Petition for Writ of Certiorari — Hi-Tech Pharmaceuticals, Inc., et al., Petitioners v. Federal Trade Commission, et al.

Supreme Court briefJun 26, 2020

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NO. ______

In the

Supreme Court

of the United States

________________

HI-TECH PHARMACEUTICALS, INC., corporation;

JARED WHEAT, individually and as officers of the

corporation; STEPHEN SMITH, individually and as

officers of National Urological Group, Inc., and

National Institute for Clinical Weight Loss, Inc.;

NATIONAL UROLOGICAL GROUP, INC., d.b.a. Warner

Laboratories, et al.; THOMASZ HOLDA, individually

and as officers of the corporations, et al.,

Petitioners,

FEDERAL TRADE COMMISSION; CERTUSBANK, N.A.,

Respondents.

________________

On Petition for Writ of Certiorari

to the United States Court of Appeals

for the Eleventh Circuit

________________

PETITION FOR WRIT OF CERTIORARI

________________

Robert F. Parsley

Anne M. Voigts

Meredith C. Lee

Counsel of Record

MILLER &

KING & SPALDING LLP

MARTIN PLLC

601 S. California Avenue

832 Georgia Avenue

Suite 100

Suite 1200

Palo Alto, CA 94304

Chattanooga, TN 37402 (650) 422-6700

(423) 756-6600

avoigts@kslaw.com

Counsel for Petitioners Jared Wheat

& Hi-Tech Pharmaceuticals, Inc.

(additional counsel listed on inside cover)

June 26, 2020

I. Cason Hewgley IV

KING & SPALDING LLP

1700 Pennsylvania Avenue NW

Washington, DC 20006

(202) 737-0500

Counsel for Petitioners Jared Wheat

& Hi-Tech Pharmaceuticals, Inc.

E. Vaughn Dunnigan

2897 N Druid Hills Road

Suite 142

Atlanta, GA 30329

(404) 663-4291

Counsel for Petitioner Stephen Smith

QUESTIONS PRESENTED

The Eleventh Circuit affirmed a $40-million

contempt sanction based on a standard found nowhere

within the four corners of the injunction that

Petitioners Hi-Tech Pharmaceuticals, Inc., Jared

Wheat, and Stephen Smith allegedly violated. But

Federal Rule of Civil Procedure 65(d) mandates, and

courts have consistently held, that injunctions must

“describe in reasonable detail—and not by referring to

the complaint or other document—the act or acts

restrained or required.” More than a decade ago, the

district court enjoined Hi-Tech from making certain

advertising claims about dietary supplements without

“competent and reliable scientific evidence.” According

to Respondent the Federal Trade Commission’s

published guidance, that standard is flexible and

context-specific, with no “fixed formula for the number

or type of studies required.” Since then, the FTC has

repeatedly asked courts to hold that that injunctive

standard can be satisfied only by product-specific,

randomized, double-blind, placebo-controlled human

clinical trials—the kind of substantiation required for

drugs, not dietary supplements.

Until now, courts have consistently rejected this

post-hoc reinterpretation of existing injunctions. But

the Eleventh Circuit permitted it, concluding that HiTech had waived the argument by failing to anticipate

and preemptively challenge the FTC’s change in

position. In so doing, the Eleventh Circuit discounted

the fact that the district court had decided the case on

the merits, without mentioning waiver. Instead, it

looked to events and evidence outside and after the

entry of the injunction to find waiver and to provide

the missing specificity. The questions presented are:

I. Can the FTC unilaterally reinterpret an

injunction years after its entry to seek

contempt sanctions based on a more

restrictive standard found nowhere in the

injunction itself or does that violate Fed. R.

Civ. P. 65(d) and due process?

II. Did Hi-Tech waive all challenges to the

specificity of the injunction in contempt

proceedings by not previously raising an

argument Hi-Tech couldn’t have foreseen?

III.Does an appellate court have discretion to

find an issue waived even though the

district court did not and its ruling on the

merits was necessary to the judgment from

which Hi-Tech appealed?

iii

PARTIES TO THE PROCEEDING

Petitioners Hi-Tech Pharmaceuticals, Inc., Jared

Wheat, and Stephen Smith were defendantsappellants below. Petitioner National Urological

Group, Inc., d.b.a. Warner Laboratories, et al., was

defendant-counter-claimant below and Petitioner

Thomasz Holda was defendant below. Respondent

Federal Trade Commission was plaintiff-counterdefendant-appellee

below

and

Respondent

CertusBank, N.A. was plaintiff below.

CORPORATE DISCLOSURE STATEMENT

Hi-Tech Pharmaceuticals, Inc. is not a publicly

traded company. It has no parent company and no

company owns 10% or more its stock.

RELATED PROCEEDINGS

This case arises from the following proceedings in

the United States District Court for the Northern

District of Georgia and the United States Court of

Appeals for the Eleventh Circuit, listed here in

chronological order:

•

FTC v. Nat’l Urological Grp., Inc., No. 1:04-CV3294-CAP (N.D. Ga. June 4, 2008), reported at 645

F. Supp. 2d 1167;

•

FTC v. Nat’l Urological Grp., Inc., No. 09-10617

(11th Cir. Dec. 15, 2009), reported at 356 F. App’x

358;

•

FTC v. Nat’l Urological Grp., Inc., No. 1:04-CV3294-CAP (N.D. Ga. May 14, 2014), available at

2014 WL 3893796;

•

FTC v. Nat’l Urological Grp., Inc., No. 14-13131

(11th Cir. May 5, 2015), reported at 785 F.3d 477;

•

FTC v. Nat’l Urological Grp., Inc., No. 1:04-CV3294-CAP (N.D. Ga. Oct. 10, 2017), available at

2017 WL 6759868;

•

FTC v. Nat’l Urological Grp., Inc., No. 17-15695

(11th Cir. Sept. 18, 2019), reported at 786 F. App’x

947.

There are no other proceedings in state or federal

trial or appellate courts, or in this Court, directly

related to this case within the meaning of this Court’s

Rule 14.1(b)(iii).

TABLE OF CONTENTS

QUESTIONS PRESENTED........................................ i

PARTIES TO THE PROCEEDING .......................... iii

CORPORATE DISCLOSURE STATEMENT ........... iv

RELATED PROCEEDINGS ...................................... v

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

PETITION FOR WRIT OF CERTIORARI ................ 1

OPINIONS BELOW ................................................... 4

JURISDICTION ......................................................... 4

CONSTITUTIONAL

AND

STATUTORY

PROVISIONS INVOLVED...................................... 5

STATEMENT OF THE CASE ................................... 5

A. Round 1: The district court grants

summary judgment and enters a

permanent injunction; the Eleventh

Circuit affirms .............................................. 8

B. Round 2: The district court holds Hi-Tech

in contempt; the Eleventh Circuit

vacates and remands .................................... 9

C. Round 3: The district court reinstates the

contempt sanction; the Eleventh Circuit

relies on waiver to affirm ........................... 11

REASONS FOR GRANTING THE PETITION....... 13

The Eleventh Circuit’s decision conflicts with

Fed. R. Civ. P. 65(d), the cases applying it,

and the due process principles underpinning

it ......................................................................... 14

A. The FTC’s rule-by-injunction violates

Rule 65(d).................................................... 14

vii

B. The

Eleventh

Circuit’s

decision

improperly lets the FTC redefine an

injunction in contempt proceedings and

conflicts with the decisions of other

courts .......................................................... 19

II. The Eleventh Circuit’s decision incorrectly

relieved the FTC of its burden to show that

the injunction specifically prohibited HiTech’s conduct .................................................... 23

A. The decision below misapplies this

Court’s precedent........................................ 24

B. The decision below deepens a lopsided

Circuit split ................................................. 25

C. The decision below flips the burden for

civil contempt ............................................. 27

III. The Eleventh Circuit’s decision stripped HiTech of its right to appeal the district court’s

judgment ............................................................ 28

CONCLUSION ......................................................... 37

APPENDIX

Appendix A

Opinion of the United States Court of

Appeals for the Eleventh Circuit,

FTC v. Nat’l Urological Grp., Inc.,

No. 17-15695 (Sept. 18, 2019) ............... App-1

Opinion of the United States Court of

Appeals for the Eleventh Circuit,

FTC v. Nat’l Urological Grp., Inc.,

No. 14-13131 (May 5, 2015) ................ App-27

viii

Appendix B

Order of the United States District

Court for the Northern District of

Georgia, FTC Comm’n v. Nat’l

Urological Grp., Inc., No. 1:04-CV3294-CAP (Dec. 20, 2017) ................... App-39

Appendix C

Corrected Order of the United States

Court of Appeals for the Eleventh

Circuit Denying Stay of Mandate,

FTC v. Nat’l Urological Grp., Inc.,

No. 17-15695 (Mar. 5, 2020) ............... App-44

Order of the United States Court of

Appeals for the Eleventh Circuit

Denying Rehearing and Rehearing en

Banc, FTC v. Nat’l Urological Grp.,

Inc., No. 17-15695 (Jan. 29, 2020) ...... App-46

Appendix D

Contempt Order of the United States

District Court for the Northern

District of Georgia, FTC v. Nat’l

Urological Grp., Inc., No. 1:04-CV3294-CAP (Oct. 10, 2017).................... App-48

Sanctions Order of the United States

District Court for the Northern

District of Georgia, FTC v. Nat’l

Urological Grp., Inc., No. 1:04-CV3294-CAP (May 14, 2014) ................. App-165

Order

Denying

Defendants’

Reconsideration of the United States

District Court for the Northern

District of Georgia, FTC v. Nat’l

Urological Grp., Inc., No. 1:04-CV3294-CAP (Aug. 7, 2012) ................... App-199

Contempt Order of the United States

District Court for the Northern

District of Georgia, FTC v. Nat’l

Urological Grp., Inc., No. 1:04-CV3294-CAP (May 11, 2012) ................. App-217

Final Judgment and Permanent

Injunction of the United States

District Court for the Northern

District of Georgia, FTC v. Nat’l

Urological Grp., Inc., No. 1:04-CV3294-CAP (Dec. 16, 2008) ................. App-231

Summary Judgment Order of the

United States District Court for the

Northern District of Georgia, FTC v.

