Opinion
Master File 00 Civ. 2843 (LAK).
February 13, 2002.
PRETRIAL ORDER NO. 51 (Confidentiality of Documents Produced by Clinical Investigators)
To expedite the flow of discovery material, facilitate the prompt resolution of disputes over confidentiality, adequately protect material entitled to be kept confidential, and ensure that protection is afforded only to material so entitled, pursuant to the Court's authority under Federal Rule of Civil Procedure 26(c), it is hereby:
ORDERED, as follows with respect to documents and things produced or made available for inspection and designation for copying by any clinical investigator retained by any of the defendants in this litigation to do clinical trials related to troglitazone (the "Clinical Investigator"). This Order is not applicable to documents and things produced or made available for inspection and copying by defendants Pfizer, Warner-Lambert Company ("Warner-Lambert"), Parke-Davis, an unincorporated division of Warner-Lambert Company, and all others associated with them (collectively known as "Warner-Lambert Defendants"), which instead are subject to Pretrial Order No. 3:
1. Nondisclosure of Confidential Documents. Except with the prior consent of Clinical Investigator, no Confidential Document, as hereinafter defined, or the substance of such Confidential Document, may be disclosed to any person except as provided in paragraph 4.
2. Definitions
2.1 For purposes of this Order, the term "document" means all written, recorded, or graphic material produced by a Clinical Investigator, whether produced pursuant to Rule 34, subpoena, by agreement, or otherwise. Responses to subpoena, deposition transcripts and exhibits, pleadings, motions, affidavits, and briefs that quote, summarize, or contain materials entitled to protection may be accorded status as a Confidential Document as provided herein, but, to the extent feasible, shall be prepared in such a manner that the confidential information is bound separately from that not entitled to protection.
2.2 The term "Confidential Document" shall mean any document produced by a Clinical Investigator which bears the legend (or which shall otherwise have had the legend recorded upon it in a way that brings it to the attention of a reasonable examiner) "Confidential-Subject to Protective Order" or "Confidential-Subject to Protective Order in Rezulin. Related Litigation" (hereinafter "Confidentiality Legent") and the date to signify that it contains information believed to be subject to protection under Fed.R.Civ.P. 26(c).
3. Redaction of Documents
3.1 Pursuant to Pretrial Order No. 44, the Clinical Investigator may redact from any Confidential Document the following information:
* patient name and initials;
* patient telephone numbers;
* patient e-mail address;
* patient social security number;
* patient driver's license number;
* patient insurance identification;
* patient address, including street, post box, city, state, and postal zip code;
* patient employer name and address;
* any of the above with respect to members of the patient's family;
* emergency contact information;
* any other information which counsel for the Clinical Investigator in good faith believes may lead to the discovery of the patient's identity.
With respect to any redaction made under the final category listed above, the redaction shall be specifically identified as having been made pursuant to that category and the redacting party shall advise all counsel of the nature of the information redacted with sufficient specificity to permit counsel to challenge the redaction.
The parties may also redact any information that 21 C.F.R. § 20.63(f) would preclude the FDA from disclosing, viz. "[t]he names and any information that would identify the voluntary reporter or any other person associated with an adverse event involving a human drug" but the parties may not redact such information concerning the identities of doctors and institutions who made such reports under compulsion of law or who made no such reports.
In the event any information in the documents produced would be sufficient to identify a particular clinical trial subject, parties receiving the documents will not contact the clinical trial subject or family members. This provision does not apply to those clinical trial subjects who may have retained counsel who may receive these documents.
3.2 If there is a dispute whether any redacted material qualifies for redaction under this paragraph, counsel may move for a ruling, which may require this Court's in camera inspection of a document on the issue of whether certain information is entitled to redaction.
4. Permissible Disclosures. Notwithstanding paragraph 1, Confidential Documents may be disclosed to counsel for the parties in this action who are actively engaged in the conduct of this lawsuit; to the partners, associates, secretaries, paralegal assistants, and employees of such counsel to the extent reasonably necessary to render professional services in the lawsuit; to persons with prior knowledge of the documents or the confidential information contained therein, and their agents; and to court officials involved in this lawsuit (including court reporters, persons operating video recording equipment at depositions, and any special master appointed by the Court). Subject to the provisions of subparagraph (c), such documents may also be disclosed:
a. to any person designated by the Court in the interest of justice, upon such terms as the Court may deem proper;
b. to persons noticed for depositions or designated as trial witnesses to the extent reasonably necessary in preparing to testify; to outside consultants, co-counsel or experts retained for the purpose of assisting counsel in the lawsuit; to third parties engaged solely in one or more aspects of organizing, filing, coding, converting, storing, or retrieving data or designing programs for handling data connected with this lawsuit, including the performance of such duties in relation to a computerized litigation support system; provided, however, that in all such cases the individual to whom disclosure is to be made under this subparagraph (b) has signed the Agreement to Maintain Confidentiality in the form attached hereto, which shall be maintained by the PEC and, if requested, submitted to the Court for in camera review;
c. to representatives of the United States Food and Drug Administration ("FDA"), or, if pursuant to subpoena, to any other government agency. Prior to any such disclosure, the PEC or other disclosing person must advise the government agency or representatives thereof receiving the disclosure of the provisions of this order.
