NICOPURE v FDA: PROTECTIVE ORDER, Jun 8, 2016

June 9, 2016 12:37 am by Gene Borio

The PDF is Here

EXCERPT:

This Order shall govern the disclosure, handling, and use of the following documents and other information in the administrative record for this case, which are hereinafter referred to as “Protected Information”:

. . .

All information that is derived from Protected Information, even if incorporated into another document or compilation or referred to in testimony, shall be treated as Protected Information

END EXCERPT

FULL TEXT:

JUN - 8 2016

Clerk, U.S. District & Bankruptcy Courts for the District of Columbia

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

Civil Action No. 16-878 (ABJ)

PROTECTIVE ORDER

Upon consideration of the parties’ joint motion for entry of a Protective Order, pursuant to 5 U.S.C. § 552a(b)(l l ) and Federal Rule of Civil Procedure 26(c), it is hereby ORDERED that:

This Order shall govern the disclosure, handling, and use of the following documents and other information in the administrative record for this case, which are hereinafter referred to as “Protected Information”:

On any document titled “PUBLIC SUBMISSION” and marked “Category:

Individual Consumer,” any personally identifying information in the “submitter information” field, includ ing but not limited to name, address, and e-mail address if that information is not disclosed elsewhere in the document; and

Any other document marked by the Food and Drug Administration (”FDA”) as “Confidential” on the document header.

All information that is derived from Protected Information, even if incorporated into another document or compilation or referred to in testimony, shall be treated as Protected Information; provided, however, that summaries or statistical compilations of Protected

I nformation that do not contain information by which specific ind ividuals can be identified are not · covered by this Order.

Defendants are authorized to release Protected I nformation covered by the Privacy Act, 5 U .S.C. § 552a, without obtaining the prior written consent of the i nd ividuals to whom such records or i nformation pertai n.

Before prod uction, a prod ucing party shall mark Protected Information with “PRODUCED SUBJECT TO PROTECTIV E ORDER,” “SUBJECT TO PROTECTIVE ORDER,” or a similar marking. For Protected Information whose med i um makes such marking i mpracticable, such as electronic fi les, a prod ucing party shal l mark any CD-ROM or d iskette case, and/or any accom panyi ng paper or emai l cover letter, with “PRODUCED SUBJECT TO PROTECTIVE ORDER,” “SUBJECT TO PROTECTIVE ORDER,” or a similar marking. Categories of docu ments may be marked general ly if the identification of ind ividual docu ments is i m practicable.

Protected I nformation may be used only for the purposes of l itigating this civil action and any appeals thereof. Except as prov ided in Paragraph 6, no person who obtains access to Protected Information pu rsuant to this Order shall disclose those documents or that i nformation without either the prior, express, wri tten consent of the prod ucing party or its counsel, or further order of the Court.

Cou nsel for the parties may disclose Protected Information only to (a) the Court and its staff, incl ud ing court reporters; (b) the attorneys of record for the parties; (c) associates and staff of the attorneys of record for the parties, but only to the extent necessary to perform their duties; (d) Defendants and their employees; (e) Plaintiff; (f) outside experts or consultants retained by any party, includ ing their associates and staff, but only to the extent necessary to provide their services; and (g) th ird-party contractors engaged i n copying, organizing, fil ing, coding, converting,

storing, or retrieving data or i nformation , i ncl ud i ng as part of a l itigation support system, but only to the extent necessary to render such serv ices.
Before Plai ntiff s cou nsel discloses Protected I nformation to any person l isted in Paragraph 6(e)-(g), that person m ust be provided with a copy of this Order, and must sign a copy of the Acknowledgment and Consent form attached hereto (Exhibit A). Plaintiff s counsel shall retai n copies of the signed Acknowledgment and Consent forms in their litigation files and shall make them avai lable to Defendants’ counsel upon request.
If Protected I nformation is disclosed to any person not l isted i n Paragraph 6, upon learn ing of such d i sclosure Pl aintiff s counsel must promptl y (a) inform Defendants of the d isclosu re, i ncludi ng the surrou nd ing facts and circumstances; and (b) req uest the return or destruction of the Protected Information and seek to mini mize any further unauthorized d isclosure.
Any person to whom Pl aintiff s counsel d iscloses Protected I nformation shall return to Plaintiff’s cou nsel (or destroy, and certify such destruction in writing to Plaintiff’s counsel) al l such materials and any copies thereof u pon termi nation of this civil action and any appeals thereof, or when they are no longer assigned or retained to work on this case, whichever comes first.
A fai lure to designate any materials as Protected I nformation shall not constitute a waiver of any party ’s assertion that the materials are covered by this Order. A produci ng party may notify a receiv ing party that Protected Information was inadvertently disclosed without first being marked as described in Paragraph 4. Upon receipt of such notice, the receivi ng party shall immed iately treat the materials as if they had been properly designated as Protected I nformation, and shal l promptly place an appropriate marki ng on the materials.
1 1 . Before filing a document containing Protected Information, a party shall move for leave to fi le the document u nder seal pursuant to LCvR 5(h). If leave i s granted, the party shall

