6-2 - INJUNCTIONS

6-2-1 - Purpose

The purpose of this section is to provide instructions and define responsibilities for those field and headquarters units involved in the development, preparation, processing, and follow-up on injunctions.

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6-2-2 - General Guidelines

An injunction is a civil process initiated to stop or prevent violation of the law, such as, to halt the flow of violative products in interstate commerce, and to correct the conditions that caused the violation to occur. See 21 U.S.C. 332; Rule 65, Rules of Civil Procedure. It is not mandatory to demonstrate that the law has been violated to seek an injunction, only that there is likelihood that it may be violated if an injunction is not entered. If a firm has a history of violations, and has promised correction in the past, but has not made the corrections, we are more likely to succeed. However, the freshness of the evidence is critical.

For an injunction action to be credible in the eyes of the Department of Justice (DOJ), the U.S. Attorney, and the court, the evidence must be current. Timeliness is an important factor when considering an injunction action, with or without a Motion for Preliminary Injunction, or a temporary restraining order (TRO). However, case quality and credibility must not be sacrificed to meet guideline time frames. The purpose of the guideline time frames is to limit, as much as can reasonably be expected, the need to update evidence. (Updating entails extra work at all levels of the case development and review process and, more importantly, delays obtaining an injunction which is intended to stop violations that adversely affect the safety or quality of products in commerce.)

Once an injunction is filed by DOJ or a U.S. Attorney, a hearing may be placed on the court calendar at any time with extremely short notice. It is imperative that the district compliance officer maintain close contact with the Office of Chief Counsel (OCC) attorney and the Assistant U.S. Attorney to be aware of any hearings on FDA actions.

When an injunction is granted, FDA has a continuing duty to monitor the injunction and to advise the court if the defendants fail to obey the terms of the decree.

Should the decree be violated, the agency must consider a civil or criminal contempt of court, or other regulatory action, in as timely a manner as used in initiating the injunction. It is, therefore, mandatory that FDA personnel responsible for initiating injunctions also adhere to the implementation procedure in “Compliance Follow-up.”

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6-2-3 - Definitions

1. Temporary Restraining Order
   Temporary restraining orders are court enforced cease and desist orders that are brought to control an emergency situation. A TRO seeks immediate, temporary relief (for a period of 10 days, which may be extended for 10 additional days) prior to the hearing for preliminary injunction.
   
   FDA recommends a TRO when the agency believes that the violation is so serious that it must be controlled immediately. A request for a TRO also has the effect of expediting review of the underlying injunction case by the court. An inadequately documented TRO request may result in the court viewing the entire injunction action as lacking credibility.
   
   At the court's discretion, the TRO request may be subjected to a hearing, but usually the court hears the matter ex parte by reviewing the documents and questioning government counsel, the FDA investigator, the district compliance officer, or other FDA personnel.
2. Preliminary Injunction
   Whether or not a TRO has been obtained, a Motion for Preliminary Injunction is subject to a full hearing in which (1) evidence by affidavit, or (2) testimony of witnesses is presented, depending on the practice of the court. Once the motion is granted, or the defendants consent to the entry of a decree, the preliminary injunction is in effect.
   
   A preliminary injunction may stand indefinitely on the court record until the case is settled or a permanent injunction has been entered, after trial. A preliminary injunction may be dismissed, or a trial for permanent injunction may be set by the court, at the request of either party, at any time.
3. Permanent Injunction
   A Decree of Permanent Injunction may be entered at any time after the complaint is filed, either following a hearing or as a result of a negotiated settlement. Defendants in an injunction proceeding may consent to a Decree of Permanent Injunction just as they consent to a Consent Decree of Condemnation in a seizure action.
   
   Should the defendant not consent to such a decree, a trial is held in which, to prevail, the government must prove each element of its case by a preponderance of the evidence. As its name implies, a Decree of Permanent Injunction remains in effect until it is dissolved by an order of the court.

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6-2-4 - General Considerations

1. When An Injunction May Be Considered
   An injunction may be considered for any significant out-of-compliance circumstance, but particularly when a health hazard has been identified. Proceeding by injunction does not preclude institution of additional or concurrent action such as recall, publicity, seizures, embargo by cooperating officials, or criminal prosecution.
   
   In considering an injunction, the agency must evaluate the seriousness of the offense, the actual or potential impact of the offense on the public, whether other possible actions could be as effective or more effective, the need for prompt judicial action, and whether it will be able to demonstrate the likelihood of the continuance of the violation in the absence of a court order. Injunction will be the action of choice when:
   1. There is a current and definite health hazard or a gross consumer deception requiring immediate action to stop the violative practice; or
   2. There are significant amounts of violative products owned by the same person in many locations, voluntary recall by the firm was refused or is significantly inadequate to protect the public, and seizures are impractical or uneconomical; or
   3. There are long-standing (chronic) violative practices that have not produced a health hazard or gross consumer fraud, but which have not been corrected through use of voluntary or other regulatory approaches.
      
      With respect to a and b above, it is helpful, but not mandatory, to show that there has been a history of prior violations, and that previous attempts to correct them through alternative warnings or sanctions have not been effective. A showing of a violative history should be made whenever possible, but especially in those cases where an imminent danger to health cannot be alleged.
2. Multi-District Injunctions
   When similar violative practices are found at two or more facilities under the same corporate management, the home district where the corporate office is located should evaluate the compliance histories of corporate facilities located in other FDA districts to determine whether there are patterns of violations or trends that indicate the presence of systemic problems that should be addressed on a multi-district basis.
   
   The centers, districts, and Office of Enforcement (OE) have a significant role in assessing these situations and in developing and coordinating a regulatory approach. The initial and continuing roles of the various offices in multi-district injunctions are described in the procedures entitled “Injunctions (Multi-district).” See exhibit 6-11. These procedures were developed to facilitate planning, and the timely preparation, processing and review of these types of cases. They must be followed as soon as a potential multi-district injunction is identified by a district or center. At its discretion, the recommending district may invoke these procedures for a single district injunction involving multiple centers.

