                                                                                                                           Opinions of the United
2005 Decisions                                                                                                             States Court of Appeals
                                                                                                                              for the Third Circuit


10-21-2005

USA v. Lane Labs-USA Inc
Precedential or Non-Precedential: Precedential

Docket No. 04-3592




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                                        PRECEDENTIAL

       UNITED STATES COURT OF APPEALS
            FOR THE THIRD CIRCUIT


                     No. 04-3592


           UNITED STATES OF AMERICA

                            v.

         LANE LABS-USA INC, a corporation;
          ANDREW J. LANE, an individual,

                                           Appellants


      Appeal from the United States District Court
               for the District of New Jersey
               (D.C. Civil No. 99-cv-05782)
      District Judge: Honorable William G. Bassler




                 Argued June 30, 2005

Before: RENDELL, BARRY and BECKER, Circuit Judges.

                (Filed October 21, 2005)
Paul J. Fishman [ARGUED]
Friedman, Kaplan, Seiler & Adelman
One Gateway Center, 25th Floor
Newark, NJ 07102

Counsel for Appellants
Lane Labs-USA Inc, a Corporation;
Andrew J. Lane, an Individual


Jeffrey A. Lamken
Baker Botts
1299 Pennsylvania Avenue, N.W.
The Warner
Washington, DC 20004-2400

Counsel for Amicus-Appellant
Washington Legal


Gerald C. Kell [ARGUED]
United States Department of Justice
P. O. Box 386
Washington, DC 20044

Counsel for Appellee
United States of America




                               2
                  OPINION OF THE COURT




RENDELL, Circuit Judge.

        In this case, we are called upon to decide whether a
district court has the power under the Federal Food, Drug and
Cosmetic Act, 21 U.S.C.§ §§ 301, et. seq. (“FDCA”), to order
a defendant found to be in violation of the Act to pay restitution
to consumers. Because a district court’s equitable powers in
such a situation are broad, we hold that an order of restitution is
properly within the jurisdiction of the court.

                                I.

        On August 11, 1994, Appellant Andrew Lane formed
Lane Labs (“Labs”) to manufacture and supply health products.
Andrew Lane is the president, director, and sole shareholder of
Labs. Labs sells its products in several different ways: directly
to consumers, through its CompassioNet Division, and through
third-party distributors. Three products are the subject of this
action: (1) BeneFin, sold in powder or tablet form as a dietary
supplement and containing shark cartilage; (2) SkinAnswer, a
skin cream containing glycoalkaloid; and (3) MGN-3, a dietary
fiber produced by the hydrolysis of rice bran with the enzymatic


                                3
extract of Shiitake mushroom, and whose main ingredient is
arabinoxylan.

        At a convention in 1997, the Food and Drug
Administration (“FDA”) first observed Labs distributing
materials promoting BeneFin to treat cancer. The FDA
informed Labs through letters and telephone conversations that
such conduct violates the FDCA. The FDA also inspected
Cartilage Consultants, Inc. (“CCI”), a company founded by
Dr. I. William Lane, Ph.D., Andrew Lane’s father. Dr. Lane has
been researching shark cartilage and its effects since 1983. He
has produced copious writings on his studies and the benefits of
shark cartilage and its possible effects on cancer. Through this
inspection, the FDA discovered that Dr. Lane actively promoted
BeneFin and SkinAnswer as potential treatments for cancer and
that he was a “paid consultant” to Labs. Labs, in turn, used its
association with Dr. Lane in the marketing of its products. For
instance, in a letter to health professionals, Labs touted Dr. Lane
as “the world’s foremost authority on shark cartilage [who] has
directed the development of BeneFin Shark Cartilage.” (Lab
Marketing Materials at A1190.) In addition, on the SkinAnswer
packaging itself, Labs placed both Dr. Lane’s photograph and
his endorsement of the product.

        Appellants marketed their products in several different
ways. They sent monthly catalogs of their products to a mailing
list they maintained. They also advertised in magazines and
maintained several websites. They operated a network of

                                4
companies, including their CompassioNet Division, which acted
as a sales agent for the products. Appellants used CCI and paid
researcher spokesmen, such as Dr. Lane and Mamdooh
Ghoneum, Ph.D, to promote the products. Other sources also
offered information about the types of products sold by Labs.
Dr. Lane’s books and writings are available for sale through
several avenues, such as Amazon.com. Health newsletters, such
as Alternatives, included claims for the products and the
television show “60 Minutes” aired a story featuring Dr. Lane
about shark cartilage as a cancer therapy.

        Investigations revealed that Appellants specifically
promoted the products to treat diseases. Employees answering
calls to Appellants’ toll-free telephone number referred callers
to an employee of CCI, who then promoted the products as
cancer and HIV treatments. Appellants sent mass mailings to
customers, including order forms and articles promoting the
products as disease treatments, some of which were written by
Drs. Lane and Ghoneum. In addition, Appellants bought in bulk
independent newsletters with claims about the products, such as
Alternatives, and included them in their mailings. Appellants
also maintained several websites with metatags concerning
cancer, Dr. Lane’s research, and claims of disease treatment.1


  1
    A metatag is a code placed in a website. These codes are
detected by search engines and increase the likelihood that a
user searching for a particular topic will be directed to a website
containing those metatags.

                                5
Appellants also promoted BeneFin as the product that was
featured on “60 Minutes” and developed by Dr. Lane.

       In September 1997, the FDA sent a warning letter to
Labs, explaining that the marketing claims for BeneFin and
SkinAnswer rendered them unapproved and misbranded drugs.
Andrew Lane wrote a response letter, claiming that the FDA’s
warning had been based on Dr. Lane’s promotional materials
and that Dr. Lane was independent of Labs even though he was
a “research consultant to my company.” In 1998, Appellants
asserted that Dr. Lane had previously worked with Labs, but was
no longer employed or consulting for Labs. Discovery then
showed that Dr. Lane was continuing to receive large consulting
fees from Labs. The FDA issued multiple warnings to Labs.
On September 22, 1999, the Department of Justice sent a notice
informing Labs of its intent to bring suit against Labs and its
president, Andrew Lane, to enjoin its continuous violations of
the FDCA through the sale and promotion of the products as
treatments and cures for cancer and other diseases. The Federal
Trade Commission (“FTC”) and the FDA both commenced
actions against defendants.

