Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caed-1_16-cv-00393/USCOURTS-caed-1_16-cv-00393-7/pdf.json

Parties Involved:
L. L.
Plaintiff
Kristi Lauris
Plaintiff
Taylor Lauris
Plaintiff
Novartis AG
Defendant
Novartis Pharmaceuticals Corporation
Defendant

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Richard M. Elias (admitted pro hac vice)

relias@egslitigation.com

Greg. G. Gutzler (admitted pro hac vice)

ggutzler@egslitigation.com

Tamara M. Spicer (admitted pro hac vice)

tspicer@egslitigation.com

ELIAS GUTZLER SPICER LLC 

1924 Chouteau Ave, Suite W

St. Louis, MO 63103

314-833-6645

Attorneys for Plaintiffs

Erin M. Bosman (State Bar No. 204987)

(ebosman@mofo.com)

Julie Y. Park (State Bar No. 259929)

(juliepark@mofo.com)

MORRISON & FOERSTER LLP

12531 High Bluff Drive

San Diego, CA 92130

Telephone: (858) 720-5100

Facsimile: (858) 720-5125

Attorneys for Defendant

NOVARTIS AG

Katherine R. Latimer (admitted pro hac vice)

Klatimer@hollingsworthllp.com

Robert E. Johnston (admitted pro hac vice)

rjohnston@hollingsworthllp.com

HOLLINGSWORTH LLP

1350 I Street, NW

Washington, DC 20185

Telephone: (202) 898-5800

Facsimile: (202) 682-1639

James A. Bruen (State Bar No. 43880)

jbruen@fbm.com

Sandra A. Edwards (State Bar No. 154578)

sedwards@fbm.com

FARELLA BRAUN + MARTEL LLP

235 Montgomery Street, 17th Floor

San Francisco, CA 94104

Telephone: (415) 954-4400

Facsimile: (415) 954-4480

Attorneys for Defendant

NOVARTIS PHARMACEUTICALS 

CORPORATION

UNITED STATES DISTRICT COURT

EASTERN DISTRICT OF CALIFORNIA

Kristi Lauris, Individually and as Successor 

In Interest to the Estate of Dainis Lauris;

Kristi Lauris as Guardian ad Litem for 

L.L.; and Taylor Lauris, 

Plaintiffs,

vs.

Novartis AG, a Global Healthcare 

Company; Novartis Pharmaceuticals 

Corporation, a Delaware Corporation, 

Defendants.

Case No. 1:16-cv-00393 LJO-SAB

ORDER RE STIPULATED PROTECTIVE 

AND CONFIDENTIALITY ORDER

(E.D. Cal. Local Rule 141.1(b)(1))

Magistrate Judge: The Hon. Stanley A. Boone

Courtroom: 9

Case 1:16-cv-00393-SAB Document 59 Filed 10/11/16 Page 1 of 15
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Plaintiffs Kristi Lauris (on behalf of herself and as successor in interest to the estate of 

Dainis Lauris and as guardian ad litem for L.L.) and Taylor Lauris, and Defendants Novartis AG 

(“NAG”) and Novartis Pharmaceuticals Corporation (“NPC”) (collectively “Defendants”) submit 

an agreed Stipulated Protective and Confidentiality Order. The parties hereby stipulate to, and 

jointly request that the Court enter, the Stipulated Protective and Confidentiality Order.

THIS STIPULATED ORDER IS ENTERED INTO by the undersigned counsel for 

Plaintiffs and for Defendants Novartis Pharmaceuticals Corporation (NPC) and Novartis AG 

(NAG) to facilitate the prompt resolution of disputes over confidentiality, and to expedite the 

exchange of discovery materials among the parties to this Order, and the undersigned jointly 

propose that the Court enter this Stipulation as an Order (hereinafter, “Protective Order”). 

THEREFORE, the undersigned having so stipulated, this Court, having determined that 

good cause exists to enter a Protective Order to cover confidential information,

It is hereby ORDERED and ADJUDGED, that: 

(1) For purposes of this Protective Order, any Party may designate as “Confidential Material” 

any information the Party reasonably and in good faith believes constitutes and reveals 

confidential trade secrets, proprietary business information, or non-public, personal, 

client, or customer information concerning individuals or other entities (including, but not 

limited to Social Security numbers, home telephone numbers and addresses, and medical 

information) that is contained in any document, written discovery response, testimony, or 

other material produced or provided by that Party or its representative(s) to the other 

Party, whether provided voluntarily, pursuant to formal discovery procedures, or 

otherwise.

