Defendants appeal summary judgment for plaintiff and a permanent injunction from the manufacture and sale of a device intended to reheve certain types of physical pain when applied to acupressure points. We AFFIRM.
The court of appeals reviews an order granting summary judgment de novo, and hence uses the same test as used in the district court. See Terry Barr Sales Agency, Inc. v. All-Lock Co.,
I.
Appellants Universal Management Services, Inc., and Natural Choice, Inc. are Ohio corporations which are managed by
In May 1995, U.S. Marshals seized over $1.2 million worth of Appellants’ devices pursuant to seizure authority under the Federal Food, Drug & Cosmetic Act, 21 U.S.C. § 301 et seq. (FDCA). J.A. at 782-84. Later that month, the Food and Drug Administration (FDA) informed Appellants that they considered the devices adulterated and subject to regulation, threatening further legal action if approval was not sought and distribution did not cease. J.A. at 78. Distribution did not cease and the Government sought the injunction that is the subject of this appeal. The district court granted summary judgment for the Government on December 30, 1997, and, in February 1998, rejected Appellants’ Motion for Reconsideration. J.A. at 774-75. The resulting judgment placed a permanent injunction against the distribution of Appellants’ products and ordered Appellants to offer full refunds to all customers who had purchased their devices after the May 1995 seizure. J.A. at 39, 50.
II.
The district court concluded that the Stimulator and Xtender are “adulterated” devices under the FDCA. Specifically, the Government claims that Appellants violated 21 U.S.C. § 331(a) and § 331(k), which prohibit misbranding or adulterating medical devices and introducing such devices into interstate commerce.
To show a violation of §§ 331(a) and (k), the Government must prove: (1) Appellants’ products are “devices” within the meaning of the FDCA; (2) the devices are adulterated or misbranded; and (3) the devices move in interstate commerce. The third element is undisputed.
A device is “adulterated” under the FDCA if it is required to receive premark-et approval (“PMA”) from the FDA but moves in commerce even though it did not receive this PMA. See 21 U.S.C. § 351(f)(1)(B); United States v. An Article of Device Consisting of 1,217 Cardboard Boxes,
Class III devices cannot be marketed unless either: (1) the manufacturer has submitted to the FDA an application for a PMA and receives approval; or (2) the manufacturer submits a “premarket notification” arguing that its device should be reclassified as Class I or II because it is substantially equivalent to an existing device so categorized and the FDA finds the devices are in fact so equivalent.
The term “device” ... means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is ...
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intending to affect the structure or any function of the body of man or other animals, and
which does not achieve its primary intended purpose through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
21 U.S.C. § 321(h).
Appellants claim that their products are not devices because they (1) achieve their primary intended purpose through chemical action and (2) do not have any effect on the structure or function of the body. As the district court found, however, Appellants presented no genuine issue of material fact that then-products operate through chemical action, and two of their own witnesses, Dr. Roy Bugay and Dr. Robert Charm, both indicated that their products do not operate through chemical action. J.A. at 34. The district court also noted that Appellants pointed to nowhere in the record to establish that their products have no effect on the structure or function of the body.
We agree with the district court. Appellants’ own description of the products supports the Government’s position. Appellants describe the Stimulator, for example, as working as follows: “the [] electrical stimuli [from the device] ... stimulate excitatory cells which release electrical potentials which set off a chain of ... reactions that send messages to the brain creating a responsive reaction that organizes peptides to return the body to homeostasis.” J.A. at 34. Appellants also assert their product relieves pain. As such, the products are intended to affect the function of the body and are, therefore, devices under 21 U.S.C. § 321(h)(3).
In their Motion for Reconsideration, Appellants raised two issues not originally presented to the district court. First, Appellants claim that it was entitled to a new trial given the malfeasance of Appellants’ original trial counsel. Second, Appellants claim that Paul A. Monea may not be personally subject to an injunction.
A.
The Notice of Appeal in this case, however, indicates that Appellants are appealing only from the district court’s order granting summary judgment to the Government and the denial of their motion for summary judgment. Appellants fail to appeal from the district court’s denial of their Motion for Reconsideration. J.A. at 55. Therefore,'Appellants are foreclosed from asking this court to review the issues rejected in the district court’s denial of their Motion for Reconsideration because the general rule is that “[i]f an appellant ... chooses to designate specific determinations in his notice of appeal — rather than simply appealing from the entire judgment — only the specified issues may be raised on appeal.” McLaurin v. Fischer,
The court must always consider its jurisdiction first and may not hear a cause over which it has no jurisdiction. See Steel Co. v. Citizens for a Better Environment,
“[Ljitigants are charged with the responsibility for complying with the Federal Rules of Appellate Procedure.” Maerki,
B.
