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

No. 21-348

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In The

Supreme Court of the United States

---------------------------------♦--------------------------------JOHNSON & JOHNSON AND JOHNSON &

JOHNSON CONSUMER COMPANIES, INC.,

Petitioners,

v.

MISSISSIPPI, ex rel. LYNN FITCH,

Attorney General of Mississippi,

Respondent.

---------------------------------♦--------------------------------On Petition For A Writ Of Certiorari

To The Supreme Court of Mississippi

---------------------------------♦--------------------------------BRIEF OF AMICUS CURIAE PRODUCT LIABILITY

ADVISORY COUNCIL, INC. IN SUPPORT OF

PETITION FOR WRIT OF CERTIORARI

---------------------------------♦--------------------------------JAMES M. BECK

Counsel of Record

REED SMITH LLP

1717 Arch Street

Suite 3100

Philadelphia, PA 19103

(215) 851-8168

jmbeck@reedsmith.com

Counsel for Amicus Curiae

Product Liability Advisory Council, Inc.

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COCKLE LEGAL BRIEFS (800) 225-6964

WWW.COCKLELEGALBRIEFS.COM

i

TABLE OF CONTENTS

Page

TABLE OF AUTHORITIES .................................

ii

INTEREST OF AMICUS CURIAE ......................

1

INTRODUCTORY STATEMENT AND SUMMARY

OF ARGUMENT ...............................................

3

1.

The Decision Below ...................................

3

2.

State-Law Demands For Scientifically Unsupported Warnings Creates Overwarning

And Reduces The Effectiveness Of FDARequired Warnings ....................................

4

The Presumption Against Preemption Applied Here Directly Flouts The Court’s

Contrary Precedents ..................................

6

Limiting Preemption To Notice-And-Comment Rulemaking Would Eliminate Most

Existing Grounds For Preemption And

Disrupt Federal Decisions .........................

7

REASONS FOR GRANTING CERTIORARI.......

8

3.

4.

I.

Allowing States To Require Warnings FDA

Finds Scientifically Unsupported Would

Lead To Overwarning And Reduce The Effectiveness Of All Product Warnings .........

8

II.

Presumptions Against Preemption In FDCA

Express Preemption Cases Conflict With

This Court’s Preemption Precedent .......... 21

III

Presumptions Against Preemption Create

Unavoidable Conflicts With Agency Decisions Having Force Of Law ........................ 24

CONCLUSION..................................................... 28

ii

TABLE OF AUTHORITIES

Page

CASES

Aetna Casualty & Surety Co. v.

Ralph Wilson Plastics Co.,

509 N.W.2d 520 (Mich. App. 1993) ..........................11

Air & Liquid Sys. Corp. v. DeVries,

139 S.Ct. 986 (2019) ..................................................9

Am. Home Prods. Corp. v. Ferrari,

562 U.S. 1254 (2011)................................................23

Am. Home Prods. Corp. v. Ferrari,

710 S.E.2d 771 (Ga. 2011) .......................................23

Ames v. Apothecon Inc.,

431 F. Supp.2d 566 (D. Md. 2006) ...........................14

Bates v. Dow Agrosciences LLC,

544 U.S. 431 (2005) ........................................... 21, 26

Bostock v. Clayton Cty., Georgia,

140 S.Ct. 1731 (2020) .................................... 6, 21, 22

Brooks v. Howmedica, Inc.,

273 F.3d 785 (8th Cir. 2001) ....................................12

Broussard v. Continental Oil Co.,

433 So.2d 354 (La. App. 1983) ................................11

Bruesewitz v. Wyeth LLC,

562 U.S. 223 (2011) ............................. 2, 6, 22, 23, 26

Buckman Co. v. Plaintiffs Legal Committee,

531 U.S. 341 (2001) .................................................25

Cerveny v. Aventis, Inc.,

855 F.3d 1091 (10th Cir. 2017) ................................12

iii

TABLE OF AUTHORITIES – Continued

Page

Cipollone v. Liggett Group, Inc.,

505 U.S. 504 (1992) ...................................................9

Cohen v. Apple Inc.,

497 F. Supp.3d 769 (N.D. Cal. 2020) .......................14

Cotton v. Buckeye Gas Products Co.,

840 F.2d 935 (D.C. Cir. 1988) ..................................13

CTIA – The Wireless Ass’n v. City of Berkeley,

487 F. Supp.3d 821 (N.D. Cal. 2020) ................. 13, 14

Doe v. Miles Laboratories, Inc.,

927 F.2d 187 (4th Cir. 1991) ....................................12

Dowhal v. SmithKline Beecham

Consumer Healthcare,

88 P.3d 1 (Cal. 2004) ...............................................10

Dunn v. Lederle Laboratories,

328 N.W.2d 576 (Mich. App. 1983) ..........................20

Ferrari v. Am. Home Prods. Corp.,

668 S.E.2d 236 (Ga. 2008), vacated,

710 S.E.2d 771 (Ga. 2011) .......................................23

Finn v. G.D. Searle & Co.,

677 P.2d 1147 (Cal. 1984)........................................11

Ford Motor Credit Co. v. Milhollin,

444 U.S. 555 (1980) ...................................................9

Gen. Motors Corp. v. Saenz,

873 S.W.2d 353 (Tex. 1993) .....................................11

Gibbons v. Bristol-Myers Squibb Co.,

919 F.3d 699 (2d Cir. 2019) .....................................14

iv

TABLE OF AUTHORITIES – Continued

Page

Greager v. McNeil-PPC, Inc.,

414 F. Supp.3d 1137 (N.D. Ill. 2019) .......................14

Heckman v. Ryder Truck Rental, Inc.,

962 F. Supp.2d 792 (D. Md. 2013) ...........................14

Hillsborough Cty., Fla. v.