Nat’l Urological Grp., Inc., No. 1:04CV-3294-CAP (June 4, 2008) ............ App-257

Appendix E

Relevant Statutes

15 U.S.C. § 45 ............................. App-347

15 U.S.C. § 52 ............................. App-361

28 U.S.C. § 1291 ......................... App-362

TABLE OF AUTHORITIES

Cases

Abbott v. Perez,

138 S. Ct. 2305 (2018)............................................ 16

Adsani v. Miller,

139 F.3d 67 (2d Cir. 1998) ............................... 29, 35

Ahanchian v. Xenon Pictures,

624 F.3d 1253 (9th Cir. 2010).......................... 31, 32

Al Bahlul v. United States,

767 F.3d 1 (D.C. Cir. 2014) .................................... 33

AngioDynamics v. Biolitec AG,

823 F.3d 1 (1st Cir. 2016) ...................................... 30

Auto Driveaway Franchise Sys.

v. Auto Driveaway Richmond

928 F.3d 670 (7th Cir. 2019).................................. 16

Basic Research, LLC v. FTC,

No. 2:09-CV-0779 CW,

2014 WL 12596497

(D. Utah Nov. 25, 2014) ..................................... 8, 22

Blackmon-Malloy v. U.S. Capitol Police Bd.,

575 F.3d 699 (D.C. Cir. 2009) .......................... 31, 32

Bloom v. Illinois,

391 U.S. 194 (1968)................................................ 21

City of Arlington v. FCC,

569 U.S. 290 (2013).................................................. 4

Comcast of Sacramento I, LLC

v. Sacramento Metro.

Cable Television Comm’n,

923 F.3d 1163 (9th Cir. 2019).......................... 32, 33

Connally v. Gen. Constr.,

269 U.S. 385 (1926)................................................ 15

CPC Int’l v. Skippy,

214 F.3d 456 (4th Cir. 2000).................................. 26

Crandon v. United States,

494 U.S. 152 (1990)................................................ 19

Doe v. Gen. Hosp. of D.C.,

434 F.2d 423 (D.C. Cir. 1970) ................................ 27

Drywall Tapers & Pointers of Greater N.Y.

v. Local 530 of Operative Plasterers &

Cement Masons Int’l Ass’n,

889 F.2d 389 (2d Cir. 1989) ................................... 19

Exxon Shipping v. Baker,

554 U.S. 471 (2008)................................................ 30

Farmer v. Banco Popular of N. Am.,

557 F. App’x 762 (10th Cir. 2014) ......................... 16

FCC v. Fox Television Stations,

556 U.S. 502 (2009)................................................ 19

Firestone Fin. v. Meyer,

796 F.3d 822 (7th Cir. 2015).................................. 31

Ford v. Kammerer,

450 F.2d 279, 280 (3d Cir. 1971) ........................... 26

FTC v. Cal. Pac. Research,

No. CV-N-88-602BRT,

1991 WL 208470

(D. Nev. Aug. 27, 1991) .......................................... 18

FTC v. Garden of Life, Inc.,

516 F. App’x 852 (11th Cir. 2013) ........................... 8

FTC v. Garden of Life, Inc.,

845 F. Supp. 2d 1328 (S.D. Fla. 2012) .............. 8, 23

xii

FTC v. Nat’l Urological Grp.,

356 F. App’x 358 (11th Cir. 2009) ........................... 9

FTC v. QT,

512 F.3d 858 (7th Cir. 2008).................................. 20

Gates v. Shinn,

98 F.3d 463 (9th Cir. 1996).................................... 27

Good Samaritan Hosp. v. Shalala,

508 U.S. 402 (1993)................................................ 17

Granny Goose Foods v. Bhd. of Teamsters

& Auto Truck Drivers Local No. 70,

415 U.S. 423 (1974).................................... 15, 25, 34

H.K. Porter v. Nat’l Friction Prods.,

568 F.2d 24 (7th Cir. 1977).................................... 25

Hall v. Hall,

138 S. Ct. 1118 (2018)............................................ 29

Hi-Tech Pharm. v. HBS Int’l,

910 F.3d 1186 (11th Cir. 2018)........................ 31, 33

Holguin-Hernandez v. United States,

140 S. Ct. 762 (2020).............................................. 30

Howe v. City of Akron,

801 F.3d 718 (6th Cir. 2015).................................. 30

Howell v. Mississippi,

543 U.S. 440 (2005)................................................ 31

Imageware v. U.S. W. Commc’ns,

219 F.3d 793 (8th Cir. 2000).................................. 26

In re Brown,

152 F.T.C. 466 (F.T.C. 2011) ................................. 18

xiii

In re HealthyLife Scis., LLC,

File No. 122 3287,

2014 WL 4651907

(F.T.C. Sept. 11, 2014) ........................................... 18

In re Nestlé HealthCare Nutrition,

151 F.T.C. 1 (F.T.C. 2011) ..................................... 18

Int’l Longshoremen’s Ass’n

v. Phila. Marine Trade Ass’n,

389 U.S. 64 (1967)................................ 14, 21, 22, 25

Int’l Union v. Bagwell,

512 U.S. 821 (1994)................................................ 19

LabMD v. FTC,

894 F.3d 1221 (11th Cir. 2018).............................. 17

Laffey v. Nw. Airlines,

740 F.2d 1071 (D.C. Cir. 1984) .............................. 30

Lampton v. Diaz,

639 F.3d 223 (5th Cir. 2011).................................. 32

Lanzetta v. New Jersey,

306 U.S. 451 (1939).................................................. 1

Lindsey v. Normet,

405 U.S. 56 (1972).................................................. 29

Liu v. SEC,

No. 18-1501, slip op. (U.S. June 22, 2020) ............ 21

Max’s Seafood Cafe ex rel. Lou-Ann

v. Quinteros,

176 F.3d 669 (3d Cir. 1999) ................................... 16

McComb v. Jacksonville Paper,

336 U.S. 187 (1949)...................................... 3, 13, 24

Moriarty v. Svec,

164 F.3d 323 (7th Cir. 1998).................................. 31

xiv

NBA Props. v. Gold,

895 F.2d 30 (1st Cir. 1990) .................................... 26

Negrón-Almeda v. Santiago,

528 F.3d 15 (1st Cir. 2008) .................................... 31

Nelson v. Adams USA,

529 U.S. 460 (2000)................................................ 30

Nutritional Health Alliance v. Shalala,

144 F.3d 220 (2d Cir. 1998) ..................................... 6

Orr v. Orr,

440 U.S. 268 (1979)................................................ 29

Pagtalunan v. Galaza,

291 F.3d 639 (9th Cir. 2002).................................. 30

PFS Distribution v. Raduechel,

574 F.3d 580 (8th Cir. 2009).................................. 31

Polo Fashions v. Stock Buyers Int’l,

760 F.2d 698 (6th Cir. 1985).................................. 26

POM Wonderful LLC v. FTC,

777 F.3d 478 (D.C. Cir. 2015) ................................ 20

Roberts v. Capital One, N.A.,

719 F. App’x 33 (2d Cir. 2017) ............................... 32

Russell C. House Transfer & Storage

v. United States,

189 F.2d 349 (5th Cir. 1951).................................. 26

Schad v. Arizona,

501 U.S. 624 (1991)................................................ 29

Schmidt v. Lessard,

414 U.S. 473 (1974)...................................... 3, 15, 25

Sessions v. Dimaya,

138 S. Ct. 1204 (2018).............................................. 3

Singleton v. Wulff,

428 U.S. 106 (1976)................................................ 30

Swift & Co. v. United States,

196 U.S. 375 (1905)................................................ 21

TiVo v. EchoStar,

646 F.3d 869 (Fed. Cir. 2011) ................................ 27

United States v. Bayer,

No. CV 07-01(JLL),

2015 WL 5822595

(D.N.J. Sept. 24, 2015)................................... passim

United States v. Clariot,

655 F.3d 550 (6th Cir. 2011).................................. 31

United States v. Hernandez-Rodriguez,

352 F.3d 1325 (10th Cir. 2003).............................. 32

United States v. Murphy,

769 F. App’x 631 (10th Cir. 2019) ......................... 31

United States v. Saccoccia,

433 F.3d 19 (1st Cir. 2005) .................................... 16

United States v. Thompson/Ctr. Arms,

504 U.S. 505 (1992)................................................ 19

United States v. Wilson,

908 F.2d 968 (4th Cir. 1990).................................. 15

Vill. of Hoffman Estates

v. Flipside, Hoffman Estates,

455 U.S. 489 (1982)................................................ 28

Whitman v. United States,

574 U.S. 1003, 135 S. Ct. 352 (2014)..................... 19

Williams v. United States,

402 F.2d 47 (10th Cir. 1967).................................. 26

xvi

Young

v. United States ex rel. Vuitton et Fils S.A.,

481 U.S. 787 (1987)................................................ 21

Constitutional Provision

U.S. Const. amend. V ..................................... 5, 15, 29

Statutes

15 U.S.C. § 52 ......................................................... 5, 6

15 U.S.C. § 45 ................................................ 5, 6, 8, 21

21 U.S.C. § 321(ff) ....................................................... 5

21 U.S.C. § 342(f) ........................................................ 6

21 U.S.C. § 343(r)(6)................................................ 6, 7

28 U.S.C. § 1257(a).................................................... 29

28 U.S.C. § 1291 ................................................ passim

28 U.S.C § 1345 ........................................................... 8

Dietary Supplement Health

and Education Act of 1994,

Pub. L. No. 103-417, 108 Stat. 4325 ....................... 6

Rules & Regulation

Fed. R. Civ. P. 65(d) .......................................... passim

Sup. Ct. R. 10 ........................................................ 4, 36

65 Fed. Reg. 1000 (Jan. 6, 2000) ................................ 7

Other Authorities

FTC, Dietary Supplements:

