Opposition Brief — Hi-Tech Pharmaceuticals, Inc., et al., Petitioners v. Federal Trade Commission, et al.

Supreme Court briefSep 4, 2020

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No. 19-1445

In the Supreme Court of the United States

HI-TECH PHARMACEUTICALS, INC., ET AL., PETITIONERS

v.

FEDERAL TRADE COMMISSION, ET AL.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT

BRIEF FOR THE FEDERAL RESPONDENT

IN OPPOSITION

ALDEN F. ABBOTT

General Counsel

JOEL MARCUS

Deputy General Counsel

MARIEL GOETZ

Attorney

Federal Trade Commission

Washington, D.C. 20580

JEFFREY B. WALL

Acting Solicitor General

Counsel of Record

Department of Justice

Washington, D.C. 20530-0001

SupremeCtBriefs@usdoj.gov

(202) 514-2217

QUESTIONS PRESENTED

After the Federal Trade Commission charged petitioners with falsely advertising dietary supplements,

the district court permanently enjoined petitioners

from, inter alia, making representations about the

weight-loss potential of covered products unless they

had “competent and reliable scientific evidence” to support those representations. When petitioners thereafter engaged in a similar marketing campaign, the district court found them in civil contempt and imposed

monetary sanctions. The questions presented are as

follows:

1. Whether the court of appeals correctly held that

petitioners had waived their argument that the injunction was ambiguous.

2. Whether the injunction gave petitioners clear notice that they were prohibited from making weight-loss

claims about their products unless those claims were

substantiated by randomized clinical trials on the products themselves.

3. Whether the court of appeals correctly held that

the district court had not abused its discretion in imposing the contempt order.

(I)

TABLE OF CONTENTS

Page

Opinions below .............................................................................. 1

Jurisdiction .................................................................................... 1

Statement ...................................................................................... 2

Argument..................................................................................... 10

Conclusion ................................................................................... 23

TABLE OF AUTHORITIES

Cases:

Abbott v. Perez, 138 S. Ct. 2305 (2018) ................................ 17

Auto Driveaway Franchise Sys., LLC v. Auto Driveaway Richmond, LLC, 928 F.3d 670 (7th Cir. 2019) ...... 18

Blackmon-Malloy v. United States Capitol Police

Bd., 575 F.3d 699 (D.C. Cir. 2009) ..................................... 15

Boyce Motor Lines, Inc. v. United States,

342 U.S. 337 (1952).............................................................. 20

Bristol-Myers Co. v. FTC, 738 F.2d 554

(2d Cir. 1984), cert. denied, 469 U.S. 1989 (1985) .......... 2, 3

FTC v. Colgate-Palmolive Co., 380 U.S. 374

(1965) .............................................................................. 19, 20

FTC v. Direct Mktg. Concepts, Inc., 624 F.3d 1 (1st

Cir. 2010)................................................................................ 2

FTC v. Pantron I Corp., 33 F.3d 1088

(9th Cir. 1994), cert. denied, 514 U.S. 1085 (1995)............. 2

Farmer v. Banco Popular of N. Am., 557 Fed. Appx.

762 (10th Cir. 2014) ............................................................. 18

Granny Goose Foods, Inc. v. Brotherhood of Teamsters & Auto Truck Drivers, 415 U.S. 423 (1974) ............ 11

H. K. Porter Co. v. National Friction Prods. Corp.,

568 F.2d 24 (7th Cir. 1978) ................................................. 13

(III)

IV

Cases—Continued:

Page

Hi-Tech Pharms., Inc. v. HBS Int’l Corp.,

910 F.3d 1186 (11th Cir. 2018) ........................................... 16

International Longshoremen’s Ass’n v. Philadelphia

Marine Trade Ass’n, 389 U.S. 64 (1967) .......................... 11

Joseph v. United States, 574 U.S. 1038 (2014) .................... 16

Liu v. SEC, 140 S. Ct. 1936 (2020) ....................................... 22

Max’s Seafood Cafe ex rel. Lou-Ann, Inc. v.

Quinteros, 176 F.3d 669 (3d Cir. 1999) ............................. 19

McComb v. Jacksonville Paper Co.,

336 U.S. 187 (1949).................................................. 10, 19, 22

Moriarty v. Svec, 164 F.3d 323 (7th Cir. 1998) ................... 15

NLRB v. Bell Aerospace Co., 416 U.S. 267 (1974) .............. 21

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

(1st Cir. 2008) ................................................................ 15, 16

Orr v. Orr, 440 U.S. 268 (1979) ............................................. 14

PFS Distribution Co. v. Raduechel, 574 F.3d 580

(8th Cir. 2009) ...................................................................... 15

Removatron Int’l Corp. v. FTC, 884 F.2d 1489

(1st Cir. 1989) ........................................................................ 2

Russell C. House Transfer & Storage Co. v. United

States, 189 F.2d 349 (5th Cir. 1951) .................................. 13

SEC v. Chenery Corp., 332 U.S. 194 (1947)......................... 21

Schad v. Arizona, 501 U.S. 624 (1991)................................. 14

Schmidt v. Lessard, 414 U.S. 473 (1974) ....................... 11, 17

Thompson Med. Co. v. FTC, 791 F.2d 189

(D.C. Cir. 1986), cert. denied, 479 U.S. 1086 (1987) .......... 2

Tivo Inc. v. Echostar Corp., 646 F.3d 869

(Fed. Cir. 2011) ............................................................. 11, 19

