Federal Trade Commission v. Hi-Tech Pharmaceuticals, Inc.

Court of Appeals for the Eleventh Circuit·Decided September 18, 2019·No. 17-15695·Unpublished

Opinion

[DO NOT PUBLISH]

IN THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT

No. 17-15695

D.C. Docket No. 1:04-cv-03294-CAP

FEDERAL TRADE COMMISSION, Plaintiff - Counter Defendant - Appellee, CERTUSBANK, N.A., Plaintiff,

versus

NATIONAL UROLOGICAL GROUP, INC., d.b.a. Warner Laboratories, et al.,

Defendants - Counter Claimants,

HI-TECH PHARMACEUTICALS, INC., corporations, JARED WHEAT, individually and as officers of the corporations, STEPHEN SMITH, individually and as officers of National Urological Group, Inc., and National Institute for Clinical Weight Loss, Inc.,

Defendants - Appellants,

THOMASZ HOLDA, individually and as officers of the corporations, et al.,

Defendants.

Appeal from the United States District Court for the Northern District of Georgia

(September 18, 2019)

Before MARTIN, ROSENBAUM, Circuit Judges, and MARTINEZ,∗ District Judge.

PER CURIAM:

The defendants in this case were enjoined from making certain claims about health products without “competent and reliable scientific evidence” to substantiate those claims. The Federal Trade Commission (“FTC”) alleged that they violated the injunction when they publicized the weight- and fat-loss benefits of the four products at issue in this case. After a bench trial, the district court agreed with the FTC and found the defendant in civil contempt. The district court consequently imposed approximately $40 million in sanctions.

Upon review, we conclude that the defendants have waived their challenge to the facial clarity of the injunction and that the district court committed no abuse of

∗ Honorable Jose Martinez, United States District Judge for the Southern District of Florida, sitting by designation.

discretion. Accordingly, we affirm the district court’s order of contempt and entry of sanctions.

I. BACKGROUND

A. Initial Entry of the Injunction at Issue Hi-Tech Pharmaceuticals, its chief executive officer (“CEO”), Jared Wheat, and its head of sales, Stephen Smith (collectively, “the defendants”), sold dietary supplements that advertised weight- and fat-loss benefits. They promised that one of their products, Thermalean, would help consumers lose “as much as 30 pounds in two months,” and that another product, Lipodrene, was “clinically proven to enable users to lose up to 42% of total body fat.” In 2004, the FTC charged the defendants with falsely advertising those products, in violation of Sections 5 and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52.

The district court granted summary judgment for the FTC. F.T.C. v. Nat’l Urological Grp., Inc., 645 F. Supp. 2d 1167, 1215 (N.D. Ga. 2008), aff’d, 356 F. App’x 358 (11th Cir. 2009). Claims about the safety and efficacy of dietary supplements, the district court noted, “must be substantiated with competent and reliable scientific evidence.” Id. at 1202. The FTC’s guide for advertisers defined “competent and reliable scientific evidence” as “tests, analyses, research, studies, or other evidence based on 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.” Id. at 1190 (citation and quotation marks omitted).

The district court agreed with the FTC’s expert, Dr. Louis Aronne, that to satisfy the FTC’s definition of “competent and reliable scientific evidence” supporting weight- and fat-loss claims regarding any product, randomized clinical trials (“RCTs”) on the advertised products are necessary. See id. at 1202. As the defendants had not conducted any RCTs on Thermalean or Lipodrene, the district court concluded that the defendants’ weight- and fat-loss claims about those products were unfounded.

In its motion for summary judgment, the FTC had attached the proposed text of a permanent injunction against the appellants. Sections II and VII of the proposed injunction banned the defendants from making unsubstantiated claims, meaning they were to refrain from making any representation about the safety, efficacy, or health or weight-loss benefits of dietary supplements unless, “at the time the representation is made, [they] possess and rely upon competent and reliable scientific evidence that substantiates the representation.” (emphasis added). The proposed injunction adopted the definition for “competent and reliable scientific evidence” from the FTC’s advertising guide.

Complaining of “space limitations,” the defendants indicated that they would not object to the proposed injunction in their opposition to summary judgment. They

instead requested “that they be given further opportunity” to voice their objections later. The district court granted the defendants’ request. Nat’l Urological Grp., Inc., 645 F. Supp. 2d at 1215.

And the defendants took advantage of their second chance. They objected to several provisions in the proposed injunction, including the definition of several terms, like “[c]overed product or service,” “drug,” or “manufacturing.” Notably, though, they did not object to the use of the phrase “competent and reliable scientific evidence.”

After overruling the defendants’ objections, the district court entered a permanent injunction against them. Just as the proposed injunction had, Sections II and VII of the final injunction prohibited the defendants from making fat- and weight-loss claims about covered products unless, at the time of the representation, the defendants relied on “competent and reliable scientific evidence that substantiates the representation.” That phrase was defined by reference to the FTC’s advertising guide, as it had been during the litigation.

The defendants appealed to this Court, raising a host of arguments. But again, significantly, they did not argue that the phrase “competent and reliable scientific evidence” was unclear. A different panel of this Court rejected the defendants’ arguments and affirmed the district court. F.T.C. v. Nat’l Urological Grp., Inc., 356 F. App’x 358, 359 (11th Cir. 2009).

B. Contempt The ink had hardly dried on filings from the first injunction case when the defendants started a new marketing campaign in 2009. This time, they touted the fat- and weight-loss benefits of four products—a reformulated version of Lipodrene, Fastin, Benzedrine, and Stimerex-ES. For example, advertisements for Lipodrene warned users not to consume the product unless “fat loss and weight loss are your intended result”; advertisements for Fastin boasted that it was an “Extreme Fat Burner”; those for Benzedrine claimed that it would “annihilate . . . fat”; and advertisements for Stimerex-ES told users that this was a product “for those who want their fat-burner to light them up all day as their pounds melt away.”

The FTC moved for an order to show cause why the defendants should not be held in contempt for marketing those four products without proper substantiation, in violation of their injunction. F.T.C. v. Nat’l Urological Grp., Inc., 785 F.3d 477, 479-80 (11th Cir. 2015). In response, the defendants argued that they had fully complied with the injunction. Id. at 481. Contending that RCTs on the products at issue were not required, the defendants offered other types of evidence that they claimed were competent and reliable scientific evidence to support their claims.

The FTC disagreed and pointed to several communications that revealed the defendants’ knowledge that the injunction could require them to conduct RCTs on

the advertised products.1 In one email, Hi-Tech’s attorneys informed Wheat that “competent and reliable scientific evidence,” as used in the injunction, meant RCTs on the marked product:

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Federal Trade Commission v. Hi-Tech Pharmaceuticals, Inc., (11th Cir. 2019).

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