F I L E D
United States Court of Appeals
Tenth Circuit
PUBLISH
February 22, 2006
UNITED STATES COURT OF APPEALS Elisabeth A. Shumaker
Clerk of Court
TENTH CIRCUIT
UNITED STATES OF AMERICA,
Plaintiff-Counter-
Defendant-Appellant,
v.
RX DEPOT, INC., corporation; RX OF
CANADA, LLC, corporation; CARL
MOORE, individual; DAVID No. 05-5003
PEOPLES, individual,
Defendants-Counter-
Claimants-Appellees.
----------------------------------
WASHINGTON LEGAL
FOUNDATION,
Amicus Curiae.
Appeal from the United States District Court
for the Northern District of Oklahoma
(D.C. No. CV-03-616-EA(M))
Mark Reiling Freeman, Appellate Staff, Civil Division, U.S. Department of
Justice (Peter D. Keisler, Assistant Attorney General, David E. O’Meilia, United
States Attorney, Scott R. McIntosh, Appellate Staff, Civil Division, U.S.
Department of Justice, Alex M. Azar II, General Counsel, Sheldon T. Bradshaw,
Chief Counsel, Food and Drug Division, Gerald F. Masoudi, Acting Chief
Counsel, Food and Drug Division, Eric M. Blumberg, Deputy Chief Counsel,
Litigation, Michael M. Levy, Associate Chief Counsel for Enforcement, United
States Department of Health and Human Services, Office of the General Counsel,
Of Counsel, with him on the briefs), Washington, D.C., for Plaintiff-Counter-
Defendant-Appellant.
Fred E. Stoops, Sr. (E. Diane Hinkle, with him on the brief), Tulsa, Oklahoma, for
Defendants-Counter-Claimants-Appellees.
Daniel J. Popeo, Richard A. Samp, Counsel of Record, Washington Legal
Foundation, Washington, D.C., filed an amicus curiae brief on behalf of
Defendants-Counter-Claimants-Appellees.
Before HENRY, McWILLIAMS and MURPHY, Circuit Judges.
MURPHY, Circuit Judge.
I. Introduction
Appellees Rx Depot, Inc., Rx of Canada, LLC, Carl Moore, and David
Peoples (collectively “Rx Depot”) facilitated the sale of prescription drugs from
Canada to customers in the United States. The United States brought suit against
Rx Depot, alleging its business practices violated provisions of the Federal Food,
Drug and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301–397. Rx Depot admitted to
violating the Act and entered into a consent decree of permanent injunction.
Subsequently, the United States sought disgorgement of Rx Depot’s profits. The
district court denied disgorgement, concluding it was not an available remedy
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under the FDCA as a matter of law. We exercise jurisdiction pursuant to 28
U.S.C. § 1291. Because the FDCA invokes courts’ general equity jurisdiction and
does not prohibit disgorgement by clear legislative command or necessary and
inescapable inference, we reverse and remand.
II. Background
Rx Depot helped consumers in the United States obtain prescription drugs
from Canada at reduced prices. A customer with a prescription from an American
physician could download forms from Rx Depot’s website or visit one of Rx
Depot’s storefront affiliates to order medications. Rx Depot then transmitted the
customer’s forms, prescription, and payment information to cooperating Canadian
pharmacies. A Canadian physician would rewrite the prescription, which was
then filled by a Canadian pharmacy and sent directly to the customer in the United
States. Rx Depot received a ten to twelve percent commission for each sale they
facilitated.
The United States filed a civil action alleging Rx Depot’s activities violated
provisions of the FDCA. Specifically, the Government alleged Rx Depot violated
§ 381(d)(1) by reimporting prescription drugs originally manufactured in the
United States and § 355(a) by introducing new drugs into interstate commerce
without FDA approval. The government sought a temporary and permanent
injunction and other equitable relief. The district court entered a preliminary
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injunction ordering Rx Depot to discontinue its business activities. The parties
then agreed to, and the district court approved, a consent decree of permanent
injunction. In the consent decree, Rx Depot admitted to violating the FDCA and
agreed not to resume its business operations. The consent decree left “to the
discretion of [the district court] the issue of what, if any, equitable relief,
including restitution and/or disgorgement, should be awarded to [the United
States].”