United States v. Clariot, 655 F.3d 550

(6th Cir. 2011) ...................................................................... 15

United States v. Hernandez-Rodriguez,

352 F.3d 1325 (10th Cir. 2003) ........................................... 15

V

Cases—Continued:

Page

Washington v. Confederated Bands & Tribes of the

Yakima Indian Nation, 439 U.S. 463 (1979) ................... 14

Williams v. United States, 402 F.2d 47

(10th Cir. 1967) .................................................................... 13

Wisniewski v. United States, 353 U.S. 901 (1957) ............. 16

Statutes and rules:

Federal Trade Commission Act:

15 U.S.C. 45 (§ 5) ............................................................... 2

15 U.S.C. 52(a) (§ 12(a)) .................................................... 2

15 U.S.C. 52(b) (§12(b))..................................................... 2

15 U.S.C. 78u(d)(5) .......................................................... 22

Fed. R. Civ. P.:

Rule 65(d) ......................................................................... 17

Rule 65(d)(1)(B) ............................................................... 17

Rule 65(d)(1)(C) ............................................................... 17

Miscellaneous:

Federal Trade Commission:

Policy Statement on Deception, 103 F.T.C. 174

(1984) ............................................................................. 2

Policy Statement Regarding Advertising

Substantiation, 104 F.T.C. 839 (1984)........................ 2

In the Supreme Court of the United States

No. 19-1445

HI-TECH PHARMACEUTICALS, INC., ET AL.,

PETITIONERS

v.

FEDERAL TRADE COMMISSION, ET AL.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT

BRIEF FOR THE FEDERAL RESPONDENT

IN OPPOSITION

OPINIONS BELOW

The opinion of the court of appeals (Pet. App. 1-26)

is not published in the Federal Reporter but is reprinted at 786 Fed. Appx. 947. The order of the district

court (Pet. App. 48-164) is not published in the Federal

Supplement but is available at 2017 WL 6759868.

JURISDICTION

The judgment of the court of appeals was entered on

September 18, 2019. A petition for rehearing was denied on January 29, 2020 (Pet. App. 46-47). On March

19, 2020, this Court extended the time within which to

file a petition for a writ of certiorari to 150 days from

the denial of a timely rehearing petition. The petition

for a writ of certiorari was filed on June 26, 2020. The

jurisdiction of this Court is invoked under 28 U.S.C.

1254(1).

(1)

2

STATEMENT

1. Section 5 of the Federal Trade Commission Act

(FTC Act) prohibits “deceptive acts or practices in or

affecting commerce” and directs the Federal Trade

Commission (FTC or Commission) to prevent such

practices. 15 U.S.C. 45. Under Section 12 of the FTC

Act, prohibited deceptive acts include “any false advertisement” relating to “food” or “drugs.” 15 U.S.C. 52(a)

and (b). An advertisement violates Sections 5 and 12 of

the FTC Act when it contains a representation that is

likely to mislead consumers acting reasonably under

the circumstances and is material to a consumer’s decision to purchase the product. FTC v. Pantron I Corp.,

33 F.3d 1088, 1095 (9th Cir. 1994), cert. denied, 514 U.S.

1085 (1995); see FTC, Policy Statement on Deception,

103 F.T.C. 174, 178 (1984).

When an advertiser makes objective claims about a

product’s performance, it represents “explicitly or by

implication that the advertiser has a reasonable basis

supporting these claims.” FTC, Policy Statement Regarding Advertising Substantiation, 104 F.T.C. 839,

839 (1984). An advertisement thus “is considered deceptive if the advertiser lacks a ‘reasonable basis’ to

support the claims made in it.” Thompson Med. Co. v.

FTC, 791 F.2d 189, 193 (D.C. Cir. 1986) (citation omitted), cert. denied, 479 U.S. 1086 (1987). For safety- and

health-related claims, a “reasonable basis” means “competent and reliable scientific evidence.” See, e.g., Removatron Int’l Corp. v. FTC, 884 F.2d 1489, 1498-1499

(1st Cir. 1989); Bristol-Myers Co. v. FTC, 738 F.2d 554,

560 (2d Cir. 1984), cert. denied, 469 U.S. 1189 (1985).

Whether an advertiser has satisfied that standard in a

particular case is a question of fact. See, e.g., FTC v.

3

Direct Mktg. Concepts, Inc., 624 F.3d 1, 8 (1st Cir.

2010); Bristol-Myers, 738 F.2d at 558-560.

2. a. Petitioners sell dietary supplements, which

they advertise as causing weight loss and other health

effects. Pet. App. 3. As relevant here, petitioners told

consumers that one product (Thermalean) “causes

rapid and substantial weight-loss, including as much as

30 pounds in two months,” and that another (Lipodrene)

was “clinically proven to enable users to lose up to 42%

of total body fat.” Id. at 291, 306 (citations omitted).

