonstrate a hazard to human

health.” 21 C.F.R. § 740.10(b)(2); see App’x 89-92.

Third, the FDA “conducted” its own “exploratory

survey” of talc and reviewed studies conducted after

the citizen petitions, none of which established that

talc was unsafe. App’x 90, 93; see 21 C.F.R.

§ 740.10(b)(3).

3. The FDA’s denial of the citizen petitions in light

of these requirements thus plainly satisfies the

express preemption clause. Pet. 38-39. As the petition

explains, far from constituting mere “inaction,”

Pet. App. 15a, the denial of a citizen petition is the

12

product of a considered administrative process that is

final, appealable, and judicially reviewable. 21 C.F.R.

§ 10.45(d); see, e.g., Nat. Res. Def. Council, Inc. v. FDA,

760 F.3d 151, 172-76 (2d Cir. 2014) (reviewing FDA

denial of citizen petitions). Here, the FDA thoroughly

considered the petitions, analyzed decades of scientific

evidence, and concluded that no warning was

required. App’x 89-93. That is a final judgment, within

the FDA’s congressionally delegated authority, as to

what the FDCA does and does not require. Section

379s bars Mississippi’s attempt to displace this

judgment and to impose a labeling requirement that

the FDCA does not impose. See Critcher, 959 F.3d at

38 (holding states may not impose “labeling

requirements that have not been imposed by Congress

or the FDA” because “impos[ing] such additional

labeling requirements” would “impose many

‘requirements’ that are not contained in the federal

statute, or the regulations issued thereunder”).

That the FDA can—but need not—deny a citizen

petition through notice and comment is of no moment.

See 21 C.F.R. § 10.30(e)(3), (h). Whatever procedure

the FDA uses, the legal force of its denial is identical:

it conclusively determines that the FDCA does not

require the requested warning. The FDA’s

discretionary choice of procedure has no bearing on

whether its final, binding decision qualifies as a

“requirement” under section 379s.

Mississippi’s attempt to impose a warning not

required by the FDCA and its implementing

regulations is expressly preempted.

13

II. The Court should grant certiorari to provide

clarity and national uniformity in federal

preemption.

As the petition explains, the Mississippi Supreme

Court’s decision exacerbates an entrenched split about

the scope of express preemption clauses. Pet. 14-19.

The Court frequently grants certiorari to correct

similar mistaken preemption rulings. E.g., Gobeille v.

Liberty Mut. Ins. Co., 577 U.S. 312, 319 (2016); Int’l

Paper Co. v. Ouellette, 479 U.S. 481, 487 (1987). It

should do so again here to restore clarity and

uniformity to federal preemption law.

A. Amici’s members include thousands of

businesses subject to federal regulatory schemes like

the FDCA, as well as those businesses’ insurers. These

comprehensive regimes advance public ends (such as

the safety of drugs, medical devices, and cosmetics),

while also ensuring a nationwide marketplace for

valuable—even life-saving—goods and services.

Compliance with these regulatory regimes

imposes significant costs on businesses. E.g., U.S.

Chamber of Commerce Found., The Regulatory

Impact on Small Business: Complex. Cumberson.

Costly. 18 (2017), https://perma.cc/G6SX-VTEC. Those

costs would be multiplied fifty-fold if states could

impose different requirements on the same conduct.

Such duplicative compliance costs stifle innovation,

drive up prices for consumers, and constrain the jobcreating powers of American businesses. Federal

preemption reduces these harms by ensuring that the

same federal regulatory standards apply uniformly

nationwide. See, e.g., Bates, 544 U.S. at 452 (FIFRA

expressly “pre-empts competing state labeling

14

standards—imagine 50 different labeling regimes

prescribing the color, font size, and wording of

warnings—that would create significant inefficiencies

for manufacturers”); Fort Halifax Packing Co. v.

Coyne, 482 U.S. 1, 11 (1987) (“ERISA’s pre-emption

provision was prompted by recognition that . . . [a]

patchwork scheme of regulation would introduce

considerable inefficiencies in benefit program

operation.”).

The FDCA’s express preemption provisions serve

the same need for clear, uniform national standards.

The provision for medical devices, 21 U.S.C. § 360k(a),

protects the “regime of detailed federal oversight” over

devices. Riegel, 552 U.S. at 316. The provision for overthe-counter drugs ensures “[n]ational uniformity for

nonprescription drugs.” 21 U.S.C. § 379r. And section

379s ensures that “national uniformity [in] the

manufacture and sale of cosmetics” is not “obstructed

by state law.” Critcher, 959 F.3d at 35.

B. For these reasons, federal preemption rules

must be uniform nationwide. Regulators and

regulated parties alike need federal standards to be

clear and uniform. “Regulators want their regulations

to be effective, and clarity promotes compliance.” Kisor

v. Wilkie, 139 S. Ct. 2400, 2421 (2019) (plurality op.)

(cleaned up). And regulated parties need to “know

what they can and cannot do.” Id. But if some courts

give less preemptive force to federal law than others,

then businesses will be subject to an inconsistent

patchwork of state and federal regulations, making

compliance unreasonably difficult and undermining

the effectiveness of federal regulatory schemes. See

Nw. Airlines, Inc. v. Duncan, 121 S. Ct. 650, 651 (2000)

15

(O’Connor, J., dissenting) (“divergent pre-emption

rules formulated by the Courts of Appeals” expose

business “to inconsistent state regulations”).