Subsequently, the district court denied restitution, reasoning Rx Depot’s
customers did not lose money in their transactions because they purchased
medications at reduced prices. The district court initially concluded disgorgement
would be an appropriate remedy. Upon reconsideration, however, the district
court determined disgorgement was not available under the FDCA as a matter of
law. Although the FDCA invokes courts’ equity jurisdiction, the district court
determined the Act’s express provision of other remedies and legislative history
create a necessary and inescapable inference that Congress intended to restrict
courts’ power to order disgorgement. The United States appeals only the district
court’s denial of disgorgement.
III. Discussion
We review questions of statutory interpretation de novo. Employers
Reinsurance Corp. v. Mid-Continent Cas. Co., 358 F.3d 757, 774 (10th Cir.
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2004). The FDCA provides, “[t]he district courts of the United States and the
United States courts of the Territories shall have jurisdiction, for cause shown to
restrain violations of [the FDCA].” 21 U.S.C. § 332(a). The issue before this
court is whether this statutory grant of jurisdiction enables district courts to order
disgorgement in appropriate cases.
In Porter v. Warner Holding Co., the Supreme Court held when Congress
invokes the equity jurisdiction of courts in a statute, “all the inherent equitable
powers of the [courts] are available for the proper and complete exercise of that
jurisdiction,” unless the statute, by “clear and valid legislative command” or
“necessary and inescapable inference,” restricts the forms of equitable relief
authorized. 328 U.S. 395, 398 (1946). The Court in Porter was examining
whether § 205(a) of the Emergency Price Control Act of 1942 (“EPCA”) 1
permitted federal courts to order restitution of rents collected in excess of
statutory maximums. Id. at 396. The Court determined restitution was authorized
by the statute because § 205(a) invoked courts’ general equity jurisdiction and the
Section 205(a) provided:
1
[T]he Administrator [of the Office of Price Administration] may
make application to the appropriate court for an order enjoining . . .
acts or practices [in violation of the statute] . . . and upon a showing
by the Administrator . . . [of] such acts or practices a permanent or
temporary injunction, restraining order, or other order shall be
granted without bond.
Emergency Price Control Act of 1942, § 205(a), 56 Stat. 23, 33.
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statute did not expressly or impliedly preclude restitution. Id. at 397–98, 403.
Moreover, the Court noted because the suit involved the public interest and not
merely a private controversy, courts’ “equitable powers assume[d] an even
broader and more flexible character.” Id. at 398.
Arguably, the Court’s decision in Porter also relied in part on the broad
language of § 205(a), which authorized “any . . . other order.” See id. at 399.
The Court’s subsequent decision in Mitchell v. Robert De Mario Jewelry, Inc.,
however, demonstrates that such inclusive language is not required. 361 U.S.
288, 291 (1960); see also Atchison, Topeka and Santa Fe Ry. Co. v. Lennen, 732
F.2d 1495, 1506 (10th Cir. 1984). In Mitchell, the Court determined the Fair
Labor Standards Act (“FLSA”) authorizes federal courts to order reimbursement
of lost wages to employees who are discriminated against or unlawfully
discharged for filing complaints under the Act. Id. at 296. The Court relied
exclusively on language in the statute granting courts authority “for cause shown,
to restrain violations of [the FLSA].” Id. at 289, 291. The Court observed that
the absence of language in the statute affirmatively confirming the power of
courts to order reimbursement did not preclude such relief in light of the statute’s
grant of general equity jurisdiction. Id. at 291. The Court explained, “[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
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power of equity to provide complete relief in the light of statutory purposes.” Id.
at 291–92. Accordingly, under Porter and Mitchell, when a statute invokes
general equity jurisdiction, courts are permitted to utilize any equitable remedy to
further the purposes of the statute absent a clear legislative command or necessary
and inescapable inference restricting the remedies available.
Amicus argues our analysis of the remedies available under the FDCA
should be guided by Meghrig v. KFC Western, Inc. instead of Porter and Mitchell.
