In Re: Gardasil Products Liability Litigation

3:22-md-03036NcwdFeb 14, 2023

Full text

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UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF NORTH CAROLINA
CHARLOTTE DIVISION
3:22-md-03036-RJC
)
IN RE: GARDASIL PRODUCTS LIABILITY ) MDL No. 3036
LITIGATION )
) THIS DOCUMENT RELATES TO
) ALL CASES
)
)
)
STIPULATED PROTECTIVE ORDER
Plaintiffs and Defendants Merck & Co., Inc. and Merck Sharp & Dohme LLC
(collectively, “Merck”) in the above-captioned action (the “Action”) hereby stipulate to the entry
of the following protective order. This Order shall apply to all cases that were (1) transferred to
this Court by the Judicial Panel on Multidistrict Litigation (“JPML”) pursuant to its August 11,
2022 Order; (2) subsequently transferred to MDL 3036 by the JPML pursuant to Rule 7.4 of the
Rules of Procedure of that Panel; or (3) originally filed in or transferred or removed to MDL
3036.
1. PURPOSES AND LIMITATIONS
Disclosure and discovery activity (including discovery requests, discovery responses and
the production of documents and/or data) in the Action is only being conducted in furtherance of
the prosecution and resolution of the Action. The Parties acknowledge that this Action is likely
to involve production of confidential, highly confidential, proprietary, or non-public personal
information for which special protection from public disclosure and from use for any purpose
other than prosecuting and defending the Action may be warranted. Accordingly, the Parties
hereby stipulate to, and request that the Court enter, the following Stipulated Protective Order
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(the “Order”).
The Parties acknowledge that this Order does not confer blanket protections on all
disclosures or responses to discovery and the protection it affords from public disclosure and use
extends only to the limited information or items that are entitled to confidential treatment under
applicable law.
2. DEFINITIONS
2.1. Challenging Party: a Party that challenges the designation of information or items
under this Order.
2.2. “CONFIDENTIAL” Information or Items: information (regardless of how it is
generated, stored or maintained) or tangible things that contain confidential and non-public
development, financial or commercial information (including current or prospective confidential
research, development, or other highly sensitive data, the disclosure of which to another Party or
Non-Party could cause a competitive disadvantage to a Producing Party or could create a
substantial risk of serious harm that could not be avoided by less restrictive means, including, for
example, pricing and cost data and analyses) or non-public personal information (e.g., medical
records, personal medical information, social security numbers, bank account numbers,
employee identification numbers and other similar pieces of information), or any other
information for which a good faith claim of need for protection from disclosure can be made
under the Federal Rules of Civil Procedure or other applicable law.
2.2.1. For purposes of this Order, CONFIDENTIAL information includes
“Confidential Health Information:” Several discovery requests have been or will be served in
this Proceeding which may seek information and documents subject to the provisions of the
Privacy Act, 5 U.S.C. § 552a, to the provisions of 45 C.F.R. §§ 164.102-164.534, or to
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provisions of 42 U.S.C. § 1306, or there may be no waiver by the patient to produce the records
to any entity outside of the requested party. Consistently, “Confidential Health Information”
means any document or information supplied in any form, or any portion thereof, that identifies
an individual or subscriber in any manner and relates to the past, present, or future care, services,
or supplies relating to the physical or mental health or condition of such individual, the provision
of health care to such individual, or the past, present, or future payment for the provision of health
care to such individual. These terms specifically include “protected health information” as such
term is defined by the Standards for Privacy of Individually Identifiable Health Information, 45
C.F.R. Parts 160 and 164, promulgated pursuant to the Health Insurance Portability and
Accountability Act of 1996. See 45 C.F.R. § 160.103 (“protected health information” and
“individually identifiable health information”). “Confidential Health information” includes, but is
not limited to, medical bills, claims forms, charge sheets, medical records, medical charts, test
results, notes, dictation, invoices, itemized billing statements, remittance advice forms,
explanations of benefits, checks, notices, and requests. “Confidential Health information” also
includes all notes, summaries, compilations, extracts, abstracts, or oral communications that
contain, are based on, or are derived from confidential health information.