In so far as we would be required to consider the merits of the issue of malfeasance of counsel as properly appealed, we find no reversible error. This court reviews the district court’s denial of the Rule 60(b) motion for an abuse of discretion. See Hood v. Hood,
Appellants argue that the district court erred in denying their Motion for Reconsideration because, they contend, the alleged wrongdoing of their former counsel, Edwin Davila, provides grounds under Federal Rule of Civil Procedure 60(b) for relieving them of the district court’s summary judgment order against them. Rules 60(b)(l)-(5) provides relief for mistakes, inadvertence, excusable neglect and other similar situations. Rule 60(b)(6) is a catchall provision that should be granted only when the movant demonstrates “extraordinary circumstances.” See Liljeberg v. Health Services Acquisition, Corp.,
The “malfeasance” that Appellants allege is essentially that Mr. Davila: (1) committed crimes (stole money, created a fictitious lawsuit, and stole a car); (2) refused to return files to them; (3) engaged in various misdeeds in the district court proceedings (copied from a law review article, a case, and a Federal Register notice; filed videotapes instead of written affidavits; failed to serve Government counsel; and taped a telephone conversation without the knowledge of all parties); and (4) inadequately represented them by making a frivolous argument, not conducting discovery, and failing to argue that an individual cannot be enjoined unless he was a “high managerial agent” who “knew that his actions violated the FDCA.”
Davila ceased representing the Appellants in August, 1997, and a new attorney, Ralph Burns, took over their representation at that time. J.A. at 459. The district court formally admitted Burns to the case in September 1997. J.A. at 461. Appellants had the opportunity, through Burns, to bring these allegations of malfeasance to the district court’s attention prior to final judgment. In fact, Burns moved successfully to reopen summary judgment on the issue of disgorgement in September 1997. J.A. at 470, 481. There is no evidence he would have been unable to similarly correct any other legal errors by Davila. Appellants began to discover the alleged malfeasance at least as early as August 1997, four months before the district court issued its summary judgment order. J.A. at 763. They filed their six complaints against Davila with the Ohio bar in October, two months before entry of summary judgment. J.A. at 832-934. In fact, prior to summary judgment, Burns chose to inform the district court of the substance of one of the complaints to the bar. J.A. at 487. He could have informed the district court of the remaining issues, allowing the district court an opportunity to give Appellants additional means for correcting any errors of Davila.
There is also no evidence that Appellants ever sought an order compelling Da-vila to return the missing files. Burns
Moreover, Appellants have failed to establish prejudice from the malfeasance. There is no evidence presented that the crimes alleged against Davila are relevant to the merits of this case. Appellants do not identify anything in the missing files that could change the case.
The issues in this case were fully briefed and decided on the merits by the district court.
C.
In their Final Brief, Appellants argue that Paul A. Monea cannot be enjoined individually because he is not a covered individual for such liability under 21 U.S.C. § 335a(b). In their Reply Brief, Appellants contend that, even if § 335a(b) does not preclude enjoining Paul A. Monea, general principles of equitable injunctions prevent subjecting him to such action.
1.
Even assuming the issue of enjoining Paul A. Monea were properly noticed in the notice of appeal, Appellants face additional obstacles preventing this court from reaching the merits of that claim. The Government contends that Appellants’ argument, that Paul A. Monea cannot be enjoined individually because he was not a “high managerial agent” with knowledge that he was violating the FDCA as required for such liability under 21 U.S.C. § 335a(b), was never presented to the district court and, therefore, cannot be considered by this court. Bailey v. Floyd County Bd. Of Educ.,
Alternatively, in their Reply Brief, Appellants contend that whether or not the Government is correct in its contention that § 335a(b) is inapplicable in this case, the standard for a civil penalty against an individual must be high, requiring more than mere employment, and Paul A. Mo-nea was not subject to injunction because he was not a responsible corporate agent. Just as their argument regarding § 335a(b) was waived, this argument is similarly waived, having not been presented to the district court. See White,
2.