(2) For the purposes of this Protective Order, “Confidential Material” shall also include any 

Protected Data, as defined hereinafter. Certain Protected Data may be subject to 

alternative or additional protections beyond those afforded Confidential Information, in 

which event the parties shall meet and confer in good faith, and, if unsuccessful, shall 

move the Court for appropriate relief.

Case 1:16-cv-00393-SAB Document 59 Filed 10/11/16 Page 2 of 15
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(3) “Protected Data” shall refer to any information that a party reasonably believes in good 

faith to be subject to federal, state or foreign data protection laws or other privacy 

obligations. Protected Data constitutes highly sensitive materials requiring special 

protection. Examples of such data protection laws include but are not limited to The 

Gramm-Leach-Bliley Act, 15 U.S.C. § 6801 et seq. (financial information); The Health 

Insurance Portability and Accountability Act and the regulations thereunder, 45 CFR Part 

160 and Subparts A and E of Part 164 (medical information); Directive 95/46/EC of the 

European Parliament and of the Council of 24 October 1995 on the Protection of 

Individuals with Regard to the Processing of Personal Data and on the Free Movement of 

Such Data, 1995 O.J. (L281/31) (European Union personal information); the Federal Data 

Protection Act of 1992 (Swiss personal information); and Personal Information Protection 

and Electronic Documents Act (PIPEDA), S.C. 2000, c. 5 (Canada personal information).

(4) Any Party may designate a document as Confidential Material by stamping it 

“Confidential,” or “Subject to Protective Order.” All pages of any document that bears 

such a legend are subject to this Confidentiality and Protective Order. The Party shall 

affix the stamp in such a manner so as not to obscure the text of the document.

(5) To the extent that matter stored or recorded in the form of electronic or magnetic media 

(including information, files, databases or programs stored on any digital or analog 

machine-readable device, computers, Internet sites, discs, networks or tapes) 

(“Computerized Material”) is produced by any party in such form, the producing Party 

may designate such materials as Confidential by marking the container that the media is 

produced in “Confidential.” Whenever any party to whom Computerized Material 

designated as Confidential is produced reduces such material to hardcopy form, that party 

shall mark the hardcopy form with the “Confidential” designation.

(6) If responses to interrogatories, requests for admission, or other written responses to 

discovery quote, summarize, or contain Confidential Material, the Parties may designate 

them as Confidential Material by marking the face of any such response with one of the 

Case 1:16-cv-00393-SAB Document 59 Filed 10/11/16 Page 3 of 15
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legends set forth in paragraph (2) above and indicating the page and line references of the 

material that is to be subject to this Protective Order.

(7) A Party may designate the transcript of any deposition in this Action or any portion 

thereof, including exhibits thereto, as Confidential Material by either so advising the court 

reporter and the Parties on the record during the taking of the deposition or within thirty 

(30) days after receipt of the deposition transcript by written designation served upon the 

Parties. If all or any portion of a deposition is designated as being subject to this 

Protective Order, the court reporter and any Party possessing any transcripts shall label the 

cover page of each transcript or copy thereof to state that the deposition includes 

Confidential Material, and shall label as confidential each of the pages of the transcript or 

exhibits that contain Confidential Material. 

(8) Any inadvertent production of any confidential or proprietary material will not result in or 

be construed as a waiver, in whole or in part, of (a) the producing Party’s claims of 

confidentiality either as to the specific information inadvertently disclosed or more 

generally as to the subject matter of the information disclosed, or (b) the party’s right to 

designate the material as confidential pursuant to this Protective Order. In the event that a 

Party inadvertently produces any Confidential Material without attaching one of the 

legends described in paragraph (2) above, the Party may subsequently designate the 

material as Confidential at any time by forwarding to the opposing Party copies of the 

material bearing one of the legends required by paragraph (2) and requesting that the 

opposing Party destroy all prior copies of the Confidential Material. Upon receipt of such 

a request, the opposing Party shall destroy all copies of the Confidential Material 

produced inadvertently and replace them with copies bearing the appropriate 

confidentiality legend.

(9) Written and oral communications between or among counsel for the Parties that refer to or 

discuss Confidential Material automatically shall be subject to this Protective Order.

Case 1:16-cv-00393-SAB Document 59 Filed 10/11/16 Page 4 of 15
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(10) Confidential Material shall be treated by the Parties and their counsel as being confidential 

and private. Any copy made of Confidential Material shall have the same status as the 

original. The disclosure and use of Confidential Material shall be confined to the 

permissible disclosures and uses set forth below. Any Confidential Material produced by 

the Parties shall be used (if otherwise relevant and admissible) solely in this case, 

including any appeals. Confidential Material shall not be used in any other legal action or 

proceeding or for any other purpose without further order of this Court. All other 

disclosure and use of Confidential Material during the pendency of this Action or after its 

termination is hereby prohibited.