An Advertising Guide for Industry (2001),

https://www.ftc.gov/system/files/documents/

plain-language/bus09-dietary-supplementsadvertising-guide-industry.pdf ..................... 2, 7, 17

xvii

Brief for Plaintiff-Appellant FTC,

FTC v. Garden of Life,

516 F. App’x 852 (11th Cir. 2013)

(No. 12-12382-AA), 2012 WL 2872220 .................. 23

Aylin Sertkaya et al.,

Key Cost Drivers of Pharmaceutical Trials

in the United States, Clinical Trials (2016),

https://www.reasearchgate.net/publication/

293640487_Key_cost_drivers_of_pharmace

utical_clinical_trials_in_the_United_States......... 11

David C. Vladeck, Director,

FTC Bureau of Consumer Protection,

Remarks on the Priorities for Dietary

Supplement Advertising Enforcement

(Oct. 22, 2009) .......................................................... 8

PETITION FOR WRIT OF CERTIORARI

Twelve years ago, the Federal Trade Commission

got an injunction against Hi-Tech that imposed one

requirement regarding the substantiation needed for

claims about dietary supplements. Ten years later, the

FTC got—and the Eleventh Circuit affirmed—a $40million sanction based on the entirely different, and

far more exacting, requirement applicable to drugs.

The injunction’s text didn’t change during that decade,

just the way the FTC wanted to interpret it. Imposing

contempt sanctions—as the district court did here—

based on a standard outside that injunction conflicts

with Fed. R. Civ. P. 65(d) and the cases applying it,

which require that an injunction’s scope be

discernable from its four corners. But the Eleventh

Circuit affirmed that decision, permitting the court to

impose crippling contempt sanctions according to its

after-the-fact interpretation.

That decision also conflicts with the law

governing contempt proceedings. After all, the first

step in imposing contempt is establishing that an

injunction’s operative command is reasonably specific.

Here, though, it took ten days of conflicting expert

testimony over what the injunction required for the

district court to conclude that the injunction’s text was

sufficiently specific. Indeed, the FTC’s experts didn’t

just disagree with Hi-Tech’s experts, but also with

each other over what the injunction required.

Determining what an injunction requires based on

after-the-fact, conflicting expert testimony flies in the

face of fundamental due process. “All are entitled to be

informed as to what the State commands or forbids.”

Lanzetta v. New Jersey, 306 U.S. 451, 453 (1939).

That’s what Federal Rule of Civil Procedure 65(d)

requires, that’s what the Constitution requires, and

that’s what—until now—cases construing them have

required.

The injunction here barred Hi-Tech from

advertising its supplements without “competent and

reliable scientific evidence” substantiating those

claims. That’s the standard that applies to dietary

supplements like those here. Then and now, according

to the FTC’s own guidance, that standard has a broad

and flexible definition: “[C]ompetent and reliable

scientific evidence” means “tests, analyses, research,

studies, or other evidence based upon the expertise of

professionals in the relevant area, that have been

conducted and evaluated in an objective manner by

persons qualified to do so, using procedures generally

accepted in the profession to yield accurate and

reliable results.” FTC, Dietary Supplements: An

Advertising

Guide

for

Industry

(2001),

https://www.ftc.gov/system/files/documents/plainlanguage/bus09-dietary-supplements-advertisingguide-industry.pdf (“Guide”).

Years later, the FTC changed its mind, deciding

that the same kind of extensive testing required for

new drugs should also be required for dietary

supplement claims. But that change in position is

indefensible: Congress established two different

regimes—the more flexible one applicable to dietary

supplements under the Dietary Supplement Health

and Education Act of 1994, and the more stringent one

applicable to drugs under the federal Food, Drug, and

Cosmetic Act.

Rather than engage in rulemaking, the FTC chose

to reinterpret existing injunctions as requiring dietary

supplements to satisfy the heightened standards for

drugs and to seek contempt sanctions if they did not.

Thus, according to the FTC (or at least its experts), the

“competent and reliable scientific evidence” standard

adopted by those injunctions has always meant that

“independent,

well-designed,

well-conducted,

randomized, double-blind, placebo-controlled clinical

trials” are required in every case. Any supplement

manufacturer under injunction who failed to predict

the FTC’s new position faces potentially companyending sanctions.

Permitting the FTC to seek sanctions based on a

more restrictive standard outside the injunction

arrogates power to the FTC at the expense of litigants’

rights to “receive explicit notice of precisely what

conduct is outlawed,” Schmidt v. Lessard, 414 U.S.

473, 476 (1974); see Fed. R. Civ. P. 65(d). “A

government of laws and not of men can never tolerate

that arbitrary power.” Sessions v. Dimaya, 138 S. Ct.

1204, 1233-34 (2018) (Gorsuch, J., concurring).

Worse, the Eleventh Circuit refused to even

consider Hi-Tech’s arguments about the injunction’s

scope based on a novel waiver doctrine endorsed by

only one other Circuit and contradicted by all the rest.

That holding misinterprets this Court’s decision in

McComb v. Jacksonville Paper, 336 U.S. 187 (1949).

The Eleventh Circuit discounted Hi-Tech’s arguments

because Hi-Tech didn’t immediately foresee that the

FTC would reinterpret the injunction years later in

contempt proceedings to impose a far more stringent

standard on different products. Worse still, the

Eleventh Circuit found waiver even though the

district court had squarely addressed the injunction’s

scope as the primary ground for its decision, with no

mention of waiver whatsoever.

The Eleventh Circuit’s decision creates one

conflict and deepens another. No other court has

sanctioned the FTC’s attempt to regulate the

supplement industry by reinterpreting injunctions in

violation of Rule 65(d). In breaking rank and

endorsing the FTC’s approach, the Eleventh Circuit

ignored this Court’s warnings about ever-expanding

administrative power and arbitrary governance. See,

e.g., City of Arlington v. FCC, 569 U.S. 290, 315 (2013)

(Roberts, C.J., dissenting) (“[T]he danger posed by the

growing power of the administrative state cannot be

dismissed.”); see also Sup. Ct. R. 10(c). Moreover, the

Eleventh Circuit’s waiver ruling, which stripped HiTech of its statutory right to appeal, deepens an

existing circuit split, further justifying this Court’s

review. See Sup. Ct. R. 10(a). This Court should grant

certiorari to address these issues.

OPINIONS BELOW

The order of the United States Court of Appeals

for the Eleventh Circuit denying rehearing en banc is

reproduced at App.46-47. The Eleventh Circuit’s

opinion is reported at 786 F. App’x 947 and reproduced

at App.1-26. The opinion of the United States District

Court for the Northern District of Georgia is reported

at 2017 WL 6759868 and reproduced at App.48-164.

JURISDICTION

The United States Court of Appeals for the

Eleventh Circuit issued its decision on September 18,

2019. It issued an order denying the petition for

rehearing en banc on January 29, 2020. This Court

issued an order on March 19, 2020 extending all

deadlines for filing petitions for certiorari to 150 days

from denial of a timely rehearing petition. This Court

has jurisdiction under 28 U.S.C. § 1254(1).

CONSTITUTIONAL AND STATUTORY

PROVISIONS INVOLVED

Federal Rule of Civil Procedure 65(d) provides:

“Every order granting an injunction … must … state

the reasons why it issued,” “state its terms

specifically,” and “describe in reasonable detail—and

not by referring to the complaint or other document—

the act or acts restrained or required.”

The Fifth Amendment’s Due Process Clause

provides in relevant part that “No person shall … be

deprived of life, liberty, or property, without due

process of law.” U.S. Const. amend. V.

The relevant portions of the statutory framework

governing the FTC’s enforcement authority, 15 U.S.C.

§§ 45, 52, are reproduced at App.347-61.

The statutory provision governing Hi-Tech’s right

to appeal the district court’s judgment, 28 U.S.C.

§ 1291, is reproduced at App.362.

STATEMENT OF THE CASE

Hi-Tech sells dietary supplements. Federal law

defines a “dietary supplement” as “a product …

intended to supplement the diet” that contains a

vitamin; mineral; herb or other botanical; amino acid;

a dietary substance used to increase total dietary

intake; or a combination of any of these ingredients.

21 U.S.C. § 321(ff). Two federal agencies oversee

supplements: the FDA, which regulates dietary

supplements and their labeling under the Dietary

Supplement Health and Education Act of 1994

(“DSHEA”), Pub. L. No. 103-417, 108 Stat. 4325, and

the FTC, which regulates dietary-supplement

advertising through general prohibitions against

“false advertis[ing]” and “unfair or deceptive acts or

practices” in Sections 5 and 12 of the FTC Act. 15

U.S.C. §§ 45(a)(1), 52.

DSHEA was enacted to eliminate “unreasonable

regulatory

barriers”

marketing

dietary

supplements. Pub. L. No. 103-417, § 2(13), (14).