Meghrig, 516 U.S. 479 (1996). Meghrig held the grant of general equity
jurisdiction in the Resource Conservation and Recovery Act’s (“RCRA”) citizen
suit provision 2 does not authorize courts to order restitution of past cleanup costs.
Id. at 487. The plaintiff in Meghrig owned property contaminated with petroleum
products. Id. at 481. After having the waste removed and disposed of, the
plaintiff brought suit against a former property owner seeking recovery of cleanup
costs the plaintiff had expended. Id. at 481–82. In concluding the remedy was
not available under RCRA, the Court recognized, but did not overrule, Porter’s
and Mitchell’s holding that a statutory grant of general equity jurisdiction
authorizes courts to use all traditional equitable powers. Id. at 487; see also
2
RCRA’s citizen suit provision authorizes district courts “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
. . . , to order such person to take such other action as may be necessary, or both .
. . .” 42 U.S.C. § 6972(a).
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United States v. Oakland Cannabis Buyers’ Coop., 532 U.S. 483, 496 (2001)
(citing Porter in a case decided after Meghrig for the proposition that courts
sitting in equity “have discretion unless a statute clearly provides otherwise”);
Miller v. French, 530 U.S. 327, 340–41 (2000) (same). Instead, the Court merely
identified RCRA as a statute that fit into the exceptions recognized by Porter and
Mitchell. Meghrig, 516 U.S. at 487. In particular, the Court determined RCRA
contained a clear legislative command and concluded Congress did not intend to
permit recovery of past cleanup costs. Id. at 484–88. The Court also determined
the recovery of past cleanup costs was not consistent with the statutory purposes
of RCRA. Id. at 483.
First, the Court reasoned the clear language of RCRA’s citizen suit
provision precludes an order of restitution for past cleanup costs. Id. at 486.
RCRA’s citizen suit provision permits suit “against 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 which may
present an imminent and substantial endangerment to health or the environment . .
. .” 42 U.S.C. § 6972(a)(1)(B). The Court observed that the requirement that
waste “may present an imminent . . . endangerment” demonstrated the provision
was directed only at harm that threatens to occur in the immediate future.
Meghrig, 516 U.S. at 485–86 (emphasis added). Thus, it concluded, costs for the
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past cleanup of waste that no longer poses a danger to health or the environment
are not recoverable. Id.
Second, the Court found evidence that Congress did not intend to authorize
restitution of past cleanup costs in both the structure of RCRA and its relation to
another environmental statute. RCRA prohibits citizen suits when either the EPA
or the State has commenced a separate enforcement action. 42 U.S.C. §
6972(b)(2)(B) & (C). Thus, if RCRA permitted restitution for past cleanup costs,
it would only provide compensation in those cases in which waste problems are
not severe or substantial enough to attract governmental attention. Meghrig, 516
U.S. at 486–87. The Court rejected this result as wholly irrational, concluding
Congress could not have intended to provide compensation for individuals with
minor waste problems while leaving individuals with severe or substantial waste
problems without a remedy. Id.
The Court’s analysis also relied on significant differences between RCRA
and the Comprehensive Environmental Response, Compensation, and Liability
Act (“CERCLA”). CERCLA, which was enacted several years after RCRA,
contains a citizen suit provision which mimics RCRA’s and authorizes courts “to
order such action as may be necessary to correct” violations of the Act. Id. at
485. Unlike RCRA, however, CERCLA also contains an explicit provision
permitting the recovery of remediation costs. Id. (citing 42 U.S.C. §
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9607(a)(4)(B)). The Court concluded the absence of similar language in RCRA
compelled an inference that Congress did not intend to provide past cleanup costs
under RCRA because it would have been unnecessary for Congress to specifically
enumerate the remedy in CERCLA if it was already encompassed within the
statute’s grant of general equity jurisdiction. Id. at 485, 487.
Finally, the Court noted an award of past cleanup costs is inconsistent with
RCRA’s purposes. Id. at 483. The primary purposes of RCRA, according to the
Court, are to reduce the generation of hazardous and solid waste and ensure its
proper treatment, storage, and disposal, not to effectuate the cleanup of waste
sites or to compensate those who have remediated waste sites. Id.