2.3. “HIGHLY CONFIDENTIAL – ATTORNEYS EYES ONLY” Information or
Items: information (regardless of how it is generated, stored or maintained) or tangible things
that contain information that is of a particularly sensitive and confidential nature and the
disclosure of which to another Party or non-Party would, in the good faith belief of the
Producing Party, create a significant risk of causing irreparable or substantial harm to the
Producing Party’s business information (regardless of how it is generated, stored or maintained)
or tangible things that contain information that is of a particularly sensitive and confidential
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nature and the disclosure of which would, in the good faith believe of the Producing Party, be
detrimental to the conduct of the Party’s business (e.g., trade secrets).
2.4. Counsel: Outside Counsel of Record and In-House Counsel (as well as their
support staff).
2.5. Designating Party: a Party or Non-Party that designates information or items that
it produces in disclosures or in responses to discovery as “CONFIDENTIAL” or as Confidential
Health Information.
2.6. Disclosure of Discovery Material: all items or information, regardless of the
medium or manner in which they are generated, stored, or maintained (including, among other
things, testimony, transcripts, and tangible things), that are produced or generated in disclosures
or responses to discovery in the Action.
2.7. Expert: a person with specialized knowledge or experience in a matter pertinent
to the Action who has been retained by a Party or its Counsel to serve as an expert witness or
consultant in the Action, as well as treating physicians who may be asked for their expert opinion
concerning certain matters in this action.
2.8. In-House Counsel: litigation attorneys who are employees of a Party to this
action. In-House Counsel does not include Outside Counsel of Record or any other outside
counsel.
2.9. Non-Party: any natural person, partnership, corporation, association, or other
legal entity not named as a Party in this Action.
2.10. Outside Counsel of Record: attorneys who are not employees of a Party to this
action but are retained to represent a Party to the Action and/or are affiliated with or contracted
by a law firm which has appeared on behalf of that Party. Any attorney retained to represent a
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Party to the Action who has not appeared as counsel of record in the Action but is not affiliated
with or contracted by a law firm that has appeared on behalf of that Party must sign the
“Acknowledgment and Agreement to Be Bound” (Exhibit A) to review or otherwise access
Protected Information. This definition includes any attorney of record for plaintiffs who have
filed a lawsuit against Merck in U.S. federal district court or state court alleging personal injury
regarding Gardasil and any attorney of record for any co-defendants in other pending U.S.
litigation in federal district court or state court alleging personal injury regarding Gardasil—
provided that the attorney of record for said plaintiffs or co-defendants is: (a) already operating
under a Protective or Confidentiality Order in another jurisdiction where the Gardasil action is
pending; or (b) agrees to be bound by this Order and executes the "Acknowledgment and
Agreement to Be Bound" (Exhibit A).
2.11. Party: any party to this Action, including all of its current officers, directors, and
employees.
2.12. Producing Party: a Party or Non-Party that produces Disclosure or Discovery
Material in this Action.
2.13. Professional Vendors: persons or entities that provide litigation support services
(e.g., photocopying, videotaping, translating, preparing exhibits or demonstrations, and
organizing, storing, or retrieving data in any form or medium) and their employees and
subcontractors.
2.14. Protected Material: any Disclosure or Discovery Material that is designated as
“CONFIDENTIAL,” Confidential Health Information or “HIGHLY CONFIDENTIAL –
ATTORNEYS EYES ONLY.”
2.15. Receiving Party: a Party that receives Disclosure or Discovery Material from a
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Producing Party.
3. SCOPE
The protections conferred by this Order cover Protected Material produced in discovery
in the Action as well as: (1) any information copied or extracted from Protected Material; (2) all
copies, excerpts, or compilations of Protected Material; (3) all summaries of Protected Material,
but this shall not include allegations in a pleading that are derived from or based on Protected
Material providing: (a) that the Protected Material is neither quoted, cited nor referenced in any
way and (b) that the source of the allegations being Protected Material is not disclosed in any
way; and (4) any testimony, conversations, or presentations by Parties or their Counsel that
might reveal Protected Material. However, the protections conferred by this Order do not cover
the following information: (a) any information that is in the public domain lawfully at the time of
disclosure to a Receiving Party or becomes part of the public domain after its disclosure to a
Receiving Party as a result of publication not involving a violation of this Order; and (b) any
information obtained by the Receiving Party from a source who obtained the information
lawfully and under no obligation of confidentiality to the Designating Party. Nothing in the
Order shall be interpreted to preclude the Receiving Party from moving the Court to permit
disclosure of the Protected Material for good cause shown or to preclude the Designating Party
from moving the Court to further restrict disclosure of the Protected Material for good cause
shown.