The consequences can be severe. Conflicting

interpretations of FDCA preemption could permit

each state to impose its own labeling requirements for

food, drugs, and cosmetics, “driving consumers . . .

crazy.” Turek v. Gen. Mills, Inc., 662 F.3d 423, 426 (7th

Cir. 2011). The FDA itself has explained that excessive

warning requirements do more harm than good, since

overwhelming consumers with warnings “can render

the warnings useless and discourage [the] use of

beneficial medications.” Cerveny v. Aventis, Inc., 855

F.3d 1091, 1102 (10th Cir. 2017) (citing FDA

guidance).

Worse still, the burden of complying with

inconsistent state and federal requirements can

prevent valuable products from being created in the

first place. That is why, this Court explained, the

FDCA preempts state regulation of medical devices:

many people would “suffer without new medical

devices if juries were allowed to apply the tort law of

50 States to all innovations.” Riegel, 552 U.S. at 326.

Similarly, the National Childhood Vaccine Injury Act

(NCVIA) preempts most products-liability suits

against vaccine manufacturers, 42 U.S.C. § 300aa22(b)(1), in order to “stabilize the vaccine market,”

Bruesewitz v. Wyeth, LLC, 562 U.S. 223, 228 (2011).

This Court thus rejected a narrow interpretation of

the NCVIA’s preemption clause, which would have

increased manufacturers’ tort liability, “lead[ing] to

. . . withdrawals of vaccines or vaccine manufacturers

from the market” and “halt[ing] the future production

16

and development of childhood vaccines in this

country.” Id. at 248-49 (Breyer, J., concurring)

(cleaned up).

3. The Mississippi Supreme Court’s holding that,

due to the presumption against preemption, the term

“requirement” in express preemption clauses applies

only to notice-and-comment regulations would have

wide-ranging consequences. Take, for example, the

FDCA’s preemption provision for medical devices,

which (as explained above) also uses the word

“requirement.” Supra at 8-9. This Court in Riegel held

that language covered premarket approval of a device.

552 U.S. at 322-23. But the Mississippi Supreme

Court’s rule would require the opposite outcome, since

the FDA does not grant premarket approval through

notice-and-comment rulemaking.

The Federal Meat Inspection Act likewise

preempts certain state “requirements in addition to,

or different than, those made under” federal law.

21 U.S.C. § 678. The Secretary of Agriculture can

impose such requirements without going through

notice and comment, and those requirements preempt

state law under any reasonable reading of the

preemption clause. E.g., Grocery Mfrs. of Am., Inc. v.

Gerace, 755 F.2d 993, 1001-03 (2d Cir. 1985). The

Mississippi Supreme Court would deprive all those

requirements of preemptive force.

One final, timely example: the Public Readiness

and Emergency Preparedness (PREP) Act immunizes

individuals and entities from state liability for taking

certain “countermeasures” against a pandemic when

the Secretary of Health and Human Services “makes

a determination that a disease or other health

17

condition or other threat to health constitutes a public

emergency.” 42 U.S.C. § 247d-6d(a)(1), (b)(1). “During

the effective period of [that] declaration,” the PREP

Act preempts most state laws that differ from “any

requirement applicable under” the PREP Act. Id.

§ 247d-6d(b)(8). But HHS issues emergency

declarations under the PREP Act without going

through notice and comment, so they could not qualify

as “requirements” under the Mississippi Supreme

Court’s decision. With the country still in the throes of

a deadly pandemic—one that has prompted a PREP

Act declaration and multiple amendments 5—the

danger of countervailing guidance from individual

states should be apparent.

5 See 85 Fed. Reg. 15,198 (Mar. 17, 2020); 85 Fed. Reg. 21,012

(Apr. 15, 2020); 85 Fed. Reg. 35,100 (June 8, 2020); 85 Fed. Reg.

52,136 (Aug. 24, 2020); 85 Fed. Reg. 79,190 (Dec. 9, 2020); 86 Fed.

Reg. 7872 (Feb. 2, 2021); 86 Fed. Reg. 9516 (Feb. 16, 2021);

86 Fed. Reg. 14,462 (Mar. 16, 2021); 86 Fed. Reg. 41,997 (Aug. 4,

2021); 86 Fed. Reg. 51,160 (Sept. 14, 2021).

18

CONCLUSION

The Court should grant the petition for certiorari.

Respectfully submitted,

Andrew R. Varcoe

Jennifer B. Dickey

U.S. CHAMBER

LITIGATION CENTER

1615 H Street NW

Washington, DC 20062

(202) 463-5337

Counsel for the Chamber

of Commerce of the

United States of America

Kenneth Stoller

AMERICAN PROPERTY

CASUALTY INSURANCE

ASSOCIATION

555 12th Street NW

Suite 550

Washington, DC 20004

Counsel for American

Property Casualty

Insurance Association

October 4, 2021

Ethan P. Davis

Counsel of Record

Matthew V.H. Noller

KING & SPALDING LLP

50 California Street

Suite 3300

San Francisco, CA 94111

(415) 318-1200

edavis@kslaw.com

Counsel for Amici Curiae

Mark Behrens

SHOOK, HARDY

& BACON L.L.P.

1800 K Street NW

Suite 1000

Washington, DC 20006

Counsel for Coalition for

Litigation Justice, Inc.