Ideus v. Teva Pharmaceuticals USA, Inc. et al
Filing
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PROPOSED PROTECTIVE ORDER. Ordered by Magistrate Judge Cheryl R. Zwart. (LAC)
UNITED STATES DISTRICT COURT
DISTRICT OF NEBRASKA
Stephanie Ideus
Civil File: 4:16-cv-03086-JMG-CRZ
Plaintiff,
vs.
Teva Pharmaceuticals USA, Inc., and Teva
Women’s Health, Inc.,
Defendants.
PROPOSED PROTECTIVE ORDER
This Order allows the parties to this action to designate certain documents produced
in discovery – for example, documents containing trade secrets or other proprietary and
confidential research, development, or commercial information, or documents containing
confidential personal information, including information deemed confidential by operation
of the Code of Federal Regulations, such as information identifying anyone who reports an
alleged adverse drug reaction or anyone who allegedly experienced an adverse drug
reaction – as confidential and subject to an enhanced level of protection from disclosure.
This Order strikes an appropriate balance between the parties’ interests in prosecuting
and defending this case, the judicial interest in the efficiency and integrity of the
discovery process, and the public interest in access to information. Therefore, due notice
having been given, and the Court being duly advised in the premises, the Court enters the
following Order:
1.
When used in this Order, the following words shall have the following
meanings:
“Documents” means (1) all written, recorded or graphic matter whatsoever and
information produced on computer disks or tapes, including all written
materials, and (2) any copies, reproductions or summaries of the
foregoing, including microfilmed, imaged or electronic copies.
“Discovery Materials” means (1) documents or other information produced by
any party or third person, whether pursuant to the applicable civil rules, by
subpoena or by agreement, other than documents that are publicly
available; (2) interrogatory or other discovery responses; and (3)
deposition testimony of any party or third person taken in this action,
exhibits thereto and/or any videos or transcripts thereof, whether in written
or computer format, and all contents of the foregoing.
“Producing Party” means any party or third person producing discovery materials,
whether pursuant to the applicable civil rules, by subpoena, or by
agreement.
“Receiving Party” means any party receiving discovery materials from a
producing party, whether pursuant to the applicable civil rules, by
subpoena, or by agreement.
“Disclose” (and any variant thereof) means to show, give, make available,
reproduce, or communicate any discovery materials, or any part or content
thereof.
“Confidential Discovery Materials” means any discovery materials that are
designated in good faith as “Confidential” by any party or third person.
Confidential Discovery Materials are those materials that constitute or
contain personal medical information or other personal information
pertaining to research subjects or patients, reporters of alleged adverse
drug events or persons or entities identified in such reports; trade secrets
or other confidential research, development, or commercial information
which may include proprietary information such as costs, pricing, budgets,
customer lists and data, distributor lists and agreements, personnel files,
and other private and personal information relating to employees; product
formulations, manufacturing procedures and standards, financial data,
identity of suppliers, identity of manufacturers, trade secrets, consumer
data, confidential research, business plans, strategies and data, marketing
plans and strategies, and any other confidential or proprietary information.
“Attorneys of Record” means attorneys of record for any of the parties to this
action, members of the firm of the attorneys of record for the parties, and
any in-house attorneys who are employed by the parties.
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2.
Any Confidential Discovery Materials produced by the producing party
and designated as such shall be used solely for the purposes of this litigation and shall not
be used for any other legal action, except by agreement of the parties or subject to a Court
Order.
3.
Disclosure of Confidential Discovery Materials other than in accordance
with the terms of this Order may subject the disclosing party to such sanctions and
remedies as the Court may deem appropriate.
4.
Subject to the terms, conditions, and restrictions of this Order,
Confidential Discovery Materials marked “Confidential” may be disclosed only to the
following persons and only to the extent such persons have a legitimate need to know the
particular Confidential Discovery Materials disclosed to them:
(a)
Persons employed by the Court and the jury empaneled in connection with
the handling of this action;
(b)
Attorneys of Record;
(c)
Employees of the Attorneys of Record working under the direct
supervision of such Attorneys of Record;
(d)
The parties, including current employees, officers, partners or directors;
(e)
Former employees, officers, partners or directors of the parties who are
potential witnesses or deponents;
(f)
Outside experts or consultants provided that prior to any disclosure the
Attorney of Record who retains the outside expert or consultant obtains
such expert’s or consultant’s agreement to the non-disclosure agreement
described in paragraph 6 below;
(g)
Certified shorthand reporters and videotape operators for the purposes of
recording the testimony of deposition witnesses and preparing a written or
videotaped record of testimony;
(h)
Independent copying services, independent computer consulting and
support services, independent translators, independent exhibit makers, and
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other independent litigation support services retained for purposes of this
litigation; and
(i)
Any other person who is designated by written stipulation of the parties to
have access to Confidential Discovery Materials, or by order of the Court
after notice to all parties upon a showing of good cause why such person
shall be so designated and opposing parties have had an opportunity to be
heard in opposition thereto.
