Poore-Rando et al v. United States of America et al

Filing 40

ORDER granting 39 Motion for Protective Order signed by Judge Benjamin H. Settle.(TG)

District Judge Benjamin H. Settle

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UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF WASHINGTON
AT TACOMA

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SAMANTHA POORE-RANDO and
MATTHEW RANDO, husband and wife,

Case No. 16-05094-BHS

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Plaintiffs,
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AMENDED STIPULATED
PROTECTIVE ORDER

v.
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UNITED STATES OF AMERICA, et al.,

Noted for Consideration:
June 6, 2017

Defendants.

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1.

PURPOSES AND LIMITATIONS
The Parties previously stipulated to, and the Court previously entered, a Protective Order

in this matter. ECF No. 36, 37. That Order addressed Plaintiff’s medical records and related
materials. The Parties wish to amend that Order to include additional discovery materials to be
produced by Defendant Ethicon Endo-Surgery, Inc., as set forth in § 2. In addition, the Parties
wish to enter a non-waiver order under Fed. R. Evid. 502(d), as suggested in the revised Model
Protective Order promulgated for the Western District.
Discovery in this action is likely to involve production of confidential, proprietary, or
private information for which special protection may be warranted. Accordingly, the parties
AMENDED STIPULATED
PROTECTIVE ORDER
C16-5094-BHS - 1

UNITED STATES ATTORNEY
700 Stewart Street, Suite 5220
Seattle, Washington 98101-1271
206-553-7970

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hereby stipulate to and petition the Court to enter the following Stipulated Protective Order. The

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parties acknowledge that this agreement is consistent with LCR 26(c). It does not confer blanket

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protection on all disclosures or responses to discovery, the protection it affords from public

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disclosure and use extends only to the limited information or items that are entitled to

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confidential treatment under the applicable legal principles, and it does not presumptively entitle

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parties to file confidential information under seal.

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2.

“CONFIDENTIAL” MATERIAL

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“Confidential” material shall include the following documents and tangible things

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produced or otherwise exchanged: Plaintiff’s medical records and any statements or reports that

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discuss Plaintiff’s medical care.

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In addition, “Confidential” material shall include documents reflecting or related to:

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(1) product design and drawings;

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(2) product manufacturing and quality control/quality assurance;

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(3) Product Inquiry Investigation files;

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(4) trade secrets or other proprietary research, development or commercial information

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including but not limited to business plans or financial information;

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(5) private individual personal health or financial information; and

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(6) documents prepared for regulatory agencies, including confidential communications

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with the FDA. The names and addresses of patients and physicians shall be redacted, as well as

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all identifying information regarding the reporters in such a manner as not to redact material data

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contained in such reports and consistent with the requirements of 21 C.F.R. 20.63(f).

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3.

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SCOPE
The protections conferred by this agreement cover not only confidential material (as

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defined above), but also (1) any information copied or extracted from confidential material; (2)

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all copies, excerpts, summaries, or compilations of confidential material; and (3) any testimony,
AMENDED STIPULATED
PROTECTIVE ORDER
C16-5094-BHS - 2

UNITED STATES ATTORNEY
700 Stewart Street, Suite 5220
Seattle, Washington 98101-1271
206-553-7970

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conversations, or presentations by parties or their counsel that might reveal confidential material.

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However, the protections conferred by this agreement do not cover information that is in the

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public domain or becomes part of the public domain through trial or otherwise.

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4.

ACCESS TO AND USE OF CONFIDENTIAL MATERIAL
4.1

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Basic Principles. A receiving party may use confidential material that is disclosed

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or produced by another party or by a non-party in connection with this case only for prosecuting,

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defending, or attempting to settle this litigation. Confidential material may be disclosed only to

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the categories of persons and under the conditions described in this agreement. Confidential

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material must be stored and maintained by a receiving party at a location and in a secure manner

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that ensures that access is limited to the persons authorized under this agreement.
4.2

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Disclosure of “CONFIDENTIAL” Information or Items. Unless otherwise

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ordered by the Court or permitted in writing by the designating party, a receiving party may