(11) Confidential Material may be disclosed only to the following persons and only insofar as 

it is reasonably necessary to the effective prosecution of the Parties’ claims and defenses:

(a) Parties, their representatives, in-house counsel and regular employees who are 

actively engaged in, or actively overseeing this case or involved in complying 

with NPC’s legal obligations to provide information to the Food and Drug 

Administration;

(b) Counsel of record for this case, including their associated attorneys, paralegal 

and secretarial personnel, and other support staff;

(c) Experts and consultants (including their employees) who are retained by a 

Party to assist in the litigation of this case;

(d) Third-party contractors and their employees who are retained by one or more 

Parties to provide litigation-support or copy services in this case;

(e) Witnesses or prospective witnesses in this case; 

(f) Court reporters and other persons involved in recording deposition testimony 

in this case; 

(g) Court personnel of the United States District Court for the Eastern District of 

California, or, if on appeal, of The United States Court of Appeals for the 

Ninth Circuit; 

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(h) Jurors in this case; and

(i) The Food and Drug Administration, to the extent NPC is required to disclose 

any Confidential Material by law.

Counsel for each Party disclosing Confidential Material in accordance with this paragraph 

shall (i) advise each person to whom such disclosure is made (except Court personnel, 

jurors, and the Food and Drug Administration) of the terms of this Protective Order and of 

the obligation of each such person to comply with those terms and (ii) provide a copy of 

this Protective Order to each such person. Prior to the disclosure of any Confidential 

Information to any person identified in subparagraphs c, d, e, and f above, such person 

shall sign an Acknowledgment, in the form attached hereto as Exhibit 1, acknowledging 

that he or she has read this Protective Order and shall abide by its terms. Counsel shall 

maintain a list of persons to whom confidential materials are disclosed (excluding jurors, 

Court personnel, and the Food and Drug Administration). Upon learning of any 

disclosure of Confidential Material to any person not authorized by this paragraph to 

receive Confidential Material, the Party who so learns shall immediately (i) inform in 

writing the Party from which the Confidential Material was originally received of such 

disclosure, including to whom the material was disclosed, and (ii) take all necessary steps 

to retrieve as soon as possible each and every copy of all Confidential Material from the 

unauthorized person and any person to whom the unauthorized person disclosed the 

Confidential Material.

(12) Documents bearing confidentiality designations shall not be used as exhibits at trial. The 

Parties shall redact confidentiality designations from any documents to be used as exhibits 

at trial and do so in a manner that ensures the redaction of the confidentiality designation 

is not visible. Alternatively, before trial, and upon request, the producing Party shall 

provide copies of such documents free of any confidentiality designation for use at trial. 

Such documents shall be used only for trial purposes and shall be destroyed or returned, 

Case 1:16-cv-00393-SAB Document 59 Filed 10/11/16 Page 6 of 15
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along with any and all copies made, to the producing Party after this case is finally 

determined as to the Party to whom the documents were produced. 

(13) Each Party agrees that in the event it is served by a non-party with a subpoena or request 

for production of Confidential Material originally received from another Party, it will give 

sufficient notice to allow that Party a reasonable opportunity to intervene to oppose such 

production. The notice shall include a description of the material sought, the date and 

location for compliance with the subpoena or request, the identity of the requester of the 

Confidential Material, the docket number of the matter where requested and all other 

information reasonably necessary to intervene and oppose such production.

(14) Personally identifiable information that a Party has designated as Protected Data based on 

its reasonable and good faith belief that the information is subject to federal, state or 

foreign data protection laws, data privacy laws, or other privacy obligations, or any of the 

information contained therein, shall be handled by the receiving Party with highest care, 

including but not limited to the procedures that they would employ to protect their own 

personally identifiable information; and the documents produced shall be stored and 

secured in a manner designed to prevent access to persons other than the above-listed 

permitted individuals, and that all such information stored in electronic form shall be 

password protected.

(15) Should any Party to whom Confidential Material is disclosed object to the designation of 

that material as proprietary, confidential, or otherwise protected, it shall make a good-faith 

effort to resolve the dispute informally with the disclosing Party. Except where good 

cause is shown, all objections to the designation of documents as Confidential Material 

must be interposed in writing no later than thirty (30) days after the close of merits 

discovery, or such objections shall be deemed waived. Should the Parties be unable to 

resolve the dispute, the Party opposing the inclusion of such material under this Protective 

Order, within a reasonable time, may apply in writing to the Court for a ruling that the 

information should not be entitled to protection under this Protective Order. The Party 

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designating the material as confidential shall have the burden of proving that said material 

is subject to protection. Until such time as the Court rules on the motion, the material that 

is the subject of the dispute shall continue to be subject to this Protective Order. 