Automated Med. Lab’ys, Inc.,

471 U.S. 707 (1985) .................................................25

Hood v. Ryobi America Corp.,

181 F.3d 608 (4th Cir. 1999) ....................................12

In re Incretin-Based Therapies Prod. Liab. Litig.,

___ F. Supp.3d ___, 2021 WL 880316 (S.D.

Cal. March 9, 2021) .................................................14

Johnson v. American Standard, Inc.,

179 P.3d 905 (Cal. 2008)..........................................10

Liriano v. Hobart Corp.,

700 N.E.2d 303 (N.Y. 1998) .....................................10

McGrath v. Bayer HealthCare

Pharmaceuticals, Inc.,

393 F. Supp.3d 161 (E.D.N.Y. 2019) ........................14

Medtronic, Inc. v. Lohr,

518 U.S. 470 (1996) .................................................25

Merck KGaA v. Integra Lifesciences I, Ltd.,

545 U.S. 193 (2005) ...................................................8

Merck Sharp & Dohme Corp. v. Albrecht,

139 S.Ct. 1668 (2019) .......................... 3, 9, 14, 15, 26

Mut. Pharm. Co. v. Bartlett,

570 U.S. 472 (2013) .................................................26

v

TABLE OF AUTHORITIES – Continued

Page

PLIVA, Inc. v. Mensing,

564 U.S. 604 (2011) ........................................... 25, 26

Puerto Rico v. Franklin

California Tax-Free Trust,

136 S.Ct. 1938 (2016) .................................... 6, 21, 23

Ramirez v. Plough, Inc.,

863 P.2d 167 (Cal. 1993)..........................................11

Ridings v. Maurice,

444 F. Supp.3d 973 (W.D. Mo. 2020) .......................14

Riegel v. Medtronic, Inc.,

552 U.S. 312 (2008) ........................... 2, 22, 23, 24, 25

Robinson v. McNeil Consumer Healthcare,

615 F.3d 861 (7th Cir. 2010) .............................. 12, 14

Sabol v. Bayer Healthcare Pharmaceuticals, Inc.,

439 F. Supp.3d 131 (S.D.N.Y. 2020) ........................14

Seufert v. Merck Sharp & Dohme Corp.,

187 F. Supp.3d 1163 (S.D. Cal. 2016) .....................14

Sykes v. Glaxo-SmithKline,

484 F. Supp.2d 289 (E.D. Pa. 2007) ........................14

Thomas v. Hoffman-LaRoche, Inc.,

949 F.2d 806 (5th Cir. 1992) .............................. 11, 12

United States v. Article of

Drug . . . Bacto-Unidisk,

394 U.S. 784 (1969) ...................................................9

Utts v. Bristol-Myers Squibb Co.,

251 F. Supp.3d 644 (S.D.N.Y. 2017),

aff ’d, 919 F.3d 699 (2d Cir. 2019)............................14

vi

TABLE OF AUTHORITIES – Continued

Page

Wyeth v. Levine,

555 U.S. 555 (2009) .................................................25

In re Zofran (Ondansetron) Prod. Liab. Litig.,

___ F. Supp.3d ___, 2021 WL 2209871

(D. Mass. June 1, 2021) ...........................................14

STATUTES & RULES

Ala. Code §22-11B-5(c) ...............................................20

S.Ct. Rule 37.2 ..............................................................1

S.Ct. Rule 37.6 ..............................................................1

21 U.S.C. §10.45(d) ........................................................3

21 U.S.C. §§301, et seq. .................................................2

21 U.S.C. §360k(a)(1) ..................................................22

21 U.S.C. §379s .............................................................5

21 U.S.C. §379s(b,d-e) ...................................................5

42 U.S.C. §§247d-6d, et seq. ..........................................8

42 U.S.C. §247d-6d ........................................................8

42 U.S.C. §247d-6d(a)(1) .............................................27

42 U.S.C. §247d-6d(b) ...................................................8

42 U.S.C. §247d-6d(b)(1-6) ..........................................27

42 U.S.C. §247d-6d(b)(8)(A) ........................................27

42 U.S.C. §247d-6d(b)(8)(A-B) ....................................27

42 U.S.C. §300aa-22(b)(1) ...........................................23

vii

TABLE OF AUTHORITIES – Continued

Page

REGULATIONS

21 C.F.R. §70.25 ..........................................................25

21 C.F.R. §73.1550(d) ..................................................24

21 C.F.R. §801.430(c-e) ...............................................24

40 Fed. Reg. 28582 (FDA July 7, 1975) ......................15

43 Fed. Reg. 1101 (FDA Jan. 6, 1978) ........................15

44 Fed. Reg. 37434 (FDA June 26, 1979) ...................15

45 Fed. Reg. 69840 (FDA Oct. 21, 1980).....................24

47 Fed. Reg. 26982 (FDA June 22, 1982) ...................24

53 Fed. Reg. 30522 (FDA Aug. 12, 1988) ....................15

71 Fed. Reg. 3922 (FDA Jan. 24, 2006) ......................15

73 Fed. Reg. 2848 (FDA Jan. 16, 2008) ........................9

73 Fed. Reg. 49603 (FDA Aug. 22, 2008) ......................9

85 Fed. Reg. 15198 (HHS March 17, 2020) ................27

85 Fed. Reg. 21012 (HHS April 15, 2020) ..................27

85 Fed. Reg. 35100 (HHS June 5, 2020) .....................27

85 Fed. Reg. 52136 (HHS Aug. 24, 2020) ...................27

85 Fed. Reg. 79190 (HHS Dec. 9, 2020) ......................27

86 Fed. Reg. 7872 (HHS Feb. 2, 2021) ........................27

86 Fed. Reg. 9516 (HHS Feb. 16, 2021) ......................27

86 Fed. Reg. 14462 (HHS March 16, 2021) ................27

86 Fed. Reg. 41977 (HHS Aug. 4, 2021) .....................27

86 Fed. Reg. 51160 (HHS Sept. 14, 2021) ..................27

viii

TABLE OF AUTHORITIES – Continued

Page

OTHER AUTHORITIES

Andrew Andrzejewski, Direct-to-Consumer Calls

to Action: Lowering the Volume of Claims

& Disclosures in Prescription Drug Broadcast Advertisements, 84 BROOK. L. REV. 571

(2019) .......................................................................19

Jenny Ange, Am I My Competitor’s Keeper? Innovator Liability in the Fifty States, 21

COLUM. SCI. & TECH. L. REV. 1 (2019) .............. 18, 19

Richard M. Cooper, Drug Labeling & Products

Liability: The Role of the Food & Drug Administration, 41 FOOD & DRUG L.J. 233 (1986) ............19

Jon Duke, et al., A Quantitative Analysis of Adverse Events and ‘Overwarning’ in Drug Labeling, 171 ARCH. OF INT. MED. 944 (2011) .............19

Fact Sheet: FDA at a Glance ......................................25

FDA, CDER, “Brief Summary & Adequate Directions for Use: Disclosing Risk Information

in Consumer-Directed Print Advertisements

& Promotional Labeling for Prescription

Drugs,” (Aug. 2015) .................................................16

FDA, CDRH, Guidance on Medical Device Patient Labeling: Final Guidance for Industry

and FDA Reviewers (2001) .....................................16

Elizabeth Grotewohl, Chapter 830: Cleaning

Products Are Coming Clean, 49 U. PAC. L. REV.

333 (2018) ................................................................18

ix

TABLE OF AUTHORITIES – Continued

Page

James A. Henderson, Jr., & Aaron D. Twerski,

Doctrinal Collapse in Products Liability: The

Empty Shell of Failure to Warn, 65 N.Y.U.L.