The advertisements included numerous other claims of

significant weight and fat loss, among other purported

benefits. Id. at 289-320. In 2004, the Commission sued

petitioners, alleging that they had made those health

claims without adequate supporting evidence. Id. at 3.

The district court determined that petitioners lacked

substantiation for their representations and granted

summary judgment to the Commission. Pet. App. 257346. The court explained that health-benefit claims

must be substantiated by “competent and reliable scientific evidence,” a flexible standard that requires evidence that “pertinent professionals would require for

the particular claim made.” Id. at 278-279. It then

found that uncontroverted expert testimony showed

that, “to substantiate weight loss claims for any product, including a dietary supplement,” an advertiser

must have well-designed, randomized, double-blind and

placebo-controlled clinical trials (RCTs) “on the product itself.” Id. at 316. The court further found that petitioners had no such evidence and that studies examining only the ingredients in the advertised products, or

similar products using different formulations, were not

adequate to support petitioners’ weight-loss claims. Id.

at 316-317.

4

The district court permanently enjoined petitioners

from making unsubstantiated claims with respect to any

weight-loss product. Pet. App. 231-256. Section II of

the injunction barred petitioners from making representations that their products cause a rapid or substantial loss of weight or fat, or that they affect human metabolism, appetite, or body fat, “unless, at the time the

representation is made, [petitioners] possess and rely

upon competent and reliable scientific evidence that

substantiates the representation.” Id. at 244. The injunction thus incorporated the “competent and reliable

scientific evidence” standard that the court had just

held required RCTs for weight-loss claims. The court’s

order defined “ ‘[c]ompetent and reliable scientific evidence’ ” as “tests, analyses, research, studies, or other

evidence based on the expertise of professionals in the

relevant area, that has 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.” Id. at 234.

The district court gave petitioners an opportunity to

object to the scope of the injunction and the definitions

used therein. Pet. App. 85. Although petitioners challenged some terms and definitions, they did not object

to the “competent and reliable scientific evidence”

standard or its definition, as it applied to their weightloss products. Ibid.; see id. at 4-5.

The court of appeals affirmed the district court’s

judgment, 356 Fed. Appx. 358, and this Court denied

review, 562 U.S. 1003. At no time in the appellate proceedings did petitioners challenge the provisions in the

injunction requiring competent and reliable scientific

evidence for weight-loss claims. Pet. App. 5, 86.

5

b. Despite the district court’s injunction, petitioners

continued to promote their dietary supplements using

the same types of unsubstantiated claims about weight

loss. Pet. App. 5-6. Beginning in 2009, petitioners

launched a new marketing campaign for four products—

Fastin, Stimerex-ES, Benzedrine, and a reformulated

version of Lipodrene. Id. at 5-6, 51-52.

Petitioner Hi-Tech touted its products’ efficacy in

causing weight loss in full-page advertisements in national publications, on its website, and on its product

packaging and labels. See Pet. App. 62-68 (describing

advertisements in detail). For example, the advertisements told consumers that Fastin is an “EXTREMELY

POTENT DIET AID! DO NOT CONSUME UNLESS

RAPID FAT AND WEIGHT LOSS ARE YOUR DESIRED RESULT.” Id. at 62-63. Advertisements for

Lipodrene similarly stated that “LIPODRENE WILL

CAUSE RAPID FAT AND WEIGHT LOSS WITH

USAGE” and encouraged consumers to “[t]ry Lipodrene® and watch the inches melt away.” Id. at 64-65.

Advertisements for Stimerex-ES likewise claimed that

the product melts away body fat. Id. at 67-68. They also

claimed that Stimerex-ES causes the same weight-loss

and metabolic effects as products containing ephedrine

alkaloids, which had been banned by the FDA, stating

that “The benefits of ephedra are now ‘Back in Black!’ ”

Ibid. Finally, advertisements claimed that Benzedrine

will “ANNIHILATE THE FAT” because of its “Unmatched Anorectic Activity to Manage Caloric Intake.”

Id. at 66. Petitioners did not conduct RCTs on any of

the advertised products. See id. at 6.

Petitioners’ lawyers warned petitioners that their

advertisements would likely violate the district court’s

6

injunction. Pet. App. 6-7, 80-84. They specifically advised petitioner Jared Wheat, the Hi-Tech CEO, that

for weight-loss claims, the injunction required doubleblind, product-specific clinical trials. * Ibid. The lawyers cautioned that “the express language in the FTC

Injunction” required product-specific substantiation,

and not simply evidence that certain ingredients could

have biological effects. Id. at 6-7. They added that the

district court would likely find that the injunction required “double-blind, clinical trials of the products” because that “is the premise upon which the FTC Injunction is based.” Id. at 7. Those warnings were consistent

with Wheat’s own understanding that, if the injunction

survived appeal, “there is nothing we can say without

doing a double-blind placebo study.” Id. at 15.

3. a. In light of petitioners’ latest marketing campaign, the Commission moved the district court for an

order directing petitioners to show cause why they

should not be held in contempt. Pet. App. 6, 51. The

court granted the motion. Id. at 7, 52.

