UNITED STATES DISTRICT COURT EASTERN DISTRICT OF NEW YORK
April 10, 2009
JACK FROBES AND KATHLEEN HOEG- FROBES, ALLEN CRISP, AND RAY WILSON, PLAINTIFFS,
STRYKER CORPORATION, AND STRYKER SALES CORPORATION, BREG, INC., DJO, LLC, DJO, INC. F/K/A DJ ORTHOPEDICS, INC., I-FLOW INC., MCKINLEY MEDICAL, LLC, MOOG, INC., ASTRAZENECA PLC, ASTRAZENECA PHARMACEUTICALS LC, ASTRAZENECA LC, ABBOTT LABORATORIES, APP PHARMACEUTICALS, LLC, PACIFIC MEDICAL, INC., B. BRAUN MEDICAL, INC., AND CURLIN MEDICAL, INC, DEFENDANTS.
KIMBERLY DAWN EVANS AND RICHARD EVANS, PLAINTIFFS,
DJO, LLC, DJO, INC. F/K/A DJ ORTHOPEDICS, INC., I-FLOW INC., MCKINLEY MEDICAL, LLC, MOOG, INC., ASTRAZENECA PLC, ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA LP, ABBOTT LABORATORIES, APP PHARMACEUTICALS, LLC, PACIFIC MEDICAL, INC., B. BRAUN MEDICAL, INC., DEFENDANTS.
KRIS PRATHER, PLAINTIFF,
STRYKER CORPORATION, AND STRYKER SALES CORPORATION, BREG, INC., DJO, LLC, DJO, INC. F/K/A DJ ORTHOPEDICS, INC., I-FLOW CORPORATION, MCKINLEY MEDICAL, LLC, MOOG, INC., ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA LP, ABBOTT LABORATORIES, APP PHARMACEUTICALS, LLC, PACIFIC MEDICAL, INC., B. BRAUN MEDICAL, INC., CURLIN MEDICAL, INC, AND SGARLATO R.P., INC. D/B/A SGARLATO LABS, INC., DEFENDANTS.
PRETRIAL ORDER NO. 1: ORDER GOVERNING THE PRODUCTION OF CONFIDENTIAL INFORMATION (CONSOLIDATED FOR PURPOSES OF DISCOVERY)
I. SCOPE OF ORDER
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 should be designated as confidential. Any party designating third party information as confidential shall have the same rights as a Supplying Party under this order with respect to such information.
III.PERMISSIBLE DISCLOSURE OF CONFIDENTIAL INFORMATION
16. Subject to paragraphs 17 and 23, a Receiving Party may show and deliver Confidential Information only to the following persons:
a. Counsel for the Receiving Party, including any in-house counsel, and the attorneys, paralegals, employees, stenographic, and clerical staff employed by such counsel to whom it is reasonably necessary to disclose the Confidential Information for purposes of the litigation;
b. Any independent contractor of counsel for the Receiving Party to whom it is reasonably necessary to disclose the Confidential Information for purposes of this litigation;
c. With respect to any Confidential Information produced by any plaintiff or third party with respect to plaintiff, any employee or agent of the Receiving Party to whom it is reasonably necessary to disclose such information;
d. Any plaintiff in the above-captioned proceedings;
e. Any outside consultant or expert to whom it is reasonably necessary to disclose Confidential Information, whether formally retained or not, subject to paragraph 17, infra;
f. Any witness for the purpose of conducting an examination of such witness during a trial or deposition; provided, however, that Confidential Information shall not lose its confidential or restricted status through such use;
g. Stenographic employees and court reporters recording or transcribing testimony in the proceedings; and
h. The Court, any Special Master appointed by the Court, any state court conducting related proceedings, and any members of their staffs to whom it is necessary to disclose Confidential Information.
i. Any insurer(s) (of any party), and their officers, directors, employees, representatives, agents and attorneys, and
j. Any reinsurers and their officers, directors, employees, representatives, agents and attorneys.