REV. 265 (1990)........................................................17

James A. Henderson, Jr. & Aaron D. Twerski,

“The Products Liability Restatement in the

Courts: An Initial Assessment,” 27 WM. MITCHELL L. REV. 7 (2000) .................................................17

W. Page Keeton, et al., Prosser & Keeton on the

Law of Torts §96 (5th ed. 1984) ..............................16

Robert G. Knaier, An Informed-Choice Duty to

Instruct? 88 CORNELL L. REV. 814 (2003) ...............18

Meghan Mangrum, “As Tennessee Halts Vaccine

Outreach to Kids, Nashville Youth Still Get

COVID-19 Shots,” Nashville Tennessean (July

16, 2021) ..................................................................20

Lars Noah, The Imperative to Warn: Disentangling the ‘Right to Know’ from the ‘Need to

Know’ About Consumer Product Hazards, 11

YALE J. REG. 293 (1994)...........................................19

Joshua E. Perry, et. al., Trust in the Balance: Prescription Drug Risks, Patient Perspectives, &

Legal (Re)considerations, 24 J. HEALTH CARE

L. & POL’Y 27 (2021) ................................................19

Restatement (Third) of Torts, Products Liability

§2, comment j (1998) ......................................... 16, 17

Douglas G. Smith, A Shift in the Preemption

Landscape?, 87 TENN. L. REV. 213 (2019) ..............19

x

TABLE OF AUTHORITIES – Continued

Page

Jeff Todd, A Rhetoric of Warning Defects, 54 S.

TEX. L. REV. 343 (2012) ...........................................18

Aaron D. Twerski, et al., The Use & Abuse of

Warnings in Products Liability – Design Defect Litigation Comes of Age, 61 CORNELL L.

REV. 495 (1976)........................................................17

W. Bradley Wendel, Technological Solutions to

Human Error and How They Can Kill You:

Understanding the Boeing 737 Max Products

Liability Litigation, 84 J. AIR L. & COM. 379

(2019) .......................................................................18

1

BRIEF OF THE PRODUCT LIABILITY

ADVISORY COUNCIL, INC. AS

AMICUS CURIAE IN SUPPORT OF

PETITION FOR WRIT OF CERTIORARI

INTEREST OF AMICUS CURIAE1

The Product Liability Advisory Council, Inc.

(“PLAC”) is a nonprofit professional association with

scores of corporate members from a broad cross-section

of American and international product manufacturing.2 These companies seek to contribute to legal

improvement and reform in the United States and

elsewhere, emphasizing law governing liability of

product manufacturers and others in the supply chain.

PLAC’s perspective is derived from the experiences of

a corporate membership spanning a diverse group of

industries in various facets of the manufacturing sector. In addition, several hundred leading product liability defense attorneys are sustaining (non-voting)

members of PLAC.

PLAC’s primary purpose is to file amicus curiae

briefs in cases affecting the development of product related litigation that impact PLAC’s members. Since

1

The parties submitted blanket amicus curiae consent letters, and timely notice has been provided, pursuant to S.Ct. Rule

37.2. Pursuant to S.Ct. Rule 37.6, amicus states that no counsel

for a party wrote this brief in whole or in part, and no counsel or

party made a monetary contribution intended to fund the preparation or submission of this brief. No person or entity, other than

the amicus curiae, its members, or its counsel, has made a monetary contribution to this brief ’s preparation or submission.

2

PLAC’s current corporate membership is listed at https://

plac.com/PLAC/Membership/Corporate_Membership.aspx.

2

1983, PLAC has filed more than 1,200 briefs as amicus

curiae in both state and federal courts, including this

Court, presenting the broad perspective of its members, and product suppliers generally, and seeking fairness and balance in the application and development

of the law as it affects product risk management.

PLAC’s interest in this matter is the profound impact on federally regulated businesses of state-law

claims seeking to impose conflicting obligations. Many

PLAC members, especially FDA-regulated entities, are

subject to federal restrictions governing what they can,

and cannot, state in product labeling. To avoid being

sitting ducks in litigation, regulated businesses depend on federal supremacy to preclude state-law liability where they comply with federal requirements.

Here, FDA denied, as scientifically unfounded, two

citizen petitions that sought precisely the same labeled warning that the State of Mississippi now demands. The federal Food, Drug and Cosmetic Act

(“FDCA”), 52 Stat. 1040, as amended, 21 U.S.C. §§301,

et seq., expressly preempts state cosmetic labeling “requirements” (with inapplicable exceptions) that are

“different from,” “in addition to,” or “otherwise not

identical with” “requirements” created through FDA’s

expert determinations. Thus, this matter presents

express preemption questions under cases such as

Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011) (vaccines), and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)

(medical devices).

PLAC’s federally-regulated members cannot serve

two masters imposing conflicting obligations. If forced

3

by massive state-law liability to ignore FDA labeling

decisions, their products will eventually resemble unregulated consumer products – festooned with multiple warning about questionable risks that consumers

tend to ignore. In Merck Sharp & Dohme Corp. v. Albrecht, 139 S.Ct. 1668 (2019) (“Albrecht”), the Court

recognized that, to enforce the FDCA, FDA has repeatedly sought to prevent overwarning in labels of products it regulates.

---------------------------------♦---------------------------------

INTRODUCTORY STATEMENT

AND SUMMARY OF ARGUMENT

As the Petition argues, this appeal presents critical preemption issues. Indisputably: (1) the relief

sought by the State of Mississippi directly contradicts

FDA’s scientific determination that cosmetic talc labels

should not warn about ovarian cancer; and (2) FDA

considered and rejected the very risk warning the

State demands. FDA did so by denying two citizen petitions after “careful review.” Pet. App. at 4a. Although

that decision was final and appealable, 21 U.S.C

§10.45(d), nobody appealed. Rather, within months, the

Mississippi Attorney General commenced the current

collateral attack on FDA’s decision.

1. The Decision Below.

As discussed more fully in the Petition, plaintiff/

respondent, Attorney General of the State of Mississippi, brought this state-law consumer protection

4

action against defendants/petitioners (collectively

“J&J”) in 2014. The State contends that J&J’s talc-containing cosmetics not warning about a claimed risk of

ovarian cancer violated Mississippi’s statute and exposed J&J to liability – $10,000 for each unit sold in

Mississippi since 1974. Pet. App. 3a-4a.

J&J raised federal preemption, arguing that Mississippi’s suit differed from FDA’s scientific-basis requirement, as applied to talc labeling by denial of two

citizen petitions involving the same risk. The State admittedly demanded the same warning that FDA had

rejected. Pet. App. 13a-15a. Nevertheless, the Mississippi Supreme Court found no preemption, following a

presumption against federal preemption – “a duty to

accept the reading that disfavors pre-emption” in cases

implicating “the historic police powers of the States.”

Pet. App. 11a, 16a-17a.

Under this presumption, the court narrowly interpreted an FDA “requirement” to exclude agency actions this Court has found preemptive. “[T]o be binding

on the public, the [FDA] must follow the notice and

comment rule making process.” Pet. App. 15a.

2. State-Law Demands For Scientifically Unsupported Warnings Creates Overwarning

And Reduces The Effectiveness Of FDA-Required Warnings.