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6-2-5 - Adequate Notice Preceding Injunction Actions

FDA strengthens its injunction actions by demonstrating in the complaint that FDA made and has documented a conscious effort to get the objectionable products or practices corrected without court involvement. For example, the defendants were notified of the violations (by letter, FDA 483, meeting, telephone call) and, despite having an opportunity to correct the violations, failed to do so.

Although there is no legal requirement to name individuals in complaints for injunction, the agency believes that by doing so, individuals will be more inclined to take immediate and active interest in seeing that the violation ceases. Also, the identification of the responsible persons will prevent their pretense that they were not subject to the injunction, and will help prevent circumvention of the injunction by changing the name of the corporation. Therefore, the individuals who have the authority and responsibility to correct or prevent the violations should be named as defendants.

During its normal case-development process, FDA will therefore strive to identify the individuals with the authority to take corrective actions and prevent future violations. Such individuals may be located at the sites of the actual or potential violation, at other offices and sites, or both. When there are questions concerning individual responsibility during the review process, assignments should be issued requesting further documentation. One principal purpose of these efforts is to ensure that individuals standing in positions of authority with respect to actual or potential violative conditions will be provided with adequate notice concerning the evidence found by FDA.

The management officials believed by FDA to have the highest level of authority in an organization should always receive notice.

1. Methods Of Giving Notice
   Notice may take a variety of forms including letters and notices from other government agencies, recalls, issuance of FDA 483s, post-inspection discussions, meetings, and telephone calls. All persons receiving notice and the circumstances (date, time, place, and substance) of notice should be documented. Recognizing that firms under FDA jurisdiction include those ranging from owner-operator to large conglomerates and that the nature of violations will vary; what is deemed adequate notice will differ from case to case. Factors to be considered in determining adequacy include, but are not limited to, complexity of the organizational structure, duties and authority of persons believed to be responsible, nature of the violation, compliance history, and the length of time elapsed between notice and filing of the case. Also, see Chapter 10 “Prior Notice” and “Regulatory Meetings.”
   
   NOTE: Rarely in injunction cases will issuance of the FDA 483 constitute adequate notice, in the absence of further notice from agency compliance officials or senior managers.
   
   The factors listed below will apply in determining the adequacy of notice. Agency records should show that sometime during case development:
   1. The individuals with authority to prevent or correct violations have been given appropriate notice of the general conditions that are violative.
   2. There is sufficient information to conclude that proper action to correct the violations has not been taken or will not be taken promptly.
   3. Reasonable efforts on the part of the agency were made and documented to get the objectionable product and practice corrected without court involvement. Any attempts by the proposed defendants to correct the problem should also be reported.

   NOTE: Normally, there should not be exceptions to meeting the requirements of a-c above concerning documentation of prior notice. However, recognizing the uniqueness of each situation, there may be cases where exceptions to the rule are justified. Justification for such exceptions must accompany the case submission.

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6-2-6 - Prerequisites For A TRO Or Preliminary Injunction

Note: Injunctions with TROs have the highest priority ranking of all legal actions. Ensuring that criteria for TROs have been met and that strategies will be developed to halt the violative conduct usually requires knowledge of FDA issues and experience. For this reason, it is recommended that experienced compliance and legal personnel be involved in all recommendations which contain TRO provisions. These persons should also be available from each reviewing unit to hand carry the case to each succeeding level, for review.

1. Timeliness
   As a general rule, a request for a TRO should be processed through the agency so that it may be filed no later than 30 days after FDA's most recent evidence that the violation is occurring.
   
   Also, as a general rule, a request for a preliminary injunction is untimely if the evidence to support it is over 60 days old at the time of filing. The freshness of the evidence is important when the case includes a Motion for Preliminary Injunction, because the government is requesting that the matter be moved ahead of other cases on the court’s calendar because of its urgency.
2. Seriousness of the Violation
   In addition to considerations of timeliness, if there is a public health threat, that factor is something that should be emphasized. It is very important to remember that we do not need to show potential harm, but if that factor is present, it is very compelling. If the threat is severe enough, the court would consider a TRO for immediate relief.
   
   The magnitude of the violation is another consideration. If the defendant is a small company with just a few employees and the violations cause little or no public health risk, a court may not grant preliminary relief, but may be receptive to granting a permanent injunction. If the violations are significant and the defendant is a major presence in the industry, the fact that the violations may have far-reaching consequences may be a compelling factor in support of preliminary relief, even if there is no direct evidence of harm.
3. Adequate Notice
   As discussed above.

To avoid the need for updating the evidence in requests for TRO or preliminary injunction, the agency is committed to prompt review when all of these prerequisites are met. The absence or weakness of a prerequisite may preclude review of the request and the transmission of the case to DOJ until the information is obtained, unless adequate justification for its omission has been provided.

When initiating requests for injunction with a TRO and in implementing compliance follow-up, all personnel will perform the investigational, analytical, and administrative tasks with a high degree of urgency. Advance notice to all involved units is necessary, so that plans for expedited processing and review may be agreed upon and accomplished.

A request for a TRO or preliminary injunction must be accompanied by the DD's Affidavit in accordance with the RPM section "Declarations" and where appropriate (for example new drug violations), the affidavit of center personnel attesting to certain facts. Supporting affidavits of experts should be obtained as soon as possible either by the district or the center.

Outside expert support is necessary in all cases except when the violations are so gross and apparent that a reasonable judge who is not familiar with the technical or scientific issues in the case would not hesitate to grant the relief without expert testimony. Because expert testimony takes time to obtain, the district or the center should begin identifying suitable candidates and forwarding the necessary background material to them at the earliest possible time.

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6-2-7 - Refreshing Evidence - Update Inspections

The referral of a Complaint for Injunction to DOJ should follow closely in time the last evidence of violations (inspectional evidence, laboratory analysis, or undercover buy), or the last communication from the proposed defendants which reveals that the violative conduct will continue. This can be controlled to a certain extent by well-timed reinspection, buys, or similar activities.