4. DURATION
Nothing contained in this Order shall limit or prohibit any Party’s ability to use Protected
Material at trial. Unless a petition identifying Protected Material with specificity requiring
additional protection is made to the trial judge in advance of the trial, once a case proceeds to
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trial, Protected Material that is introduced at trial and admitted into evidence pursuant to the
Rules of Evidence becomes public, and will be presumptively available to all members of the
public. Notwithstanding this Paragraph, any Party may petition the Court to provide additional
protections to Protected Material at the time of trial. Where a petition to provide additional
protections to Protected Material has been made to the Court in advance of or at the time of trial,
the Protected Material identified in said petition shall be treated in accordance with this Order
unless the Court has ruled on and denied the petition.
Even after Final Disposition of the Action, for Protected Material not used or introduced
at trial, the confidentiality obligations imposed by this Order shall remain in effect until a
Designating Party agrees otherwise in writing or a court order otherwise directs. “Final
Disposition” shall be deemed to be the later of: (1) dismissal of all claims and defenses in the
Action, with or without prejudice; and (2) final judgment herein after the completion and
exhaustion of all appeals, rehearings, remands, trials, or reviews of the Action, including the time
limits for filing any motions or applications for extension of time pursuant to applicable law.
This Court will retain jurisdiction to enforce the terms of this Order following the Final
Disposition of the Action.
5. DESIGNATING PROTECTED MATERIAL
5.1. Exercise of Care and Good Faith in Designating Material for Protection. Each
Party or Non-Party that designates information or items for protection under this Order must take
reasonable care to limit any such designation to specific material that qualifies for protection
under this Order. Each Party or Non-Party may only designate the material it believes, in good
faith, is subject to protection under the Federal Rules of Civil Procedure or other applicable law.
5.2. Manner and Timing of Designations. Except as otherwise provided in this Order
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or as otherwise stipulated or ordered, Disclosure or Discovery Material that qualifies for
protection under this Order must be clearly so designated before the material is disclosed or
produced.
5.3. Designation in conformity with this Order requires:
(a) for information in documentary form (e.g., paper or electronic documents,
but excluding transcripts of depositions or other pretrial proceedings), that the Producing Party
affix the legend “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL – ATTORNEYS EYES
ONLY” to each page that contains Protected Material or, in the case of native file production, in
conformity with the Stipulation and Order Regarding Production of Documents and Information.
The “Confidential” or “Highly Confidential – Attorneys Eyes Only” designation should not
obscure or interfere with the legibility of the designated material.
In the event that an inspection of original documents or materials must occur, a
Party or Non-Party that makes original documents or materials available for inspection pursuant
to the Federal Rules of Civil Procedure need not designate them for protection until after the
inspecting Party has indicated which material it would like copied and produced. During the
inspection and before the designation, all of the material made available for inspection shall be
deemed “CONFIDENTIAL.” After the inspecting Party has identified the documents it wants
copied and produced, the Producing Party must determine which documents, or pages thereof,
qualify for protection under this Order. Then, before producing the specified documents, the
Producing Party must affix the appropriate legend (“CONFIDENTIAL” or “HIGHLY
CONFIDENTIAL – ATTORNEYS EYES ONLY”) to each document or page of a document
that contains Protected Material.
(b) for testimony given in deposition or in other pretrial proceedings, that all
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deposition testimony or testimony during other pretrial proceedings shall be treated as
“CONFIDENTIAL” for a period of 30 days from the date of receipt by Outside Counsel of
Record of a final transcript during which a Designating Party may identify the specific portions
of testimony as to which protection is sought. At the expiration of that 30-day period, only those
portions that are specifically identified will qualify for protection under this Order. Any rough
transcript that is generated before receipt by Outside Counsel of Record of a final transcript also
shall be treated during the 30-day period as if it had been designated “CONFIDENTIAL” in its
entirety unless otherwise agreed. After the expiration of that period, the transcript shall be
treated only as actually designated (e.g., “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL –
ATTORNEYS EYES ONLY”).