The FDCA expressly preempts state cosmetic

“requirements” that fail to meet the degree of scientific support mandated by FDA. “[N]o state . . . may

5

establish . . . 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[n FDA] requirement specifically applicable to [that] cosmetic under this chapter.” 21 U.S.C. §379s.3

In addition to the deep and profound differences of

opinion, thoroughly discussed in the Petition, between

federal appellate courts and state high courts on the

two key preemption-related issues, the Mississippi

court ruling is inimical to long-held FDA labeling policy. For over forty years, the Agency has developed and

enforced requirements that all warnings for regulated

products have specified levels of scientific support.

FDA’s scientific requirements have been developed,

inter alia, to prevent excessive and unsupported

warnings from drowning out more important label information and from diluting the impact of warnings

generally. This Court has joined the vast majority of

lower courts, as well as commentators and the American Law Institute, to recognize the validity of FDA’s

concerns.

The Mississippi court’s refusal to give preemptive

effect to a recent FDA labeling decision that the warning in question was, and is, scientifically unsupported

strikes at the heart of this longstanding basis for FDA

decisionmaking. Even more than private litigation, untrammeled state enforcement of disparate and less

3

The three exceptions in §379s(b,d-e), an FDA-approved

state exemption, product liability litigation, and certain state initiatives, are inapplicable.

6

rigorous warning requirements – backed by potentially

astronomical liability – is especially likely to cause regulated product manufacturers to engage in precisely

the sort litigation-averse overwarning that FDA has

spent decades trying to prevent.

3. The Presumption Against Preemption Applied Here Directly Flouts The Court’s Contrary Precedents.

The Mississippi court negated Congress’ express

preemption clause, and disregarded this Court’s precedents, first by applying a presumption against preemption, Pet. App. 15a (invoking “a duty to accept the

reading that disfavors preemption”).

In Puerto Rico v. Franklin California Tax-Free

Trust, 136 S.Ct. 1938 (2016), the Court explicitly repudiated such presumptions in cases involving express

preemption clauses, as such presumptions fail to accord due respect to statutory language. Congress’

words control over extratextual considerations, such as

whether the subject is of “historic” state concern. Pet.

App. 11a. “Only the written word is the law.” Bostock v.

Clayton Cty., Georgia, 140 S.Ct. 1731, 1737 (2020).

Indeed, even before Puerto Rico v. Franklin’s explicit rejection, the Court twice declined to apply such

presumptions in prescription medical product express

preemption cases, despite dissents urging that it do so.

For example in Bruesewitz v. Wyeth, the Court’s evenhanded construction of an express preemption clause

required finding that the National Childhood Vaccine

7

Injury Act of 1986 preempted design defect claims. But

in an almost identical case, a state high court applying

a legally improper presumption reached a directly contrary result.

4. Limiting Preemption To Notice-And-Comment Rulemaking Would Eliminate Most Existing Grounds For Preemption And Disrupt

Federal Decisions.

Second, the Mississippi court held it could disregard FDA’s decision altogether, since denial of citizen

petitions seeking identical relief did not involve “notice-and-comment rule making.” Pet. App. 15a. That restrictive rationale would eliminate preemption for

most of what FDA does, including actions that the

Court held supported preemption in previous FDA-related cases. Notice-and-comment rulemaking has not

been the exclusive basis for preemption. Other recognized grounds include formally rejecting a warning label, and any agency action carrying the force of law.

The Court has consistently recognized FDA requirements as supporting both express and implied

preemption. For decades, FDA has regulated product

warnings as it did here, through product-specific labeling decisions, including adjudication of citizen petitions. FDA has not approved a product-specific label

through notice-and-comment rulemaking in decades.

The ruling below is incompatible with virtually all of

the Court’s recent FDCA preemption precedent.

8

The ramifications extend well beyond the FDCA.

The Public Readiness & Emergency Preparedness Act,

119 Stat. 2818, 42 U.S.C. §§247d-6d, et. seq. (“PREP

Act”), provides immunity from suit, enforced by federal preemption, for persons responding to public

health emergencies such as the COVID-19 pandemic.

Id. §247d-6d. This immunity is not created through notice-and-comment rulemaking, but rather by formal

administrative “declarations” that are published in the

Federal Register. Id. §247d-6d(b). Making notice-andcomment rulemaking a prerequisite to express federal

preemption would expose everyone responding to the

current pandemic to state-law litigation and liability.

---------------------------------♦---------------------------------

REASONS FOR GRANTING CERTIORARI

I.

Allowing States To Require Warnings FDA

Finds Scientifically Unsupported Would

Lead To Overwarning And Reduce The Effectiveness Of All Product Warnings.

A primary function of FDA, and other federal

agencies regulating products, is to evaluate the risks

and benefits of those products and to ensure that their

labeling accurately warns of product dangers. See

Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S.

193, 196 (2005). Where, as here, the agency formally

acted, “[i]t is enough for us that the expert agency

charged with the enforcement of remedial legislation

has determined [what] is desirable for the public

health, for we are hardly qualified to second-guess

9

[FDA].” United States v. Article of Drug . . . BactoUnidisk, 394 U.S. 784, 791-92 (1969).

FDA’s “label information is designed to ‘prevent

overwarning’ so that less important information does

not ‘overshadow’ more important information.” Albrecht,

139 S.Ct. at 1672 (2019). Therefore, FDA labeling requirements are “designed to exclude ‘[e]xaggeration of

risk, or inclusion of speculative or hypothetical risks,’

that ‘could discourage appropriate [product] use.’ ” Id.4

More generally, a product label’s “[m]eaningful

disclosure does not mean more disclosure. Rather, it describes a balance between competing considerations of

complete disclosure and the need to avoid informational overload.” Ford Motor Credit Co. v. Milhollin,

444 U.S. 555, 568 (1980) (citation and quotation marks

omitted) (emphasis original). Likewise, the Court rejected an overbroad foreseeability-based approach to

asbestos warnings as “impos[ing] a difficult and costly

burden on manufacturers, while simultaneously overwarning users.” Air & Liquid Sys. Corp. v. DeVries, 139

S.Ct. 986, 994 (2019). The national economy is greatly

burdened when manufacturers of products sold nationwide are subjected to “diverse, nonuniform, and confusing . . . labeling and advertising regulations.” Cipollone

v. Liggett Group, Inc., 505 U.S. 504, 514 (1992) (footnote

omitted).

4

Quoting 73 Fed. Reg. 49603, 49605-606 (FDA Aug. 22,

2008), and 73 Fed. Reg. 2848, 2851 (FDA Jan. 16, 2008).

10

Dilution of significant product warnings through

overwarning is a well-known and longstanding product liability concern:

Requiring too many warnings trivializes and

undermines the[ir] entire purpose . . . , drowning out cautions against latent dangers of

which a user might not otherwise be aware.

Such a requirement would neutralize the effectiveness of warnings as an inexpensive way

to allow consumers to adjust their behavior

based on knowledge of a product’s inherent

dangers.

Liriano v. Hobart Corp., 700 N.E.2d 303, 308 (N.Y.

1998) (citation omitted).

