United States of America et al v. Bostwick Laboratories

Filing 94

PROTECTIVE ORDER. Signed by Magistrate Judge Karen L. Litkovitz on 7/11/2013. (art)

UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF OHIO
WESTERN DIVISION
United States of America
ex rei. Michael Daugherty,

Civil Action No. 1:08 CV 354
District JudgeS. Arthur Spiegel

Plaintiff-Relator,
Magistrate Judge Karen L. Litkovitz

v.
Bostwick Laboratories
and
David Bostwick
Defendants.
PROTECTIVE ORDER
It is ordered that the following terms and provisions will govern the production

and use of certain documents, information, and evidence ("Produced Material") to be
produced by the Parties (Defendant Bostwick Laboratories, Defendant David Bostwick,
and Relator are referred to herein collectively as the "Parties") or any third party in
connection with the above-captioned action (each, a "Producing Person"):
1.

"Confidential Information" is that Produced Material which the Parties

reasonably believe in good faith constitutes either (a) personal health or personal
financial information of individuals, or personal information contained in an employee's
personnel file; and/or (b) trade secrets or other confidential research, development or
commercial information subject to confidential treatment under Rule 26(c)(l)(G), Fed. R.
Civ. P.
Pursuant to the HIPAA Privacy Rule, a covered entity such as Bostwick
Laboratories is permitted to disclose protected health information in the course of a

judicial proceeding if certain "satisfactory assurances" are received. This Protective
Order hereby provides Bostwick Laboratories or any other covered entity compelled to
produce documents in this litigation with the requisite satisfactory assurances under
HIPAA. See 45 C.F.R. § 164.512(e)(l)(iv). In accordance with the HIPAA Privacy Rule,
this Protective Order allows for the disclosure and receipt of a patient's protected health
information, in the possession of a covered entity, for the limited purpose of this
litigation, including at depositions, hearings, or other judicial proceedings in this
litigation. In accordance with the HIPAA Privacy Rule, this Protective Order specifically
prohibits the Parties from using or disclosing the protected health information for any
purpose other than this litigation for which such information was requested. 45 C.F.R.
§164.512(e)(l)(v)(A). Also in accordance with the HIPAA Privacy Rule, the protected
health information disclosed to any persons listed in Paragraphs 5 and 6 of this Protective
Order, including all copies made, shall be destroyed at the conclusion of this litigation. 45
C.F.R. § 164.512(e)(l )(v)(B).
This Protective Order also permits and authorizes the Parties to disclose
individually identifying health, personal and financial information of nonparty patients
during discovery in this case. The Court further finds that it is not possible to identify
and contact all nonparty patients whose names or other personal, identifying information
may be produced and that removal or deletion of all such information is not practical or
feasible. Therefore, the Court hereby authorizes and ORDERS, to the extent a court order
is necessary under state law, that the Parties are permitted to disclose individually
identifying health, personal, and financial information, records and data regarding

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nonparty patients during discovery in this case, including information otherwise
privileged or confidential under state law.
2.

"Confidential- Attorneys' Eyes Only Information" is that Produced

Material which is so designated by the Producing Person, which designation may be used
only for the following types of Confidential Information that is dated after July 1, 2011:
(1) Sensitive confidential business or financial information and records,

reflecting pricing agreements or pricing proposals dated after July 1, 2011, which were
offered to actual or potential customers or obtained from suppliers, distributors, or private
payors; and
(2) Competitive business information, including non-public financial or
marketing analyses or comparisons of competitors' products or services and strategic
planning.
3.

All documents containing Confidential Information or Confidential-

Attorneys' Eyes Only Information shall be clearly labeled as either "Confidential
Information" or "Confidential- Attorneys' Eyes Only Information" by the Producing
Person. To the extent that only portions of a document contain Confidential- Attorneys'
Eyes Only Information, the Producing Person shall clearly identify the portions that do
not contain information subject to the Attorneys' Eyes Only designation. Electronic
information may be designated by labeling the disk or other media containing the
designated information as "Confidential Information" or "Confidential - Attorneys' Eyes
Only Information."
Interrogatory answers or other responses to written discovery and information
contained therein may be designated by means of a statement at the conclusion of each

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answer specifying the "Confidential Information" or "Confidential- Attorneys' Eyes
Only Information" contained therein or by other means that clearly indicate what portion
of the answer or information is to be designated and by labeling the front of any set of
interrogatory answers or other responses to written discovery indicating that it contains
either "Confidential Information" or "Confidential- Attorneys' Eyes Only Information."
4.