5.
Before disclosing any Confidential Discovery Materials to any person
specified in paragraph 4(e) or 4(f), above, disclosing counsel shall advise said persons of
this Order and said person must agree in writing to the non-disclosure agreement attached
hereto as Exhibit A, which states that such persons agree (1) to be bound by the terms
hereof, (2) to maintain Confidential Discovery Materials in confidence, and (3) not to
disclose Confidential Discovery Materials to anyone other than in accordance with the
terms of this Order. All deposition witnesses to whom Confidential Discovery Materials
are disclosed at deposition must agree in writing to the non-disclosure agreement attached
hereto as Exhibit A, and are hereby ordered (1) to maintain Confidential Discovery
Materials in confidence and (2) not to disclose Confidential Discovery Materials to
anyone other than in accordance with the terms of this Order. Each party shall maintain a
file containing such certifications and, upon request, forward those certifications to the
producing party within ten (10) days of such request. In no event shall any disclosure of
Confidential Discovery Materials be made to competitors of Defendants, including any
person who, upon reasonable and good faith inquiry could be determined to be, an
employee of a competitor of Defendants, irrespective of whether such person is retained
as an expert or consultant by counsel for Plaintiff.
6.
Any party desiring to designate particular Discovery Materials as
Confidential Discovery Materials must place upon such materials in a conspicuous
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manner so as to not obliterate, cover, or interfere with the reading of such material a
marking which reads: “CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER.”
7.
In addition, to protect against unauthorized disclosure of confidential
personal information or invasion of the physician-patient privilege and/or individual
privacy interests or rights, the parties may redact from Confidential Discovery Materials
names, addresses, and other identifying information pertaining to: research subjects or
patients; reporters of alleged adverse events or persons or entities identified in such
reports (however, the remainder of such reports shall be disclosed provided they
otherwise are discoverable); and other individuals or entities whose names and other
identifying information are protected from disclosure by the regulations of the Food,
Drug & Cosmetics Act, including, but not limited to, 21 C.F.R. §20.63, 21 C.F.R.
§20.111, 21 C.F.R. §20.112, 21 C.F.R. §50.25, 21 C.F.R. §314.80, and 21 C.F.R. §803.9,
by the regulations of the Health Insurance Portability and Accountability Act of 1996
(HIPAA), or by any other relevant rules or regulations.
8.
Discovery Materials disclosed at a deposition may be designated by a
party as Confidential Discovery Materials by indicating on the record at the deposition
that the specific part of the testimony and/or any exhibits marked for identification is
confidential, and is subject to the provisions of the Order. In such situations, the
questions and answers designated as confidential may be transcribed separately from the
remainder of the deposition. Counsel for any party may exclude from the room during
any portion of a deposition any person not entitled under this Order to receive
Confidential Discovery Materials while such materials are being disclosed and/or
discussed. A party may also designate discovery materials disclosed at such depositions
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as confidential by notifying all parties in writing, within fifteen (15) days of receipt of the
transcript by the attorneys of record for the designating party, of the specific pages and
lines of the transcript which contain Confidential Discovery Materials. Each party shall
attach a copy of such written statement to the face of the transcript and each copy thereof
in his or her possession, custody or control. During such fifteen (15) day period, all
Discovery Materials shall be treated as Confidential Discovery Materials.
9.
By making any such Confidential Discovery Materials available during
the course of this litigation, the producing party does not waive any trade secret or other
confidential protection that might otherwise be afforded over those materials.
Furthermore, by designating any Discovery Materials “confidential,” the parties do not
acknowledge that any such Discovery Materials are relevant or discoverable in this
action. This Order shall not constitute a waiver of any right to seek discovery of, or
alternatively to resist discovery of, any material in this action.
10.