In a case involving an FDA-regulated over-thecounter product, another state high court held that “a

truthful warning of an uncertain or remote danger

may mislead the consumer into misjudging the [product’s] dangers,” leading to “medically unwise decision[s].” Dowhal v. SmithKline Beecham Consumer

Healthcare, 88 P.3d 1, 14 (Cal. 2004). “Requiring manufacturers to warn their products’ users in all instances” would create “an onerous burden” and “invite

mass consumer disregard and ultimate contempt for

the warning process.” Johnson v. American Standard,

Inc., 179 P.3d 905, 914 (Cal. 2008) (citation and quotation marks omitted). In a prescription drug case:

[C]ommon sense and experience suggest

that if every report of a possible risk, no matter how speculative, conjectural, or tentative,

imposed an affirmative duty to give some

11

warning, a manufacturer would be required to

inundate physicians indiscriminately with

notice of any and every hint of danger, thereby

inevitably diluting the force of any specific

warning given.

Finn v. G.D. Searle & Co., 677 P.2d 1147, 1153 (Cal.

1984) (citations omitted). Additional warnings can be

“ineffective or even counterproductive if the warning

inserts became so large and cumbersome that a user

could not easily find the warning.” Ramirez v. Plough,

Inc., 863 P.2d 167, 175-76 (Cal. 1993).5

Numerous federal courts of appeal agree. Applying

Mississippi law, Thomas v. Hoffman-LaRoche, Inc., 949

F.2d 806 (5th Cir. 1992), noted that “forc[ing] drug

manufacturers to list, and perhaps contraindicate,

every possible risk” would be unwise:

[P]hysicians will begin to ignore or discount

the warnings provided by the drug manufacturers. Permitting a jury to find liability on

such a basis would undermine the important

5

See Gen. Motors Corp. v. Saenz, 873 S.W.2d 353, 360-61

(Tex. 1993) (“the more instructions and warnings that are printed

in one place . . . the less likely that any one instruction or warning

will be noticed”); Aetna Casualty & Surety Co. v. Ralph Wilson

Plastics Co., 509 N.W.2d 520, 523 (Mich. App. 1993) (“excessive

warnings” are “counterproductive, causing ‘sensory overload’ that

literally drowns crucial information in a sea of mind-numbing detail”) (citation omitted); Broussard v. Continental Oil Co., 433

So.2d 354, 358 (La. App. 1983) (consumers would “read none of

the warnings if the [product] became cluttered with the warnings”).

12

role of warnings as a device to communicate

vital information to physicians.

Id. at 816 n.40.

Treating “strengthen[ing] warnings” as “something always to be encouraged” is “mistaken.” Cerveny

v. Aventis, Inc., 855 F.3d 1091, 1102 (10th Cir. 2017).

“FDA views overwarnings as problematic because they

can render the warnings useless” and “discourage

use of beneficial” products. Id. “If pharmaceutical

companies were required to warn of every suspected

risk . . . , the consuming public would be so barraged

with warnings that it would undermine the effectiveness of these warnings.” Doe v. Miles Laboratories, Inc.,

927 F.2d 187, 194 (4th Cir. 1991).

[T]he proliferation of label detail threatens to undermine the effectiveness of warnings altogether. . . . Well-meaning attempts to

warn of every possible accident lead over time

to voluminous yet impenetrable labels – too

prolix to read and too technical to understand.

Hood v. Ryobi America Corp., 181 F.3d 608, 611 (4th

Cir. 1999) (citation omitted).

“Space on product labeling material is also a factor,” since “the most effective labels are those with

large, bold warnings and a simple design.” Brooks v.

Howmedica, Inc., 273 F.3d 785, 796-97 (8th Cir. 2001)

(en banc) (citations omitted). See Robinson v. McNeil

Consumer Healthcare, 615 F.3d 861, 869 (7th Cir. 2010)

(“information overload” from overwarning “would make

label warnings worthless to consumers”) (Posner, J.)

13

(citations omitted); Cotton v. Buckeye Gas Products Co.,

840 F.2d 935, 938 (D.C. Cir. 1988) (“inclusion of each

extra item dilutes the punch of every other item,” creating “obvious information costs”).

District court decisions decrying overwarning are

legion, and most common in preemption contexts. Last

year, preemption vindicated a federal agency order rejecting scientifically unfounded cellphone radiation

risk warnings, contrary to a municipal ordinance:

Given the specificity of the warning required

. . . , the implied risk to safety if the warning

is not followed (a risk the FCC has concluded

does not exist), and the acknowledged controversy . . . , the FCC could properly conclude

that the [local] ordinance – as worded – overwarns.

CTIA – The Wireless Ass’n v. City of Berkeley, 487

F. Supp.3d 821, 834 (N.D. Cal. 2020) (citation and quotation marks omitted).

This year, “FDA’s approach to warning labels”

preempted multi-district litigation demanding scientifically unsupported cancer warnings. Unlike unregulated products bearing “dozens of warnings, with little

regard for . . . remoteness or obviousness”:

FDA is concerned not only with avoiding insufficient warnings . . . , but also avoiding

over-warning (that is, warning against risks

that are unduly speculative, hypothetical, or

not adequately supported by science). . . .

FDA takes a more measured approach that is

14

intended to provide accurate information to

medical professionals and patients without

unduly discouraging the use of the product.

In re Zofran (Ondansetron) Prod. Liab. Litig., ___

F. Supp.3d ___, 2021 WL 2209871, at *2 (D. Mass. June

1, 2021).6

6

See, e.g., In re Incretin-Based Therapies Prod. Liab. Litig.,

___ F. Supp.3d ___, 2021 WL 880316, at *8 (S.D. Cal. March 9,

2021) (following Albrecht); Cohen v. Apple Inc., 497 F. Supp.3d

769, 785 (N.D. Cal. 2020) (cell phone class action; same reasoning

as CTIA, supra); Ridings v. Maurice, 444 F. Supp.3d 973, 992

(W.D. Mo. 2020) (“FDA prefers a cautious approach” so that “only

scientifically accurate information appears in the approved labeling”) (citation and quotation marks omitted); Sabol v. Bayer Healthcare Pharmaceuticals, Inc., 439 F. Supp.3d 131, 147 (S.D.N.Y.

2020) (following Albrecht); Greager v. McNeil-PPC, Inc., 414

F. Supp.3d 1137, 1141 (N.D. Ill. 2019) (“[o]verwarning, just like

underwarning, can similarly have a negative effect on patient

safety and public health”) (citation and quotation marks omitted);

McGrath v. Bayer HealthCare Pharmaceuticals, Inc., 393

F. Supp.3d 161, 169 (E.D.N.Y. 2019) (following Albrecht); Utts v.

Bristol-Myers Squibb Co., 251 F. Supp.3d 644, 659-60 (S.D.N.Y.

