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McClain v. Ethicon Endo-Surgery, Inc.

United States District Court, D. Nebraska

October 21, 2019


          Michael K. Huffer Attorneys for Defendant Ethicon Endo-Surgery, Inc.

          Christopher P Welsh Welsh & Welsh, PC LLO Attorneys for Plaintiffs Keith E. McClain and Joyce A. McClain



         Plaintiffs Keith E. McClain and Joyce A. McClain and Defendant Ethicon Endo-Surgery, Inc. (“EES”) (collectively, the “Parties”), contemplate that discovery in the above-referenced action will involve the exchange of information and the production of documents and other materials that may contain trade secrets or information otherwise of a confidential or proprietary nature. As a result, the Parties agree to the following Stipulated Protective Order/Confidentiality Agreement (“Protective Order”) that shall govern confidentiality of documents and information produced in this litigation.

         1. Introduction, Scope, and Applicability.

         This Protective Order shall govern all documents and information exchanged (whether in writing, electronic, or other form) during this action, including, but not limited to, documents produced by the Parties or non-parties, deposition testimony, interrogatory answers, and responses to requests for admission, including materials identified in Paragraph 7 below, for which confidentiality is claimed. The documents and information governed by this Protective Order shall be collectively referred to as “Confidential Material.”

         This Protective Order is applicable to the Parties and any non-parties or potential future parties involved in this litigation. It is further applicable to the Parties' attorneys, agents, representatives, officers, and/or employees; to all Consultants retained by any party or Parties' attorneys; to all signatories to Exh. A; and to all other persons authorized under this Protective Order or any other Order of this Court to receive or review Confidential Material. It is expressly ordered that this Protective Order will not be used, in any manner or form, direct or indirect, as evidence in any trial or any hearing, or referred to in any trial or any hearing on the merits of this case, save and except a hearing which involves issues related to the enforcement of any provision of this Protective Order. This provision is an essential part of this Protective Order and is not severable from any remaining paragraph or provision thereof.

         2. Designation of Confidential Material.

         Confidential Material constitutes or relates to non-public, sensitive, or confidential information. This includes, but is not limited to, sensitive commercial information, financial or business plans, trade secrets, proprietary or sensitive research and development information, and private individual personal, health, or financial information. Such Confidential Material shall be so identified by including on each page the legend “Confidential, ” without obscuring, altering, or interfering with the legibility of the original page. For electronically stored information (“ESI”) produced in image form, the legend shall be stamped onto each image. For ESI produced in native form, the designating party shall rename each file to include, at the end of the file and prior to the file extension, the term “Confidential.”

         Except with the prior consent of the producing party or upon prior order of a court of competent jurisdiction, Confidential Material shall not be disclosed except in accordance with the terms, conditions, and restrictions of this Protective Order.

         3. Documents Prepared for Regulatory Agencies and Permissible Redactions Generally.

         Certain documents prepared in compliance with the regulations of the United States Food and Drug Administration contain material that is privileged and confidential under the patient-physician privilege or specific federal regulations governing clinical trials and adverse device experience reporting. To protect these privileges, all such documents produced by EES in response to a discovery request shall have redacted all information regarding the patient, physician, and reporter required to be protected by all applicable laws and regulations. Such redaction shall not be done in such a manner as to redact material data contained in such reports. It is the intent of this paragraph to be consistent with the requirements of 21 C.F.R. 20.63(f).

         The producing party may redact from production information or material that is protected from disclosure by applicable privilege or immunity, that is governed by any applicable privacy law or regulation, that contains commercially-sensitive or proprietary non-responsive information, or that any order entered in this action allows to be redacted. In preparing document families for production, the producing party also may withhold entire attachments that are wholly non-responsive to any claim or defense and may produce slip-sheets in their place. All redactions must be clearly marked and identified. Any failure to redact information consistent with this paragraph does not waive any right to claims of privilege or privacy, or any objection, including relevancy, as to the information not redacted, the specific document containing that information, or any other produced document.

         4. Limitations on Use of Confidential Material.

         Subject to Paragraph 5 of this Protective Order, no Confidential Material shall, without prior written consent of the designating party: (a) be disclosed to anyone other than the Court and the persons and entities specified in Paragraph 5 hereof; or (b) be used by anyone other than the designating party for any purpose whatsoever other than the prosecution or defense of this litigation. Nothing herein shall detract from, or affect in any way, confidentiality obligations to which the Parties may be subject pursuant to agreements independent of this litigation.

         Unless specifically provided otherwise in this Protective Order, each Authorized Person identified in Paragraph 5 below (other than the Court and its staff) who has possession or control of Confidential Material (including any person or entity acting on behalf of, or for the benefit of, such Authorized Person as permitted in this Protective Order): (a) shall not permit or enable unauthorized dissemination of Confidential Material to anyone; (b) shall take all necessary and prudent measures to preserve the security of Confidential Material, including measures to minimize risks of hacking of, and other unauthorized access to, systems on which Confidential Material is stored or through which it is transmitted; and (c) shall physically store, maintain, and transmit Confidential Material solely within the United States.

         5. Limitations on Persons Authorized to Have Access to Confidential Material.

         Access to and disclosure of Confidential Material shall be limited to Authorized Personnel listed in this paragraph and shall not be provided, shown, made available, or communicated in any way to any other person or entity. Authorized Personnel are:

(a) Counsel for Plaintiffs, including partners and associates of counsel, and their paralegals, administrative assistants, secretaries, and other members of their clerical and administrative staffs;
(b) Counsel for the Defendant, including partners and associates of counsel, and their paralegals, administrative assistants, secretaries, and other members of their clerical and administrative staffs;
(c) Plaintiffs;
(d) Defendant;
(e) Outside experts or outside consultants for any party, including their administrative assistants, secretaries, and other members of the clerical and administrative staffs of those outside experts or outside consultants whose advice and consultation are being or will be used by such party in connection with this proceeding, including any motions in this proceeding.

         However, outside experts or outside consultants, as used in this paragraph, shall not include any employee of the receiving party. A party desiring to disclose Confidential Material to outside experts or consultants shall first obtain from each expert or consultant a Written Acknowledgments to Abide by the Terms of the Stipulation and Protective Agreement Regarding Confidentiality (“Acknowledgement”) in the form provided in Exhibit A.[1]

         Notwithstanding any other provision of this Order, disclosure of another party's Confidential Material to a Competitor of that party is prohibited. For purposes of this Protective Order, a “Competitor” is defined as a person or entity that is engaged in developing, selling, or buying goods or services in the same market as the disclosing party. A party shall not disclose to a consultant another party's Confidential Material without first: (i) making a duly diligent inquiry to confirm that the consultant is not a Competitor of the other party; and (ii) obtaining from the consultant a written declaration, under penalty of perjury, that he or she is not a Competitor of the designating party. The disclosing party shall retain each consultant's declaration for the Court's in camera review in the event of a dispute between the parties;

(f) The Court, the Court's staff, and the jury in this litigation;
(g) Employees of outside vendors providing coy services and exhibit preparation services in connection ...

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