In so far as we would be required to consider the argument regarding Paul A. Monea’s individual liability as properly appealed, it is also without merit. First, § 335a(b) does not apply to this case. That section concerns the wholly unrelated issue of debarment of individuals for misconduct relating to the development and approval of generic drug products. See, e.g., Bae v. Shalala,
Second, even the new argument in the Reply Brief relying on general principles is unhelpful to Appellants. According to statements of FDA investigator Frederick Lochner and Paul A. Monea himself, Paul A. Monea was in charge of managing day-to-day activities, J.A. at 780-81, and had supervisory responsibilities. J.A. at 717. Undisputed evidence indicates that he supervised shipping, inventory, and customer service. This role is sufficient to subject him to injunction. See United States v. Dotterweich,
IV.
Below, the Government requested its costs and any such other relief the court deemed proper, including equitable disgorgement of profits.
A.
The FDCA provides only three remedies for violations: (1) injunctive relief, 21 U.S.C. § 332; (2) criminal prosecution, 21 U.S.C. § 333; and (3) seizure, 21 U.S.C. § 334. To rule on Appellants’ first contention, that the FDCA does not permit orders of restitution, we must consider the scope of injunctive relief authorized under § 332.
The district court in this case was sitting as a court of equity. See 21 U.S.C. § 332(a) (granting the district court jurisdiction to restrain violations of FDCA). Restitution and disgorgement are part of courts’ traditional equitable authority. See Mertens v. Hewitt Associates,
This court has made it clear that, if “review of the ... statute and its accompanying legislative history fails to reveal a clear congressional intent to displace the equitable powers of the federal courts, [the court] must construe the [statute] as preserving the courts’ inherent power.” Hadix,
A contrary standard upon which Appellants rely, that the statute must explicitly authorize restitution, was accepted by the Ninth Circuit in United States v. Parkinson,
The court below took as the touchstone for decision the principle that to be upheld the jurisdiction here contested “must be expressly conferred by an act of Congress or be necessarily implied from a congressional enactment.” In this, the court was mistaken. The proper criterion is that laid down in Porter v. Warner Holding Co. 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 light of statutory purposes.
DeMario,
Appellants also rely on a number of district court cases that determine that recalls and disgorgement are unavailable under the FDCA. See United States v. C.E.B. Prods., Inc.,
We reject the holdings in the Parkinson and C.E.B. Products line of cases. First, the existence of the remedy of seizure exists alongside an explicit authorization for injunctive relief to cure violations of the FDCA. 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 such exceptions as we see fit. 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. Moreover, even accepting the references to legislative concerns relied upon by the Parkinson and C.E.B. Products line, 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. Finally, as DeMario instructs, we must presume that Congress is cognizant of the scope of equity, knows what it is doing when it provides for general equitable relief in a regulatory statute, and can use that knowledge to clearly and explicitly limit the scope of a court’s equitable powers under any particular regulatory structure in which such an authorization lies. See DeMario,
Appellants have not established that the FDCA by “a necessary and inescapable inference, restricts the court’s jurisdiction in equity.” DeMario,
B.
Next, we must determine whether restitution was an appropriate remedy on
Appellants first argue that the FDA’s charge itself should preclude restitution. The FDA charge, they claim, was only that Appellants marketed a product without required approval, rather than that the product didn’t perform as it was intended. If the performance is not questioned and no deficiency in the same is established, they contend that there has been no detriment to consumers justifying the restitution order. In other words, Appellants contend that restitution was unwarranted because there is no evidence that consumers received anything less than what they bargained for.
The approval process exists to protect consumers’ health and their pocketbooks. One of the primary goals of the FDCA is to protect consumers from economic harm. See H.R. Conf. Rep. No. 74-2755, at 1 (1988) (one purpose is to prevent “deceit upon the purchasing public”); United States v. Article, Sudden Change,
Appellants claim that the order of restitution was inappropriately punitive is also without merit. Appellants contend that the district court’s statements that the ruling would “send a message” to deter future violations indicates a punitive intent, contrary to the purposes of restitution. The statement, however, merely emphasizes the deterrent effect of the order, an effect consistent with the FDCA’s purpose in protecting the public health. “Future compliance may be more definitely assured if one is compelled to restore one’s illegal gains.” Porter,
Appellants also claim that restitution is punitive because, unlike disgorgement which removes ill-gotten gain by forcing surrender of profits, restitution requires a return of the entire purchase price, included in which are costs and profits. See Sec. Exch. Comm’n v. Blatt,
Despite Appellants’ contentions, their violation was also more than a mere technicality. Congress set up a sophisticated statutory scheme for the regulation of medical devices, and the requirement that devices be approved or cleared by the FDA before marketing is at the heart of the scheme. See H.R.Rep. No. 94-853, at 14 (1976). Thus, Appellants’ failure to achieve such clearance violates a key component of the regulatory scheme. And, in the context of public health and safety, the district court’s equitable authority is broader and more flexible to support such a regulatory scheme than in ordinary litigation.