Inadvertent failure to designate Discovery Materials as confidential at the
time of production may be remedied by supplemental written notice. If such notice is
given, the identified materials shall thereafter be fully subject to this Order as if they had
initially been designated as Confidential Discovery Materials, provided that there shall be
no sanction for any use or disclosure of such material prior to designation. The
inadvertent disclosure by the producing party of Confidential Discovery Materials,
regardless of whether such materials were so designated at the time of disclosure, shall
not be deemed a waiver, in whole or in part, of a party’s claim of confidentiality, either as
to the specific discovery materials disclosed or as to any other Discovery Materials
relating thereto or on the same or related subject matter.
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11.
If a receiving party desires to disclose any part of any Confidential
Discovery Materials in any manner not in accordance with the terms of this Order, the
party seeking to make such disclosure shall obtain the written agreement of the producing
party to so proceed or, in the absence of such agreement, shall seek the approval of the
Court by way of a motion filed with the Court.
12.
This Order is without prejudice to any party’s right to assert the attorney-
client, work-product, or other privileges or doctrines, or to any party’s right to contest the
designation of Confidential Discovery Materials. A party shall not be obligated to
challenge the designation of any particular Discovery Materials as being confidential at
the time such designation is made and failure to do so shall not preclude a subsequent
challenge thereto. In the event that any party to this litigation disagrees at any point in
these proceedings with the designation by the producing party of Discovery Materials as
being confidential, the parties shall first try to dispose of such dispute in good faith on an
informal basis by conferring directly with counsel for the producing party. The
challenging party must explain the basis for its belief that the designation was not proper
and must give the producing 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 designation. If the dispute cannot be resolved, the objecting party may seek
appropriate relief from the court. Any objections to such a designation, when made, shall
be in writing and shall specify the nature of any objection. Any designated Confidential
Discovery Materials shall remain as such under the terms of this Order until the Court
makes a determination otherwise.
13.
Nothing in this Order restricts or affects the rights of the producing party
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to use or disclose any Confidential Discovery Materials produced by such party. Any
such use or disclosure of Confidential Discovery Materials by the producing party shall
not be deemed a waiver of the terms of this Order. Nothing in this Order, or any
proceeding undertaken pursuant hereto, shall be deemed to have the effect of a waiver by
any Party of, or otherwise deemed to alter the confidentiality or non-confidentiality of,
any information. Nor shall compliance with this Order operate as an admission as to the
admissibility of any information.
14.
All Discovery Materials provided by non-parties may be made, by
separate written agreement, specifically subject to the terms of this Order. Such
nonparties and/or the parties may designate Discovery Materials as confidential in
accordance with this Order. Any designation by such non-parties and/or the parties shall
have the same force and effect as if made pursuant to the terms of this Order. The
provisions of paragraph 12 relating to a challenge on the assertion of confidential status
shall apply to Discovery Materials designated confidential by nonparties.
15.
Without written permission from the designating party or a court order
secured after appropriate notice to all interested persons, a party may not file in the public
record in this action any Confidential Discovery Materials. In the event disclosure of
sealed materials is sought, no portion of the materials thus sealed shall be released except
upon notice to the producing party made by the party or non-party seeking disclosure,
proof of which shall be made to the Court, and after a full opportunity for hearing upon
the matter.
16.
Confidential Discovery Material shall not be filed with the Court except
when required in connection with matters pending before the Court.
If filed, any
Confidential Discovery Material shall be filed as “restricted access” in accordance
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with the Court’s rule and procedures.
17.
Confidential Discovery Material may be introduced by any party at the
time of trial or at any court hearing, provided it is submitted under seal initially by the
party seeking to use Confidential Discovery Material. At the time that such material is
introduced, the Court shall issue such Order as it deems appropriate for maintaining the
confidentiality of such material.
18.
If a receiving party learns that, by inadvertence or otherwise, it has
disclosed any Confidential Discovery Materials to any person or in any circumstance not
authorized under this Protective Order, the receiving party must immediately (a) notify
the producing party in writing of the unauthorized disclosures, (b) use its best efforts to
retrieve all copies of the Confidential Discovery Materials, (c) inform the person or
persons to whom the unauthorized disclosures were made of all the terms of this
Protective Order, and (d) request such person or persons to execute the non-disclosure
agreement attached hereto as Exhibit A.
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19.