Thus, rather than overruling or limiting Porter’s and Mitchell’s general rule
that a grant of equity jurisdiction enables courts to order any form of equitable
relief, Meghrig merely demonstrates that a statute’s particular characteristics may
preclude application of the rule. See Meghrig, 516 U.S. at 487. Additionally,
Meghrig is distinguishable from the present case, and from Porter and Mitchell,
because it involved a controversy between private parties relying on a statutory
provision for private causes of action, not an enforcement action by the
government to protect the public. As the Court pointed out in Porter, “equitable
powers assume an even broader and more flexible character” in suits involving
the public interest. 328 U.S. at 398. Thus, Meghrig’s restrictive view of the
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remedies available under RCRA’s citizen suit provision is likely due in part to the
private nature of actions brought under the provision. See United States v. Price,
688 F.2d 204, 213–14 (3d Cir. 1982) (observing that 42 U.S.C. § 6973, a RCRA
provision which authorizes the EPA to bring suit to restrain violations of the Act,
confers upon courts broad authority to grant equitable relief). For these reasons,
the general rule announced in Porter, and followed by Mitchell and Meghrig,
guides our analysis. 3
3
Amicus contends that by implying additional remedies in a statute where
Congress authorized only specified forms of relief, Mitchell exemplifies the type
of analysis the Supreme Court once employed in implying private rights of action.
Amicus notes that the Supreme Court abandoned implying private rights of action
in Alexander v. Sandoval, and argues the Court similarly abandoned implying
equitable remedies in Meghrig. Sandoval, 532 U.S. 275 (2001); Meghrig v. KFC
Western, Inc., 516 U.S. 479 (1996). As discussed above, Meghrig did not
overrule or limit Porter and Mitchell. Mitchell v. Robert De Mario Jewelry, Inc.,
361 U.S. 288 (1960); Porter v. Warner Holding Co., 328 U.S. 395 (1946). To the
extent amicus argues Sandoval should persuade this court that the reasoning of
Porter and Mitchell have been abandoned by the Supreme Court, we disagree.
The line of cases from J.I. Case Co. v. Borak to Sandoval discusses the
circumstances in which courts should imply a right of action allowing private
parties to sue to enforce a statute when the statute itself does not explicitly
authorize any such action. J.I. Case, 377 U.S. 426, 431–33 (1964), abrogated by
Sandoval, 532 U.S. 275 (implying private right of action because it effectuated
the purpose of the statute); Sandoval, 532 U.S. at 293 (refusing to imply private
right of action where there was no evidence Congress intended to provide one).
These cases are not applicable here for two reasons. First, we are not being asked
to imply a private right of action under the FDCA. Second, while the statutes at
issue in J.I. Case and Sandoval did not explicitly authorize private rights of
action, the FDCA, and the statutes at issue in Porter, Mitchell, and Meghrig,
contain an explicit grant of general equity jurisdiction. Although that grant does
not enumerate all available forms of equitable relief, a general grant of equity
jurisdiction has long been recognized as authorizing courts to employ all their
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Section 332(a) of the FDCA invokes the equity jurisdiction of courts using
the same statutory language the Supreme Court construed in Mitchell to authorize
all traditional equitable remedies. Compare 21 U.S.C. § 332(a) (“district courts .
. . shall have jurisdiction, for cause shown to restrain violations”), with 29 U.S.C.
§ 217 (“district courts . . . shall have jurisdiction, for cause shown, to restrain
violations”); see Mitchell, 361 U.S. at 289, 291–92. Disgorgement is a traditional
equitable remedy. FTC v. Gem Merch. Corp., 87 F.3d 466, 469 (11th Cir. 1996).
Moreover, because the present action was brought by the government to protect
the public health and safety, courts’ equitable jurisdiction under the statute
“assume[s] an even broader and more flexible character.” Porter, 328 U.S. at
398. Thus, disgorgement is available under the FDCA unless (1) there is a clear
legislative command or necessary and inescapable inference prohibiting
disgorgement or (2) disgorgement is inconsistent with the purposes of the FDCA.