FTC Action

       The FTC filed a complaint against Labs, Andrew Lane,
Cartilage Consultants, Inc. and Dr. Lane, contending that they
inappropriately advertised and promoted BeneFin and
SkinAnswer as effective in the prevention, treatment, and cure

                              6
of cancer. The FTC specifically sought monetary relief to
redress injury to consumers resulting from defendants’
violations of the Federal Trade Commission Act, including the
refund of monies paid and the disgorgement of ill-gotten
monies. Labs and Andrew Lane entered into a Consent Decree
with the FTC and judgment was entered against Labs (but not
Andrew Lane) in the amount of $1 million. A permanent
injunction was also ordered, prohibiting defendants from
representing that BeneFin or any other shark cartilage product
“prevents, treats or cures cancer unless, at the time the
representation is made, defendants possess and rely upon
competent and reliable scientific evidence that substantiates the
representation.”

FDA Action

        On December 10, 1999, the FDA filed a Complaint for
Permanent Injunction, alleging that Labs’ promotional claims
brought their products under 21 U.S.C. § 321(g)(1)(B)’s
definition of “drugs” and that they were “new drugs” within the
meaning of § 321(p) being distributed without requisite FDA
approval in violation of 21 U.S.C. § 331(d) and § 355(a). It
also alleged that the products were misbranded within the
meaning of § 353(f)(1) because they lacked adequate directions
for use and were being distributed and held for sale in violation
of § 331(a) and (k). The Complaint sought a permanent
injunction to prevent Labs from committing further violations



                               7
and also requested that the Court “grant such other and further
relief as it deems just and proper.” (Compl. at A113-121.)

       In June of 2002, the FDA moved for summary judgment
and amended the Complaint to seek both a permanent injunction
and equitable relief in the form of restitution for purchasers of
the products since September 22, 1999 (the date FDA notified
Labs of its intention to file the present action) and disgorgement
of profits, if such profits were not exhausted through restitution.

District Court’s Disposition

        On July 12, 2004, the District Court granted the
government’s motion for summary judgment, issued a
permanent injunction against the future sales of the products
until a new drug application was approved for them, and ordered
restitution to all purchasers of the products since September 22,
1999.      The District Court’s Order also provided for
unannounced FDA inspections of Lane Labs at Labs’ expense,
and granted the FDA discretion to force Labs to undertake
certain corrective actions. The Court concluded that all three
products were drugs because Labs intended to market them for
use in the treatment or cure of disease as evidenced by their
promotion of them for cancer, HIV, and AIDS. The Court
further held that the products were unapproved new and
misbranded drugs. The Court found that Labs’ violations had
been recurring, noted that Appellants did not appear to



                                8
recognize the wrongful nature of their conduct, and had not
voluntarily ceased the challenged practices.

                               II.

       The District Court had jurisdiction over this matter
pursuant to 28 U.S.C. § 1331, as it arose under the FDCA. It
had jurisdiction to restrain the violations pursuant to 21 U.S.C.
§ 332. We have jurisdiction under 28 U.S.C. § 1291 over this
appeal from the District Court’s order granting summary
judgment to the FDA, enjoining defendants from engaging in
certain activities, and directing defendants to pay restitution.

                              III.

        Appellants contend that the District Court did not have
the authority to order restitution under the FDCA.2 This is a
question of law, which we review de novo. Pierce v.
Underwood, 487 U.S. 552, 558 (1988). Appellants urge that
restitution cannot be awarded in this case because the FDCA
does not expressly provide for such a remedy and restitution is



  2
     This is the only issue currently on appeal. Appellants had
raised several other issues, but reached an agreement with the
government as to them before oral argument. Therefore, the
issue of a District Court’s jurisdiction and authority to order
restitution under the FDCA is the only issue still before us.

                               9
inconsistent with the policy, purpose, and legislative history of
the FDCA.

      The District Court based its power to order restitution on
21 U.S.C. § 332(a), which states:

              The district courts of the United
              States and the United States courts
              of the Territories shall have
              jurisdiction, for cause shown, to
              restrain violations of section 331 of
              this title, except paragraphs (h), (i),
              and (j).

        It is undisputed that this provision invokes the equitable
jurisdiction of the District Court. See Porter v. Warner Holding
Co., 328 U.S. 395, 397-98 (1946) (noting that a court’s
jurisdiction was “equitable” where the government “invoked the
jurisdiction of the District Court to enjoin acts and practices
made illegal by the Act”). Appellants claim that the specific
language of § 332 that permits the District Court “to restrain
violations” also limits its jurisdiction to injunctive orders that
would require them to cease their offensive conduct. They
argue, further, that the remedial structure of the FDCA and
principles of statutory construction require us to find such a
limitation to the court’s power.




                                10
        While arguably a close call, we conclude that applicable
Supreme Court jurisprudence has mapped out the contours of a
district court’s equitable powers in much more expansive terms
than Appellants recognize. Though the FDCA does not
specifically authorize restitution, such specificity is not required
where the government properly invokes a court’s equitable
jurisdiction under this statute. Although recent cases have tested
the propositions upon which we rely, we believe that the FDCA
grants district courts sitting in equity the authority to order
restitution.

                                A.

        Our review of the case law begins with the Supreme
Court’s opinion in Porter v. Warner Holding Company. In
Porter, the Office of Price Administration sought an injunction
against the Warner Holding Company under § 205(a) of the
Emergency Price Control Act of 1942 to prevent Warner from
collecting rents from tenants in excess of those permitted by the
applicable maximum rent regulations issued under the Act. The
complaint was later amended to seek, in addition, an order of
restitution to certain tenants who were entitled to a refund of any
rent that exceeded the regulatory maximum. Id. at 396-97. The
Administrator instituted proceedings under § 205(a) of the Act,
which provided:




                                11
              Whenever in the judgment of the
              Administrator any person has
              engaged or is about to engage in
              any acts or practices which
              constitute or will constitute a
              violation of any provision of
              section 4 of this Act, he may make
              application to the appropriate court
              for an order enjoining such acts or
              practices, or for an order enforcing
              compliance with such provision,
              and upon a showing by the
              Administrator that such person has
              engaged or is about to engage in
              any such acts or practices a
              permanent or temporary injunction,
              restraining order, or other order
              shall be granted without bond.




Id. at 397. The Supreme Court held that, although the language
of Section 205(a) did not explicitly grant the power to order
restitution, such power was within a district court’s equitable
jurisdiction. The Court explained:




                              12
Unless otherwise provided by
statute, all the inherent equitable
powers of the District Court are
available for the proper and
c o m p le te e x erc is e o f th a t
jurisdiction . . . . Power is thereby
resident in the District Court, in
exercising this jurisdiction to do
equity and to mould [sic] each
decree to the necessities of the
particular case. It may act so as . .
. to accord full justice to all the real
parties in interest . . . . In addition,
the court may . . . give whatever
other relief may be necessary under
the circumstances. Only in that
way can equity do complete rather
than truncated justice.