The district court again determined that weight-loss

claims must be supported by well-designed RCTs “on

the product itself ” or its equivalent. Pet. App. 223-225

(citation and emphasis omitted). The court did not allow

petitioners to offer any substantiation evidence other

than RCTs, finding that principles of issue preclusion

applied. Id. at 225.

b. The court of appeals vacated the district court’s

ruling, holding that issue-preclusion principles did not

The FTC acquired Wheat’s communications with his lawyers because they were transmitted using a monitored prison-email system. Pet. App. 6 n.1. The district court ruled that the communications were admissible, and petitioners did not challenge that ruling

on appeal. Ibid.; see id. at 79-80.

*

7

apply because the contempt litigation involved different

weight-loss products and claims. Pet. App. 37-38. The

court of appeals remanded for the district court to

“make findings about whether any evidence of substantiation, if admissible, satisfies the standard of the injunctions for ‘competent and reliable scientific evidence.’ ” Id. at 38.

c. On remand, the district court conducted a bench

trial to determine whether petitioners had “competent

and reliable scientific evidence” to support their advertising claims. Pet. App. 10.

The Commission presented detailed expert testimony on what that standard requires for weight-loss

claims—namely, RCTs on the products themselves.

Pet. App. 124-133. Petitioners, meanwhile, offered various ingredient studies, measuring factors such as metabolism rather than weight or fat loss. See id. at 134.

They also relied on clinical trials of other products with

different formulations and different ingredients from

the products at issue. See id. at 133-136. The Commission’s experts testified that petitioners’ proposed substantiation did not amount to competent and reliable

scientific evidence of the weight- and fat-loss claims for

the particular products at issue. See ibid. The district

court also expressed “concerns regarding the credibility of the defendants’ experts and their ultimate substantiation opinions.” Id. at 136; see id. at 136-147.

The district court found petitioners in contempt for

violating the injunction and imposed $40 million in sanctions. Pet. App. 7; see id. at 48-164.

The district court rejected petitioners’ argument

that its prior injunction was unclear. The court noted

that petitioners “were given an opportunity to object to

the scope of the injunction[] before [it was] entered, but

8

they did not object to any of the provisions they ostensibly challenge now.” Pet. App. 85. The court observed

that, if petitioners were unsure of what was required by

“ ‘competent and reliable scientific evidence,’ ” “they

could have easily asked, but they did not.” Id. at 84-85.

It also determined that voluminous evidence, including

the advice of their own lawyers, demonstrated that petitioners had understood what the injunction required.

Id. at 74-85. In addition, the court emphasized that the

context in which the injunction was entered made clear

that any weight-loss claims needed to be supported by

RCTs on the products themselves. Id. at 86-87. The

court noted that its summary judgment order, issued

just weeks before the injunction, had held that “ ‘competent and reliable scientific evidence’ ” required RCTs

for weight- and fat-loss claims, and that the injunction

had used that “very same” language. Id. at 87.

The district court next determined that the Commission had shown by clear and convincing evidence that

petitioners had violated the injunction, since no RCTs

had been performed on any of the four products at issue.

Pet. App. 104-151. The court ordered sanctions to compensate consumers for petitioners’ violations, emphasizing petitioners’ “intentional defiance” of the court’s

orders and “the pervasiveness of their contumacious

conduct.” Id. at 159-163.

4. The court of appeals affirmed. Pet. App. 1-26.

The court of appeals first held that petitioners had

waived any objection to the clarity of the injunction.

Pet. App. 12-19. It explained that petitioners were “calculating actors who stayed silent concerning the purported ambiguity about which they now complain” and

then “deliberately engaged in self-serving activities

they knew seriously risked violating the injunction.” Id.

9

at 14-15. The court rejected petitioners’ argument that

they “could not reasonably have been expected to know

in 2008 that the FTC would later seek to hold them in

contempt for failing to substantiate different advertising claims with a product-specific RCTs standard.” Id.

at 18. The court explained that the requirement of a

product-specific RCT for the types of claims at issue

was not an “unexpected interpretation” but had been

well known to petitioners and their lawyers for years.

Ibid.

The court of appeals next held that the district court

had not clearly erred in finding that petitioners’ evidence failed to substantiate their claims. Pet. App.

19-23. The court of appeals emphasized the district

court’s “detailed,” “extensive reasoning,” finding it supported by the evidence. Id. at 20-22. The court of appeals further observed that the district court had found

many of petitioners’ experts to be either unqualified or

not credible. Id. at 21-22.

Finally, the court of appeals rejected petitioners’ argument that the district court had impermissibly

shifted to them the burden of disproving contempt. Pet.

App. 23. The court of appeals determined that the district court had properly placed the burden on the Commission to show, by clear and convincing evidence, that

petitioners had violated the injunction. Ibid. The court

of appeals concluded that the Commission had met that

burden by proving that petitioners “were again making

weight- and fat-loss claims about products without having RCTs on the products themselves, even though the

[district] court had held that only RCTs on the products

themselves could be ‘competent and reliable scientific

evidence’ the last time.” Ibid.

10

ARGUMENT

Petitioners challenge (Pet. 13-36) the court of appeals’ holdings that they had waived their challenge to

the injunction’s clarity and that they had adequate notice of the substantiation standard required to comply

with the injunction. The court of appeals’ unpublished

decision is correct and does not conflict with any decision of this Court or of any other court of appeals. Further review is not warranted.