Each Party shall provide notice to all other Parties if it reasonably expects to
reference or use Protected Material at a deposition, hearing or other proceeding so that the other
parties can ensure that only authorized individuals who have signed the “Acknowledgment and
Agreement to Be Bound” (Exhibit A) are present at those proceedings. The use of a document as
an exhibit at a deposition shall not in any way affect its designation as “CONFIDENTIAL” or
“HIGHLY CONFIDENTIAL – ATTORNEYS EYES ONLY.”
(c) for information produced in some form other than documentary form and
for any other tangible items, that the Producing Party affix in a prominent place on the exterior of
the container or containers in which the information or item is stored the legend
“CONFIDENTIAL” or “HIGHLY CONFIDENTIAL – ATTORNEYS EYES ONLY.” If only a
portion or portions of the information or item warrant protection, the Producing Party, to the
extent practicable, shall identify the protected portion(s).
5.4. Inadvertent Failures to Designate. If corrected within 90 days after production or
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for good cause shown, an inadvertent failure to designate qualified information or items does not,
standing alone, waive the Designating Party’s right to secure protection under this Order for such
material. Upon correction of a designation, the Receiving Party must make reasonable efforts to
assure that the material is treated in accordance with the provisions of this Order.
6. CHALLENGING CONFIDENTIALITY DESIGNATIONS
6.1. Meet and Confer. In the event of a challenge to a designation, the Challenging
Party shall initiate the dispute resolution process by providing written notice of each designation
it is challenging, and describing the basis for each challenge and why the challenged documents
are relevant to the litigation to the appropriate Outside Counsel of Record for Designating Party
(the “Written Notice”). To avoid ambiguity as to whether a challenge has been made, the
Written Notice must recite that the challenge to confidentiality is being made in accordance with
this specific paragraph of the Order. The Parties shall attempt to resolve each challenge in good
faith and must begin the process by conferring directly (in person or by telephone) within 10
days of the date of service of notice. In conferring, the Challenging Party must explain the basis
for its belief that the confidentiality designation was not proper and must give the Designating
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.
6.2. Judicial Intervention With Respect to Confidentiality Designations. If the
challenge cannot be resolved through the meet and confer process, the Designating Party shall
apply to the Court for a ruling that a document (or category of documents) designated as
Protected Material is entitled to the specified level of protection (the “Designation Motion”):
(a) If a Challenging Party’s Written Notice pursuant to paragraph 6.1 above
challenges the designation of less than fifty documents, the Designating Party shall have thirty
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days from the date of the Written Notice to file its Designation Motion.
(b) If a Challenging Party’s Written Notice challenges the designation of fifty
to one hundred documents, the Designating Party shall have forty-five days from the date of the
Written Notice to file its Designation Motion.
(c) The burden of persuasion in any such challenge proceeding shall be on the
Designating Party.
(d) While any challenge pursuant to this paragraph is pending, all Parties shall
continue to afford the material in question the level of protection to which it is entitled under the
Designating Party’s designation until the Court rules on the challenge.
(e) If the Designating Party fails to timely file its Designation Motion, absent
an agreement between the parties or an order from the Court for an extension of time, then the
documents, testimony or information challenged by the Challenging Party shall be de-designated
and no longer be deemed or treated as Protected Material.
7. ACCESS TO AND USE OF PROTECTED MATERIAL
7.1. Basic Principles. A Receiving Party may use Protected Material that is disclosed
or produced by another Party or by a Non-Party in connection with this Action and/or pending
state court actions alleging personal injury regarding Gardasil only for prosecuting, defending, or
attempting to settle the Action and/or a pending state court action alleging personal injury
regarding Gardasil. Such Protected Material may be disclosed only to the categories of persons
and under the conditions described in this Order. When the Action has been terminated, a
Receiving Party must comply with the provisions of Section 14 below.