Moreover, the comprehensiveness
of this equitable jurisdiction is not
to be denied or limited in the
absence of a clear and valid
legislative command. Unless a
statute in so many words, or by a
necessary and inescapable
inference, restricts the court’s
jurisdiction in equity, the full scope

                  13
               of that jurisdiction is       to   be
               recognized and applied.

Id. at 398 (citations and internal quotations omitted).

        Based on such clear and sweeping language, it would
appear that a district court sitting in equity may order restitution
unless there is an explicit statutory limitation on the district
court’s equitable jurisdiction and powers. “The great principles
of equity, securing complete justice, should not be yielded to
light inferences, or doubtful construction.” Id. (citation
omitted). Yet, Appellants urge that the statutory language in
Porter is distinguishable from the language of 21 U.S.C.
§ 332(a) in such a way as to merit a different result here. In
Porter, § 205(a) of the Emergency Price Control Act granted
jurisdiction to enter a “permanent or temporary injunction,
restraining order, or other order” (emphasis added). Since
§ 332(a) makes no mention of any “other order” nor includes
any language that suggests alternative equitable remedies may
be available under the FDCA, Appellants claim that restitution
is not authorized by the statute. This argument, however, was
foreclosed by the Supreme Court in Mitchell v. Robert de Mario
Jewelry, Inc., 361 U.S. 288 (1960).

       In Mitchell, the Supreme Court not only reinforced its
ruling in Porter, but expanded its scope as well. There, the
Secretary of Labor brought an action under the Fair Labor
Standards Act (“FLSA”) to enjoin discrimination against three

                                14
employees who sought the aid of the Secretary of Labor to
recover wages allegedly unpaid in violation of the Act. In
addition, the Secretary sought reimbursement for wages lost by
the employee-victims of the discrimination based on § 17 of the
FLSA, which grants the district courts jurisdiction “for cause
shown, to restrain violations of section 15.” Mitchell, 361 U.S.
at 289-90. Citing Porter, the Supreme Court held that the
district court had jurisdiction to “order an employer to reimburse
employees, unlawfully discharged or otherwise discriminated
against, for wages lost because of that discharge or
discrimination.” Id. at 296. The Court noted that the absence of
language that could be said to support an affirmative
confirmation of the power to order restitution, such as the “other
order” provision in Porter, did not preclude the district court
from ordering reimbursement. The Court explained:

              When Congress entrusts to an
              equity court the enforcement of
              prohibitions contained in a
              regulatory enactment, it must be
              taken to have acted cognizant of the
              historic power of equity to provide
              complete relief in the light of
              statutory purposes. As this Court
              long ago recognized, there is
              inherent in the Courts of Equity a
              jurisdiction . . . to give effect to the
              policy of the legislature.

                                15
Id. at 291-92 (citations and internal quotations omitted). The
Court thus held that when a statutory provision gives the courts
power to “enforce prohibitions” contained in a regulation or
statute, Congress will be deemed to have granted as much
equitable authority as is necessary to further the underlying
purposes and policies of the statute.

        Accordingly, we view Porter and Mitchell as having
charted an analytical course that seems fairly easy to follow: (1)
a district court sitting in equity may order restitution unless there
is a clear statutory limitation on the district court’s equitable
jurisdiction and powers; and (2) restitution is permitted only
where it furthers the purposes of the statute. Numerous courts
have followed this approach in opining about a court’s power to
order restitution or disgorgement under several different statutes
that granted open-ended enforcement powers to the courts. See
FTC v. Gem Merch. Corp., 87 F.3d 466, 470 (11th Cir. 1996)
(finding disgorgement to be appropriate under the Federal Trade
Commission Act and Porter); SEC v. First City Fin. Corp., 890
F.2d 1215, 1230 (D.C. Cir. 1989) (relying on Porter to award
disgorgement under the Securities Exchange Act of 1934);
Commodity Futures Trading Comm’n v. Co Petro Mktg. Group,
Inc., 680 F.2d 573, 583-84 (9th Cir. 1982) (permitting
disgorgement under the Commodity Exchange Act); Interstate
Commerce Comm’n v. B&T Transp. Co., 613 F.2d 1182, 1184-
85 (1st Cir. 1980) (applying Porter and Mitchell to permit
restitution under the Motor Carrier Act); Commodity Futures
Trading Comm’n v. Hunt, 591 F.2d 1211, 1222-23 (7th Cir.

                                 16
1979) (holding that Porter authorized disgorgement under the
Commodity Exchange Act). Thus, we must now examine the
scope of the grant of equitable authority under the FDCA and
the policies and purposes underlying the statute to ensure that
ordering restitution furthers such purposes.

                               B.

       The statutory grant of equitable power of 21 U.S.C.
§ 332(a) at issue here is identical to the language the Supreme
Court considered in Mitchell. Compare Mitchell, 361 U.S. at
289 (“[T]he District Courts are given jurisdiction ‘for cause
shown, to restrain violations of section 15. . . .’” (quoting FLSA
§ 17)), with 21 U.S.C. § 332(a) (“The district courts . . . shall
have jurisdiction, for cause shown, to restrain violations of
section 331 of this title. . . .”). Consequently, the Supreme
Court’s reasoning in Mitchell applies with equal force in the
instant case. Since nothing in the FDCA creates a “necessary
and inescapable inference” that the equitable power of district
courts under § 332(a) is limited, we conclude that the authority
given is broad enough to encompass all equitable remedies that
would further the purposes of the Act.

        Appellants and amicus argue that the FDA’s failure to
seek restitution for long periods of time, including during the
first thirteen years after the FDCA’s enactment, is strong
evidence that such power is not granted by the statute. They
point to BankAmerica Corp. v. United States, 462 U.S. 122,

                               17
131 (1983), where the Court stated, “ just as established practice
may shed light on the extent of power conveyed by general
statutory language, so the want of assertion of power by those
who presumably would be alert to exercise it, is equally
significant in determining whether such power was actually
conferred.” Appellants point out that, as recently as 1992, a
senior FDA official responsible for enforcement published an
article that did not even list restitution among its available
enforcement tools and remedies. Marie A. Urban, The FDA’s
Policy on Seizures, Injunctions, Civil Fines, and Recalls, 47
Food & Drug L.J. 411 (1992). However, “‘[a]uthority granted
by Congress . . . cannot evaporate through lack of
administrative exercise.’” BankAmerica Corp., 462 U.S. at 131
(quoting FTC v. Bunte Brothers, Inc., 312 U.S. 349, 352
(1941)). That the FDA has rarely sought restitution under
§ 332(a) does not create a “necessary and inescapable inference”
that Congress stripped district courts of their equitable power to
award it.