2017) (quoted in Ridings), aff ’d sub nom. Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699 (2d Cir. 2019); Seufert v. Merck

Sharp & Dohme Corp., 187 F. Supp.3d 1163, 1175 (S.D. Cal. 2016)

(rejecting liability that “would encourage prophylactic labeling

changes by manufacturers” and “lead to overwarning”); Heckman

v. Ryder Truck Rental, Inc., 962 F. Supp.2d 792, 803 (D. Md. 2013)

(“tak[ing] into account” whether more warnings would “undermine the effectiveness of warnings altogether”) (citation omitted);

Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289, 312 (E.D. Pa.

2007) (plaintiffs seek “the very result the FDA wants to avoid, i.e.,

overwarning, exaggeration, and defensive labeling”); Ames v.

Apothecon Inc., 431 F. Supp.2d 566, 573 (D. Md. 2006) (“warnings

must be brief and focused to be effective”).

15

As this case demonstrates, prevention of overwarning has a strong regulatory component. For over

40 years, FDA has opposed warnings about unsubstantiated risks. In 1975, it cautioned that scientifically dubious warnings “would result in such uncertainty and

confusion that the usefulness of [existing] warnings in

protecting the public against possible harm would be

severely undermined, if not destroyed.” 40 Fed. Reg.

28582, 28583 (FDA July 7, 1975). Four years later FDA

rejected inclusion of “general statements on good professional practice” because they could “transform labeling into small text-books of medicine.” 44 Fed. Reg.

37434, 37436 (FDA June 26, 1979).

This remains FDA’s bottom-line position. Support

includes, of course, the 2008 Federal Register statements cited in Albrecht, supra.7 Current agency guidance on warning effectiveness states:

Including too many warnings and precautions, over-warning, dilutes the strength of all

of the hazard alerts. . . . Careless designation

can have the same diluting effect as overwarning. . . . Repeated exposure to unnecessary hazard alerts (not relevant or already

7

See, supra, n.4. See also 71 Fed. Reg. 3922, 3935 (FDA Jan.

24, 2006) (“labeling that includes theoretical hazards not wellgrounded in scientific evidence can cause meaningful risk information to lose its significance”) (citation and quotation marks

omitted); 53 Fed. Reg. 30522, 30530 (FDA Aug. 12, 1988) (“too

many warning statements reduce the impact of important statements”); 43 Fed. Reg. 1101, 1104 (FDA Jan. 6, 1978) (“A plethora

of warnings about insubstantial questions would be difficult for

consumers to evaluate.”).

16

known) reduces the effectiveness of the important warnings and precautions.

FDA, CDRH, Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Reviewers, at 42 (2001). “[E]xhaustive lists” of “minor risks

detract from, and make it difficult for, consumers to

comprehend and retain information about the more

important risks.” FDA, CDER, “Brief Summary & Adequate Directions for Use: Disclosing Risk Information

in Consumer-Directed Print Advertisements & Promotional Labeling for Prescription Drugs,” at 4 (Aug.

2015) (revised draft guidance).8

Drawbacks of product overwarning have also been

addressed by scholarly commentators. The American

Law Institute’s Third Restatement of Torts recognizes

that excessive warnings “may be ignored by users and

consumers and may diminish the significance of warnings about [other] risks” and “could reduce the efficacy

of warnings generally.” Restatement (Third) of Torts,

Products Liability §2, comment j (1998). Professors

Prosser and Keeton criticized overwarning as reflecting a “naive belief that one can warn against all significant risks. Too much detail can be counterproductive.”

W. Page Keeton, et al., Prosser & Keeton on the Law of

Torts §96, at 686 (5th ed. 1984).

8

The cited FDA documents are available at: https://www.

fda.gov/media/71030/download (last visited Sept. 23, 2021), and

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatory

information/guidances/ucm069984.pdf (last visited Sept 23, 2021),

respectively.

17

Law review articles by the ALI’s reporters for the

Third Restatement exemplify academic commentary on

overwarning. “[T]he greatest part of the costs of overwarning are nonmonetary and easily ignored.” James

A. Henderson, Jr., & Aaron D. Twerski, Doctrinal Collapse in Products Liability: The Empty Shell of Failure

to Warn, 65 N.Y.U.L. REV. 265, 297 (1990) (footnote

omitted). “[A]n environment crowded with warnings of

remote risks,” leads consumers to “overreact, investing

too heavily in their versions of ‘safety.’ ” Id. at 296 (footnote omitted).

[W]arning about relatively remote risks generates substantial social costs which in most

cases outweigh any corresponding benefits in

reducing accident costs. The most significant

social cost . . . is the reduced effectiveness of

potentially helpful warnings directed towards

risks which are not remote.

Id. (footnote omitted).

Unnecessary or unsupported warnings “diminish

the significance of warnings and tend to clutter warning labels with useless information.” James A. Henderson, Jr. & Aaron D. Twerski, “The Products Liability

Restatement in the Courts: An Initial Assessment,” 27

WM. MITCHELL L. REV. 7, 16 (2000). “[W]arnings, in order to be effective, must be selective. . . . If even remote

risks are to be forced to the consumer’s attention, the

danger signal is diluted.” Aaron D. Twerski, et al., The

Use & Abuse of Warnings in Products Liability – Design

18

Defect Litigation Comes of Age, 61 CORNELL L. REV.

495, 514, 517 (1976). 9

Similar commentary decries overwarning in FDCAspecific contexts. Liability pressures cause companies

to “add information to the label based on singular instances of harm[ ] that the FDA may have deemed unnecessary.” Jenny Ange, Am I My Competitor’s Keeper?

Innovator Liability in the Fifty States, 21 COLUM. SCI.

& TECH. L. REV. 1, 23-24 (2019).

Multiple studies have shown that too many

warnings . . . decrease the effectiveness of

each warning, lead to information overload for

patients, and discourage patients from using

an otherwise beneficial drug. . . . Over-warning may also result in information clutter –

important information about researched side

effects may be lost in the label among the

9

See also, e.g., W. Bradley Wendel, Technological Solutions

to Human Error and How They Can Kill You: Understanding the

Boeing 737 Max Products Liability Litigation, 84 J. AIR L. & COM.

379, 405 (2019) (“Over-warning and unhelpful presentation of

warnings are already well-recognized problems in flight deck design.”); Elizabeth Grotewohl, Chapter 830: Cleaning Products Are

Coming Clean, 49 U. PAC. L. REV. 333, 349 (2018) (“too much information on a product’s label reduces the chance that consumers

and domestic workers will accurately evaluate the information”);

Jeff Todd, A Rhetoric of Warning Defects, 54 S. TEX. L. REV. 343,

374, 377 (2012) (“the aggregation of nonmaterial disclosures will

make the cost of reading and remembering outweigh the benefits

to the average user, who will not read them”) (footnote omitted);

Robert G. Knaier, An Informed-Choice Duty to Instruct? 88 CORNELL L. REV. 814, 853 (2003) (“The more that product manufacturers warn of risks that never materialize, the less likely product

users are to heed those warnings.”).