17. Before disclosing Confidential Information to any person who is a current employee of or a current consultant to (a) a manufacturer or distributor of pain pumps other than Defendants or (b) a manufacturer or distributor of anesthetic medications deliverable by pain pumps other than Defendants, the party wishing to make such disclosure shall give at least ten (10) days' advance notice in writing to the counsel for the party who designated such information as confidential, stating sufficient information concerning the proposed recipient that does not identify the proposed recipient but is sufficient to permit an informed decision to be made with respect to any potential objection, including at a minimum, the name of the medical device or pharmaceutical manufacturer or distributor and the nature of the person's relationship thereto. A current employee or current consultant is defined as one who actually provides consulting services during the pendency of this litigation and receives income for such services. If, within the 10-day period, the Supplying Party files a motion objecting to the proposed disclosure, then the party seeking disclosure may not disclose any Confidential Information to that person until ten days have elapsed after the appeal period from a Court order denying the motion. In making such motion, it shall be the Supplying Party's burden to demonstrate good cause for preventing such disclosure. The Supplying Party will have opportunities to request that the Court direct the party wishing to make disclosure to produce additional information about the proposed recipient and to submit any other papers and argument it feels necessary to allow the Court to make an informed decision. If the Court allows disclosure of the Confidential Information, the Information remains Confidential Information and the person shall be bound by this order.
18. Disclosure of Confidential Information beyond the terms of this Protective Order may be made only if the Supplying Party designating the material as confidential consents in writing to such disclosure, or if the Court, after reasonable written notice to all affected parties, orders such disclosure. The terms of this Order shall not apply to any publicly available information or documents.
IV. USE OF CONFIDENTIAL INFORMATION
19. Persons having knowledge of Confidential Information by virtue of their participation in the proceedings, or by virtue of obtaining any documents or other Confidential Information produced or disclosed in the proceedings pursuant to this Protective Order, shall use that Confidential Information only in connection with the good faith litigation of the proceedings or a Related Action in which the Receiving Party is permitted by this Order to use Confidential Information.
20. Notwithstanding any other provisions hereof, nothing herein shall restrict any party's counsel from rendering advice to its clients with respect to the proceedings or a Related Action in which the Receiving Party is permitted by this Order to use Confidential Information and, in the course thereof, relying upon Confidential Information, provided that in rendering such advice, counsel shall not disclose any other party's Confidential Information other than in a manner provided for in this Protective Order.
21. Nothing contained in this Protective Order shall preclude any party from using its own Confidential Information in any manner it sees fit, without prior consent of any party or the Court.
V. PROTECTION OF CONFIDENTIAL INFORMATION
22. Counsel shall take all reasonable and necessary steps to assure the security of any Confidential Information and will limit access to Confidential Information to those persons authorized by this Protective Order. In particular, if counsel for any party makes documents produced pursuant to this Order available via the Internet, such counsel shall take all reasonable and necessary steps to ensure that the Internet site is secure and may not be accessed by individuals who are not authorized to review Confidential Information and who have not executed the Acknowledgment described in paragraph 23 herein. At a minimum, any Internet site must require each individual user to have a distinct log-in and password and should utilize encryption in order to ensure the security of the information in transit from the host to the client terminal. Upon request by any Supplying Party, following good cause, any party using an Internet site must certify to the Supplying Party that the Internet site is secure and may only be accessed pursuant to this Order.
23. Prior to the disclosure of any Confidential Information to any person identified in paragraph 16(b), 16(e) or 16(j), each putative recipient of Confidential Information shall be provided with a copy of this Protective Order, which he or she shall read. Upon reading this Protective Order, such person shall sign an Acknowledgment, in the form annexed hereto as Exhibit A, acknowledging that he or she has read this Protective Order and shall abide by its terms. These Acknowledgments are strictly confidential. Counsel for each party shall maintain the Acknowledgments without giving copies to the other side. The parties expressly agree, and it is hereby ordered that, except in the event of a violation of this Order, they will make no attempt to seek copies of the Acknowledgments or to determine the identities of the persons signing them. If the Court finds that any disclosure is necessary to investigate a violation of this Order, the disclosure will be limited to outside counsel only and outside counsel shall not disclose any information to their clients that could tend to identify any Acknowledgment signatory unless and until there is specific evidence that a particular signatory may have violated the Order, in which case limited disclosure may be made with respect to that signatory. Persons who come into contact with Confidential Information for clerical or administrative purposes, and who do not retain copies or extracts thereof, are not required to execute Acknowledgments but must comply with the terms of this Order.