                                C.

        Appellants argue that ordering restitution does not further
the purpose of the FDCA, which they contend is limited to
protecting consumers from dangerous and harmful products.
They distinguish Porter and Mitchell in this regard, claiming that
restitution supported the statutory purposes of the violated Acts
in each of those cases in a way that it does not here. In Porter,
the purpose of the Emergency Price Control Act was to guard

                                18
against inflation and monetary harm to consumers. There is
little doubt that refunding the excess rents paid was a means of
reducing the threat of inflation and righting, to some extent, the
wrongs committed against the renters. Similarly, Appellants
argue that safeguarding employee whistleblowers from financial
harm was one of the purposes of the FLSA, the statute at issue
in Mitchell. Reimbursing for lost wages directly accomplishes
this objective. Appellants also note that because enforcement of
the FLSA depends on employee-initiated claims, the
reimbursement of an employee’s wages lost due to her
employer’s violation of the Act provides an incentive for
employees to bring such suits, thereby ensuring greater fairness
in employment practices.

       We agree that protecting consumer health and safety is a
primary purpose of the FDCA. See 21 U.S.C. § 321(p)
(defining a “new drug” as a drug “not generally recognized
among experts . . . as safe and effective for use”); 21 U.S.C.
§ 393(b) (establishing the FDA’s mission to promote and protect
public health). Appellants argue that since this purpose is not of
a financial nature, restitution should not be ordered in equity.
We are not convinced, however, that the purposes of the FDCA
are as limited as Appellants suggest. Cf. FDA v. Brown &
Williamson Tobacco Corp., 529 U.S. 120, 133 (2000) (“[I]t is
evident that one of the Act’s core objectives is to ensure that any
product regulated by the FDA is ‘safe’ and ‘effective’ for its
intended use.”) (emphasis added). The FDCA and its legislative
history make it clear that Congress intended the statute to protect

                                19
the financial interests of consumers as well their health. See
United States v. An Article . . . Consisting of 216 Cartoned
Bottles, 409 F.2d 734, 740 (2d Cir. 1969) (“A primary purpose
of the [FDCA] is the protection of the ultimate consumer’s
economic interests.”); United States v. Parkinson, 240 F.2d 918,
921 (9th Cir. 1956) (noting that, though the court believed
restitution was improper under the FDCA, the Act
“[u]nquestionably [includes] a subsidiary purpose to protect the
purses of the public and to prevent the vending of alleged
remedies, which at best were useless, to fatten the pockets of the
exploiter”).

        The economic purposes of the FDCA are evidenced in
part by the statute itself. One of the FDCA’s explicit mandates
to the Secretary of Health and Human Services is to “promote
honesty and fair dealing in the interest of consumers.”
21 U.S.C. § 341.3 Such a mandate protects not only the public’s
health, but also its economic interest in purchasing products that
are what they claim to be. Indeed, the FDCA explicitly prohibits
labeling and advertising that may deceive consumers as to the
quality or content of products. See 21 U.S.C. § 331
(prohibiting the misbranding of food, drugs, devices, or


    3
      Though both 21 U.S.C. § 341 and Federal Security
Administrator v. Quaker Oats Company, infra, relate to the
FDCA’s regulation of food, the objectives they describe reflect
the overall purposes of the FDCA and are therefore relevant to
our analysis.

                               20
cosmetics); 21 U.S.C. § 352 (defining “misbranded drugs” to
include any drugs labeled or packaged in a misleading manner).
Preventing such deception has as much to do with ensuring
customers receive the value they expect from products as it does
ensuring their safety. 21 U.S.C. § 352(i); Fed. Sec. Adm’r v.
Quaker Oats Co., 318 U.S. 218, 230 (1943); United States v.
Two Bags, etc., 147 F.2d 123, 127 (6th Cir. 1945). As the
Supreme Court noted, the FDCA “protect[s] the consumer from
‘economic adulteration,’ by which less expensive ingredients
were substituted . . . so as to make the product, although not in
itself deleterious, inferior to that which the consumer expected
to receive when purchasing a product with the name under
which it was sold.” Quaker Oats, 318 U.S. at 230. Similarly, by
requiring drug packaging to represent correctly the quantity of
drugs the packages contain, the FDCA seeks to ensure
customers receive the full value of their purchase. 21 U.S.C.
§ 352(b); see also United States v. Articles of Drug, etc., 442 F.
Supp. 1236, 1241 (S.D.N.Y. 1978) (finding drugs to be
misbranded because they were sold in packages that contained
less than the 100 capsules that the packages purported to
contain).

       The legislative history likewise supports the view that
one purpose of the FDCA is to protect consumers’ financial
interests. During its deliberations about the Act, Congress stated
that prevention of deceit upon the purchasing public and
protection of consumers from unscrupulous competition were
among its purposes. See H.R. Rep. No. 75-2716, at 1 (1938)

                               21
(Conf. Rep.) (recommending that the FDCA pass “for the
purposes of safeguarding the public health, preventing deceit
upon the purchasing public, and for other purposes”); H.R. Rep.
No. 74-2755 at 1 (1936) (same); id. at 2 (stating that the FDCA
will “protect the many from unscrupulous competition” and
“provide a bulwark of consumer confidence”); id. at 3 (noting
that the FDCA “amplifies and strengthens the provisions
designed to safeguard the public health and prevent deception”).
The statute was aimed at protecting both “the consumer’s health
and pocketbook.” Id. at 2; see also id. at 9 (describing how the
remedy of seizure aids in protecting against actions that “at best
rob the consumer’s pocketbook, and at worst rob him of health
or life”). During the Senate debate on the FDCA, Senator
Copeland argued explicitly that the bill was intended to prevent
drug manufacturers from “exploiting the American people” and
“taking money from innocent people making them believe that
they are going to be cured.” 79 Cong. Rec. S5023 (Apr. 4,
1935).