Requests for reinspection, undercover buys, or similar activities should be coordinated with the center and OCC. Assignments for update inspections will be issued directly from the center after consultation with OCC. The update findings and the district's recommendation based upon this most current evidence should be transmitted concurrently to OCC and the center.

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6-2-8 - Procedures And Timeframes For Review And Referral Of Injunction

The principal features of timely injunction actions include carefully prepared recommendations that are fully supported by facts, the early alert of headquarters to probable injunction situations, and concurrent review of injunction recommendations by the center and OCC.

1. When the district is considering injunction as the probable action of choice, the compliance officer or CSO must orally alert and consult with their supervisor, the appropriate center compliance unit, and, if legal or strategic issues are apparent, OCC (Deputy Chief Counsel for Litigation) and DCMO at the earliest possible date. A conference call among these offices should be considered as the means of that early alert. The district should make every effort to make this, and any other consultation with the center and OCC and DCMO, informative enough to preclude later "surprises." The district representatives will promptly prepare a memorandum of any decisions or assignments coming out of such contact and promptly send a copy to those participating in the discussion. The district will keep the center, and OCC and DCMO contacts apprised of significant developments prior to and after the recommendation is made.
   
   Once the initial decision to seek injunction has been made, the district should ensure that high priority is given to preparing the EIR, completing relevant sample analyses, and preparing the necessary documents.
   
   The center will assign a compliance officer and, as necessary, technical staff to assist the district in processing the injunction recommendation, if injunction seems appropriate based on the early contacts. The center will promptly notify the assigned district compliance officer or director of the compliance branch of the names and telephone numbers of the center contact persons.
   
   OCC will, as necessary, assign an attorney to advise the district in the inspection/evidence gathering stage or in preparation of the injunction recommendation.
   
   The centers and OCC will assign persons who will be available to work on the injunction with no current conflicts in schedule through adjudication.
   
   NOTE: If it becomes necessary during the case development/review process to resolve agency policy or reach an agency decision on a controversial issue (including the action of choice), the district, center, or OCC should contact the Director of OE (HFC-200) who will promptly convene an ad hoc committee for timely resolution (in person or by conference call).
   
   The district will forward copies of the FDA 483 from the most recent inspection and other significant supporting documentation of apparent violations to the assigned center contact at the earliest possible time, as it becomes available, by expeditious means (such as by FAX, over-night delivery, or CMS (CFSAN, CDER, and CVM only ). If a TRO is being sought, such copies should also be sent concurrently to OCC (to the assigned attorney or, if no attorney has been assigned, to the Deputy Chief Counsel for Litigation) and DCMO. The district will promptly call the center contact (and OCC and DCMO, if applicable) to advise that the documents were sent and to ensure their receipt. Except in TROs and unusual circumstances, when a preliminary or permanent injunction is sought, the district should send only the FDA 483 and the injunction recommendations to OCC. OCC will review the entire injunction upon referral from the center.
   
2. Within 10 working days after completion of the inspection, the compliance branch director will sign off on the district's injunction recommendation. The district will hand-carry the recommendation to the center contacts, or send it by other expeditious means (e.g., via CMS (Compliance Management System) for cases sent to CFSAN, CDER, or CVM) ; and send a copy of the recommendation (memorandum and draft legal documents only) to DCMO (HFC-210). The recommendation should state clearly the injunctive relief sought and should be accompanied by a draft complaint, the appropriate ancillary pleadings, and all supporting evidence. The recommendation, and not the complaint, should contain the district's proposed detailed prayer for relief. See the RPM section "Injunction Recommendation". To facilitate headquarters' review, the district recommendation, District Director Declaration, and draft complaint must cross-reference evidence discussed to the FDA 483, EIR, analytical worksheet, items of correspondence, etc.
   
   Districts are encouraged to recommend potential expert witnesses, either FDA or external, when forwarding the recommendation.
   
3. The Assigned Center CSO Is Responsible For:
   
   1. reviewing the findings reported by the district, the district’s draft documents, and the defendants’ response, if any, for technical/scientific supportability, and regulatory policy and requirements, including the adequacy of prior notice;
   2. approving the district’s proposed conduct to be enjoined, ensuring that the requirements are adequate and reasonable;
   3. identifying scientific, technical and/or policy expert witnesses who will support the action, and prepare the first draft of their declarations, if needed.

   NOTE: All changes to the draft documents should be made as tracked changes on an electronic file copy, or shown on a paper copy submitted with the package. The center’s concurrence memo to OCC should reference where changes have been made in the draft documents.

   The center will forward its concurrence memo and the case documents to OCC as soon as possible; and send a copy of the concurrence memo with its attachments to the district, and DCMO (HFC-210).  The concurrence memo should identify the strengths and any weaknesses in the case and the status of expert witness testimony, including the name, title, address, and telephone number of experts who have agreed to review the case or support the case.  Referral of the case will not be held up by the center if an expert has not been identified.  However, the center must be actively pursuing this matter and providing status reports to OCC.

   If it does not concur with the recommendation, the center should promptly and orally notify the district, DCMO, and Office of Chief Counsel (Deputy Chief Counsel for Litigation). The center should also promptly prepare and send a non-concurrence memo to the district, any OCC contact persons, and DCMO/OE (HFC-210). The memo should include a detailed explanation for the non-concurrence. The district may ask OE to convene an ad hoc committee if there is a credible basis to dispute the disapproval and discussion with the center has failed to resolve the difference of opinion.

4. OCC will conduct a legal review, prepare the referral letter, revise the complaint as necessary, prepare the consent decree, and forward the final referral for injunction to DOJ within 10 working days. OCC will have final responsibility for ensuring that pleadings documents conform to the style and other requirements of the appropriate district court.