(16) CLAWBACK OF PRIVILEGED MATERIAL

(16.1) To facilitate the expeditious production of voluminous documents, the parties 

agree that a producing Party may produce documents without detailed, or any, 

review to determine whether a privilege or other immunity from discovery applies 

to some of the documents. Any disclosure of a privileged document within a 

category of documents that was either not reviewed or was only reviewed by 

computerized means will constitute an inadvertent production for the following 

paragraphs.

(16.2) The inadvertent production by any Party in the course of discovery in these 

proceedings of a document subject to a claim of privilege, work product, or other 

applicable privilege or protection, will not result in a waiver of any of the 

foregoing protections, whether in these or any other proceedings, for the produced 

document or any other withheld document covering the same or similar subject 

matter, pursuant to Federal Rule of Evidence 502(d). 

(16.3) If a Party believes that it has inadvertently produced any such privileged or 

protected materials, it shall promptly notify in writing the receiving Parties of the 

claim of privilege. Upon such notice, the receiving Parties shall promptly: (1) use 

commercially reasonable efforts to locate and destroy all copies of the material in 

their possession, custody or control, including material stored in any litigationsupport or other database and all notes or other work product reflecting the content 

of the material, and notify the producing Party that they have done so; and (2) take 

all commercially reasonable steps to retrieve and destroy all copies of the 

inadvertently produced material or documents from other persons, if any, to whom 

such documents or materials were distributed. Receiving counsel shall certify in 

Case 1:16-cv-00393-SAB Document 59 Filed 10/11/16 Page 8 of 15
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writing to the producing party’s counsel that any notes or other work product 

reflecting the inadvertently disclosed document’s contents have been destroyed by 

counsel, the receiving party, and any experts or others in their employment. If, 

however, a receiving Party disputes the producing Party’s assertion of privilege, 

the receiving Party shall notify the producing Party in writing within 15 business 

days of receiving the producing Party’s notice. Within 30 business days of 

receiving such notice of dispute, the Parties shall meet and confer to resolve the 

dispute. If they are unable to resolve their dispute, the receiving Party may submit 

the issue to the Court. In any such submission, the disputed documents or material 

shall be filed, if at all, under seal.

(17) When a Party wishes to use a document that has been designated as confidential in support 

of a motion or other filing with the Court, it will attempt to consult with the Party that has 

made the confidentiality designation (a) to resolve a way to present the evidence without 

the necessity of filing it with the Court; or (b) if no such resolution can be reached, to 

arrange for appropriate protection under seal.

(18) This Protective Order shall not prevent the Parties from using or disclosing their own 

documents and other materials in any manner, notwithstanding their designation as 

Confidential Material subject to this Protective Order. The use or disclosure by a Party of 

its own documents or materials shall not terminate, waive or otherwise diminish in any 

way the status of such documents or materials as Confidential Materials subject to this 

Protective Order.

(19) Upon the final determination, including any appeals related thereto, all Confidential 

Material of an opposing Party should be returned or destroyed. Within thirty (30) days 

after the date of final determination, all attorneys in possession of Confidential Material 

shall return all Confidential Material to the disclosing Party or, alternatively, shall 

immediately destroy all such material. This provision does not apply to materials that 

Defendants are required to maintain and report pursuant to statutory and regulatory 

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obligations, such as adverse event information submitted to the FDA. All counsel of 

record shall, within forty-five days of this final determination, certify that all Confidential 

Material, including any such material disclosed to any other entity, has been returned or 

destroyed. The sole exception to the requirements described above is that information that 

has been incorporated into attorney work product or other privileged documents need not 

be returned or destroyed. Such information shall be retained by the person to whom the 

information was produced, and shall be treated as Confidential Material in accordance 

with this Order.

(20) This Protective Order shall not enlarge or affect the proper scope of discovery in this or 

any other litigation, nor shall this Protective Order imply that material designated (or not 

designated) as Confidential Material under the terms of this Protective Order is properly 

discoverable, relevant or admissible in this or any other litigation.

(21) Each Party shall retain all rights and remedies available to it under the law for the 

enforcement of this order against anyone who violates it.

(22) The restrictions of this Protective Order shall continue to apply after this action is finally 

determined and the Court shall retain jurisdiction for all purposes in connection therewith. 

All persons receiving or given access to Confidential Material in accordance with the 

terms of this Protective Order consent to the continuing jurisdiction of the Court for the 

purposes of enforcing this Protective Order and remedying any violations thereof.