Protected Material must be stored and maintained by a Receiving Party at a location and
in a secure manner that ensures that access is limited to the persons authorized under this Order.
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7.2. Disclosure of “CONFIDENTIAL” Information or Items. Unless otherwise
ordered by the Court or permitted in writing by the Designating Party, a Receiving Party may
disclose any information or item designated “CONFIDENTIAL” only to:
(a) the Receiving Party’s Outside Counsel of Record in the Action, as well as
employees or independent contractors of said Outside Counsel of Record to whom it is
reasonably necessary to disclose the information for purposes of the Action;
(b) the officers, directors, and employees (including In-House Counsel) of the
Receiving Party to whom it is reasonably necessary to disclose the information for purposes of
the Action;
(c) Experts (as defined in this Order) of the Receiving Party to whom
disclosure is reasonably necessary for purposes of the Action and who have signed the
“Acknowledgment and Agreement to Be Bound” (Exhibit A), provided that, if such Expert is
acting solely as a Consultant/Non-Testifying Expert and (1) is currently an employee of
GlaxoSmithKline (GSK) or (2) is currently consulting with GSK with respect to any HPV
vaccine or (3) if such Consultant is developing an HPV vaccine, he or she first complies with the
notice requirements of Section 7.4(a) below;
(d) the Court and its personnel, jurors in the action, any appellate courts and
its personnel, Special Master, if one is appointed, and its personnel and mediators and its
personnel;
(e) court reporters and their staff, professional jury or trial consultants, mock
jurors, and Professional Vendors to whom disclosure is reasonably necessary for purposes of the
Action and who have signed the “Acknowledgment and Agreement to Be Bound” (Exhibit A);
(f) witnesses in the Action who have signed the “Acknowledgment and
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Agreement to Be Bound” (Exhibit A);
(g) witnesses who testify at depositions or at the trial or a hearing in this
Action;
(h) Plaintiff’s current or former healthcare provider who has signed the
“Acknowledgment and Agreement to Be Bound” (Exhibit A) to maintain the confidentiality of
any document provided that no copies of the Protected Material shall be left in the possession of
the healthcare provider witness and copies of that Protected Material shall not be attached to or
included with any original or copy of the transcript of any deposition provided to the healthcare
provider; however, copies of the Protected Material shall be attached to the deposition transcript
and made available for the use of the deponent in the event he or she testifies at trial. Counsel
present at the deposition should make a good faith effort to obtain the healthcare provider’s
agreement on the record to maintaining confidentiality, and no counsel shall make efforts to
dissuade the healthcare provider from refusing to agree on the record to maintaining the
confidentiality of any such documents; and the author or recipient of a document containing the
information.
7.3. Disclosure of “HIGHLY CONFIDENTIAL – ATTORNEYS EYES ONLY”
Information or Items. Unless otherwise ordered by the Court or permitted in writing by the
Designating Party, a Receiving Party may only disclose any information or item designated
“HIGHLY CONFIDENTIAL – ATTORNEYS EYES ONLY” to:
(a) the Receiving Party’s Outside Counsel of Record in the Action, as well as
employees or independent contractors of said Outside Counsel of Record to whom it is
reasonably necessary to disclose the information for purposes of the Action;
(b) Experts (as defined in this Order) of the Receiving Party to whom
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disclosure is reasonably necessary for purposes of the Action and who have signed the
“Acknowledgment and Agreement to Be Bound” (Exhibit A), provided that, if such Expert is
acting solely as a Consultant/Non-Testifying Expert and (1) is currently an employee of
GlaxoSmithKline (GSK) or (2) is currently consulting with GSK with respect to any HPV
vaccine or (3) if such Consultant is developing an HPV vaccine, he or she first complies with the
notice requirements of Section 7.4(a) below;
(c) the healthcare provider(s) who recommended or prescribed Plaintiff’s
Gardasil vaccine dose(s) at issue in the litigation during his or her deposition in this Action
provided that he or she has first signed “Acknowledgment and Agreement to Be Bound” (Exhibit
A) on the record to maintain the confidentiality of any document. No copies of the Protected
Material shall be left in the possession of the healthcare provider witness and copies of that
Protected Material shall not be attached to or included with any original or copy of the transcript
of any deposition provided to the healthcare provider. Counsel present at the deposition shall
obtain the healthcare provider’s agreement on the record to maintaining confidentiality
consistent with the Protective Order and “Acknowledgment and Agreement to Be Bound”
(Exhibit A), and no counsel shall make efforts to dissuade the healthcare provider from refusing
to agree on the record to maintaining the confidentiality of any such documents; the Court and its
personnel, jurors in the action, any appellate courts and its personnel, Special Master, if one is
appointed, and its personnel and mediators and its personnel;
(d) the Court and its personnel, jurors in the action, any appellate courts and
its personnel, Special Master, if one is appointed, and its personnel and mediators and its
personnel;
(e) court reporters and their staff, professional jury or trial consultants, mock
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jurors, and Professional Vendors to whom disclosure is reasonably necessary for purposes of the
Action and who have signed the “Acknowledgment and Agreement to Be Bound” (Exhibit A)
and
(f) the author or recipient of a document containing the information.