file a pu bl ic version of the sealed document, with the Protected Information redacted, as soon as practicable. If leave is denied, the parties shall confer to discuss proced u res necessary to prevent the d isclosu re of the Protected I nformation. Prior to using any Protected Information in open cou rt, counsel for the parties shal l confer to di scuss proced u res necessary to prevent the disclosure of that i nformation, includ ing, without limitation, mov ing the Court to close the proceed ings.
Nothing in this Order shal l be construed to l imit the right of either party to i ntrod uce Protected Information into evidence, subject to the Federal Ru les of Civ i l Proced ure, Federal Rules of Evidence, applicable statutes or regulations, and any privacy protections the Court deems appropriate.
This Order shall continue to be bind i ng after the final termi nation of this l i tigation. With in 60 days after the termi nation of th is civil action and any appeals thereof, all Protected I nformation and any copies thereof -i ncl ud i ng documents created by Plai ntiff or its counsel, or anyone worki ng on their behalf -shal l be returned to Defendants or their counsel or destroyed, except for court filings retained by Plaintiff s counsel as part of their l itigation files, which shall remain subject to the terms of this Order. Within 60 days after the termi nation of this civi l action and any appeals thereof, Plai ntiff s cou nsel wil l certify to Defendants’ counsel that all such material has been retu rned or destroyed.
Th is Order d oes not constitute a ru l ing on the question whether any particu lar document is confidential and does not constitute a rul ing on any potential objection to the asserted confidential ity of any record, other than objections based on the Pri vacy Act.

Each party reserves the right to seek to modify the terms of this Order at any time, and each party reserves the right to oppose any motion to modify the terms of this Order.
SO ORDE:r
Dated : 0- L\ {a
United States District Judge

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

N ICOPURE LABS, LLC,

Plai ntiff,

V. Civil Action No. 16-878 (ABJ)

FOOD AND DRUG ADMINISTRATION,
et al.,

Defendants.

ACKNOWLEDGEMENT AND CONSENT

l hereby certify that:

I . I have read the Protecti ve Order (the “Order”) entered by the Court in this case and I u nderstand its terms.
I understand that Protected I nformation is bei ng prov i ded to me u nder the terms of the Order, and that those materials are to be used only for pu rposes of thi s l itigation and for no other purpose.
I agree to be fully bou nd by the prov isions of the Order, including i ts provisions l i miti ng the use of Protected I nformation and restricti ng its fu rther d isclosure.
I agree to return all Protected Information and any copies thereof to Plai ntiff’s counsel (or to destroy such materials, and to certify their destruction in writi ng to Plaintiff’s counsel) u pon termi nation of this civ i l action and any appeals thereof, or when I am no longer assigned or retai ned to work on this case, whichever comes first.
I u nderstand that my obligations under the Order shall survive the termination of this case and are bind ing u pon me for all time.

I hereby submit to the ju risd iction of the U nited States District Court for the District of Colum bia for purposes of enforcement of the Order.
I u nderstand that a v iolation of the Order is punishable by contempt of Court and may su bject me to sanctions and such other rel ief as the Cou rt may order.

Dated: ——— Signature: ————

Print Name : ———

2

Leave a Reply

The primary purpose of this site is to provide information in a timely manner. Postings should be informative. The usual rules apply: No libel, no profanity, no personal abuse, keep it on topic, and short.

If you are scheduled as a court witness, CHECK with your lawyer before posting anything here!