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disclose any confidential material only to:
(a)

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the receiving party’s counsel of record in this action, as well as employees

of counsel to whom it is reasonably necessary to disclose the information for this litigation;
(b)

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the officers, directors, and employees (including in house counsel) of the

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receiving party to whom disclosure is reasonably necessary for this litigation, unless the parties

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agree that a particular document or material produced is for Attorney’s Eyes Only and is so

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designated;
(c)

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experts and consultants to whom disclosure is reasonably necessary for

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this litigation and who have signed the “Acknowledgment and Agreement to Be Bound” (Exhibit

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A);

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(d)

the Court, court personnel, and court reporters and their staff;

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(e)

copy or imaging services retained by counsel to assist in the duplication of

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confidential material, provided that counsel for the party retaining the copy or imaging service
AMENDED STIPULATED
PROTECTIVE ORDER
C16-5094-BHS - 3

UNITED STATES ATTORNEY
700 Stewart Street, Suite 5220
Seattle, Washington 98101-1271
206-553-7970

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instructs the service not to disclose any confidential material to third parties and to immediately

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return all originals and copies of any confidential material;
(f)

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during their depositions, witnesses in the action to whom disclosure is

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reasonably necessary and who have signed the “Acknowledgment and Agreement to Be Bound”

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(Exhibit A), unless otherwise agreed by the designating party or ordered by the Court. Pages of

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transcribed deposition testimony or exhibits to depositions that reveal confidential material must

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be separately bound by the court reporter and may not be disclosed to anyone except as permitted

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under this agreement;
(g)

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the author or recipient of a document containing the information or a

custodian or other person who otherwise possessed or knew the information.
4.3

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Filing Confidential Material. Before filing confidential material or discussing or

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referencing such material in court filings, the filing party shall confer with the designating party

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to determine whether the designating party will remove the confidential designation, whether the

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document can be redacted, or whether a motion to seal or stipulation and proposed order is

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warranted. Local Civil Rule 5(g) sets forth the procedures that must be followed and the

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standards that will be applied when a party seeks permission from the court to file material under

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seal.

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5.

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DESIGNATING PROTECTED MATERIAL
5.1

Exercise of Restraint and Care in Designating Material for Protection. Each party

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or non-party that designates information or items for protection under this agreement must take

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care to limit any such designation to specific material that qualifies under the appropriate

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standards. The designating party must designate for protection only those parts of material,

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documents, items, or oral or written communications that qualify, so that other portions of the

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material, documents, items, or communications for which protection is not warranted are not

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swept unjustifiably within the ambit of this agreement.
AMENDED STIPULATED
PROTECTIVE ORDER
C16-5094-BHS - 4

UNITED STATES ATTORNEY
700 Stewart Street, Suite 5220
Seattle, Washington 98101-1271
206-553-7970

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Mass, indiscriminate, or routinized designations are prohibited. Designations that are

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shown to be clearly unjustified or that have been made for an improper purpose (e.g., to

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unnecessarily encumber or delay the case development process or to impose unnecessary

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expenses and burdens on other parties) expose the designating party to sanctions.

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If it comes to a designating party’s attention that information or items that it designated

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for protection do not qualify for protection, the designating party must promptly notify all other

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parties that it is withdrawing the mistaken designation.

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5.2

Manner and Timing of Designations. Except as otherwise provided in this

agreement (see, e.g., second paragraph of section 5.2(a) below), or as otherwise stipulated or

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ordered, disclosure or discovery material that qualifies for protection under this agreement must

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be clearly so designated before or when the material is disclosed or produced.

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(a)

Information in documentary form: (e.g., paper or electronic documents

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and deposition exhibits, but excluding transcripts of depositions or other pretrial or trial

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proceedings), the designating party must affix the word “CONFIDENTIAL” to each page that

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contains confidential material. If only a portion or portions of the material on a page qualifies for

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protection, the producing party also must clearly identify the protected portion(s) (e.g., by

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making appropriate markings in the margins).