“Recognizing the health benefits of dietary

supplements, Congress enacted DSHEA to ensure

that supplements can be marketed and sold without

following the stringent requirements imposed on

drugs.” United States v. Bayer, No. CV 07-01(JLL),

2015 WL 5822595, at *3 (D.N.J. Sept. 24, 2015);

see Nutritional Health Alliance v. Shalala, 144 F.3d

220, 224 (2d Cir. 1998).

After DSHEA, if a supplement isn’t marketed as

a drug—i.e., the manufacturer does not claim it can

“diagnose, mitigate, treat, cure, or prevent a specific

disease or class of diseases,” 21 U.S.C. § 343(r)(6)—it

can’t be regulated as a drug. Instead, it must be

regulated as a food, Pub. L. No. 103-417, § 3(a), and

presumed safe unless the FDA shows it is

“adulterated.” See 21 U.S.C. § 342(f). DSHEA lets a

dietary-supplement advertiser make claims about

how a supplement affects the human body’s structure

or function if the claim has “substantiation” rendering

it “truthful and

§ 343(r)(6)(B). 1

not

misleading.”

U.S.C.

DSHEA does not, however, specify what

“substantiation” is required to render structurefunction claims like the ones here “truthful and not

misleading” and thus permissible under the FTC Act.

Guide at 3. Thus, in April 2001, the FTC published an

advertising guide for the dietary-supplement

industry. Under the Guide, dietary-supplement

advertisers may advertise a supplement’s efficacy if

the claim is supported by “competent and reliable

scientific evidence.” Id. at 21. As noted above, the

Guide defines “competent and reliable scientific

evidence” broadly. Id. It explains that “[t]here is no

fixed formula for the number or type of studies

required[.]” Id. at 9; Bayer, 2015 WL 5822595, at *3-4

(rejecting FTC’s position that “competent and reliable

scientific evidence” in a consent decree required

product-specific, randomized, clinical trials for

structure-function claim about supplements). And

“studies on the precise formula used in the advertised

product are not required.” Bayer, 2015 WL 5822595,

at *4.

The FTC has neither withdrawn nor amended the

Guide, but after the injunction’s entry here, the FTC

began a crusade to replace the Guide’s “flexible,”

“context specific” substantiation standard with a

“more precise” one. See David C. Vladeck, Director,

1 For example, a weight-loss supplement manufacturer, like HiTech, may state that a product “causes weight loss”—if that

statement is supported by adequate scientific “substantiation”—

but may not claim that its products cure obesity. 65 Fed. Reg.

1000, 1027 (Jan. 6, 2000).

FTC Bureau of Consumer Protection, Remarks on the

Priorities for Dietary Supplement Advertising

Enforcement 11 (Oct. 22, 2009). One way it did so was

by reinterpreting pre-existing consent decrees and

injunctions, which had adopted the Guide’s “flexible”

standard, as instead incorporating an inflexible one

that required product-specific, randomized, clinical

trials. See, e.g., Basic Research v. FTC, No. 2:09-CV0779 CW, 2014 WL 12596497, at *4-5 (D. Utah Nov.

25, 2014) (rejecting FTC’s effort to require randomized

clinical trials for all weight-loss claims); FTC v.

Garden of Life, Inc., 845 F. Supp. 2d 1328, 1334-35

(S.D. Fla. 2012) (same), aff’d in part, vacated in part,

516 F. App’x 852 (11th Cir. 2013); Bayer, 2015 WL

5822595, at *3-4 (similar). No court had agreed with

the FTC before the decisions here.

A. Round 1: The district court grants

summary judgment and enters a

permanent injunction; the Eleventh

Circuit affirms.

This litigation began in 2004, when the FTC sued

Hi-Tech and others, contending that their advertising

violated 15 U.S.C. §§ 45(a), 52. Doc. 1 ¶ 1. 2 The FTC

claimed that Hi-Tech was making weight-loss and

other efficacy claims about three dietary supplements

without a scientific basis. The district court had

jurisdiction under 28 U.S.C § 1345.

In 2008, the district court granted summary

judgment for the FTC and entered an injunction. That

injunction didn’t condition future efficacy claims for

2 Docket citations refer to FTC v. National Urological Group,

No. 1:04-CV-3294-CAP (N.D. Ga.).

other dietary supplements on “independent, welldesigned, well-conducted, randomized, double-blind,

placebo-controlled clinical trials.” Instead, it

prohibited future efficacy claims about any

supplement absent “competent and reliable scientific

evidence” substantiating those claims. App.244. That

standard was borrowed from the Guide, which

disavowed a one-size-fits-all, inflexible approach to

substantiation. App.234. Nor did the injunction itself

mention randomized clinical trials, let alone require

them.

On appeal Hi-Tech contended, among other

things, that the FTC’s substantiation standard

improperly restricted commercial speech. The

Eleventh Circuit summarily affirmed. FTC v. Nat’l

Urological Grp., 356 F. App’x 358 (11th Cir. 2009). But

Hi-Tech didn’t argue—and couldn’t have argued—that

that standard wasn’t specific enough to require

randomized, clinical trials for all supplements. And for

good reason: The injunction didn’t say it required

them, and the FTC’s petition for contempt concerning

different products wouldn’t be filed for another two

years.

B. Round 2: The district court holds HiTech in contempt; the Eleventh Circuit

vacates and remands.

In 2011, the FTC moved to hold Hi-Tech and

others in civil contempt for violating the 2008

injunction based on new claims about four new

supplements. See Doc. 332. The FTC contended that,

despite the injunction’s reference to “competent and

reliable scientific evidence,” only randomized clinical

trials could substantiate those efficacy claims.

Doc. 332-1, at 11-23. Based on purported violations of

this new, higher standard, the FTC sought kill-thecompany sanctions.

In response, Hi-Tech argued that the injunction,

which never mentioned randomized clinical trials, was

insufficiently specific under Rule 65(d). Doc. 346, at

14-21; Doc. 349; Doc. 396, at 2-15. Hi-Tech explained

that the contempt motion addressed new claims about

new products never at issue in Round 1 and that the

district court had held in Round 1 that “[d]ifferent

scientific evidence is required for different claims

impacting different products.” App.279.

Nonetheless, the district court found Hi-Tech in

contempt, holding Hi-Tech collaterally estopped from

contending that randomized clinical trials were not

required for the new products. App.222-27; App.21012. It held that even though the injunction never

mentioned randomized clinical trials and even though

new and different products (and claims) were at issue,

Hi-Tech was bound by the FTC’s expert opinion on

summary judgment in Round 1 that randomized

clinical trials should be required for all efficacy claims.

App.315-17. The district court thus refused to consider

any of Hi-Tech’s other substantiation evidence. Doc.

524, at 38; App.165-70.

After a bench trial on remedies, the district court

imposed a $40-million sanction. App.183-89.

On appeal, the Eleventh Circuit rejected the

district court’s collateral-estoppel ruling, vacated the

contempt order, and remanded for further

proceedings. App.35. It held that collateral estoppel

didn’t apply because “[t]he issue decided in [Round 1]

involved different representations, different products,

and the interpretation of a different legal standard.”

App.36. Because that holding was enough for vacatur,

the Eleventh Circuit didn’t reach Hi-Tech’s lack-ofspecificity argument. Far from deeming it waived or,

as the FTC argued, decided in Round 1, the court

deemed it “premature.” App.38.

C. Round 3: The district court reinstates

the contempt sanction; the Eleventh

Circuit relies on waiver to affirm.

On remand, Hi-Tech, Wheat, and Smith

continued to object, under Rule 65(d), that the

injunction didn’t specifically require randomized,

clinical trials for the efficacy claims at issue. Doc. 8761, at 3-8; Doc. 883, at 8-12; Doc. 959, at 4-8; Doc. 963,

at 1-17; Doc. 965, at 10-19, 31-37 & n.14.

The Round 3 proceedings culminated in 2017 with

a 10-day bench trial featuring multiple experts

disputing what standard the injunction required for

substantiation. Docs. 945-54. The FTC’s experts said

that only randomized clinical trials—at potentially

prohibitive cost—could provide “competent and

reliable scientific evidence,” while Hi-Tech’s experts

said other kinds of scientific studies could (and did)

provide substantiation. 3 But the FTC’s experts

couldn’t even agree amongst themselves on what

would satisfy that standard, differing over how long

and how large such studies had to be.

3 Some drug-level randomized clinical trials can cost tens or

even hundreds of millions of dollars to complete. See, e.g., Aylin

Sertkaya et al., Key Cost Drivers of Pharmaceutical Trials in the

United States, Clinical Trials (2016), https://www.reasearchgate.

net/publication/293640487_Key_cost_drivers_of_pharmaceutical

_clinical_trials_in_the_United_States.

Petitioners offered six claim-substantiation

experts from various fields, including clinical

research, nutrition, exercise physiology, weight-loss

medicine, and pharmacology. Each of these experts

considered the injunction’s language and the Guide’s

instruction. And agreeing that randomized, productspecific, placebo-controlled trials were not the only

way to support Hi-Tech’s claims, those experts

provided substantiation evidence that the FTC’s

experts couldn’t clearly and convincingly overcome.

Despite this battle of experts, the district court

again found Hi-Tech in contempt, re-imposing the

same $40-million sanction. App.159-64. The court

deemed the injunction reasonably specific based not

on what was in it, but what was outside it:

communications with Wheat’s lawyers, prior court

rulings, expert opinions, and the failure to

immediately anticipate and object to this issue in

Round 1. App.57-58, App.60, App.69, App.98-99. From

this, the district court concluded, the enjoined parties

subjectively “understood their obligations under the

injunctions; it is, therefore, clear and unambiguous.”