19

other miscellaneous warnings, leading to negative information costs.

Id. at 24 (footnotes omitted). “Underapplication of the

preemption doctrine may lead manufacturers to seek

to include warnings in product labeling that are not

supported by science.” Douglas G. Smith, A Shift in the

Preemption Landscape?, 87 TENN. L. REV. 213, 244

(2019).10 The Mississippi court’s refusal to recognize

preemption threatens all the detrimental effects that

10

See also, e.g., Joshua E. Perry, et. al., Trust in the Balance:

Prescription Drug Risks, Patient Perspectives, & Legal (Re)considerations, 24 J. HEALTH CARE L. & POL’Y 27, 49-50 (2021) (“overwarning of prescription drug side effects which can lead to adverse impacts on prescribing decisions”) (footnote omitted); Andrew Andrzejewski, Direct-to-Consumer Calls to Action: Lowering

the Volume of Claims & Disclosures in Prescription Drug Broadcast Advertisements, 84 BROOK. L. REV. 571, 573 (2019) (overwarning can “dilute the warnings for the most serious side effects” and

cause “ ‘therapeutic noncompliance’ with prescriptions”) (footnotes omitted); Jon Duke, et al., A Quantitative Analysis of Adverse Events and ‘Overwarning’ in Drug Labeling, 171 ARCH. OF

INT. MED. 944, 945 (2011) (survey showing that the average prescription drug package insert included 49 potential adverse drug

events; 10% listed over 500); Lars Noah, The Imperative to Warn:

Disentangling the ‘Right to Know’ from the ‘Need to Know’ About

Consumer Product Hazards, 11 YALE J. REG. 293, 382-83 (1994)

(if “labeling included warnings of all possible side effects, the cacophony of risk information could undermine a doctor’s ability to

appreciate warnings about meaningful hazards”) (footnote omitted); Richard M. Cooper, Drug Labeling & Products Liability: The

Role of the Food & Drug Administration, 41 FOOD & DRUG L.J.

233, 238 (1986) (rational physician prescribing “is not advanced if

a drug is made to appear riskier . . . due to the over-dramatization

of risk information or the presentation of risk information that

should not rationally influence prescribing (or treatment) decisions”).

20

have been acknowledged by FDA, the Court, the lower

courts, commentators, and the American Law Institute.

The risks of overwarning are only magnified here,

where plaintiff is a political branch of government, not

a private litigant. Although this litigation involves

an FDA-regulated cosmetic, Mississippi’s next target

could easily be an essential vaccine. Some state governments have participated in the torrent of attacks

on COVID-19 vaccines (and vaccination generally) despite the vaccines being approved or authorized by

FDA based on the best available scientific evidence.

One state has prohibited mandatory COVID-19 vaccination of school children,11 and another state’s Department of Health “issued a directive halting all child

vaccination outreach efforts.”12

In this environment, should the decision below

stand, it is hardly far-fetched to envision state attorneys general, or other state actors, suing to demand

scientifically questionable vaccine warnings that flunk

FDA’s rigorous standards. Overwarning has always

been an issue in vaccine litigation. See Dunn v. Lederle

Laboratories, 328 N.W.2d 576, 580-81 (Mich. App.

1983) (vaccine users’ “susceptibility to danger” is individualized; “excessive warnings” lead to “sensory

11

Ala. Code §22-11B-5(c).

Meghan Mangrum, “As Tennessee Halts Vaccine Outreach

to Kids, Nashville Youth Still Get COVID-19 Shots,” Nashville

Tennessean (July 16, 2021).

12

21

overload” and “may be counterproductive”) (citation

omitted).

Even before the Court rejected presumptions

against express preemption, it recognized preemption

where it could not “imagine 50 different labeling regimes prescribing the color, font size, and wording of

warnings.” Bates v. Dow Agrosciences LLC, 544 U.S.

431, 452 (2005).

II.

Presumptions Against Preemption In

FDCA Express Preemption Cases Conflict

With This Court’s Preemption Precedent.

In Puerto Rico v. Franklin, 136 S.Ct. 1938, the

Court flatly rejected any “presumption” where, as

here, Congress expressly mandates preemption. Where

a federal “statute contains an express pre-emption

clause, we do not invoke any presumption against preemption.” Id. at 1946 (citation and quotation marks

omitted). Instead, courts “focus on the plain wording of

the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.” Id. (citations

and quotation marks omitted). The Court “has explained many times” that “people are entitled to rely

on the law as written, without fearing that courts

might disregard its plain terms based on some extratextual consideration.” Bostock, 140 S.Ct. at 1749 (citations omitted).

When the express terms of a statute give us

one answer and extratextual considerations

22

suggest another, it’s no contest. Only the written word is the law.

Id. at 1737.

Even before abolishing presumptions against express preemption, the Court twice declined to apply

such a presumption in prescription medical product

cases. Like this case, Riegel involved the term “requirement,” as used in a similar FDCA preemption clause

for medical devices. 552 U.S. at 323-25.13 Despite the

dissent’s criticism for not “accept[ing] the reading that

disfavors preemption,” id. at 335 (Ginsburg, J., dissenting) (citation and quotation marks omitted), Riegel

gave “requirement” its ordinary meaning. Id. at 325

(refusing to “turn somersaults to create” a preemption

limitation “not required or even suggested by the broad

language Congress chose”). “[G]eneral tort duties” imposed preempted “requirements.” Id. at 327-28.

The Mississippi court here did what Riegel would

not – impose an extratextual limit on the “broad” term

“requirement,” as employed by Congress in an FDCA

express preemption clause. It invoked the identical “accept the reading that disfavors pre-emption” presumption as the Riegel dissent.

Bruesewitz likewise eschewed any presumption

against preemption in holding that the Vaccine Act expressly preempted state-law claims attacking vaccine

13

See 21 U.S.C. §360k(a)(1) (preempting state “requirements” that are “different from, or in addition to, any [FDA] requirement applicable . . . to the device”).

23

design. The statutory preemption clause barred suits

over “side effects that were unavoidable even though

the vaccine was properly prepared” and carried “proper

directions and warnings.” 42 U.S.C. §300aa-22(b)(1).

Despite Congress not explicitly mentioning “design,”

Bruesewitz held that “[i]f a manufacturer could be held

liable for failure to use a different design, the word ‘unavoidable’ would do no work.” 562 U.S. at 232.

Almost simultaneously, the same supposed obligation to “disfavor[ ] preemption,” led the Georgia Supreme Court to a conclusion diametrically opposed to

Bruesewitz. The Georgia court unanimously found no

preemption – with the same presumption a central element. See Ferrari v. Am. Home Prods. Corp., 668

S.E.2d 236, 242 (Ga. 2008), vacated, 710 S.E.2d 771

(Ga. 2011). “[R]esolv[ing] any ambiguity . . . against

preemption,” Ferrari wrongly concluded that the statute “does not preempt all design defect claims against

vaccine manufacturers.” Id.14

Riegel and Bruesewitz demonstrate how this presumption against preemption acts as an invitation to

error and presaged such presumptions’ outright abolition in Puerto Rico v. Franklin. Otherwise, vaccination

– “one of the greatest achievements of public health

in the 20th century,” Bruesewitz, 562 U.S. at 226

14

Ferrari was decided while Bruesewitz was pending. This

Court vacated and remanded Ferrari in light of Bruesewitz, Am.