1. Petitioners contend (Pet. 23-36) that they did not

waive their challenge to the clarity of the injunction’s

requirement of “competent and reliable scientific evidence.” The court of appeals correctly held that petitioners had waived any such challenge. Pet. App. 12-19.

a. Courts sometimes may be required to issue injunctions of a “generality * * * necessary to prevent

further violations where a proclivity for unlawful conduct has been shown.” McComb v. Jacksonville Paper

Co., 336 U.S. 187, 192 (1949). When that occurs, defendants cannot avoid civil contempt by “undert[aking] to

make their own determination of what the decree

meant”—knowing that “they acted at their peril”—and

contending that “the plan or scheme which they adopted

was not specifically enjoined.” Ibid. Put differently,

civil contempt sanctions are available if a defendant is

not an “unwitting victim[] of the law” but rather has

taken “a calculated risk * * * under the threat of contempt.” Id. at 193.

The court of appeals here applied McComb’s

“common-sense” conclusion that a defendant cannot

avoid civil contempt by “staying silent about purported

ambiguities” in an injunction, “deliberately engaging in

activities that risk violating” it, and then “pleading ignorance after those risky activities are indeed found to

11

violate the injunction.” Pet. App. 12. The court explained that petitioners were “calculating actors” who

had “deliberately engaged in self-serving activities they

knew seriously risked violating the injunction.” Id. at

14-15. Although petitioners now suggest (Pet. 24) that

they merely neglected to “immediately object to even

latent uncertainties when [the] injunction [wa]s entered,” the court found that they had affirmatively and

repeatedly declined opportunities to contest the injunction’s standard of “competent and reliable scientific evidence,” and that they understood the consequences of

that choice. See Pet. App. 15-16.

Petitioners contend (Pet. 25) that this case is governed

not by McComb but by three subsequent decisions—

International Longshoremen’s Ass’n v. Philadelphia

Marine Trade Ass’n, 389 U.S. 64 (1967), Schmidt v. Lessard, 414 U.S. 473 (1974) (per curiam), and Granny

Goose Foods, Inc. v. Brotherhood of Teamsters & Auto

Truck Drivers, 415 U.S. 423 (1974)—that they assert

“painted” McComb’s holding “into a corner.” But none

of those decisions discussed McComb or addressed a

failure to promptly apprise the district court of an alleged ambiguity in an injunction. In Schmidt, the parties had sought timely clarification from the district

court. 414 U.S. at 476 n.1. In Longshoremen, counsel

likewise asked the district court for clarification several

times, yet the court “steadfastly refused to explain the

meaning of the order.” 389 U.S. at 70-71. And in

Granny Goose Foods, the underlying temporary restraining order had expired by the time of the conduct

that had allegedly violated it, so the Court did not interpret a duly issued injunction at all—much less one to

which the bound party had failed to object. 415 U.S. at

431-433; see Tivo Inc. v. Echostar Corp., 646 F.3d 869,

12

887 (Fed. Cir. 2011) (en banc) (distinguishing Granny

Goose and Longshoremen on similar grounds).

In a related vein, petitioners contend (Pet. 27-28)

that applying the waiver doctrine in civil contempt proceedings relieves the complaining party of its burden to

show that the injunction was clear and unambiguous.

That argument is incorrect. Here, the court of appeals

was “satisfied that the FTC ha[d] carried its prima facie

burden of showing the clarity of the injunction,” Pet.

App. 17, and the district court likewise properly placed

on the Commission the burden to establish the elements

of contempt, see id. at 69-70.

b. Petitioners assert (Pet. 25) that the court of appeals’ decision deepens a circuit split over whether “defendants can challenge the specificity of an injunction in

contempt proceedings.” No such circuit split exists or

is implicated here.

As an initial matter, the court of appeals’ unpublished decision here does not establish binding precedent in the Eleventh Circuit. See Pet. App. 2. As a

result, it cannot “add[] to” any circuit split, as petitioners contend (Pet. 25).

In any event, the court of appeals did not hold that

defendants can never challenge the specificity of an injunction in contempt proceedings. Instead, it merely

found that, on these facts, petitioners had affirmatively

waived any challenge to the injunction’s requirement of

“competent and reliable scientific evidence.” See Pet.

App. 16 (finding waiver because petitioners “stayed silent about the supposed ambiguity of which they now

complain, were repeatedly informed by counsel that

they risked contempt for using anything other than

RCTs to substantiate their claims, knowingly proceeded anyway in the face of that risk * * * and now

13

plead ignorance”). None of the decisions on which petitioners rely involved a defendant who failed to seek

clarification of a known purported ambiguity despite

several opportunities to do so. And none of those decisions held that the doctrine of waiver is categorically inapplicable in contempt proceedings—or even discussed

waiver at all. See H. K. Porter Co. v. National Friction

Prods. Corp., 568 F.2d 24, 26-27 (7th Cir. 1978) (concluding that a judgment incorporating the parties’ settlement agreement was not a true injunction that could

trigger a contempt finding); Williams v. United States,

402 F.2d 47, 48-49 (10th Cir. 1967) (rejecting defendant’s argument that an injunction was insufficiently

specific); Russell C. House Transfer & Storage Co. v.