        Appellants and amicus argue that § 332(a) was designed
only to fill a gap in the previous enactment by allowing a prompt
injunctive action to prevent products from entering commerce.
During the Congressional debates, Senator Copeland noted:

              Under the present law action can
              only be taken by crim inal
              prosecution of the shipper or the
              seizure of his goods after he has

                               22
              distributed them in interstate
              commerce. . . . Under the bill a
              provision is made whereby the
              G o v ern m e nt c a n re stra in a
              manufacturer by injunction from
              shipping goods in violation of the
              law or from the repetitious
              advertising of such goods. This
              would stop the offense promptly and
              at its source.

78 Cong. Rec. 8960 (1934) (statement of Sen. Copeland)
(emphasis added). The final Senate and House Reports on the
bill were to the same effect. S. Rep. No. 91, 75th Cong., 1st
Sess. 4 (1937) (the bill “adds injunction, temporary and
permanent, as a means for prohibiting adulteration and
misbranding”) (emphasis added); H.R. Rep. No. 2139, 75th
Cong., 3d Sess. 3 (1938) (the bill “provides a new enforcement
procedure . . . by authorizing the courts to enjoin violations”).
Appellants and amicus argue that nothing in the legislative
history suggests that Congress viewed § 332 as granting courts
authority to order restitution, or any other backward-looking
relief, and cite in support a 1954 Harvard Law Review note that
“not one word in the five years of legislative hearings on the
FDCA intimates that any kind of affirmative relief was meant to
be provided by [§ 332].” Note, Developments in the Law – The
Federal Food, Drug, and Cosmetic Act, 67 Harv. L. Rev. 632,
719 (1954).

                               23
       They also argue that construing § 332 to encompass
backward-looking monetary relief such as restitution would turn
Congress’s intent on its head because one reason Congress
added § 332 was to provide an option that was less punitive to
manufacturers than the seizure provisions and criminal sanctions
already in the Act. For example, the House Report states:

              In some cases [an injunction]
              should avoid the hardship and
              expenses to litigants in seizure
              cases. In many instances seizure is
              a harsh remedy and should be
              discouraged or confined to those
              cases where the public protection
              requires such action. In many
              cases, it is believed, the use of
              injunctions can be used with equal
              effectiveness and with less
              hardship.

H.R. Rep. 75-2139, at 3-4 (1938). Thus, Appellants and amicus
argue that, since restitution is almost always more harsh than
seizure, restitution was plainly not contemplated by Congress at
the time the FDCA’s injunction provision was enacted. As the
amicus puts it, “[c]ompared to restitution, seizure is small
potatoes—it merely wrests the product itself from circulation. .
. . The imposition of such enormous and potentially debilitating
restitution orders, which far exceed the civil and criminal

                              24
penalties under the Act, cannot be reconciled with Congress’s
effort to authorize prohibitory injunctions as an alternative to
seizure ‘with equal effectiveness and less hardship.’” Amicus
Br. at 8.

        The Court of Appeals for the Sixth Circuit properly
rejected this argument in Universal Management, reasoning that
“even if Congress expressed some concern that seizure should
remain the harshest relief available, there is no convincing
argument that, in all cases, restitution creates a more harsh result
than seizure, procedurally or substantively.” 191 F.3d at 762.
The court went on to find that “even accepting the references to
legislative concerns . . . these concerns are far from a clear
statement of Congress’s intent to exclude restitution, recalls,
disgorgement, or any other traditional form of equitable relief.”
Id. Given that Congress expressly provided for general
equitable relief, “[Mitchell] instructs, we must presume that
Congress is cognizant of the scope of equity. . . .” We agree
with this analysis.

        Thus, both the FDCA and its legislative history support
the view that protecting consumers’ economic interests is an
important objective of the Act. Though this economic purpose
is not as central to the FDCA as protecting public health, one
objective need not be the sole guide for how a court constructs
a statute that has multiple purposes. See McKart v. United
States, 395 U.S. 185, 192 (1969) (weighing the multiple
purposes Congress had in mind when it enacted a selective

                                25
service provision, rather than finding one purpose to be crucial).
Our conclusion that economic protection of consumers is a
purpose of the FDCA is consistent with the position of the
courts of appeals for three other circuits. United States v.
Universal Mgmt. Servs., Inc., 191 F.3d 750, 763 (6th Cir. 1999);
An Article . . . Consisting of 216 Cartoned Bottles, 409 F.2d at
740; Parkinson, 240 F.2d at 921.

        Restitution that reimburses consumers who paid for
unapproved drugs, and may have been defrauded or deceived
about their effectiveness, restores aggrieved parties to the same
economic position they enjoyed before the Act was violated.
This strengthens the financial protection offered to the public by
the FDCA and enhances consumer confidence in the drug
market. Whether or not Congress specifically contemplated
restitution under the FDCA, the ability to order this remedy is
within the broad equitable power granted to the district courts to
further the economic protection purposes of the statute.

       Restitution also serves a deterrent function embodied in
the district court’s authority to “restrain violations of section
331.” 21 U.S.C. § 332(a). As in Porter, where the Court ruled
that “a restitution order [was] appropriate and necessary to
enforce compliance with the Act and to give effect to its
purposes,” 328 U.S. at 400, we note that the restitution ordered
by the District Court will deter future violations of the FDCA by
the Appellants. Such a forward-looking deterrent effect is an
important ancillary consequence of restitution. See id. (“Future

                               26
compliance may be more definitely assured if one is compelled
to restore one’s illegal gains.”) Given Appellants’ repeated
violations of the FDCA, committed despite numerous warnings
from the FDA, it was within the District Court’s equitable
discretion to award restitution in order to prevent further
violations.

                              IV.

       The analysis propounded by the Supreme Court in Porter
and Mitchell leads us to the conclusion that the District Court
was authorized to order restitution. We recognize, however, that
the analytic course set by the Court in these cases has not been
entirely smooth. Appellants point to two recent cases that they
believe divert the analysis away from Porter and Mitchell. We
believe that these cases are merely bumps in the road and not, as
Appellants suggest, roadblocks to the conclusion we have
reached. Nevertheless, they are worthy of discussion.

                               A.

       In Meghrig v. KFC Western, Inc., 516 U.S. 479 (1996),
the Supreme Court considered whether the citizen’s suit
provisions of the Resource Conservation and Recovery Act of
1976 (“RCRA”) include a right to recover the prior cost of
cleaning up toxic waste that does not endanger health or the
environment at the time of suit. Id. at 481. The plaintiff sought
such costs under a statutory provision that gave individuals the

                               27
right to bring a civil action against owners or operators who
contributed to the handling, storing, or treatment of hazardous
waste that “may present an imminent and substantial
endangerment to health or the environment.”                  42§
§ 6972(a)(1)(B). The plaintiff, joined by the government,
characterized such costs as equitable restitution and argued that
they were properly awarded under RCRA’s authorization “to
restrain any person who has contributed or who is contributing
to the past or present handling, storage, treatment,
transportation, or disposal of any solid or hazardous waste . . .
[or] to order such person to take such action as may be
necessary.” Meghrig, 516 U.S. at 482 (quoting 42§ § 6972(a)).