Rx Depot and amicus first contend the text of the FDCA limits the remedies
available under the Act to forward-looking remedies. They argue the term
“restrain” in § 332(a) envisions stopping ongoing violations of the Act or
traditional equitable powers. See Porter, 328 U.S. at 398. Thus, there is a
statutory anchor for the equitable remedies here that is not present in cases where
private rights of action are implied. For these reasons, we decline amicus’
invitation to construe broadly the reasoning of Sandoval as overruling dissimilar,
long-standing precedent. See State Oil Co. v. Khan, 522 U.S. 3, 20 (1997) (“it is
th[e] [Supreme] Court’s prerogative alone to overrule one of its precedents”).
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preventing future ones, not punishing past violations. Thus, they urge, the
backward-looking remedy of disgorgement is expressly prohibited by the statute.
In Mitchell, the Supreme Court interpreted the statutory command “to
restrain violations” to permit the arguably backward-looking remedy of
restitution. 361 U.S. at 296; see also Atchison, 732 F.2d at 1506–07.
Subsequently, in Meghrig, the Court observed that the term “restrain” in RCRA
envisions forward-looking, prohibitory injunctions. 516 U.S. at 484. In that case,
however, the Court also relied heavily on other language expressed and implied in
the statute in concluding restitution of past cleanup costs was not available. See
id. at 483–87. Moreover, the Court did not explicitly overrule Mitchell’s holding
that backward-looking remedies are permitted under a grant of authority to
restrain violations. In light of these considerations, we do not think the presence
of the term “restrain” in a statutory grant of general equity jurisdiction is
dispositive evidence of Congress’s intent to limit remedies to those that are
forward-looking. 4
4
It is not clear that disgorgement is solely a backward-looking remedy. One
purpose of disgorgement is to deter future violations of the law by making illegal
conduct unprofitable. See Porter, 328 U.S. at 400. When disgorgement is
ordered to prevent future violations of the law it is a forward-looking remedy.
See e.g., SEC v. First Jersey Sec., Inc., 101 F.3d 1450, 1475 (2d Cir. 1996)
(noting primary purpose of disgorgement under federal securities laws is forward-
looking deterrence); United States v. Carson, 52 F.3d 1173, 1182 (2d Cir. 1995)
(observing that disgorgement of recently acquired profits may serve forward-
looking purpose of preventing future violations); cf. United States v. Lane Labs-
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Rx Depot and amicus also rely on United States v. Philip Morris USA, Inc.
in arguing that a statutory grant of equity jurisdiction “to restrain violations”
authorizes only forward-looking remedies. 396 F.3d 1190 (D.C. Cir. 2005). In
Philip Morris, a divided panel of the District of Columbia Circuit held
disgorgement was not available under the Racketeer Influenced and Corrupt
Organizations Act (“RICO”), 18 U.S.C. §§ 1961–68. Id. at 1202. RICO
authorizes district courts
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 . . . ; or ordering dissolution or reorganization of any
enterprise . . . .
18 U.S.C. § 1964(a). Citing Meghrig, the court reasoned the statutory language
“to prevent and restrain” limited courts to ordering forward-looking remedies
aimed at preventing future violations of the Act. Id. at 1199. But see id. at
1220–22 (Tatel, J., dissenting) (arguing that Porter and Mitchell, not Meghrig,
control). The court also relied on the fact that the remedies enumerated in the
statute’s jurisdictional grant are all forward-looking. Thus, the court applied the
canons noscitur a sociis and ejusdem generis to conclude that any authorized
remedies beyond those specifically mentioned in the statute must be similarly
USA Inc., 427 F.3d 219, 229 (3d Cir. 2005) (noting restitution is forward-looking
because it can serve deterrent function).
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forward-looking. Id. at 1200. But see id. at 1224 (Tatel, J., dissenting)
(questioning the applicability of the canons in light of the statute’s command that
the list of remedies is not exhaustive).