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6-2-9 - Required Documents

1. When seeking only a permanent injunction, FDA prepares, for filing, the following documents:
   1. Complaint for Injunction (drafted by district);
   2. Injunction Recommendation (prepared by district); and,
   3. Consent Decree of Permanent Injunction (prepared by OCC based on "Conduct to be Enjoined" section in Injunction Recommendation).
2. When seeking a preliminary injunction (but no TRO), the following additional documents should be prepared:
   1. District Director Declaration in support of Motion for Preliminary Injunction (prepared by district);
   2. Declaration of Expert(s) (prepared by center);
   3. Motion for Preliminary Injunction (prepared by district);
   4. Notice of Motion for Preliminary Injunction (prepared by district);
   5. Proposed Order of Preliminary Injunction (prepared by district); and,
   6. Letter to DOJ/OCL (prepared by OCC)
3. In cases where a TRO is to be sought, the following additional documents should be prepared:
   1. Temporary Restraining Order (prepared by district);
   2. Motion for Temporary Restraining Order (prepared by district);
   3. Notice of Motion for Temporary Restraining Order (prepared by district); and
   4. District Director Declaration in support of Motion for TRO (prepared by district)

The sections that follow give instruction and guidance for preparing a number of these documents. Model letters, paragraphs, a District Director Declaration, and complaint provisions are found in Exhibits 6-12 through 6-22. Examples from cases that have been approved in the recent past can also be found on ORA’s intranet site. As each case is unique, the examples should be used only as general guides and, with the possible exception of legal citations, should not automatically be used verbatim in any case. The structure of the documents must conform to the case at hand.

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6-2-10 - Injunction Recommendation

The memorandum prepared by the district should be entitled "Permanent Injunction Recommendation" or "Preliminary Injunction Recommendation," or "Injunction with Temporary Restraining Order," as appropriate. Include a statement that a TRO has been considered and the reasons for or against recommending a TRO in the action. The recommendation should contain sections as outlined below:

1. Business And Individuals To Be Enjoined
   Report the full name and address of the business and each individual to be enjoined. Where action is to be brought against an individual, either separately or with a business, the place where the individual resides should be stated. Service of process, unless made personally upon an individual (usually at the place of business), must be made at his/her residence.
   
   Where an action is to be brought against a business, state the name and address, as well as the job title (if known) of the officer or agent upon whom service of process may be made, as injunctions are usually filed in the judicial district where the subject plant is located.
   
2. Legal Status
   Give the exact corporate name (as it appears on the records of incorporation collected by the district), the state in which incorporated, and the name, address, and job title of each officer and employee named in the complaint. If a corporation is operating as a foreign corporation within the state where injunction is sought, determine who is registered as the agent for the corporation in that state.
   
   In the case of a partnership or sole ownership, give the full names and addresses of the individual partners or owners. In the case of individuals, give their relationship to the business or conduct to be enjoined.
   
3. Products Involved
   Identify the specific products or class of products involved in the injunction action.
   
4. Alleged Violation
   List the sections of the prohibited acts violated, and, where applicable, sections of the Acts, as codified in the U.S. Code, which form the substantive basis of the complaint (for example 21 U.S.C. 352(a), 351(a)(2)(B)). Give a brief statement of how each section of the Act has been (or will be) violated. Provide a summary of the specific practices sought to be enjoined. Because the proposed Complaint for Injunction and affidavits will contain specific details, these details should not be repeated in the summary. However, be specific enough so that the headquarters reviewing units will understand clearly the practices you are seeking to enjoin. Do not report that the firm has "gross deviations from GMP." Rather, report specifics, such as, "the firm does not assay finished products," or "the firm has had six recalls of subpotent drugs because of inadequate process controls."
   
5. Summary Of Evidence
   Refer to the appropriate paragraphs in the complaint and district director declaration for the evidence which supports the requested relief. Do not repeat the detailed information on inspectional findings which will be contained in the affidavits and complaint. Do report results of analysis on pertinent samples. In separate paragraphs, point out strengths and any weaknesses in the case and provide the district's rationale for why injunction (or TRO) remains appropriate.
   
6. Conduct To Be Enjoined
   State clearly, completely, and precisely the relief to be sought. Do not use the short form presented in the draft complaint.

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6-2-11 - Cover Letter To DoJ

The cover letter transmitting the case to the Department of Justice/Office of Consumer Litigation, Civil Division, will be prepared by OCC and will identify the action sought (TRO, preliminary injunction or permanent injunction), briefly summarize the case, highlighting legal, evidentiary, and tactical issues worthy of note including, when necessary, the significance of the evidence. The letter should simply refer to the complaint (and affidavits) in summarizing the facts (see Exhibits 6-13 & 6-14), and should not repeat, in detail, the information contained in the complaint (or accompanying affidavits) except as is necessary to summarize the findings and explain their significance.

The cover letter should contain a summarized background section which includes a statement of the proposed defendants' business, the kinds of products the proposed defendants make or distribute, the importance to the public of the products and their intended uses, problems generally recognized in the production or distribution of these products, and the risks or consequences that may result from a failure to comply with the laws involved. One issue that generally requires explanation is recordkeeping, its purpose and the possible consequences of incomplete and inadequate records.

Because the Department of Justice (DOJ) and Assistant U.S. Attorneys (AUSAs) are often reluctant to file injunction cases unless they believe that the administrative process has been exhausted, the cover letter should contain a section justifying the need for injunctive relief that refers to the prior notice and warnings and history of the defendants described in the affidavit of the District Director.

To forestall a potential negative impression about the case by AUSAs who are often unaware of the very strong case law in support of injunctions under the Act, the cover letter will also contain standard legal paragraphs. One paragraph will explain, with case citations, the special rules that apply to statutory injunctions under the Act; for example, the fact the irreparable harm need not be shown (see Exhibit 6-15). The other standard paragraph, where appropriate, will contain a brief legal discussion of the law with respect to the violation at issue (see Exhibits 6-16, 6-17, and 6-18).

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6-2-12 - Complaint For Injunction

The district will draft a proposed Complaint for Injunction that will be reviewed by the center and OCC.

The complaint consists of sections covering jurisdiction, venue, identification of defendants, a statement explaining the nature of the products involved, the purpose of the law that is being violated, a summary of evidence of the violations alleged, a brief reference to prior inspections, prior warnings, and historical non-compliance, and a short-form prayer for relief.