        The Court rejected the notion that a district court’s
equitable power under RCRA included the authority to award a
plaintiff costs for past cleanup efforts. The Supreme Court
found it “apparent” that neither of the two equitable remedies
provided – to restrain or to order further action – contemplated
an award of past cleanup costs. Id. at 484. It noted that the
Comprehensive Environmental Response, Compensation, and
Liability Act of 1980 (“CERCLA”), which Congress enacted
after RCRA, explicitly provided for recovery of cleanup costs
despite the fact that CERCLA, like RCRA, provided district
courts with the power “to order such action as may be
necessary” to correct violations. There would have been no
need for Congress to enumerate this specific remedy in
CERCLA if the power “to order such action as may be
necessary” already encompassed it. Moreover, CERCLA’s

                               28
specification of this provision indicated to the Court that
Congress “knew how to provide for the recovery of cleanup
costs” when it wanted to do so. Id. at 485.

       The Court also believed that the text of § 6972(a), which
limits citizen suits to circumstances in which the hazardous
waste “may present[] an imminent and substantial endangerment
to health or the environment,” precluded recovery of prior
cleanup costs. The Court read this language to indicate that the
provision “was designed to provide a remedy that ameliorates
present or obviates the risk of future ‘imminent’ harms.” Id. at
486. Since waste that the plaintiff has already disposed of
presents no risk of future harm, recovery for past cleanup efforts
would be inherently backward-looking, and therefore not
available under the forward-looking language of § 6972(a).

       Finally, the Court cited RCRA’s “elaborate enforcement
provisions” as evidence that Congress would have specifically
provided for recovery costs if this had been its intent. Id. at 487.
“[W]here a statute expressly provides a particular remedy or
remedies, a court must be chary of reading others into it.” Id. at
488 (quoting Middlesex County Sewerage Auth. v. Nat’l Sea
Clammers Assn., 453 U.S. 1, 14-15 (1981)). Given the
complexity of RCRA’s enforcement scheme, the Court refused
to “assume[] that Congress intended to authorize by implication
additional judicial remedies.” Id.




                                29
        We view Meghrig as distinguishable from the instant
case, and from Porter and Mitchell, in several ways. First,
Meghrig involved a citizen’s suit remedy, not an enforcement
action by the government like the suit before us. As the Court
noted in Porter, a court’s equitable powers “assume an even
broader and more flexible character” when the public interest is
involved than when “only a private controversy is at stake.” 328
U.S. at 398. Thus, it is natural that the Court would tend to
adopt a more restrictive view of RCRA in Meghrig than it
adopted towards the statute in question in Porter. Second,
RCRA’s text imposed limitations on the equitable power of the
district courts that are not present in FDCA’s broad
authorization “to restrain violations of section 331.”
Specifically, RCRA focused on preventing future harm by
limiting citizen suits to situations with a risk of “imminent and
substantial” harm. There was no such limitation in the statutes
considered in Porter or Mitchell, nor in the provision of the
FDCA we examine here.

        Third, there is a considerable difference between the type
of “restitution” – if that is how it is properly characterized – that
the plaintiff sought in Meghrig and that which the government
seeks in this case. In Meghrig, the plaintiff claimed that the
former owners of a contaminated property were responsible for
equitable restitution because they allegedly contributed to the
waste on the property. The money sought as restitution was
essentially the cost of clean-up, which can be huge. 516 U.S. at
482. By contrast, the restitution sought by the government here

                                 30
is reimbursement of the money consumers paid Appellants for
products that violated the FDCA; that is, the restitution the
government seeks is directly traceable to the Appellants’
offensive conduct and the harm this conduct caused consumers.
The consequence of this distinction is that the “restitution”
requested in Meghrig resembles traditional damages far more
than the restitution that the government seeks here. Restitution
is properly sought in equity “where money or property identified
as belonging in good conscience to the plaintiff could clearly be
traced to particular funds or property in the defendant’s
possession.” Great-West Life & Annuity Ins. Co. v. Knudson,
534 U.S. 204, 213 (2002). While that is the case here, it was not
so in Meghrig.         The Court undoubtedly weighed the
nontraditional nature of the “restitution” sought in Meghrig
against the plaintiffs. See Meghrig, 516 U.S. at 484 (rejecting
“the award of recovery of past cleanup costs, whether these are
denominated as ‘damages’ or ‘equitable restitution’”).
Moreover, the peculiar character of restitution requested in that
case further distinguishes it from Porter, Mitchell, and this one.

       Lastly, the Court was very concerned in Meghrig about
disrupting the detailed remedial scheme that Congress provided.
We agree with the Court’s sentiment that “a court must be chary
of reading” other remedies into a statute where an elaborate
enforcement provision for remedying violations has been set
forth. Id. at 488. However, one cannot compare the elaborate
remedial scheme of RCRA with that of the FDCA. Unlike
RCRA, the FDCA has no citizen’s suit provision to provide a

                               31
remedy for individuals harmed. See 21 U.S.C. § 337. While
§ 332 broadly grants authority to restrain any violations of
§ 331, the FDCA’s more specific remedial provisions address a
few particular kinds of violations, such as improprieties during
the approval process, 21 U.S.C. § 335b, or the sale of drug
samples, 21 U.S.C. § 333(b). Finally, the one provision of the
FDCA that does mention reimbursement, 21 U.S.C.
§ 360h(b)(2)(C), actually grants the FDA expanded
administrative powers, rather than diminishing a district court’s
judicial power. Accordingly, whereas the Court in Meghrig
found the extensive remedial scheme of RCRA imposed a
limitation on the remedies available, the provisions of FDCA
before us are not so restricted and Meghrig is of limited import
for our purposes.4 Nor is there any indication, either in Meghrig
or since, that the Court has abandoned the holdings of Porter and

  4
     Indeed, it could be said that Meghrig, involving RCRA, is
sui generis. The statutory provisions addressed in both Porter
and Mitchell contained certain damage provisions that were
viewed as inconsistent with, or competing against, the award of
restitution. See Mitchell, 361 U.S. at 303 (Whittaker, J.,
dissenting) (arguing that § 16 of the FLSA precluded the
restitution award the government sought); Porter, 328 U.S. at
404 (Rutledge, J., dissenting) (rejecting restitution because “the
scheme of enforcement was highly integrated with the parts
precisely tooled and minutely geared”). Nonetheless, the Court
in both instances, had little difficulty in finding the grant of
equitable authority to be sufficient to include the award of
restitution.