Testimony at a deposition or hearing concerning Confidential Information

or Confidential- Attorneys' Eyes Only Information may be designated as subject to this
Protective Order by an appropriate statement at the time of the giving of such testimony
or in writing within thirty (30) days after receipt of each volume of such transcript. Until
such time period expires, the portion of any such transcript shall be treated as
Confidential Information or Confidential- Attorneys' Eyes Only Information unless
otherwise specified in writing or on the record at the hearing or deposition. All copies of
portions of transcripts that contain material designated as Confidential Information or
Confidential- Attorneys' Eyes Only Information shall be marked prominently "Subject
to Protective Order" on the cover thereof. No testimony shall be deemed subject to this
Protective Order unless specifically designated as such. Either Party's designation of
testimony as Confidential Information or Confidential- Attorneys' Eyes Only
Information shall be limited to only that part of the testimony that it in good faith and
reasonably believes is protected by federal or state law or is otherwise confidential and/or
proprietary. To the extent deposition testimony is designated as subject to this Protective
Order, attendance during that portion of the deposition shall be limited to those
individuals authorized to access such information under Paragraph 5 or Paragraph 6, as
applicable.

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5.

Confidential Information may not be disclosed by any person to anyone

other than:
a.

The Court;

b.

The Parties, including their current or former officers, directors,
agents, employees, and consultants;

c.

Counsel of record and associated counsel and employees or agents
of counsel of record or associated counsel;

d.

Court reporters, stenographers, or video operators at depositions,
court, or arbitral proceedings at which Confidential Information is
disclosed;

e.

Discovery consultants, processors and vendors, and outside
document copying services;

f.

Document coding or computerization services, demonstrative
exhibit vendors and jury consultants;

g.

Associated personnel of any person within the above subcategories
(a) through (f) for whom access to Confidential Information is
necessary to assist such persons in the action, including any Court
personnel assisting the Court, litigation assistants, paralegals,
secretarial or other clerical personnel, stenographers or other
persons involved in taking or transcribing testimony in this action,
and principals and employees ofthe firm with which consultants or
experts are associated;

h.

Deponents and other persons who may provide testimony in this
matter and their counsel, if any;

1.

Any person who authored, received, or who otherwise has already
been provided access to the Confidential Information in the
ordinary course of business;

j.

Independent experts and consultants retained by counsel of record
to assist them in connection with this action; and

k.

Such other persons as the Parties may mutually agree upon in
writing.

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6.

Confidential- Attorneys' Eyes Only Information may not be disclosed by

any person to anyone other than:
a.

The Court;

b.

Counsel and Bostwick Laboratories' in-house counsel directly
managing the litigation;

c.

Counsel of record and associated counsel and employees or agents
of counsel of record or associated counsel;

d.

Court reporters, stenographers, or video operators at depositions,
court, or arbitral proceedings at which Confidential - Attorneys
Eyes Only Information is disclosed;

e.

Discovery consultants, processors and vendors, and outside
document copying services;

f.

Document coding or computerization services, demonstrative
exhibit vendors and jury consultants;

g.

Associated personnel of any person within the above subcategories
(a) through (f) for whom access to Confidential- Attorneys' Eyes
Only Information is necessary to assist such persons in the action,
including any Court personnel assisting the Court, litigation
assistants, paralegals, secretarial or other clerical personnel,
stenographers or other persons involved in taking or transcribing
testimony in this action, and principals and employees ofthe firm
with which consultants or experts are associated;

h.

Deponents who have created or received, in the scope of their
employment, the Confidential- Attorneys' Eyes Only Information
that may provide testimony in this matter and their counsel, if any;

1.

Any person known to have created or received, in the scope of
their employment, the Confidential- Attorneys' Eyes Only
Information outside of the discovery process in the Matter; and

j.

Independent experts and consultants retained by counsel of record
to assist them in connection with this action; and

k.

Such other persons as the Parties may mutually agree upon in
writing.

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7.

Any Party who wishes to use Confidential Information or Confidential-

Attorneys' Eyes Only Information in any affidavit, brief, memorandum or other paper to
be filed with the Court in this litigation must first move for leave to file such material
under seal. Any sealed information shall be filed with the Clerk of Court in an envelope
marked "DOCUMENTS UNDER SEAL PURSUANT TO ORDER OF COURT DATED
_ _ _ _ _ 2013" pursuant to Local Rule 79.3. The filing of documents under seal
shall be without prejudice to the Parties' rights under Section 12 of this Protective Order.
8.

Prior to disclosing Confidential Information or Confidential- Attorneys'

Eyes Only Information to those individuals authorized in Paragraphs 5(e)-G) and 6(e)-G)
above, the Parties shall obtain a signed agreement in the form ofExhibit A hereto from
the party to whom the Confidential Information or Confidential - Attorneys' Eyes Only
Information is to be disclosed. Such agreement shall be retained by counsel throughout
the course ofthe action, including any appeals.
9.