The district court did not abuse its discretion in determining restitution was appropriate in this case. The district court seemed to fairly balance the equities in the case. There is evidence that Appellants continued to distribute their product without seeking any approval even after they were put on notice of their violation by the FDA in May 1995, J.A. at 91-92, distributed after district court issued a preliminary injunction, J.A. at 323-25, and obstructed FDA inspections, J.A. at 252, 309-10, 288-89, 281-82. Appellants were hardly mere flies caught in the web of technical government regulation. Appellants marketed a device to the consuming public, a public that the FDCA regulatory structure seeks to protect. Appellants marketed their product in clear violation of the FDCA. They continued to sell to the public even after the FDA notified them that their product could not be sold without FDA approval. For these reasons, the district court’s order of restitution was well within its discretion.
V.
Accordingly, we AFFIRM the district court’s order of summary judgment in favor of the Government.
Notes
. Both parties focus their analysis on the Stimulator when debating coverage underthe FDCA’s definition of a device. Appellants fail to present this court with a distinction between the XTender and the Stimulator. The argument might be made that the XTender is merely an accessory to the Stimulator, sold separately, and does not independently satisfy the definition of "device.” This court, however, will not speculate as to the factual or legal basis for such a claim. Because Appellants speak of their product as a singular entity, failing to distinguish between their functions or coverage under the FDCA, this court must treat them as such. See United States v. Mal-iszewski,
. Moreover, if Appellants are correct that the Stimulator operates through chemical action, it would likely be subject to regulation as a drug or drug delivery device under the FDCA. See, e.g., 21 U.S.C. §§ 321(a), 355(a), 352(o).
.Alternatively, Appellants asserted below that their device is similar to a device marketed before 1976, thereby obviating the need for PMA. The district court concluded, however, that Appellants made only a conclusoiy claim to support this and pointed to no specific record evidence in support.
Appellants also claim that their product is not subject to a PMA because it is exempt from FDA approval. This argument is based on the contention that the Stimulator is identical to another device, the "Accu-Magic,” which is considered a Class I device and is "listed” with the FDA as a therapeutic massage device — a class of products exempt from the premarket clearance requirement of the Medical Device Amendments to the FDCA. The device listing requirement, 21 U.S.C. § 360(j), is a means by which the FDA keeps a current inventory of devices marketed in the
Neither argument presented above is made on this appeal as a means of illustrating the FDA lacked authority to regulate Appellants’ product. Each, however, is presented as evidence that Appellants' violation was minor and should not have warranted an order of restitution. That subject is discussed in Section V of this Memorandum.
. In fact, there is evidence Burns contemplated doing so but apparently decided against it. J.A. at 459.
. Although they mention a study that they claim relates to substantial equivalence of the Stimulator to another device, “substantial equivalence” is a judgment for the FDA, not the courts, and therefore the absence of that study is not relevant to the courts’ decisions.
. The two cases primarily relied upon by Appellants, United States v. Cirami,
. Appellants originally claimed that the Government never requested restitution and that, as such, the court should not have ordered the same sua sponte. However, as counsel for Appellants conceded during oral argument, the Government's request for “any other such relief” is sufficiently broad language so as to include restitution within its scope.
Federal Rule of Civil Procedure 54(c) provides that, "[e]xcept as to a party against whom a judgment is entered by default, every final judgment shall grant the relief to which the party in whose favor it is rendered is entitled, even if the party has not demanded such relief in the party’s pleadings.” As this court has recognized, this rule allows a district court to order restitution in an appropriate case even when it has not been requested in the Complaint. See Shearson/American Express, Inc.v. Mann,
. Other courts have also recognized that Parkinson was no longer good law after DeMario. See, e.g., ICC v. B & T Transportation Co.,