App.91.

In reaching that conclusion, the district court

considered and rejected on the merits Hi-Tech’s

arguments that the injunction wasn’t reasonably

specific. App.71, App.104, App.117. And in that 2017

order, it detailed for the first time the more exacting

standard it said Hi-Tech should have anticipated.

App.124, App.130-34.

The Eleventh Circuit affirmed, concluding that

Hi-Tech, Wheat, and Smith should have objected to

the injunction’s lack of specificity back in Round 1,

years before the contempt proceedings. App.12-19.

The court brushed aside what it called Hi-Tech’s “chief

argument on appeal,” that “the injunction is too

ambiguous to be enforced.” App.12. Though the

Eleventh Circuit acknowledged that the FTC had

always borne the burden of showing that the

injunction was unambiguous, it deemed Hi-Tech’s

objection waived, holding that Hi-Tech’s argument

“has been squarely foreclosed by McComb v.

Jacksonville Paper, 336 U.S. 187 (1949).” App.11-12.

The Eleventh Circuit defended its holding even

over Hi-Tech’s argument that it was entitled to appeal

the merits because they were the basis for the district

court’s decision. “We don’t disagree,” the court said.

App.17. But, relying on a single word (“ostensibly”), it

held that the district court had alternatively found

waiver by noting that, back in Round 1 before the

contempt proceedings, Petitioners “did not object to

any of the provisions they ostensibly challenge” now.

App.18 (emphasis in original).

The court further concluded that the FTC had

won the battle of experts, that Hi-Tech should have

had product-specific, randomized, double-blind,

placebo-controlled clinical trials for claims about the

four new products, and that the $40-million sanction

would stand. App.19-26.

Hi-Tech petitioned for rehearing, which was

denied. This petition followed.

REASONS FOR GRANTING THE PETITION

Neither the district court nor the appellate court

concluded that the injunction’s plain language

required the type of clinical trials required for drugs.

Instead, the district court derived that standard only

after a ten-day bench trial with competing expert

testimony over what the injunction meant. By

affirming that decision, and thus permitting the FTC

to reinterpret the injunction based on matters outside

its four corners, the Eleventh Circuit’s decision

conflicts with Rule 65(d), the case law applying it, and

due process. And by holding that Hi-Tech had waived

any challenge to the injunction’s scope, the decision

conflicts with this Court’s precedents, deepens an

existing circuit split, and impermissibly flips the

burden of proof in a contempt action. Finally, by

concluding that Hi-Tech had waived its right to

challenge the grounds for the district court’s reimposition of sanctions, the Eleventh Circuit denied

Hi-Tech the right to appeal that judgment. Each error

alone warrants review. Together, they cry out for it.

The Eleventh Circuit’s decision conflicts

with Fed. R. Civ. P. 65(d), the cases applying

it, and the due process principles

underpinning it.

By permitting the FTC to rewrite injunctions

after the fact, the Eleventh Circuit’s decision ignores

regulated parties’ due process rights, deviates from

this Court’s case law, and conflicts with lower court

cases.

A. The FTC’s rule-by-injunction violates

Rule 65(d).

The injunction here is “too vague to be sustained

as a valid exercise of federal judicial authority.” Int’l

Longshoremen’s Ass’n v. Phila. Marine Trade Ass’n,

389 U.S. 64, 73-74 (1967). When it was entered, no

reasonable person would have understood its text—

drawn from the FTC’s own Guide—to be satisfied only

by double-blind, product-specific, placebo-controlled

studies when the injunction contained no such

requirement, and when the Guide disavowed any fixed

formula for substantiation. Holding Hi-Tech to that

new standard now violates Rule 65(d), offends due

process, and conflicts with this Court’s case law, and

that of other Circuits.

1. Notice of legally binding rules is the most basic

requirement of due process. See, e.g., Connally v. Gen.

Constr., 269 U.S. 385, 391 (1926). Accordingly, “those

against whom an injunction is issued should receive

fair and precisely drawn notice of what the injunction

actually prohibits.” Granny Goose Foods v. Bhd. of

Teamsters & Auto Truck Drivers Local No. 70, 415

U.S. 423, 444 (1974); Schmidt, 414 U.S. at 476 (same).

Rule 65(d) “embodies” that “fundamental due process

requirement of notice.” United States v. Wilson, 908

F.2d 968 (4th Cir. 1990); see U.S. Const., amend. V.

Thus, Rule 65(d)’s specificity provisions “are no mere

technical requirements,” but exist “to prevent

uncertainty and confusion on the part of those faced

with injunctive orders, and to avoid the possible

founding of a contempt citation on a decree too vague

to be understood.” Schmidt, 414 U.S. at 476.

To comport with due process, Rule 65 requires an

injunction to say precisely what the enjoined party

must do or not do; accordingly, every injunction must

“describe in reasonable detail—and not by referring to

the complaint or other document—the act or acts

restrained or required.” Fed. R. Civ. P. 65(d).

2. Here, the injunction prohibited future efficacy

claims about supplements absent “competent and

reliable scientific evidence” substantiating those

claims. App.244. It never conditioned future efficacy

claims for other products on “independent, welldesigned, well-conducted, randomized, double-blind,

placebo-controlled clinical trials”—the standard

applied and upheld below. Because this higher

standard is found nowhere within the injunction’s four

corners, that should have been the end of the matter.

It wasn’t. Instead, the Eleventh Circuit held that

matters outside the injunction’s text and after its

entry—including expert testimony and Hi-Tech’s

subjective knowledge—supplied the textual specificity

lacking on the injunction’s face.

That ruling conflicts with this Court’s

jurisprudence and that of other Circuits. “Rule 65(d)

protects the party against which an injunction is

issued by requiring clear notice as to what that party

must do or refrain from doing.” Abbott v. Perez, 138 S.

Ct. 2305, 2321 (2018). Appellate courts have thus held

that unless an injunction is “a standalone separate

document that spells out within its four corners

exactly what the enjoined parties must or must not

do,” it “does not comply with Rule 65(d).” Auto

Driveaway Franchise Sys. v. Auto Driveaway

Richmond, 928 F.3d 670, 676 (7th Cir. 2019); see also,

e.g., Farmer v. Banco Popular of N. Am., 557 F. App’x

762, 766-67 (10th Cir. 2014) (A “strict approach” to

Rule 65(d) “mandates that the parties be able to

interpret the injunction from the four corners of the

order”); Max’s Seafood Cafe ex rel. Lou-Ann v.

Quinteros, 176 F.3d 669, 673 (3d Cir. 1999) (limiting

injunction’s scope to “what is within the four corners”);

United States v. Saccoccia, 433 F.3d 19, 28 (1st Cir.

2005) (“The test is whether the putative contemnor is

able to ascertain from the four corners of the order

precisely what acts are forbidden.”). Even the

Eleventh Circuit has understood (and followed) this

fundamental principle in the not-so-distant past. See

LabMD v. FTC, 894 F.3d 1221, 1235-36 (11th Cir.

2018) (holding that “[b]eing held in contempt and

sanctioned pursuant to an insufficiently specific

injunction is … a denial of due process,” and that an

“indeterminable standard of reasonableness” only

ascertainable through expert testimony was

unenforceable).

Here, however, the Eleventh Circuit affirmed a

$40-million contempt sanction based on a standard

determined only after a 10-day bench trial. That

conflicts with Rule 65(d), this Court’s case law, and

case law from other Circuits.

3. Even assuming extrinsic evidence were

relevant, Hi-Tech still had no notice from the

injunction that the more stringent standard would

apply to all supplements. The injunction’s “competent

and reliable scientific evidence” standard was

borrowed from FTC guidance, which sets forth a

flexible definition that varies by product. Guide at 9.

The injunction never mentioned randomized clinical

trials, let alone required them. Cf. Good Samaritan

Hosp. v. Shalala, 508 U.S. 402, 417 (1993) (“[T]he

consistency of an agency’s position is a factor in

assessing the weight that position is due.”). At no time

would a reasonable person have equated “competent

and reliable scientific evidence” with (and only with)

“independent,

well-designed,

well-conducted,

randomized, double-blind, placebo-controlled clinical

trials.”

The FTC doesn’t really think that this language

requires randomized clinical trials either. In other

cases, the FTC has sought more aggressive injunctions

that expressly require randomized clinical trials for

certain claims, including weight-loss claims, see, e.g.,

Doc. 744-25 at 6-7 (Iovate consent decree). Because the

FTC didn’t do that here, it had to argue that two

patently distinct standards were in fact the same. But

the FTC’s use elsewhere of different, clearer language

requiring randomized clinical trials tacitly concedes

that the injunction here didn’t require them. See In re

HealthyLife Scis., File No. 122 3287, 2014 WL

4651907, at *27 (F.T.C. Sept. 11, 2014) (consent order

requiring randomized clinical trials); In re Brown, 152

F.T.C. 466, 481-82 (F.T.C. 2011) (same); In re Nestlé

HealthCare Nutrition, 151 F.T.C. 1, 11, 13 (F.T.C.

2011) (same); FTC v. Cal. Pac. Research, No. CV-N-88602BRT, 1991 WL 208470, at *1 (D. Nev. Aug. 27,

1991) (injunction requiring the same).

4. But assume that’s not true, and that

“competent and reliable scientific evidence” can be

plausibly interpreted as meaning (without actually

saying) “only independent, well-designed, wellconducted, randomized, double-blind, placebocontrolled clinical trials.” Under this counterfactual

scenario, that standard is susceptible to at least two

meanings and therefore still fatally ambiguous. It’s

hard to seriously dispute this. To figure out what the

injunction meant required a 10-day bench trial with

expert testimony and other extrinsic evidence where

even the FTC’s own experts couldn’t agree over what

would satisfy the injunction.