Confidential Information and Confidential- Attorneys' Eyes Only

Information may be used by the Parties solely for the prosecution or defense of the claims
in this action and shall not be used for any other purpose, including without limitation
any business, commercial, competitive, or personal purpose, and shall not be disclosed
except as provided in this Protective Order.
10.

Confidential Information and Confidential- Attorneys' Eyes Only

Information shall be stored under the direct control of counsel, who shall use its best
efforts to prevent any disclosure thereof except in accordance with the terms of this
Protective Order. At the conclusion of this case, all Confidential Information and
Confidential- Attorneys' Eyes Only Information, and all copies thereof shall be

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destroyed or returned to the Producing Person.
11.

Restrictions and obligations set forth herein relating to Confidential

Information and Confidential- Attorneys' Eyes Only Information shall not apply to any
Produced Material which: (a) is already public knowledge or becomes public knowledge
through disclosure in open court; or (b) the Producing Person agrees, or the Court rules,
has become public knowledge other than as a result of disclosure by the party receiving
the Confidential Information and Confidential- Attorneys' Eyes Only Information.
12.

In the event that any Party believes that any Confidential Information and

Confidential- Attorneys' Eyes Only Information does not contain protected health
information, or is not confidential or proprietary and, therefore, should not be subject to
this Protective Order, the Party shall state the grounds for the objection in writing and
serve it on the Producing Person. The objecting Party shall thereafter try to resolve such
disputes in good faith on an informal basis with the Producing Person. In the event the
dispute cannot be resolved informally within fourteen (14) days after the Producing
Person's receipt of the notice, the Producing Person may file an appropriate application
with the Court requesting that the designated Produced Material be treated as subject to
the Protective Order. The Party making the designation shall have the burden of proving
that the material should be treated as designated. During the pendency of any motion to
reclassify Produced Materials that have been designated as "Subject to Protective Order,"
the Parties shall adhere to the previously designated classification. However, if no motion
is filed within fourteen (14) days of the receipt of the notice of objection, the designated
Produced Material shall no longer be treated as "Subject to Protective Order." All costs
of such a challenge, including but not limited to attorneys' fees, shall be borne by the

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Party that incurred said cost, unless the Court otherwise orders.
13.

This Protective Order is without prejudice to the right of any Party or

nonparty to argue that certain information designated as Confidential Information or
Confidential- Attorneys' Eyes Only Information: (a) should not be subject to this
Protective Order; (b) is not relevant to any issue in this case; or (c) otherwise should not
be admitted as evidence in the case. By entering into this stipulation, neither Party
concedes that any information produced in this litigation does in fact contain protected
health information, confidential information or proprietary information.
14.

The inadvertent disclosure ofunmarked Produced Material that the

Producing Person believes should have been designated as Confidential Information or
Confidential- Attorneys' Eyes Only Information shall not be deemed to be a waiver or
impairment of the Party's or Producing Person's right to make designations under this
Protective Order going forward, either as to the specific material in question or as to any
other materials relating thereto or to the same or related subject matter. On the other
hand, no person shall be subject to any penalty or sanction for any otherwise appropriate
use of any material before they have been designated pursuant to this Protective Order.
This provision shall be governed by, and this Protective Order is entered pursuant to,
Federal Rule of Evidence 502. To the extent that the terms of this provision conflict with
Rule 502, that Rule shall control as to any inadvertent disclosure of privileged
information.
15.

A Producing Person must take reasonable steps to prevent inadvertent

disclosure of material subject to claims of protection under the attorney-client privilege,
work product doctrine, and/or other doctrines or privileges of nondisclosure ("Privileged

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Material"). Even with reasonable preventative measures, production of documents may
result in inadvertent disclosure of Privileged Material. If a Producing Person learns of an
inadvertent disclosure, the Producing Person may notify in writing the Receiving Party
that the production was inadvertent and demand the return of the Privileged Material. On
such demand, the Receiving Party must promptly return, sequester or destroy all copies
of the identified Privileged Material to the Producing Person and may not further disclose
or use the information contained in the Privileged Material for any purpose, other than in
connection with the service or filing of a motion seeking a ruling of the Court as to
whether the Privileged Material is protected by privilege and should be returned to the
Producing Person. Ifthe Receiving Party seeks to challenge the claimed privileged status
of any Privileged Material, it shall use reasonable efforts in presenting such a motion to
preserve the confidentiality of the Privileged Material, including filing the Privileged
Material in a sealed envelope and seeking review in camera. Ifthe Court determines that
the Privileged Material is privileged and that the disclosure of the Privileged Material
was inadvertent, as set forth in Federal Rule ofEvidence 502(b), the Receiving Party may
not utilize the Privileged Material in the litigation or disclose it to any third-party. As set
forth in Federal Rules of Evidence 502(d) and (e), this Protective Order constitutes the
entry of an Order by this Court that the inadvertent disclosure of Privileged Material by
any Party in connection with this matter, will not constitute in any respect a waiver in any
other federal or state proceeding, regardless ofwhether a finding of waiver is sought by a
Party or non-party in that proceeding.
16.