United States, 189 F.2d 349, 351 (5th Cir. 1951) (finding

that an injunction was not broad enough to prohibit defendant’s conduct).

2. Petitioners contend (Pet. 28-36) that the court of

appeals’ waiver ruling “stripped” them of their right to

appeal the injunction. Pet. 28 (emphasis omitted). They

assert (Pet. 29) that, because the district court decided

“on the merits” that the injunction was specific enough,

the court of appeals was powerless to find waiver. That

contention misapprehends both decisions below.

a. The court of appeals concluded that the district

court had found waiver and had addressed the substance of petitioners’ arguments only in the alternative.

Pet. App. 17-18. The court of appeals observed that the

district court had “expressed doubt that [petitioners’

ambiguity] arguments were properly before it.” Id. at

18. And the court of appeals stated that “there can be

no doubt that the district court in fact concluded that

the defendants had waived their ambiguity arguments.”

Ibid.

14

Petitioners contest (Pet. 34) the court of appeals’

characterization of the district court’s decision, relying

in large part on the district court’s statement that “the

court does not find the absence of a timely appellate

challenge dispositive,” Pet. App. 86. But that observation does not indicate that the district court rejected

waiver. Rather, it shows that the district court viewed

the lack of an appeal as merely one of petitioners’ several failures to “object to any of the provisions that they

ostensibly challenge now.” Id. at 85; see id. at 84-86.

Given that, the court of appeals reasonably concluded

that the district court in fact found waiver. See id. at

18. And in all events, that factbound question about the

appropriate construction of the district court’s decision

does not warrant this Court’s review.

If a district court relies on “multiple rationales”—

including both waiver and a claim’s lack of substantive

merit—a court of appeals “can affirm on any basis.”

Pet. App. 18. This Court has never suggested to the

contrary, as petitioners acknowledge. See Pet. 29; cf.

Washington v. Confederated Bands & Tribes of the Yakima Indian Nation, 439 U.S. 463, 476 n.20 (1979) (explaining that a prevailing party is “of course free to defend its judgment on any ground properly raised below”). Petitioners instead rely (Pet. 29) on “another line

of cases” concerning this Court’s jurisdiction to review

questions passed on by a state court, though not

pressed by the parties there. See Schad v. Arizona,

501 U.S. 624, 630 n.2 (1991) (opinion of Souter, J.); Orr

v. Orr, 440 U.S. 268, 274-275 (1979). Those decisions are

inapposite. The question here is not whether a reviewing court has jurisdiction to review questions passed on

by a lower court, but whether a reviewing court must

address a merits question if a lower court has rejected

15

a claim both because it was waived and because it lacks

merit.

b. Petitioners contend (Pet. 30) that the courts of appeals are divided over whether they are required, or

merely permitted, to address a question that was waived

or forfeited in the district court yet decided on the merits there. Even assuming that some division exists

among the courts of appeals, this case does not implicate it.

First, as discussed, the court of appeals concluded

only that it could find an issue waived on appeal where,

as one of “multiple rationales,” a district court had “in

fact concluded that the defendants had waived their

* * * arguments.” Pet. App. 18. By contrast, petitioners identify (Pet. 31-32) decisions from six courts of appeals that treated an issue as preserved where a district

court decided it solely on the merits despite circumstances that might have suggested waiver. See United

States v. Clariot, 655 F.3d 550, 556 (6th Cir. 2011) (finding issue preserved where “[n]o one disagree[d] that the

district court addressed the issue”); PFS Distribution

Co. v. Raduechel, 574 F.3d 580, 598 (8th Cir. 2009) (finding appellate review appropriate where “the district

court did address the arguments”); Blackmon-Malloy

v. United States Capitol Police Bd., 575 F.3d 699, 707

(D.C. Cir. 2009) (finding appellate review appropriate

where the district court “clearly addressed the merits”);

Negrón-Almeda v. Santiago, 528 F.3d 15, 26 (1st Cir.

2008) (finding issue preserved where the district court

addressed it “head-on” and “without reservation”);

United States v. Hernandez-Rodriguez, 352 F.3d 1325,

1328 (10th Cir. 2003) (considering issue that the district

court “raised * * * sua sponte”); Moriarty v. Svec,

164 F.3d 323, 328 (7th Cir. 1998) (rejecting argument

16

that an appeals court “cannot consider the merits” of a

theory that was actually “relied upon in deciding the

case”) (citation omitted). Far from discussing the merits “without reservation,” Negrón-Almeda, 528 F.3d at

26, the district court here described in detail petitioners’ repeated failures to object to the injunction. See

Pet. App. 84-86.

Second, petitioners assert that the Eleventh Circuit

itself has issued a published decision adopting their preferred rule, under which a litigant is “entitled to challenge” a district court ruling on an argument that the

litigant failed to preserve before the district court itself.