That, too, conflicts with existing contempt case

law because when courts are faced with an ambiguous

order, the tie goes to the defendant. “The

longstanding, salutary rule in contempt cases is that

ambiguities and omissions in orders redound to the

benefit of the person charged with contempt.” Drywall

Tapers & Pointers of Greater N.Y. v. Local 530 of

Operative Plasterers & Cement Masons Int’l Ass’n, 889

F.2d 389, 400 (2d Cir. 1989) (Mahoney, J., concurring

in part). Permitting the FTC to redefine injunctions in

contempt proceedings “would turn [their] normal

construction … upside-down, replacing the doctrine of

lenity with a doctrine of severity.” Crandon v. United

States, 494 U.S. 152, 178 (1990) (Scalia, J., concurring

in judgment). And because an injunction has both

criminal and civil applications, Int’l Union v. Bagwell,

512 U.S. 821, 827-28 (1994), “the rule of lenity governs

its interpretation in both settings.” Whitman v. United

States, 574 U.S. 1003, 135 S. Ct. 352, 353-54 (2014)

(mem.); see United States v. Thompson/Ctr. Arms, 504

U.S. 505, 518 n.10 (1992) (plurality opinion); id. at 519

(Scalia, J., concurring in judgment).

B. The

Eleventh

Circuit’s

decision

improperly lets the FTC redefine an

injunction in contempt proceedings and

conflicts with the decisions of other

courts.

1. As the administrative state ballooned,

Congress passed the Administrative Procedure Act as

a “working compromise, in which broad delegations of

discretion were tolerated as long as they were checked

by extensive procedural safeguards.” FCC v. Fox

Television Stations, 556 U.S. 502, 537 (2009)

(Kennedy, J., concurring). Here, the FTC sought to

avoid those procedural safeguards by reinterpreting

broadly worded injunctions to impose a new standard

at odds with DSHEA. Accordingly, the FTC asserts

that companies enjoined from making efficacy claims

without “competent and reliable scientific evidence”—

like Hi-Tech—now must come up with “independent,

well-designed, well-conducted, randomized, doubleblind, placebo-controlled clinical trials” to support

their claims.

If the FTC believed that was the appropriate

standard, it could have tried to promulgate a rule

establishing it. It didn’t, for obvious reasons. 4 Or it

could have brought a new enforcement action against

Hi-Tech. It didn’t do that either. It didn’t even seek

prospective modification of the injunction to

incorporate this new, more demanding standard.

Instead, the FTC instituted contempt proceedings,

contending that its change in position could be

enforced by reading it backwards into an injunction

4 The FTC would have failed. “Placebo-controlled, double-blind

testing is not a legal requirement for consumer products.” FTC v.

QT, 512 F.3d 858, 861 (7th Cir. 2008); see id. (“Nothing in the

Federal Trade Commission Act, the foundation of this litigation,

requires placebo-controlled, double-blind studies.”). In POM

Wonderful v. FTC, 777 F.3d 478, 497 (D.C. Cir. 2015), the D.C.

Circuit impliedly rejected the FTC’s position. There, the consent

decree provision at issue explicitly required “randomized and

controlled human clinical trials.” Id. at 497, 502. The D.C. Circuit

distinguished that provision, which pertained to “diseaserelated” claims, from another, which pertained to “more general

claims about health benefits,” and which required only

“competent and reliable scientific evidence” not “randomized,

controlled, human clinical trials support.” Id. at 489 (emphasis

omitted).

issued more than a decade earlier. That flouts this

Court’s recent caution that administrative agencies’

abuse of equitable remedies cannot be tolerated. Cf.

Liu v. SEC, No. 18-1501, slip op. (U.S. June 22, 2020). 5

2. Even more problematic, the FTC sought to

enforce its new “rule” in contempt proceedings bereft

of the normal safeguards applicable to enforcement

actions. Civil contempt proceedings leave the offended

judge solely responsible for identifying, prosecuting,

adjudicating, and sanctioning the contumacious

conduct. Young v. United States ex rel. Vuitton et Fils

S.A., 481 U.S. 787, 822 (1987) (Scalia, J., concurring

in judgment); Bloom v. Illinois, 391 U.S. 194, 202

(1968) (noting that the contempt power is uniquely

“liable to abuse”). So courts are “bound, by the first

principles of justice, not to sanction a decree so vague

as to put the whole conduct of the defendants’ business

at the peril of a summons for contempt.” Swift & Co.

v. United States, 196 U.S. 375, 396 (1905); Int’l

Longshoremen’s Ass’n, 389 U.S. at 76 (Contempt “is a

potent weapon. When it is founded upon a decree too

5 Decided the week this petition was filed, Liu supports vacatur

here for an independent reason: the $40-million sanction against

Hi-Tech was based on its gross revenue, not net profits. Doc. 902

at 50-51, 56; Doc. 945 at 14; Doc. 953 at 118-21, 125-27; Doc. 965

at 62. That’s impermissible under Liu, where this Court held,

“[b]y incorporating these longstanding equitable principles into

[15 U.S.C.] § 78u(d)(5), Congress prohibited the SEC from

seeking an equitable remedy in excess of a defendant’s net profits

from wrongdoing.” Slip op. at 12. Because the statute here, 15

U.S.C. § 45, authorizes “equitable relief” in the same way as

§ 78u(d)(5), it incorporates this same principle and is therefore

subject to the same limitation recognized in Liu. For this reason

alone, this Court should grant this petition, vacate the sanction,

and remand for recalculation in light of Liu.

vague to be understood, it can be a deadly one”).

“Congress responded to that danger by requiring that

a federal court frame its orders so that those who must

obey them will know what the court intends to require

and what it means to forbid.” Int’l Longshoremen’s

Ass’n, 389 U.S. at 76. Both courts below ignored these

requirements.

3. This isn’t the only case where the FTC has

sought to reinterpret existing language in injunctions

or consent decrees to require a more stringent

standard. But this is the only one where the FTC’s

after-the-fact revision was affirmed. Every other court

to have considered the attempt has rejected it.

In Bayer, the court held that “competent and

reliable scientific evidence does not require drug-level

clinical trials, and the Government cannot try to

reinvent this standard through expert testimony.”

2015 WL 5822595, at *15. “The Government cannot

seek contempt on the basis of a lone expert who

proposes a standard that was not disclosed to industry

until the day the government filed its contempt

motion,” the court explained, especially “where, as

here, that testimony is inconsistent with the agency’s

own guidance.” Id. The court reiterated that “[t]he

Government cannot enter into a consent decree using

the general competent and reliable scientific evidence

standard and then subsequently require [randomized

clinical trials] through the expert testimony it

produces in a contempt action.” Id. at *15.

Similarly, in Basic Research, the court rejected

the FTC’s effort to require randomized clinical trials

for all weight-loss claims. The court held that a

consent decree requiring “competent and reliable

scientific evidence” to support certain representations

did not require randomized clinical trials. 2014 WL

12596497, at *4-5. The court held that demanding

“Gold Standard” clinical trials “exceed[ed] the

requirements” of the consent decree. Id. at *4, 13.

And again in Garden of Life, the court held that a

consent decree speaking only of “competent and

reliable scientific evidence” couldn’t be redefined

through expert testimony that would “require [the]

Court to read additional requirements into the

Consent Decree,” which it would have to do if

randomized clinical trials were required. 6 845 F. Supp.

2d at 1334-35.

Despite this previously unbroken line of

authority, the district court concluded the opposite—

and worse yet, the Eleventh Circuit affirmed. That

warrants granting certiorari.

II. The Eleventh Circuit’s decision incorrectly

relieved the FTC of its burden to show that

the injunction specifically prohibited HiTech’s conduct.

To affirm the $40-million contempt sanction and

find waiver, the Eleventh Circuit looked outside the

injunction’s four corners to, among other things, HiTech’s purported subjective knowledge and expert

testimony. It justified doing so because Petitioners

had not anticipated and objected to this rewriting

6 The FTC did not appeal Bayer or Basic Research. Although it

did appeal Garden of Life, it didn’t argue that randomized clinical

trials were the only way to satisfy the competent-and-reliablescientific-evidence requirement. Brief for Plaintiff-Appellant

FTC at *5, FTC v. Garden of Life, 516 F. App’x 852 (11th Cir.

2013) (No. 12-12382-AA), 2012 WL 2872220.

immediately in Round 1. In so holding, the Eleventh

Circuit misapplied this Court’s decision in McComb v.

Jacksonville Paper, 336 U.S. 187 (1949), and deepened

a circuit split regarding when an enjoined party must

assert its lack-of-specificity argument.

A. The decision below misapplies this

Court’s precedent.

The Eleventh Circuit wrongly inferred from

McComb that an enjoined party must immediately

object to even latent uncertainties when an injunction

is entered or forever waive its right to challenge that

injunction. That’s not what McComb says. McComb

merely held that the enjoined party should have

objected upon entry of the injunction, where the

injunction cross-referenced two statutes that

“provide[] the formula by which the amounts [of wages

and overtime pay] can be simply computed.” 336 U.S.

at 194. Critically, the statutes provided detailed

formulas, down to the hour and the cent, for paying

wages. See id. Thus, the injunction was specific

enough, despite the statutory cross-reference, to put a

reader immediately on notice of precisely what it

required—and thus enable the enjoined party to object

on that basis.