7.4. Procedures for Disclosing Information or Items Designated “CONFIDENTIAL”
or “HIGHLY CONFIDENTIAL – ATTORNEYS EYES ONLY” Pursuant to Section 7.2(c) and
7.3.
(a) Unless otherwise ordered by the Court or agreed to in writing by the
Designating Party, a Party may disclose information or items that have been designated
“CONFIDENTIAL” or “HIGHLY CONFIDENTIAL – ATTORNEYS EYES ONLY” to an
Expert acting solely as a Consultant/Non-Testifying Expert who (1) is currently an employee of
GlaxoSmithKline plc (“GSK”) or (2) is currently consulting with GSK with respect to any HPV
vaccine or (3) if such Consultant is developing an HPV vaccine, pursuant to Sections 7.2(c) and
7.3 above only if that Party first makes a written request to the Designating Party that (1)
identifies the general categories of “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL –
ATTORNEYS EYES ONLY” information that the Receiving Party seeks permission to disclose
to the Expert; (2) sets forth the full name of the Consultant/Non-Testifying Expert and the city
and state of his or her primary residence; (3) attaches a copy of the Consultant/Non-Testifying
Expert’s current resume, (4) identifies the Consultant/Non-Testifying Expert’s current
employer(s), and (5) identifies compensation or funding for work in the Consultant/Non-
Testifying Expert’s areas of expertise from GSK or from any entity or person who is developing
an HPV vaccine at any time during the preceding three years. If the identity of the individual to
whom disclosure is sought is protected pursuant to Fed.R. Civ. P. 26(b)(4)(D) or otherwise non-
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discoverable, the party wishing to make such a disclosure can, in the alterative, provide the
Counsel who designated such information as “CONFIDENTIAL” or “HIGHLY
CONFIDENTIAL – ATTORNEYS EYES ONLY” with 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.
(b) A Party that receives a timely written objection must meet and confer with
the Designating Party (either in person or by telephone) to try to resolve the matter by agreement
within seven days of the written objection. If the dispute is not resolved during the meet and
confer, the Party receiving the objection may seek relief from the Court.
8. PROTECTED MATERIAL SUBPOENAED OR ORDERED PRODUCED IN
OTHER LITIGATION
If a Receiving Party is served with a subpoena or a court order issued in other litigation
that compels disclosure of any information or items designated in the Action as
“CONFIDENTIAL” or “HIGHLY CONFIDENTIAL – ATTORNEYS EYES ONLY” that Party
must:
(a) promptly notify in writing the Designating Party’s Counsel and include in
such notification a copy of the subpoena or court order;
(b) promptly notify in writing the party who caused the subpoena or order to
issue in the other litigation that some or all of the material covered by the subpoena or order is
subject to this Order and must include a copy of this Order with the notification; and
(c) cooperate with respect to all reasonable procedures sought to be pursued
by the Designating Party whose Protected Material may be affected.