Pet. 33 (quoting Hi-Tech Pharms., Inc. v. HBS Int’l

Corp., 910 F.3d 1186, 1194 (11th Cir. 2018)). Even if the

unpublished decision here could be construed to adopt

a conflicting view, it would not affect the prevailing rule

in the Eleventh Circuit. And to the extent petitioners

rely on any “equivocation” within the Eleventh Circuit,

Pet. 32, that would not justify this Court’s review, as

“[i]t is primarily the task of a Court of Appeals to reconcile its internal difficulties.” Wisniewski v. United

States, 353 U.S. 901, 902 (1957) (per curiam).

Finally, even if this case implicated a circuit conflict,

this Court’s review would not be warranted. The Court

“do[es] not often review the circuit courts’ procedural

rules,” including rules about waiver. See Joseph v.

United States, 574 U.S. 1038, 1040 (2014) (Kagan, J., respecting the denial of certiorari).

3. Petitioners separately contend (Pet. 14-23) that

the court of appeals erred in determining that they had

fair notice of the injunction’s requirements.

a. To the extent petitioners are repurposing the arguments made before the court of appeals “that the injunction is too ambiguous to be enforced,” the court did

17

not reach that question. Pet. App. 12. Instead, as discussed above, the court found that this argument was

waived. Id. at 12-19. And the court of appeals’ waiver

decision does not independently warrant this Court’s

review. See pp. 10-16, supra.

In any event, petitioners’ challenge to the clarity of

the injunction lacks merit. Federal Rule of Civil Procedure 65(d) requires an injunction to “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.” Fed. R. Civ. P.

65(d)(1)(B) and (C). The Rule is meant “to prevent uncertainty and confusion” by those bound by an order

“too vague to be understood.” Lessard, 414 U.S. at 476;

see Abbott v. Perez, 138 S. Ct. 2305, 2321 (2018) (“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.”).

Petitioners received the required clear notice here.

The injunction barred petitioners from representing

that their products cause a rapid or substantial loss of

weight or fat, or that they affect human metabolism, appetite, or body fat, unless those representations are

supported by “competent and reliable scientific evidence.” Pet. App. 244. It defined “[c]ompetent and reliable scientific evidence” as “tests, analyses, research,

studies, or other evidence based on the expertise of professionals in the relevant area, that has 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.” Id. at

234.

18

Petitioners assert (Pet. 14-15) that “no reasonable

person would have understood [the] text” of the injunction to require RCTs on the specific weight-loss products at issue. But in its then-recent order granting the

Commission’s motion for summary judgment, the district court had construed the term “competent and reliable scientific evidence” in precisely that way as applied

to petitioners’ weight-loss products. Pet. App. 316-317.

The court’s incorporation of the same standard into the

injunction itself clearly apprised petitioners that

weight-loss claims were required to be substantiated by

RCTs, or at least equivalently reliable evidence. Petitioners’ own lawyers interpreted the injunction the

same way and advised petitioners accordingly. Id. at 67. And petitioner Wheat also understood the injunction

that way, as he acknowledged in several communications. Id. at 15, 110 & n.23. To the extent the court of

appeals addressed the clarity of the injunction in the

course of its waiver determination, it thus properly observed that, “[a]t the very least, * * * the defendants

were on notice that RCTs were likely to be required.”

Id. at 18-19.

Petitioners appear to contend (Pet. 12, 16-17, 23) that

a party who is alleged to have violated an injunction cannot be subjected to contempt sanctions if a court or restrained party must look to any evidence outside the

four corners of the injunction to determine its application to a particular factual context. But petitioner relies

on decisions criticizing injunctions that did not impose

the relevant standards in a standalone document, or

that merely cross-referenced another document for

their substance. See, e.g., Auto Driveaway Franchise

Sys., LLC v. Auto Driveaway Richmond, LLC, 928 F.3d

670 (7th Cir. 2019); Farmer v. Banco Popular of N. Am.,

19

557 Fed. Appx. 762 (10th Cir. 2014); Max’s Seafood Cafe

ex rel. Lou-Ann, Inc. v. Quinteros, 176 F.3d 669 (3d Cir.

1999). By contrast, the relevant standard at issue here

(“competent and reliable scientific evidence”) appears

within the injunction itself. Pet. App. 244. And courts

routinely uphold injunctions that use a term of art or

otherwise require resort to outside sources to determine how the terms of the injunction apply to certain

facts. See, e.g., Tivo Inc., 646 F.3d at 882-883 (explaining that, in patent cases, “[t]he primary question on contempt should be whether the newly accused product is

so different from the product previously found to infringe that it raises ‘a fair ground of doubt as to the

wrongfulness of the defendant’s conduct’ ”) (citation

omitted).