                               32
Mitchell that we follow today. See United States v. Oakland
Cannabis Buyers’ Coop., 532 U.S. 483, 496 (2001) (citing
Porter after the Meghrig decision for the proposition that
equitable “discretion is displaced only by a ‘clear and valid
legislative command’”); Miller v. French, 530 U.S. 327, 340
(2000) (same).

       The other case deserving of attention is the recent
decision of the Court of Appeals for the District of Columbia in
United States v. Phillip Morris, 396 F.3d 1190 (D.C. Cir. 2005),
petition for cert. filed, 74 U.S.L.W. 3050 (July 18, 2005), where
the court considered whether the statutory grant of equitable
power to district courts under the Racketeer Influenced and
Corrupt Organization Act (“RICO”) included the power to order
disgorgement. RICO gave district courts jurisdiction:

              to prevent and restrain violations of
              [RICO] by issuing appropriate
              orders, including, but not limited
              to: ordering any person to divest
              himself of any interest, direct or
              indirect, in any enterprise;
              imposing reasonable restrictions on
              the future activities or investments
              of any person, including, but not
              limited to, prohibiting any person
              from engaging in the same type of
              endeavor as the enterprise engaged

                               33
              in, the activities of which affect
              interstate or foreign commerce; or
              ordering dissolution or
              reorganization of any enterprise,
              making due provision for the rights
              of innocent persons.

18 U.S.C. § 1964(a). The court noted that the purpose of every
order listed in § 1964(a) was to prevent future violations of
RICO. Applying the canons of noscitur a sociis and ejusdem
generis, the court concluded it would “expand on the remedies
explicitly included in the statute only with remedies similar in
nature.” Phillip Morris, 396 F.3d at 1200. Since disgorgement
was “a quintessentially backward-looking remedy focused on
remedying the effects of past conduct to restore the status quo,”
id. at 1198, it was fundamentally different from the remedies
listed in § 1964(a), and therefore excluded from the district
court’s power. The court rejected the argument that Porter and
Mitchell compelled a different result, finding that, even under
those cases, the power to order disgorgement “is not within the
terms of [RICO’s] statutory grant [of equitable power], nor any
necessary implication of the language of the statute.” Id. at
1199. The court also relied on Meghrig for the proposition that
RICO’s elaborate enforcement structure limited the equitable
remedies available. Id.

      In a strong dissent, Judge Tatel contended that Porter and
Mitchell permitted a court sitting in equity to order

                               34
disgorgement under RICO. He argued that the presence of an
elaborate statutory scheme was not a controlling factor, given
that the statutes at issue in both Porter and Mitchell also
included detailed remedial schemes. The presence of any
conflicting or duplicate recovery was not significant to the
Supreme Court in either case. Id. at 1217-18. Judge Tatel
distinguished Meghrig on the grounds that it involved a citizen’s
suit, whereas the government brought suit in Phillip Morris in
the public’s interest. He also noted that RICO’s statutory
scheme resembled the statute considered in Porter more than
RCRA, on which Meghrig was based. Id. at 1220-21. Judge
Tatel concluded that Porter and Mitchell, not Meghrig,
controlled and that RICO contained no “necessary and
inescapable inference” that limited the district court’s
jurisdiction in equity and precluded an order for disgorgement.
Id. at 1222.

        Without opining as to whether Phillip Morris was rightly
or wrongly decided (and the government urges, not surprisingly,
that it was wrongly decided), we believe that it is easily
distinguishable from the instant case. RICO’s grant of equitable
jurisdiction was far less broad than the FDCA’s grant we
consider here. RICO listed several specific types of relief aimed
at making it difficult or impossible for a violator to commit
future violations. There is nothing comparable in the text or
structure of the FDCA that provides the “necessary and
inescapable inference” that Congress had limited the equitable
power of district courts to award restitution. Rather, 21 U.S.C.

                               35
§ 332(a) simply gives blanket authority to district courts to
“restrain violations of section 331.” Furthermore, to the extent
that the Court of Appeals for the District of Columbia rested its
decision on Meghrig, we have already distinguished that case
from the circumstances before us. In short, we do not find
Phillip Morris persuasive here.

                                B.

       Additionally, there is case law and commentary that
discusses how we should apply Porter and Mitchell to the
specific context of the FDCA. Since both Appellants and
amicus draw extensively on these sources to support their
arguments against restitution in this context, we address them
directly.

       Nearly fifty years ago, in United States v. Parkinson, 240
F.2d 918 (9th Cir. 1956), the Court of Appeals for the Ninth
Circuit rejected the government’s request to collect restitution
under the FDCA. Though it recognized that one of the purposes
of the Act was “to protect the purses of the public,” id. at 921,
the court held that “neither the [FDCA] nor any other legislation
gives the District Court jurisdiction to grant” restitution, id. at
922. Parkinson does not survive Porter and Mitchell. First, it
was based on the premise that “[t]he use of the extraordinary
remedies of equity in governmental litigation should never be
permitted by the courts unless clearly authorized by the statute
in express terms.” Id. This proposition is at odds with the

                                36
Supreme Court’s reasoning in these cases. In addition,
Parkinson predates Mitchell, which expanded the reasoning of
Porter to a statutory grant of equitable power identical to the
grant included in the FDCA. Compare Mitchell, 361 U.S. at 289
(“[T]he District Courts are given jurisdiction ‘for cause shown,
to restrain violations of section 15. . . .’” (quoting FLSA § 17)),
with 21 § 332(a) (“The district courts . . . shall have jurisdiction,
for cause shown, to restrain violations of section 331 of this
title. . . .”). We are, of course, bound by Mitchell, even if the
Parkinson court was not. Finally, it is important to note that we
do agree with Parkinson about the FDCA’s “subsidiary purpose”
to protect the economic interests of consumers. Parkinson, 240
F.2d at 921. We part ways with the Ninth Circuit Court of
Appeals only in its pre-Mitchell holding that a district court
sitting in equity cannot order restitution to further this statutory
purpose.

