PRETRIAL ORDER NO. 1: ORDER GOVERNING THE PRODUCTION OF CONFIDENTIAL INFORMATION (CONSOLIDATED FOR PURPOSES OF DISCOVERY)
1. This Order shall govern the three captioned actions above, consolidated for purposes of discovery by Magistrate Judge Marilyn D. Go on September 17, 2008 ("the Proceedings"), as well as any related actions that have been or will be originally filed in, transferred to, or removed to this Court and assigned thereto ("Related Action").
2. Disclosure and discovery activity in these proceedings are likely to involve production of confidential, proprietary, or private information for which special protection from public disclosure and from use for any purpose other than prosecuting this litigation would be warranted. Accordingly, the parties hereby stipulate to and petition the Court to enter the following Pretrial Order No. 1: Order Governing the Production of Confidential Information ("Protective Order" or "Order").
3. This Protective Order shall govern all documents, the information contained therein, and all other information produced or disclosed during the proceedings, including all copies, excerpts, summaries, or compilations thereof, whether revealed in a document, deposition, other testimony, discovery response or otherwise, by any party to the proceedings (the "Supplying Party") to any other party or parties (the "Receiving Party"). The term "Document" as used herein includes designated documents or electronically stored information including writings, drawings, graphs, charts, photographs, sound recordings, images, and other data or data compilations - stored in any medium from which information can be obtained either directly or, if necessary, after translation by the responding party into a reasonably usable form. This Protective Order is binding upon the parties to the proceedings, including their respective corporate parents, subsidiaries and affiliates and their respective attorneys, agents, experts, consultants, representatives, officers and employees and others as set forth in this Order. This Order is also binding on any individual or entity who obtains any documents or other Confidential Information produced or disclosed in the proceedings pursuant to this Protective Order, including those parties' respective corporate parents, subsidiaries and affiliates and their respective attorneys, agents, experts, consultants, representatives, officers and employees and others as set forth in this Protective Order.
4. Should any third parties agree to be bound by the terms and conditions of this Protective Order and state their agreement in writing to a party subject to this Protective Order, such third party shall be deemed a Supplying Party for purposes of this Protective Order.
5. The entry of this Protective Order does not prevent any party from seeking a further order of this Court pursuant to Federal Rule of Civil Procedure 26(c).
6. Nothing herein shall be construed to affect in any manner the relevance or admissibility at trial or any other court proceeding of any document, testimony, or other evidence.
7. The parties acknowledge that this Order does not confer blanket protections on all disclosures or responses to discovery and that the protection it affords extends only to the limited information or items that are entitled under the applicable legal principles to treatment as confidential.
II.DESIGNATION OF CONFIDENTIAL INFORMATION
8. In designating material as "CONFIDENTIAL," the Supplying Party will make such designation only as to that material that it in good faith believes to be entitled to confidential treatment under applicable law or would disclose the parties' private financial information, private competitive information, trade secrets, confidential scientific information, personal or medical information, business strategies, research, development information or strategies, information relating to ownership or control of any non-public company, information required by law to be maintained in confidence by any person, information protected from disclosure by government regulations, and all copies, abstracts, charts, summaries, and notes made from material properly designated as Confidential. "Confidential Information" as used herein means any information that the Supplying Party believes in good faith constitutes, reflects, discloses, or contains information subject to protection under Federal Rule of Civil Procedure 26(c) or other applicable law, whether it is a document (electronic or otherwise), information contained in a document, information revealed during a deposition or other testimony, information revealed in an interrogatory response or information otherwise revealed.
9. Specific documents and discovery responses produced by the Supplying Party shall, if appropriate, be designated as "Confidential" by marking the pages of the document that contain Confidential Information as follows: "CONFIDENTIAL" or "CONFIDENTIAL -- SUBJECT TO PROTECTIVE ORDER." Except as provided in paragraphs 14 and 28, documents that do not bear the foregoing designation are not Confidential Information as that term is used in this Order.
10. To the extent that matter stored or recorded in the form of electronic or magnetic media (including information, files, databases or programs stored on any digital or analog machine-readable device, computers, Internet sites, discs, networks or tapes) ("Computerized Material") is produced by any party in such form, the Supplying Party may designate such matters as confidential by cover letter referring generally to such matter, or by designation in the accompanying load file. Whenever any party to whom Computerized Material designated as confidential is produced reduces such material to hardcopy or image form, that party shall mark the hardcopy form with the "CONFIDENTIAL" designation.
11. Confidential information includes information that would identify patients and persons associated with adverse events involving human drugs or medical devices (excluding Plaintiffs), and research subjects. See 21 C.F.R. 314.430 and 21 C.F.R. 20.63. Defendants shall not be compelled to disclose this identifying information and a defendant may redact this identifying information from discovery materials before production, provided however that such defendant shall maintain an un-redacted copy of such discovery material for any further review by the Court.
Nothing in this paragraph shall prohibit any party hereto from withholding or redacting information for any other valid reason, e.g., to protect the attorney-client communications, to protect attorney work product, or to protect any other legal privilege that may apply. All redactions shall be clearly marked on the produced version of the document.
12. Pursuant to 21 C.F.R. §§ 314.430(e) & (f) and 20.63(f), the names of any patients that are not redacted pursuant to Paragraph 11 shall be treated as confidential, regardless of whether the document containing such names is designated as Confidential Information. No such person shall be contacted, either directly or indirectly, based on information so disclosed without the express written permission of the Supplying Party.
13. Any material produced or provided in the proceedings for inspection is to be treated by the Receiving Party as Confidential Information pending the copying and delivery of any copies of same by the Supplying Party to the Receiving Party.
14. Information disclosed at a deposition taken in connection with the proceedings may be designated as Confidential Information by: (a) designating testimony as confidential on the record during the taking of the deposition, and/or (b) designating the portions of the transcript that are confidential in a letter to be served on the court reporter and opposing counsel within thirty (30) calendar days of the Supplying Party's receipt of the transcript of a deposition. The court reporter will indicate the portions designated as confidential and segregate them as appropriate. Designations of transcripts will apply to audio, video, or other recordings of the testimony. The court reporter shall clearly mark any transcript released prior to the expiration of the 30-day period as "Confidential -- Subject to Further Confidentiality Review." Such transcripts will be treated as Confidential Information until the expiration of the 30-day period.
15. A party in the proceedings may designate as Confidential Information any document or information produced by or testimony given by any other person or entity that the party reasonably believes qualifies as such party's Confidential Information pursuant to this Protective Order. If any third party produces information that any party in good faith believes constitutes its Confidential Information, the party claiming confidentiality shall designate the information as such within thirty (30) days of its receipt of such information. Any party receiving information from a third party shall treat such information as confidential during this thirty (30) day period while all parties have an opportunity to review the information and determine whether it ...