d. Documents designated as CONFIDENTIAL and produced in this matter may also be disclosed to counsel representing plaintiffs in other Rezulin-related litigations against defendants, if all of the following conditions are met:
(1) counsel receiving CONFIDENTIAL documents pursuant to this paragraph must in writing:
(i) agree to be bound by the terms of this Protective Order, and
(ii) submit to the jurisdiction of this Court for purposes of enforcement of this Protective Order against them; and
(2) a protective order of confidentiality on substantially identical terms to this one, or on such other terms as the Clinical Investigator may agree to, shall have been entered in each pending case in which such counsel wishes to use documents disclosed under this paragraph; and
(3) counsel receiving CONFIDENTIAL documents pursuant to this paragraph agree to stipulate promptly to entry of a protective order of confidentiality on substantially identical terms as this one, or on such other terms as the parties may agree to, in any new cases that they may bring related to Rezulin in which they seek to use any such documents.
5. Challenges to Confidentiality Designations. The parties may apply to the Court for a ruling that a document (or category of documents) designated as a Confidential Document(s) is not entitled to such status and protection. Before any such application is filed, counsel for the parties and Clinical Investigator (or counsel for Clinical Investigator if represented by counsel) shall attempt to resolve the issue through discussions. If such discussions are unsuccessful and a party files an application, Clinical Investigator shall be given notice of the application and an opportunity to respond. To maintain confidential status, the proponent of confidentiality must show by a preponderance of the evidence that there is good cause for the document to have such protection.
6. Confidential Information at Trial, Hearing or Depositions. Nothing herein prohibits any party from using these confidential documents at a hearing, trial or deposition so long as they have executed the attached Agreement to Maintain Confidentiality.
7. Subpoena by Other Courts or Agencies. If another court or an administrative agency subpoenas or orders production of Confidential Documents that the parties have obtained under the terms of this Order, the parties shall promptly notify the Clinical Investigator of the pendency of such subpoena or order.
8. Filing. Confidential Documents need not be filed with the clerk except when required in connection with motions under Fed.R.Civ.P. 12 or 56 or other matters pending before the court. If filed, they shall be filed under seal and shall remain sealed while in the office of the clerk so long as they retain their status as Confidential Documents.
9. Client Consultations. Nothing in this Order shall prevent or otherwise restrict counsel from rendering advice to their clients and, in the course thereof, relying generally on examination of Confidential Documents; provided, however, that in rendering such advice and otherwise communicating with such clients, counsel shall not make specific disclosure of any item so designated except pursuant to the procedures of paragraph 4(b) and (c).
10. Use. Persons obtaining access to Confidential Documents under this Order shall use the information only for preparation and trial of cases docketed in MDL 1348 (including trials, appeals and retrials of such cases after remand to a transferor court), and shall not use such information for any other purposes, including business, governmental, commercial, administrative, or judicial proceedings.
11. Non-Termination. The provisions of this Order shall not terminate at the conclusion of this action. This Order shall remain in full force and effect and each person subject to this Order shall continue to be subject to the jurisdiction of this Court for the purposes of enforcement of the confidentiality terms of this Order. Within 120 days after final conclusion of all aspects of this lawsuit, Confidential Documents and all copies of same (other than exhibits of record) shall be returned to the Clinical Investigator who produced the documents or shall be destroyed. All counsel of record shall make certification of compliance herewith and shall deliver the same to Plaintiffs' Liaison Counsel, Lieff, Cabraser, Heimann Bernstein, 780 Third Avenue, 48th Floor, New York, N Y 10017, attention Steven E. Fineman. Should any Clinical Investigator wish to obtain copies of such certifications, they shall submit their names and mailing addresses to Plaintiffs' Liaison Counsel, who shall mail all certifications to such requesting Third Parties within 150 days of the conclusion of the litigation.
12. Modification Permitted. Nothing in this Order shall prevent a party or Clinical Investigator from seeking modification of this Order, or from objecting to discovery that it believes otherwise to be improper.
13. Responsibility of Attorneys. The attorneys of record are responsible for employing reasonable measures, consistent with this Order, to control duplication of, access to, and distribution of Confidential Documents. Parties shall not duplicate any Confidential Document except working copies and for filing in court under seal. All copies made of Confidential Documents shall bear the confidential designation.
14. No Waiver.
14.1 Review of the Confidential Documents and information by counsel, experts or consultants for the litigants in the lawsuit shall not waive the confidentiality of the documents or objections to production.
14.2 The inadvertent, unintentional, or in camera disclosure of Confidential Documents and information shall not, under any circumstances, be deemed a waiver, in whole or in party, of any party's claims of confidentiality.
15. Nothing contained in this Protective Order and no action taken pursuant to it shall prejudice the right of any party to contest the alleged confidentiality, relevancy, admissibility, or discoverability of the Confidential Documents and information sought.
16. No document shall be deemed Confidential under this order if it has been produced as non-confidential, by agreement or court order, in any other case.
17. This Protective Order will bind the parties and their counsel in all cases docketed in MDL 1348 and will remain in effect in all such cases after remand to transferor courts.
SO ORDERED.