Felony FDCA charges often rest in whole or in part on a theory that the FDA was defrauded in its regulatory capacity. Because of this, what FDA knew or did not know is often relevant to a prosecution. Accordingly, it is generally useful to attempt to obtain from a target of an investigation all correspondence with FDA and notes of conversations it has had with FDA pertaining to the subject matter. Targets frequently have documents of this nature that FDA does not have -- for example, company notes of meetings or phone conversations. Obtaining such information early gives notice of potential defenses and issues, and helps prevent targets from manufacturing records at a later date when it would be necessary to account for not having provided them to the grand jury earlier.
PRACTICE TIP: The definitions and instructions are useful boilerplate (in any type of investigation) that requires various procedures from those complying with the subpoena, and provides a useful framework when there are disputes about compliance. The requirement for notification of missing documents (instructions ¶ 9) becomes particularly useful if the company learns that "rogue" employees destroyed responsive documents. That paragraph requires the company to come forward with such information.
The corporation should be told early that a custodian will be required to describe the search and responsive documents to the grand jury, as contemplated by the instructions. This practice ensures that an employee of the corporation will be knowledgeable about the production, and able to answer questions. It also minimizes attorney-client and accountability problems that arise when attorneys take total control of document production, and there are significant questions about compliance with the subpoena.
OCL has used this type of subpoena in varied circumstances, including investigations involving: the failure of registered drug and device manufacturers to follow required good manufacturing practices; fraudulent practices of clinical investigators participating in new drug or other studies; the manufacture and distribution of counterfeit versions of legitimate drugs or components of legitimate drugs.
Name of Company
1. "The Company" means (a) [Name of Company], irrespective of the names under which it has done business; (b) all of its predecessors, subsidiaries (including, but not limited to, [any subsidiary central to the investigation], affiliates, branches, divisions, groups, operations, units, parent organizations, plants, and any joint ventures of which it is a part (including, but not limited to, [any parent that is significant to the investigation]; and (c) each of the present or former officers, directors, employees, agents, and representatives of [Name of Company] or the entities listed in subparagraph (b) above.
2. "Communication" means any transmission or exchange of information between two or more persons, orally or in writing, and includes, without limitation, any conversation, contact or discussion, whether face-to-face or by means of telephone, telegraph, telex, electronic or other media, whether by chance or design.
3. "Document" means every writing or record of whatever type and description in the possession, custody or control of the Company (including all writings and records that have been transferred from the Company to its accountants, attorneys, or consultants), however made, and includes all handwritten, typed, printed, recorded, transcribed, taped, filmed, graphic- or sound-reproduction material, magnetic cards or cartridges, optical storage devices, and computer records, printouts, runs, cards, tapes, or disks (together with all programming instructions and other material necessary for their use). "Document" includes every copy of every document where such copy is not identical to the original because of any addition, deletion, alteration, or notation. "Document" specifically includes, but is not limited to, statements or charts of organization; telephone and personnel directories; press releases; announcements; notices; statements of procedure and policy; biographies and personnel files; individual appointment calendars and schedules; card files; diaries; records of email; telephone logs; routing slips; records or evidence of incoming and outgoing telephone calls; itineraries; activity reports; travel vouchers and accounting; bank records; accounting and bookkeeping records and materials; financial records and statements; external or internal correspondence; cables; telexes; teletypes; telegrams; telecopies; verbal or written communications; memoranda; letters; messages; reports; plans; forecasts; summaries; briefing materials; studies; notes; working papers; graphs; maps; charts; diagrams; agendas; minutes; transcripts, records, or summaries of any meeting, conversation, conference or communication; and all attachments to any of the items set forth in this paragraph.
4. "Relate to" means to make a statement about, refer to, discuss, describe, reflect, identify, deal with, consist of, or in any way pertain, in whole or in part, to the subject. Where a request is for documents that "relate to" a subject, "relate to" means "in any way relate to, directly or indirectly".
5. "FDA" means the United States Food and Drug Administration or any employee thereof.
1. The Company is required to produce to the Grand Jury all documents responsive, in whole or in any part, to this subpoena schedule, regardless of where located, that are in the possession, custody, or control of the Company, including those documents in the possession, custody, or control of any of the Company's officers, directors, employees, agents, representatives, accountants, or attorneys. Accordingly, the Company must designate, as "Custodian of Records," an officer or employee having personal and thorough knowledge of the Company's records, who is to be responsible for the Company's search for, and production of, responsive documents.