Although we express no opinion regarding whether, or in what
circumstances, disgorgement is authorized under RICO, Philip Morris is
inapposite to our decision here because the court relied on statutory language in
RICO not present in the FDCA. See id. at 1199 (“In the RICO Act, Congress
provided a statute granting jurisdiction defined with the sort of limitations not
present in the FLSA or the EPCA.”). In any event, we note that Philip Morris did
not question the continued validity of Porter and Mitchell, the cases we rely on
here. See id. at 1200 (ruling out disgorgement remedy using Porter test). 5
Rx Depot and amicus next contend that because the FDCA explicitly
authorizes certain remedies, we should be reluctant to infer additional remedies.
Defendants and amicus fail to recognize that by granting courts general equity
jurisdiction, Congress authorized all traditional equitable remedies. As the Court
noted in Mitchell, “[w]hen Congress entrusts to an equity court the enforcement
5
Two other circuits have concluded RICO does not categorically prohibit
disgorgement. See Richard v. Hoechst Celanese Chem. Group, Inc., 355 F.3d
345, 354–55 (5th Cir. 2003); Carson, 52 F.3d at 1181. In both cases, however,
the courts went on to determine disgorgement was not appropriate under the facts
of the particular cases before them. Richard, 355 F.3d at 354–55; Carson, 52
F.3d at 1181–82.
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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.” 361 U.S. at 291–92. Thus, we need not infer any remedies;
rather, all equitable remedies are available unless Congress’s express provision of
other remedies creates a necessary and inescapable inference that those remedies
are exclusive.
In Porter, the Court determined the express provision of certain remedies in
the EPCA did not create a necessary and inescapable inference limiting courts’
authority to order unenumerated equitable remedies. 328 U.S. at 402. In addition
to general equity jurisdiction, the EPCA provided for criminal, civil, and
administrative remedies. Specifically, individuals faced criminal fines and
imprisonment for violations of the Act. EPCA, § 205(b), 56 Stat. 23, 33.
Individuals injured by a violation of the act could file a civil suit seeking treble
damages plus attorneys’ fees. Id. § 205(e), 56 Stat. at 34. If an individual was
prevented from bringing a civil suit for various reasons, the Administrator of the
Office of Price Administration (“Administrator”) could sue for damages on behalf
of the United States. Id. Finally, the Administrator had authority to suspend a
violator’s license. Id. § 205(f)(2), 56 Stat. at 35. Despite these express remedies,
the Court in Porter concluded the grant of general equity jurisdiction in the EPCA
was not restricted. Porter, 328 U.S. at 402.
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The express remedies provided in the FDCA are similar to those available
under the EPCA. In addition to general equity jurisdiction, the FDCA explicitly
provides for criminal, civil, and administrative remedies. See 21 U.S.C. § 333
(providing for criminal fines and imprisonment and civil monetary penalties); id.
§ 360h(b) & (e) (authorizing Secretary of Health and Human Services
(“Secretary”) to order recall, repair, replacement, or refund of purchase price for
medical devices); id. § 350a(e)(1)(B) (authorizing Secretary to recall adulterated
or misbranded infant formula); id. § 360pp(a) & (b) (granting district courts
equity jurisdiction and providing for civil monetary penalties for violation of
statutory provisions relating to electronic products). These remedies are no more
expansive or comprehensive than those found in the EPCA. Seizure is the only
express remedy provided for in the FDCA that was not also authorized by the
EPCA. Id. § 334. This single additional remedy, however, does not create a
necessary and inescapable inference that Congress intended to exclude all other
remedies.
Amicus further argues the specific authorization of restitution for certain
medical devices in one provision of the FDCA shows Congress did not intend to
allow disgorgement under another provision of the Act. The FDCA permits the
Secretary to order the manufacturer, importer, or distributor of a medical device
found in violation of the Act to refund the purchase price of the device to
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customers. Id. § 360h(b)(2)(C). Before ordering a refund, the Secretary must
determine that the device presents an unreasonable risk of substantial harm to the
public health; there are reasonable grounds to believe the device is defective; the
defect was caused by the manufacturer, importer, distributor, or retailer; and other
remedies are inadequate to eliminate the risk posed by the device. Id. §
360h(b)(1)(A). Amicus contends the detailed showing required to permit
restitution is inconsistent with the view that Congress intended to provide for the
similar remedy of disgorgement upon a mere showing of a violation of the Act.