        More recently, the Court of Appeals for the Sixth Circuit
rejected the reasoning in Parkinson and ordered a party to pay
restitution under the FDCA. Universal Mgmt. Servs., Inc., 191
F.3d at 764. In that case, the defendant sold electric gas grill
lighters equipped with finger grips as pain reliving devices
without obtaining FDA approval. Id. at 754. The court held that
the grant of equitable power in § 332(a) was so broad that it was
within the district court’s authority to order restitution. See id.
at 762 (“The express provision for general equitable relief
without the enumeration of any exceptions makes it difficult for
this court to find any legitimate means for implicitly carving out

                                 37
such exceptions as we see fit.”). Following Porter, and
concluding that Parkinson was no longer good law after
Mitchell, id. at 761, the Sixth Circuit Court of Appeals held that
nothing in the FDCA precludes a district court from ordering
restitution and that it was an appropriate remedy to make victims
whole, id. at 762-63. Notably, the court relied on Porter without
discussing Meghrig or treating that case as a limitation on the
equitable powers granted by § 332(a).

        In the years since Universal Management, the FDA has
negotiated three consent decrees with drug companies that
included significant disgorgement amounts. In 1999, just two
months after Universal Management was decided, Abbott
Laboratories agreed to pay $100 million to the government as
part of a consent decree. Consent Decree of Permanent Inj.,
United States v. Abbott Labs., Civ. Action No. 99C 7135, 1999
U.S. Dist. LEXIS 18897, at *9 (D. Ill. filed Nov. 2, 1999). In
October 2000, Wyeth-Ayerst agreed to pay $30 million in
disgorgement as part the remedial measures implemented under
a consent decree. Consent Decree of Condemnation and
Permanent Inj., United States v. Various Articles of Drug, No.
3:00-CV-359 (E.D. Tenn. filed Oct. 3, 2000). Most recently,
Schering-Plough paid $500 million for equitable disgorgement
as part of a consent decree. Consent Decree of Permanent Inj.,
United States v. Schering-Plough Corp., No. C-02-2397 (JAP)
(D.N.J. filed May 20, 2002).




                               38
        Amicus and other commentators have responded
vigorously to these consent decrees and to the Universal
Management decision. The authors of several recent articles
have raised numerous arguments as to why Porter and Mitchell
do not, or should not, authorize courts to order restitution or
disgorgement under the FDCA. See William V. Vodra & Arthur
N. Levine, Anchors Away:               The Food and Drug
Administration’s Use of Disgorgement Abandons Legal
Moorings, 59 Food & Drug L.J. 1 (2004); Jeffrey N. Gibbs &
John R. Fleder, Can FDA Seek Restitution or Disgorgement?,
58 Food & Drug L.J. 129 (2003); Erika King & Elizabeth M.
Walsh, The Authority of a Court to Order Disgorgement for
Violations of the Current Good Manufacturing Practices
Requirement of the Federal Food, Drug, and Cosmetic Act, 58
Food & Drug L.J. 149 (2003). To the extent that the arguments
of commentators are relevant to the instant case, their central
claim is that awarding restitution under the FDCA would rewrite
or improperly expand the remedies available under the statute.
Amicus Br. at 9; Gibbs & Fleder, supra, at 147. They argue that
the ability under § 332(a) “to restrain violations” contemplates
only forward-looking remedies and that this mandate excludes
restitution. Amicus Br. at 9; Gibbs & Fleder, supra, at 142-43.
The commentators and amicus rely heavily on Meghrig in
making these claims.

       These arguments, which were considered and rejected by
the Supreme Court in Porter and Mitchell, essentially replicate
the positions of the justices who wrote in dissent in each case.

                              39
See Mitchell, 361 U.S. at 303 (Whittaker, J., dissenting); Porter,
328 U.S. at 404 (Rutledge, J., dissenting). Moreover, to the
extent these authors rely on Meghrig, we reiterate our view that
Meghrig did not overrule Porter or Mitchell. Once Congress
invokes the equity jurisdiction of the district courts, a “clear and
valid legislative command” or a “necessary and inescapable
inference” is still required to restrict a court’s authority in
equity. Porter, 328 U.S. at 398. Since Congress has placed no
unambiguous restriction on equity jurisdiction under § 332(a),
the arguments of amicus and other commentators are little more
than entreaties that we ignore or overrule Porter and Mitchell,
neither of which we have the power to do.

        Also, we view amicus and the commentators as making
a fundamental error in analyzing whether restitution is available:
they view this primarily as a question of what remedies are
provided by the FDCA rather than, as we have emphasized, a
question of the scope of the express legislative grant of equitable
power under § 332(a). The District Court did not “discover” an
implied remedy, but rather exercised the equitable power that
Congress explicitly granted to it under the FDCA. Thus,
contrary to the dire warning from amicus, Amicus Br. at 25 n.3,
this case is not a regression back to the “heady days” in which
the courts used J.I. Case Co. v. Borak, 377 U.S. 426 (1964), and
its progeny to find implied remedies under statutes. Corr. Servs.
Corp. v. Malesko, 534 U.S. 61, 75 (2001) (Scalia, J.,
concurring). The Supreme Court made it clear in Meghrig that
courts must consider a statute’s remedial scheme as one method

                                40
for inquiring into whether there is a “necessary and inescapable
inference” that Congress limited the equitable jurisdiction of the
district courts. Yet, the inquiry into statutory remedies is not as
limiting in the context of a grant of equitable authority as it is in
the context of implied remedies. In the latter situation, there is
a presumption that “[t]he express provision of one method of
enforcing a substantive rule suggests that Congress intended to
preclude others.” Alexander v. Sandoval, 532 U.S. 275, 290
(2001). In the former context, however, there is a presumption
that “[w]hen Congress entrusts to an equity court the
enforcement of prohibitions contained in a regulatory enactment,
it must be taken to have acted cognizant of the historic power of
equity to provide complete relief in light of the statutory
purposes.” Mitchell, 361 U.S. at 291-92. That presumption
applies here and directs us to uphold the District Court’s order
for restitution.

                                 V.

       The arguments and analysis of Appellants and the
commentators are creative and forceful, but, for now, are merely
arguments as to why the Supreme Court should draw finer lines
around a court’s authority to fashion specific remedies within a
broad statutory grant of equitable power. Until the Court
overrules Porter and Mitchell, we are bound by the reasoning of
those cases. Given the breadth and open-ended nature of
§ 332(a), and the direct correlation between the language of that
provision and the directives in Porter and Mitchell, we hold that

                                 41
the District Court here did have the power to grant restitution.
We will therefore AFFIRM its order.

_____________________




                              42