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(b)

Testimony given in deposition or in other pretrial or trial proceedings: the

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parties must identify on the record, during the deposition, hearing, or other proceeding, all

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protected testimony, without prejudice to their right to so designate other testimony after

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reviewing the transcript. Any party or non-party may, within fifteen days after receiving a

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deposition transcript, designate portions of the transcript, or exhibits thereto, as confidential.

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(c)

Other tangible items: the producing party must affix in a prominent place

on the exterior of the container or containers in which the information or item is stored the word

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AMENDED STIPULATED
PROTECTIVE ORDER
C16-5094-BHS - 5

UNITED STATES ATTORNEY
700 Stewart Street, Suite 5220
Seattle, Washington 98101-1271
206-553-7970

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“CONFIDENTIAL.” If only a portion or portions of the information or item warrant protection,

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the producing party, to the extent practicable, shall identify the protected portion(s).
5.3

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Inadvertent Failures to Designate. If timely corrected, an inadvertent failure to

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designate qualified information or items does not, standing alone, waive the designating party’s

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right to secure protection under this agreement for such material. Upon timely correction of a

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designation, the receiving party must make reasonable efforts to ensure that the material is

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treated in accordance with the provisions of this agreement.

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6.

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CHALLENGING CONFIDENTIALITY DESIGNATIONS
6.1

Timing of Challenges. Any party or non-party may challenge a designation of

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confidentiality at any time. Unless a prompt challenge to a designating party’s confidentiality

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designation is necessary to avoid foreseeable, substantial unfairness, unnecessary economic

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burdens, or a significant disruption or delay of the litigation, a party does not waive its right to

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challenge a confidentiality designation by electing not to mount a challenge promptly after the

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original designation is disclosed.

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6.2

Meet and Confer. The parties must make every attempt to resolve any dispute

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regarding confidential designations without court involvement. Any motion regarding

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confidential designations or for a protective order must include a certification, in the motion or in

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a declaration or affidavit, that the movant has engaged in a good faith meet and confer

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conference with other affected parties in an effort to resolve the dispute without court action. The

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certification must list the date, manner, and participants to the conference. A good faith effort to

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confer requires a face-to-face meeting or a telephone conference.

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6.3

Judicial Intervention. If the parties cannot resolve a challenge without court

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intervention, the designating party may file and serve a motion to retain confidentiality under

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Local Civil Rule 7 (and in compliance with Local Civil Rule 5(g), if applicable). The burden of

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persuasion in any such motion shall be on the designating party. Frivolous challenges, and those
AMENDED STIPULATED
PROTECTIVE ORDER
C16-5094-BHS - 6

UNITED STATES ATTORNEY
700 Stewart Street, Suite 5220
Seattle, Washington 98101-1271
206-553-7970

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made for an improper purpose (e.g., to harass or impose unnecessary expenses and burdens on

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other parties) may expose the challenging party to sanctions. All parties shall continue to

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maintain the material in question as confidential until the court rules on the challenge.

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7.

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PROTECTED MATERIAL SUBPOENAED OR ORDERED PRODUCED
IN OTHER LITIGATION
If a party is served with a subpoena or a court order issued in other litigation that compels

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disclosure of any information or items designated in this action as “CONFIDENTIAL,” that

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party must:
(a)

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promptly notify the designating party in writing and include a copy of the

subpoena or court order;
(b)

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promptly notify in writing the party who caused the subpoena or order to

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issue in the other litigation that some or all of the material covered by the subpoena or order is

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subject to this agreement. Such notification shall include a copy of this agreement; and
(c)

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cooperate with respect to all reasonable procedures sought to be pursued

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by the designating party whose confidential material may be affected.

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8.

UNAUTHORIZED DISCLOSURE OF PROTECTED MATERIAL

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If a receiving party learns that, by inadvertence or otherwise, it has disclosed confidential

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material to any person or in any circumstance not authorized under this agreement, the receiving

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party must immediately (a) notify in writing the designating party of the unauthorized

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disclosures, (b) use its best efforts to retrieve all unauthorized copies of the protected material,

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(c) inform the person or persons to whom unauthorized disclosures were made of all the terms of

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this agreement, and (d) request that such person or persons execute the “Acknowledgment and

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Agreement to Be Bound” that is attached hereto as Exhibit A.