If the Designating Party timely seeks a protective order, the Party served with the
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subpoena or court order shall not produce any information designated in this action as
“CONFIDENTIAL” or “HIGHLY CONFIDENTIAL – ATTORNEYS EYES ONLY” before a
determination by an appropriate court, unless the Party has obtained the Designating Party’s
permission. The Designating Party shall bear the burden and expense of seeking protection in
that court of its confidential material.
Nothing in these provisions should be construed as authorizing or encouraging a
Receiving Party in this Action to disobey a lawful directive from another court.
9. APPLICABILITY OF THIS STIPULATED PROTECTIVE ORDER TO NON-
PARTIES
9.1. Order Applicable to Non-Parties. The terms of this Order are applicable to
information produced by Non-Parties in the Action and designated either by the Non-Party or by
any Party as “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL – ATTORNEYS EYES
ONLY.” Such information produced by Non-Parties in connection with this Action is protected
by the remedies and relief provided by this Order.
9.2. Request to a Party Seeking Non-Party Confidential Information. In the event that
a Party is required, by a valid discovery request, to produce a Non-Party’s confidential
information in its possession, and the Party is subject to an agreement with the Non-Party not to
produce the Non-Party’s confidential information, then the Party shall:
(a) promptly notify in writing the Requesting Party and the Non-Party that
some or all of the information requested is subject to a confidentiality agreement with a Non-
Party;
(b) promptly provide the Non-Party with a copy of this Order, the relevant
discovery request(s), and a reasonably specific description of the information requested; and
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(c) make the information requested available for inspection by the Non-Party.
If the Non-Party fails to object or seek a protective order from this Court within 14 days
of receiving the notice and accompanying information, the Party that received the discovery
request may produce the Non-Party’s responsive confidential information. If the Non-Party
timely seeks a protective order, the Party that received the discovery request shall not produce
any information in its possession or control that is subject to the confidentiality agreement with
the Non-Party before a determination by the Court. Absent a court order to the contrary, the
Non-Party shall bear the burden and expense of seeking protection in this Court of its Protected
Material.
10. FILING OF PROTECTED MATERIAL
Pursuant to Local Civil Rule 6.1(b), unless the Court orders otherwise, any documents
that have been designated as “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL –
ATTORNEYS EYES ONLY” under this Order that are filed with the Court shall be filed under
seal. This requirement also applies to any motion, pleading, declaration, memorandum or other
material submitted to the Court that discloses, reveals, incorporates, reflects or otherwise
includes, in whole or in part, documents that are designated “CONFIDENTIAL” or “HIGHLY
CONFIDENTIAL – ATTORNEYS EYES ONLY.” Pursuant to Local Civil Rule 6.1(g), any
materials filed under seal pursuant to this paragraph shall be filed with a non-confidential
description of the sealed materials.
11. UNAUTHORIZED DISCLOSURE OF PROTECTED MATERIAL
If a Receiving Party learns that, by inadvertence or otherwise, it has disclosed Protected
Material to any person or in any circumstance not authorized under this Order, the Receiving
Party must immediately: (a) notify in writing the Designating Party’s Counsel of the
Case 3:22-md-03036-KDB Document 70 Filed 02/14/23 Page 18 of 22
19
unauthorized disclosures, (b) use its best efforts to retrieve all unauthorized copies of the
Protected Material, (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 to execute the
“Acknowledgment and Agreement to Be Bound” that is attached hereto as Exhibit A.
12. INADVERTENT PRODUCTION OF PRIVILEGED OR OTHERWISE
PROTECTED MATERIAL
Nothing in this Order shall be construed to prohibit a Producing Party from seeking relief
from any inadvertent or unintentional disclosure of confidential, privileged, or work-product
information. Nothing in this Order shall diminish the legal rights of any person seeking such
relief. When a Producing Party gives notice to Receiving Parties that certain inadvertently
produced material is subject to a claim of privilege or other protection, the obligations of the
Receiving Parties are those set forth in Federal Rule of Civil Procedure 26(b)(5)(B). Pursuant to
Federal Rule of Evidence 502(d), neither the attorney-client privilege nor the work product
protection is waived by inadvertent production in this Action or any other action. This Protective
Order shall be interpreted to provide the maximum protection allowed by Federal Rule of
Evidence 502(d).