Home Prods. Corp. v. Ferrari, 562 U.S. 1254 (2011), and the Georgia court reversed its position, Am. Home Prods. Corp. v. Ferrari,

710 S.E.2d 771, 772 (Ga. 2011).

24

(quotation marks and footnote omitted) – could be attacked in innumerable lawsuits.

Granting certiorari will prevent perpetuation of

an obsolete preemption standard that still frequently

leads courts into serious error. “Congress is entitled to

know what meaning this Court will assign to terms

regularly used in its enactments.” Riegel, 552 U.S. at

324 (the term “requirement”).

III. Presumptions Against Preemption Create

Unavoidable Conflicts With Agency Decisions Having Force of Law.

Limiting preemptive agency actions to only those

decisions reached by notice-and-comment rulemaking

would be a recipe for chaos. Such rulemaking, which

usually takes several years, is not normally how FDA

or other agencies regulate product warnings.

Tampons are the only FDA-regulated product in

the last forty years with labeling created by noticeand-comment rulemaking. See 21 C.F.R. §801.430(c-e)

(specifying exact text of tampon labeling for toxic shock

syndrome). The rule was proposed on October 21, 1980.

45 Fed. Reg. 69840 (FDA Oct. 21, 1980). It became effective on December 20, 1982. 47 Fed. Reg. 26982,

26990 (FDA June 22, 1982). Even in an extraordinary

situation, creating a product warning through noticeand-comment rulemaking took more than two years.

Ordinary FDA product-specific regulations simply

incorporate general labeling requirements. E.g., 21

C.F.R. §73.1550(d) (labeling for talc, used as a color

25

additive, “shall conform to the requirements of §70.25

of this chapter”).

Since FDA regulates tens of thousands of products,15 creation of individual product labeling through

notice-and-comment rulemaking would be an impossibility.

Moreover, all of the Court’s FDCA-related preemption cases since Hillsborough Cty., Fla. v. Automated

Med. Lab’ys, Inc., 471 U.S. 707 (1985), address agency

requirements created by means other than notice-andcomment rulemaking:

•

Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996),

FDA medical device clearance;

•

Buckman Co. v. Plaintiffs Legal Committee,

531 U.S. 341 (2001), FDA medical device clearance;

•

Riegel, 552 U.S. 312, FDA medical device premarket approval;

•

Wyeth v. Levine, 555 U.S. 555 (2009), FDA-approved prescription drug label change;

•

PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011),

FDA abbreviated generic drug approval;

15

See Fact Sheet: FDA at a Glance (listing approximate

number of FDA-regulated products by category), available at

https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance

(last visited Sept. 23, 2021).

26

•

Mut. Pharm. Co. v. Bartlett, 570 U.S. 472

(2013), FDA abbreviated generic drug approval;

•

Albrecht, 139 S.Ct. 1668, FDA-approved prescription drug labeling.

This Court recently identified FDA’s “formal[ ] rejecti[on of ] a warning label,” and any “other agency action carrying the force of law” as preempting state

law. Albrecht, 139 S.Ct. at 1679 (citations omitted). If

notice-and-comment rulemaking were essential to

preemption, as the Mississippi court held, then all the

above decisions would have reached the same result –

no preemptive FDCA “requirement,” and therefore, no

preemption. However, the Court shuns anti-preemption arguments that would “render . . . pre-emption

largely meaningless,” PLIVA, 564 U.S. at 620, or “mean

that . . . the vast majority – if not all” preemption precedent was “wrongly decided.” Mut. Pharm., 570 U.S. at

489. It should do so again, here.

Again, the ramifications of the Mississippi court’s

decision extend well beyond the FDCA. No notice-andcomment rulemaking occurred in Bruesewitz, 562 U.S.

223, only an individual vaccine compensation proceeding. Id. at 230-31. The governmental action found

potentially preemptive in Bates, like here, was an

agency’s registration of an individual product label under generally applicable labeling regulations. 544 U.S.

at 434-35, 440.

The Mississippi court’s reasoning would also sink

ongoing efforts to control the COVID-19 pandemic into

27

a swamp of state-law litigation. The PREP Act authorizes broad immunity from pandemic-related litigation.

“[C]overed person[s]” are “immune from suit and liability under Federal and State law,” for “all claims”

involving “administration” or “use” of a “covered

[pandemic] countermeasure.” 42 U.S.C. §247d-6d(a)(1).

PREP Act immunity is triggered by a formal “declaration” from the Secretary of Health & Human Services

– not by notice-and-comment rulemaking. Id. §247d6d(b)(1-6). Immunity is enforced by the Act’s express

preemption clause, which, as here, uses “requirement”

to describe preemptive federal actions. Id. §247d6d(b)(8)(A-B). In March 2020, the HHS secretary issued the statutorily authorized declaration, which has

been broadened and extended multiple times.16

In Mississippi, without notice-and-comment rulemaking, the COVID-19 PREP Act declaration provides

no immunity because it is not a preemptive federal “requirement[ ] applicable under this section.” Id. §247d6d(b)(8)(A). Unless the Petition is granted and that decision reversed, everyone combatting the COVID-19

pandemic – from vaccine manufacturers to hospital administrators faced with limited treatment resources –

remains exposed to state-law litigation and liability, in

direct contravention of manifest congressional intent.

16

See 85 Fed. Reg. 15198 (HHS March 17, 2020), as

amended, 85 Fed. Reg. 21012 (April 15, 2020); 85 Fed. Reg. 35100

(June 5, 2020); 85 Fed. Reg. 52136 (Aug. 24, 2020); 85 Fed. Reg.

79190 (Dec. 9, 2020); 86 Fed. Reg. 7872 (Feb. 2, 2021); 86 Fed.

Reg. 9516 (Feb. 16, 2021); 86 Fed. Reg. 14462 (March 16, 2021),

86 Fed. Reg. 41977 (Aug. 4, 2021); 86 Fed. Reg. 51160 (Sept. 14,

2021).

28

Thus, this case is of critical importance, not only to

FDA’s regulatory scheme, but to public health generally.

---------------------------------♦---------------------------------

CONCLUSION

The Petition for a Writ of Certiorari should be

granted.

Respectfully submitted,

OCTOBER 4, 2021

JAMES M. BECK

Counsel of Record

REED SMITH LLP

Three Logan Square

Suite 3100

1717 Arch Street

Philadelphia, PA 19103

(215) 851-8168

jmbeck@reedsmith.com

Counsel for Amicus Curiae

Product Liability Advisory Council, Inc.