But that isn’t the case here, where the injunction

called for “competent and reliable scientific evidence,”

a standard which requires “the expertise of

professionals” to determine what is required for each

product. App.234, App.240-44. The standard is broad

by design and, without more, unclear about what it

requires in any given case. All that was clear when the

injunction was entered was that it did not require

randomized clinical trials in every case.

Subsequent Supreme Court cases painted

McComb’s already narrow exception into a corner,

emphasizing the due process guarantee that “those

against whom an injunction is issued should receive

fair and precisely drawn notice” in the injunction itself

“of what the injunction actually prohibits.” Granny

Goose Foods, 415 U.S. at 444. Indeed, in International

Longshoremen’s Association, this Court reversed a

civil-contempt finding “founded upon a decree too

vague to be understood,” calling the error “serious and

decisive.” 389 U.S. at 76. And in Schmidt, a decree

telling defendants “not to enforce the present

Wisconsin scheme against those in the appellee’s

class” could not support a contempt finding because “it

plainly does not satisfy the important requirements of

Rule 65(d).” 414 U.S. at 476-77 (cleaned up). The

Eleventh Circuit’s decision here cannot be squared

with those cases.

B. The decision below deepens a lopsided

Circuit split.

The Eleventh Circuit’s decision also adds to an

uneven circuit split regarding whether an accused

party may be held in contempt for violating an

injunction that does not clearly encompass the

accused conduct.

1. Consistent with this Court’s precedent, nearly

every Circuit has for decades consistently answered

that question with a resounding “no.” The majority

rule is that defendants can challenge the specificity of

an injunction in contempt proceedings. See, e.g., H.K.

Porter v. Nat’l Friction Prods., 568 F.2d 24, 26-27 (7th

Cir. 1977), as amended (Jan. 5, 1978) (contempt

proceedings “were improper because the … order …

failed to comply” with Rule 65(d)); Williams v. United

States, 402 F.2d 47, 48-49 (10th Cir. 1967)

(considering fully defendant’s specificity argument on

appeal from contempt); Russell C. House Transfer &

Storage v. United States, 189 F.2d 349, 351 (5th Cir.

1951) (holding that a defendant can challenge the

scope of an injunction in a contempt proceeding).

Moreover, courts have consistently sustained

those challenges where the injunction does not clearly

encompass the complained-of conduct. See, e.g.,

Imageware v. U.S. W. Commc’ns, 219 F.3d 793, 797

(8th Cir. 2000) (reversing contempt finding for

violating a protective order because the alleged

contemnors “could reasonably, even if perhaps

erroneously, have believed that [the documents in

question] were not subject to [the protective order]”);

NBA Props. v. Gold, 895 F.2d 30, 31-33 (1st Cir. 1990)

(reversing contempt finding where sustaining it would

require “reading the decree rather strongly against,

rather than to the benefit of, the person charged with

contempt” (cleaned up)); Polo Fashions v. Stock Buyers

Int’l, 760 F.2d 698, 700 (6th Cir. 1985) (while “the

validity of the injunction is not an issue in … contempt

[proceedings],” specificity is, and an injunction must

be “sufficiently clear and specific to provide the basis

for … contempt” (emphasis added)); Ford v.

Kammerer, 450 F.2d 279, 280 (3d Cir. 1971) (finding

injunction unenforceable in contempt proceedings

because “the provisions of the order contain no

prohibitory language explicitly addressed to” the acts

at issue); see also CPC Int’l v. Skippy, 214 F.3d 456,

459 (4th Cir. 2000) (“terse and sweeping injunction”

“d[id] not comply with the requirements of Rule

65(d)”); Gates v. Shinn, 98 F.3d 463, 467-72 (9th Cir.

1996) (reversing contempt finding because the consent

decree lacked specificity, “a predicate to a finding of

contempt”); Doe v. Gen. Hosp. of D.C., 434 F.2d 423,

424-25 (D.C. Cir. 1970) (declining to find defendants

in contempt given “possible confusion” regarding

injunction’s meaning).

3. Until now the only court to rule differently was

the Federal Circuit, which, in a 7-5 en banc decision,

relied on McComb to find a lack-of-specificity defense

waived because it had not been raised immediately on

the injunction’s entry—even though the injunction

itself didn’t directly address the question. TiVo v.

EchoStar, 646 F.3d 869, 884-88 (Fed. Cir. 2011). But

as TiVo’s powerful—and correct—dissent observes,

“no other court has read McComb in this way.” Id. at

896-97 (Dyk, J., dissenting in part and collecting

cases). That was true, at least until the Eleventh

Circuit’s decision here.

C. The decision below flips the burden for

civil contempt.

The Eleventh Circuit’s holding isn’t really about

waiver. Instead, it rests on a fundamental error about

the issue presented. The relevant question isn’t

whether the injunction is invalid because it is vague.

(It is, but that’s not the point.) Rather, it’s whether a

court can lawfully hold a party in contempt where the

injunction does not unambiguously prohibit the

purportedly contumacious conduct.

That subtle but important difference determines

who bears the burden of proof. In a constitutional

vagueness challenge, “the complainant”—i.e., HiTech—“must demonstrate that the law is

impermissibly vague.” Vill. of Hoffman Estates v.

Flipside, Hoffman Estates, 455 U.S. 489, 497 (1982).

But in a contempt proceeding, the “petitioning

party”—here,

the

FTC—must

“clearly

and

convincingly show the district court that (1) the

injunction was valid and lawful; [and] (2) the order

was clear, definite, and unambiguous.” App.11.

The Eleventh Circuit made no pretense of holding

the FTC to its burden. It never said that the injunction

was specific or unambiguous, only that it was

“reasonable, particularly when we consider that the

defendants did not object to the phrase.” App.17.

Instead, it rejected Hi-Tech’s argument on this point

without any explanation, citing McComb to conclude

that “[t]o the extent that the defendants make this

argument to suggest that ambiguity objections can

never be waived, we find that contention to be

meritless.” App.16-17.

But calling a contention “meritless” doesn’t make

it so. A contempt finding cannot be based on an

ambiguous or non-specific injunction. It was the FTC’s

burden to show that the injunction unambiguously

prohibited Hi-Tech’s conduct. It couldn’t—as shown by

the district court needing a ten-day bench trial to

determine what the standard should be. “Waiver” has

no place here, where the Eleventh Circuit didn’t

explain how Hi-Tech could waive something that the

FTC had the burden to show.

III. The Eleventh Circuit’s decision stripped HiTech of its right to appeal the district court’s

judgment.

If the above were not enough, the opinion below

also denied Hi-Tech its statutory right to appeal by

holding that Hi-Tech had abandoned its specificity

arguments. The district court decided that issue on the

merits, with no mention of waiver or forfeiture. This

Court should grant review to clarify that, under 28

U.S.C. § 1291, a Court of Appeals cannot ignore the

district court’s stated ground for judgment by finding

waiver of an issue the district court passed upon.

1. Under § 1291, “[t]he courts of appeals … have

jurisdiction of appeals from all final decisions of the

district courts of the United States.” The

“[j]urisdiction of the courts of appeals is not

discretionary,” but instead is conferred as a “‘matter of

right.’” Adsani v. Miller, 139 F.3d 67, 77 (2d Cir. 1998);

see Hall v. Hall, 138 S. Ct. 1118, 1124 (2018). To

arbitrarily deprive an appellant of that right violates

due process. See U.S. Const. amend. V; Adsani, 139

F.3d at 76-77 (citing Lindsey v. Normet, 405 U.S. 56,

77 (1972)).

This Court has never addressed the question

presented here. But another line of cases reveals that

there’s only one right answer. When deciding whether

to grant review of a federal question in “a judgment

rendered by the highest court of a State” under 28

U.S.C. § 1257(a), this Court may grant review even if

the parties had not pressed the issue if the State court

passed on it. See, e.g., Schad v. Arizona, 501 U.S. 624,

630 n.2 (1991); Orr v. Orr, 440 U.S. 268, 274-75 (1979).

Thus, when a State’s highest court decides an issue,

this Court may review it even if the parties had never

pressed it. What might otherwise have been waiver or

forfeiture is cured by the State court’s decision.

That makes good sense. After all, waiver and

forfeiture rules exist primarily to serve the interests

of “judicial efficiency and finality.” Holguin-

Hernandez v. United States, 140 S. Ct. 762, 767 (2020)

(Alito, J., concurring). Thus, “[r]equiring a party to

bring an error to the attention of the court enables the

court to correct itself, obviating the need for an appeal.

At the very least, the court can explain its reasoning

and thus assist the appellate process.” Id. But finding

a fully briefed-and-considered issue waived, like the

Eleventh Circuit did here, serves neither interest and

offends “the public policy favoring disposition of cases

on their merits.” E.g., Pagtalunan v. Galaza, 291 F.3d

639, 642 (9th Cir. 2002).

2. Although many Circuits—including the

Eleventh—have held that a district court’s deciding an

issue can cure an appellant’s prior failure to have

raised and pressed it, the Circuits disagree over

whether addressing such an issue on appeal is

mandatory or discretionary.

Generally, “a federal appellate court does not

consider an issue not passed upon below.” Singleton v.

Wulff, 428 U.S. 106, 120 (1976). Nor are federal

appellate courts required to address an issue raised

for the first time on appeal. Nelson v. Adams USA, 529

U.S. 460, 469 (2000). And the Circuits agree that an

issue may be waived or forfeited for a later appeal

where a party could have raised it in an earlier appeal

but didn’t. See, e.g., AngioDynamics v. Biolitec AG, 823

F.3d 1, 4 (1st Cir. 2016); Howe v. City of Akron, 801

F.3d 718, 741-43 (6th Cir. 2015). But in each instance,

an appellate court retains discretion to decide whether

to address an abandoned issue. Exxon Shipping v.