This argument is unpersuasive. Section 360h describes only the Secretary’s
powers in administering the Act. The section says nothing about remedies that
may be ordered by courts. We decline to read the FDCA’s grant of expanded
administrative powers as a diminishment of the federal courts’ judicial powers
under a grant of general equity jurisdiction. See Porter, 328 U.S. at 401–02.
This reading is especially unwarranted in light of § 360h(d), which specifically
provides that “[c]ompliance with an [administrative refund order] shall not relieve
any person from liability under Federal or State law.” 21 U.S.C. § 360h(d).
Finally, Rx Depot argues the legislative history of the FDCA, which
indicates that Congress intended seizure to be the harshest remedy available under
the Act, precludes disgorgement. We are not convinced, however, that seizure is
harsher than disgorgement in all circumstances. See United States v. Universal
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Mgmt. Servs., Inc., 191 F.3d 750, 762 (6th Cir. 1999) (concluding restitution is
not necessarily harsher than seizure). Procedurally, the seizure remedy permitted
under the FDCA is arguably harsher than disgorgement. The FDCA permits
administrative seizure on the basis of an ex parte showing of reasonable belief.
21 U.S.C. § 344(g). Disgorgement, on the other hand, is only permitted after a
party is found by a court to be in violation of the Act and only at the court’s
discretion. Additionally, seizure is not necessarily harsher than disgorgement in
terms of monetary loss to a company. Seizure of a company’s inventory deprives
the company of both capital investment and potential profit, whereas
disgorgement only deprives a company of its profits. Although court-ordered
disgorgement over an extended period of time may operate as a harsher remedy
than a one-time seizure, the opposite is likely true for disgorgement ordered over
a shorter time period. Thus, even if Congress intended seizure to be the harshest
remedy available under the statute, it does not follow that Congress necessarily
and inescapabably intended to preclude disgorgement in all circumstances.
Because the FDCA does not contain a clear legislative command or compel
a necessary and inescapable inference precluding disgorgement, an order of
disgorgement is permitted if it furthers the purposes of the FDCA. See Porter,
328 U.S. at 400; Atchison, 732 F.2d at 1507. The FDCA’s primary purpose is to
protect the public health. United States v. An Article of Drug . . . Bacto-Unidisk,
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394 U.S. 784, 798 (1969). To be sure, the public health is protected not only by
halting current violations of the Act, but also by deterring future violations.
Disgorgement, which deprives wrongdoers of their ill-gotten gains, deters
violations of the law by making illegal activity unprofitable. SEC v. Fischbach
Corp., 133 F.3d 170, 175 (2d Cir. 1997). As the Court noted in Porter, “[f]uture
compliance may be more definitely assured if one is compelled to restore one’s
illegal gains.” 328 U.S. at 400. Therefore, disgorgement furthers the purposes of
the FDCA.
In sum, the FDCA invokes courts’ general equity jurisdiction by
authorizing courts “to restrain violations” of the Act. This broad grant of equity
jurisdiction is not restricted by the text of the statute, its express provision of
certain legal and administrative remedies, or its legislative history. Moreover,
disgorgement furthers the purposes of the FDCA by deterring future violations of
the Act which may put the public health and safety at risk. Therefore, according
to the analysis established in Porter and Mitchell, we conclude disgorgement is
permitted under the FDCA in appropriate cases. 6
6
Because the district court determined disgorgement was not available
under the FDCA, it did not examine whether there were any ill-gotten gains to be
disgorged or whether disgorgement was appropriate under the facts of this case.
Therefore, we remand for the district court to address this issue in the first
instance. See R. Eric Peterson Constr. Co. v. Quintek, Inc. (In re R. Eric
Peterson Constr. Co.), 951 F.2d 1175, 1182 (10th Cir. 1991).
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Our determination that disgorgement is authorized by the FDCA is
supported by decisions in several other circuits. Although we are the first circuit
to address disgorgement under the FDCA, two circuits have held recently that
restitution is authorized by the Act. These decisions, and the analysis employed
by the courts in reaching them, substantiate our reasoning here.