NOTE: Complaints for Injunction should not contain lengthy descriptions or prayers. They will be primarily summaries. Detailed information will be provided in the other documents submitted to the court.

The HEADING of the complaint should follow the local court format. All court requirements as to the form of the complaint must be followed.

Next there should be an INTRODUCTORY paragraph establishing that the complaint is being filed under the Act, 21 U.S.C. 332(a), and referring generally to the activities the government is seeking to enjoin. Citations to additional statutes establishing jurisdiction and venue should be added to this introductory paragraph or included in a separate paragraph. See Exhibit 6-19, model ¶ 1.

Following this is a paragraph identifying the CORPORATE DEFENDANT by name, where it is incorporated, and all addresses where business is done within the court's jurisdiction. The district should confirm current corporate status with the Secretary of State. See Exhibit 6-19, model ¶ 2.

In situations where the local plant problems stem from action (or inaction) of a corporate headquarters located in another judicial district, the injunction should be drafted in a manner and filed in a venue that will address and correct the basic cause of the problem. For example, there may be one or more other plants operating under the same policy of corporate neglect. In such a case, limiting the action to the problem in the one plant, or bringing the case against local management of the one plant may not result in correction of the basic problem. Rather, in such a case, the action should be brought against the corporate headquarters and be drawn so as to apply to all corporate facilities.

Next, separate paragraphs should identify EACH INDIVIDUAL DEFENDANT by name, title, address where he/she does business within the court's jurisdiction, and include a summary of his/her positions and responsibility. See Exhibit 6-19, model ¶ 3.

It is not sufficient to name an individual simply because he/she has a title that suggests responsibility. FDA is interested in those individuals who have the actual authority to correct the conditions and prevent their recurrence. In most situations, this will usually include, at a minimum, the president of the firm and the person in charge of the plant. While it is not necessary to have had personal contact with the president, the evidence should indicate that the defendant is the active chief executive, and not just the holder of an honorary title.

In charging an individual who is not physically located within the jurisdiction where the case is brought, include wording such as: "The defendant, John C. Doe, an individual, is the Area Director of Operations of said corporation and as such is responsible for the manner in which the corporation's plant is operated within the jurisdiction of this Court."

The next paragraph identifies the NATURE OF THE BUSINESS, with specific mention of the PRODUCTS sought TO BE ENJOINED by name and its (their) intended use, if applicable. Reference to the INTERSTATE NEXUS should also be made in this paragraph. The length of this statement will depend on the complexity of the case and on the tactical benefit of having a statement early in the complaint. See Exhibit 6-19, model ¶ 4.

The next paragraph establishes that the products fall within the APPLICABLE DEFINITIONS covered by the Act (that is it is a drug, device, or food), and that describes the adulteration, misbranding, or other charges. This paragraph can be combined with Paragraph 5. See Exhibit 6-19, model ¶ 5.

Next are paragraphs summarizing the defendants' MOST RECENT VIOLATIVE INSPECTION or ACTIVITY. If applicable, mention should also be made in the paragraphs immediately following, to prior enforcement actions including, seizures, regulatory correspondence warning of similar conduct, and state inspections. However, detailed descriptions of prior illegal conduct, such as details of previous inspections and regulatory history, should not be given. See Exhibit 6-19, model ¶ 6. The summarizing statement will include, in most cases, a list of specific or significant inspectional observations from only the most recent inspection. These inspectional observations should be arranged so that the most significant observations are listed first.

If there is more than one "recent inspection," list the significant observations made during each inspection. A "recent inspection" is one that has been concluded within 60 calendar days of the district's Injunction Recommendation to headquarters.

Next are paragraphs identifying the SPECIFIC PROHIBITED ACTs, under 21 U.S.C. 331, which has been violated. See Exhibit 6-19, model ¶ 7.

Next is a paragraph establishing that the defendant has had PRIOR NOTICE of his/her illegal conduct, and alleging that this conduct has continued despite warnings. This paragraph should list the warnings, most recent first, and state the dates and manner of the warnings. See Exhibit 6-19, model ¶ 8.

Next is a paragraph alleging that the VIOLATIONS MAY WELL CONTINUE UNLESS THE DEFENDANT IS ENJOINED. See Exhibit 6-19, model ¶ 9.

Next is a SUMMARY PRAYER FOR RELIEF requesting that the defendants, and all those acting in concert with them, be enjoined from directly or indirectly engaging in certain specified illegal acts and be further restrained from engaging in illegal activity until certain conditions have been met. (A detailed prayer for relief, identical to that included in the proposed consent decree, should not be put in the complaint.) The prayer in the complaint will usually be one paragraph. See Exhibit 6-19, model ¶ 10.

NOTE: The proposed Consent Decree of Permanent Injunction will contain the complete relief sought by the government.

The prayer is completed with paragraphs requesting (1) a temporary restraining order, a preliminary injunction (if applicable), and permanent injunction; (2) a provision for costs; and (3) a request for such other relief as the court deems just and proper. See Exhibit 6-19, model ¶ 10.

The complaint ends with a SIGNATURE PAGE. See Exhibit 6-19, model ¶ 11.

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6-2-13 - Declarations

Most jurisdictions will accept declarations in support of a motion for preliminary relief or for a Temporary Restraining Order. If the court requires live testimony in support of a motion for TRO or preliminary injunction, the declaration may be converted to testimony.

NOTE: 28 U.S.C. 1746 provides for the optional use of declarations in lieu of affidavits, thereby avoiding the need for a notary public. This is particularly useful for experts and resident investigators when a notary is unavailable. Declarations filed under 28 U.S.C. 1746 have exactly the same legal weight and significance as affidavits. Where either an affidavit or declaration is used, follow Exhibit 6-20. The 28 U.S.C. 1746 declaration should state, "Pursuant to 28 U.S.C. 1746, I hereby declare under penalty of perjury that the foregoing statement is true and correct to the best of my information and belief."