If a receiving party is served with a subpoena or an order issued in other
litigation that would compel disclosure of any Confidential Discovery Materials, the
receiving party must so notify the producing party immediately, in writing, and no more
than three court days after receiving the subpoena or order. Such notification must
include a copy of the subpoena or court order. The receiving party must also
immediately, in writing, inform the party who caused the subpoena or order to issue in
the other litigation that some or all the material covered by the subpoena or order is the
subject of this Protective Order. In addition, the receiving party must deliver a copy of
this Protective Order promptly to the party in the other action who caused the subpoena
or order to issue. The purpose of imposing these duties is to alert the interested parties to
the existence of this Protective Order and to afford the producing party an opportunity to
try to protect its confidentiality interests in the court from which the subpoena or order
issued. The producing party shall bear the burdens and the expenses of seeking
protection of its confidential material in the other court – and nothing in these provisions
should be construed as authorizing or encouraging the receiving party to disobey a lawful
directive from another court. If the producing party timely seeks a protective order in the
other court, the receiving party served with the subpoena or court order shall not produce
any Confidential Discovery Materials before a determination by the court from which the
subpoena or order issued, unless the receiving party has obtained permission from the
producing party.
20.
The Parties shall confer in good faith prior to trial in an attempt to devise
protective procedures to be applicable at trial that are satisfactory to the Court.
21.
At the conclusion of this litigation, including any appeals from any
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judgment or order entered by the Court and any retrial, at the request of the producing
party, the receiving party shall forward all executed non-disclosure agreements to the
producing party within thirty (30) days, retrieve all Confidential Discovery Materials
from testifying experts, consulting experts, and any other person or entity to whom the
receiving party has disclosed Confidential Discovery Materials, and, at its option, within
thirty (30) days either: (1) destroy all received Confidential Discovery Materials by such
party and shall certify in writing that such destruction has occurred; or (2) return all
received Confidential Discovery Materials to the producing party and certify in writing
that all such discovery materials have been returned. If the producing party is not
notified of which option the discovering party has chosen, it will be presumed that option
(1) was chosen. Upon written request of the producing party, the discovering party shall
confirm that
one of the foregoing options has
been implemented. However,
notwithstanding any other provision of this paragraph, all Confidential Discovery
Materials shall remain subject to this Order.
22.
This Order shall be without prejudice to the right of the parties or any third
person to request additional protection under applicable laws for discovery requests
hereafter served by any party or to seek modification of this Order upon a showing of
good cause.
23.
The terms of this Order shall not be construed as any limitation upon the
right of any party to offer into evidence any documents, response, or information
designated as confidential.
24.
This Order shall be binding upon the parties hereto, counsel for the parties,
and upon the parties’ and their counsels’ successors, executors, personal representatives,
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administrators, heirs, legal representatives, assigns, subsidiaries, divisions, employees,
agents, independent contractors, and other persons or organizations over which they have
control. The parties, their counsel and employees of such counsel, and their expert
witnesses, consultants and representatives retained in connection with this action each
expressly stipulates to the personal jurisdiction of this Court for purposes of any
proceeding brought by a party to this action to enforce this Order.
25.
This Court retains jurisdiction over the parties, counsel for the parties, and
all persons, firms, corporations or organizations to whom this Order applies for purposes
of enforcement of this Order following the conclusion of this action.
Entered this 15th day of February, 2017.
s/Cheryl R. Zwart
United States Magistrate Judge
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EXHIBIT A
UNITED STATES DISTRICT COURT
DISTRICT OF NEBRASKA
Stephanie Ideus
Civil File: 4:16-cv-03086-JMG-CRZ
Plaintiff,
vs.
Teva Pharmaceuticals USA, Inc., and Teva
Women’s Health, Inc.,
Defendants.
I,
, hereby certify my understanding that
Confidential Discovery Materials are being provided to me pursuant to the terms and
restrictions of an Order entered by the United States District Court for the District of
Nebraska in connection with the action entitled Stephanie Ideus v. Teva Pharmaceuticals
USA, Inc., et al., Case No. 4:16-cv-03086.
I further certify that I have been provided a copy of and have read the Order. I
understand that the Order prohibits me from either using or disclosing Confidential
Discovery Materials for any purpose other than as set forth in and pursuant to the Order
entered by the Court. I hereby agree to subject myself to the jurisdiction of the Court for
purposes of enforcement of the terms and restrictions of the Order. I understand that
violation of the Order is punishable as contempt of court.
Date:
Signature
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