Baker, 554 U.S. 471, 487 (2008). Here, the court’s

discretion breaks in favor of review on the merits.

Consistent with that principle, several Circuits

hold that a district court’s deciding an otherwise

waived or forfeited issue cures the failure to raise it.

See, e.g., Hi-Tech Pharm. v. HBS Int’l, 910 F.3d 1186,

1194 (11th Cir. 2018); Firestone Fin. v. Meyer, 796

F.3d 822, 825-26 (7th Cir. 2015); Ahanchian v. Xenon

Pictures, 624 F.3d 1253, 1260 n.8 (9th Cir. 2010);

Blackmon-Malloy v. U.S. Capitol Police Bd., 575 F.3d

699, 707-08 (D.C. Cir. 2009). Take, for example, the

First Circuit’s rule: When “an argument is raised

belatedly in the district court but that court, without

reservation, elects to decide it on the merits, the

argument is deemed preserved for later appellate

review.” Negrón-Almeda v. Santiago, 528 F.3d 15, 26

(1st Cir. 2008).

But the Circuits split over the nature of the cure.

“Views vary about whether application of the

[forfeiture] rule is discretionary.” United States v.

Murphy, 769 F. App’x 631, 640 (10th Cir. 2019)

(acknowledging Circuit split).

Six Circuits view deciding the issue on the merits

as taking the issue outside the waiver or forfeiture

doctrines altogether, with the result that appealing it

becomes a matter of right. See, e.g., Negrón-Almeda,

528 F.3d at 26 (1st Cir.); United States v. Clariot, 655

F.3d 550, 556 (6th Cir. 2011) (“[T]here can be no

forfeiture where the district court nevertheless

addressed the merits of the issue.” (cleaned up));

Moriarty v. Svec, 164 F.3d 323, 328 (7th Cir. 1998) (an

“appellant can always challenge the legal theory upon

which the district court relied in its decision”); PFS

Distribution v. Raduechel, 574 F.3d 580, 598 (8th Cir.

2009) (“We cannot say [cross-appellant] waived these

arguments, however, because the district court did

address the arguments in its order …”); HernandezRodriguez, 352 F.3d at 1328 (10th Cir.) (appeal from a

district court’s sua sponte ruling governed not by plain

error, but by the normal standard of appellate review);

Blackmon-Malloy, 575 F.3d at 707 (D.C. Cir.)

(discretionary forfeiture rule “does not apply where

the district court nevertheless addressed the merits of

the issue”).

But in at least three other Circuits, it is within the

appellate court’s discretion to review the issue. See,

e.g., Roberts v. Capital One, N.A., 719 F. App’x 33, 35

(2d Cir. 2017) (choosing to “exercise our discretion to

address the merits” of an issue not pressed but

decided); Lampton v. Diaz, 639 F.3d 223, 227 n.14 (5th

Cir. 2011) (asking whether addressing the otherwise

forfeited issue would prejudice appellee); Comcast of

Sacramento I v. Sacramento Metro. Cable Television

Comm’n, 923 F.3d 1163, 1168-69 (9th Cir. 2019)

(stating that “the waiver rule does not have obvious

application here” and exercising discretion to address

issue). Flipping traditional waiver doctrine on its

head, the rule in these Circuits erroneously permits

discretion that works to deny, rather than to afford,

review on the merits.

On this point, there is even equivocation within

some Circuits. Compare, e.g., Ahanchian, 624 F.3d at

1260 n.8 (Ninth Circuit’s waiver rule “does not apply

where the district court nevertheless addressed the

merits of the issue” not explicitly raised by the party

(cleaned up)) and Blackmon-Malloy, 575 F.3d at 70708 (D.C. Cir.) (discretionary forfeiture rule “does not

apply where the district court nevertheless addressed

the merits of the issue”) with Comcast of Sacramento

I, 923 F.3d at 1168-69 (9th Cir.) (treating matter as

discretionary) and Al Bahlul v. United States, 767

F.3d 1, 48 (D.C. Cir. 2014) (Rogers, J., concurring and

dissenting) (“De novo review of a forfeited issue is

permitted where the lower court has nevertheless

addressed the merits of the issue.” (cleaned up)).

Exacerbating this confusion, the decision below

throws a wrench into the Eleventh Circuit’s own case

law. The waiver ruling here, App.17-18, conflicts with

the Eleventh Circuit’s prior holding that, “after the

district court considered the merits of at least two of

[appellee]’s three arguments and relied on them in

granting the motion to dismiss, [appellant] was

entitled to challenge those arguments on appeal

whether or not it had done so in the district court.” HiTech Pharm., 910 F.3d at 1194.

This split is significant: Under one view, the Court

of Appeals must address the issue; under the other, it

may (or may not). In other words, under one view,

there is a right to appeal, under the other, at best a

possibility.

The latter view is wrong. As explained above,

where the district court decides an issue and relies on

the decision to support its judgment—as here—the

aggrieved party should have an absolute right to

appeal it under § 1291. Discretion that denies review

on the merits cannot be part of this calculus, otherwise

the right to appeal isn’t really a right.

3. This case clearly implicates the split. Before

finding Hi-Tech in contempt, the district court first

decided that the injunction had stated “its terms

specifically,” which is always required by Rule 65(d).

See Granny Goose Foods, 415 U.S. at 444. That

question was fully briefed, App.60-62, App.69-101,

App.103-04, App.117, App.150-51 n.29 (addressing

specificity and clarity of injunction), and was an

essential predicate for holding Petitioners in

contempt, App.69-70 (proving civil contempt requires

clear and convincing evidence that, among other

things, the injunction order was clear).

To be sure, the District Court questioned whether

Petitioners should have attacked the injunction’s lack

of specificity immediately by taking it up back in their

2008 appeal, App.73-74, App.85-86, App.97-99. But it

never held that the issue had been forfeited, let alone

affirmatively waived. Instead, it viewed that absence

as evidence that the injunction was specific, i.e., that

Petitioners must have known subjectively what it

meant. App.85-86. In fact, the district court addressed

the issue head-on precisely because it did “not find the

absence of a timely appellate challenge [in 2008]

dispositive.” App.86 (emphasis added); accord App.71,

72, 99 (the district court “will proceed through the civil

contempt framework … while addressing each of the

defendants’ defenses thereto,” “will address” the issue,

and “will address the argument again”—and doing so).

Because the district court’s opinion plainly didn’t

contain a waiver or forfeiture ruling, the Eleventh

Circuit had to create one. Glossing over the 40 pages

analyzing how the injunction was specific under Rule

65(d) in light of the evidence from the ten-day bench

trial, App.60-62, App.69-101, App.103-04, App.117,

App.150-51 n.29, and giving dispositive weight to a

single adverb, the Eleventh Circuit ignored the ruling

that was there in favor of one that wasn’t, and held the

issue waived because it wasn’t raised in 2008. “[T]he

[district] court said that ‘the defendants were given an

opportunity to object to the scope of the injunctions

before they were entered, but they did not object to any

of the provisions they ostensibly challenge now.’”

App.18. “So there can be no doubt,” the Court of

Appeals said, “that the district court in fact concluded

that the defendants had waived their ambiguity

arguments.” App.18. But the record leaves no doubt

that, throughout the post-remand contempt

proceedings in 2017, Petitioners repeatedly

challenged whether the injunction was specific. Doc.

876-1, at 3-8; Doc. 879, at 4-6; Doc. 883, at 7-10; Doc.

957, at 7-11; Doc. 963, at 1-12, 17-23; Doc. 965, at 1014, 31 n.14. And the Court never explained how it

could have concluded that the issue was “premature”

in the first contempt appeal if it was in fact waived.

Hi-Tech challenged whether the injunction was

specific, and the district court decided it was specific

enough. Accordingly, Hi-Tech was entitled to appeal

that ruling per § 1291, and the Eleventh Circuit had

no discretion to deny that right.

4. This issue warrants review. Otherwise, some

appellants may be afforded their right to appeal under

§ 1291, while others—like the Petitioners here—may

not. The latter scenario violates due process. See

Adsani, 139 F.3d at 76-77.

Confirming the right to appeal from what the

district court actually and necessarily decides

wouldn’t dilute waiver or forfeiture doctrines.

Appellate courts could still, for example, decline to

address issues where waiver or forfeiture provides an

alternative ground for the district court’s judgment.

Granting review here would, however, clarify the

waiver doctrine’s scope in relation to § 1291. Because

the Circuits disagree over that basic question, a

consistent answer that applies across the country is

important to litigants. See Sup. Ct. R. 10.

This Court should grant certiorari and hold that,

consistent with § 1291, the Courts of Appeals lack

discretion to disregard as waived an issue that the

district court necessarily decided.

CONCLUSION

For the foregoing reasons, this Court should grant

the petition for certiorari.

Respectfully submitted,

E. Vaughn Dunnigan

Anne M. Voigts

2897 N Druid Hills Road Counsel of Record

Suite 142

KING & SPALDING LLP

Atlanta, GA 30329

601 S. California Avenue

Suite 100

Counsel for Petitioner

Palo Alto, CA 94304

Stephen Smith

(650) 422-6700

avoigts@kslaw.com

Robert F. Parsley

Meredith C. Lee

MILLER & MARTIN PLLC

832 Georgia Ave., Suite 1200

Chattanooga, TN 37402

I. Cason Hewgley IV

KING & SPALDING LLP

1700 Pennsylvania Ave. NW

Washington, DC 20006

June 26, 2020

Counsel for Petitioners

Jared Wheat & Hi-Tech

Pharmaceuticals, Inc.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.