If the court requires affidavits from investigators or analysts or others having firsthand knowledge of the facts, they should be furnished by the district along with the draft complaint. However, where significant information is discovered in the course of the inspection and is not contained in the FDA 483 or other document, but is within the personal knowledge of the investigator, that observation, discussion of event, or incident should be the subject of a brief declaration by the investigator. Where a separate declaration is used for an investigator, the relevant FDA 483 issued by that investigator should be attached thereto. In some cases, a declaration may also be necessary for the investigator to summarize and explain the significance of the most recent inspectional findings consistent with his or her experience as an FDA investigator.

The declarations of: (1) the district director or designee; (2) an investigator (where necessary to support information in the complaint not contained in the FDA 483 or to summarize the significance of the findings); (3) appropriate center official (to document such things as the lack of an NDA or the failure to register a product or facility); and (4) experts, are the only declarations that will routinely be used in support of injunctions.

The declarations should be factual and, except in the case of declarations by experts, not contain conclusions, or opinions. In all cases, each declaration must provide lucid, succinct, and impressive support of the complaint.

The declarations should set forth the identity of the declarant, his/her position with FDA and his/her duties in that position. If it is an expert's declaration, his/her qualifications to draw conclusions or offer opinions must be summarized at the beginning of the declaration and should be supported with an attached copy of the expert's curriculum vitae.

Because the granting or denial of a TRO or preliminary injunction may rest upon the sufficiency of the declarations submitted with the complaint, care should be taken to ensure that every statement in the complaint is covered with equal or greater specificity in the declaration. Violative conditions unrelated to the charge should not be included. Unimpressive violative conditions should not be included; however, a number of less impressive violative conditions may often be grouped to become more impressive when their combined effect is to make a potentially hazardous condition.

NOTE: Listing a series of minor infractions has the effect on a court of minimizing the significance of the case and distracting the focus away from the significant problems.

The facts in the district director's declaration are derived from a review of documents contained in the district files and the declaration should so state. The following specific information should be covered in the declaration:

1. statement of the position occupied by declarant;
2. duties of the declarant in that position;
3. legal status or business set-up of the defendant firms;
4. address of business;
5. identity of individual defendants, where they perform their duties, and in at least as much detail as in the complaint, their authority and responsibilities;
6. a statement that the defendants are doing (or do) interstate business in a product known as (brand name);
7. the label and labeling of the products (If the labeling is available, it should be attached to the declaration, appropriately identified. If exhibits are not available, relevant portions of the labeling should be quoted when applicable to the charges in the complaint);
8. if relevant to the charges, establishment inspections performed and the facts revealed thereby;
9. a statement that samples from recent interstate shipments have been obtained, briefly citing the labeling accompanying the shipments, if pertinent;
10. sample evidence (include the name of product sampled, and the laboratory findings that confirm the alleged violations);
11. prior actions such as warnings, notice, and seizures and FDA attempts to obtain correction, broken promises or other evidence of bad faith, such as statements by defendants clearly showing an intent to continue the violations, in detail as pertains to each defendant; and,
12. a statement that, despite the previous actions, the defendants are still engaged in violative conduct.

NOTE: All declarations should be prepared in final form, but not be signed, and should be double-spaced. They represent the facts that can be sworn to by an individual. However, changes made in a case during the review process may require changes in the declarations.

To ensure that the declarations remain accurate, the following will apply:

1. The declarant will carefully review the final copy before the case is submitted. The only signed version should be the final version after all changes have been agreed upon, reviewed, and cleared by the signer.
2. If substantive changes are made in the declaration, the reviewing office proposing the change will check with the district to ensure the individual can attest to the truthfulness and accuracy of the added material. OCC will be responsible for incorporating all approved changes into the final.
3. In no case will a declaration be modified without the knowledge and express consent of the declarant.

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6-2-14 - Consent Decree

OCC will prepare the consent decree, using the Conduct-to-be-Enjoined section of the district's Injunction Recommendation, as cleared by the center. See model provisions in Exhibit 6-19. Any substantive changes or additions made by OCC after the center's initial clearance must be cleared by the center and district.

In drafting a consent decree, OCC is expected to seek center approval on matters germane to its original review, including reconditioning or reprocessing plans, CGMP requirements, commanded recalls, cessation of product manufacturing or distribution operations, and measures that could affect availability of medically necessary products. OCC is expected to seek the district’s approval on matters requiring district follow-up activities, such as reinspection frequency and rates, reviews of defendant’s corrective actions, and witnessing destruction and disposition of goods.

Also, during litigation, representatives of those offices with a direct interest in the case will keep each other informed of developments, including changes proposed by DOJ attorneys, to ensure that a consent decree is filed that is acceptable to the agency (district, center, and OCC).

Local court rules or local U.S. Attorney's practices may require additional relief from the standard model. The relief should be clearly stated and each paragraph numbered. Elaborate outline format with numerous subparagraphs should be avoided. FDA should not seek relief if it cannot be obtained (e.g., do not propose to allow reconditioning of a product if it cannot be accomplished). Also, if the relief provides for the company to obtain a consultant, do not require, as part of the relief, that FDA approve of the consultant.

The following should be included in consent decrees:

1. An INTRODUCTORY UNNUMBERED PARAGRAPH establishing that a Complaint for Injunction was filed on a specific date and naming each corporate and individual defendant against whom the complaint was filed, and a statement that the defendants have consented to entry of the decree without contest (See Exhibit 6-21, model ¶ 1.);
2. A TRANSITIONAL DIRECTIVE that states, “IT IS HEREBY ORDERED, ADJUDGED, AND DECREED, that:…” (See Exhibit 6-21, model ¶ 2.);
3. A paragraph establishing the COURT'S JURISDICTION. Such as “This court has jurisdiction over the subject matter and all parties to this action.” (No specific jurisdictional cite is necessary.) (See Exhibit 6-21, model ¶ 3.);
4. A paragraph stating that the CLAIM FOR RELIEF is appropriate (No specific statutory cite is necessary.) (See Exhibit 6-21, model ¶ 4.);
5. A paragraph incorporating introductory language establishing that the DEFENDANT, and ALL THOSE in active concert with the defendant are PERMANENTLY ENJOINED from doing the acts enumerated in the Decree:
   1. The statutory cite for the definition of the article that is the subject of the injunction (See Exhibit 6-21, model ¶ 5.);
   2. A statement that defendants are permanently enjoined from committing any illegal act with respect to the article or the specifically named articles, the same articles designated by any other name, as well as any other products having or purporting to have a similar composition, appearance, name, or intended use (or similar appropriate language). (See Exhibit 6-21, model ¶ 5.); and,
   3. When decrees allow for activity to resume after procedures have been implemented ensuring compliance with the terms of the decree, a further paragraph requiring that defendants remain in compliance with these procedures (See Exhibit 6-21, model ¶ 5.);
6. A paragraph providing for ADDITIONAL INSPECTION AUTHORITY (See Exhibit 6-21, model ¶ 6.);
7. REQUIREMENTS IMPOSED ON DEFENDANTS, should ADDITIONAL INSPECTIONS REVEAL VIOLATIVE CONDITIONS (See Exhibit 6-21, model ¶ 7.);
8. REIMBURSEMENT for additional inspection costs and contempt proceedings, IF THE DECREE IS VIOLATED (See Exhibit 6-21, model ¶ 8.);
9. NOTICE to THOSE ASSOCIATED WITH DEFENDANT; AFFIDAVIT of COMPLIANCE (See Exhibit 6-21, model ¶ 9.);
10. OPTIONAL NOTICE to CUSTOMERS; AFFIDAVIT of COMPLIANCE (See Exhibit 6-21, model ¶ 10.);
11. OPTIONAL NOTICE to EMPLOYEES; AFFIDAVIT of COMPLIANCE (See Exhibit 6-21, model ¶ 11.);
12. OPTIONAL RECALL/REFUND provision; AFFIDAVIT of COMPLIANCE (See Exhibit 6-21, model ¶ 12.);
13. OPTIONAL DESTRUCTION PROVISION (See Exhibit 6-21, model ¶ 13.)
14. NOTICE to FDA PRIOR to CHANGES in CORPORATE STRUCTURE/NOTICE to SUCCESSORS or ASSIGNS (See Exhibit 6-21, model ¶ 14.);
15. STANDARD of REVIEW PROVISION (See Exhibit 6-21, model ¶ 15.);
16. CONTINUING JURISDICTION (See Exhibit 6-21, model ¶ 16.);
17. PROVISION for COSTS (See Exhibit 6-21, model ¶ 17.); and,
18. SIGNATURE PAGE (See Exhibit 6-21, model ¶ 18.).

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6-2-15 - Costs Of Supervision

All injunction actions should provide for the payment of costs incurred to ensure that the defendants are brought into, and remain in compliance with terms of, the court's order before they can resume operations subject to the order.

The following charges apply to all injunctions:

• Investigation time: 266% of GS-11/4 hourly rate
• Analytical time: 266% of GS-12/4 hourly rate
• Per diem actually paid to an FDA employee will be paid at the current existing rates expressed in GSA's Federal Travel Directory.
• Miscellaneous expenses: actual cost

The minimum charge for services shall be not less than the charge for one hour. Additional charges shall be in multiples of one hour, disregarding fractions of less than 1/2 hour, as follows:

• 1 hour through 1 hour, 29 minutes - charge 1 hour
• 1-1/2 hours through 2 hours, 29 minutes - charge 2 hours

Consult with Office of Chief Counsel before notifying the firm by letter that it may resume operation (see Exhibit 6-12) and before sending an initial bill setting forth the charges for all work performed to get the firm in compliance (see Exhibit 6-22). Do not use a letter to notify either the firm or the U.S. Attorney that costs have been paid, because this may result in the injunction being inadvertently canceled.

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6-2-16 - Compliance Follow-Up

Once the injunction has been granted, the Court relies on FDA to monitor the defendants' compliance and to advise the Court on compliance with the terms of the injunction.

It is the responsibility of the district to ensure that prompt attention is given to the following:

1. Consult with Office of Chief Counsel (OCC) as to service of copies of the court's decree.

2. Determine the firm's plans to bring the operation into compliance and, where applicable, the plans for destruction, reconditioning, or recall of material on hand and finished goods in the market place.

3. Where the injunction contains a provision for the firm to designate an expert to supervise compliance with the terms of the decree, it should specify that the expert must certify in writing to FDA that the terms of the decree have been complied with before FDA makes any inspection, and that the firm must submit a written list of corrections to FDA.
   
   Find out whether the firm has hired a qualified expert, and determine his/her qualifications. FDA does not disapprove of experts selected by defendants when defendants are required by a consent decree to retain expert consultants. However, FDA may elect not to accept a consultant’s report of findings. FDA acceptance of the consultant's findings may include consideration of such factors as the adequacy, completeness, or accuracy of the filed report, if an obvious conflict of interest is uncovered, or if the consultant’s competency does not meet a regulatory standard (for example, as required in the drug CGMP regulations at 21 CFR 211.22).

4. Monitor status of the accomplishment of the above. Promptly advise OCC and the appropriate center of any problems regarding non-compliance with the decree. Maintain close contact, including visits, as necessary, to ensure that the firm is brought into compliance before operations subject to the injunction are resumed.
   
   NOTE: Inspections made under an injunction are performed under the authority of the appropriate Act and the decree entered by the court. When visiting the firm, provide a copy of the decree to managerial personnel and document that you have done so. This will facilitate any contempt action that may be necessary.
   
   Following determination by the district that the defendants appear to be in compliance with the requirements of the "unless and until" provisions of the decree, the defendants should be so notified in writing and advised that such determination does not, however, relieve them of their responsibility for compliance with the Act or other provisions of the decree that continue in effect (see Exhibit 6-12).
   
   NOTE: If a copy of this notice is furnished to the U.S. Attorney, it may inadvertently trigger a dismissal action, unless the U.S. Attorney is also reminded that there are other provisions of the injunction that remain in effect.
   