Indeed, this Court has recognized that the level of

specificity that petitioners appear to demand is not

practical for many injunctions. Requiring an injunction

to delineate all possible specific violations—rather than

identify a general class of identifiable, impermissible

behavior—“would give tremendous impetus to [a] program of experimentation with disobedience of the law”

and would “operate to prevent accountability for persistent contumacy.” McComb, 336 U.S. at 192-193. The

Court reaffirmed a similar principle in FTC v. ColgatePalmolive Co., 380 U.S. 374 (1965), where it rejected a

challenge to the specificity of a Commission cease-anddesist order. The Court explained that such orders

must be “ ‘sufficiently clear and precise’ ” to be understood, but also broad enough to encompass possible variations in wrongdoing—especially where the bound parties have already “been caught violating the [FTC]

Act.” Id. at 392, 395 (citation omitted). The Court accordingly upheld the challenged order, which it found

20

was “as specific as the circumstances will permit.” Id.

at 393; see Boyce Motor Lines, Inc. v. United States,

342 U.S. 337, 340 (1952).

Petitioners’ several other attacks on the clarity of

the “competent and reasonable scientific evidence”

standard likewise lack merit. First, petitioners contend

(Pet. 2-3, 20-21) that the Commission “changed its

mind” about the substantiation required for their claims

and improperly sought to “reinterpret” the injunction

by reading a more stringent requirement “backwards

into” it. To the contrary, the Commission has maintained from the beginning of this litigation that weightloss claims for petitioners’ dietary supplements must be

substantiated by product-specific RCTs. See D. Ct.

Doc. 172-1, at 40 (Aug. 24, 2007). Indeed, the district

court found that at “no point in the nine years after the

summary judgment order and injunctions were entered

did anyone from the FTC tell the defendants that anything but RCTs were required.” Pet. App. 89.

Second, petitioners emphasize (Pet. 17) the general

principle that the Commission’s standard of “ ‘competent and reliable scientific evidence’ ” is “flexible” and

“varies by product.” Although that is true, the district

court found in 2008 that the same kinds of claims for the

same kinds of products at issue here require productspecific RCTs. See Pet. App. 316. That finding, combined with several indicators of petitioners’ actual

knowledge “that RCTs were likely to be required” for

the advertising claims at issue, id. at 18-19, made sufficiently clear the application of the “competent and reliable scientific evidence” standard in the circumstances

here. And contrary to petitioners’ repeated assertion

(e.g., Pet. i, 1, 2, 13), the district court did not require

the equivalent of a drug-level clinical trial. See Pet.

21

App. 109-115. Indeed, the court of appeals found that

the district court had not necessarily required RCTs

themselves but had “used as the standard the level of

reliability and competency afforded by RCTs on the advertised products.” Id. at 23.

Third, petitioners suggest (Pet. 20) that the Commission was forbidden from taking the position in this litigation that RCTs are required for certain weight-loss

products, because it should have made that stance clear

in formal rulemaking. But agencies have broad discretion in deciding whether to proceed by case-by-case adjudication or rulemaking. See, e.g., NLRB v. Bell Aerospace Co., 416 U.S. 267, 294 (1974); SEC v. Chenery

Corp., 332 U.S. 194, 203 (1947). Petitioners provide no

reason to cabin that discretion for the specific types of

weight-loss marketing claims at issue here. And here,

the Commission sought and obtained from the district

court a summary-judgment decision holding that RCTs

were required to substantiate petitioners’ weight-loss

claims.

b. The district court did not clearly err when it found

that petitioners lacked competent and reliable scientific

evidence to substantiate the particular claims at issue.

Pet. App. 19-24. As the court of appeals observed, “the

district court detailed its extensive reasoning as to why

the defendants’ evidence was inadequate and why protections offered by tests like RCTs would be necessary

for the claims at issue.” Id. at 20. That analysis included the district court’s assessment of the qualifications and credibility of the Commission’s experts, as

compared to the “lacking” credentials and “disturbing”

credibility problems it perceived with some of petitioners’ experts. Id. at 21. The court of appeals ultimately

determined that the district court had not clearly erred

22

in finding that petitioners had failed to introduce substantiation evidence “as reliable and as competent as results derived from RCTs on the marketed products.”

Id. at 23. That factbound application of the clear-error

standard was correct and does not warrant this Court’s

review.

4. Petitioners briefly suggest (Pet. 21 n.5) that this

Court should grant the petition, vacate the decision below, and remand for further consideration in light of

Liu v. SEC, 140 S. Ct. 1936 (2020). In Liu, the Court

determined that Congress had incorporated equitable

principles into 15 U.S.C. 78u(d)(5), so that the SEC in a

civil enforcement action can obtain disgorgement only

of “a defendant’s net profits from wrongdoing.” 140 S. Ct.

at 1946. But petitioners’ passing argument about the

amount of the district court’s contempt sanction here

has been forfeited. Petitioners did not press below, and

the court of appeals did not pass on, any argument that

the $40 million sanction was improperly calculated

based on gross revenues rather than net profits. In addition, the limitation announced in Liu does not apply

to civil contempt proceedings, where a court’s power extends to “the requirements of full remedial relief.”

McComb, 336 U.S. at 193; see Pet. App. 160-161, 163

(finding that “consumer redress in the amount of the

gross receipts” was an appropriate contempt sanction,

particularly in light of petitioners’ “pattern of contemptuous conduct” and “intentional defiance of the court’s

injunctions”).

23

CONCLUSION

The petition for a writ of certiorari should be denied.

Respectfully submitted.

ALDEN F. ABBOTT

General Counsel

JOEL MARCUS

Deputy General Counsel

MARIEL GOETZ

Attorney

Federal Trade Commission

SEPTEMBER 2020

JEFFREY B. WALL

Acting Solicitor General

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.

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Opposition Brief — Hi-Tech Pharmaceuticals, Inc., et al., Petitioners v. Federal Trade Commission, et al. | Frix