Case 1:16-cv-00393-SAB Document 59 Filed 10/11/16 Page 10 of 15
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Dated: October 7, 2016 /s/ Sandra A. Edwards

James A. Bruen (State Bar No. 43880)

(jbruen@fbm.com)

Sandra A. Edwards (State Bar No. 154578)

(sedwards@fbm.com)

 FARELLA BRAUN + MARTEL LLP

 235 Montgomery Street, 17th Floor

 San Francisco, CA 94104

 Telephone: (415) 954-4400

 Facsimile: (415) 954-4480

/s/ Robert E. Johnston

Katharine R. Latimer (pro hac vice)

(klatimer@hollingsworthllp.com)

Robert E. Johnston (pro hac vice)

(rjohnston@hollingsworthllp.com)

 HOLLINGSWORTH LLP

 1350 I Street, NW

 Washington, D.C. 20005

 Telephone: (202) 898-5800

 Facsimile: (202) 682-1639

Attorneys for Defendant Novartis 

Pharmaceuticals Corporation

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Dated: October 7, 2016 /s/ Julie Y. Park

Erin M. Bosman (State Bar No. 204987)

(ebosman@mofo.com)

Julie Y. Park (State Bar No. 259929)

(juliepark@mofo.com)

 MORRISON & FOERSTER LLP

 12531 High Bluff Drive

 San Diego, CA 92130

 Telephone: (858) 720-5100

 Facsimile: (858) 720-5125

Attorneys for Defendant Novartis AG

Dated: October 7, 2016 /s/ Richard M. Elias

Richard M. Elias

Greg G. Gutzler

Tamara M. Spicer

 ELIAS GUTZLER SPICER LLC

 1924 Chouteau Ave., Suite W

 St. Louis, MO 63103

 (314) 833-6645

 (314) 621-7607 (fax)

 (all admitted pro hac vice)

OF COUNSEL:

James D. Weakley

Bar No. 082853

 WEAKLEY & ARENDT, LLP

 1630 East Shaw Avenue, Suite 176

 Fresno, CA 93710

 (559) 221-5256

 (559) 221-5262 (fax)

Attorneys for Plaintiffs

ORDER

Pursuant to the stipulation of the parties, IT IS HEREBY ORDERED that:

1. The protective order is entered;

2. The parties are advised that pursuant to the Local Rules of the United States

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District Court, Eastern District of California, any documents which are to be 

filed under seal will require a written request which complies with Local

Rule 141; and

3. The party making a request to file documents under seal shall be required to 

show good cause for documents attached to a nondispositive motion or 

compelling reasons for documents attached to a dispositive motion. Pintos v. 

Pacific Creditors Ass’n, 605 F.3d 665, 677-78 (9th Cir. 2009). 

IT IS SO ORDERED.

Dated: October 11, 2016 

UNITED STATES MAGISTRATE JUDGE

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EXHIBIT 1

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UNITED STATES DISTRICT COURT

EASTERN DISTRICT OF CALIFORNIA

Kristi Lauris, Individually and as Successor 

In Interest to the Estate of Dainis Lauris;

Kristi Lauris as Guardian ad Litem for 

L.L.; and Taylor Lauris, 

Plaintiffs,

vs.

Novartis AG, a Global Healthcare 

Company; Novartis Pharmaceuticals 

Corporation, a Delaware Corporation, 

Defendants.

Case No. 1:16-cv-00393 LJO-SAB

ACKNOWLEDGMENT AND AGREEMENT 

TO BE BOUND BY PROTECTIVE

AND CONFIDENTIALITY ORDER

The undersigned agrees and declares under penalty of perjury the following:

I hereby attest that information or documents designated confidential are provided to me 

subject to the Stipulated Protective and Confidentiality Order (the “Order”) that was issued by the 

United States District Court for the Eastern District of California on _________________, 2016, 

in the above-captioned case. I have read this Order in its entirety and agree to comply with and to 

be bound by all the terms of this Order. I understand that my execution of this Acknowledgment, 

indicating my agreement to be bound by this Order, is a prerequisite to my review of any 

information or documents designated as confidential pursuant to the Order. I also 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 Order 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 

Eastern District of California for the purpose of enforcing the terms of this Order, even if such 

enforcement proceedings occur after termination of these proceedings.

Date: ___________________________________________________________

City and State where sworn and signed: ________________________________

Printed Name: ____________________________________________________

Signature: ________________________________________________________

Case 1:16-cv-00393-SAB Document 59 Filed 10/11/16 Page 15 of 15