   If the district's follow-up discloses that the firm has met the provisions of the decree and notice has issued, the district will schedule a follow-up inspection to be performed in 3 to 4 months and quarterly thereafter until the firm maintains a state of compliance for one year. The firm shall be inspected at least annually thereafter. (Deviation from this schedule is appropriate in those instances where plant operations are on a seasonal basis. In that event, the firm shall be scheduled and inspected at the beginning of the next operating season.)

Should any reinspection or analysis of samples disclose that the defendants are not meeting the terms of the decree, a variety of regulatory actions are available to FDA, including:

1. Reinstatement of Decree
   Motion to petition the Court to reinstate the "unless and until" provisions of the existing decree, based on the fact that defendants regressed from an in-compliance state (as certified in formal notice) to an out-of-compliance state. The effect of this action is to again close the firm until corrections have been made and verified. If the decree allows for a recall, upon request by FDA, this, too, may be considered.

2. Seizure

3. Civil Contempt
   A civil contempt is an action to force compliance, requesting the court to impose a penalty upon the defendant for continued noncompliance. The penalty may be monetary or confinement of individual defendants for each day or for each violative act until the terms of the decree are met.

4. Criminal Contempt
   A criminal contempt action is not to coerce compliance, but to punish prior behavior. The penalty does not depend upon future actions.

5. Prosecution

6. Civil money penalties (for example, for medical devices)

7. Administrative sanctions such as Withdrawal of Applications.

NOTE: The foregoing regulatory actions may be applied individually, sequentially, or concurrently. The consideration of any regulatory action should be discussed with the center, DCMO, and OCC.

Recommendations for any action taken as the result of a violation of a decree shall be processed in the same manner and with the same urgency as the original injunction. The district compliance office will prepare a recommendation. For criminal contempt, see the RPM section "Contempt of Court; Violation of Probation". For prosecution see the RPM section, "Criminal Prosecution After 305 Notice". Should contempt be the action of choice, the district will also prepare a Petition for Order to Show Cause why the defendants should not be held in contempt. . (See Exhibits 6-23 and 6-24)

Change in ownership or identity of defendant firm should be noted. In the case of a change in ownership or corporate identity of the firm, report detailed facts on the changes to the center and the OCC for a determination whether the new ownership or corporate entity are covered by the injunction. Rule 65(e), Federal Rules of Civil Procedure, discusses persons covered by injunctions.

If a firm under injunction goes out of business, take the following steps:

1. Maintain the file as an open injunction for one year.

2. Check the status of the firm at the end of six months and one year after being reported out of business.

3. Make an effort to determine whether the firm has moved to another location and another district should be notified of the status of the firm. Notify any such district about the injunction.

4. If the injunction is against an individual as well as a firm, determine the individual's present occupation, and whether or not it is similar to the type of business for which he/she was enjoined. If so, notify the center and OCC.

5. If the firm remains out of business after one year, notify OCC and the appropriate center of your intention to close the file in 60 days unless either component has further information which requires consideration.

6. After the 60 day waiting period, if no further information is received, and the injunction was a preliminary one, notify the U.S. Attorney in writing that the firm has ceased operations and the government recommends closing the injunction file.

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6-2-17 - Vacating Injunctions

FDA does not ordinarily initiate requests to vacate injunctions whether issued by consent decrees or court orders. Nor will the agency join with a defendant in filing a motion to request such relief unless: (1) the agency has recent evidence (e.g., within the last 6-8 months) that the defendant is in compliance with the FDCA, applicable regulations, and the decree or order; (2) the defendant has remained in continuous compliance with the FDCA, applicable regulations, and the decree or order for the life of the sunset provision (virtually always five years); and (3) the defendant has given FDA an opportunity to consider whether or not to object to the motion. FDA has frequently agreed not to oppose such motions when these three criteria have been met. A long violative history or lack of cooperation by the defendant will also affect FDA’s response to a motion seeking to have an injunction vacated.

If a defendant contacts the appropriate district(s) to discuss the possibility of vacating an injunction, the defendant should be instructed to prepare a written request specifically describing the evidence to show how it has met each of the foregoing criteria.  That request should be forwarded to OCC (Deputy Chief Counsel for Litigation), the relevant center(s), and OE, together with the district's views, which should include a description of the results of the most recent inspection and the defendant's overall inspection history since the injunction was entered. If OCC, the district, the center, and OE do not object to vacating the injunction, OCC will inform the defendant's counsel that FDA will not oppose a motion requesting such relief.

Thereafter, the defendant's counsel should prepare, in draft, a short motion briefly describing the sunset provision, the defendant's compliance therewith, and the fact that FDA has read the motion and does not object to the relief sought. If OCC agrees with the motion, it will take steps to contact the Department of Justice so that the motion may be filed without opposition from the United States.

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6-2-18 - Distribution

1. Approved Cases
   The center should send their approval memo and the case documents to OCC by the quickest means available; and send a copy of their approval memo and its attachments to the district and DCMO (HFC-210).

   When the transmittal letter to DOJ is signed by OCC, it will send that letter, and the case documents to OCL/DOJ; and send a copy of the transmittal letter and its attachments to the district, the center, and DCMO (HFC-210).

2. Disapproved Cases
   The center should send their disapproval memo to the district, any OCC contact persons, and DCMO (HFC-210).

   Once the center approves (or disapproves) the case, all units creating correspondence on the case will ensure that copies are transmitted to the center, with a copy for Office of Chief Counsel, so that the Administrative File is complete.

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6-2-19 - Issuing Press Releases

The recommendation to issue a press release is made jointly by the OCC attorney assigned to the case, the ORA case officers (the district compliance officer or OE), and the center (Office of Compliance). The decision to issue a press release is made by FDA’s Office of Public Affairs. The roles and responsibilities of these offices in making these decisions, and in drafting, clearing, and issuing press releases are described in “Procedures for Issuing Press Releases on Enforcement Actions (Seizures & Injunctions).” (See Exhibit 6-10) Follow these procedures and the accompanying models for drafting press releases concerning seizures and injunction actions.

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