In Universal Management, the Sixth Circuit upheld an order of restitution
requiring a party who sold adulterated medical devices to provide refunds to its
customers. 191 F.3d at 762. The court relied on Porter and Mitchell in refusing
to interpret the FDCA as limiting the equitable jurisdiction of federal courts
because it found no clear congressional intent to impose such a limit. Id. at
761–62. The court acknowledged there was some evidence of congressional
intent that seizure should be the harshest remedy available under the Act, but
concluded that such concerns were far from a clear statement from Congress to
exclude restitution, especially when it was not clear that restitution is harsher than
seizure in all circumstances. Id. at 762.
The Third Circuit similarly upheld the authority of courts to order
restitution under the FDCA in a case involving misbranding of and failure to
obtain FDA approval for dietary supplements and skin cream purported to prevent
and treat cancer. United States v. Lane Labs-USA Inc., 427 F.3d 219, 220 (3d
Cir. 2005). Applying Porter and Mitchell, the court determined that a district
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court sitting in equity may order restitution unless the statute clearly limits the
court’s equitable jurisdiction or restitution does not further the purposes of the
statute. Id. at 225. The court found no evidence in the FDCA limiting equity
jurisdiction. Id. at 226. Moreover, the court determined restitution furthered the
purposes of the statute because it protected the financial interests of consumers
and deterred individuals from violating the Act. Id. at 227, 229. The court also
distinguished Meghrig and Philip Morris. Regarding Meghrig, the court noted
that the Supreme Court’s decision rested on explicit language in RCRA and the
Act’s elaborate remedial scheme, neither of which are present in the FDCA. Id.
at 231–32. The court also observed that, unlike the case before it, Meghrig did
not involve an enforcement action by the government in which equitable powers
are broader and more flexible. Id. at 231. Finally, the court noted that the
“restitution” of past cleanup costs sought in Meghrig resembled traditional
damages, and thus was different than the restitution sought under the FDCA,
which was directly traceable to the plaintiff’s illegal conduct and the harm it
caused consumers. Id. The court distinguished Philip Morris by observing that
the grant of equity jurisdiction in RICO is much narrower than that in the FDCA.
Id. at 233. Specifically, the court noted, RICO expressly enumerates specific
remedies, all of which are aimed at making it difficult or impossible to violate the
Act in the future. Id. The FDCA, on the other hand, contains no such list. Id.
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The only other circuit to address restitution under the FDCA is the Ninth
Circuit. In 1956, the court held that restitution is not available under the FDCA
in United States v. Parkinson. 240 F.2d 918, 922 (9th Cir. 1956). The court’s
decision was based on the statute’s failure to explicitly grant courts authority to
order restitution. Id. The court explained, “[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. The court
distinguished Porter by noting that the EPCA was enacted in wartime and
contained explicit language, specifically the term “other orders,” authorizing the
use of remedies not enumerated in the statute. Id. at 920 & n.6. The Ninth
Circuit’s rationale in Parkinson, however, was subsequently rejected by the
Supreme Court in Mitchell. In Mitchell, the Court reaffirmed Porter in holding
equitable remedies need not be expressly authorized by a statute; rather, a grant of
general equity jurisdiction is sufficient to enable a court to exercise all traditional
equitable powers absent explicit or implicit evidence to the contrary. Mitchell,
361 U.S. at 290–292. Moreover, the Court noted “the applicability of this
principle is not to be denied, either because the Court [in Porter] considered a
wartime statute, or because, having set forth the governing inquiry, it went on to
find in the language of the statute affirmative confirmation of the power to order
reimbursement.” Id. at 291. Because Parkinson’s reasoning was later rejected by
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Mitchell, it is not persuasive. See Lane Labs, 427 F.3d at 233–34 (rejecting
reasoning of Parkinson).
IV. Conclusion
For the foregoing reasons, this court REVERSES the district court’s denial
of disgorgement and REMANDS the matter for further proceedings not
inconsistent with this opinion.
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