24. Any party that is served with a subpoena or other notice compelling the production of discovery materials produced by another party must immediately give written notice of such subpoena or other notice to the original Supplying Party. Upon receiving such notice, the original Supplying Party shall bear the burden of opposing, if it deems appropriate, the subpoena on grounds of confidentiality.
25. All counsel shall at all times keep secure all notes, abstractions, or other work product derived from or containing Confidential Information; shall be obligated to maintain the confidentiality of such work product; and shall not disclose or reveal the contents of said notes, abstractions or other work product after the documents, materials, or other things, or portions thereof (and the information contained therein) and information are returned and surrendered. Nothing in this agreement requires the Receiving Party's counsel to disclose work product at the conclusion of the case.
26. If a Receiving Party learns of any unauthorized disclosure of Confidential Information by it or by any person to whom it has disclosed confidential information pursuant to this Protective Order, it shall immediately (a) inform the Supplying Party in writing of all pertinent facts relating to such disclosure, (b) immediately request return of all copies of the Confidential Information, (c) inform the person or persons to whom unauthorized disclosures were made of all the terms of this Order, and (d) request such person or persons execute the Acknowledgment that is attached hereto as Exhibit A.
27. Within thirty (30) days of the conclusion of any attorney's last case in this proceeding (or such case in which the Receiving Party is permitted by this Order to use Confidential Information), including any appeals related thereto, at the written request and option of the Supplying Party, such attorney and any persons to whom he or she disclosed Confidential Information pursuant to this Order shall at the Supplying Party's expense (a) return and surrender Confidential Information, or (b) destroy Confidential Information and certify the destruction of all such information, and (c) certify the destruction of available electronic data stores containing any Confidential Information and copies thereof. Such persons shall return or surrender or certify the destruction of any discovery materials produced by the Supplying Party and any and all copies (electronic or otherwise), summaries, notes, compilations, and memoranda related thereto; provided, however, that counsel may retain their privileged communications, work product, Acknowledgments pursuant to paragraph 23, and all court-filed documents even though they contain discovery materials produced by the Supplying Party, but such retained privileged communications and work product shall remain subject to the terms of this Protective Order. At the written request of the Supplying Party, any person or entity having custody or control of recordings, notes, memoranda, summaries or other written materials, and all copies thereof, relating to or containing discovery materials produced by the Supplying Party shall deliver to the Supplying Party an affidavit certifying that reasonable efforts have been made to assure that all such discovery materials produced by the Supplying Party and any copies thereof, any and all records notes, memoranda, summaries, or other written material regarding the discovery materials produced by the Supplying Party (except for privileged communications, work product and court-filed documents as stated above) have been delivered to the Supplying Party in accordance with the terms of this Protective Order. 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.
VI. CHANGES IN AND OBJECTIONS TO DESIGNATION OF INFORMATION
28. Inadvertent production of any document or information without a designation of confidentiality will not be deemed to waive a later claim to its confidential nature or preclude the Supplying Party from designating said document or information as confidential at a later date.
Any Supplying Party may designate as Confidential Information or withdraw a Confidential Information designation from any material that it has produced; provided, however, that such redesignation shall be effective only as of the date of such redesignation. Such redesignation shall be accomplished by notifying counsel for each party in writing of such redesignation. Upon receipt of any redesignation that designates material as confidential, the Receiving Party shall (i) treat such material in accordance with this Order; (ii) take reasonable steps to notify any persons known to have possession of any such material of such redesignation under this Protective Order; and (iii) promptly endeavor to procure all copies of such material from any persons known to have possession of such material who are not entitled to receipt under paragraph 16.