13. MISCELLANEOUS
13.1. Right to Further Relief and Modification by the Court. Nothing in this Order
abridges the right of any person to seek its modification by the Court in the future. The Court
retains the right to allow disclosure of any subject covered by this stipulation or to modify this
stipulation at any time in the interest of justice.
13.2. Right to Assert Other Objections. No Party waives through entry of this Order
any right it otherwise would have to object to disclosing or producing any information or item on
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any ground not addressed in this Order. Similarly, no Party waives any right to object on any
ground to use in evidence of any of the material covered by this Order.
13.3. Right of a Party to Use Its Own Documents. Nothing in this Order shall affect a
Party’s use or disclosure of its own documents in any way, or documents that are no longer
deemed confidential, either by the parties’ agreement or by court order.
13.4. Right to Redact Certain Information. The Producing Party may redact Personal
Identifying Information, Protected Health Information, non-responsive trade secrets, and any
other information required by federal or state law or regulation to be redacted.
14. FINAL DISPOSITION
Within 60 days after this action has reached its Final Disposition (as defined in Paragraph
4 of this Order) each Receiving Party must return all Protected Material obtained in the Action to
the Producing Party or destroy such material. As used in this subdivision, all “Protected
Material” includes all copies, abstracts, compilations, summaries, and any other format
reproducing or capturing any of the Protected Material. Whether the Protected Material is
returned or destroyed, the Receiving Party must submit a written certification to the Producing
Party (and, if not the same person or entity, to the Designating Party) by the 60-day deadline that
affirms that the Receiving Party has not retained any copies of the “Protected Material.
Notwithstanding this provision, Counsel are entitled to retain archival copies of all pleadings,
motion papers and accompanying exhibits, trial, deposition and hearing transcripts, legal
memoranda, correspondence, deposition and trial exhibits, expert reports, attorney work product,
and consultant and expert work product, even if such materials contain Protected Material. Any
such archival copies that contain or constitute Protected Material remain subject to this Order as
set forth in Section 4.
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IT IS SO STIPULATED, THROUGH COUNSEL OF RECORD.
Dated: January 27, 2023
Respectfully submitted,
/s/ Bijan Esfandiari
Bijan Esfandiari
WISNER BAUM, LLP
11111 Santa Monica Blvd., Suite 1750
Los Angeles, CA 90019
Telephone: (310) 207-3233
Facsimile: (310) 820-7444
besfandiari@wisnerbaum.com
PLAINTIFFS’ CO-LEAD
COUNSEL
Dated: January 27, 2023
Respectfully submitted,
/s/ Allyson M. Julien
GOLDMAN ISMAIL TOMASELLI
BRENNAN & BAUM LLP
Allyson M. Julien
200 South Wacker Drive
22nd Floor
Chicago, IL 60606
Telephone: (312) 881-5968
ajulien@goldmanismail.com
DEFENDANTS’ CO-LEAD
COUNSEL
Signed: February 14, 2023
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EXHIBIT A
ACKNOWLEDGEMENT AND AGREEMENT TO BE BOUND
I, _______________________________ of _____________________________declare
under penalty of perjury that I have read in its entirety and understand the Stipulated Protective
Order that was issued by the United States District Court for the Western District of North
Carolina, Charlotte Division on _________________ in In Re: Gardasil Product Liability
Litigation, MDL Docket No. 3036, 3:22-md-03036-RJC.
I agree to comply with and to be bound by all terms of this Stipulated Protective Order,
and I understand and acknowledge that failure to so comply could expose me to sanctions and
punishment in the nature of contempt. I solemnly promise that I will not disclose in any manner
any information or item that is subject to this Stipulated Protective Order to any person or entity
except in strict compliance with the provisions of this Order.
I further agree to submit to the jurisdiction of the United States District Court for the
Western District of North Carolina, Charlotte Division for the purpose of enforcing the terms of
this Stipulated Protective Order, even if such enforcement proceedings occur after termination of
this action.
Date: __________________________
City and State where sworn and signed: _______________________________
Printed name: _______________________________
Signature: ________________________________
Case 3:22-md-03036-KDB Document 70 Filed 02/14/23 Page 22 of 22

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