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AMENDED STIPULATED
PROTECTIVE ORDER
C16-5094-BHS - 7

UNITED STATES ATTORNEY
700 Stewart Street, Suite 5220
Seattle, Washington 98101-1271
206-553-7970

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9.

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INADVERTENT PRODUCTION OF PRIVILEGED OR OTHERWISE PROTECTED
MATERIAL

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When a producing party gives notice to receiving parties that certain inadvertently

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produced material is subject to a claim of privilege or other protection, the obligations of the

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receiving parties are those set forth in Federal Rule of Civil Procedure 26(b)(5)(B). This

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provision is not intended to modify whatever procedure may be established in an e-discovery

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order or agreement that provides for production without prior privilege review. The parties agree

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to the entry of a non-waiver order under Fed. R. Evid. 502(d), as set forth herein.

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10.

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NON TERMINATION AND RETURN OF DOCUMENTS
Within 60 days after the termination of this action, including all appeals, each receiving

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party must return all confidential material to the producing party, including all copies, extracts

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and summaries thereof. Alternatively, the parties may agree upon appropriate methods of

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destruction.

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Notwithstanding this provision, counsel are entitled to retain one archival copy of all

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documents filed with the court, trial, deposition, and hearing transcripts, correspondence,

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deposition and trial exhibits, expert reports, attorney work product, and consultant and expert

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work product, even if such materials contain confidential material.

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AMENDED STIPULATED
PROTECTIVE ORDER
C16-5094-BHS - 8

UNITED STATES ATTORNEY
700 Stewart Street, Suite 5220
Seattle, Washington 98101-1271
206-553-7970

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The confidentiality obligations imposed by this agreement shall remain in effect until a

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designating party agrees otherwise in writing or a court orders otherwise. IT IS SO

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STIPULATED, THROUGH COUNSEL OF RECORD.

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DATED this 6th day of June, 2017.
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ANNETTE L. HAYES
United States Attorney

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s/ Whitney Passmore
Priscilla T. Chan, WSBA #28533
[e-mail]
Whitney Passmore, NC #38421
[e-mail]
Assistant United States Attorney
United States Attorney’s Office
700 Stewart Street, Suite 5220
Seattle, WA 98101-1271

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Attorneys for Defendant United States

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DATED this 6th day of June, 2017.

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HAROLD KARLSVIK, P.S.

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s/ Harold Karlsvik
Harold Karlsvik, WSBA #23026
[e-mail]
Harold Karlsvik Attorney at Law
P.O. Box 292
South Bend, WA 98586

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Attorneys for Plaintiff

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DATED this 6th day of June, 2017.
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BETTS, PATTERSON & MINES, P.S.

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s/ Christopher W. Tompkins
Christopher W. Tompkins, WSBA #11686
[e-mail]
Betts, Patterson & Mines, P.S.
701 Pike St, Suite 1400
Seattle, WA 98101

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Attorney for Defendants Johnson & Johnson; Ethicon
Endo-Surgery, Inc.

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AMENDED STIPULATED
PROTECTIVE ORDER
C16-5094-BHS - 9

UNITED STATES ATTORNEY
700 Stewart Street, Suite 5220
Seattle, Washington 98101-1271
206-553-7970

ORDER
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PURSUANT TO STIPULATION, IT IS SO ORDERED.
IT IS FURTHER ORDERED that pursuant to Fed. R. Evid. 502(d), the production of any

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documents in this proceeding shall not, for the purposes of this proceeding or any other

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proceeding in any other court, constitute a waiver by the producing party of any privilege

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applicable to those documents, including the attorney-client privilege, attorney work-product

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protection, or any other privilege or protection recognized by law.

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DATED: June 7, 2017

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A

BENJAMIN H. SETTLE
United States District Judge

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AMENDED STIPULATED
PROTECTIVE ORDER
C16-5094-BHS - 10

UNITED STATES ATTORNEY
700 Stewart Street, Suite 5220
Seattle, Washington 98101-1271
206-553-7970