29. Inadvertent production of any document or information that a party later claims should not have been produced because of a privilege, including but not limited to the attorney-client privilege or work product doctrine, will not be deemed to waive a later claim to its privileged or confidential nature. The Supplying Party may request the return of any Inadvertently Produced Privileged Document. A request for the return of an Inadvertently Produced Document shall identify the document inadvertently produced and the basis for withholding such document from production. If a party or nonparty requests the return, pursuant to this paragraph, of any Inadvertently Produced Privileged Document then in the custody of another party or nonparty, such other party shall within five (5) business days return to the requesting party or nonparty the Inadvertently Produced Privileged Document and all copies thereof. If the party returning such material does not agree with the privilege designation, the party returning such material will then write a letter to all parties setting forth its good faith, litigation-driven reason for believing that the returned material is not privileged. If the issue cannot be resolved between the parties, the Supplying Party may then move the Court to rule on the material's status. The parties shall have the benefit of all limitations on waiver afforded by Federal Rule of Evidence 502. Any inadvertent disclosure of privileged information shall not operate as a waiver in any other federal or state proceeding, and the parties' agreement regarding the effect of inadvertent disclosure of privileged information shall be binding on nonparties.
30. A Receiving Party that elects to initiate a challenge to a Supplying Party's confidentiality designation must accordingly do so pursuant to a good faith, litigation driven need and must begin the process by sending a letter to the Supplying Party outlining the documents to be de-designated and setting forth any good faith, litigation-driven reason for believing that the returned material is not confidential. The Receiving Party should then confer directly (in voice to voice dialogue; other forms of communication are not sufficient) with counsel for the Supplying Party. In conferring, the challenging party must explain the basis for its belief that the confidentiality designation was not proper and must give the Supplying Party an opportunity to review the designated material, to reconsider the circumstances, and, if no change in designation is offered, to explain the basis for the chosen designation. A Receiving Party may proceed to the next stage of the challenge process only if it has engaged in this meet and confer first. If the issue cannot be resolved between the parties, the Supplying Party may then move the Court to rule on the material's confidentiality. Each such motion must be accompanied by a competent declaration that affirms that the movant has complied with the meet and confer requirements imposed in this paragraph and that sets forth with specificity the justification for the confidentiality designation that was given by the Supplying Party in the meet and confer dialogue. In resolving a motion filed pursuant to this paragraph, the Supplying Party bears the burden of establishing entitlement to protection and confidentiality of the disputed material. Pending resolution of any such motion, the material designated as "Confidential" shall remain as protected discovery material pursuant to this Order.
VII. FILING PAPERS IN COURT RECORDS
31. Without written permission from counsel of record for the Supplying Party or a Court order secured after appropriate notice to all interested persons, a party may not file in the public record in the proceedings any Confidential Information. Any Confidential Information that is filed with the Court, and any pleading, motion or other paper filed with the Court containing or disclosing any such Confidential Information shall be filed under seal and shall bear the legend:
"THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION COVERED BY A PROTECTIVE ORDER OF THE COURT AND IS SUBMITTED UNDER SEAL PURSUANT TO THAT PROTECTIVE ORDER. THE CONFIDENTIAL CONTENTS OF THIS DOCUMENT MAY NOT BE DISCLOSED WITHOUT EXPRESS ORDER OF THE COURT."
Said Confidential Information and/or other papers shall be kept under seal until further order of the Court and shall be filed in accordance with all applicable Court and local rules; however, said Confidential Information and other papers filed under seal shall be available to the Court and counsel of record, and to all other persons entitled to receive the Confidential Information contained therein under the terms of this Order.
VIII. MISCELLANEOUS PROVISION
32. Notwithstanding any other provision in the order, nothing in this Order shall affect or modify Defendants' ability to review Plaintiffs' information and report such information to any applicable regulatory agencies as required by law or in fulfillment of any request.
IT IS SO ORDERED.
DATED this ______ day of __________________, 2009.
Marilyn D. Go, United States Magistrate Judge
(CONSOLIDATED FOR PURPOSES OF DISCOVERY)
I, _____________________________ acknowledge that I have read and understand the Protective Order Re: Confidentiality of Discovery Materials in this action governing the non-disclosure of Confidential or Trade Secret discovery material. I agree that I will not disclose such discovery material to anyone other than for purposes of this litigation and that at the conclusion of the litigation I will return all such discovery material to the party or attorney from whom I received it. By acknowledging these obligations under this Protective Order, I understand that I am submitting myself to the jurisdiction of the United States District Court, Eastern District of New York for the purpose of any issue or dispute arising hereunder and that my willful violation of any term of the Protective Order could subject me to punishment for contempt of Court.
DATED this ______ day of __________________, 2009. ______________________________
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