2. The Custodian is to separate the documents to be produced according to the particular paragraph of this subpoena schedule to which they are responsive, and place the documents responsive to each paragraph in a separate file folder or other enclosure. (If a document is responsive to more than one paragraph, it is to be placed in the file folder of the first paragraph to which it is responsive.) The Custodian shall mark each folder with the Company's name, the date of the subpoena, and the paragraph of this subpoena schedule to which the documents are responsive.
3. Each page of the document should be identified in the lower right-hand corner by the initials of the Company, followed by a consecutive number, preferably marked in red or dark blue so that copies can be distinguished from original numbered documents.
4. An asterisk (*) preceding a numbered paragraph, or portion of a paragraph, means that, instead of producing the documents requested by that paragraph, or portion of a paragraph, the Company may submit a statement setting forth the requested information, provided that the Custodian is prepared to testify as to the accuracy and completeness of each statement.
5. On the subpoena return date, the Custodian is to appear before the Grand Jury, produce the documents called for, and be examined concerning the Company's production.
6. No document called for by this subpoena shall be destroyed, modified, redacted, removed, or otherwise made inaccessible to the Grand Jury.
7. The conjunctions "and" and "or" are to be construed interchangeably in the manner that gives this subpoena schedule the broadest reading.
8. The singular form of a word shall be construed to include within its meaning the plural form of the word and vice versa and the use of any tense of any verb shall be considered to also include all other tenses in a manner that gives this subpoena schedule the broadest reading.
9. If the Company has knowledge of any document that would be responsive to this subpoena schedule but has been lost, destroyed, or discarded, it shall identify to the extent possible each such document and provide an explanation of the loss, destruction, or discarding (including identification of each person authorizing or having knowledge of the loss, destruction or discarding).
10. If the Company withholds from production any responsive document on the ground of any privilege, it shall list each such document by date, type, addressee, author (and if different, the preparer and signatory), general subject matter, number of pages, paragraph of the subpoena to which the document is responsive, and indicated or known circulation, including the names and titles of all persons to whom the document, or a copy thereof, or any part thereof, was shown. In addition, it shall indicate the privilege asserted with respect to each such document in sufficient detail to facilitate a determination of the validity of the claim of privilege. Any subpoenaed document withheld as privileged, or for any other reason not produced to the Grand Jury, shall be maintained by the Company in a secure location.
III. Time PeriodExcept as otherwise provided, the time period covered by this subpoena shall be from _______________ __, ____, to the date of service of the subpoena.
IV. Documents to be Produced
*1. Documents sufficient to show the full legal name, principal office address, date of formation, place of formation, and form of organization (for example, corporation, partnership or individual proprietorship) of the Company, its parent organization, if any, and all subsidiaries and affiliates of each.
2. The Company's Articles of Incorporation and By-Laws, including all amendments thereto, from the date of formation.
*3. Documents sufficient to show the full:
(c) period of employment,
(d) social security number,
(e) date and place of birth,
(f) last known business and residence address and telephone number,
(g) period of ownership,
(h) share of ownership, and
(i) annual salary, dividend, or other remuneration,
of each person who at any time during the subpoena period was an officer, director, owner, partner, or employee of the Company responsible for ________. For each person identified in response to this paragraph, documents sufficient to describe the scope and nature of that person's responsibility with or relationship to the Company at all times during the subpoena period.
[Certain of the information requested, e.g., social security and birth information, may eventually be needed for completing form OBD 111, witness immunity requests.]
4. A copy of each organization chart showing the structure of the officers or employees of the Company.
5. All documents that set forth the policy or procedures of any part of the Company concerning ________________.
6. One original (or copy if no originals are available) of each advertisement, pamphlet, publication, label, and any other promotional material produced or disseminated by the Company during the subpoena period that relates to _______________.
*7. Documents sufficient to show the monthly sales figures for __________, in each of its forms and concentrations, during the subpoena period.
8. All documents, including correspondence, notes of conversations, and emails that relate to any contacts with the FDA relating to ________________________.
9. The complete personnel file of [employees whose credibility is important, who may be witnesses for any party at trial, or who may become targets. This information is important for both offensive and defensive purposes].
[cited in USAM 4-8.215]