This Protective Order may be amended only by Order of the Court.

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17.

Notwithstanding any ofthe non-disclosure obligations set forth in the

Protective Order, such obligations shall not extend to any Material required to be
produced by an appropriate subpoena, court order, a regulatory agency, or otherwise by
law. To the extent that the information subpoenaed includes protected health information,
the Parties understand that disclosure of protected health information must comply with
the HIPAA Privacy Rule and state law. Should a Party or its counsel be served with a
subpoena or other notice seeking disclosure or production of Confidential Information or
Confidential- Attorneys' Eyes Only Information, including protected health information,
that Party shall give notice to counsel for the other Party promptly and in writing,
sufficiently in advance of the requested production date to allow the counsel for the Party
or such other interested person or entity an opportunity to object to the requested
production.
18.

Nothing herein shall affect the right of a Producing Person to use or in any

way to disclose to its officers, directors, employees, attorneys, consultants or experts, or
to any other person, its own information. Such disclosure shall not waive the protections
of this Protective Order and shall not entitle other parties or their attorneys to disclose
such information in violation of it, unless by such disclosure of the Producing Person the
information becomes public knowledge.
18.

Any allegations regarding violation of this Protective Order shall be

submitted to the Court for adjudication.

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SUBJECT TO FURTHER ORDER OF THE COURT

?ka...r.Spiegel
L~
S. Arthur

Date:

United States)(~ct. Judge

Is/_ _ _ _ _ _ _ _ _ _ __

Is/_ _ _ _ _ _ _ _ _ __

Jennifer M. Verkamp (0067198)
Frederick M. Morgan, Jr. (0027687)
James F. Keller (0059295)
Morgan Verkamp LLC
700 Walnut Street, Suite 400
Cincinnati, OH 45202
Telephone [phone]
Facsimile: [phone]
[e-mail]
[e-mail]
[e-mail]

W. Jeffrey Sefton (0075671)
Keating Muething & Klekamp PLL
One East Fourth St.
Suite 1400
Cincinnati, Ohio 45202
Telephone [phone]
Facsimile [phone]
j sefton@kmklaw .com
Trial Attorney for Defendant Bostwick
Laboratories
Of Counsel:
MichaelS. Gardener
Matthew D. Levitt
Stefanie Giuliano Abhar
Mintz Levin Cohn Ferris Glovsky
and Popeo, P.C.
One Financial Center
Boston, MA 02111
Telephone: [phone]
Facsimile: [phone]
[e-mail]
[e-mail]
[e-mail]

Attorneys for Relator

HopeS. Foster
Mintz Levin Cohn Ferris Glovsky
and Popeo, P.C.
701 Pennsylvania Avenue N.W., Suite 900
Washington, DC 20004
Telephone: [phone]
Facsimile: [phone]
[e-mail]
Attorneys for Defendant Bostwick
Laboratories
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Is/_ _ _ _ _ _ _ _ _ _ __
Christopher L. Muzzo, Esq.
THE FURNIER LAW GROUP LLC
6725 Miami Avenue, Suite 100
Cincinnati, Ohio 45243
Telephone: [phone]
Facsimile: [phone]
[e-mail]

Of Counsel:
Stephen A. Miller, Esq.
Calli J. Varner, Esq.
COZEN O'CONNOR
1900 Market Street
Philadelphia, PA 19103
Telephone: [phone]
Facsimile: [phone]
[e-mail]
[e-mail]
Attorneys for Defendant David Bostwick

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EXHIBIT A
AGREEMENT REGARDING PROTECTIVE ORDER

- - - - - - - - - - - - - - - - - - - - - - - ' r e s i d i n g at

states that he or she is employed by _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
and has read the Protective Order entered into by the parties to the action entitled
UNITED STATES OF AMERICA ex rei. MICHAEL DAUGHERTY v. BOSTWICK
LABORATORIES AND DAVID BOSTWICK, Civil Action No. 1:08-cv-354, and
agrees that he or she will not disclose any Confidential Information or Confidential Attorneys' Eyes Only Information (as defined in said Protective Order) except in
accordance with the terms of said Order, or the terms of any Order modifying it of which
he or she has notice. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ also states that he or she
agrees to submit to the personal jurisdiction of the Southern District of Ohio, with respect
to any proceeding relating to enforcement of said Protective Order.
Dated: _ _ _ _ __
_ _ _ _ _ _ _ _ _ _ [Signature]

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